{"pages":[{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-001","page":1,"lines":[{"cnt":[[1334,196],[1770,196],[1770,345],[1334,345]],"region":{"top_left_x":1334,"top_left_y":196,"width":437,"height":149},"line":1,"column":0,"font_size":59,"is_printed":true,"is_handwritten":false,"id":"b95b1bc54c1044219131b5e38d50a65f","type":"page_info","conversion_output":false,"children_ids":["90137b59919c449eb2fc6662ede28848","7dea268bf9d54d44bbf2ba178f537481"],"text":"","text_display":""},{"cnt":[[1476,206],[1766,206],[1766,276],[1476,276]],"region":{"top_left_x":1475,"top_left_y":205,"width":291,"height":72},"line":2,"column":0,"font_size":59,"is_printed":true,"is_handwritten":false,"id":"90137b59919c449eb2fc6662ede28848","type":"text","conversion_output":false,"parent_id":"b95b1bc54c1044219131b5e38d50a65f","text":"Boehringer","text_display":"\nBoehringer","confidence":0.99951171875,"confidence_rate":0.9999674404968648},{"cnt":[[1476,270],[1734,270],[1734,340],[1476,340]],"region":{"top_left_x":1475,"top_left_y":269,"width":259,"height":72},"line":3,"column":0,"font_size":59,"is_printed":true,"is_handwritten":false,"id":"7dea268bf9d54d44bbf2ba178f537481","type":"text","conversion_output":false,"parent_id":"b95b1bc54c1044219131b5e38d50a65f","text":"Ingelheim","text_display":"\nIngelheim","confidence":1,"confidence_rate":1},{"cnt":[[242,416],[1821,416],[1821,2568],[242,2568]],"region":{"top_left_x":242,"top_left_y":415,"width":1579,"height":2153},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d1722b9ed954ea1bea1cc11cc4c4855","type":"table","conversion_output":true,"children_ids":["6e00a05927a14b1f8bcf6ca656708e44","299c4052d1124d71ae017275829a78a3","1c8b4a775c9940a191777104337984f9","8e8d59da2ed5481090ac16c124e43848","ebe78722c8034b08b72cb29a8826afa7","ef65a9991af14ebaa03df7a7116bea54","c0bb12a62d0a4b318f61e22ea261c686","cf09255e1a5847b09de0b9c3c5c7bdcb","68cbea65c3744e48a52088568b30730c","0b20596eff994fbca59559a593d72f5a","2558c643b2a6456e8d55012e9b670373","de2c8850a9334f71a42ce9e65704c37c","6f0fd50e526248238d0e0a81b3de0d0d","49a4b47049cc4b3ab3973c69f200faa7","ba5e09523a6a4d3282684d94bfa7ec56","7306f5ab47f648cbad0f7fd952870a4d","801a14922fa1414aad928e1ca5ffa886","7eadd68ca3d049d8863e6cc64526b7b0","79f392e6e5014b58970920b547e03acc","3f7638d4ace849a496c4d353ed6158d6","dd0fcff3de9a42bc97fd4de29db47dfa","fec7fe29aa9f4d27aae67496e9fad6ae","b0e4603e15d749888340a0f8eb03d180","6cc8d43252c6497d9e20aa75f6b8ae26","1bfae659579541e1a770f8f4909da661","c1dd472b65c641cb98fce67c8d0ea1c6","74508828a393428d84314b9efa815674","b149a58bc18e4cc7aab8fd15520ccdf3","a46315aece6e4803be6284588f8bf215","5bbdc2a89f114c7284174d0a66418b4b","d419857333f940a1be83bd3477a97fa3","67b6d730be2d4a62b5accba1a12515ff"],"text":"\\begin{tabular}{|l|l|}\n\\hline Clinical Trial Protocol & Doc. No.: c02155180-06 \\\\\n\\hline EudraCT No.: & 2011-004148-23 \\\\\n\\hline BI Investigational Product(s): & Linagliptin (BI 1356) \\\\\n\\hline Title: & A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA \\\\\n\\hline Clinical Phase: & IV \\\\\n\\hline Trial Clinical Monitor: & \\\\\n\\hline & Phone Fax \\\\\n\\hline \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nCo-ordinating Investigators: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}} \\\\\n\\hline \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nStatus: \\\\\nFinal Protocol (Revised Protocol (based on global amendment 2))\n\\end{tabular}} \\\\\n\\hline Version and Date: & Version: 3.0 \\\\\n\\hline & Page 1 of 123 \\\\\n\\hline \\multicolumn{2}{|r|}{\\begin{tabular}{l}\nProprietary confidential information. \\\\\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\\begin{tabular}{|l|l|}\n\\hline Clinical Trial Protocol & Doc. No.: c02155180-06 \\\\\n\\hline EudraCT No.: & 2011-004148-23 \\\\\n\\hline BI Investigational Product(s): & Linagliptin (BI 1356) \\\\\n\\hline Title: & A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA \\\\\n\\hline Clinical Phase: & IV \\\\\n\\hline Trial Clinical Monitor: & \\\\\n\\hline & Phone Fax \\\\\n\\hline \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nCo-ordinating Investigators: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}} \\\\\n\\hline \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nStatus: \\\\\nFinal Protocol (Revised Protocol (based on global amendment 2))\n\\end{tabular}} \\\\\n\\hline Version and Date: & Version: 3.0 \\\\\n\\hline & Page 1 of 123 \\\\\n\\hline \\multicolumn{2}{|r|}{\\begin{tabular}{l}\nProprietary confidential information. \\\\\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","confidence":0.99169921875,"confidence_rate":0.9999673125947193},{"cnt":[[263,415],[606,415],[606,2568],[263,2568]],"region":{"top_left_x":262,"top_left_y":415,"width":344,"height":2153},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e00a05927a14b1f8bcf6ca656708e44","type":"table_column","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[656,2568],[660,413],[1804,415],[1801,2570]],"region":{"top_left_x":656,"top_left_y":413,"width":1149,"height":2157},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"299c4052d1124d71ae017275829a78a3","type":"table_column","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,420],[1822,420],[1822,532],[242,532]],"region":{"top_left_x":242,"top_left_y":419,"width":1580,"height":114},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c8b4a775c9940a191777104337984f9","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,551],[1822,551],[1822,602],[242,602]],"region":{"top_left_x":242,"top_left_y":550,"width":1580,"height":52},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e8d59da2ed5481090ac16c124e43848","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,677],[1822,677],[1822,843],[242,843]],"region":{"top_left_x":242,"top_left_y":677,"width":1580,"height":167},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ebe78722c8034b08b72cb29a8826afa7","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,864],[1822,864],[1822,1053],[242,1053]],"region":{"top_left_x":242,"top_left_y":863,"width":1580,"height":190},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef65a9991af14ebaa03df7a7116bea54","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,1055],[1822,1055],[1822,1103],[242,1103]],"region":{"top_left_x":242,"top_left_y":1055,"width":1580,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0bb12a62d0a4b318f61e22ea261c686","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,1087],[1824,1087],[1824,1196],[242,1196]],"region":{"top_left_x":242,"top_left_y":1087,"width":1582,"height":109},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf09255e1a5847b09de0b9c3c5c7bdcb","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,1269],[1824,1269],[1824,1375],[242,1375]],"region":{"top_left_x":242,"top_left_y":1269,"width":1582,"height":107},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68cbea65c3744e48a52088568b30730c","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[241,1384],[1822,1382],[1823,2120],[242,2122]],"region":{"top_left_x":240,"top_left_y":1382,"width":1583,"height":741},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b20596eff994fbca59559a593d72f5a","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,2133],[1822,2133],[1822,2190],[242,2190]],"region":{"top_left_x":242,"top_left_y":2132,"width":1580,"height":59},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2558c643b2a6456e8d55012e9b670373","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,2216],[1822,2216],[1822,2271],[242,2271]],"region":{"top_left_x":242,"top_left_y":2215,"width":1580,"height":56},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de2c8850a9334f71a42ce9e65704c37c","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,2315],[1822,2315],[1822,2370],[242,2370]],"region":{"top_left_x":242,"top_left_y":2314,"width":1580,"height":56},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f0fd50e526248238d0e0a81b3de0d0d","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[242,2400],[1822,2400],[1822,2536],[242,2536]],"region":{"top_left_x":242,"top_left_y":2399,"width":1580,"height":137},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49a4b47049cc4b3ab3973c69f200faa7","type":"table_row","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"","text_display":""},{"cnt":[[265,422],[806,422],[806,477],[265,477]],"region":{"top_left_x":265,"top_left_y":421,"width":542,"height":57},"line":19,"column":0,"font_size":47,"is_printed":true,"is_handwritten":false,"id":"ba5e09523a6a4d3282684d94bfa7ec56","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"Clinical Trial Protocol","text_display":"Clinical Trial Protocol","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1402,443],[1637,443],[1637,528],[1402,528]],"region":{"top_left_x":1402,"top_left_y":442,"width":236,"height":86},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7306f5ab47f648cbad0f7fd952870a4d","type":"complex_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","children_ids":["fb2b9e0681f04e96affe97ec2a2eedbf","66879a34013545c9885ac6410d1630ff"],"text":"Doc. No.: c02155180-06","text_display":"Doc. No.: c02155180-06","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1407,447],[1564,447],[1564,482],[1407,482]],"region":{"top_left_x":1407,"top_left_y":447,"width":157,"height":35},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb2b9e0681f04e96affe97ec2a2eedbf","type":"text","conversion_output":false,"parent_id":"7306f5ab47f648cbad0f7fd952870a4d","text":"Doc. No.:","text_display":"Doc. No.:","confidence":1,"confidence_rate":1},{"cnt":[[1407,489],[1633,489],[1633,528],[1407,528]],"region":{"top_left_x":1407,"top_left_y":488,"width":226,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66879a34013545c9885ac6410d1630ff","type":"text","conversion_output":false,"parent_id":"7306f5ab47f648cbad0f7fd952870a4d","text":"c02155180-06","text_display":" c02155180-06","confidence":1,"confidence_rate":1},{"cnt":[[290,558],[534,558],[534,597],[290,597]],"region":{"top_left_x":290,"top_left_y":557,"width":245,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"801a14922fa1414aad928e1ca5ffa886","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"EudraCT No.:","text_display":"EudraCT No.:","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99169921875,"confidence_rate":0.9995098010938792},{"cnt":[[684,558],[944,558],[944,592],[684,592]],"region":{"top_left_x":684,"top_left_y":557,"width":261,"height":36},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7eadd68ca3d049d8863e6cc64526b7b0","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"2011-004148-23","text_display":"2011-004148-23","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[288,751],[590,751],[590,841],[288,841]],"region":{"top_left_x":288,"top_left_y":751,"width":302,"height":90},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79f392e6e5014b58970920b547e03acc","type":"complex_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","children_ids":["0b6d772791084aafa34456022bf1f318","f995c5b561c04fd4986d4e8371b36237"],"text":"BI Investigational Product(s):","text_display":"BI Investigational Product(s):","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[293,751],[590,751],[590,795],[293,795]],"region":{"top_left_x":292,"top_left_y":751,"width":298,"height":44},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b6d772791084aafa34456022bf1f318","type":"text","conversion_output":false,"parent_id":"79f392e6e5014b58970920b547e03acc","text":"BI Investigational","text_display":"BI Investigational","confidence":1,"confidence_rate":1},{"cnt":[[293,797],[479,797],[479,836],[293,836]],"region":{"top_left_x":292,"top_left_y":797,"width":188,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f995c5b561c04fd4986d4e8371b36237","type":"text","conversion_output":false,"parent_id":"79f392e6e5014b58970920b547e03acc","text":"Product(s):","text_display":" Product(s):","confidence":1,"confidence_rate":1},{"cnt":[[684,751],[1018,751],[1018,795],[684,795]],"region":{"top_left_x":684,"top_left_y":751,"width":334,"height":44},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f7638d4ace849a496c4d353ed6158d6","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"Linagliptin (BI 1356)","text_display":"Linagliptin (BI 1356)","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[293,871],[382,871],[382,915],[293,915]],"region":{"top_left_x":292,"top_left_y":870,"width":91,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd0fcff3de9a42bc97fd4de29db47dfa","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"Title:","text_display":"Title:","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[679,866],[1796,866],[1796,1053],[679,1053]],"region":{"top_left_x":679,"top_left_y":866,"width":1118,"height":187},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fec7fe29aa9f4d27aae67496e9fad6ae","type":"complex_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","children_ids":["fcb50fe599df47129481160102b0c3b3","5711ee31465f4dbc8c081e1f47978b78","5e5309576ccd4c958473b5dbecb3ef31","bb1d3ffd58c749dfa6236633b837a23e"],"text":"A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA","text_display":"A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[684,871],[1769,871],[1769,915],[684,915]],"region":{"top_left_x":684,"top_left_y":870,"width":1085,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fcb50fe599df47129481160102b0c3b3","type":"text","conversion_output":false,"parent_id":"fec7fe29aa9f4d27aae67496e9fad6ae","text":"A multicenter, international, randomized, parallel group, double-blind,","text_display":"A multicenter, international, randomized, parallel group, double-blind,","confidence":1,"confidence_rate":1},{"cnt":[[684,917],[1713,917],[1713,961],[684,961]],"region":{"top_left_x":684,"top_left_y":916,"width":1030,"height":45},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5711ee31465f4dbc8c081e1f47978b78","type":"text","conversion_output":false,"parent_id":"fec7fe29aa9f4d27aae67496e9fad6ae","text":"placebo-controlled CArdiovascular Safety \\& Renal Microvascular","text_display":" placebo-controlled CArdiovascular Safety \\& Renal Microvascular","confidence":1,"confidence_rate":1},{"cnt":[[684,961],[1792,961],[1792,1002],[684,1002]],"region":{"top_left_x":684,"top_left_y":960,"width":1108,"height":43},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e5309576ccd4c958473b5dbecb3ef31","type":"text","conversion_output":false,"parent_id":"fec7fe29aa9f4d27aae67496e9fad6ae","text":"outcomE study with LINAgliptin, 5 mg once daily in patients with type","text_display":" outcomE study with LINAgliptin, 5 mg once daily in patients with type","confidence":1,"confidence_rate":1},{"cnt":[[684,1004],[1543,1004],[1543,1048],[684,1048]],"region":{"top_left_x":684,"top_left_y":1004,"width":859,"height":45},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb1d3ffd58c749dfa6236633b837a23e","type":"text","conversion_output":false,"parent_id":"fec7fe29aa9f4d27aae67496e9fad6ae","text":"2 diabetes mellitus at high vascular risk. CARMELINA","text_display":" 2 diabetes mellitus at high vascular risk. CARMELINA","confidence":1,"confidence_rate":1},{"cnt":[[293,1060],[539,1060],[539,1099],[293,1099]],"region":{"top_left_x":292,"top_left_y":1059,"width":248,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0e4603e15d749888340a0f8eb03d180","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"Clinical Phase:","text_display":"Clinical Phase:","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[684,1060],[735,1060],[735,1101],[684,1101]],"region":{"top_left_x":684,"top_left_y":1059,"width":51,"height":43},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6cc8d43252c6497d9e20aa75f6b8ae26","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"IV","text_display":"IV","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[288,1103],[521,1103],[521,1186],[288,1186]],"region":{"top_left_x":288,"top_left_y":1103,"width":233,"height":84},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1bfae659579541e1a770f8f4909da661","type":"complex_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","children_ids":["6fd912575516441f99f4db0b090dceba","2246a02a70e240d7953fbe4017b1e7e6"],"text":"Trial Clinical Monitor:","text_display":"Trial Clinical Monitor:","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[293,1108],[516,1108],[516,1145],[293,1145]],"region":{"top_left_x":292,"top_left_y":1108,"width":224,"height":37},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fd912575516441f99f4db0b090dceba","type":"text","conversion_output":false,"parent_id":"1bfae659579541e1a770f8f4909da661","text":"Trial Clinical","text_display":"Trial Clinical","confidence":1,"confidence_rate":1},{"cnt":[[293,1152],[447,1152],[447,1186],[293,1186]],"region":{"top_left_x":292,"top_left_y":1151,"width":155,"height":36},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2246a02a70e240d7953fbe4017b1e7e6","type":"text","conversion_output":false,"parent_id":"1bfae659579541e1a770f8f4909da661","text":"Monitor:","text_display":" Monitor:","confidence":1,"confidence_rate":1},{"cnt":[[679,1281],[799,1281],[799,1368],[679,1368]],"region":{"top_left_x":679,"top_left_y":1280,"width":121,"height":89},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1dd472b65c641cb98fce67c8d0ea1c6","type":"complex_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","children_ids":["4567c8df5a124227a4c185e605f53ae0","f13789ef2e2f431b90a306e17417a424"],"text":"Phone Fax","text_display":"Phone Fax","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[684,1285],[792,1285],[792,1320],[684,1320]],"region":{"top_left_x":684,"top_left_y":1285,"width":109,"height":35},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4567c8df5a124227a4c185e605f53ae0","type":"text","conversion_output":false,"parent_id":"c1dd472b65c641cb98fce67c8d0ea1c6","text":"Phone","text_display":"Phone","confidence":1,"confidence_rate":1},{"cnt":[[684,1327],[755,1327],[755,1364],[684,1364]],"region":{"top_left_x":684,"top_left_y":1326,"width":72,"height":38},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f13789ef2e2f431b90a306e17417a424","type":"text","conversion_output":false,"parent_id":"c1dd472b65c641cb98fce67c8d0ea1c6","text":"Fax","text_display":" Fax","confidence":1,"confidence_rate":1},{"cnt":[[256,1387],[1803,1387],[1803,2130],[256,2130]],"region":{"top_left_x":255,"top_left_y":1386,"width":1549,"height":745},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74508828a393428d84314b9efa815674","type":"table_spanning_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","children_ids":["c8273ceb84374dd088214c29f0a4a68c"],"text":"","text_display":"\\begin{tabular}{l}\nCo-ordinating Investigators: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[292,1395],[1187,1395],[1187,2110],[292,2110]],"region":{"top_left_x":292,"top_left_y":1395,"width":895,"height":715},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8273ceb84374dd088214c29f0a4a68c","type":"complex_cell","conversion_output":false,"parent_id":"74508828a393428d84314b9efa815674","children_ids":["8a767177450f4451bc66ddce90281f74","d3ba013cd48b4f20babfb911d5d343a1","c19d779faaec47b4a617e0d76df2eefa","8a876c9556964bc9aac58a3d13fe0f43","9313fad3e7764185930987216c55e7b6","509e403469b6411ba2655c4dd7c3a501","24da626361ab403ba2abf4e9f4579e7c","a213c0acbd7749168ecbc7ee82defeb1"],"text":"\\begin{tabular}{l}\nCo-ordinating Investigators: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nCo-ordinating Investigators: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[293,1396],[530,1396],[530,1437],[293,1437]],"region":{"top_left_x":292,"top_left_y":1395,"width":238,"height":43},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a767177450f4451bc66ddce90281f74","type":"text","conversion_output":false,"parent_id":"c8273ceb84374dd088214c29f0a4a68c","text":"Co-ordinating","text_display":"Co-ordinating","confidence":1,"confidence_rate":1},{"cnt":[[293,1437],[521,1437],[521,1481],[293,1481]],"region":{"top_left_x":292,"top_left_y":1437,"width":229,"height":45},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3ba013cd48b4f20babfb911d5d343a1","type":"text","conversion_output":false,"parent_id":"c8273ceb84374dd088214c29f0a4a68c","text":"Investigators:","text_display":" Investigators:","confidence":1,"confidence_rate":1},{"cnt":[[684,1548],[797,1548],[797,1587],[684,1587]],"region":{"top_left_x":684,"top_left_y":1547,"width":113,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c19d779faaec47b4a617e0d76df2eefa","type":"text","conversion_output":false,"parent_id":"c8273ceb84374dd088214c29f0a4a68c","text":"Phone:","text_display":"\nPhone:","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[1108,1548],[1181,1548],[1181,1587],[1108,1587]],"region":{"top_left_x":1107,"top_left_y":1547,"width":75,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a876c9556964bc9aac58a3d13fe0f43","type":"text","conversion_output":false,"parent_id":"c8273ceb84374dd088214c29f0a4a68c","text":"Fax:","text_display":"\nFax:","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[684,1810],[797,1810],[797,1849],[684,1849]],"region":{"top_left_x":684,"top_left_y":1810,"width":113,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9313fad3e7764185930987216c55e7b6","type":"text","conversion_output":false,"parent_id":"c8273ceb84374dd088214c29f0a4a68c","text":"Phone:","text_display":"\nPhone:","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[1099,1810],[1172,1810],[1172,1849],[1099,1849]],"region":{"top_left_x":1098,"top_left_y":1810,"width":75,"height":40},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"509e403469b6411ba2655c4dd7c3a501","type":"text","conversion_output":false,"parent_id":"c8273ceb84374dd088214c29f0a4a68c","text":"Fax:","text_display":"\nFax:","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[684,2068],[797,2068],[797,2107],[684,2107]],"region":{"top_left_x":684,"top_left_y":2068,"width":113,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24da626361ab403ba2abf4e9f4579e7c","type":"text","conversion_output":false,"parent_id":"c8273ceb84374dd088214c29f0a4a68c","text":"Phone:","text_display":"\nPhone:","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[1108,2068],[1186,2068],[1186,2110],[1108,2110]],"region":{"top_left_x":1107,"top_left_y":2068,"width":80,"height":42},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a213c0acbd7749168ecbc7ee82defeb1","type":"text","conversion_output":false,"parent_id":"c8273ceb84374dd088214c29f0a4a68c","text":"Fax:","text_display":"\nFax:","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[265,2133],[1803,2133],[1803,2188],[265,2188]],"region":{"top_left_x":265,"top_left_y":2132,"width":1539,"height":56},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b149a58bc18e4cc7aab8fd15520ccdf3","type":"table_spanning_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","children_ids":["847adb84cf494dc8bdc1aa0e79b3e96f"],"text":"","text_display":"\\begin{tabular}{l}\nStatus: \\\\\nFinal Protocol (Revised Protocol (based on global amendment 2))\n\\end{tabular}","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[292,2137],[1751,2137],[1751,2186],[292,2186]],"region":{"top_left_x":292,"top_left_y":2137,"width":1459,"height":49},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"847adb84cf494dc8bdc1aa0e79b3e96f","type":"complex_cell","conversion_output":false,"parent_id":"b149a58bc18e4cc7aab8fd15520ccdf3","children_ids":["29b9608cc1e043daa801b92a0e5a5343","caaa319365cd43a2be446d13c3a11775"],"text":"\\begin{tabular}{l}\nStatus: \\\\\nFinal Protocol (Revised Protocol (based on global amendment 2))\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nStatus: \\\\\nFinal Protocol (Revised Protocol (based on global amendment 2))\n\\end{tabular}","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[293,2140],[410,2140],[410,2176],[293,2176]],"region":{"top_left_x":292,"top_left_y":2139,"width":119,"height":38},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29b9608cc1e043daa801b92a0e5a5343","type":"text","conversion_output":false,"parent_id":"847adb84cf494dc8bdc1aa0e79b3e96f","text":"Status:","text_display":"Status:","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[684,2137],[1750,2137],[1750,2186],[684,2186]],"region":{"top_left_x":684,"top_left_y":2137,"width":1067,"height":49},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"caaa319365cd43a2be446d13c3a11775","type":"text","conversion_output":false,"parent_id":"847adb84cf494dc8bdc1aa0e79b3e96f","text":"Final Protocol (Revised Protocol (based on global amendment 2))","text_display":"\nFinal Protocol (Revised Protocol (based on global amendment 2))","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[288,2225],[594,2225],[594,2259],[288,2259]],"region":{"top_left_x":288,"top_left_y":2224,"width":307,"height":36},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a46315aece6e4803be6284588f8bf215","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"Version and Date:","text_display":"Version and Date:","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[684,2225],[889,2225],[889,2264],[684,2264]],"region":{"top_left_x":684,"top_left_y":2224,"width":206,"height":40},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bbdc2a89f114c7284174d0a66418b4b","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"Version: 3.0","text_display":"Version: 3.0","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[974,2321],[1198,2321],[1198,2363],[974,2363]],"region":{"top_left_x":974,"top_left_y":2321,"width":224,"height":42},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d419857333f940a1be83bd3477a97fa3","type":"simple_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","text":"Page 1 of 123","text_display":"Page 1 of 123","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,2400],[1803,2400],[1803,2536],[265,2536]],"region":{"top_left_x":265,"top_left_y":2399,"width":1539,"height":137},"line":60,"column":0,"font_size":24,"is_printed":true,"is_handwritten":false,"id":"67b6d730be2d4a62b5accba1a12515ff","type":"table_spanning_cell","conversion_output":false,"parent_id":"8d1722b9ed954ea1bea1cc11cc4c4855","children_ids":["51255fea8c174affa82eb9be6bf81792"],"text":"","text_display":"\\begin{tabular}{l}\nProprietary confidential information. \\\\\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.\n\\end{tabular}","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[286,2404],[1801,2404],[1801,2526],[286,2526]],"region":{"top_left_x":285,"top_left_y":2404,"width":1516,"height":123},"line":61,"column":0,"font_size":24,"is_printed":true,"is_handwritten":false,"id":"51255fea8c174affa82eb9be6bf81792","type":"complex_cell","conversion_output":false,"parent_id":"67b6d730be2d4a62b5accba1a12515ff","children_ids":["c8bb2e6997724b7db5256c22933afb94","88f49ac5a40445e4b69b040736c53f0f","5b08385776924fffb248d4802c580732"],"text":"\\begin{tabular}{l}\nProprietary confidential information. \\\\\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nProprietary confidential information. \\\\\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.\n\\end{tabular}","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":0.8125913143157959,"confidence_rate":0.9994033538355513},{"cnt":[[790,2409],[1297,2409],[1297,2444],[790,2444]],"region":{"top_left_x":789,"top_left_y":2408,"width":508,"height":36},"line":62,"column":0,"font_size":24,"is_printed":true,"is_handwritten":false,"id":"c8bb2e6997724b7db5256c22933afb94","type":"text","conversion_output":false,"parent_id":"51255fea8c174affa82eb9be6bf81792","text":"Proprietary confidential information.","text_display":"Proprietary confidential information.","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[293,2446],[1796,2446],[1796,2485],[293,2485]],"region":{"top_left_x":292,"top_left_y":2445,"width":1505,"height":40},"line":63,"column":0,"font_size":24,"is_printed":true,"is_handwritten":false,"id":"88f49ac5a40445e4b69b040736c53f0f","type":"text","conversion_output":false,"parent_id":"51255fea8c174affa82eb9be6bf81792","text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.8125913143157959,"confidence_rate":0.9982575955149643},{"cnt":[[293,2490],[1766,2490],[1766,2524],[293,2524]],"region":{"top_left_x":292,"top_left_y":2489,"width":1475,"height":36},"line":64,"column":0,"font_size":24,"is_printed":true,"is_handwritten":false,"id":"5b08385776924fffb248d4802c580732","type":"text","conversion_output":false,"parent_id":"51255fea8c174affa82eb9be6bf81792","text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":" This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-002","page":2,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"deb84b2881f14a5bb137dfb5fda64a37","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef98690bf6dd454f98490d831a9cbabe","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a99a5921db8467c8f78a34338898acb","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b1cc70c81c54771bc0031ca64d2fa17","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23f02bed40c946239a080548f126c56b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1594,210],[1816,210],[1816,254],[1594,254]],"region":{"top_left_x":1594,"top_left_y":210,"width":223,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8561f6afd5754700b359ddff665f6575","type":"page_info","conversion_output":false,"text":"Page 2 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1208,338],[1208,395],[242,395]],"region":{"top_left_x":242,"top_left_y":338,"width":967,"height":58},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"619046d343684af7a16b72ce198ed7e7","type":"section_header","conversion_output":false,"children_ids":["b333944fc6014e0fbd25d1b64798a52b"],"text":"","text_display":""},{"cnt":[[247,343],[1204,343],[1204,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":958,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b333944fc6014e0fbd25d1b64798a52b","type":"text","conversion_output":true,"parent_id":"619046d343684af7a16b72ce198ed7e7","text":"CLINICAL TRIAL PROTOCOL SYNOPSIS","text_display":"\n\n\\section*{CLINICAL TRIAL PROTOCOL SYNOPSIS}","confidence":1,"confidence_rate":1},{"cnt":[[244,432],[1855,432],[1855,2556],[244,2556]],"region":{"top_left_x":244,"top_left_y":431,"width":1611,"height":2126},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d60d408d906b41e9bfdae0bd2d5f3283","type":"table","conversion_output":true,"children_ids":["2d978caf17ec4357919789d9cf178e1f","b100efb6a0ff4a2b9a7d706165108c37","22d03cc715464688a5be5eeab776589a","1dd1ef603c1b4f56a50c3844189b01a2","926e0b74912b43f8a4aeadd463feb77e","41ab333e73814793ab9fc4fd44427861","a530dd0165264463aedf83f1557508ad","9f06fd975a8544d2a55970eb69a39455","c8f5db3cb86b4c9da9ef1b526edbc0a5","e534a8b3a8704baab0a3fc8e3c0b3778","00e99cde455f4ecc820874e5d2f57cb2","23370553c9374e1f9cbd7336eee56b98","a30ce88a30b544cf80a5844330cb51bd","cd21ecd3a01444ff996c6da68783afd1","286c9eb0da7a43d795f18c99cd1f7ba3","7d1ceee4424a494183c42468a6f02799","f79d90ea992748a282410ea00392ba20","55e07caff07f4af198867ce32f51829c","6d1db2abaf934089927d260011732ea3","9c6de55e748c461db03ad7dc56b92b96","47843ec0be8244a484ae9225ed1afa33","64bebb2633f34c61aad6626b7316e7d5","8f38a55f16ee42c196ae823e190371fc","ce5b82358a994e3f8667bb0fd6e99157","6d796a74f7274906bf42eabd851cf8c6","492e18e4d5964b2f936c04ade884f674","f9020906853f47f1b41a7ec73dede0fd","1fa45c9c064846a6a7f2cf211e53a982","12b80d975d2a461f954771f66b3dc412","11e77572ea2e4497b0fdf5a42eb837df","d268547be8fc4eeb8e58107353b78c2a","26f9eafed57346a794ae1f10b8889549"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}} & \\multirow[t]{3}{*}{Tabulated Trial Protocol} & \\multirow{3}{*}{} \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}} & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline Title of trial: & \\multicolumn{3}{|c|}{A multicenter, international, randomized, parallel group, double-blind, placebocontrolled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA} \\\\\n\\hline \\multicolumn{4}{|l|}{Co-ordinating Investigators} \\\\\n\\hline \\multicolumn{4}{|c|}{\\begin{tabular}{l}\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}} \\\\\n\\hline Trial site(s): & \\multicolumn{3}{|l|}{Approximately 600} \\\\\n\\hline Clinical phase: & \\multicolumn{3}{|l|}{IV} \\\\\n\\hline Objective(s): & \\multicolumn{3}{|l|}{\\begin{tabular}{l}\nThe primary objective is to demonstrate non-inferiority (by means of comparing the upper limit of a two-sided \\(95 \\%\\) confidence interval with the non-inferiority margin of 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy on top of standard of care) with respect to time to first occurrence of any of the adjudicated components of the primary composite endpoint (i.e. cardiovascular (CV) death [including fatal stroke, fatal MI and sudden death], non-fatal stroke or non-fatal myocardial infarction (MI) (excluding silent MI) and hospitalisation for unstable angina pectoris) in patients with type 2 diabetes mellitus (T2DM). \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal disease (ESRD), sustained decrease in estimated global glomerular filtration rate (eGFR) \\(\\geq 5 0 4 0 \\%\\) from baseline), will be investigated separately with a test on superiority.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}} & \\multirow[t]{3}{*}{Tabulated Trial Protocol} & \\multirow{3}{*}{} \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}} & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline Title of trial: & \\multicolumn{3}{|c|}{A multicenter, international, randomized, parallel group, double-blind, placebocontrolled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA} \\\\\n\\hline \\multicolumn{4}{|l|}{Co-ordinating Investigators} \\\\\n\\hline \\multicolumn{4}{|c|}{\\begin{tabular}{l}\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}} \\\\\n\\hline Trial site(s): & \\multicolumn{3}{|l|}{Approximately 600} \\\\\n\\hline Clinical phase: & \\multicolumn{3}{|l|}{IV} \\\\\n\\hline Objective(s): & \\multicolumn{3}{|l|}{\\begin{tabular}{l}\nThe primary objective is to demonstrate non-inferiority (by means of comparing the upper limit of a two-sided \\(95 \\%\\) confidence interval with the non-inferiority margin of 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy on top of standard of care) with respect to time to first occurrence of any of the adjudicated components of the primary composite endpoint (i.e. cardiovascular (CV) death [including fatal stroke, fatal MI and sudden death], non-fatal stroke or non-fatal myocardial infarction (MI) (excluding silent MI) and hospitalisation for unstable angina pectoris) in patients with type 2 diabetes mellitus (T2DM). \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal disease (ESRD), sustained decrease in estimated global glomerular filtration rate (eGFR) \\(\\geq 5 0 4 0 \\%\\) from baseline), will be investigated separately with a test on superiority.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","confidence":0.8742108345031738,"confidence_rate":0.9995839047630842},{"cnt":[[244,431],[497,431],[497,2556],[244,2556]],"region":{"top_left_x":244,"top_left_y":431,"width":254,"height":2126},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d978caf17ec4357919789d9cf178e1f","type":"table_column","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[608,431],[859,430],[864,2556],[612,2557]],"region":{"top_left_x":607,"top_left_y":430,"width":257,"height":2127},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b100efb6a0ff4a2b9a7d706165108c37","type":"table_column","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[1089,431],[1326,431],[1326,2556],[1089,2556]],"region":{"top_left_x":1089,"top_left_y":431,"width":238,"height":2126},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22d03cc715464688a5be5eeab776589a","type":"table_column","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[1451,431],[1851,431],[1851,2556],[1451,2556]],"region":{"top_left_x":1450,"top_left_y":431,"width":402,"height":2126},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1dd1ef603c1b4f56a50c3844189b01a2","type":"table_column","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,440],[1858,440],[1858,576],[244,576]],"region":{"top_left_x":244,"top_left_y":440,"width":1615,"height":137},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"926e0b74912b43f8a4aeadd463feb77e","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,581],[1853,581],[1853,719],[244,719]],"region":{"top_left_x":244,"top_left_y":580,"width":1610,"height":139},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41ab333e73814793ab9fc4fd44427861","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,721],[1856,721],[1856,859],[244,859]],"region":{"top_left_x":244,"top_left_y":721,"width":1612,"height":139},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a530dd0165264463aedf83f1557508ad","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,864],[1853,864],[1853,963],[244,963]],"region":{"top_left_x":244,"top_left_y":863,"width":1610,"height":100},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f06fd975a8544d2a55970eb69a39455","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,967],[1856,967],[1856,1147],[244,1147]],"region":{"top_left_x":244,"top_left_y":967,"width":1612,"height":181},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8f5db3cb86b4c9da9ef1b526edbc0a5","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,1159],[1856,1159],[1856,1244],[244,1244]],"region":{"top_left_x":244,"top_left_y":1158,"width":1612,"height":86},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e534a8b3a8704baab0a3fc8e3c0b3778","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,1315],[1853,1315],[1853,1838],[244,1838]],"region":{"top_left_x":244,"top_left_y":1315,"width":1610,"height":523},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00e99cde455f4ecc820874e5d2f57cb2","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,1840],[1853,1840],[1853,1884],[244,1884]],"region":{"top_left_x":244,"top_left_y":1840,"width":1610,"height":44},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23370553c9374e1f9cbd7336eee56b98","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,1909],[1853,1909],[1853,1953],[244,1953]],"region":{"top_left_x":244,"top_left_y":1909,"width":1610,"height":44},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a30ce88a30b544cf80a5844330cb51bd","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[244,1971],[1856,1971],[1856,2547],[244,2547]],"region":{"top_left_x":244,"top_left_y":1971,"width":1612,"height":577},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd21ecd3a01444ff996c6da68783afd1","type":"table_row","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":""},{"cnt":[[249,436],[965,436],[965,581],[249,581]],"region":{"top_left_x":248,"top_left_y":435,"width":717,"height":146},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"286c9eb0da7a43d795f18c99cd1f7ba3","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["60e142cba05146f092eb3dd40b7dcae2"],"text":"","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[256,445],[573,445],[573,574],[256,574]],"region":{"top_left_x":255,"top_left_y":444,"width":319,"height":130},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60e142cba05146f092eb3dd40b7dcae2","type":"complex_cell","conversion_output":false,"parent_id":"286c9eb0da7a43d795f18c99cd1f7ba3","children_ids":["dd698d4779874918b3911be637023ffd","9e72993ec4934fae828a90a45a6ccf03"],"text":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[258,445],[541,445],[541,489],[258,489]],"region":{"top_left_x":257,"top_left_y":444,"width":285,"height":45},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd698d4779874918b3911be637023ffd","type":"text","conversion_output":false,"parent_id":"60e142cba05146f092eb3dd40b7dcae2","text":"Name of company:","text_display":"Name of company:","confidence":1,"confidence_rate":1},{"cnt":[[258,532],[571,532],[571,571],[258,571]],"region":{"top_left_x":257,"top_left_y":532,"width":314,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e72993ec4934fae828a90a45a6ccf03","type":"text","conversion_output":false,"parent_id":"60e142cba05146f092eb3dd40b7dcae2","text":"Boehringer Ingelheim","text_display":"\nBoehringer Ingelheim","confidence":1,"confidence_rate":1},{"cnt":[[1094,440],[1324,440],[1324,857],[1094,857]],"region":{"top_left_x":1093,"top_left_y":440,"width":231,"height":417},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d1ceee4424a494183c42468a6f02799","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["e9a57cce48b847db94a273096a9a6f2c"],"text":"","text_display":"Tabulated Trial Protocol","cell_row":0,"cell_column":2,"cell_row_span":3,"cell_col_span":1},{"cnt":[[1096,445],[1319,445],[1319,530],[1096,530]],"region":{"top_left_x":1095,"top_left_y":444,"width":225,"height":87},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9a57cce48b847db94a273096a9a6f2c","type":"complex_cell","conversion_output":false,"parent_id":"7d1ceee4424a494183c42468a6f02799","children_ids":["fbd47415dc8d461a8aa0d64e27fa2262","0e9cb37c3b4d47f981ec0d7ee684ff81"],"text":"Tabulated Trial Protocol","text_display":"Tabulated Trial Protocol","cell_row":0,"cell_column":2,"cell_row_span":3,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1128,445],[1287,445],[1287,479],[1128,479]],"region":{"top_left_x":1128,"top_left_y":444,"width":160,"height":36},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fbd47415dc8d461a8aa0d64e27fa2262","type":"text","conversion_output":false,"parent_id":"e9a57cce48b847db94a273096a9a6f2c","text":"Tabulated","text_display":"Tabulated","confidence":1,"confidence_rate":1},{"cnt":[[1101,491],[1319,491],[1319,525],[1101,525]],"region":{"top_left_x":1100,"top_left_y":490,"width":220,"height":36},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e9cb37c3b4d47f981ec0d7ee684ff81","type":"text","conversion_output":false,"parent_id":"e9a57cce48b847db94a273096a9a6f2c","text":"Trial Protocol","text_display":" Trial Protocol","confidence":1,"confidence_rate":1},{"cnt":[[1460,440],[1851,440],[1851,857],[1460,857]],"region":{"top_left_x":1459,"top_left_y":440,"width":393,"height":417},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f79d90ea992748a282410ea00392ba20","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"","text_display":"","cell_row":0,"cell_column":3,"cell_row_span":3,"cell_col_span":1},{"cnt":[[251,574],[661,574],[661,719],[251,719]],"region":{"top_left_x":250,"top_left_y":573,"width":411,"height":146},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55e07caff07f4af198867ce32f51829c","type":"complex_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["88a79145eea24dd1a3f4d5e650d40c8f","192097ad4c4048bb9a26bde775c8f33d"],"text":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.8742108345031738,"confidence_rate":0.996804314654501},{"cnt":[[258,585],[652,585],[652,627],[258,627]],"region":{"top_left_x":257,"top_left_y":585,"width":395,"height":42},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"88a79145eea24dd1a3f4d5e650d40c8f","type":"text","conversion_output":false,"parent_id":"55e07caff07f4af198867ce32f51829c","text":"Name of finished product:","text_display":"Name of finished product:","confidence":1,"confidence_rate":1},{"cnt":[[258,673],[407,673],[407,714],[258,714]],"region":{"top_left_x":257,"top_left_y":672,"width":151,"height":43},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"192097ad4c4048bb9a26bde775c8f33d","type":"text","conversion_output":false,"parent_id":"55e07caff07f4af198867ce32f51829c","text":"Trajenta \\({ }^{\\circledR}\\)","text_display":"\nTrajenta \\({ }^{\\circledR}\\)","confidence":0.8742108345031738,"confidence_rate":0.9936188417138295},{"cnt":[[249,721],[850,721],[850,857],[249,857]],"region":{"top_left_x":248,"top_left_y":721,"width":602,"height":136},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d1db2abaf934089927d260011732ea3","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["9bf4ad7ca1c84e048e85ecc1f24a635f"],"text":"","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[256,726],[661,726],[661,857],[256,857]],"region":{"top_left_x":255,"top_left_y":725,"width":406,"height":132},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9bf4ad7ca1c84e048e85ecc1f24a635f","type":"complex_cell","conversion_output":false,"parent_id":"6d1db2abaf934089927d260011732ea3","children_ids":["2da662b9ee214733a2e753b4e1f93441","7626df9fda29419596990f78ad0a591f"],"text":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":0.98828125,"confidence_rate":0.9997733342357968},{"cnt":[[258,728],[656,728],[656,769],[258,769]],"region":{"top_left_x":257,"top_left_y":728,"width":400,"height":42},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2da662b9ee214733a2e753b4e1f93441","type":"text","conversion_output":false,"parent_id":"9bf4ad7ca1c84e048e85ecc1f24a635f","text":"Name of active ingredient:","text_display":"Name of active ingredient:","confidence":1,"confidence_rate":1},{"cnt":[[258,813],[564,813],[564,857],[258,857]],"region":{"top_left_x":257,"top_left_y":813,"width":308,"height":44},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7626df9fda29419596990f78ad0a591f","type":"text","conversion_output":false,"parent_id":"9bf4ad7ca1c84e048e85ecc1f24a635f","text":"Linagliptin (BI 1356)","text_display":"\nLinagliptin (BI 1356)","confidence":0.98828125,"confidence_rate":0.9995467198489623},{"cnt":[[253,864],[497,864],[497,958],[253,958]],"region":{"top_left_x":253,"top_left_y":863,"width":245,"height":96},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c6de55e748c461db03ad7dc56b92b96","type":"complex_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["1694824a6aab41aba5f030ff590a14b6","924bf9ecf98a4f14866ed78f2d8003c5"],"text":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[258,868],[474,868],[474,905],[258,905]],"region":{"top_left_x":257,"top_left_y":868,"width":218,"height":38},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1694824a6aab41aba5f030ff590a14b6","type":"text","conversion_output":false,"parent_id":"9c6de55e748c461db03ad7dc56b92b96","text":"Protocol date:","text_display":"Protocol date:","confidence":1,"confidence_rate":1},{"cnt":[[258,915],[495,915],[495,954],[258,954]],"region":{"top_left_x":257,"top_left_y":914,"width":238,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"924bf9ecf98a4f14866ed78f2d8003c5","type":"text","conversion_output":false,"parent_id":"9c6de55e748c461db03ad7dc56b92b96","text":"5 February 2013","text_display":"\n5 February 2013","confidence":1,"confidence_rate":1},{"cnt":[[622,866],[850,866],[850,954],[622,954]],"region":{"top_left_x":621,"top_left_y":866,"width":229,"height":88},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47843ec0be8244a484ae9225ed1afa33","type":"complex_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["8411d93dd95448dc93883e89575aeef6","328393a5969946a0918327626c08b9fd"],"text":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[626,868],[845,868],[845,905],[626,905]],"region":{"top_left_x":626,"top_left_y":868,"width":219,"height":38},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8411d93dd95448dc93883e89575aeef6","type":"text","conversion_output":false,"parent_id":"47843ec0be8244a484ae9225ed1afa33","text":"Trial number:","text_display":"Trial number:","confidence":1,"confidence_rate":1},{"cnt":[[631,915],[748,915],[748,949],[631,949]],"region":{"top_left_x":630,"top_left_y":914,"width":119,"height":36},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"328393a5969946a0918327626c08b9fd","type":"text","conversion_output":false,"parent_id":"47843ec0be8244a484ae9225ed1afa33","text":"1218.22","text_display":"\n1218.22","confidence":1,"confidence_rate":1},{"cnt":[[1462,868],[1752,868],[1752,951],[1462,951]],"region":{"top_left_x":1462,"top_left_y":868,"width":291,"height":84},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64bebb2633f34c61aad6626b7316e7d5","type":"complex_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["61b12782e5df4193a0339b501e97036a","cc5bacd3efc84dccb3e6b66e342ee2d9"],"text":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","cell_row":3,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1464,868],[1683,868],[1683,903],[1464,903]],"region":{"top_left_x":1464,"top_left_y":868,"width":220,"height":36},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61b12782e5df4193a0339b501e97036a","type":"text","conversion_output":false,"parent_id":"64bebb2633f34c61aad6626b7316e7d5","text":"Revision date:","text_display":"Revision date:","confidence":1,"confidence_rate":1},{"cnt":[[1464,910],[1748,910],[1748,944],[1464,944]],"region":{"top_left_x":1464,"top_left_y":909,"width":284,"height":36},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cc5bacd3efc84dccb3e6b66e342ee2d9","type":"text","conversion_output":false,"parent_id":"64bebb2633f34c61aad6626b7316e7d5","text":"22 November 2016","text_display":"\n22 November 2016","confidence":1,"confidence_rate":1},{"cnt":[[253,974],[449,974],[449,1009],[253,1009]],"region":{"top_left_x":253,"top_left_y":974,"width":196,"height":35},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f38a55f16ee42c196ae823e190371fc","type":"simple_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"Title of trial:","text_display":"Title of trial:","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[608,967],[1851,967],[1851,1145],[608,1145]],"region":{"top_left_x":607,"top_left_y":967,"width":1245,"height":178},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce5b82358a994e3f8667bb0fd6e99157","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["81adcf8e80ac4b5e9afdaba34af793c4"],"text":"","text_display":"A multicenter, international, randomized, parallel group, double-blind, placebocontrolled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":3},{"cnt":[[612,970],[1851,970],[1851,1145],[612,1145]],"region":{"top_left_x":612,"top_left_y":969,"width":1240,"height":176},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81adcf8e80ac4b5e9afdaba34af793c4","type":"complex_cell","conversion_output":false,"parent_id":"ce5b82358a994e3f8667bb0fd6e99157","children_ids":["6bbbccb828434b56a9e00d42cf760e9c","593734e91c694454be5267ef17a39f70","a574f631e97745fba07e700124ff6cf3","72e862539d3c421599403f4768e9e090"],"text":"A multicenter, international, randomized, parallel group, double-blind, placebocontrolled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA","text_display":"A multicenter, international, randomized, parallel group, double-blind, placebocontrolled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":3,"confidence":1,"confidence_rate":1},{"cnt":[[617,974],[1844,974],[1844,1016],[617,1016]],"region":{"top_left_x":617,"top_left_y":974,"width":1228,"height":42},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6bbbccb828434b56a9e00d42cf760e9c","type":"text","conversion_output":false,"parent_id":"81adcf8e80ac4b5e9afdaba34af793c4","text":"A multicenter, international, randomized, parallel group, double-blind, placebo-","text_display":"A multicenter, international, randomized, parallel group, double-blind, placebo","confidence":1,"confidence_rate":1},{"cnt":[[617,1016],[1833,1016],[1833,1060],[617,1060]],"region":{"top_left_x":617,"top_left_y":1015,"width":1216,"height":45},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"593734e91c694454be5267ef17a39f70","type":"text","conversion_output":false,"parent_id":"81adcf8e80ac4b5e9afdaba34af793c4","text":"controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with","text_display":"controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with","confidence":1,"confidence_rate":1},{"cnt":[[617,1060],[1817,1060],[1817,1106],[617,1106]],"region":{"top_left_x":617,"top_left_y":1059,"width":1200,"height":47},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a574f631e97745fba07e700124ff6cf3","type":"text","conversion_output":false,"parent_id":"81adcf8e80ac4b5e9afdaba34af793c4","text":"LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high","text_display":" LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high","confidence":1,"confidence_rate":1},{"cnt":[[617,1103],[1066,1103],[1066,1142],[617,1142]],"region":{"top_left_x":617,"top_left_y":1103,"width":449,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72e862539d3c421599403f4768e9e090","type":"text","conversion_output":false,"parent_id":"81adcf8e80ac4b5e9afdaba34af793c4","text":"vascular risk. CARMELINA","text_display":" vascular risk. CARMELINA","confidence":1,"confidence_rate":1},{"cnt":[[244,1159],[1851,1159],[1851,1241],[244,1241]],"region":{"top_left_x":244,"top_left_y":1158,"width":1608,"height":84},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d796a74f7274906bf42eabd851cf8c6","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["2ddb4bf09eac4b11ba79ddac34d9ca4c"],"text":"","text_display":"Co-ordinating Investigators","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":4},{"cnt":[[249,1163],[472,1163],[472,1244],[249,1244]],"region":{"top_left_x":248,"top_left_y":1163,"width":224,"height":81},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ddb4bf09eac4b11ba79ddac34d9ca4c","type":"complex_cell","conversion_output":false,"parent_id":"6d796a74f7274906bf42eabd851cf8c6","children_ids":["c8fb7d5afab1494d9469545be582b679","135b59a841344c389bed0bc9cfbcc4b8"],"text":"Co-ordinating Investigators","text_display":"Co-ordinating Investigators","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":4,"confidence":1,"confidence_rate":1},{"cnt":[[253,1163],[467,1163],[467,1202],[253,1202]],"region":{"top_left_x":253,"top_left_y":1163,"width":215,"height":40},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8fb7d5afab1494d9469545be582b679","type":"text","conversion_output":false,"parent_id":"2ddb4bf09eac4b11ba79ddac34d9ca4c","text":"Co-ordinating","text_display":"Co-ordinating","confidence":1,"confidence_rate":1},{"cnt":[[253,1200],[449,1200],[449,1244],[253,1244]],"region":{"top_left_x":253,"top_left_y":1200,"width":196,"height":44},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"135b59a841344c389bed0bc9cfbcc4b8","type":"text","conversion_output":false,"parent_id":"2ddb4bf09eac4b11ba79ddac34d9ca4c","text":"Investigators","text_display":" Investigators","confidence":1,"confidence_rate":1},{"cnt":[[244,1308],[1851,1308],[1851,1852],[244,1852]],"region":{"top_left_x":244,"top_left_y":1308,"width":1608,"height":544},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"492e18e4d5964b2f936c04ade884f674","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["753f1df8adb649e5859fa73058d2a791"],"text":"","text_display":"\\begin{tabular}{l}\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":4},{"cnt":[[617,1319],[1064,1319],[1064,1836],[617,1836]],"region":{"top_left_x":617,"top_left_y":1319,"width":447,"height":517},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"753f1df8adb649e5859fa73058d2a791","type":"complex_cell","conversion_output":false,"parent_id":"492e18e4d5964b2f936c04ade884f674","children_ids":["fc2d111390474e09beda124514527de6","4cd2795788ab440f8ca4d1856b3bc08b","db236b14989049ebbb16b0b8c6fe6f25","b4910f91ab8d4449b1e937d265808d9e","a64f4e7453b242bfb2aa5eb23595a4bc","bbccb3d061f8441d87cff7aa52b2a397"],"text":"\\begin{tabular}{l}\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax: \\\\\nPhone: \\\\\nFax:\n\\end{tabular}","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":4,"confidence":1,"confidence_rate":1},{"cnt":[[617,1320],[718,1320],[718,1354],[617,1354]],"region":{"top_left_x":617,"top_left_y":1319,"width":102,"height":36},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc2d111390474e09beda124514527de6","type":"text","conversion_output":false,"parent_id":"753f1df8adb649e5859fa73058d2a791","text":"Phone:","text_display":"Phone:","confidence":1,"confidence_rate":1},{"cnt":[[995,1320],[1064,1320],[1064,1357],[995,1357]],"region":{"top_left_x":994,"top_left_y":1319,"width":70,"height":38},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cd2795788ab440f8ca4d1856b3bc08b","type":"text","conversion_output":false,"parent_id":"753f1df8adb649e5859fa73058d2a791","text":"Fax:","text_display":"\nFax:","confidence":1,"confidence_rate":1},{"cnt":[[617,1555],[718,1555],[718,1594],[617,1594]],"region":{"top_left_x":617,"top_left_y":1554,"width":102,"height":40},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db236b14989049ebbb16b0b8c6fe6f25","type":"text","conversion_output":false,"parent_id":"753f1df8adb649e5859fa73058d2a791","text":"Phone:","text_display":"\nPhone:","confidence":1,"confidence_rate":1},{"cnt":[[990,1557],[1064,1557],[1064,1596],[990,1596]],"region":{"top_left_x":990,"top_left_y":1556,"width":74,"height":41},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b4910f91ab8d4449b1e937d265808d9e","type":"text","conversion_output":false,"parent_id":"753f1df8adb649e5859fa73058d2a791","text":"Fax:","text_display":"\nFax:","confidence":1,"confidence_rate":1},{"cnt":[[617,1799],[721,1799],[721,1833],[617,1833]],"region":{"top_left_x":617,"top_left_y":1798,"width":104,"height":36},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a64f4e7453b242bfb2aa5eb23595a4bc","type":"text","conversion_output":false,"parent_id":"753f1df8adb649e5859fa73058d2a791","text":"Phone:","text_display":"\nPhone:","confidence":1,"confidence_rate":1},{"cnt":[[990,1796],[1064,1796],[1064,1836],[990,1836]],"region":{"top_left_x":990,"top_left_y":1796,"width":74,"height":40},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bbccb3d061f8441d87cff7aa52b2a397","type":"text","conversion_output":false,"parent_id":"753f1df8adb649e5859fa73058d2a791","text":"Fax:","text_display":"\nFax:","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":4,"confidence":1,"confidence_rate":1},{"cnt":[[251,1845],[435,1845],[435,1884],[251,1884]],"region":{"top_left_x":250,"top_left_y":1844,"width":186,"height":40},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9020906853f47f1b41a7ec73dede0fd","type":"simple_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"Trial site(s):","text_display":"Trial site(s):","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99755859375,"confidence_rate":0.9998713560994533},{"cnt":[[612,1838],[1849,1838],[1849,1888],[612,1888]],"region":{"top_left_x":612,"top_left_y":1837,"width":1237,"height":52},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fa45c9c064846a6a7f2cf211e53a982","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["9e2650882ead4d21852f26a233a586d6"],"text":"","text_display":"Approximately 600","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":3},{"cnt":[[617,1845],[896,1845],[896,1884],[617,1884]],"region":{"top_left_x":617,"top_left_y":1844,"width":279,"height":40},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e2650882ead4d21852f26a233a586d6","type":"simple_cell","conversion_output":false,"parent_id":"1fa45c9c064846a6a7f2cf211e53a982","text":"Approximately 600","text_display":"Approximately 600","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":3,"confidence":1,"confidence_rate":1},{"cnt":[[251,1912],[477,1912],[477,1953],[251,1953]],"region":{"top_left_x":250,"top_left_y":1911,"width":227,"height":42},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12b80d975d2a461f954771f66b3dc412","type":"simple_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"Clinical phase:","text_display":"Clinical phase:","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[608,1907],[1851,1907],[1851,1958],[608,1958]],"region":{"top_left_x":607,"top_left_y":1906,"width":1245,"height":52},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11e77572ea2e4497b0fdf5a42eb837df","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["27f818faf2c7401ea79cb5761c8e3c6b"],"text":"","text_display":"IV","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":3},{"cnt":[[615,1909],[663,1909],[663,1953],[615,1953]],"region":{"top_left_x":614,"top_left_y":1909,"width":50,"height":44},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27f818faf2c7401ea79cb5761c8e3c6b","type":"simple_cell","conversion_output":false,"parent_id":"11e77572ea2e4497b0fdf5a42eb837df","text":"IV","text_display":"IV","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":3,"confidence":1,"confidence_rate":1},{"cnt":[[251,1974],[444,1974],[444,2017],[251,2017]],"region":{"top_left_x":250,"top_left_y":1973,"width":195,"height":45},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d268547be8fc4eeb8e58107353b78c2a","type":"simple_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","text":"Objective(s):","text_display":"Objective(s):","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[605,1969],[1842,1969],[1842,2547],[605,2547]],"region":{"top_left_x":605,"top_left_y":1969,"width":1237,"height":579},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"26f9eafed57346a794ae1f10b8889549","type":"table_spanning_cell","conversion_output":false,"parent_id":"d60d408d906b41e9bfdae0bd2d5f3283","children_ids":["603568a090ec400abe44b5aa52a4c056"],"text":"","text_display":"\\begin{tabular}{l}\nThe primary objective is to demonstrate non-inferiority (by means of comparing the upper limit of a two-sided \\(95 \\%\\) confidence interval with the non-inferiority margin of 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy on top of standard of care) with respect to time to first occurrence of any of the adjudicated components of the primary composite endpoint (i.e. cardiovascular (CV) death [including fatal stroke, fatal MI and sudden death], non-fatal stroke or non-fatal myocardial infarction (MI) (excluding silent MI) and hospitalisation for unstable angina pectoris) in patients with type 2 diabetes mellitus (T2DM). \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal disease (ESRD), sustained decrease in estimated global glomerular filtration rate (eGFR) \\(\\geq 5 0 4 0 \\%\\) from baseline), will be investigated separately with a test on superiority.\n\\end{tabular}","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":3},{"cnt":[[610,1971],[1824,1971],[1824,2547],[610,2547]],"region":{"top_left_x":610,"top_left_y":1971,"width":1214,"height":577},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"603568a090ec400abe44b5aa52a4c056","type":"complex_cell","conversion_output":false,"parent_id":"26f9eafed57346a794ae1f10b8889549","children_ids":["067f31a7a29d441ca0b004822bdca7c5","26aafc13821947d0a1aaa40dd2faef36","01ed15a7ad794ad09ff94d7954708755","5fe404bf6954483e83d60cdaaeb2d172","ca96611841b846d9ae082ba3302eb694","0d8805f3f7384bcd93d39ac49a12aecf","96367583624f4687ac0bf13d15509bd1","3e14835a3aea492bad29727ee6c88152","ca3fa9d2c6714f34aa29b03ffe61cb1a","f8dde0f0e37d4659a2f1d0787dc04d32","ed97440d7fd2487ea15ebcf6c9f0e8dc","e68130b7209041d38f09a13991ed9b59","013281ebeff846fd8ffc4de9a07b8cb5","55778cf9b9454750a6b0d64c9fab4616"],"text":"\\begin{tabular}{l}\nThe primary objective is to demonstrate non-inferiority (by means of comparing the upper limit of a two-sided \\(95 \\%\\) confidence interval with the non-inferiority margin of 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy on top of standard of care) with respect to time to first occurrence of any of the adjudicated components of the primary composite endpoint (i.e. cardiovascular (CV) death [including fatal stroke, fatal MI and sudden death], non-fatal stroke or non-fatal myocardial infarction (MI) (excluding silent MI) and hospitalisation for unstable angina pectoris) in patients with type 2 diabetes mellitus (T2DM). \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal disease (ESRD), sustained decrease in estimated global glomerular filtration rate (eGFR) \\(\\geq 5 0 4 0 \\%\\) from baseline), will be investigated separately with a test on superiority.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe primary objective is to demonstrate non-inferiority (by means of comparing the upper limit of a two-sided \\(95 \\%\\) confidence interval with the non-inferiority margin of 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy on top of standard of care) with respect to time to first occurrence of any of the adjudicated components of the primary composite endpoint (i.e. cardiovascular (CV) death [including fatal stroke, fatal MI and sudden death], non-fatal stroke or non-fatal myocardial infarction (MI) (excluding silent MI) and hospitalisation for unstable angina pectoris) in patients with type 2 diabetes mellitus (T2DM). \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal disease (ESRD), sustained decrease in estimated global glomerular filtration rate (eGFR) \\(\\geq 5 0 4 0 \\%\\) from baseline), will be investigated separately with a test on superiority.\n\\end{tabular}","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":3,"confidence":0.39234398945459104,"confidence_rate":0.9991938103015594},{"cnt":[[617,1978],[1789,1978],[1789,2017],[617,2017]],"region":{"top_left_x":617,"top_left_y":1978,"width":1172,"height":40},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"067f31a7a29d441ca0b004822bdca7c5","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"The primary objective is to demonstrate non-inferiority (by means of comparing the","text_display":"The primary objective is to demonstrate non-inferiority (by means of comparing the","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[617,2015],[1817,2015],[1817,2057],[617,2057]],"region":{"top_left_x":617,"top_left_y":2015,"width":1200,"height":42},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"26aafc13821947d0a1aaa40dd2faef36","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"upper limit of a two-sided \\(95 \\%\\) confidence interval with the non-inferiority margin of","text_display":" upper limit of a two-sided \\(95 \\%\\) confidence interval with the non-inferiority margin of","confidence":0.9609746932983398,"confidence_rate":0.999572057141256},{"cnt":[[617,2057],[1803,2057],[1803,2096],[617,2096]],"region":{"top_left_x":617,"top_left_y":2056,"width":1186,"height":40},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01ed15a7ad794ad09ff94d7954708755","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy on top","text_display":" 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy on top","confidence":0.9922044211998582,"confidence_rate":0.9999130468565459},{"cnt":[[617,2098],[1796,2098],[1796,2137],[617,2137]],"region":{"top_left_x":617,"top_left_y":2098,"width":1179,"height":40},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5fe404bf6954483e83d60cdaaeb2d172","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"of standard of care) with respect to time to first occurrence of any of the adjudicated","text_display":" of standard of care) with respect to time to first occurrence of any of the adjudicated","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[617,2135],[1720,2135],[1720,2176],[617,2176]],"region":{"top_left_x":617,"top_left_y":2134,"width":1103,"height":43},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca96611841b846d9ae082ba3302eb694","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"components of the primary composite endpoint (i.e. cardiovascular (CV) death","text_display":" components of the primary composite endpoint (i.e. cardiovascular (CV) death","confidence":0.9722528108395636,"confidence_rate":0.999652660152706},{"cnt":[[617,2220],[617,2174],[1734,2176],[1734,2222]],"region":{"top_left_x":616,"top_left_y":2173,"width":1118,"height":50},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d8805f3f7384bcd93d39ac49a12aecf","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"[including fatal stroke, fatal MI and sudden death], non-fatal stroke or non-fatal","text_display":" [including fatal stroke, fatal MI and sudden death], non-fatal stroke or non-fatal","confidence":1,"confidence_rate":1},{"cnt":[[617,2213],[1748,2213],[1748,2257],[617,2257]],"region":{"top_left_x":617,"top_left_y":2213,"width":1131,"height":44},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96367583624f4687ac0bf13d15509bd1","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"myocardial infarction (MI) (excluding silent MI) and hospitalisation for unstable","text_display":" myocardial infarction (MI) (excluding silent MI) and hospitalisation for unstable","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[617,2255],[1540,2255],[1540,2298],[617,2298]],"region":{"top_left_x":617,"top_left_y":2254,"width":924,"height":45},"line":84,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e14835a3aea492bad29727ee6c88152","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"angina pectoris) in patients with type 2 diabetes mellitus (T2DM).","text_display":" angina pectoris) in patients with type 2 diabetes mellitus (T2DM).","confidence":1,"confidence_rate":1},{"cnt":[[617,2301],[1819,2301],[1819,2344],[617,2344]],"region":{"top_left_x":617,"top_left_y":2300,"width":1202,"height":45},"line":85,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca3fa9d2c6714f34aa29b03ffe61cb1a","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"If non-inferiority has been demonstrated, then the primary composite endpoint will be","text_display":"\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be","confidence":1,"confidence_rate":1},{"cnt":[[617,2342],[1780,2342],[1780,2386],[617,2386]],"region":{"top_left_x":617,"top_left_y":2342,"width":1163,"height":44},"line":86,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8dde0f0e37d4659a2f1d0787dc04d32","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"tested for superiority and the other objective, to assess the impact of treatment with","text_display":" tested for superiority and the other objective, to assess the impact of treatment with","confidence":1,"confidence_rate":1},{"cnt":[[617,2384],[1761,2384],[1761,2425],[617,2425]],"region":{"top_left_x":617,"top_left_y":2383,"width":1145,"height":42},"line":87,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed97440d7fd2487ea15ebcf6c9f0e8dc","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal","text_display":" respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[617,2423],[1759,2423],[1759,2464],[617,2464]],"region":{"top_left_x":617,"top_left_y":2422,"width":1143,"height":43},"line":88,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e68130b7209041d38f09a13991ed9b59","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"disease (ESRD), sustained decrease in estimated global glomerular filtration rate","text_display":" disease (ESRD), sustained decrease in estimated global glomerular filtration rate","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[617,2462],[1711,2462],[1711,2506],[617,2506]],"region":{"top_left_x":617,"top_left_y":2461,"width":1094,"height":45},"line":89,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"013281ebeff846fd8ffc4de9a07b8cb5","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"(eGFR) \\(\\geq 5 0 4 0 \\%\\) from baseline), will be investigated separately with a test on","text_display":" (eGFR) \\(\\geq 5 0 4 0 \\%\\) from baseline), will be investigated separately with a test on","confidence":0.39234398945459104,"confidence_rate":0.9896581122439275},{"cnt":[[617,2503],[780,2503],[780,2542],[617,2542]],"region":{"top_left_x":617,"top_left_y":2503,"width":164,"height":40},"line":90,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55778cf9b9454750a6b0d64c9fab4616","type":"text","conversion_output":false,"parent_id":"603568a090ec400abe44b5aa52a4c056","text":"superiority.","text_display":" superiority.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":91,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e25da8a24bf142d08c6841f6522e6b5d","type":"section_header","conversion_output":false,"children_ids":["7f2257adb08b43a19203731e755391c4"],"text":"","text_display":""},{"cnt":[[795,2586],[1300,2586],[1300,2620],[795,2620]],"region":{"top_left_x":794,"top_left_y":2585,"width":506,"height":36},"line":92,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7f2257adb08b43a19203731e755391c4","type":"text","conversion_output":true,"parent_id":"e25da8a24bf142d08c6841f6522e6b5d","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":1,"confidence_rate":1},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":93,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b312e5ead187475bb2591688f3fae65b","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":94,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"28c385c859b44a64956b4d7ea6cc3c43","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-003","page":3,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1879c9e9a5404ff1b391f7c386404645","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15e3576699fc42c0b0986cb35484caa9","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b07c9ac46904048bfe6361ab5e57314","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d06292f3f2b649cb8c68c4f3ca6b4fa5","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4febf70b8fb54b7ba5ca3f8e0e989624","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1594,210],[1816,210],[1816,254],[1594,254]],"region":{"top_left_x":1594,"top_left_y":210,"width":223,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27c196f7a13f46c2b2a9b1c66db5455e","type":"page_info","conversion_output":false,"text":"Page 3 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1855,334],[1855,2549],[244,2549]],"region":{"top_left_x":244,"top_left_y":333,"width":1611,"height":2217},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c4712db2266343ac99479bf2466a4ff0","type":"table","conversion_output":true,"children_ids":["a461ec1bfb9042fdbcd29e1f25f56c3f","259ac877f6224f72a40f8d7b8bb1c472","3a8354057d374896a9bace9a8102e8c0","173224c64048435ba42aad83a0c78d8b","faecba8e349041ee8cb42ae8ac31a918","2e935257100741ea97cb83d9f68925f2","22471d647b884dfc8840164565cbe630","f2c9f17fd938407e98d15b09dd5d53ed","c84790b6444e4f99bed8f26a16e646d5","cf5dffa456704d8e8480b0c73c6085fe","703e8281b4d94668bd8c7732760f7471","540e4709b35242b580aaee76a54ffc2c","923c22ed0a7b4010a24989cc40d4818f","14264214106c4f1c81c51846d7078482","4338cb1941bb48ec82732c63436c5eb4","0d3653ae5f3f46549c51c35f85a5f19d","6031dd8fcbef4ecf8175440ac54086ff","9d7b7fbd28d04b5eb1bd2f1c67c8317c","fbe0db8498254e50bbc28f6ea43d7669","85b161ba63f24c77af4e1331b44493e3","35e6600667a5462c96ac73c4724d5ff9","dec089f0add7494e800211058dbf85cf","94b78b45056c4c89bc38930f899f0e81","1a2b15721f4c450493597bb09b094a1a","ee2e2694831b4f85b32ae97fe39711d7","16b48216c19a4da5b40aa426a3575d06","31243eb8866040ae8fc9744322f588ec","7918076c862d4e4d96bd1b7e454b8ed7","1bfd9f5dfd4241a5aaeb7d8f228b8965","85a6f4ecdd7646b0bedf714d966d08e2","ae3981ae5022410a90b0beab5fc049be","2e29e63bd39842d2ac11665845392692","0705fc247eb249b895ee947a099e88bf","efcb989069be4873bc04a8c14526bcad","b224193e048d49839c088303786bee1f","ce04c571441442968e615da46bc03bc0","78e348180c454af594ad657aebd15c50"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline \\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular} & & \\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular} & \\multirow{3}{*}{} \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular} & & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline Methodology: & & & This randomized, double-blind, placebo controlled, parallel group study compares treatment with linagliptin ( 5 mg once daily) to treatment with placebo (matching tablets once daily) as add-on therapy to standard of care. \\\\\n\\hline \\multicolumn{4}{|l|}{\\begin{tabular}{l}\nNo. of patients: \\\\\ntotal entered: \\\\\neach treatment: \\\\\nAn estimated 83007000 randomized patients to obtain a minimum of 625611 primary endpoint events. \\\\\nAn estimated \\(4150 3 5 0 0\\) randomized patients per treatment group.\n\\end{tabular}} \\\\\n\\hline Diagnosis : & T2DM & & \\\\\n\\hline Criteria for inclusion: & & & \\begin{tabular}{l}\n1. Documented diagnosis of T2DM before visit 1(screening). \\\\\n2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors if \\(\\geq\\) consecutive 7 days. \\\\\n3. Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than \\(10 \\%\\) within the 8 weeks prior to randomization compared with the daily insulin dose at randomization. \\\\\n4. HbA1c of \\(\\geq 6.5 \\%\\) and \\(\\leq 10.0 \\%\\) at visit 1 (screening) \\\\\n5. Age \\(\\geq 18\\) years at visit 1 (screening). For Japan only: Age \\(\\geq 20\\) years at visit 1 \\\\\n6. Body Mass Index (BMI) \\(\\leq 45 kg / m ^{2}\\) at visit 1 (screening) \\\\\n7. Signed and dated written informed consent by date of visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure \\\\\n8.High risk of CV events defined by: \\\\\n- Albuminuria (micro or macro) and previous macrovascular disease: defined according to section 3.3.2 and/or \\\\\n- Impaired renal function with predefined UACR: for criteria see section 3.3.2 Refer to section 3.3.3 for exclusion criteria.\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nTest product(s): \\\\\ndose: \\\\\nmode of admin.:\n\\end{tabular} & \\begin{tabular}{l}\nLinagliptin \\\\\n5 mg \\\\\nTablets per os\n\\end{tabular} & & \\\\\n\\hline & & & \\\\\n\\hline mode of admin.: & Tablets per os & & \\\\\n\\hline Duration of treatment: & & & Estimated 4854 months treatment period from first patient randomized, depending on observed number of primary endpoint events. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular} & & \\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular} & \\multirow{3}{*}{} \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular} & & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline Methodology: & & & This randomized, double-blind, placebo controlled, parallel group study compares treatment with linagliptin ( 5 mg once daily) to treatment with placebo (matching tablets once daily) as add-on therapy to standard of care. \\\\\n\\hline \\multicolumn{4}{|l|}{\\begin{tabular}{l}\nNo. of patients: \\\\\ntotal entered: \\\\\neach treatment: \\\\\nAn estimated 83007000 randomized patients to obtain a minimum of 625611 primary endpoint events. \\\\\nAn estimated \\(4150 3 5 0 0\\) randomized patients per treatment group.\n\\end{tabular}} \\\\\n\\hline Diagnosis : & T2DM & & \\\\\n\\hline Criteria for inclusion: & & & \\begin{tabular}{l}\n1. Documented diagnosis of T2DM before visit 1(screening). \\\\\n2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors if \\(\\geq\\) consecutive 7 days. \\\\\n3. Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than \\(10 \\%\\) within the 8 weeks prior to randomization compared with the daily insulin dose at randomization. \\\\\n4. HbA1c of \\(\\geq 6.5 \\%\\) and \\(\\leq 10.0 \\%\\) at visit 1 (screening) \\\\\n5. Age \\(\\geq 18\\) years at visit 1 (screening). For Japan only: Age \\(\\geq 20\\) years at visit 1 \\\\\n6. Body Mass Index (BMI) \\(\\leq 45 kg / m ^{2}\\) at visit 1 (screening) \\\\\n7. Signed and dated written informed consent by date of visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure \\\\\n8.High risk of CV events defined by: \\\\\n- Albuminuria (micro or macro) and previous macrovascular disease: defined according to section 3.3.2 and/or \\\\\n- Impaired renal function with predefined UACR: for criteria see section 3.3.2 Refer to section 3.3.3 for exclusion criteria.\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nTest product(s): \\\\\ndose: \\\\\nmode of admin.:\n\\end{tabular} & \\begin{tabular}{l}\nLinagliptin \\\\\n5 mg \\\\\nTablets per os\n\\end{tabular} & & \\\\\n\\hline & & & \\\\\n\\hline mode of admin.: & Tablets per os & & \\\\\n\\hline Duration of treatment: & & & Estimated 4854 months treatment period from first patient randomized, depending on observed number of primary endpoint events. \\\\\n\\hline\n\\end{tabular}","confidence":0.48566436767578125,"confidence_rate":0.9990126139897068},{"cnt":[[244,333],[592,333],[592,2550],[244,2550]],"region":{"top_left_x":244,"top_left_y":333,"width":348,"height":2218},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a461ec1bfb9042fdbcd29e1f25f56c3f","type":"table_column","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[612,333],[847,333],[847,2550],[612,2550]],"region":{"top_left_x":612,"top_left_y":333,"width":236,"height":2218},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"259ac877f6224f72a40f8d7b8bb1c472","type":"table_column","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[1096,333],[1324,333],[1324,2550],[1096,2550]],"region":{"top_left_x":1095,"top_left_y":333,"width":229,"height":2218},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a8354057d374896a9bace9a8102e8c0","type":"table_column","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[1450,2550],[1459,332],[1776,333],[1768,2551]],"region":{"top_left_x":1450,"top_left_y":331,"width":327,"height":2221},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"173224c64048435ba42aad83a0c78d8b","type":"table_column","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,340],[1858,340],[1858,483],[244,483]],"region":{"top_left_x":244,"top_left_y":339,"width":1615,"height":144},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"faecba8e349041ee8cb42ae8ac31a918","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,485],[1853,485],[1853,621],[244,621]],"region":{"top_left_x":244,"top_left_y":484,"width":1610,"height":137},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e935257100741ea97cb83d9f68925f2","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,623],[1856,623],[1856,764],[244,764]],"region":{"top_left_x":244,"top_left_y":623,"width":1612,"height":141},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22471d647b884dfc8840164565cbe630","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,766],[1856,766],[1856,863],[244,863]],"region":{"top_left_x":244,"top_left_y":765,"width":1612,"height":98},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2c9f17fd938407e98d15b09dd5d53ed","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,869],[1856,869],[1856,1003],[244,1003]],"region":{"top_left_x":244,"top_left_y":869,"width":1612,"height":135},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c84790b6444e4f99bed8f26a16e646d5","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,1005],[1856,1005],[1856,1210],[244,1210]],"region":{"top_left_x":244,"top_left_y":1005,"width":1612,"height":206},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf5dffa456704d8e8480b0c73c6085fe","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,1217],[1856,1217],[1856,1266],[244,1266]],"region":{"top_left_x":244,"top_left_y":1217,"width":1612,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"703e8281b4d94668bd8c7732760f7471","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,1279],[1858,1279],[1858,2140],[244,2140]],"region":{"top_left_x":244,"top_left_y":1279,"width":1615,"height":862},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"540e4709b35242b580aaee76a54ffc2c","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,2143],[1858,2143],[1858,2288],[244,2288]],"region":{"top_left_x":244,"top_left_y":2142,"width":1615,"height":146},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"923c22ed0a7b4010a24989cc40d4818f","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,2290],[1856,2290],[1856,2391],[244,2391]],"region":{"top_left_x":244,"top_left_y":2290,"width":1612,"height":102},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14264214106c4f1c81c51846d7078482","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,2401],[1856,2401],[1856,2449],[244,2449]],"region":{"top_left_x":244,"top_left_y":2400,"width":1612,"height":50},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4338cb1941bb48ec82732c63436c5eb4","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[244,2454],[1858,2454],[1858,2548],[244,2548]],"region":{"top_left_x":244,"top_left_y":2453,"width":1615,"height":96},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d3653ae5f3f46549c51c35f85a5f19d","type":"table_row","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":""},{"cnt":[[253,345],[580,345],[580,478],[253,478]],"region":{"top_left_x":253,"top_left_y":344,"width":328,"height":135},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6031dd8fcbef4ecf8175440ac54086ff","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["637ab937b864408a94dff4984f91ef7b","e660947492d540cc887d1939ef723615"],"text":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[258,347],[546,347],[546,391],[258,391]],"region":{"top_left_x":257,"top_left_y":346,"width":289,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"637ab937b864408a94dff4984f91ef7b","type":"text","conversion_output":false,"parent_id":"6031dd8fcbef4ecf8175440ac54086ff","text":"Name of company:","text_display":"Name of company:","confidence":1,"confidence_rate":1},{"cnt":[[258,434],[573,434],[573,473],[258,473]],"region":{"top_left_x":257,"top_left_y":434,"width":317,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e660947492d540cc887d1939ef723615","type":"text","conversion_output":false,"parent_id":"6031dd8fcbef4ecf8175440ac54086ff","text":"Boehringer Ingelheim","text_display":"\nBoehringer Ingelheim","confidence":1,"confidence_rate":1},{"cnt":[[1096,345],[1322,345],[1322,432],[1096,432]],"region":{"top_left_x":1095,"top_left_y":344,"width":227,"height":89},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d7b7fbd28d04b5eb1bd2f1c67c8317c","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["615bf3a2115540859c3d43026ec7ba51","eb770fb68d0f4b6a9274824470093607"],"text":"\\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular}","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1128,347],[1289,347],[1289,381],[1128,381]],"region":{"top_left_x":1128,"top_left_y":346,"width":162,"height":36},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"615bf3a2115540859c3d43026ec7ba51","type":"text","conversion_output":false,"parent_id":"9d7b7fbd28d04b5eb1bd2f1c67c8317c","text":"Tabulated","text_display":"Tabulated","confidence":1,"confidence_rate":1},{"cnt":[[1101,393],[1319,393],[1319,427],[1101,427]],"region":{"top_left_x":1100,"top_left_y":392,"width":220,"height":36},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb770fb68d0f4b6a9274824470093607","type":"text","conversion_output":false,"parent_id":"9d7b7fbd28d04b5eb1bd2f1c67c8317c","text":"Trial Protocol","text_display":"\nTrial Protocol","confidence":1,"confidence_rate":1},{"cnt":[[1462,342],[1840,342],[1840,761],[1462,761]],"region":{"top_left_x":1462,"top_left_y":342,"width":378,"height":420},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fbe0db8498254e50bbc28f6ea43d7669","type":"table_spanning_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"","text_display":"","cell_row":0,"cell_column":3,"cell_row_span":3,"cell_col_span":1},{"cnt":[[253,485],[661,485],[661,621],[253,621]],"region":{"top_left_x":253,"top_left_y":484,"width":408,"height":137},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85b161ba63f24c77af4e1331b44493e3","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["15514474bf894b189afd1845ef019cc6","ef985f3c05344eaaa44ba45d4e6f61a8"],"text":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.48566436767578125,"confidence_rate":0.9829508787495259},{"cnt":[[258,490],[652,490],[652,529],[258,529]],"region":{"top_left_x":257,"top_left_y":489,"width":395,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15514474bf894b189afd1845ef019cc6","type":"text","conversion_output":false,"parent_id":"85b161ba63f24c77af4e1331b44493e3","text":"Name of finished product:","text_display":"Name of finished product:","confidence":1,"confidence_rate":1},{"cnt":[[258,577],[407,577],[407,616],[258,616]],"region":{"top_left_x":257,"top_left_y":577,"width":151,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef985f3c05344eaaa44ba45d4e6f61a8","type":"text","conversion_output":false,"parent_id":"85b161ba63f24c77af4e1331b44493e3","text":"Trajenta \\({ }^{\\circledR}\\)","text_display":"\nTrajenta \\({ }^{\\circledR}\\)","confidence":0.48566436767578125,"confidence_rate":0.9661924300344652},{"cnt":[[253,623],[661,623],[661,761],[253,761]],"region":{"top_left_x":253,"top_left_y":623,"width":408,"height":139},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35e6600667a5462c96ac73c4724d5ff9","type":"table_spanning_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["cbd7a30822714cdd9d1cc476c8c94c58"],"text":"","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1},{"cnt":[[256,628],[661,628],[661,759],[256,759]],"region":{"top_left_x":255,"top_left_y":627,"width":406,"height":132},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cbd7a30822714cdd9d1cc476c8c94c58","type":"complex_cell","conversion_output":false,"parent_id":"35e6600667a5462c96ac73c4724d5ff9","children_ids":["4949b8fee28843e6b8ba94a5d3401a6a","9e89a22738214bcb9f44037062b4ec59"],"text":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99267578125,"confidence_rate":0.9998586412895639},{"cnt":[[258,630],[656,630],[656,671],[258,671]],"region":{"top_left_x":257,"top_left_y":630,"width":400,"height":42},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4949b8fee28843e6b8ba94a5d3401a6a","type":"text","conversion_output":false,"parent_id":"cbd7a30822714cdd9d1cc476c8c94c58","text":"Name of active ingredient:","text_display":"Name of active ingredient:","confidence":1,"confidence_rate":1},{"cnt":[[258,715],[564,715],[564,754],[258,754]],"region":{"top_left_x":257,"top_left_y":715,"width":308,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e89a22738214bcb9f44037062b4ec59","type":"text","conversion_output":false,"parent_id":"cbd7a30822714cdd9d1cc476c8c94c58","text":"Linagliptin (BI 1356)","text_display":"\nLinagliptin (BI 1356)","confidence":0.99267578125,"confidence_rate":0.9997173025614129},{"cnt":[[253,770],[497,770],[497,860],[253,860]],"region":{"top_left_x":253,"top_left_y":770,"width":245,"height":91},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dec089f0add7494e800211058dbf85cf","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["7c94d41ead2d4916947311b7e6d8641e","0414977fbbca4ff78bc804d1c1b3d5b0"],"text":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[258,775],[472,775],[472,810],[258,810]],"region":{"top_left_x":257,"top_left_y":775,"width":215,"height":35},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c94d41ead2d4916947311b7e6d8641e","type":"text","conversion_output":false,"parent_id":"dec089f0add7494e800211058dbf85cf","text":"Protocol date:","text_display":"Protocol date:","confidence":1,"confidence_rate":1},{"cnt":[[258,817],[495,817],[495,856],[258,856]],"region":{"top_left_x":257,"top_left_y":816,"width":238,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0414977fbbca4ff78bc804d1c1b3d5b0","type":"text","conversion_output":false,"parent_id":"dec089f0add7494e800211058dbf85cf","text":"5 February 2013","text_display":"\n5 February 2013","confidence":1,"confidence_rate":1},{"cnt":[[624,770],[850,770],[850,856],[624,856]],"region":{"top_left_x":623,"top_left_y":770,"width":227,"height":86},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94b78b45056c4c89bc38930f899f0e81","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["4a066540aea1423c8b870558b5ce79be","5412b34e8d184bd0a18cc10d22464cef"],"text":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[626,770],[845,770],[845,810],[626,810]],"region":{"top_left_x":626,"top_left_y":770,"width":219,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a066540aea1423c8b870558b5ce79be","type":"text","conversion_output":false,"parent_id":"94b78b45056c4c89bc38930f899f0e81","text":"Trial number:","text_display":"Trial number:","confidence":1,"confidence_rate":1},{"cnt":[[631,817],[748,817],[748,851],[631,851]],"region":{"top_left_x":630,"top_left_y":816,"width":119,"height":36},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5412b34e8d184bd0a18cc10d22464cef","type":"text","conversion_output":false,"parent_id":"94b78b45056c4c89bc38930f899f0e81","text":"1218.22","text_display":"\n1218.22","confidence":1,"confidence_rate":1},{"cnt":[[1462,770],[1752,770],[1752,851],[1462,851]],"region":{"top_left_x":1462,"top_left_y":770,"width":291,"height":82},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a2b15721f4c450493597bb09b094a1a","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["a6b092dadd9f4921a1de8a30fd301fa0","b989b6eeb72547fe99a0768a581253a6"],"text":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","cell_row":3,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999871474379078},{"cnt":[[1467,775],[1683,775],[1683,807],[1467,807]],"region":{"top_left_x":1466,"top_left_y":775,"width":218,"height":33},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6b092dadd9f4921a1de8a30fd301fa0","type":"text","conversion_output":false,"parent_id":"1a2b15721f4c450493597bb09b094a1a","text":"Revision date:","text_display":"Revision date:","confidence":1,"confidence_rate":1},{"cnt":[[1464,814],[1748,814],[1748,851],[1464,851]],"region":{"top_left_x":1464,"top_left_y":814,"width":284,"height":38},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b989b6eeb72547fe99a0768a581253a6","type":"text","conversion_output":false,"parent_id":"1a2b15721f4c450493597bb09b094a1a","text":"22 November 2016","text_display":"\n22 November 2016","confidence":0.99951171875,"confidence_rate":0.999974295041004},{"cnt":[[253,876],[463,876],[463,916],[253,916]],"region":{"top_left_x":253,"top_left_y":876,"width":210,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee2e2694831b4f85b32ae97fe39711d7","type":"simple_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"Methodology:","text_display":"Methodology:","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[612,872],[1768,872],[1768,998],[612,998]],"region":{"top_left_x":612,"top_left_y":871,"width":1157,"height":128},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16b48216c19a4da5b40aa426a3575d06","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["8d9050a641a94b92a6925c053f3c16b4","8442a0adf15c481793dd7c5059e22788","d517d8ce0f8b4623b899c609f3f45412"],"text":"This randomized, double-blind, placebo controlled, parallel group study compares treatment with linagliptin ( 5 mg once daily) to treatment with placebo (matching tablets once daily) as add-on therapy to standard of care.","text_display":"This randomized, double-blind, placebo controlled, parallel group study compares treatment with linagliptin ( 5 mg once daily) to treatment with placebo (matching tablets once daily) as add-on therapy to standard of care.","cell_row":4,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":0.9853515625,"confidence_rate":0.9999407780733317},{"cnt":[[617,876],[1761,876],[1761,916],[617,916]],"region":{"top_left_x":617,"top_left_y":876,"width":1145,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d9050a641a94b92a6925c053f3c16b4","type":"text","conversion_output":false,"parent_id":"16b48216c19a4da5b40aa426a3575d06","text":"This randomized, double-blind, placebo controlled, parallel group study compares","text_display":"This randomized, double-blind, placebo controlled, parallel group study compares","confidence":1,"confidence_rate":1},{"cnt":[[617,913],[1743,913],[1743,955],[617,955]],"region":{"top_left_x":617,"top_left_y":913,"width":1126,"height":42},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8442a0adf15c481793dd7c5059e22788","type":"text","conversion_output":false,"parent_id":"16b48216c19a4da5b40aa426a3575d06","text":"treatment with linagliptin ( 5 mg once daily) to treatment with placebo (matching","text_display":" treatment with linagliptin ( 5 mg once daily) to treatment with placebo (matching","confidence":0.9853515625,"confidence_rate":0.9998378506723944},{"cnt":[[617,955],[1407,955],[1407,994],[617,994]],"region":{"top_left_x":617,"top_left_y":954,"width":790,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d517d8ce0f8b4623b899c609f3f45412","type":"text","conversion_output":false,"parent_id":"16b48216c19a4da5b40aa426a3575d06","text":"tablets once daily) as add-on therapy to standard of care.","text_display":" tablets once daily) as add-on therapy to standard of care.","confidence":0.9990234375,"confidence_rate":0.9999844915544187},{"cnt":[[244,1003],[1853,1003],[1853,1219],[244,1219]],"region":{"top_left_x":244,"top_left_y":1003,"width":1610,"height":217},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31243eb8866040ae8fc9744322f588ec","type":"table_spanning_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["8947fe248a3543c0bd6963994a175f97"],"text":"","text_display":"\\begin{tabular}{l}\nNo. of patients: \\\\\ntotal entered: \\\\\neach treatment: \\\\\nAn estimated 83007000 randomized patients to obtain a minimum of 625611 primary endpoint events. \\\\\nAn estimated \\(4150 3 5 0 0\\) randomized patients per treatment group.\n\\end{tabular}","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":4},{"cnt":[[246,1005],[1840,1005],[1840,1210],[246,1210]],"region":{"top_left_x":246,"top_left_y":1005,"width":1594,"height":206},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8947fe248a3543c0bd6963994a175f97","type":"complex_cell","conversion_output":false,"parent_id":"31243eb8866040ae8fc9744322f588ec","children_ids":["bfecdd1fefee4082877929713704be7d","cab9b8b8f3e144b684c0ab83b8d04839","5a65110f0c754069a5b666b1207c1485","167613e700504508a94ce7128e768d97"],"text":"\\begin{tabular}{l}\nNo. of patients: \\\\\ntotal entered: \\\\\neach treatment: \\\\\nAn estimated 83007000 randomized patients to obtain a minimum of 625611 primary endpoint events. \\\\\nAn estimated \\(4150 3 5 0 0\\) randomized patients per treatment group.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nNo. of patients: \\\\\ntotal entered: \\\\\neach treatment: \\\\\nAn estimated 83007000 randomized patients to obtain a minimum of 625611 primary endpoint events. \\\\\nAn estimated \\(4150 3 5 0 0\\) randomized patients per treatment group.\n\\end{tabular}","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":4,"confidence":0.5843896865844727,"confidence_rate":0.9963273958618651},{"cnt":[[253,1010],[481,1010],[481,1049],[253,1049]],"region":{"top_left_x":253,"top_left_y":1009,"width":229,"height":41},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bfecdd1fefee4082877929713704be7d","type":"text","conversion_output":false,"parent_id":"8947fe248a3543c0bd6963994a175f97","text":"No. of patients:","text_display":"No. of patients:","confidence":1,"confidence_rate":1},{"cnt":[[329,1072],[577,1072],[577,1205],[329,1205]],"region":{"top_left_x":329,"top_left_y":1072,"width":248,"height":133},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cab9b8b8f3e144b684c0ab83b8d04839","type":"column","conversion_output":false,"parent_id":"8947fe248a3543c0bd6963994a175f97","children_ids":["80bc28b4ab92470199bf73d6586d084b","a7f6a6455b624d3cbdd3e2fa09da0f2e"],"text":"","text_display":""},{"cnt":[[331,1074],[541,1074],[541,1109],[331,1109]],"region":{"top_left_x":331,"top_left_y":1074,"width":211,"height":35},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80bc28b4ab92470199bf73d6586d084b","type":"text","conversion_output":false,"parent_id":"cab9b8b8f3e144b684c0ab83b8d04839","text":"total entered:","text_display":"\ntotal entered:","confidence":1,"confidence_rate":1},{"cnt":[[331,1167],[573,1167],[573,1201],[331,1201]],"region":{"top_left_x":331,"top_left_y":1166,"width":243,"height":36},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7f6a6455b624d3cbdd3e2fa09da0f2e","type":"text","conversion_output":false,"parent_id":"cab9b8b8f3e144b684c0ab83b8d04839","text":"each treatment:","text_display":"\neach treatment:","confidence":1,"confidence_rate":1},{"cnt":[[610,1070],[1834,1070],[1834,1156],[610,1156]],"region":{"top_left_x":610,"top_left_y":1070,"width":1224,"height":86},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a65110f0c754069a5b666b1207c1485","type":"column","conversion_output":false,"parent_id":"8947fe248a3543c0bd6963994a175f97","children_ids":["90d36634360e4405b8788c2e2417052e","46fe36c8df784bc18b8d849cb1a6001a"],"text":"","text_display":""},{"cnt":[[612,1072],[1830,1072],[1830,1116],[612,1116]],"region":{"top_left_x":612,"top_left_y":1072,"width":1219,"height":44},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90d36634360e4405b8788c2e2417052e","type":"text","conversion_output":false,"parent_id":"5a65110f0c754069a5b666b1207c1485","text":"An estimated 83007000 randomized patients to obtain a minimum of 625611 primary","text_display":"\nAn estimated 83007000 randomized patients to obtain a minimum of 625611 primary","confidence":0.6944424589164555,"confidence_rate":0.9959565748268435},{"cnt":[[617,1114],[850,1114],[850,1153],[617,1153]],"region":{"top_left_x":617,"top_left_y":1113,"width":233,"height":40},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"46fe36c8df784bc18b8d849cb1a6001a","type":"text","conversion_output":false,"parent_id":"5a65110f0c754069a5b666b1207c1485","text":"endpoint events.","text_display":" endpoint events.","confidence":1,"confidence_rate":1},{"cnt":[[615,1164],[1545,1164],[1545,1206],[615,1206]],"region":{"top_left_x":614,"top_left_y":1164,"width":931,"height":42},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"167613e700504508a94ce7128e768d97","type":"text","conversion_output":false,"parent_id":"8947fe248a3543c0bd6963994a175f97","text":"An estimated \\(4150 3 5 0 0\\) randomized patients per treatment group.","text_display":"\nAn estimated \\(4150 3 5 0 0\\) randomized patients per treatment group.","confidence":0.5843896865844727,"confidence_rate":0.9926682797448857},{"cnt":[[249,1222],[417,1222],[417,1261],[249,1261]],"region":{"top_left_x":248,"top_left_y":1221,"width":169,"height":40},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7918076c862d4e4d96bd1b7e454b8ed7","type":"simple_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"Diagnosis :","text_display":"Diagnosis :","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[617,1219],[721,1219],[721,1256],[617,1256]],"region":{"top_left_x":617,"top_left_y":1219,"width":104,"height":38},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1bfd9f5dfd4241a5aaeb7d8f228b8965","type":"simple_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"T2DM","text_display":"T2DM","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1284],[458,1284],[458,1369],[249,1369]],"region":{"top_left_x":248,"top_left_y":1283,"width":211,"height":87},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85a6f4ecdd7646b0bedf714d966d08e2","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["8e03b88e27e44bfa8641410676f57379","7578aed2cb114862ac19f186018e6591"],"text":"Criteria for inclusion:","text_display":"Criteria for inclusion:","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999871474379078},{"cnt":[[253,1291],[375,1291],[375,1325],[253,1325]],"region":{"top_left_x":253,"top_left_y":1290,"width":123,"height":36},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e03b88e27e44bfa8641410676f57379","type":"text","conversion_output":false,"parent_id":"85a6f4ecdd7646b0bedf714d966d08e2","text":"Criteria","text_display":"Criteria","confidence":1,"confidence_rate":1},{"cnt":[[253,1330],[454,1330],[454,1367],[253,1367]],"region":{"top_left_x":253,"top_left_y":1329,"width":201,"height":38},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7578aed2cb114862ac19f186018e6591","type":"text","conversion_output":false,"parent_id":"85a6f4ecdd7646b0bedf714d966d08e2","text":"for inclusion:","text_display":" for inclusion:","confidence":0.99951171875,"confidence_rate":0.999974295041004},{"cnt":[[605,1277],[1842,1277],[1842,2140],[605,2140]],"region":{"top_left_x":605,"top_left_y":1277,"width":1237,"height":864},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae3981ae5022410a90b0beab5fc049be","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["ba9db224c53b47ce8ac3192d67972c23","c6632c3bfd61489cb11ea0e160b44b9b","56712e12ffca47a3b71c00d65aaa84ab","32ade4960afc4086ae505541360a33a1","c104924169dd467895c583c0709c9778","c5128d60f33a4cbcaa995b47d42bdfd2","c1feba2638494f94a745f33726afb2d2","6a1ea675e40044a1850c65acdd36d5b6","093c3f1ec40645a0ae93ce41f43a99ea","04e24381846347ba9914261e5c307c77","1b3623053b2547bfad2fb7e3f31ad22e","0d4f4eeaa4964aa0bef0e3f0cef89d9e","97508c182c3b48abbad6356a2dfea4a0","8ca9f4c667984704b1627336fb4d0a3e","2d44f908613a4a20b92301c98d8ec03d","ffa1e09b967d4558bfe30c004ead641c","77da9b7c0ae649c5a3d701cfe55105d5","2f3f33903ab3465d89784cc7578b611b","999a7af7d36d4b70bff7e9848adb3976"],"text":"\\begin{tabular}{l}\n1. Documented diagnosis of T2DM before visit 1(screening). \\\\\n2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors if \\(\\geq\\) consecutive 7 days. \\\\\n3. Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than \\(10 \\%\\) within the 8 weeks prior to randomization compared with the daily insulin dose at randomization. \\\\\n4. HbA1c of \\(\\geq 6.5 \\%\\) and \\(\\leq 10.0 \\%\\) at visit 1 (screening) \\\\\n5. Age \\(\\geq 18\\) years at visit 1 (screening). For Japan only: Age \\(\\geq 20\\) years at visit 1 \\\\\n6. Body Mass Index (BMI) \\(\\leq 45 kg / m ^{2}\\) at visit 1 (screening) \\\\\n7. Signed and dated written informed consent by date of visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure \\\\\n8.High risk of CV events defined by: \\\\\n- Albuminuria (micro or macro) and previous macrovascular disease: defined according to section 3.3.2 and/or \\\\\n- Impaired renal function with predefined UACR: for criteria see section 3.3.2 Refer to section 3.3.3 for exclusion criteria.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n1. Documented diagnosis of T2DM before visit 1(screening). \\\\\n2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors if \\(\\geq\\) consecutive 7 days. \\\\\n3. Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than \\(10 \\%\\) within the 8 weeks prior to randomization compared with the daily insulin dose at randomization. \\\\\n4. HbA1c of \\(\\geq 6.5 \\%\\) and \\(\\leq 10.0 \\%\\) at visit 1 (screening) \\\\\n5. Age \\(\\geq 18\\) years at visit 1 (screening). For Japan only: Age \\(\\geq 20\\) years at visit 1 \\\\\n6. Body Mass Index (BMI) \\(\\leq 45 kg / m ^{2}\\) at visit 1 (screening) \\\\\n7. Signed and dated written informed consent by date of visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure \\\\\n8.High risk of CV events defined by: \\\\\n- Albuminuria (micro or macro) and previous macrovascular disease: defined according to section 3.3.2 and/or \\\\\n- Impaired renal function with predefined UACR: for criteria see section 3.3.2 Refer to section 3.3.3 for exclusion criteria.\n\\end{tabular}","cell_row":7,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":0.53125,"confidence_rate":0.999507205313068},{"cnt":[[617,1286],[1474,1286],[1474,1325],[617,1325]],"region":{"top_left_x":617,"top_left_y":1286,"width":857,"height":40},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba9db224c53b47ce8ac3192d67972c23","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"1. Documented diagnosis of T2DM before visit 1(screening).","text_display":"1. Documented diagnosis of T2DM before visit 1(screening).","confidence":1,"confidence_rate":1},{"cnt":[[615,1332],[1764,1332],[1764,1376],[615,1376]],"region":{"top_left_x":614,"top_left_y":1332,"width":1150,"height":45},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6632c3bfd61489cb11ea0e160b44b9b","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic","text_display":"\n2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic","confidence":1,"confidence_rate":1},{"cnt":[[615,1374],[1775,1374],[1775,1415],[615,1415]],"region":{"top_left_x":614,"top_left_y":1373,"width":1162,"height":43},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56712e12ffca47a3b71c00d65aaa84ab","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"background medication, excluding treatment with GLP-1 receptor agonists, DPP-4","text_display":" background medication, excluding treatment with GLP-1 receptor agonists, DPP-4","confidence":1,"confidence_rate":1},{"cnt":[[617,1413],[1407,1413],[1407,1454],[617,1454]],"region":{"top_left_x":617,"top_left_y":1412,"width":790,"height":43},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"32ade4960afc4086ae505541360a33a1","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"inhibitors or SGLT-2 inhibitors if \\(\\geq\\) consecutive 7 days.","text_display":" inhibitors or SGLT-2 inhibitors if \\(\\geq\\) consecutive 7 days.","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[615,1461],[1766,1461],[1766,1500],[615,1500]],"region":{"top_left_x":614,"top_left_y":1461,"width":1152,"height":40},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c104924169dd467895c583c0709c9778","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"3. Stable antidiabetic background medication (unchanged daily dose) for at least 8","text_display":"\n3. Stable antidiabetic background medication (unchanged daily dose) for at least 8","confidence":1,"confidence_rate":1},{"cnt":[[615,1503],[1821,1503],[1821,1542],[615,1542]],"region":{"top_left_x":614,"top_left_y":1502,"width":1208,"height":40},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5128d60f33a4cbcaa995b47d42bdfd2","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"weeks prior to randomization. If insulin is part of the background therapy, the average","text_display":" weeks prior to randomization. If insulin is part of the background therapy, the average","confidence":1,"confidence_rate":1},{"cnt":[[617,1540],[1835,1540],[1835,1583],[617,1583]],"region":{"top_left_x":617,"top_left_y":1539,"width":1219,"height":45},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1feba2638494f94a745f33726afb2d2","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"daily insulin dose should not have changed by more than \\(10 \\%\\) within the 8 weeks prior","text_display":" daily insulin dose should not have changed by more than \\(10 \\%\\) within the 8 weeks prior","confidence":0.974609375,"confidence_rate":0.9997293152807948},{"cnt":[[615,1581],[1632,1581],[1632,1625],[615,1625]],"region":{"top_left_x":614,"top_left_y":1580,"width":1019,"height":45},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a1ea675e40044a1850c65acdd36d5b6","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"to randomization compared with the daily insulin dose at randomization.","text_display":" to randomization compared with the daily insulin dose at randomization.","confidence":1,"confidence_rate":1},{"cnt":[[615,1627],[1393,1627],[1393,1671],[615,1671]],"region":{"top_left_x":614,"top_left_y":1627,"width":779,"height":44},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"093c3f1ec40645a0ae93ce41f43a99ea","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"4. HbA1c of \\(\\geq 6.5 \\%\\) and \\(\\leq 10.0 \\%\\) at visit 1 (screening)","text_display":"\n4. HbA1c of \\(\\geq 6.5 \\%\\) and \\(\\leq 10.0 \\%\\) at visit 1 (screening)","confidence":0.9446697235107422,"confidence_rate":0.9991246923591488},{"cnt":[[617,1678],[1743,1678],[1743,1721],[617,1721]],"region":{"top_left_x":617,"top_left_y":1677,"width":1126,"height":45},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04e24381846347ba9914261e5c307c77","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"5. Age \\(\\geq 18\\) years at visit 1 (screening). For Japan only: Age \\(\\geq 20\\) years at visit 1","text_display":"\n5. Age \\(\\geq 18\\) years at visit 1 (screening). For Japan only: Age \\(\\geq 20\\) years at visit 1","confidence":0.98876953125,"confidence_rate":0.9998798582110203},{"cnt":[[617,1724],[1457,1724],[1457,1772],[617,1772]],"region":{"top_left_x":617,"top_left_y":1723,"width":841,"height":50},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b3623053b2547bfad2fb7e3f31ad22e","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"6. Body Mass Index (BMI) \\(\\leq 45 kg / m ^{2}\\) at visit 1 (screening)","text_display":"\n6. Body Mass Index (BMI) \\(\\leq 45 kg / m ^{2}\\) at visit 1 (screening)","confidence":0.9970703125,"confidence_rate":0.9999633258295789},{"cnt":[[615,1774],[1690,1774],[1690,1818],[615,1818]],"region":{"top_left_x":614,"top_left_y":1774,"width":1076,"height":45},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d4f4eeaa4964aa0bef0e3f0cef89d9e","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"7. Signed and dated written informed consent by date of visit 1(screening) in","text_display":"\n7. Signed and dated written informed consent by date of visit 1(screening) in","confidence":0.53125,"confidence_rate":0.9923159844158345},{"cnt":[[615,1816],[1819,1816],[1819,1860],[615,1860]],"region":{"top_left_x":614,"top_left_y":1815,"width":1205,"height":45},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97508c182c3b48abbad6356a2dfea4a0","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"accordance with Good Clinical Practice (GCP) and local legislation prior to any study","text_display":" accordance with Good Clinical Practice (GCP) and local legislation prior to any study","confidence":1,"confidence_rate":1},{"cnt":[[617,1857],[866,1857],[866,1901],[617,1901]],"region":{"top_left_x":617,"top_left_y":1857,"width":249,"height":45},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ca9f4c667984704b1627336fb4d0a3e","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"related procedure","text_display":" related procedure","confidence":1,"confidence_rate":1},{"cnt":[[617,1903],[1137,1903],[1137,1947],[617,1947]],"region":{"top_left_x":617,"top_left_y":1903,"width":521,"height":45},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d44f908613a4a20b92301c98d8ec03d","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"8.High risk of CV events defined by:","text_display":"\n8.High risk of CV events defined by:","confidence":0.9863464774098247,"confidence_rate":0.9996647491569907},{"cnt":[[677,1954],[1803,1954],[1803,1998],[677,1998]],"region":{"top_left_x":676,"top_left_y":1953,"width":1127,"height":45},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ffa1e09b967d4558bfe30c004ead641c","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"- Albuminuria (micro or macro) and previous macrovascular disease: defined","text_display":"\n- Albuminuria (micro or macro) and previous macrovascular disease: defined","confidence":1,"confidence_rate":1},{"cnt":[[741,1995],[1213,1995],[1213,2035],[741,2035]],"region":{"top_left_x":741,"top_left_y":1995,"width":473,"height":40},"line":84,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77da9b7c0ae649c5a3d701cfe55105d5","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"according to section 3.3.2 and/or","text_display":" according to section 3.3.2 and/or","confidence":1,"confidence_rate":1},{"cnt":[[677,2046],[1814,2046],[1814,2090],[677,2090]],"region":{"top_left_x":676,"top_left_y":2046,"width":1139,"height":44},"line":85,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f3f33903ab3465d89784cc7578b611b","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"- Impaired renal function with predefined UACR: for criteria see section 3.3.2","text_display":"\n- Impaired renal function with predefined UACR: for criteria see section 3.3.2","confidence":0.99951171875,"confidence_rate":0.999994115673962},{"cnt":[[617,2094],[1227,2094],[1227,2134],[617,2134]],"region":{"top_left_x":617,"top_left_y":2094,"width":611,"height":40},"line":86,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"999a7af7d36d4b70bff7e9848adb3976","type":"text","conversion_output":false,"parent_id":"ae3981ae5022410a90b0beab5fc049be","text":"Refer to section 3.3.3 for exclusion criteria.","text_display":" Refer to section 3.3.3 for exclusion criteria.","confidence":1,"confidence_rate":1},{"cnt":[[249,2143],[582,2143],[582,2288],[249,2288]],"region":{"top_left_x":248,"top_left_y":2142,"width":335,"height":146},"line":87,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e29e63bd39842d2ac11665845392692","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["e0f9bef3239d45cca3fa11f8fbcb652f","1324b5ebb5a544b788fcee1e077f472a","6a1b400607424251a14adf292512a25b"],"text":"\\begin{tabular}{l}\nTest product(s): \\\\\ndose: \\\\\nmode of admin.:\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTest product(s): \\\\\ndose: \\\\\nmode of admin.:\n\\end{tabular}","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[253,2147],[490,2147],[490,2187],[253,2187]],"region":{"top_left_x":253,"top_left_y":2147,"width":238,"height":40},"line":88,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0f9bef3239d45cca3fa11f8fbcb652f","type":"text","conversion_output":false,"parent_id":"2e29e63bd39842d2ac11665845392692","text":"Test product(s):","text_display":"Test product(s):","confidence":0.99951171875,"confidence_rate":0.9999767431038692},{"cnt":[[331,2198],[419,2198],[419,2235],[331,2235]],"region":{"top_left_x":331,"top_left_y":2198,"width":88,"height":37},"line":89,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1324b5ebb5a544b788fcee1e077f472a","type":"text","conversion_output":false,"parent_id":"2e29e63bd39842d2ac11665845392692","text":"dose:","text_display":"\ndose:","confidence":1,"confidence_rate":1},{"cnt":[[331,2244],[580,2244],[580,2279],[331,2279]],"region":{"top_left_x":331,"top_left_y":2244,"width":250,"height":35},"line":90,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a1b400607424251a14adf292512a25b","type":"text","conversion_output":false,"parent_id":"2e29e63bd39842d2ac11665845392692","text":"mode of admin.:","text_display":"\nmode of admin.:","confidence":1,"confidence_rate":1},{"cnt":[[612,2143],[824,2143],[824,2288],[612,2288]],"region":{"top_left_x":612,"top_left_y":2142,"width":213,"height":146},"line":91,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0705fc247eb249b895ee947a099e88bf","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["5c28162144714f95b3e1ca32cf7f7bc0","d2ca2c422d864a2aa6d29d7f623f0fd0","2db825ad4c644d5196ad82c6eb096194"],"text":"\\begin{tabular}{l}\nLinagliptin \\\\\n5 mg \\\\\nTablets per os\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nLinagliptin \\\\\n5 mg \\\\\nTablets per os\n\\end{tabular}","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[617,2147],[780,2147],[780,2187],[617,2187]],"region":{"top_left_x":617,"top_left_y":2147,"width":164,"height":40},"line":92,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c28162144714f95b3e1ca32cf7f7bc0","type":"text","conversion_output":false,"parent_id":"0705fc247eb249b895ee947a099e88bf","text":"Linagliptin","text_display":"Linagliptin","confidence":1,"confidence_rate":1},{"cnt":[[617,2193],[695,2193],[695,2235],[617,2235]],"region":{"top_left_x":617,"top_left_y":2193,"width":79,"height":42},"line":93,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2ca2c422d864a2aa6d29d7f623f0fd0","type":"text","conversion_output":false,"parent_id":"0705fc247eb249b895ee947a099e88bf","text":"5 mg","text_display":"\n5 mg","confidence":1,"confidence_rate":1},{"cnt":[[617,2244],[817,2244],[817,2283],[617,2283]],"region":{"top_left_x":617,"top_left_y":2244,"width":201,"height":40},"line":94,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2db825ad4c644d5196ad82c6eb096194","type":"text","conversion_output":false,"parent_id":"0705fc247eb249b895ee947a099e88bf","text":"Tablets per os","text_display":"\nTablets per os","confidence":1,"confidence_rate":1},{"cnt":[[331,2405],[580,2405],[580,2440],[331,2440]],"region":{"top_left_x":331,"top_left_y":2405,"width":250,"height":35},"line":95,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"efcb989069be4873bc04a8c14526bcad","type":"simple_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"mode of admin.:","text_display":"mode of admin.:","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[622,2401],[829,2401],[829,2444],[622,2444]],"region":{"top_left_x":621,"top_left_y":2400,"width":208,"height":45},"line":96,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b224193e048d49839c088303786bee1f","type":"simple_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"Tablets per os","text_display":"Tablets per os","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,2461],[596,2461],[596,2500],[249,2500]],"region":{"top_left_x":248,"top_left_y":2460,"width":349,"height":40},"line":97,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce04c571441442968e615da46bc03bc0","type":"simple_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","text":"Duration of treatment:","text_display":"Duration of treatment:","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[612,2454],[1840,2454],[1840,2546],[612,2546]],"region":{"top_left_x":612,"top_left_y":2453,"width":1228,"height":93},"line":98,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78e348180c454af594ad657aebd15c50","type":"complex_cell","conversion_output":false,"parent_id":"c4712db2266343ac99479bf2466a4ff0","children_ids":["7ac440fdc10545c9b98c9bca89431034","baa93f3dacef476a849cf851ea64ed15"],"text":"Estimated 4854 months treatment period from first patient randomized, depending on observed number of primary endpoint events.","text_display":"Estimated 4854 months treatment period from first patient randomized, depending on observed number of primary endpoint events.","cell_row":11,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[617,2461],[1821,2461],[1821,2500],[617,2500]],"region":{"top_left_x":617,"top_left_y":2460,"width":1205,"height":40},"line":99,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ac440fdc10545c9b98c9bca89431034","type":"text","conversion_output":false,"parent_id":"78e348180c454af594ad657aebd15c50","text":"Estimated 4854 months treatment period from first patient randomized, depending on","text_display":"Estimated 4854 months treatment period from first patient randomized, depending on","confidence":1,"confidence_rate":1},{"cnt":[[617,2497],[1255,2497],[1255,2541],[617,2541]],"region":{"top_left_x":617,"top_left_y":2497,"width":638,"height":45},"line":100,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"baa93f3dacef476a849cf851ea64ed15","type":"text","conversion_output":false,"parent_id":"78e348180c454af594ad657aebd15c50","text":"observed number of primary endpoint events.","text_display":" observed number of primary endpoint events.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":101,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"41a4316425bb433bbf0f8a6038ffe44b","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":102,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"02a0a49949504d7b9c48fdbaca3cad1d","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":103,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"10997651a4a149c8a9acc74058fd89ce","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-004","page":4,"lines":[{"cnt":[[247,119],[612,119],[612,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":367,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"777ebba1d9c548ddad7b462b9cac69f8","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1821,119],[1821,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":318,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8316732723f54d0bb2b1d9b67b460d3f","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,164],[601,164],[601,203],[244,203]],"region":{"top_left_x":244,"top_left_y":164,"width":357,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"713401e7caf4481d8d106b83d95c1799","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[637,208],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":396,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d61e1d56da3844d7ab20302c3b9c6b92","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,208],[1110,208],[1110,249],[868,249]],"region":{"top_left_x":868,"top_left_y":207,"width":243,"height":42},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02758459b11b443183a5bb7e6aa19adf","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1592,206],[1816,206],[1816,254],[1592,254]],"region":{"top_left_x":1592,"top_left_y":205,"width":225,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f79a1a37de21490f8c6f73c76b5ab9e2","type":"page_info","conversion_output":false,"text":"Page 4 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1832,331],[1832,2481],[242,2481]],"region":{"top_left_x":242,"top_left_y":331,"width":1591,"height":2150},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ff181aa23c8455fa0fe588b6306f8ea","type":"table","conversion_output":true,"children_ids":["f23ee70a27e2498cb9eefcd670537d65","f850299f8a094453b7df7788fa3eabca","a283f2c251294af29ef7df6744b5984d","0e4f0be814a441a499f0800c07c66daa","5da3516d1c634191b52f97231a0bd493","33949c7404b24831a3be4f8b4c4cf5e9","0b957de23d134d448ac28216565b06f9","a9ac6b9aa02d474da2448894fdec87b1","18532ba949114e2c91f6f414504a66dd","91e869e2c7964b94bc30b9b97550daed","4466c6d0e264458ba82a6f28f7b33a73","8d045df8238f4c42b0087d8b790c6696","555616ea589b4a34af7923fcbd2214ed","f517eabc570244a1941db981df5d0f77","9e40392f54224bc2918f17c3b58f038d","429b8d48a61f44cbb3c4c50220e94d12","ed9dc2ad1b7b4df7be0394756725a882","6c1dc09431894a0e96743eb150f6f182","decc7e93fb8d4fe4af6bed4df1ff3ce6","6ca340f0fa694c0bb81c2d02e58c82e4","65cf1ec7588741e1bbfe600c11aae977","7af6b48ef7cf4430aa63507cf2270c2b"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}} & \\multirow[t]{5}{*}{\\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular}} & \\multirow{5}{*}{} \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\multirow{2}{*}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}} & & & \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline Criteria for efficacy: & \\multicolumn{3}{|c|}{\\begin{tabular}{l}\nThe primary endpoint in this trial is time to the first occurrence of any of the following by adjudicationed confirmed components of the primary composite endpoint (4 3-point MACE): CV death (including fatal stroke, fatal MI and sudden death), non-fatal MI (excluding silent MI)-or non-fatal stroke and hospitalisation for unstable angina pectoris. \\\\\nThe key secondary endpoints are is time to the first occurrence of any of the following by adjudication confirmed components: \\\\\n- CV death (including fatal stroke, fatal MI and sudden death), non fatal MI (excluding silent MI), non fatal stroke ( 3 point MACE) \\\\\n- Composite renal endpoint (renal death, sustained ESRD, sustained decrease of \\(50 4 0 \\%\\) or more in eGFR) \\\\\nThe primary endpoint ( \\(4\\) 3-point MACE) will be tested for non-inferiority. Thereafter, if non-inferiority has been demonstrated, the \\(4\\)-point MACE and the combined composite renal endpoint will be tested separately (- in parallel) for superiority. In ease the 4 point MACE and/or the composite renal endpoint is significantly superior, the 3 point MACE will be tested for superiority.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}} & \\multirow[t]{5}{*}{\\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular}} & \\multirow{5}{*}{} \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\multirow{2}{*}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}} & & & \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline Criteria for efficacy: & \\multicolumn{3}{|c|}{\\begin{tabular}{l}\nThe primary endpoint in this trial is time to the first occurrence of any of the following by adjudicationed confirmed components of the primary composite endpoint (4 3-point MACE): CV death (including fatal stroke, fatal MI and sudden death), non-fatal MI (excluding silent MI)-or non-fatal stroke and hospitalisation for unstable angina pectoris. \\\\\nThe key secondary endpoints are is time to the first occurrence of any of the following by adjudication confirmed components: \\\\\n- CV death (including fatal stroke, fatal MI and sudden death), non fatal MI (excluding silent MI), non fatal stroke ( 3 point MACE) \\\\\n- Composite renal endpoint (renal death, sustained ESRD, sustained decrease of \\(50 4 0 \\%\\) or more in eGFR) \\\\\nThe primary endpoint ( \\(4\\) 3-point MACE) will be tested for non-inferiority. Thereafter, if non-inferiority has been demonstrated, the \\(4\\)-point MACE and the combined composite renal endpoint will be tested separately (- in parallel) for superiority. In ease the 4 point MACE and/or the composite renal endpoint is significantly superior, the 3 point MACE will be tested for superiority.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","confidence":0.8493533134460449,"confidence_rate":0.9992227782564134},{"cnt":[[247,331],[585,331],[585,2482],[247,2482]],"region":{"top_left_x":246,"top_left_y":331,"width":340,"height":2151},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f23ee70a27e2498cb9eefcd670537d65","type":"table_column","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[605,331],[860,330],[865,2482],[610,2482]],"region":{"top_left_x":605,"top_left_y":330,"width":261,"height":2153},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f850299f8a094453b7df7788fa3eabca","type":"table_column","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[1087,331],[1324,331],[1324,2482],[1087,2482]],"region":{"top_left_x":1087,"top_left_y":331,"width":238,"height":2151},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a283f2c251294af29ef7df6744b5984d","type":"table_column","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[1444,331],[1828,331],[1828,2482],[1444,2482]],"region":{"top_left_x":1443,"top_left_y":331,"width":386,"height":2151},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e4f0be814a441a499f0800c07c66daa","type":"table_column","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[242,340],[1833,340],[1833,483],[242,483]],"region":{"top_left_x":242,"top_left_y":340,"width":1592,"height":143},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5da3516d1c634191b52f97231a0bd493","type":"table_row","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[242,483],[1833,483],[1833,531],[242,531]],"region":{"top_left_x":242,"top_left_y":482,"width":1592,"height":50},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"33949c7404b24831a3be4f8b4c4cf5e9","type":"table_row","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[242,570],[1833,570],[1833,619],[242,619]],"region":{"top_left_x":242,"top_left_y":570,"width":1592,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b957de23d134d448ac28216565b06f9","type":"table_row","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[242,626],[1833,626],[1833,674],[242,674]],"region":{"top_left_x":242,"top_left_y":625,"width":1592,"height":50},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9ac6b9aa02d474da2448894fdec87b1","type":"table_row","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[242,709],[1831,709],[1831,757],[242,757]],"region":{"top_left_x":242,"top_left_y":708,"width":1589,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18532ba949114e2c91f6f414504a66dd","type":"table_row","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[242,768],[1833,768],[1833,867],[242,867]],"region":{"top_left_x":242,"top_left_y":768,"width":1592,"height":100},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91e869e2c7964b94bc30b9b97550daed","type":"table_row","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[242,865],[1833,865],[1833,1519],[242,1519]],"region":{"top_left_x":242,"top_left_y":865,"width":1592,"height":655},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4466c6d0e264458ba82a6f28f7b33a73","type":"table_row","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":""},{"cnt":[[247,340],[965,340],[965,483],[247,483]],"region":{"top_left_x":246,"top_left_y":340,"width":719,"height":143},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d045df8238f4c42b0087d8b790c6696","type":"table_spanning_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","children_ids":["cf1fee39d8564508a8d1d35a8e00cfa6"],"text":"","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[256,345],[571,345],[571,476],[256,476]],"region":{"top_left_x":255,"top_left_y":344,"width":317,"height":133},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf1fee39d8564508a8d1d35a8e00cfa6","type":"complex_cell","conversion_output":false,"parent_id":"8d045df8238f4c42b0087d8b790c6696","children_ids":["27cc2c13ca8147d4a918ab91c6fb8077","48cf715c76b64ad096ea943fa64bffa3"],"text":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[256,349],[544,349],[544,389],[256,389]],"region":{"top_left_x":255,"top_left_y":349,"width":289,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27cc2c13ca8147d4a918ab91c6fb8077","type":"text","conversion_output":false,"parent_id":"cf1fee39d8564508a8d1d35a8e00cfa6","text":"Name of company:","text_display":"Name of company:","confidence":1,"confidence_rate":1},{"cnt":[[260,439],[571,439],[571,476],[260,476]],"region":{"top_left_x":260,"top_left_y":439,"width":312,"height":38},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48cf715c76b64ad096ea943fa64bffa3","type":"text","conversion_output":false,"parent_id":"cf1fee39d8564508a8d1d35a8e00cfa6","text":"Boehringer Ingelheim","text_display":"\nBoehringer Ingelheim","confidence":1,"confidence_rate":1},{"cnt":[[1094,345],[1322,345],[1322,757],[1094,757]],"region":{"top_left_x":1093,"top_left_y":344,"width":229,"height":413},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"555616ea589b4a34af7923fcbd2214ed","type":"table_spanning_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","children_ids":["2a2193dcda3941e68c7ae98adb1d111b"],"text":"","text_display":"\\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular}","cell_row":0,"cell_column":2,"cell_row_span":5,"cell_col_span":1},{"cnt":[[1099,345],[1322,345],[1322,430],[1099,430]],"region":{"top_left_x":1098,"top_left_y":344,"width":224,"height":87},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a2193dcda3941e68c7ae98adb1d111b","type":"complex_cell","conversion_output":false,"parent_id":"555616ea589b4a34af7923fcbd2214ed","children_ids":["44c3303cb6524f719c7eca433ab4df8d","ed0f54bf9d284a20abfa8bcdb019ab28"],"text":"\\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular}","cell_row":0,"cell_column":2,"cell_row_span":5,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1131,349],[1290,349],[1290,384],[1131,384]],"region":{"top_left_x":1130,"top_left_y":349,"width":160,"height":35},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44c3303cb6524f719c7eca433ab4df8d","type":"text","conversion_output":false,"parent_id":"2a2193dcda3941e68c7ae98adb1d111b","text":"Tabulated","text_display":"Tabulated","confidence":1,"confidence_rate":1},{"cnt":[[1101,393],[1317,393],[1317,425],[1101,425]],"region":{"top_left_x":1100,"top_left_y":393,"width":218,"height":33},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed0f54bf9d284a20abfa8bcdb019ab28","type":"text","conversion_output":false,"parent_id":"2a2193dcda3941e68c7ae98adb1d111b","text":"Trial Protocol","text_display":"\nTrial Protocol","confidence":1,"confidence_rate":1},{"cnt":[[1460,340],[1828,340],[1828,759],[1460,759]],"region":{"top_left_x":1460,"top_left_y":340,"width":369,"height":420},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f517eabc570244a1941db981df5d0f77","type":"table_spanning_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"","text_display":"","cell_row":0,"cell_column":3,"cell_row_span":5,"cell_col_span":1},{"cnt":[[256,474],[659,474],[659,619],[256,619]],"region":{"top_left_x":255,"top_left_y":473,"width":404,"height":146},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e40392f54224bc2918f17c3b58f038d","type":"complex_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","children_ids":["210278f7c2fc44769ed19c7914940b17","d66d0f58d8144799afbfc7c406b55ac3"],"text":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.8493533134460449,"confidence_rate":0.9961199273252863},{"cnt":[[256,488],[652,488],[652,531],[256,531]],"region":{"top_left_x":255,"top_left_y":487,"width":397,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"210278f7c2fc44769ed19c7914940b17","type":"text","conversion_output":false,"parent_id":"9e40392f54224bc2918f17c3b58f038d","text":"Name of finished product:","text_display":"Name of finished product:","confidence":1,"confidence_rate":1},{"cnt":[[260,575],[405,575],[405,614],[260,614]],"region":{"top_left_x":260,"top_left_y":575,"width":146,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d66d0f58d8144799afbfc7c406b55ac3","type":"text","conversion_output":false,"parent_id":"9e40392f54224bc2918f17c3b58f038d","text":"Trajenta \\({ }^{\\circledR}\\)","text_display":"\nTrajenta \\({ }^{\\circledR}\\)","confidence":0.8493533134460449,"confidence_rate":0.9922549096145337},{"cnt":[[256,628],[659,628],[659,757],[256,757]],"region":{"top_left_x":255,"top_left_y":628,"width":404,"height":129},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"429b8d48a61f44cbb3c4c50220e94d12","type":"complex_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-004.jpg?height=129\\&width=404\\&top_left_y=628\\&top_left_x=255)","text_display":"![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-004.jpg?height=129\\&width=404\\&top_left_y=628\\&top_left_x=255)","cell_row":3,"cell_column":0,"cell_row_span":2,"cell_col_span":1},{"cnt":[[254,628],[645,628],[645,757],[254,757]],"region":{"top_left_x":253,"top_left_y":628,"width":392,"height":129},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed9dc2ad1b7b4df7be0394756725a882","type":"table_spanning_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","children_ids":["fe1a4e609ff3468baffb371a19d2ecfb"],"text":"","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":2,"cell_col_span":1},{"cnt":[[255,630],[655,630],[655,757],[255,757]],"region":{"top_left_x":255,"top_left_y":630,"width":400,"height":127},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe1a4e609ff3468baffb371a19d2ecfb","type":"complex_cell","conversion_output":false,"parent_id":"ed9dc2ad1b7b4df7be0394756725a882","children_ids":["51c3b58d06c7471f80a7713906196f5f","dd12bf9a6d924246a95c0f4cb7805bcc"],"text":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":2,"cell_col_span":1,"confidence":0.9873046875,"confidence_rate":0.9997543265945972},{"cnt":[[256,630],[654,630],[654,669],[256,669]],"region":{"top_left_x":255,"top_left_y":630,"width":400,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51c3b58d06c7471f80a7713906196f5f","type":"text","conversion_output":false,"parent_id":"fe1a4e609ff3468baffb371a19d2ecfb","text":"Name of active ingredient:","text_display":"Name of active ingredient:","confidence":1,"confidence_rate":1},{"cnt":[[256,713],[564,713],[564,757],[256,757]],"region":{"top_left_x":255,"top_left_y":713,"width":310,"height":44},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd12bf9a6d924246a95c0f4cb7805bcc","type":"text","conversion_output":false,"parent_id":"fe1a4e609ff3468baffb371a19d2ecfb","text":"Linagliptin (BI 1356)","text_display":"\nLinagliptin (BI 1356)","confidence":0.9873046875,"confidence_rate":0.9995087135446166},{"cnt":[[256,773],[495,773],[495,861],[256,861]],"region":{"top_left_x":255,"top_left_y":773,"width":241,"height":88},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c1dc09431894a0e96743eb150f6f182","type":"complex_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","children_ids":["fe5d425dbdc044bebe1bb0d6a0333bf1","b23f606751f84810ba516e25d34750f7"],"text":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[256,773],[475,773],[475,812],[256,812]],"region":{"top_left_x":255,"top_left_y":773,"width":220,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe5d425dbdc044bebe1bb0d6a0333bf1","type":"text","conversion_output":false,"parent_id":"6c1dc09431894a0e96743eb150f6f182","text":"Protocol date:","text_display":"Protocol date:","confidence":1,"confidence_rate":1},{"cnt":[[256,817],[493,817],[493,858],[256,858]],"region":{"top_left_x":255,"top_left_y":816,"width":238,"height":43},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b23f606751f84810ba516e25d34750f7","type":"text","conversion_output":false,"parent_id":"6c1dc09431894a0e96743eb150f6f182","text":"5 February 2013","text_display":"\n5 February 2013","confidence":1,"confidence_rate":1},{"cnt":[[620,768],[848,768],[848,856],[620,856]],"region":{"top_left_x":619,"top_left_y":768,"width":229,"height":88},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"decc7e93fb8d4fe4af6bed4df1ff3ce6","type":"complex_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","children_ids":["bdb5e903ab3f4c46a21de7d22b58cb53","907cd247777a49e5a5f2c2ca23c91062"],"text":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[624,773],[845,773],[845,808],[624,808]],"region":{"top_left_x":624,"top_left_y":773,"width":222,"height":35},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bdb5e903ab3f4c46a21de7d22b58cb53","type":"text","conversion_output":false,"parent_id":"decc7e93fb8d4fe4af6bed4df1ff3ce6","text":"Trial number:","text_display":"Trial number:","confidence":1,"confidence_rate":1},{"cnt":[[631,819],[746,819],[746,849],[631,849]],"region":{"top_left_x":631,"top_left_y":819,"width":116,"height":31},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"907cd247777a49e5a5f2c2ca23c91062","type":"text","conversion_output":false,"parent_id":"decc7e93fb8d4fe4af6bed4df1ff3ce6","text":"1218.22","text_display":"\n1218.22","confidence":1,"confidence_rate":1},{"cnt":[[1462,773],[1750,773],[1750,854],[1462,854]],"region":{"top_left_x":1462,"top_left_y":773,"width":289,"height":81},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ca340f0fa694c0bb81c2d02e58c82e4","type":"complex_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","children_ids":["ff4cc5bcacd8449f9433002aa159f856","975808a0323c44ce96626dc96f80fc3c"],"text":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","cell_row":5,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1467,773],[1681,773],[1681,808],[1467,808]],"region":{"top_left_x":1466,"top_left_y":773,"width":216,"height":35},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff4cc5bcacd8449f9433002aa159f856","type":"text","conversion_output":false,"parent_id":"6ca340f0fa694c0bb81c2d02e58c82e4","text":"Revision date:","text_display":"Revision date:","confidence":1,"confidence_rate":1},{"cnt":[[1467,819],[1746,819],[1746,851],[1467,851]],"region":{"top_left_x":1466,"top_left_y":819,"width":280,"height":33},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"975808a0323c44ce96626dc96f80fc3c","type":"text","conversion_output":false,"parent_id":"6ca340f0fa694c0bb81c2d02e58c82e4","text":"22 November 2016","text_display":"\n22 November 2016","confidence":1,"confidence_rate":1},{"cnt":[[251,870],[562,870],[562,914],[251,914]],"region":{"top_left_x":251,"top_left_y":869,"width":312,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65cf1ec7588741e1bbfe600c11aae977","type":"simple_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","text":"Criteria for efficacy:","text_display":"Criteria for efficacy:","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[610,865],[1822,865],[1822,1517],[610,1517]],"region":{"top_left_x":610,"top_left_y":865,"width":1212,"height":652},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7af6b48ef7cf4430aa63507cf2270c2b","type":"table_spanning_cell","conversion_output":false,"parent_id":"9ff181aa23c8455fa0fe588b6306f8ea","children_ids":["4a2851b43cd84ac88cc2f5f5f76bb334"],"text":"","text_display":"\\begin{tabular}{l}\nThe primary endpoint in this trial is time to the first occurrence of any of the following by adjudicationed confirmed components of the primary composite endpoint (4 3-point MACE): CV death (including fatal stroke, fatal MI and sudden death), non-fatal MI (excluding silent MI)-or non-fatal stroke and hospitalisation for unstable angina pectoris. \\\\\nThe key secondary endpoints are is time to the first occurrence of any of the following by adjudication confirmed components: \\\\\n- CV death (including fatal stroke, fatal MI and sudden death), non fatal MI (excluding silent MI), non fatal stroke ( 3 point MACE) \\\\\n- Composite renal endpoint (renal death, sustained ESRD, sustained decrease of \\(50 4 0 \\%\\) or more in eGFR) \\\\\nThe primary endpoint ( \\(4\\) 3-point MACE) will be tested for non-inferiority. Thereafter, if non-inferiority has been demonstrated, the \\(4\\)-point MACE and the combined composite renal endpoint will be tested separately (- in parallel) for superiority. In ease the 4 point MACE and/or the composite renal endpoint is significantly superior, the 3 point MACE will be tested for superiority.\n\\end{tabular}","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":3},{"cnt":[[613,865],[1822,865],[1822,1517],[613,1517]],"region":{"top_left_x":612,"top_left_y":865,"width":1210,"height":652},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a2851b43cd84ac88cc2f5f5f76bb334","type":"complex_cell","conversion_output":false,"parent_id":"7af6b48ef7cf4430aa63507cf2270c2b","children_ids":["b6dbfc64abe946e5a40ca57318808954","69b832e0a792466f9a3145727a4c710a","e7878c23f172441791c40f61b621ad0b","a7bea2313a1c42c08d7acf21dfd3d9cc","53eaa553dd4a4c84a607dcd73bbff8c1","c198cf7517974b20b0d23a02d5546d62","bd2fdcbdb9594d88b8a1df60ec844f5d","b67f76347e6b41dcafc8064e786a7cba","66d3752d8f3040469b24325ecd4ebe9d","25cb76694e27448d83f041918ff05ab1","70d89d2cc10f45b7b633c8d646660d1a","2e11b411743a44c48a539c64b3bed700","8b0872895bc24f23a1d66f983dc84183","0d41e91274d947bfa4fdf743cb0255af","d0fd775f97444a629ff17d86c504cbbb","50140e045c1d4fd4ad698561ac323b57"],"text":"\\begin{tabular}{l}\nThe primary endpoint in this trial is time to the first occurrence of any of the following by adjudicationed confirmed components of the primary composite endpoint (4 3-point MACE): CV death (including fatal stroke, fatal MI and sudden death), non-fatal MI (excluding silent MI)-or non-fatal stroke and hospitalisation for unstable angina pectoris. \\\\\nThe key secondary endpoints are is time to the first occurrence of any of the following by adjudication confirmed components: \\\\\n- CV death (including fatal stroke, fatal MI and sudden death), non fatal MI (excluding silent MI), non fatal stroke ( 3 point MACE) \\\\\n- Composite renal endpoint (renal death, sustained ESRD, sustained decrease of \\(50 4 0 \\%\\) or more in eGFR) \\\\\nThe primary endpoint ( \\(4\\) 3-point MACE) will be tested for non-inferiority. Thereafter, if non-inferiority has been demonstrated, the \\(4\\)-point MACE and the combined composite renal endpoint will be tested separately (- in parallel) for superiority. In ease the 4 point MACE and/or the composite renal endpoint is significantly superior, the 3 point MACE will be tested for superiority.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe primary endpoint in this trial is time to the first occurrence of any of the following by adjudicationed confirmed components of the primary composite endpoint (4 3-point MACE): CV death (including fatal stroke, fatal MI and sudden death), non-fatal MI (excluding silent MI)-or non-fatal stroke and hospitalisation for unstable angina pectoris. \\\\\nThe key secondary endpoints are is time to the first occurrence of any of the following by adjudication confirmed components: \\\\\n- CV death (including fatal stroke, fatal MI and sudden death), non fatal MI (excluding silent MI), non fatal stroke ( 3 point MACE) \\\\\n- Composite renal endpoint (renal death, sustained ESRD, sustained decrease of \\(50 4 0 \\%\\) or more in eGFR) \\\\\nThe primary endpoint ( \\(4\\) 3-point MACE) will be tested for non-inferiority. Thereafter, if non-inferiority has been demonstrated, the \\(4\\)-point MACE and the combined composite renal endpoint will be tested separately (- in parallel) for superiority. In ease the 4 point MACE and/or the composite renal endpoint is significantly superior, the 3 point MACE will be tested for superiority.\n\\end{tabular}","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":3,"confidence":0.8680369754955564,"confidence_rate":0.9995884089121925},{"cnt":[[617,870],[1683,870],[1683,909],[617,909]],"region":{"top_left_x":617,"top_left_y":869,"width":1067,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6dbfc64abe946e5a40ca57318808954","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"The primary endpoint in this trial is time to the first occurrence of any of the","text_display":"The primary endpoint in this trial is time to the first occurrence of any of the","confidence":1,"confidence_rate":1},{"cnt":[[615,911],[1713,911],[1713,950],[615,950]],"region":{"top_left_x":615,"top_left_y":911,"width":1099,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69b832e0a792466f9a3145727a4c710a","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"following by adjudicationed confirmed components of the primary composite","text_display":" following by adjudicationed confirmed components of the primary composite","confidence":1,"confidence_rate":1},{"cnt":[[615,948],[1773,948],[1773,987],[615,987]],"region":{"top_left_x":615,"top_left_y":948,"width":1159,"height":40},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7878c23f172441791c40f61b621ad0b","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"endpoint (4 3-point MACE): CV death (including fatal stroke, fatal MI and sudden","text_display":" endpoint (4 3-point MACE): CV death (including fatal stroke, fatal MI and sudden","confidence":0.9743301252433412,"confidence_rate":0.9996941044997544},{"cnt":[[615,990],[1796,990],[1796,1029],[615,1029]],"region":{"top_left_x":615,"top_left_y":989,"width":1182,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7bea2313a1c42c08d7acf21dfd3d9cc","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"death), non-fatal MI (excluding silent MI)-or non-fatal stroke and hospitalisation for","text_display":" death), non-fatal MI (excluding silent MI)-or non-fatal stroke and hospitalisation for","confidence":0.94758484326303,"confidence_rate":0.9994085397981401},{"cnt":[[615,1031],[965,1031],[965,1070],[615,1070]],"region":{"top_left_x":615,"top_left_y":1030,"width":350,"height":41},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"53eaa553dd4a4c84a607dcd73bbff8c1","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"unstable angina pectoris.","text_display":" unstable angina pectoris.","confidence":1,"confidence_rate":1},{"cnt":[[615,1068],[1693,1068],[1693,1109],[615,1109]],"region":{"top_left_x":615,"top_left_y":1067,"width":1078,"height":43},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c198cf7517974b20b0d23a02d5546d62","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"The key secondary endpoints are is time to the first occurrence of any of the","text_display":"\nThe key secondary endpoints are is time to the first occurrence of any of the","confidence":0.99462890625,"confidence_rate":0.9999343244746269},{"cnt":[[615,1109],[1359,1109],[1359,1148],[615,1148]],"region":{"top_left_x":615,"top_left_y":1109,"width":744,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bd2fdcbdb9594d88b8a1df60ec844f5d","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"following by adjudication confirmed components:","text_display":" following by adjudication confirmed components:","confidence":1,"confidence_rate":1},{"cnt":[[679,1151],[1782,1151],[1782,1190],[679,1190]],"region":{"top_left_x":679,"top_left_y":1150,"width":1104,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b67f76347e6b41dcafc8064e786a7cba","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"- CV death (including fatal stroke, fatal MI and sudden death), non fatal MI","text_display":"\n- CV death (including fatal stroke, fatal MI and sudden death), non fatal MI","confidence":0.9907309989212081,"confidence_rate":0.9998850408604659},{"cnt":[[739,1192],[1520,1192],[1520,1231],[739,1231]],"region":{"top_left_x":739,"top_left_y":1192,"width":781,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66d3752d8f3040469b24325ecd4ebe9d","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"(excluding silent MI), non fatal stroke ( 3 point MACE)","text_display":" (excluding silent MI), non fatal stroke ( 3 point MACE)","confidence":0.981997201812419,"confidence_rate":0.9997116793484231},{"cnt":[[679,1234],[1801,1234],[1801,1273],[679,1273]],"region":{"top_left_x":679,"top_left_y":1233,"width":1122,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25cb76694e27448d83f041918ff05ab1","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"- Composite renal endpoint (renal death, sustained ESRD, sustained decrease","text_display":"\n- Composite renal endpoint (renal death, sustained ESRD, sustained decrease","confidence":1,"confidence_rate":1},{"cnt":[[739,1273],[1147,1273],[1147,1310],[739,1310]],"region":{"top_left_x":739,"top_left_y":1272,"width":408,"height":38},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70d89d2cc10f45b7b633c8d646660d1a","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"of \\(50 4 0 \\%\\) or more in eGFR)","text_display":" of \\(50 4 0 \\%\\) or more in eGFR)","confidence":0.8980846189586371,"confidence_rate":0.9970185925638418},{"cnt":[[615,1312],[1819,1312],[1819,1351],[615,1351]],"region":{"top_left_x":615,"top_left_y":1311,"width":1205,"height":41},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e11b411743a44c48a539c64b3bed700","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"The primary endpoint ( \\(4\\) 3-point MACE) will be tested for non-inferiority. Thereafter,","text_display":"\nThe primary endpoint ( \\(4\\) 3-point MACE) will be tested for non-inferiority. Thereafter,","confidence":0.8680369754955564,"confidence_rate":0.9985420847540311},{"cnt":[[615,1353],[1782,1353],[1782,1392],[615,1392]],"region":{"top_left_x":615,"top_left_y":1353,"width":1168,"height":40},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b0872895bc24f23a1d66f983dc84183","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"if non-inferiority has been demonstrated, the \\(4\\)-point MACE and the combined","text_display":" if non-inferiority has been demonstrated, the \\(4\\)-point MACE and the combined","confidence":0.9776882169671808,"confidence_rate":0.9997406720642826},{"cnt":[[615,1395],[1773,1395],[1773,1434],[615,1434]],"region":{"top_left_x":615,"top_left_y":1394,"width":1159,"height":40},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d41e91274d947bfa4fdf743cb0255af","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"composite renal endpoint will be tested separately (- in parallel) for superiority. In","text_display":" composite renal endpoint will be tested separately (- in parallel) for superiority. In","confidence":0.9545879364013672,"confidence_rate":0.9994894104850626},{"cnt":[[615,1432],[1805,1432],[1805,1475],[615,1475]],"region":{"top_left_x":615,"top_left_y":1431,"width":1191,"height":45},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0fd775f97444a629ff17d86c504cbbb","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"ease the 4 point MACE and/or the composite renal endpoint is significantly superior,","text_display":" ease the 4 point MACE and/or the composite renal endpoint is significantly superior,","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[615,1473],[1294,1473],[1294,1512],[615,1512]],"region":{"top_left_x":615,"top_left_y":1473,"width":680,"height":40},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50140e045c1d4fd4ad698561ac323b57","type":"text","conversion_output":false,"parent_id":"4a2851b43cd84ac88cc2f5f5f76bb334","text":"the 3 point MACE will be tested for superiority.","text_display":" the 3 point MACE will be tested for superiority.","confidence":1,"confidence_rate":1},{"cnt":[[790,2664],[1300,2664],[1300,2702],[790,2702]],"region":{"top_left_x":790,"top_left_y":2663,"width":510,"height":40},"line":64,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3a63904dcfd64e48af79d99c20ba6e3d","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.98388671875,"confidence_rate":0.999613300697489},{"cnt":[[292,2700],[1802,2700],[1802,2739],[292,2739]],"region":{"top_left_x":292,"top_left_y":2700,"width":1511,"height":39},"line":65,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bb9af4e77ee8456882e59ef1f9bf2591","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.9833984375,"confidence_rate":0.9998593299547832},{"cnt":[[295,2744],[1770,2744],[1770,2780],[295,2780]],"region":{"top_left_x":294,"top_left_y":2743,"width":1477,"height":38},"line":66,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8046f3f2cd214633b1413c2aedd264c4","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-005","page":5,"lines":[{"cnt":[[247,119],[612,119],[612,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":367,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af4c57b938664109a345c67b859f6c72","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f526ca50e63249b2ac25c0facd14772c","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c75d7826fcc4955b06a5131433f6fb1","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[637,208],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":396,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4043aa4fe6f4afb9c6090e0c31197d8","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1110,210],[1110,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":243,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b6dbd745ff244da878146ae374faf79","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1592,208],[1816,208],[1816,254],[1592,254]],"region":{"top_left_x":1592,"top_left_y":207,"width":225,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"152ef7ed31e943b48b52d034a392f755","type":"page_info","conversion_output":false,"text":"Page 5 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1834,331],[1834,870],[242,870]],"region":{"top_left_x":242,"top_left_y":331,"width":1593,"height":540},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9481e1f41c54402a341ae8fad906f77","type":"table","conversion_output":true,"children_ids":["ec4fc7f18bb543bfae62f854e8fbefdf","71b1db1d819e48628710b7a57dfeb70c","8282e5df99cd4ed88da407d909bfc438","6195c2bbf5d34523b5b001b5c647498e","5ec52f61ae2c4dc69687037b6fb1db98","708a532030f84ac29fd2477cb3246903","22f81d14203c4c228359db1832ca5cac","db7cde3e12eb49cc8b0954f2876485c9","5889be5d368a4191918e234fd2755e51","58a19df8813e4b8ba9d0173095c18ec7","042866094c69484fa794fdaa27ddd5dd","190d6d85528145bd9c5c048c784095f2","fd98085433484170adc3ee8b4d95f2cf","9e7c2ff64a614bcea4a964813bef7504","286280daf0884491ac9ade9f234b338b","15467b21877b424e8eba7edc21b1d717","42bfedb57bcf4e8b9d51743397504464","cb29aee8108546cca7a21ecf255eeac9"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}} & \\multirow[t]{5}{*}{Tabulated Trial Protocol} & \\multirow{5}{*}{} \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta®\n\\end{tabular} & & & \\\\\n\\hline \\multicolumn{2}{|l|}{\\multirow{2}{*}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}}} & & \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}} & \\multirow[t]{5}{*}{Tabulated Trial Protocol} & \\multirow{5}{*}{} \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta®\n\\end{tabular} & & & \\\\\n\\hline \\multicolumn{2}{|l|}{\\multirow{2}{*}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}}} & & \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.98291015625,"confidence_rate":0.9998461050526888},{"cnt":[[251,331],[498,331],[498,870],[251,870]],"region":{"top_left_x":251,"top_left_y":331,"width":247,"height":539},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec4fc7f18bb543bfae62f854e8fbefdf","type":"table_column","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[620,331],[852,331],[852,872],[620,872]],"region":{"top_left_x":619,"top_left_y":331,"width":234,"height":542},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71b1db1d819e48628710b7a57dfeb70c","type":"table_column","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[1096,331],[1322,331],[1322,872],[1096,872]],"region":{"top_left_x":1096,"top_left_y":331,"width":226,"height":542},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8282e5df99cd4ed88da407d909bfc438","type":"table_column","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[1458,331],[1750,331],[1750,872],[1458,872]],"region":{"top_left_x":1457,"top_left_y":331,"width":294,"height":542},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6195c2bbf5d34523b5b001b5c647498e","type":"table_column","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[242,340],[1838,340],[1838,483],[242,483]],"region":{"top_left_x":242,"top_left_y":340,"width":1596,"height":143},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ec52f61ae2c4dc69687037b6fb1db98","type":"table_row","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[242,483],[1835,483],[1835,536],[242,536]],"region":{"top_left_x":242,"top_left_y":482,"width":1594,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"708a532030f84ac29fd2477cb3246903","type":"table_row","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[242,570],[1833,570],[1833,621],[242,621]],"region":{"top_left_x":242,"top_left_y":570,"width":1592,"height":52},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22f81d14203c4c228359db1832ca5cac","type":"table_row","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[242,626],[1835,626],[1835,676],[242,676]],"region":{"top_left_x":242,"top_left_y":625,"width":1594,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db7cde3e12eb49cc8b0954f2876485c9","type":"table_row","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[242,711],[1833,711],[1833,762],[242,762]],"region":{"top_left_x":242,"top_left_y":710,"width":1592,"height":52},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5889be5d368a4191918e234fd2755e51","type":"table_row","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[242,764],[1835,764],[1835,870],[242,870]],"region":{"top_left_x":242,"top_left_y":763,"width":1594,"height":107},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58a19df8813e4b8ba9d0173095c18ec7","type":"table_row","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":""},{"cnt":[[251,338],[852,338],[852,483],[251,483]],"region":{"top_left_x":251,"top_left_y":337,"width":602,"height":146},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"042866094c69484fa794fdaa27ddd5dd","type":"table_spanning_cell","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","children_ids":["b32a68aec1fa46c788076cbc156ee63b"],"text":"","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[256,345],[571,345],[571,481],[256,481]],"region":{"top_left_x":255,"top_left_y":344,"width":317,"height":137},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b32a68aec1fa46c788076cbc156ee63b","type":"complex_cell","conversion_output":false,"parent_id":"042866094c69484fa794fdaa27ddd5dd","children_ids":["0540a324d023442ab9bcd939fcd102e0","313056e0c5af4a8c83010571240cee25"],"text":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[256,349],[544,349],[544,389],[256,389]],"region":{"top_left_x":255,"top_left_y":349,"width":289,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0540a324d023442ab9bcd939fcd102e0","type":"text","conversion_output":false,"parent_id":"b32a68aec1fa46c788076cbc156ee63b","text":"Name of company:","text_display":"Name of company:","confidence":1,"confidence_rate":1},{"cnt":[[258,437],[571,437],[571,476],[258,476]],"region":{"top_left_x":258,"top_left_y":436,"width":314,"height":41},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"313056e0c5af4a8c83010571240cee25","type":"text","conversion_output":false,"parent_id":"b32a68aec1fa46c788076cbc156ee63b","text":"Boehringer Ingelheim","text_display":"\nBoehringer Ingelheim","confidence":1,"confidence_rate":1},{"cnt":[[1094,340],[1322,340],[1322,759],[1094,759]],"region":{"top_left_x":1093,"top_left_y":340,"width":229,"height":420},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"190d6d85528145bd9c5c048c784095f2","type":"table_spanning_cell","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","children_ids":["ecf8f072761a4a2ebfa016a4cdd96b10"],"text":"","text_display":"Tabulated Trial Protocol","cell_row":0,"cell_column":2,"cell_row_span":5,"cell_col_span":1},{"cnt":[[1099,345],[1322,345],[1322,430],[1099,430]],"region":{"top_left_x":1098,"top_left_y":344,"width":224,"height":87},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecf8f072761a4a2ebfa016a4cdd96b10","type":"complex_cell","conversion_output":false,"parent_id":"190d6d85528145bd9c5c048c784095f2","children_ids":["34cb5ed30bfd4a8ba475d8d203e4c87a","fea74d9e98a74324ab835d5c47b1bde4"],"text":"Tabulated Trial Protocol","text_display":"Tabulated Trial Protocol","cell_row":0,"cell_column":2,"cell_row_span":5,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1131,349],[1287,349],[1287,384],[1131,384]],"region":{"top_left_x":1130,"top_left_y":349,"width":158,"height":35},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34cb5ed30bfd4a8ba475d8d203e4c87a","type":"text","conversion_output":false,"parent_id":"ecf8f072761a4a2ebfa016a4cdd96b10","text":"Tabulated","text_display":"Tabulated","confidence":1,"confidence_rate":1},{"cnt":[[1101,391],[1317,391],[1317,425],[1101,425]],"region":{"top_left_x":1100,"top_left_y":390,"width":218,"height":36},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fea74d9e98a74324ab835d5c47b1bde4","type":"text","conversion_output":false,"parent_id":"ecf8f072761a4a2ebfa016a4cdd96b10","text":"Trial Protocol","text_display":" Trial Protocol","confidence":1,"confidence_rate":1},{"cnt":[[1460,340],[1750,340],[1750,762],[1460,762]],"region":{"top_left_x":1460,"top_left_y":340,"width":291,"height":422},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd98085433484170adc3ee8b4d95f2cf","type":"table_spanning_cell","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","text":"","text_display":"","cell_row":0,"cell_column":3,"cell_row_span":5,"cell_col_span":1},{"cnt":[[254,488],[659,488],[659,621],[254,621]],"region":{"top_left_x":253,"top_left_y":487,"width":406,"height":135},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e7c2ff64a614bcea4a964813bef7504","type":"complex_cell","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","children_ids":["52a26828bc8c492e98d4a5a842af4c86","3ef75ff4b7e64c14854e9d26dd60a07f"],"text":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta®\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta®\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.98291015625,"confidence_rate":0.9993845622981056},{"cnt":[[256,490],[652,490],[652,531],[256,531]],"region":{"top_left_x":255,"top_left_y":489,"width":397,"height":43},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52a26828bc8c492e98d4a5a842af4c86","type":"text","conversion_output":false,"parent_id":"9e7c2ff64a614bcea4a964813bef7504","text":"Name of finished product:","text_display":"Name of finished product:","confidence":1,"confidence_rate":1},{"cnt":[[256,575],[405,575],[405,617],[256,617]],"region":{"top_left_x":255,"top_left_y":575,"width":151,"height":42},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ef75ff4b7e64c14854e9d26dd60a07f","type":"text","conversion_output":false,"parent_id":"9e7c2ff64a614bcea4a964813bef7504","text":"Trajenta®","text_display":"\nTrajenta®","confidence":0.98291015625,"confidence_rate":0.9987695033597761},{"cnt":[[251,626],[852,626],[852,762],[251,762]],"region":{"top_left_x":251,"top_left_y":625,"width":602,"height":137},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"286280daf0884491ac9ade9f234b338b","type":"table_spanning_cell","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","children_ids":["6d5599c0940b441d9d79793a78d988f2"],"text":"","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":2,"cell_col_span":2},{"cnt":[[256,628],[659,628],[659,759],[256,759]],"region":{"top_left_x":255,"top_left_y":628,"width":404,"height":132},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d5599c0940b441d9d79793a78d988f2","type":"complex_cell","conversion_output":false,"parent_id":"286280daf0884491ac9ade9f234b338b","children_ids":["3963278d846e40d39f64d70e70026ec2","289510f95b4c4246be2e60ee0da80498"],"text":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":2,"cell_col_span":2,"confidence":0.98486328125,"confidence_rate":0.9997067267013856},{"cnt":[[256,630],[656,630],[656,672],[256,672]],"region":{"top_left_x":255,"top_left_y":630,"width":402,"height":42},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3963278d846e40d39f64d70e70026ec2","type":"text","conversion_output":false,"parent_id":"6d5599c0940b441d9d79793a78d988f2","text":"Name of active ingredient:","text_display":"Name of active ingredient:","confidence":1,"confidence_rate":1},{"cnt":[[256,713],[562,713],[562,757],[256,757]],"region":{"top_left_x":255,"top_left_y":713,"width":308,"height":44},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"289510f95b4c4246be2e60ee0da80498","type":"text","conversion_output":false,"parent_id":"6d5599c0940b441d9d79793a78d988f2","text":"Linagliptin (BI 1356)","text_display":"\nLinagliptin (BI 1356)","confidence":0.98486328125,"confidence_rate":0.9994135394119988},{"cnt":[[254,768],[495,768],[495,863],[254,863]],"region":{"top_left_x":253,"top_left_y":768,"width":243,"height":95},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15467b21877b424e8eba7edc21b1d717","type":"complex_cell","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","children_ids":["c0c30b8f475640249b27b157af01d332","0fc62031403d416baea6150c8a61ac11"],"text":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[256,773],[475,773],[475,812],[256,812]],"region":{"top_left_x":255,"top_left_y":773,"width":220,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0c30b8f475640249b27b157af01d332","type":"text","conversion_output":false,"parent_id":"15467b21877b424e8eba7edc21b1d717","text":"Protocol date:","text_display":"Protocol date:","confidence":1,"confidence_rate":1},{"cnt":[[256,819],[493,819],[493,858],[256,858]],"region":{"top_left_x":255,"top_left_y":819,"width":238,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0fc62031403d416baea6150c8a61ac11","type":"text","conversion_output":false,"parent_id":"15467b21877b424e8eba7edc21b1d717","text":"5 February 2013","text_display":"\n5 February 2013","confidence":1,"confidence_rate":1},{"cnt":[[624,768],[848,768],[848,861],[624,861]],"region":{"top_left_x":624,"top_left_y":768,"width":224,"height":93},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42bfedb57bcf4e8b9d51743397504464","type":"complex_cell","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","children_ids":["db49e82a742847c98f1e05b0f88ea614","2b20b3ee8c7b42ad97e394f13ef76e8e"],"text":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[624,773],[845,773],[845,812],[624,812]],"region":{"top_left_x":624,"top_left_y":773,"width":222,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db49e82a742847c98f1e05b0f88ea614","type":"text","conversion_output":false,"parent_id":"42bfedb57bcf4e8b9d51743397504464","text":"Trial number:","text_display":"Trial number:","confidence":1,"confidence_rate":1},{"cnt":[[629,819],[746,819],[746,858],[629,858]],"region":{"top_left_x":628,"top_left_y":819,"width":119,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b20b3ee8c7b42ad97e394f13ef76e8e","type":"text","conversion_output":false,"parent_id":"42bfedb57bcf4e8b9d51743397504464","text":"1218.22","text_display":"\n1218.22","confidence":1,"confidence_rate":1},{"cnt":[[1458,768],[1750,768],[1750,863],[1458,863]],"region":{"top_left_x":1457,"top_left_y":768,"width":294,"height":95},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb29aee8108546cca7a21ecf255eeac9","type":"complex_cell","conversion_output":false,"parent_id":"d9481e1f41c54402a341ae8fad906f77","children_ids":["87404fbfa76b4fb6a373c05edcf4b32d","d189052d27a741eabcb36eb55cc1c0aa"],"text":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","cell_row":5,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1467,773],[1681,773],[1681,812],[1467,812]],"region":{"top_left_x":1466,"top_left_y":773,"width":216,"height":40},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87404fbfa76b4fb6a373c05edcf4b32d","type":"text","conversion_output":false,"parent_id":"cb29aee8108546cca7a21ecf255eeac9","text":"Revision date:","text_display":"Revision date:","confidence":1,"confidence_rate":1},{"cnt":[[1462,817],[1748,817],[1748,858],[1462,858]],"region":{"top_left_x":1462,"top_left_y":816,"width":286,"height":43},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d189052d27a741eabcb36eb55cc1c0aa","type":"text","conversion_output":false,"parent_id":"cb29aee8108546cca7a21ecf255eeac9","text":"22 November 2016","text_display":"\n22 November 2016","confidence":1,"confidence_rate":1},{"cnt":[[790,2664],[1300,2664],[1300,2700],[790,2700]],"region":{"top_left_x":790,"top_left_y":2663,"width":510,"height":38},"line":43,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"33c96da9a7954db88968abff820038fb","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2700],[1802,2700],[1802,2739],[292,2739]],"region":{"top_left_x":292,"top_left_y":2700,"width":1511,"height":39},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2c55cb83c1bc4e1cb182299627702dbb","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.98291015625,"confidence_rate":0.9998551570410098},{"cnt":[[295,2744],[1770,2744],[1770,2780],[295,2780]],"region":{"top_left_x":294,"top_left_y":2743,"width":1477,"height":38},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"45552a8309344d178d9f2dd90ba284ed","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-006","page":6,"lines":[{"cnt":[[247,121],[612,121],[612,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":367,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"274bb2a86cb84f2d9de2ea5fb690a720","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecf47c47e794459aa181f97ee5bec4b4","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,164],[601,164],[601,203],[244,203]],"region":{"top_left_x":244,"top_left_y":164,"width":357,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a45edc203a8645e2806cc3bcba406304","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[642,208],[642,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":400,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b93eecaf7c0402e87176672e70350b6","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,208],[1112,208],[1112,249],[868,249]],"region":{"top_left_x":868,"top_left_y":207,"width":245,"height":42},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad8282d404b740cd94d674518625b87c","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1592,206],[1816,206],[1816,254],[1592,254]],"region":{"top_left_x":1592,"top_left_y":205,"width":225,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9ba8caf87294e5f88b760bd451eef71","type":"page_info","conversion_output":false,"text":"Page 6 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1832,331],[1832,2481],[242,2481]],"region":{"top_left_x":242,"top_left_y":331,"width":1591,"height":2150},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79bad2b2a6fa46af9b9e82980be7b098","type":"table","conversion_output":true,"children_ids":["fcaaaf7e5e114d1ebf133d59fa84b9b5","890d93c4a64e4ffd9f551c297fedf9ff","26c1dfe0299c49af9b40da7cd29178d9","2be1883490f548338bce7b33c8170b81","3bdb272751684c4cafdc7f3439dbb216","7e3bb72f076343c98be61f7f830260b9","aeb4e076c695476baead6c1eced2d41f","de4f5dba5a834e7b84594d77b19f5dc5","b8e583d67e704baeb2a23e3498d5be01","923c24428e8b4688bb092a84e18b6b92","981c030212f54b77941ab96d649f0c38","2b1171a4da3a4f898b372a2d0e01a3dc","c6fb481ec6394de6be1fd6aa8cb28957","6cbf11aa11524263bed3af200eed5073","cc9b235c7d5a4484babc8c57020d81d2","be5b2583d5744fe581810842a5d090a9","11a7352227164480bb5c836a8f4ec155","2faaf462ae7940cea901c531bd6a2c41","c355dc9266bb46b6946c17bbe9848422","0939c531fef944e6a3dfd8622d089d4f","4e0a0ee6c1d24278b6c7719210f63f6e","96f70a415d174132a3a4f4c8c5c99a7f","ec931365dc1a400ba5810a8d41a7544b","322149e14c3942259bea335f87d0aed2","6efa1c48907f4119bab768f2b8622414","b2bf94d33eaa4877aee448b3024db9b3"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline \\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular} & & \\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular} & \\multirow{3}{*}{} \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}} & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline \\multicolumn{4}{|c|}{} \\\\\n\\hline \\multirow[t]{2}{*}{Criteria for safety:} & \\multicolumn{3}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nSecondary and tertiary CV and renal endpoints are described above and in Section 7. \\\\\nIn addition, incidence and intensity of adverse events, physical examination, vital signs, electrocardiogram (ECG) and change from baseline in laboratory parameters will be assessed.\n\\end{tabular}}} \\\\\n\\hline & & & \\\\\n\\hline Statistical methods: & \\multicolumn{3}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nFor the primary analyses a Cox proportional hazards regression model of time to first event with factor treatment and geographical region will be conducted. The primary analyses will be performed on the full analysis set Treated Set following the intent-to-treat principle. The first null hypothesis states that linagliptin is inferior to placebo by a hazard ratio of at least 1.3 regarding the primary composite endpoint. \\\\\nThe study is powered to reject that hypothesis. \\\\\nIf the non-inferiority test with margin 1.3 has revealed a significant result, then two separate hypothesis tests for \\\\\na) the primary composite endpoint \\\\\nb) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated \\(GFR \\geq 5 0 4 0 \\%\\) from baseline) \\\\\nwill be tested for superiority in parallel, each with the Cox proportional hazards regression model for time to first event. To adjust for multiplicity a sequentially\n\\end{tabular}}} \\\\\n\\hline & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular} & & \\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular} & \\multirow{3}{*}{} \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}} & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline \\multicolumn{4}{|c|}{} \\\\\n\\hline \\multirow[t]{2}{*}{Criteria for safety:} & \\multicolumn{3}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nSecondary and tertiary CV and renal endpoints are described above and in Section 7. \\\\\nIn addition, incidence and intensity of adverse events, physical examination, vital signs, electrocardiogram (ECG) and change from baseline in laboratory parameters will be assessed.\n\\end{tabular}}} \\\\\n\\hline & & & \\\\\n\\hline Statistical methods: & \\multicolumn{3}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nFor the primary analyses a Cox proportional hazards regression model of time to first event with factor treatment and geographical region will be conducted. The primary analyses will be performed on the full analysis set Treated Set following the intent-to-treat principle. The first null hypothesis states that linagliptin is inferior to placebo by a hazard ratio of at least 1.3 regarding the primary composite endpoint. \\\\\nThe study is powered to reject that hypothesis. \\\\\nIf the non-inferiority test with margin 1.3 has revealed a significant result, then two separate hypothesis tests for \\\\\na) the primary composite endpoint \\\\\nb) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated \\(GFR \\geq 5 0 4 0 \\%\\) from baseline) \\\\\nwill be tested for superiority in parallel, each with the Cox proportional hazards regression model for time to first event. To adjust for multiplicity a sequentially\n\\end{tabular}}} \\\\\n\\hline & & & \\\\\n\\hline\n\\end{tabular}","confidence":0.856151819229126,"confidence_rate":0.9994718824975403},{"cnt":[[247,331],[576,331],[576,2482],[247,2482]],"region":{"top_left_x":246,"top_left_y":331,"width":330,"height":2151},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fcaaaf7e5e114d1ebf133d59fa84b9b5","type":"table_column","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[608,331],[864,331],[864,2482],[608,2482]],"region":{"top_left_x":608,"top_left_y":331,"width":256,"height":2151},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"890d93c4a64e4ffd9f551c297fedf9ff","type":"table_column","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[1094,331],[1324,331],[1324,2482],[1094,2482]],"region":{"top_left_x":1093,"top_left_y":331,"width":232,"height":2151},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"26c1dfe0299c49af9b40da7cd29178d9","type":"table_column","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[1444,331],[1805,331],[1805,2482],[1444,2482]],"region":{"top_left_x":1443,"top_left_y":331,"width":363,"height":2151},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2be1883490f548338bce7b33c8170b81","type":"table_column","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[242,343],[1835,343],[1835,483],[242,483]],"region":{"top_left_x":242,"top_left_y":342,"width":1594,"height":141},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3bdb272751684c4cafdc7f3439dbb216","type":"table_row","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[242,485],[1833,485],[1833,619],[242,619]],"region":{"top_left_x":242,"top_left_y":485,"width":1592,"height":134},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e3bb72f076343c98be61f7f830260b9","type":"table_row","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[242,626],[1833,626],[1833,759],[242,759]],"region":{"top_left_x":242,"top_left_y":625,"width":1592,"height":135},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aeb4e076c695476baead6c1eced2d41f","type":"table_row","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[242,768],[1833,768],[1833,863],[242,863]],"region":{"top_left_x":242,"top_left_y":768,"width":1592,"height":95},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de4f5dba5a834e7b84594d77b19f5dc5","type":"table_row","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[241,866],[1833,864],[1834,1609],[242,1611]],"region":{"top_left_x":240,"top_left_y":863,"width":1595,"height":749},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8e583d67e704baeb2a23e3498d5be01","type":"table_row","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[242,1610],[1833,1608],[1833,1660],[242,1662]],"region":{"top_left_x":241,"top_left_y":1607,"width":1593,"height":56},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"923c24428e8b4688bb092a84e18b6b92","type":"table_row","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[242,1687],[1833,1687],[1833,1818],[242,1818]],"region":{"top_left_x":242,"top_left_y":1687,"width":1592,"height":132},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"981c030212f54b77941ab96d649f0c38","type":"table_row","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[242,1853],[1833,1853],[1833,2065],[242,2065]],"region":{"top_left_x":242,"top_left_y":1852,"width":1592,"height":213},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b1171a4da3a4f898b372a2d0e01a3dc","type":"table_row","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[242,2109],[1833,2109],[1833,2482],[242,2482]],"region":{"top_left_x":242,"top_left_y":2108,"width":1592,"height":374},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6fb481ec6394de6be1fd6aa8cb28957","type":"table_row","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":""},{"cnt":[[251,345],[571,345],[571,481],[251,481]],"region":{"top_left_x":251,"top_left_y":344,"width":321,"height":137},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6cbf11aa11524263bed3af200eed5073","type":"complex_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["1c2f40e2b0b3429c897bf9823b300002","e52144ed431546e2aa8a2ef308bc7ae8"],"text":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[256,345],[544,345],[544,389],[256,389]],"region":{"top_left_x":255,"top_left_y":344,"width":289,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c2f40e2b0b3429c897bf9823b300002","type":"text","conversion_output":false,"parent_id":"6cbf11aa11524263bed3af200eed5073","text":"Name of company:","text_display":"Name of company:","confidence":1,"confidence_rate":1},{"cnt":[[260,437],[571,437],[571,476],[260,476]],"region":{"top_left_x":260,"top_left_y":436,"width":312,"height":41},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e52144ed431546e2aa8a2ef308bc7ae8","type":"text","conversion_output":false,"parent_id":"6cbf11aa11524263bed3af200eed5073","text":"Boehringer Ingelheim","text_display":"\nBoehringer Ingelheim","confidence":1,"confidence_rate":1},{"cnt":[[1105,345],[1322,345],[1322,430],[1105,430]],"region":{"top_left_x":1105,"top_left_y":344,"width":217,"height":87},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cc9b235c7d5a4484babc8c57020d81d2","type":"complex_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["6aba81db8e5c46e69866a3148399c00a","95043b2c771246dc871cda713d6f5bb2"],"text":"\\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTabulated \\\\\nTrial Protocol\n\\end{tabular}","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1131,349],[1290,349],[1290,384],[1131,384]],"region":{"top_left_x":1130,"top_left_y":349,"width":160,"height":35},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6aba81db8e5c46e69866a3148399c00a","type":"text","conversion_output":false,"parent_id":"cc9b235c7d5a4484babc8c57020d81d2","text":"Tabulated","text_display":"Tabulated","confidence":1,"confidence_rate":1},{"cnt":[[1103,391],[1317,391],[1317,425],[1103,425]],"region":{"top_left_x":1103,"top_left_y":390,"width":215,"height":36},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95043b2c771246dc871cda713d6f5bb2","type":"text","conversion_output":false,"parent_id":"cc9b235c7d5a4484babc8c57020d81d2","text":"Trial Protocol","text_display":"\nTrial Protocol","confidence":1,"confidence_rate":1},{"cnt":[[1460,340],[1815,340],[1815,759],[1460,759]],"region":{"top_left_x":1460,"top_left_y":340,"width":355,"height":420},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be5b2583d5744fe581810842a5d090a9","type":"table_spanning_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":"","cell_row":0,"cell_column":3,"cell_row_span":3,"cell_col_span":1},{"cnt":[[254,488],[659,488],[659,619],[254,619]],"region":{"top_left_x":253,"top_left_y":487,"width":406,"height":132},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11a7352227164480bb5c836a8f4ec155","type":"complex_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["5eeccbec80534557ab2ea56af0d2a4fc","eaca1b8ca79d4a3cbd1b8e269b822194"],"text":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.856151819229126,"confidence_rate":0.9963090294001592},{"cnt":[[256,490],[652,487],[652,529],[256,532]],"region":{"top_left_x":255,"top_left_y":487,"width":397,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5eeccbec80534557ab2ea56af0d2a4fc","type":"text","conversion_output":false,"parent_id":"11a7352227164480bb5c836a8f4ec155","text":"Name of finished product:","text_display":"Name of finished product:","confidence":1,"confidence_rate":1},{"cnt":[[260,575],[405,575],[405,614],[260,614]],"region":{"top_left_x":260,"top_left_y":575,"width":146,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eaca1b8ca79d4a3cbd1b8e269b822194","type":"text","conversion_output":false,"parent_id":"11a7352227164480bb5c836a8f4ec155","text":"Trajenta \\({ }^{\\circledR}\\)","text_display":"\nTrajenta \\({ }^{\\circledR}\\)","confidence":0.856151819229126,"confidence_rate":0.9926316820642873},{"cnt":[[254,628],[848,628],[848,782],[254,782]],"region":{"top_left_x":253,"top_left_y":628,"width":595,"height":155},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2faaf462ae7940cea901c531bd6a2c41","type":"table_spanning_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["30a8740dafb14ce3831791dc7d4dced9"],"text":"","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[256,630],[659,630],[659,757],[256,757]],"region":{"top_left_x":255,"top_left_y":630,"width":404,"height":127},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30a8740dafb14ce3831791dc7d4dced9","type":"complex_cell","conversion_output":false,"parent_id":"2faaf462ae7940cea901c531bd6a2c41","children_ids":["5640a64ce26148a88e4ed7eb9fd8c42b","ca46cba51d404e98819a124b9648790e"],"text":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":0.98779296875,"confidence_rate":0.9997638327189674},{"cnt":[[256,630],[654,630],[654,669],[256,669]],"region":{"top_left_x":255,"top_left_y":630,"width":400,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5640a64ce26148a88e4ed7eb9fd8c42b","type":"text","conversion_output":false,"parent_id":"30a8740dafb14ce3831791dc7d4dced9","text":"Name of active ingredient:","text_display":"Name of active ingredient:","confidence":1,"confidence_rate":1},{"cnt":[[256,713],[564,713],[564,757],[256,757]],"region":{"top_left_x":255,"top_left_y":713,"width":310,"height":44},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca46cba51d404e98819a124b9648790e","type":"text","conversion_output":false,"parent_id":"30a8740dafb14ce3831791dc7d4dced9","text":"Linagliptin (BI 1356)","text_display":"\nLinagliptin (BI 1356)","confidence":0.98779296875,"confidence_rate":0.9995277212129194},{"cnt":[[256,773],[495,773],[495,861],[256,861]],"region":{"top_left_x":255,"top_left_y":773,"width":241,"height":88},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c355dc9266bb46b6946c17bbe9848422","type":"complex_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["84d1b42a32e249818ddd886ba4e93df4","abf5474482b14dbdab760f226a10379c"],"text":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[256,773],[475,773],[475,808],[256,808]],"region":{"top_left_x":255,"top_left_y":773,"width":220,"height":35},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84d1b42a32e249818ddd886ba4e93df4","type":"text","conversion_output":false,"parent_id":"c355dc9266bb46b6946c17bbe9848422","text":"Protocol date:","text_display":"Protocol date:","confidence":1,"confidence_rate":1},{"cnt":[[256,817],[493,817],[493,858],[256,858]],"region":{"top_left_x":255,"top_left_y":816,"width":238,"height":43},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abf5474482b14dbdab760f226a10379c","type":"text","conversion_output":false,"parent_id":"c355dc9266bb46b6946c17bbe9848422","text":"5 February 2013","text_display":"\n5 February 2013","confidence":1,"confidence_rate":1},{"cnt":[[622,768],[848,768],[848,856],[622,856]],"region":{"top_left_x":621,"top_left_y":768,"width":227,"height":88},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0939c531fef944e6a3dfd8622d089d4f","type":"complex_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["9949bbbfeed248e1a0689620e107239e","887fdc586fed451ead90b8a05457a628"],"text":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[624,773],[843,773],[843,808],[624,808]],"region":{"top_left_x":624,"top_left_y":773,"width":219,"height":35},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9949bbbfeed248e1a0689620e107239e","type":"text","conversion_output":false,"parent_id":"0939c531fef944e6a3dfd8622d089d4f","text":"Trial number:","text_display":"Trial number:","confidence":1,"confidence_rate":1},{"cnt":[[631,819],[746,819],[746,849],[631,849]],"region":{"top_left_x":631,"top_left_y":819,"width":116,"height":31},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"887fdc586fed451ead90b8a05457a628","type":"text","conversion_output":false,"parent_id":"0939c531fef944e6a3dfd8622d089d4f","text":"1218.22","text_display":"\n1218.22","confidence":1,"confidence_rate":1},{"cnt":[[1462,773],[1750,773],[1750,854],[1462,854]],"region":{"top_left_x":1462,"top_left_y":773,"width":289,"height":81},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e0a0ee6c1d24278b6c7719210f63f6e","type":"complex_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["6a80c025cee74aa18c0f2704d45aa97c","bf0f4dd759874194b2403c3846297ce8"],"text":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","cell_row":3,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1467,773],[1681,773],[1681,808],[1467,808]],"region":{"top_left_x":1466,"top_left_y":773,"width":216,"height":35},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a80c025cee74aa18c0f2704d45aa97c","type":"text","conversion_output":false,"parent_id":"4e0a0ee6c1d24278b6c7719210f63f6e","text":"Revision date:","text_display":"Revision date:","confidence":1,"confidence_rate":1},{"cnt":[[1467,817],[1746,817],[1746,854],[1467,854]],"region":{"top_left_x":1466,"top_left_y":816,"width":280,"height":38},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf0f4dd759874194b2403c3846297ce8","type":"text","conversion_output":false,"parent_id":"4e0a0ee6c1d24278b6c7719210f63f6e","text":"22 November 2016","text_display":"\n22 November 2016","confidence":1,"confidence_rate":1},{"cnt":[[247,865],[1822,865],[1822,1613],[247,1613]],"region":{"top_left_x":246,"top_left_y":865,"width":1576,"height":749},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96f70a415d174132a3a4f4c8c5c99a7f","type":"table_spanning_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"","text_display":"","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":4},{"cnt":[[247,1611],[569,1611],[569,1825],[247,1825]],"region":{"top_left_x":246,"top_left_y":1611,"width":323,"height":215},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec931365dc1a400ba5810a8d41a7544b","type":"table_spanning_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["e116793b6a614b12a18e4c5b4ef4fc36"],"text":"","text_display":"Criteria for safety:","cell_row":5,"cell_column":0,"cell_row_span":2,"cell_col_span":1},{"cnt":[[251,1620],[534,1620],[534,1660],[251,1660]],"region":{"top_left_x":251,"top_left_y":1620,"width":284,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e116793b6a614b12a18e4c5b4ef4fc36","type":"simple_cell","conversion_output":false,"parent_id":"ec931365dc1a400ba5810a8d41a7544b","text":"Criteria for safety:","text_display":"Criteria for safety:","cell_row":5,"cell_column":0,"cell_row_span":2,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[610,1609],[1812,1609],[1812,1818],[610,1818]],"region":{"top_left_x":610,"top_left_y":1608,"width":1203,"height":211},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"322149e14c3942259bea335f87d0aed2","type":"table_spanning_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["56eed16030df47ccb28fb60ff19c2e01"],"text":"","text_display":"\\begin{tabular}{l}\nSecondary and tertiary CV and renal endpoints are described above and in Section 7. \\\\\nIn addition, incidence and intensity of adverse events, physical examination, vital signs, electrocardiogram (ECG) and change from baseline in laboratory parameters will be assessed.\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":2,"cell_col_span":3},{"cnt":[[610,1611],[1803,1611],[1803,1816],[610,1816]],"region":{"top_left_x":610,"top_left_y":1611,"width":1194,"height":206},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56eed16030df47ccb28fb60ff19c2e01","type":"complex_cell","conversion_output":false,"parent_id":"322149e14c3942259bea335f87d0aed2","children_ids":["1ef0d7e304be4b01951f088d89150257","99df6fc9e7404a359b0e9488355ce450","997bb7950993479cb78b4d6c82060f5b","8fc5ec615962400e9e917c1edfb3e4d5"],"text":"\\begin{tabular}{l}\nSecondary and tertiary CV and renal endpoints are described above and in Section 7. \\\\\nIn addition, incidence and intensity of adverse events, physical examination, vital signs, electrocardiogram (ECG) and change from baseline in laboratory parameters will be assessed.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nSecondary and tertiary CV and renal endpoints are described above and in Section 7. \\\\\nIn addition, incidence and intensity of adverse events, physical examination, vital signs, electrocardiogram (ECG) and change from baseline in laboratory parameters will be assessed.\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":2,"cell_col_span":3,"confidence":1,"confidence_rate":1},{"cnt":[[617,1616],[1796,1616],[1796,1655],[617,1655]],"region":{"top_left_x":617,"top_left_y":1615,"width":1180,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ef0d7e304be4b01951f088d89150257","type":"text","conversion_output":false,"parent_id":"56eed16030df47ccb28fb60ff19c2e01","text":"Secondary and tertiary CV and renal endpoints are described above and in Section 7.","text_display":"Secondary and tertiary CV and renal endpoints are described above and in Section 7.","confidence":1,"confidence_rate":1},{"cnt":[[615,1696],[1755,1696],[1755,1736],[615,1736]],"region":{"top_left_x":615,"top_left_y":1696,"width":1140,"height":40},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99df6fc9e7404a359b0e9488355ce450","type":"text","conversion_output":false,"parent_id":"56eed16030df47ccb28fb60ff19c2e01","text":"In addition, incidence and intensity of adverse events, physical examination, vital","text_display":"\nIn addition, incidence and intensity of adverse events, physical examination, vital","confidence":1,"confidence_rate":1},{"cnt":[[615,1736],[1778,1736],[1778,1775],[615,1775]],"region":{"top_left_x":615,"top_left_y":1735,"width":1163,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"997bb7950993479cb78b4d6c82060f5b","type":"text","conversion_output":false,"parent_id":"56eed16030df47ccb28fb60ff19c2e01","text":"signs, electrocardiogram (ECG) and change from baseline in laboratory parameters","text_display":" signs, electrocardiogram (ECG) and change from baseline in laboratory parameters","confidence":1,"confidence_rate":1},{"cnt":[[615,1777],[852,1777],[852,1812],[615,1812]],"region":{"top_left_x":615,"top_left_y":1776,"width":238,"height":36},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fc5ec615962400e9e917c1edfb3e4d5","type":"text","conversion_output":false,"parent_id":"56eed16030df47ccb28fb60ff19c2e01","text":"will be assessed.","text_display":" will be assessed.","confidence":1,"confidence_rate":1},{"cnt":[[251,1862],[544,1862],[544,1899],[251,1899]],"region":{"top_left_x":251,"top_left_y":1862,"width":293,"height":38},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6efa1c48907f4119bab768f2b8622414","type":"simple_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","text":"Statistical methods:","text_display":"Statistical methods:","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[610,1855],[1812,1855],[1812,2479],[610,2479]],"region":{"top_left_x":610,"top_left_y":1855,"width":1203,"height":625},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b2bf94d33eaa4877aee448b3024db9b3","type":"table_spanning_cell","conversion_output":false,"parent_id":"79bad2b2a6fa46af9b9e82980be7b098","children_ids":["30bbc8cb15fa43549de6455de2cad997"],"text":"","text_display":"\\begin{tabular}{l}\nFor the primary analyses a Cox proportional hazards regression model of time to first event with factor treatment and geographical region will be conducted. The primary analyses will be performed on the full analysis set Treated Set following the intent-to-treat principle. The first null hypothesis states that linagliptin is inferior to placebo by a hazard ratio of at least 1.3 regarding the primary composite endpoint. \\\\\nThe study is powered to reject that hypothesis. \\\\\nIf the non-inferiority test with margin 1.3 has revealed a significant result, then two separate hypothesis tests for \\\\\na) the primary composite endpoint \\\\\nb) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated \\(GFR \\geq 5 0 4 0 \\%\\) from baseline) \\\\\nwill be tested for superiority in parallel, each with the Cox proportional hazards regression model for time to first event. To adjust for multiplicity a sequentially\n\\end{tabular}","cell_row":7,"cell_column":1,"cell_row_span":2,"cell_col_span":3},{"cnt":[[610,1855],[1805,1855],[1805,2479],[610,2479]],"region":{"top_left_x":610,"top_left_y":1855,"width":1196,"height":625},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30bbc8cb15fa43549de6455de2cad997","type":"complex_cell","conversion_output":false,"parent_id":"b2bf94d33eaa4877aee448b3024db9b3","children_ids":["1b17c9dba38d463196c1a1e5c5cbae8a","eaa964df6eaa4c039a618f26568a1484","532fdd8d9aa3431a911f2acb7fc7a4d1","b85326ea3280416d8baa8e1bc3951df2","d974325952374e91bb124b78df157467","f7927bd12efc41ef8bcf99a4824d2f8d","79341f1b06ca4b829c842280c8f6ffad","dab09734ae0749a1949246b61ff6df32","6f4cf7fc13ac4b1bb5365a5758a92788","877b68538cc64aae80af6ca264e6bc33","6ed85bd2022b47c4bb8c28a5617f69f3","51f489e4ab3b4e94b31494769c75cbb3","a85df3e5832f4764b1ba94a91a58a1cf"],"text":"\\begin{tabular}{l}\nFor the primary analyses a Cox proportional hazards regression model of time to first event with factor treatment and geographical region will be conducted. The primary analyses will be performed on the full analysis set Treated Set following the intent-to-treat principle. The first null hypothesis states that linagliptin is inferior to placebo by a hazard ratio of at least 1.3 regarding the primary composite endpoint. \\\\\nThe study is powered to reject that hypothesis. \\\\\nIf the non-inferiority test with margin 1.3 has revealed a significant result, then two separate hypothesis tests for \\\\\na) the primary composite endpoint \\\\\nb) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated \\(GFR \\geq 5 0 4 0 \\%\\) from baseline) \\\\\nwill be tested for superiority in parallel, each with the Cox proportional hazards regression model for time to first event. To adjust for multiplicity a sequentially\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nFor the primary analyses a Cox proportional hazards regression model of time to first event with factor treatment and geographical region will be conducted. The primary analyses will be performed on the full analysis set Treated Set following the intent-to-treat principle. The first null hypothesis states that linagliptin is inferior to placebo by a hazard ratio of at least 1.3 regarding the primary composite endpoint. \\\\\nThe study is powered to reject that hypothesis. \\\\\nIf the non-inferiority test with margin 1.3 has revealed a significant result, then two separate hypothesis tests for \\\\\na) the primary composite endpoint \\\\\nb) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated \\(GFR \\geq 5 0 4 0 \\%\\) from baseline) \\\\\nwill be tested for superiority in parallel, each with the Cox proportional hazards regression model for time to first event. To adjust for multiplicity a sequentially\n\\end{tabular}","cell_row":7,"cell_column":1,"cell_row_span":2,"cell_col_span":3,"confidence":0.4220450942446167,"confidence_rate":0.9990914107915994},{"cnt":[[615,1860],[1810,1860],[1810,1899],[615,1899]],"region":{"top_left_x":615,"top_left_y":1859,"width":1196,"height":41},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b17c9dba38d463196c1a1e5c5cbae8a","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"For the primary analyses a Cox proportional hazards regression model of time to first","text_display":"For the primary analyses a Cox proportional hazards regression model of time to first","confidence":1,"confidence_rate":1},{"cnt":[[615,1899],[1787,1899],[1787,1940],[615,1940]],"region":{"top_left_x":615,"top_left_y":1899,"width":1172,"height":42},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eaa964df6eaa4c039a618f26568a1484","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"event with factor treatment and geographical region will be conducted. The primary","text_display":" event with factor treatment and geographical region will be conducted. The primary","confidence":1,"confidence_rate":1},{"cnt":[[615,1938],[1792,1938],[1792,1980],[615,1980]],"region":{"top_left_x":615,"top_left_y":1938,"width":1177,"height":42},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"532fdd8d9aa3431a911f2acb7fc7a4d1","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"analyses will be performed on the full analysis set Treated Set following the intent-","text_display":" analyses will be performed on the full analysis set Treated Set following the intent-","confidence":1,"confidence_rate":1},{"cnt":[[615,1980],[1805,1980],[1805,2019],[615,2019]],"region":{"top_left_x":615,"top_left_y":1979,"width":1191,"height":40},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b85326ea3280416d8baa8e1bc3951df2","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"to-treat principle. The first null hypothesis states that linagliptin is inferior to placebo","text_display":"to-treat principle. The first null hypothesis states that linagliptin is inferior to placebo","confidence":1,"confidence_rate":1},{"cnt":[[615,2019],[1653,2019],[1653,2060],[615,2060]],"region":{"top_left_x":615,"top_left_y":2018,"width":1039,"height":43},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d974325952374e91bb124b78df157467","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"by a hazard ratio of at least 1.3 regarding the primary composite endpoint.","text_display":" by a hazard ratio of at least 1.3 regarding the primary composite endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[615,2113],[1269,2113],[1269,2157],[615,2157]],"region":{"top_left_x":615,"top_left_y":2113,"width":654,"height":44},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7927bd12efc41ef8bcf99a4824d2f8d","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"The study is powered to reject that hypothesis.","text_display":"\nThe study is powered to reject that hypothesis.","confidence":1,"confidence_rate":1},{"cnt":[[615,2164],[1782,2164],[1782,2203],[615,2203]],"region":{"top_left_x":615,"top_left_y":2163,"width":1168,"height":40},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79341f1b06ca4b829c842280c8f6ffad","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"If the non-inferiority test with margin 1.3 has revealed a significant result, then two","text_display":"\nIf the non-inferiority test with margin 1.3 has revealed a significant result, then two","confidence":1,"confidence_rate":1},{"cnt":[[615,2205],[1013,2205],[1013,2244],[615,2244]],"region":{"top_left_x":615,"top_left_y":2205,"width":399,"height":40},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dab09734ae0749a1949246b61ff6df32","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"separate hypothesis tests for","text_display":" separate hypothesis tests for","confidence":1,"confidence_rate":1},{"cnt":[[744,2251],[1262,2251],[1262,2293],[744,2293]],"region":{"top_left_x":743,"top_left_y":2251,"width":520,"height":42},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f4cf7fc13ac4b1bb5365a5758a92788","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"a) the primary composite endpoint","text_display":"\na) the primary composite endpoint","confidence":1,"confidence_rate":1},{"cnt":[[744,2297],[1695,2297],[1695,2341],[744,2341]],"region":{"top_left_x":743,"top_left_y":2297,"width":952,"height":45},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"877b68538cc64aae80af6ca264e6bc33","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"b) the composite renal endpoint (i.e. renal death, sustained ESRD,","text_display":"\nb) the composite renal endpoint (i.e. renal death, sustained ESRD,","confidence":1,"confidence_rate":1},{"cnt":[[808,2339],[1681,2339],[1681,2383],[808,2383]],"region":{"top_left_x":808,"top_left_y":2338,"width":874,"height":45},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ed85bd2022b47c4bb8c28a5617f69f3","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"sustained decrease in estimated \\(GFR \\geq 5 0 4 0 \\%\\) from baseline)","text_display":" sustained decrease in estimated \\(GFR \\geq 5 0 4 0 \\%\\) from baseline)","confidence":0.4220450942446167,"confidence_rate":0.9882525179360664},{"cnt":[[615,2394],[1732,2394],[1732,2435],[615,2435]],"region":{"top_left_x":615,"top_left_y":2394,"width":1117,"height":42},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51f489e4ab3b4e94b31494769c75cbb3","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"will be tested for superiority in parallel, each with the Cox proportional hazards","text_display":"\nwill be tested for superiority in parallel, each with the Cox proportional hazards","confidence":1,"confidence_rate":1},{"cnt":[[615,2435],[1769,2435],[1769,2477],[615,2477]],"region":{"top_left_x":615,"top_left_y":2435,"width":1154,"height":42},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a85df3e5832f4764b1ba94a91a58a1cf","type":"text","conversion_output":false,"parent_id":"30bbc8cb15fa43549de6455de2cad997","text":"regression model for time to first event. To adjust for multiplicity a sequentially","text_display":" regression model for time to first event. To adjust for multiplicity a sequentially","confidence":1,"confidence_rate":1},{"cnt":[[790,2664],[1300,2664],[1300,2702],[790,2702]],"region":{"top_left_x":790,"top_left_y":2663,"width":510,"height":40},"line":69,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"001f044590194f8998fd62dc1a960102","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9833984375,"confidence_rate":0.9996014862638709},{"cnt":[[292,2700],[1802,2700],[1802,2739],[292,2739]],"region":{"top_left_x":292,"top_left_y":2700,"width":1511,"height":39},"line":70,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"21d8744d7c6044519a2235d355d66360","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.98291015625,"confidence_rate":0.9998551570410098},{"cnt":[[295,2746],[1770,2746],[1770,2780],[295,2780]],"region":{"top_left_x":294,"top_left_y":2745,"width":1477,"height":36},"line":71,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a701119d37754c128f7fe0fe601b7317","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-007","page":7,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e3edd3595794098849c9ecf28378db5","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a518e189ebcc495cb45607ce139aa25a","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"012514eabe5d46c4a85c84f4ce035811","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c7da2e72b6e4a929933ce6922e12fcd","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2fc33a1d65e4d09837f243cf8cf7840","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1594,210],[1816,210],[1816,254],[1594,254]],"region":{"top_left_x":1594,"top_left_y":210,"width":223,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77d6b7e39d8c4c10aed9f3f064f88817","type":"page_info","conversion_output":false,"text":"Page 7 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1832,331],[1832,925],[242,925]],"region":{"top_left_x":242,"top_left_y":331,"width":1591,"height":595},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"defad155605c4bd5b3face7eaefeb67a","type":"table","conversion_output":true,"children_ids":["06ea3c2ee5a24db9a38f1c9c651dc0ec","52cad8aeafad4cc688fc338713216f94","6b609fef993f404d990f9b8d64a79b18","10e7b0332eaa4de6830fa573c210141d","5a667ed59e2d45fe8338b153e1dd699f","7c8adc35ef2142958f88c108cbe89f18","3da872f0d915438aae7a564a3fd33ff0","b5d3789ea96e4288876f995eedded8e8","63f5b308c66a436e9c6bec3409a720a9","15494c93a03f4b18a25b3dc6152b96f4","ed79e1fd3ca14c16ae8e18f5f926d6ba","80faa579f18b493ba8d917e39cb7d4d4","1d00619a5ce04b348cba9f3a8a9d01b4","aed0f0d57bce4b29a5bbc261cd1519b6","93e6bb84fbbe4c48ade467da86fa6c4f","48f998fe83154edb9ef00b27dafa7a38","f162f10ee9ff4d958149a77a4bfd65a5","f3172f3044a9439092a34b594c91b461","76f85f136f33456488ba6178385d0e4c","af2b3c7462694a26b9114dec443c6921"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}} & \\multirow[t]{5}{*}{Tabulated Trial Protocol} & \\multirow{5}{*}{} \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\multicolumn{2}{|l|}{\\multirow{2}{*}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}}} & & \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline \\multicolumn{4}{|c|}{rejective multiple test procedure will be applied.} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}} & \\multirow[t]{5}{*}{Tabulated Trial Protocol} & \\multirow{5}{*}{} \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular} & & & \\\\\n\\hline \\multicolumn{2}{|l|}{\\multirow{2}{*}{\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}}} & & \\\\\n\\hline & & & \\\\\n\\hline \\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular} & \\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular} & & \\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular} \\\\\n\\hline \\multicolumn{4}{|c|}{rejective multiple test procedure will be applied.} \\\\\n\\hline\n\\end{tabular}","confidence":0.6431164741516113,"confidence_rate":0.9973758928768081},{"cnt":[[251,331],[498,331],[498,925],[251,925]],"region":{"top_left_x":251,"top_left_y":331,"width":247,"height":595},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06ea3c2ee5a24db9a38f1c9c651dc0ec","type":"table_column","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[613,331],[859,331],[859,925],[613,925]],"region":{"top_left_x":612,"top_left_y":331,"width":248,"height":595},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52cad8aeafad4cc688fc338713216f94","type":"table_column","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[1094,331],[1340,331],[1340,925],[1094,925]],"region":{"top_left_x":1093,"top_left_y":331,"width":248,"height":595},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b609fef993f404d990f9b8d64a79b18","type":"table_column","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[1460,331],[1757,331],[1757,925],[1460,925]],"region":{"top_left_x":1460,"top_left_y":331,"width":298,"height":595},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10e7b0332eaa4de6830fa573c210141d","type":"table_column","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[242,340],[1835,340],[1835,483],[242,483]],"region":{"top_left_x":242,"top_left_y":340,"width":1594,"height":143},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a667ed59e2d45fe8338b153e1dd699f","type":"table_row","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[242,483],[1833,483],[1833,536],[242,536]],"region":{"top_left_x":242,"top_left_y":482,"width":1592,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c8adc35ef2142958f88c108cbe89f18","type":"table_row","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[242,566],[1833,566],[1833,621],[242,621]],"region":{"top_left_x":242,"top_left_y":565,"width":1592,"height":57},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3da872f0d915438aae7a564a3fd33ff0","type":"table_row","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[242,621],[1833,621],[1833,676],[242,676]],"region":{"top_left_x":242,"top_left_y":621,"width":1592,"height":56},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5d3789ea96e4288876f995eedded8e8","type":"table_row","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[242,704],[1833,704],[1833,762],[242,762]],"region":{"top_left_x":242,"top_left_y":704,"width":1592,"height":58},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63f5b308c66a436e9c6bec3409a720a9","type":"table_row","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[242,762],[1833,762],[1833,867],[242,867]],"region":{"top_left_x":242,"top_left_y":761,"width":1592,"height":107},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15494c93a03f4b18a25b3dc6152b96f4","type":"table_row","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[242,861],[1833,861],[1833,916],[242,916]],"region":{"top_left_x":242,"top_left_y":860,"width":1592,"height":56},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed79e1fd3ca14c16ae8e18f5f926d6ba","type":"table_row","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":""},{"cnt":[[249,336],[857,336],[857,485],[249,485]],"region":{"top_left_x":248,"top_left_y":335,"width":609,"height":151},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80faa579f18b493ba8d917e39cb7d4d4","type":"table_spanning_cell","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","children_ids":["285eb33461fd4a379311eccd031b02b2"],"text":"","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[254,345],[576,345],[576,481],[254,481]],"region":{"top_left_x":253,"top_left_y":344,"width":323,"height":137},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"285eb33461fd4a379311eccd031b02b2","type":"complex_cell","conversion_output":false,"parent_id":"80faa579f18b493ba8d917e39cb7d4d4","children_ids":["b9a8cf734df840cf8e9131963205e133","e4de3a377fc04725927106a5a7d273f4"],"text":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of company: \\\\\nBoehringer Ingelheim\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[256,345],[544,345],[544,389],[256,389]],"region":{"top_left_x":255,"top_left_y":344,"width":289,"height":45},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b9a8cf734df840cf8e9131963205e133","type":"text","conversion_output":false,"parent_id":"285eb33461fd4a379311eccd031b02b2","text":"Name of company:","text_display":"Name of company:","confidence":1,"confidence_rate":1},{"cnt":[[256,432],[576,432],[576,476],[256,476]],"region":{"top_left_x":255,"top_left_y":432,"width":321,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e4de3a377fc04725927106a5a7d273f4","type":"text","conversion_output":false,"parent_id":"285eb33461fd4a379311eccd031b02b2","text":"Boehringer Ingelheim","text_display":"\nBoehringer Ingelheim","confidence":1,"confidence_rate":1},{"cnt":[[1094,338],[1340,338],[1340,762],[1094,762]],"region":{"top_left_x":1093,"top_left_y":337,"width":248,"height":425},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d00619a5ce04b348cba9f3a8a9d01b4","type":"table_spanning_cell","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","children_ids":["a5ab946cfc20496c95b3b308ec1bb6c2"],"text":"","text_display":"Tabulated Trial Protocol","cell_row":0,"cell_column":2,"cell_row_span":5,"cell_col_span":1},{"cnt":[[1096,343],[1324,343],[1324,435],[1096,435]],"region":{"top_left_x":1096,"top_left_y":342,"width":229,"height":93},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5ab946cfc20496c95b3b308ec1bb6c2","type":"complex_cell","conversion_output":false,"parent_id":"1d00619a5ce04b348cba9f3a8a9d01b4","children_ids":["7d16ff99e6cb490581947295599c8b09","528d7d0658654fe597693b2940722097"],"text":"Tabulated Trial Protocol","text_display":"Tabulated Trial Protocol","cell_row":0,"cell_column":2,"cell_row_span":5,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1126,345],[1290,345],[1290,384],[1126,384]],"region":{"top_left_x":1126,"top_left_y":344,"width":164,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d16ff99e6cb490581947295599c8b09","type":"text","conversion_output":false,"parent_id":"a5ab946cfc20496c95b3b308ec1bb6c2","text":"Tabulated","text_display":"Tabulated","confidence":1,"confidence_rate":1},{"cnt":[[1099,391],[1317,391],[1317,430],[1099,430]],"region":{"top_left_x":1098,"top_left_y":390,"width":220,"height":41},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"528d7d0658654fe597693b2940722097","type":"text","conversion_output":false,"parent_id":"a5ab946cfc20496c95b3b308ec1bb6c2","text":"Trial Protocol","text_display":" Trial Protocol","confidence":1,"confidence_rate":1},{"cnt":[[1458,338],[1757,338],[1757,764],[1458,764]],"region":{"top_left_x":1457,"top_left_y":337,"width":301,"height":427},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aed0f0d57bce4b29a5bbc261cd1519b6","type":"table_spanning_cell","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","text":"","text_display":"","cell_row":0,"cell_column":3,"cell_row_span":5,"cell_col_span":1},{"cnt":[[251,483],[661,483],[661,621],[251,621]],"region":{"top_left_x":251,"top_left_y":482,"width":411,"height":140},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"93e6bb84fbbe4c48ade467da86fa6c4f","type":"complex_cell","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","children_ids":["67b0618e23914772a812411323903a67","0515e94347584e7386216aec230f4d4c"],"text":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of finished product: \\\\\nTrajenta \\({ }^{\\circledR}\\)\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.6431164741516113,"confidence_rate":0.9895448149060546},{"cnt":[[256,488],[654,488],[654,531],[256,531]],"region":{"top_left_x":255,"top_left_y":487,"width":400,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67b0618e23914772a812411323903a67","type":"text","conversion_output":false,"parent_id":"93e6bb84fbbe4c48ade467da86fa6c4f","text":"Name of finished product:","text_display":"Name of finished product:","confidence":1,"confidence_rate":1},{"cnt":[[256,575],[410,575],[410,617],[256,617]],"region":{"top_left_x":255,"top_left_y":575,"width":156,"height":42},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0515e94347584e7386216aec230f4d4c","type":"text","conversion_output":false,"parent_id":"93e6bb84fbbe4c48ade467da86fa6c4f","text":"Trajenta \\({ }^{\\circledR}\\)","text_display":"\nTrajenta \\({ }^{\\circledR}\\)","confidence":0.6431164741516113,"confidence_rate":0.9791989407074578},{"cnt":[[249,621],[857,621],[857,764],[249,764]],"region":{"top_left_x":248,"top_left_y":621,"width":609,"height":143},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48f998fe83154edb9ef00b27dafa7a38","type":"table_spanning_cell","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","children_ids":["cdbd0bcc43244977a8ee734d1b4f275e"],"text":"","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":2,"cell_col_span":2},{"cnt":[[254,626],[661,626],[661,762],[254,762]],"region":{"top_left_x":253,"top_left_y":625,"width":409,"height":137},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cdbd0bcc43244977a8ee734d1b4f275e","type":"complex_cell","conversion_output":false,"parent_id":"48f998fe83154edb9ef00b27dafa7a38","children_ids":["010301c4f1ff4120949f46de607f8926","60de261ae45f4e3285deec2b43b6fa70"],"text":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nName of active ingredient: \\\\\nLinagliptin (BI 1356)\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":2,"cell_col_span":2,"confidence":0.99072265625,"confidence_rate":0.9998207728643796},{"cnt":[[256,628],[659,628],[659,669],[256,669]],"region":{"top_left_x":255,"top_left_y":628,"width":404,"height":42},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"010301c4f1ff4120949f46de607f8926","type":"text","conversion_output":false,"parent_id":"cdbd0bcc43244977a8ee734d1b4f275e","text":"Name of active ingredient:","text_display":"Name of active ingredient:","confidence":1,"confidence_rate":1},{"cnt":[[256,713],[567,713],[567,757],[256,757]],"region":{"top_left_x":255,"top_left_y":713,"width":312,"height":44},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60de261ae45f4e3285deec2b43b6fa70","type":"text","conversion_output":false,"parent_id":"cdbd0bcc43244977a8ee734d1b4f275e","text":"Linagliptin (BI 1356)","text_display":"\nLinagliptin (BI 1356)","confidence":0.99072265625,"confidence_rate":0.9996415778511254},{"cnt":[[254,764],[498,764],[498,861],[254,861]],"region":{"top_left_x":253,"top_left_y":763,"width":245,"height":98},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f162f10ee9ff4d958149a77a4bfd65a5","type":"complex_cell","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","children_ids":["c5708ace739f4ac0829fbc08b8697c8b","5b2d949298874e58ac18a630928ee702"],"text":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nProtocol date: \\\\\n5 February 2013\n\\end{tabular}","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[256,768],[475,768],[475,812],[256,812]],"region":{"top_left_x":255,"top_left_y":768,"width":220,"height":45},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5708ace739f4ac0829fbc08b8697c8b","type":"text","conversion_output":false,"parent_id":"f162f10ee9ff4d958149a77a4bfd65a5","text":"Protocol date:","text_display":"Protocol date:","confidence":1,"confidence_rate":1},{"cnt":[[256,815],[493,815],[493,858],[256,858]],"region":{"top_left_x":255,"top_left_y":814,"width":238,"height":45},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b2d949298874e58ac18a630928ee702","type":"text","conversion_output":false,"parent_id":"f162f10ee9ff4d958149a77a4bfd65a5","text":"5 February 2013","text_display":"\n5 February 2013","confidence":1,"confidence_rate":1},{"cnt":[[617,768],[852,768],[852,858],[617,858]],"region":{"top_left_x":617,"top_left_y":768,"width":236,"height":91},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3172f3044a9439092a34b594c91b461","type":"complex_cell","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","children_ids":["353bc6c96a8546e9ae4e25f2480f46e7","2fb1f619cf4b44dbab12251586359471"],"text":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTrial number: \\\\\n1218.22\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[624,773],[848,773],[848,812],[624,812]],"region":{"top_left_x":624,"top_left_y":773,"width":224,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"353bc6c96a8546e9ae4e25f2480f46e7","type":"text","conversion_output":false,"parent_id":"f3172f3044a9439092a34b594c91b461","text":"Trial number:","text_display":"Trial number:","confidence":1,"confidence_rate":1},{"cnt":[[629,815],[751,815],[751,854],[629,854]],"region":{"top_left_x":628,"top_left_y":814,"width":123,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fb1f619cf4b44dbab12251586359471","type":"text","conversion_output":false,"parent_id":"f3172f3044a9439092a34b594c91b461","text":"1218.22","text_display":"\n1218.22","confidence":1,"confidence_rate":1},{"cnt":[[1460,768],[1755,768],[1755,858],[1460,858]],"region":{"top_left_x":1460,"top_left_y":768,"width":295,"height":91},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76f85f136f33456488ba6178385d0e4c","type":"complex_cell","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","children_ids":["2a5ca9a08273417a8c048e899dfc8291","721519218ba74fb29b550b30a1583b3b"],"text":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nRevision date: \\\\\n22 November 2016\n\\end{tabular}","cell_row":5,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1462,773],[1681,773],[1681,808],[1462,808]],"region":{"top_left_x":1462,"top_left_y":773,"width":220,"height":35},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a5ca9a08273417a8c048e899dfc8291","type":"text","conversion_output":false,"parent_id":"76f85f136f33456488ba6178385d0e4c","text":"Revision date:","text_display":"Revision date:","confidence":1,"confidence_rate":1},{"cnt":[[1462,815],[1750,815],[1750,854],[1462,854]],"region":{"top_left_x":1462,"top_left_y":814,"width":289,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"721519218ba74fb29b550b30a1583b3b","type":"text","conversion_output":false,"parent_id":"76f85f136f33456488ba6178385d0e4c","text":"22 November 2016","text_display":"\n22 November 2016","confidence":1,"confidence_rate":1},{"cnt":[[247,865],[1759,865],[1759,916],[247,916]],"region":{"top_left_x":246,"top_left_y":865,"width":1514,"height":51},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af2b3c7462694a26b9114dec443c6921","type":"table_spanning_cell","conversion_output":false,"parent_id":"defad155605c4bd5b3face7eaefeb67a","children_ids":["fcf03a33f43a4c09b58a08fcd300404a"],"text":"","text_display":"rejective multiple test procedure will be applied.","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":4},{"cnt":[[615,865],[1340,865],[1340,911],[615,911]],"region":{"top_left_x":615,"top_left_y":865,"width":726,"height":47},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fcf03a33f43a4c09b58a08fcd300404a","type":"simple_cell","conversion_output":false,"parent_id":"af2b3c7462694a26b9114dec443c6921","text":"rejective multiple test procedure will be applied.","text_display":"rejective multiple test procedure will be applied.","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":4,"confidence":1,"confidence_rate":1},{"cnt":[[790,2664],[1300,2664],[1300,2700],[790,2700]],"region":{"top_left_x":790,"top_left_y":2663,"width":510,"height":38},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e0926985270c40da90d244defef4705d","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2700],[1800,2700],[1800,2739],[292,2739]],"region":{"top_left_x":292,"top_left_y":2700,"width":1509,"height":39},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fd2f97243793426ea5c824ee3892ce72","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.9951171875,"confidence_rate":0.9999588683049504},{"cnt":[[297,2746],[1770,2746],[1770,2780],[297,2780]],"region":{"top_left_x":296,"top_left_y":2745,"width":1475,"height":36},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"71debcd7c4e841c5b57ce46c575f3cb7","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-008","page":8,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30d56e3ac2634726a3d75e0a031cd3d2","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2961ab3dcb634c9c9fea7d495263909a","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"374ce8875e794d08923db556ee615525","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,208],[637,208],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":207,"width":394,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d05c6c9bef7848ca84f1c87f10ad4b94","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f83e5ef9cc8041099b9130cac532b868","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1594,210],[1816,210],[1816,254],[1594,254]],"region":{"top_left_x":1594,"top_left_y":210,"width":223,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a3b08394c8d46f69b6139ecea5cdd17","type":"page_info","conversion_output":false,"text":"Page 8 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[592,338],[592,391],[242,391]],"region":{"top_left_x":242,"top_left_y":338,"width":350,"height":53},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"31ac525a6cef4233af0e6aff3ca15956","type":"figure_label","conversion_output":false,"text":"FLOW CHART","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[226,429],[1880,429],[1880,2243],[226,2243]],"region":{"top_left_x":226,"top_left_y":429,"width":1655,"height":1815},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49849896663d42aa920874818f1af4fb","type":"table","conversion_output":true,"children_ids":["63d8139c23394120bc92b8629497c383","3cc03042e7e04afc9dfadf67e5eae377","cb38f2bc22004e99847f80d2e21571cd","e7b0a6ca260d4c5396999a30e6407ab6","e54cf56fba734616b33d5d0df535e74b","014b7d2658234abea967560cb909c5a1","6e83ec6faa784f1a89ce37c8ce01b1b1","5e39175716e24359aefbdb232a882fac","15a00b7cdc044be592b9710b03902418","d4d25823214c41c0a0e1b72faa79ffc6","51ddce8c848d46bd9025d003a358526a","214e764b2b264cb99967e5c334948dba","2c4367d6641148988db99ad64d0079c2","24d1bc012c3249e086a652c149cb942e","20750419eea0446d9c7e7331435ec516","2d979299a6a1450494f2693cebf9eca4","c8ac1d23112544a0949a0b1736e944c6","924c709830d645809e250824f22f5d94","9f8f26b6215b4cc9898f889d7e960e53","1540e1b4853448e8864989546edfc2dc","02269645bdc74cbfb12f8f697d90bbcf","daa07a9585dc4d1586b1e307cc0d5471","2d07d7b193ad4f4685df29484ca5c7bc","7a23447762724405bd8f2c1179140b39","52ac27a6782740c98e5652db780252e3","137d9638880748f2b7d9a3b539c02be2","a0c623385830487aa45dcaaed22d0968","72a507dcd1ed46ccbdae27a033872cf3","f5a5ad6aa8cf447aa1fe880854c1df6e","7ef3e43dbdb84593a38bcad7ea0918a8","c70b22eade524546a300c74a266d04fb","86a6ea7680074d79b3d440eeebaf6138","27ee6cb9df804a7ab2f65f8f9889e43a","6b1a9d523d1949d1b50c6d012bc71e30","74d6d9494c44445ba428b0d444737654","e40a7f63c90e4ccd93015f74c1e3c058","857027368f5e446b8e3acb22752906fe","81550bc159084ddabd9fa624c1938c26","e0f8b706df4a484b8472026424423f53","b7ad141dae214cebb26d80b8ce8abbfe","f9b54fce724e453ab30d7430ee25a41a","1cce77cd2e8943a2971fd6c604f3bad3","82003882d98a45e8be733903705cf540","708d718611e74a5bb7b2d09054f2661c","7eddf9403026451f8a66aa620f45e565","f5f45a60544e485384094cbf14761681","a75532116eb644d5a9989d4e98799f5b","a55e36271d1349a9940418b709ffc9a5","da3d682389824d0b91ceba788b11e7c4","8d448509976e456e9d1e2cc409571393","5d5c65ec13634ebc80ae54f08fc4142e","6e340763545a49ddb5678f9870daf174","bb72c14d15e6423d99b271ec56eea3e2","452466200876469c8296f83dd9b092a4","89420d40226e4eb78a5b7d8ef279433b","18a23b53dc8744cf8c6d3036941f8b05","038df6dcd8b14490905f8073241a496b","921308e8bc4b4beb9f06ec080d9a0332","6f29e6c6c3fa40d5a40d4e76e968fa25","1e211192900449b8ab42ec7e37d0c844","38a5b04863b24bca8654849e76ea90f4","d6b611dae06a43a0a762c9338e881ab4","0f32370f2884498594f45852558b301f","608fdadf761b4c5c8fb186370f7eb85d","0c35905db95b4a928304c9c16d09d655","c8fdef0c74c24427a72f4d24825d61c8","f670a1dcd6fe4a2ea416f1e4a1a23b00","23ed1031f370487aa01455ab045bd19d","ec926752cccf46d7807a30dc5920bd15","f766cc4a0f42402b91ee20ba3ffb5182","fa3686f3ce8b4222a5cbc7fcce9c1942","a90aba40ea564321a55f53df87c0398e","74b325e811cd4cca84eb48598c44156e","f322f8cf5a1b43a5969de4f8449b7e66","4d5359b6b4bf4a84a09f80ce2bce49d0","e796f85d40e1455bb4521ea152791a2b","3577cf8d1423468f983b12eb79357538","3d704d90b4774e3582158a4ed5ecc735","75f9bce706b34bb9915fe533979bf9c9","3849b7066d0045b1bfe7d37c1884d7c4","0adf799831c74c3aa8b5446ffa3e3bda","96039498288047268a505d1ed959f2c0","8bed545867cb46988a7bdaeb32b43945","139e1c889ca243e9a1c30665ff0e2f4b","f20d6cfe1b9248be84d1cae468bfa039","221aff7996b24e9d9901199be246e64d","73500dfc8a1548e686edf224122f4862","4704012b713e464098851d5cfa6896b3","3a5fb0996fcb4673b66664fd7ac70912","1b565bddc3614d10bf937d3ebd9e79b0","a416f5cfd29446f9b1c9f108aa6413bb","350c6571bef94d178328c7cf7a43e07d","273e01a02ec24db09c617cff393278d0","32fd69b8ba774a5898b9f8fa73cdd36f","39ed477d6a064c1386342f4521b264f3","30028f86b57c48279ed1ad74122ef134","a080bd5f2280455a95b2bdb574a3a57f","b1bcd01696d248348d6fcb5471579eb0","94a8c8c6f18a472581f34c21aa0c91b2","a31ea92f1083491eb9a04abb7c0e28a5","3c2a23c1387348a8af099354c3d95fad","0695c6add53f44e8968b6ae0c6491761","023466d9a8b347909488be4c2bbaba08","a4bcc62f41fd4876a8dd509948efb2dd","d435185fee4e415e98e6406dcd1a3b6a","d02b53b53ec546c78acb5db8f640a7f5","e06ab2c946944f83a6d16d8fdffc4441","d0764f0814b94f57a470796b3c10a3c9","e59f24c190c94699967e5e1ebd8e9ba2","d199452fca154155918be68ff5271401","1c47200ff63443e4b09bbc7a2f060c79","b38b5804e53a4bc197261ddff9a14855","c1417e92ae5e4027b0669f9dfce16d60","729cdf9682844183b8e225cbc6f5e07c","b98fa70e2efc42e2b6c585ba0afa8c63","ad535ed47e1f47c29ee3767dfe1374b6","3cdb4ae9407e4210882131e36c085100","c6dd49f353294ef3b06e2b2baebc9930","9bfae3c9f1cd4e1d9665232cba77f49e","7e44988e092a4e939c34c6ef37dabfd3","896ca50fa1ac4494baff74243a9d91ee","1e3142e23ac64be899ae522765385faa","3b3bb6b3363b434094283ee026eba5df","fb0dfe6370e445078165db3f6f86ee0c","866b88ab587d4470b7e9e0610abba034","21ad650317974857a7bf3e0d9d59b5d4","da058153f8b342288a62fedd45d38c16","d22205ac9eea4f38bfd1b8ce0e644d61","48d90ee7f631466786e93a7517d55c5e","9b2a8b9496f8409cad1fb1dcf9352e31","838ccf9132b146f09fef6c365e08c066","3744ee4a9d8940ce98e47c70c93c5b2d","81b941fdbc444c6097d8000b712694fb","72bd8abe8f5c452eb2effd11aded5e26","60f080bfeecf42e08a01d47108a9b9c3","2750ab6a4bc144eda289375a7983f7d3","6f6eff6a851149ea8315c2f7b50f4d13","5f2a1101f241452d9b6d88887ff59637","712af175f93a4a61ac5b499ae5ef45b5","a72618f29ce6457a967d8e23c315dcfa","c46cd072e28b41ba9eb2e5ae51761b36","2da6eb99eb9443f6a78c29286e2cfad9","ae66897260c14f749fc0d0697cfec7d0","d1ac5e166d0a4e25b8ac2fce5a125d89","fb8b9e59da0d406ca58a1e6e8d08db11","634361396acb4fd5a062acdc1b15c3a0","b3a10c7a64dd429eaf0f564fd6df2fa7","9833b2c0fa3a4358a72b36af1a16b8b5","233a27b3d2494495a0118500c8949e58","1bb35fea2a0f4b94ac6a501582490140","0807fe5a1217468a95888ac96f9d2059","adb4af7cfa1e4b91b084f0bc344554bd","1d00b804ecb74dad97843e883ed50513","04bd1fa431114b06b2a3203a88af84cc","c7e99eda1bfe45298020b2ab7c8e265c","da031bdce2df4399be4f283d56bd9efa","264052a3944d49bfb939caac92b06aed","c3cd73b7647f47e19ba0978a61120efe","f94206cf03b84f05b975a0152f03ea20","3d9cda45874e48489122f014a718fb7f","4c52d7f2307b4feea95fa0fd012c4c61","c724711c092d4c348af325cd092848f1","54c76689ddff4c12b45d4b79bf980636","5b970c6e78de4cd5917bff52e98b136a","7ac649ea37e44e799e3f4e692f367adb","a15fa50eb4374f3a99d174f08a19b0fa","9958152ab4cc4e5bb7e9bc12b17ace9b","9bc57936902842a89521236f57ec9e92","96655c7ce6b24a2faa60595a95cab680","ae64c728c3614302a92696ab507dca78","ac20c2aeedf84f7186a8a0d569621e96","5c44408e148e467aa206a6658708e2e6","3929130932e649e0a1a689411e3176a5","931ca78840ce46b19cff4ad7f8557be7","e9c10a0e5a8d4502ad398b677251fca7","79a0236fbc444012aef1c50d48b9b60a","61691aee66034550bb7e269dbeff48b0","07150a25fe4c4307bbc1e0846ae90068","4e8ebedf4adc44c5ab8822f9b99ae877","16078b9981aa433d982e1061b96e1dd5","671d4700b63e4d63958acd0616b268d6","d001dbe84abe4dc19b290c69af30bc02","50f38b075f0c4eff9b80f8d9058ae1cb","44ad2f63ceab410aa719ee98e1002894","bb93796a4353453f8e4fa8b85db5ccd5","d124b73430d2459fb77089fb7aad605a","cef72754ea064f4e94b6c51841e1ced6","c6397d610bd846c4919333d0027bebe3","ffc005bb074647b790e1a37b31fcf416","6afeeac85d4d4237a5616465abf23f84","b3063b7fc25c41ebbea845fded89ff58","bf64de7c911046bc8f173e4501dcdcb8","79b9780af62f4ee985e0c60cf28abcb1","99b7c800e9b948a2b2e5dcc852455862","b6d61a2a889a4292ba53958fcb49b55c","208950f19fb94aa8b16c48723f75ec8b","6fda2f757a9f4e729c8ae24f95f03825","58823c57407540b5ac11ba821794ca29","ae422bb29e2244ca95a8caee51a4f753","606fd09ab1524c57a2a1990bcb1a2c8b","9dae2229a170488ba91245057abfb2b1","2c8acb3309a84627b29699588869537d","77bf9c4c75e44c67aab6617a0a47ed8b","87fcc97c6e3e4adb87964f5823c1a6e1","7d18d1102fa64ccc81623ecb7913b01b","9c2578eb2ead4882afc8ee53bebc8820","99e269abbe324869af02d8c3e76deaa0","700ee918c33b4c04b25f3314bb92c14c"],"selected_labels":["31ac525a6cef4233af0e6aff3ca15956"],"text":"\\begin{tabular}{|l|l|l|l|l|l|l|l|l|}\n\\hline Trial period & Screening & \\multicolumn{6}{|c|}{Treatment period} & FU \\\\\n\\hline Visit & 1 & 2 & 3 & 4 & 5 & 6 to N & EOT \\({ }^{\\text {C }}\\) & \\(F U ^{ D }\\) \\\\\n\\hline Week & -2 & 0 & 12 & 36 & 60 & 84 to \\(N ^{ B }\\) & - & - \\\\\n\\hline Days from randomization & \\(-14^{ A }\\) & 0 & 84 & 252 & 420 & 588 to N \\(^{ B }\\) & - & EOT + 30 \\\\\n\\hline Time window (days) \\({ }^{ O }\\) & \\(+13{ }^{\\text {A }}\\) & & \\(\\pm 7\\) & \\(\\pm 14\\) & \\(\\pm 14\\) & \\(\\pm 14\\) & \\(\\pm 14\\) & +7 \\\\\n\\hline Informed consent & X & & & & & & & \\\\\n\\hline In-/exclusion criteria & X & X & & & & & & \\\\\n\\hline Medical history/ concomitant diagnoses & X & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & \\\\\n\\hline Physical examination \\({ }^{\\text {F }}\\) & & X & & X & & X & X & \\(X ^{ D }\\) \\\\\n\\hline Vital signs & X & X & X & X & X & X & X & \\(X ^{ D }\\) \\\\\n\\hline Height & X \\({ }^{\\text {E }}\\) & & & & & & & \\\\\n\\hline Weight & X \\({ }^{\\text {E }}\\) & & & X & X & X & X & \\\\\n\\hline Waist circumference & & X & & X & X & X & X & \\\\\n\\hline & & & & & & & & \\\\\n\\hline 12-lead-ECG \\({ }^{\\text {H }}\\) & & X & & X & X & X & X & \\(X ^{ D }\\) \\\\\n\\hline Pregnancy Test \\({ }^{ I }\\) & & X & & X & X & X & X & \\\\\n\\hline Fasted home blood glucose monitoring \\({ }^{\\text {J }}\\) & & X & X & X & X & X & X & \\\\\n\\hline Safety laboratory \\({ }^{\\text {K }}\\) & X & X & X & X & X & X & X & \\(X ^{ D }\\) \\\\\n\\hline UACR \\({ }^{\\text {Q }}\\) & X & \\(X ^{ A }\\) & & X & & \\(X ^{ K }\\) & X & \\(X ^{ D }\\) \\\\\n\\hline \\(HbA _{1 c }\\) & X & X & X & X & X & X & X & \\\\\n\\hline Lipid panel & & X & & X & & \\(X ^{ K }\\) & X & \\(X ^{ D }\\) \\\\\n\\hline eGFR \\({ }^{\\text {L }}\\) & X & X & X & X & X & X & X & \\(X ^{ D }\\) \\\\\n\\hline Pharmacogenetic sampling \\({ }^{\\text {P }}\\) & & X & & & & & & \\\\\n\\hline Adverse events/outcome events \\({ }^{\\text {M }}\\) & X & X & X & X & X & X & X & X \\\\\n\\hline Concomitant therapy & X & X & X & X & X & X & X & X \\\\\n\\hline Randomization (IRT) \\({ }^{ N }\\) & & X & & & & & & \\\\\n\\hline Dispense study medication (IRT) \\({ }^{ N }\\) & & X & X & X & X & X & & \\\\\n\\hline Return study medication/ medication compliance check & & & X & X & X & X & X & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{FLOW CHART}\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|}\n\\hline Trial period & Screening & \\multicolumn{6}{|c|}{Treatment period} & FU \\\\\n\\hline Visit & 1 & 2 & 3 & 4 & 5 & 6 to N & EOT \\({ }^{\\text {C }}\\) & \\(F U ^{ D }\\) \\\\\n\\hline Week & -2 & 0 & 12 & 36 & 60 & 84 to \\(N ^{ B }\\) & - & - \\\\\n\\hline Days from randomization & \\(-14^{ A }\\) & 0 & 84 & 252 & 420 & 588 to N \\(^{ B }\\) & - & EOT + 30 \\\\\n\\hline Time window (days) \\({ }^{ O }\\) & \\(+13{ }^{\\text {A }}\\) & & \\(\\pm 7\\) & \\(\\pm 14\\) & \\(\\pm 14\\) & \\(\\pm 14\\) & \\(\\pm 14\\) & +7 \\\\\n\\hline Informed consent & X & & & & & & & \\\\\n\\hline In-/exclusion criteria & X & X & & & & & & \\\\\n\\hline Medical history/ concomitant diagnoses & X & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & \\\\\n\\hline Physical examination \\({ }^{\\text {F }}\\) & & X & & X & & X & X & \\(X ^{ D }\\) \\\\\n\\hline Vital signs & X & X & X & X & X & X & X & \\(X ^{ D }\\) \\\\\n\\hline Height & X \\({ }^{\\text {E }}\\) & & & & & & & \\\\\n\\hline Weight & X \\({ }^{\\text {E }}\\) & & & X & X & X & X & \\\\\n\\hline Waist circumference & & X & & X & X & X & X & \\\\\n\\hline & & & & & & & & \\\\\n\\hline 12-lead-ECG \\({ }^{\\text {H }}\\) & & X & & X & X & X & X & \\(X ^{ D }\\) \\\\\n\\hline Pregnancy Test \\({ }^{ I }\\) & & X & & X & X & X & X & \\\\\n\\hline Fasted home blood glucose monitoring \\({ }^{\\text {J }}\\) & & X & X & X & X & X & X & \\\\\n\\hline Safety laboratory \\({ }^{\\text {K }}\\) & X & X & X & X & X & X & X & \\(X ^{ D }\\) \\\\\n\\hline UACR \\({ }^{\\text {Q }}\\) & X & \\(X ^{ A }\\) & & X & & \\(X ^{ K }\\) & X & \\(X ^{ D }\\) \\\\\n\\hline \\(HbA _{1 c }\\) & X & X & X & X & X & X & X & \\\\\n\\hline Lipid panel & & X & & X & & \\(X ^{ K }\\) & X & \\(X ^{ D }\\) \\\\\n\\hline eGFR \\({ }^{\\text {L }}\\) & X & X & X & X & X & X & X & \\(X ^{ D }\\) \\\\\n\\hline Pharmacogenetic sampling \\({ }^{\\text {P }}\\) & & X & & & & & & \\\\\n\\hline Adverse events/outcome events \\({ }^{\\text {M }}\\) & X & X & X & X & X & X & X & X \\\\\n\\hline Concomitant therapy & X & X & X & X & X & X & X & X \\\\\n\\hline Randomization (IRT) \\({ }^{ N }\\) & & X & & & & & & \\\\\n\\hline Dispense study medication (IRT) \\({ }^{ N }\\) & & X & X & X & X & X & & \\\\\n\\hline Return study medication/ medication compliance check & & & X & X & X & X & X & \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.31019998190458864,"confidence_rate":0.9987513069274144},{"cnt":[[244,429],[811,429],[811,2243],[244,2243]],"region":{"top_left_x":244,"top_left_y":429,"width":567,"height":1815},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63d8139c23394120bc92b8629497c383","type":"table_column","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[841,429],[997,429],[997,2243],[841,2243]],"region":{"top_left_x":840,"top_left_y":429,"width":158,"height":1815},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3cc03042e7e04afc9dfadf67e5eae377","type":"table_column","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[1036,429],[1087,429],[1087,2243],[1036,2243]],"region":{"top_left_x":1036,"top_left_y":429,"width":52,"height":1815},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb38f2bc22004e99847f80d2e21571cd","type":"table_column","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[1138,429],[1186,429],[1186,2243],[1138,2243]],"region":{"top_left_x":1137,"top_left_y":429,"width":50,"height":1815},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7b0a6ca260d4c5396999a30e6407ab6","type":"table_column","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[1225,429],[1290,429],[1290,2243],[1225,2243]],"region":{"top_left_x":1225,"top_left_y":429,"width":65,"height":1815},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e54cf56fba734616b33d5d0df535e74b","type":"table_column","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[1322,429],[1391,429],[1391,2243],[1322,2243]],"region":{"top_left_x":1321,"top_left_y":429,"width":71,"height":1815},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"014b7d2658234abea967560cb909c5a1","type":"table_column","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[1428,429],[1584,429],[1584,2243],[1428,2243]],"region":{"top_left_x":1427,"top_left_y":429,"width":158,"height":1815},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e83ec6faa784f1a89ce37c8ce01b1b1","type":"table_column","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[1626,429],[1730,429],[1730,2243],[1626,2243]],"region":{"top_left_x":1625,"top_left_y":429,"width":105,"height":1815},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e39175716e24359aefbdb232a882fac","type":"table_column","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[1773,429],[1858,429],[1858,2243],[1773,2243]],"region":{"top_left_x":1773,"top_left_y":429,"width":86,"height":1815},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15a00b7cdc044be592b9710b03902418","type":"table_column","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,457],[1882,457],[1882,500],[226,500]],"region":{"top_left_x":226,"top_left_y":456,"width":1656,"height":45},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4d25823214c41c0a0e1b72faa79ffc6","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,514],[1882,514],[1882,556],[226,556]],"region":{"top_left_x":226,"top_left_y":514,"width":1656,"height":42},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51ddce8c848d46bd9025d003a358526a","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,572],[1882,572],[1882,616],[226,616]],"region":{"top_left_x":226,"top_left_y":571,"width":1656,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"214e764b2b264cb99967e5c334948dba","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,613],[1882,613],[1882,698],[226,698]],"region":{"top_left_x":226,"top_left_y":613,"width":1656,"height":86},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c4367d6641148988db99ad64d0079c2","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,726],[1882,726],[1882,772],[226,772]],"region":{"top_left_x":226,"top_left_y":726,"width":1656,"height":47},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24d1bc012c3249e086a652c149cb942e","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,777],[1882,777],[1882,827],[226,827]],"region":{"top_left_x":226,"top_left_y":776,"width":1656,"height":52},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20750419eea0446d9c7e7331435ec516","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,834],[1882,834],[1882,887],[226,887]],"region":{"top_left_x":226,"top_left_y":834,"width":1656,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d979299a6a1450494f2693cebf9eca4","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,894],[1882,894],[1882,949],[226,949]],"region":{"top_left_x":226,"top_left_y":894,"width":1656,"height":56},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8ac1d23112544a0949a0b1736e944c6","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,952],[1882,952],[1882,1007],[226,1007]],"region":{"top_left_x":226,"top_left_y":951,"width":1656,"height":56},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"924c709830d645809e250824f22f5d94","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1005],[1882,1005],[1882,1067],[226,1067]],"region":{"top_left_x":226,"top_left_y":1004,"width":1656,"height":63},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f8f26b6215b4cc9898f889d7e960e53","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1064],[1882,1064],[1882,1127],[226,1127]],"region":{"top_left_x":226,"top_left_y":1064,"width":1656,"height":63},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1540e1b4853448e8864989546edfc2dc","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1122],[1882,1122],[1882,1187],[226,1187]],"region":{"top_left_x":226,"top_left_y":1122,"width":1656,"height":65},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02269645bdc74cbfb12f8f697d90bbcf","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1184],[1882,1184],[1882,1244],[226,1244]],"region":{"top_left_x":226,"top_left_y":1184,"width":1656,"height":61},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"daa07a9585dc4d1586b1e307cc0d5471","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1246],[1881,1243],[1882,1297],[226,1300]],"region":{"top_left_x":225,"top_left_y":1242,"width":1657,"height":59},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d07d7b193ad4f4685df29484ca5c7bc","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1296],[1881,1290],[1882,1361],[226,1367]],"region":{"top_left_x":225,"top_left_y":1290,"width":1657,"height":77},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a23447762724405bd8f2c1179140b39","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1359],[1881,1357],[1882,1419],[226,1422]],"region":{"top_left_x":225,"top_left_y":1356,"width":1657,"height":66},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52ac27a6782740c98e5652db780252e3","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1428],[1881,1424],[1882,1484],[226,1488]],"region":{"top_left_x":225,"top_left_y":1423,"width":1657,"height":65},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"137d9638880748f2b7d9a3b539c02be2","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1488],[1882,1488],[1882,1546],[226,1546]],"region":{"top_left_x":226,"top_left_y":1488,"width":1656,"height":58},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0c623385830487aa45dcaaed22d0968","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1546],[1881,1541],[1882,1603],[226,1607]],"region":{"top_left_x":225,"top_left_y":1541,"width":1657,"height":67},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72a507dcd1ed46ccbdae27a033872cf3","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1599],[1882,1599],[1882,1661],[226,1661]],"region":{"top_left_x":226,"top_left_y":1598,"width":1656,"height":63},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5a5ad6aa8cf447aa1fe880854c1df6e","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1665],[1881,1661],[1882,1721],[226,1724]],"region":{"top_left_x":225,"top_left_y":1661,"width":1657,"height":64},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ef3e43dbdb84593a38bcad7ea0918a8","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1721],[1881,1717],[1882,1781],[226,1784]],"region":{"top_left_x":225,"top_left_y":1717,"width":1657,"height":68},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c70b22eade524546a300c74a266d04fb","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1774],[1882,1774],[1882,1836],[226,1836]],"region":{"top_left_x":226,"top_left_y":1773,"width":1656,"height":63},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"86a6ea7680074d79b3d440eeebaf6138","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1843],[1882,1843],[1882,1900],[226,1900]],"region":{"top_left_x":226,"top_left_y":1842,"width":1656,"height":59},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27ee6cb9df804a7ab2f65f8f9889e43a","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1903],[1882,1903],[1882,1956],[226,1956]],"region":{"top_left_x":226,"top_left_y":1902,"width":1656,"height":54},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b1a9d523d1949d1b50c6d012bc71e30","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,1960],[1882,1960],[1882,2015],[226,2015]],"region":{"top_left_x":226,"top_left_y":1960,"width":1656,"height":56},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74d6d9494c44445ba428b0d444737654","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,2022],[1882,2022],[1882,2080],[226,2080]],"region":{"top_left_x":226,"top_left_y":2022,"width":1656,"height":58},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e40a7f63c90e4ccd93015f74c1e3c058","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,2079],[1881,2075],[1882,2135],[226,2139]],"region":{"top_left_x":225,"top_left_y":2075,"width":1657,"height":64},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"857027368f5e446b8e3acb22752906fe","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[226,2144],[1882,2144],[1882,2241],[226,2241]],"region":{"top_left_x":226,"top_left_y":2144,"width":1656,"height":98},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81550bc159084ddabd9fa624c1938c26","type":"table_row","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"","text_display":""},{"cnt":[[249,461],[431,461],[431,498],[249,498]],"region":{"top_left_x":249,"top_left_y":461,"width":182,"height":38},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0f8b706df4a484b8472026424423f53","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Trial period","text_display":"Trial period","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[845,461],[995,461],[995,496],[845,496]],"region":{"top_left_x":845,"top_left_y":461,"width":151,"height":35},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7ad141dae214cebb26d80b8ce8abbfe","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Screening","text_display":"Screening","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1041,457],[1730,457],[1730,500],[1041,500]],"region":{"top_left_x":1041,"top_left_y":456,"width":689,"height":45},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9b54fce724e453ab30d7430ee25a41a","type":"table_spanning_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","children_ids":["2d4eaf75d7174c0ab6f9a2f932760357"],"text":"","text_display":"Treatment period","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":6},{"cnt":[[1248,461],[1518,461],[1518,496],[1248,496]],"region":{"top_left_x":1248,"top_left_y":461,"width":270,"height":35},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d4eaf75d7174c0ab6f9a2f932760357","type":"simple_cell","conversion_output":false,"parent_id":"f9b54fce724e453ab30d7430ee25a41a","text":"Treatment period","text_display":"Treatment period","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":6,"confidence":1,"confidence_rate":1},{"cnt":[[1787,447],[1842,447],[1842,493],[1787,493]],"region":{"top_left_x":1787,"top_left_y":447,"width":56,"height":47},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1cce77cd2e8943a2971fd6c604f3bad3","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"FU","text_display":"FU","cell_row":0,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,521],[327,521],[327,553],[249,553]],"region":{"top_left_x":249,"top_left_y":521,"width":79,"height":33},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"82003882d98a45e8be733903705cf540","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Visit","text_display":"Visit","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[912,521],[933,521],[933,553],[912,553]],"region":{"top_left_x":912,"top_left_y":521,"width":21,"height":33},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"708d718611e74a5bb7b2d09054f2661c","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"1","text_display":"1","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1046,521],[1080,521],[1080,553],[1046,553]],"region":{"top_left_x":1045,"top_left_y":521,"width":36,"height":33},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7eddf9403026451f8a66aa620f45e565","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"2","text_display":"2","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1149,521],[1175,521],[1175,553],[1149,553]],"region":{"top_left_x":1149,"top_left_y":521,"width":26,"height":33},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5f45a60544e485384094cbf14761681","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"3","text_display":"3","cell_row":1,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1248,521],[1271,521],[1271,553],[1248,553]],"region":{"top_left_x":1248,"top_left_y":521,"width":24,"height":33},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a75532116eb644d5a9989d4e98799f5b","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"4","text_display":"4","cell_row":1,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,521],[1377,521],[1377,553],[1343,553]],"region":{"top_left_x":1342,"top_left_y":521,"width":36,"height":33},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a55e36271d1349a9940418b709ffc9a5","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"5","text_display":"5","cell_row":1,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1456,521],[1557,521],[1557,553],[1456,553]],"region":{"top_left_x":1455,"top_left_y":521,"width":102,"height":33},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da3d682389824d0b91ceba788b11e7c4","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"6 to N","text_display":"6 to N","cell_row":1,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1631,512],[1725,512],[1725,551],[1631,551]],"region":{"top_left_x":1630,"top_left_y":511,"width":95,"height":41},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d448509976e456e9d1e2cc409571393","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"EOT \\({ }^{\\text {C }}\\)","text_display":"EOT \\({ }^{\\text {C }}\\)","cell_row":1,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":0.98828125,"confidence_rate":0.9994388262906106},{"cnt":[[1778,514],[1847,514],[1847,556],[1778,556]],"region":{"top_left_x":1777,"top_left_y":514,"width":70,"height":42},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d5c65ec13634ebc80ae54f08fc4142e","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(F U ^{ D }\\)","text_display":"\\(F U ^{ D }\\)","cell_row":1,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":0.9980478286743164,"confidence_rate":0.9998778775015811},{"cnt":[[249,581],[341,581],[341,613],[249,613]],"region":{"top_left_x":249,"top_left_y":580,"width":93,"height":34},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e340763545a49ddb5678f9870daf174","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Week","text_display":"Week","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[896,576],[940,576],[940,613],[896,613]],"region":{"top_left_x":896,"top_left_y":576,"width":44,"height":38},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb72c14d15e6423d99b271ec56eea3e2","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"-2","text_display":"-2","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1046,576],[1080,576],[1080,613],[1046,613]],"region":{"top_left_x":1045,"top_left_y":576,"width":36,"height":38},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"452466200876469c8296f83dd9b092a4","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"0","text_display":"0","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1138,576],[1184,576],[1184,613],[1138,613]],"region":{"top_left_x":1137,"top_left_y":576,"width":47,"height":38},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89420d40226e4eb78a5b7d8ef279433b","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"12","text_display":"12","cell_row":2,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1239,576],[1285,576],[1285,613],[1239,613]],"region":{"top_left_x":1239,"top_left_y":576,"width":47,"height":38},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18a23b53dc8744cf8c6d3036941f8b05","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"36","text_display":"36","cell_row":2,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1340,576],[1380,576],[1380,613],[1340,613]],"region":{"top_left_x":1340,"top_left_y":576,"width":40,"height":38},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"038df6dcd8b14490905f8073241a496b","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"60","text_display":"60","cell_row":2,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1442,572],[1568,572],[1568,611],[1442,611]],"region":{"top_left_x":1441,"top_left_y":571,"width":128,"height":40},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"921308e8bc4b4beb9f06ec080d9a0332","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"84 to \\(N ^{ B }\\)","text_display":"84 to \\(N ^{ B }\\)","cell_row":2,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":0.8166069517573078,"confidence_rate":0.9915939721077186},{"cnt":[[1667,579],[1695,579],[1695,613],[1667,613]],"region":{"top_left_x":1667,"top_left_y":578,"width":28,"height":36},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f29e6c6c3fa40d5a40d4e76e968fa25","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"-","text_display":"-","cell_row":2,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1806,579],[1829,579],[1829,613],[1806,613]],"region":{"top_left_x":1805,"top_left_y":578,"width":24,"height":36},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e211192900449b8ab42ec7e37d0c844","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"-","text_display":"-","cell_row":2,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,639],[634,639],[634,680],[249,680]],"region":{"top_left_x":249,"top_left_y":638,"width":385,"height":42},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38a5b04863b24bca8654849e76ea90f4","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Days from randomization","text_display":"Days from randomization","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[885,632],[956,632],[956,673],[885,673]],"region":{"top_left_x":884,"top_left_y":631,"width":72,"height":43},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6b611dae06a43a0a762c9338e881ab4","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(-14^{ A }\\)","text_display":"\\(-14^{ A }\\)","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.6464584842324257,"confidence_rate":0.969320033266469},{"cnt":[[1046,634],[1080,634],[1080,673],[1046,673]],"region":{"top_left_x":1045,"top_left_y":633,"width":36,"height":41},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f32370f2884498594f45852558b301f","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"0","text_display":"0","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1138,634],[1184,634],[1184,673],[1138,673]],"region":{"top_left_x":1137,"top_left_y":633,"width":47,"height":41},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"608fdadf761b4c5c8fb186370f7eb85d","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"84","text_display":"84","cell_row":3,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1230,634],[1290,634],[1290,673],[1230,673]],"region":{"top_left_x":1229,"top_left_y":633,"width":61,"height":41},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c35905db95b4a928304c9c16d09d655","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"252","text_display":"252","cell_row":3,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1324,634],[1396,634],[1396,673],[1324,673]],"region":{"top_left_x":1324,"top_left_y":633,"width":72,"height":41},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8fdef0c74c24427a72f4d24825d61c8","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"420","text_display":"420","cell_row":3,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1433,632],[1578,632],[1578,671],[1433,671]],"region":{"top_left_x":1432,"top_left_y":631,"width":146,"height":40},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f670a1dcd6fe4a2ea416f1e4a1a23b00","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"588 to N \\(^{ B }\\)","text_display":"588 to N \\(^{ B }\\)","cell_row":3,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":0.31019998190458864,"confidence_rate":0.9503803935337948},{"cnt":[[1667,650],[1695,650],[1695,673],[1667,673]],"region":{"top_left_x":1667,"top_left_y":650,"width":28,"height":24},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23ed1031f370487aa01455ab045bd19d","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"-","text_display":"-","cell_row":3,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1773,618],[1854,618],[1854,694],[1773,694]],"region":{"top_left_x":1773,"top_left_y":617,"width":81,"height":77},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec926752cccf46d7807a30dc5920bd15","type":"complex_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","children_ids":["30bb57f7f85348e194be8688f2a7060f","587407d3d2bc4d96b81a01935e1da1ff"],"text":"EOT + 30","text_display":"EOT + 30","cell_row":3,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":0.985358476638794,"confidence_rate":0.9990785642613285},{"cnt":[[1776,618],[1854,618],[1854,655],[1776,655]],"region":{"top_left_x":1775,"top_left_y":617,"width":79,"height":38},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30bb57f7f85348e194be8688f2a7060f","type":"text","conversion_output":false,"parent_id":"ec926752cccf46d7807a30dc5920bd15","text":"EOT","text_display":"EOT","confidence":1,"confidence_rate":1},{"cnt":[[1778,659],[1852,659],[1852,691],[1778,691]],"region":{"top_left_x":1777,"top_left_y":659,"width":75,"height":33},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"587407d3d2bc4d96b81a01935e1da1ff","type":"text","conversion_output":false,"parent_id":"ec926752cccf46d7807a30dc5920bd15","text":"+ 30","text_display":" + 30","confidence":0.985358476638794,"confidence_rate":0.9981579775664775},{"cnt":[[249,728],[571,728],[571,772],[249,772]],"region":{"top_left_x":249,"top_left_y":728,"width":323,"height":45},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f766cc4a0f42402b91ee20ba3ffb5182","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Time window (days) \\({ }^{ O }\\)","text_display":"Time window (days) \\({ }^{ O }\\)","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.6022179126739502,"confidence_rate":0.9851949266685474},{"cnt":[[880,728],[965,728],[965,767],[880,767]],"region":{"top_left_x":879,"top_left_y":728,"width":87,"height":40},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa3686f3ce8b4222a5cbc7fcce9c1942","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(+13{ }^{\\text {A }}\\)","text_display":"\\(+13{ }^{\\text {A }}\\)","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.7247109413146973,"confidence_rate":0.9800772338919336},{"cnt":[[1138,726],[1184,726],[1184,770],[1138,770]],"region":{"top_left_x":1137,"top_left_y":726,"width":47,"height":44},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a90aba40ea564321a55f53df87c0398e","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(\\pm 7\\)","text_display":"\\(\\pm 7\\)","cell_row":4,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1230,726],[1290,726],[1290,770],[1230,770]],"region":{"top_left_x":1229,"top_left_y":726,"width":61,"height":44},"line":84,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74b325e811cd4cca84eb48598c44156e","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(\\pm 14\\)","text_display":"\\(\\pm 14\\)","cell_row":4,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1327,735],[1391,735],[1391,770],[1327,770]],"region":{"top_left_x":1326,"top_left_y":735,"width":66,"height":35},"line":85,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f322f8cf5a1b43a5969de4f8449b7e66","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(\\pm 14\\)","text_display":"\\(\\pm 14\\)","cell_row":4,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990236759185791,"confidence_rate":0.9996744526699629},{"cnt":[[1474,735],[1538,735],[1538,770],[1474,770]],"region":{"top_left_x":1473,"top_left_y":735,"width":66,"height":35},"line":86,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d5359b6b4bf4a84a09f80ce2bce49d0","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(\\pm 14\\)","text_display":"\\(\\pm 14\\)","cell_row":4,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1647,735],[1711,735],[1711,770],[1647,770]],"region":{"top_left_x":1646,"top_left_y":735,"width":66,"height":35},"line":87,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e796f85d40e1455bb4521ea152791a2b","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(\\pm 14\\)","text_display":"\\(\\pm 14\\)","cell_row":4,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":0.9980475902557373,"confidence_rate":0.9993487727470386},{"cnt":[[1792,726],[1842,726],[1842,770],[1792,770]],"region":{"top_left_x":1791,"top_left_y":726,"width":52,"height":44},"line":88,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3577cf8d1423468f983b12eb79357538","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"+7","text_display":"+7","cell_row":4,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,793],[495,793],[495,823],[249,823]],"region":{"top_left_x":249,"top_left_y":792,"width":247,"height":31},"line":89,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d704d90b4774e3582158a4ed5ecc735","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Informed consent","text_display":"Informed consent","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[896,779],[940,779],[940,816],[896,816]],"region":{"top_left_x":896,"top_left_y":778,"width":44,"height":38},"line":90,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"75f9bce706b34bb9915fe533979bf9c9","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,848],[541,848],[541,883],[249,883]],"region":{"top_left_x":249,"top_left_y":848,"width":293,"height":35},"line":91,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3849b7066d0045b1bfe7d37c1884d7c4","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"In-/exclusion criteria","text_display":"In-/exclusion criteria","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[896,837],[940,837],[940,876],[896,876]],"region":{"top_left_x":896,"top_left_y":836,"width":44,"height":40},"line":92,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0adf799831c74c3aa8b5446ffa3e3bda","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1043,837],[1080,837],[1080,876],[1043,876]],"region":{"top_left_x":1043,"top_left_y":836,"width":38,"height":40},"line":93,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96039498288047268a505d1ed959f2c0","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":6,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,908],[809,908],[809,947],[249,947]],"region":{"top_left_x":249,"top_left_y":907,"width":560,"height":41},"line":94,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8bed545867cb46988a7bdaeb32b43945","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Medical history/ concomitant diagnoses","text_display":"Medical history/ concomitant diagnoses","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[896,894],[940,894],[940,931],[896,931]],"region":{"top_left_x":896,"top_left_y":894,"width":44,"height":37},"line":95,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"139e1c889ca243e9a1c30665ff0e2f4b","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,968],[454,968],[454,1007],[249,1007]],"region":{"top_left_x":249,"top_left_y":967,"width":205,"height":40},"line":96,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f20d6cfe1b9248be84d1cae468bfa039","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Demographics","text_display":"Demographics","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[896,949],[940,949],[940,991],[896,991]],"region":{"top_left_x":896,"top_left_y":949,"width":44,"height":42},"line":97,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"221aff7996b24e9d9901199be246e64d","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1018],[562,1018],[562,1067],[249,1067]],"region":{"top_left_x":249,"top_left_y":1018,"width":314,"height":49},"line":98,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73500dfc8a1548e686edf224122f4862","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Physical examination \\({ }^{\\text {F }}\\)","text_display":"Physical examination \\({ }^{\\text {F }}\\)","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.69921875,"confidence_rate":0.9906286182432489},{"cnt":[[1043,1018],[1080,1018],[1080,1051],[1043,1051]],"region":{"top_left_x":1043,"top_left_y":1018,"width":38,"height":33},"line":99,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4704012b713e464098851d5cfa6896b3","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":9,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1018],[1276,1018],[1276,1051],[1244,1051]],"region":{"top_left_x":1243,"top_left_y":1018,"width":33,"height":33},"line":100,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a5fb0996fcb4673b66664fd7ac70912","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":9,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1018],[1527,1018],[1527,1051],[1490,1051]],"region":{"top_left_x":1490,"top_left_y":1018,"width":37,"height":33},"line":101,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b565bddc3614d10bf937d3ebd9e79b0","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":9,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1018],[1695,1018],[1695,1051],[1663,1051]],"region":{"top_left_x":1662,"top_left_y":1018,"width":33,"height":33},"line":102,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a416f5cfd29446f9b1c9f108aa6413bb","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":9,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1792,1005],[1842,1005],[1842,1051],[1792,1051]],"region":{"top_left_x":1791,"top_left_y":1004,"width":52,"height":47},"line":103,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"350c6571bef94d178328c7cf7a43e07d","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ D }\\)","text_display":"\\(X ^{ D }\\)","cell_row":9,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999674404968648},{"cnt":[[249,1088],[403,1088],[403,1124],[249,1124]],"region":{"top_left_x":249,"top_left_y":1087,"width":155,"height":38},"line":104,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"273e01a02ec24db09c617cff393278d0","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Vital signs","text_display":"Vital signs","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[896,1074],[937,1074],[937,1111],[896,1111]],"region":{"top_left_x":896,"top_left_y":1073,"width":42,"height":38},"line":105,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"32fd69b8ba774a5898b9f8fa73cdd36f","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1043,1074],[1080,1074],[1080,1111],[1043,1111]],"region":{"top_left_x":1043,"top_left_y":1073,"width":38,"height":38},"line":106,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"39ed477d6a064c1386342f4521b264f3","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":10,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1147,1074],[1179,1074],[1179,1111],[1147,1111]],"region":{"top_left_x":1147,"top_left_y":1073,"width":33,"height":38},"line":107,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30028f86b57c48279ed1ad74122ef134","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":10,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1076],[1276,1076],[1276,1111],[1244,1111]],"region":{"top_left_x":1243,"top_left_y":1076,"width":33,"height":35},"line":108,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a080bd5f2280455a95b2bdb574a3a57f","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":10,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1074],[1377,1074],[1377,1111],[1343,1111]],"region":{"top_left_x":1342,"top_left_y":1073,"width":36,"height":38},"line":109,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1bcd01696d248348d6fcb5471579eb0","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":10,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1074],[1527,1074],[1527,1108],[1490,1108]],"region":{"top_left_x":1490,"top_left_y":1073,"width":37,"height":36},"line":110,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94a8c8c6f18a472581f34c21aa0c91b2","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":10,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1074],[1695,1074],[1695,1108],[1663,1108]],"region":{"top_left_x":1662,"top_left_y":1073,"width":33,"height":36},"line":111,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a31ea92f1083491eb9a04abb7c0e28a5","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":10,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1792,1060],[1842,1060],[1842,1111],[1792,1111]],"region":{"top_left_x":1791,"top_left_y":1059,"width":52,"height":52},"line":112,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c2a23c1387348a8af099354c3d95fad","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ D }\\)","text_display":"\\(X ^{ D }\\)","cell_row":10,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1143],[348,1143],[348,1182],[249,1182]],"region":{"top_left_x":249,"top_left_y":1142,"width":100,"height":40},"line":113,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0695c6add53f44e8968b6ae0c6491761","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Height","text_display":"Height","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[896,1117],[944,1117],[944,1166],[896,1166]],"region":{"top_left_x":896,"top_left_y":1117,"width":49,"height":49},"line":114,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"023466d9a8b347909488be4c2bbaba08","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X \\({ }^{\\text {E }}\\)","text_display":"X \\({ }^{\\text {E }}\\)","cell_row":11,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.79577433061786,"confidence_rate":0.9880488503128435},{"cnt":[[249,1205],[357,1205],[357,1242],[249,1242]],"region":{"top_left_x":249,"top_left_y":1204,"width":109,"height":38},"line":115,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4bcc62f41fd4876a8dd509948efb2dd","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Weight","text_display":"Weight","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[896,1184],[944,1184],[944,1228],[896,1228]],"region":{"top_left_x":896,"top_left_y":1184,"width":49,"height":44},"line":116,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d435185fee4e415e98e6406dcd1a3b6a","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X \\({ }^{\\text {E }}\\)","text_display":"X \\({ }^{\\text {E }}\\)","cell_row":12,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9960966110229492,"confidence_rate":0.9997941776536621},{"cnt":[[1244,1191],[1276,1191],[1276,1228],[1244,1228]],"region":{"top_left_x":1243,"top_left_y":1191,"width":33,"height":37},"line":117,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d02b53b53ec546c78acb5db8f640a7f5","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":12,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1191],[1377,1191],[1377,1228],[1343,1228]],"region":{"top_left_x":1342,"top_left_y":1191,"width":36,"height":37},"line":118,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e06ab2c946944f83a6d16d8fdffc4441","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":12,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1191],[1527,1191],[1527,1228],[1490,1228]],"region":{"top_left_x":1490,"top_left_y":1191,"width":37,"height":37},"line":119,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0764f0814b94f57a470796b3c10a3c9","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":12,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1191],[1695,1191],[1695,1228],[1663,1228]],"region":{"top_left_x":1662,"top_left_y":1191,"width":33,"height":37},"line":120,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e59f24c190c94699967e5e1ebd8e9ba2","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":12,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1263],[541,1263],[541,1297],[249,1297]],"region":{"top_left_x":249,"top_left_y":1262,"width":293,"height":36},"line":121,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d199452fca154155918be68ff5271401","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Waist circumference","text_display":"Waist circumference","cell_row":13,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1043,1246],[1080,1246],[1080,1286],[1043,1286]],"region":{"top_left_x":1043,"top_left_y":1246,"width":38,"height":40},"line":122,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c47200ff63443e4b09bbc7a2f060c79","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":13,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1246],[1276,1246],[1276,1286],[1244,1286]],"region":{"top_left_x":1243,"top_left_y":1246,"width":33,"height":40},"line":123,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b38b5804e53a4bc197261ddff9a14855","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":13,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1246],[1377,1246],[1377,1286],[1343,1286]],"region":{"top_left_x":1342,"top_left_y":1246,"width":36,"height":40},"line":124,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1417e92ae5e4027b0669f9dfce16d60","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":13,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1246],[1527,1246],[1527,1286],[1490,1286]],"region":{"top_left_x":1490,"top_left_y":1246,"width":37,"height":40},"line":125,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"729cdf9682844183b8e225cbc6f5e07c","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":13,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1246],[1695,1246],[1695,1286],[1663,1286]],"region":{"top_left_x":1662,"top_left_y":1246,"width":33,"height":40},"line":126,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b98fa70e2efc42e2b6c585ba0afa8c63","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":13,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1373],[454,1373],[454,1412],[249,1412]],"region":{"top_left_x":249,"top_left_y":1373,"width":205,"height":40},"line":127,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad535ed47e1f47c29ee3767dfe1374b6","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"12-lead-ECG \\({ }^{\\text {H }}\\)","text_display":"12-lead-ECG \\({ }^{\\text {H }}\\)","cell_row":15,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.998046875,"confidence_rate":0.9999325872780016},{"cnt":[[1043,1371],[1080,1371],[1080,1403],[1043,1403]],"region":{"top_left_x":1043,"top_left_y":1370,"width":38,"height":33},"line":128,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3cdb4ae9407e4210882131e36c085100","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":15,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1373],[1276,1373],[1276,1403],[1244,1403]],"region":{"top_left_x":1243,"top_left_y":1373,"width":33,"height":30},"line":129,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6dd49f353294ef3b06e2b2baebc9930","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":15,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1368],[1377,1368],[1377,1401],[1343,1401]],"region":{"top_left_x":1342,"top_left_y":1368,"width":36,"height":33},"line":130,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9bfae3c9f1cd4e1d9665232cba77f49e","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":15,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1368],[1527,1368],[1527,1403],[1490,1403]],"region":{"top_left_x":1490,"top_left_y":1368,"width":37,"height":35},"line":131,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e44988e092a4e939c34c6ef37dabfd3","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":15,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1373],[1695,1373],[1695,1401],[1663,1401]],"region":{"top_left_x":1662,"top_left_y":1373,"width":33,"height":28},"line":132,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"896ca50fa1ac4494baff74243a9d91ee","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":15,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1792,1359],[1842,1359],[1842,1403],[1792,1403]],"region":{"top_left_x":1791,"top_left_y":1359,"width":52,"height":44},"line":133,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e3142e23ac64be899ae522765385faa","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ D }\\)","text_display":"\\(X ^{ D }\\)","cell_row":15,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":0.99755859375,"confidence_rate":0.9998370538543804},{"cnt":[[249,1435],[477,1435],[477,1481],[249,1481]],"region":{"top_left_x":249,"top_left_y":1435,"width":228,"height":47},"line":134,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b3bb6b3363b434094283ee026eba5df","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Pregnancy Test \\({ }^{ I }\\)","text_display":"Pregnancy Test \\({ }^{ I }\\)","cell_row":16,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.98828125,"confidence_rate":0.9996071453292111},{"cnt":[[1043,1433],[1080,1433],[1080,1470],[1043,1470]],"region":{"top_left_x":1043,"top_left_y":1432,"width":38,"height":38},"line":135,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb0dfe6370e445078165db3f6f86ee0c","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":16,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1433],[1285,1433],[1285,1470],[1244,1470]],"region":{"top_left_x":1243,"top_left_y":1432,"width":43,"height":38},"line":136,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"866b88ab587d4470b7e9e0610abba034","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":16,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1433],[1377,1433],[1377,1470],[1343,1470]],"region":{"top_left_x":1342,"top_left_y":1432,"width":36,"height":38},"line":137,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"21ad650317974857a7bf3e0d9d59b5d4","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":16,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1433],[1527,1433],[1527,1470],[1490,1470]],"region":{"top_left_x":1490,"top_left_y":1432,"width":37,"height":38},"line":138,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da058153f8b342288a62fedd45d38c16","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":16,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1433],[1695,1433],[1695,1470],[1663,1470]],"region":{"top_left_x":1662,"top_left_y":1432,"width":33,"height":38},"line":139,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d22205ac9eea4f38bfd1b8ce0e644d61","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":16,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1497],[804,1497],[804,1543],[249,1543]],"region":{"top_left_x":249,"top_left_y":1497,"width":555,"height":47},"line":140,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48d90ee7f631466786e93a7517d55c5e","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Fasted home blood glucose monitoring \\({ }^{\\text {J }}\\)","text_display":"Fasted home blood glucose monitoring \\({ }^{\\text {J }}\\)","cell_row":17,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9951171875,"confidence_rate":0.9999093601751348},{"cnt":[[1043,1488],[1080,1488],[1080,1527],[1043,1527]],"region":{"top_left_x":1043,"top_left_y":1488,"width":38,"height":40},"line":141,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b2a8b9496f8409cad1fb1dcf9352e31","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":17,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1147,1488],[1179,1488],[1179,1527],[1147,1527]],"region":{"top_left_x":1147,"top_left_y":1488,"width":33,"height":40},"line":142,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"838ccf9132b146f09fef6c365e08c066","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":17,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1488],[1276,1488],[1276,1525],[1244,1525]],"region":{"top_left_x":1243,"top_left_y":1488,"width":33,"height":37},"line":143,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3744ee4a9d8940ce98e47c70c93c5b2d","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":17,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1488],[1377,1488],[1377,1525],[1343,1525]],"region":{"top_left_x":1342,"top_left_y":1488,"width":36,"height":37},"line":144,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81b941fdbc444c6097d8000b712694fb","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":17,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1488],[1527,1488],[1527,1525],[1490,1525]],"region":{"top_left_x":1490,"top_left_y":1488,"width":37,"height":37},"line":145,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72bd8abe8f5c452eb2effd11aded5e26","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":17,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1488],[1695,1488],[1695,1527],[1663,1527]],"region":{"top_left_x":1662,"top_left_y":1488,"width":33,"height":40},"line":146,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60f080bfeecf42e08a01d47108a9b9c3","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":17,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1557],[507,1557],[507,1601],[249,1601]],"region":{"top_left_x":249,"top_left_y":1557,"width":258,"height":44},"line":147,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2750ab6a4bc144eda289375a7983f7d3","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Safety laboratory \\({ }^{\\text {K }}\\)","text_display":"Safety laboratory \\({ }^{\\text {K }}\\)","cell_row":18,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9580078125,"confidence_rate":0.9987750552570733},{"cnt":[[896,1553],[937,1553],[937,1587],[896,1587]],"region":{"top_left_x":896,"top_left_y":1552,"width":42,"height":36},"line":148,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f6eff6a851149ea8315c2f7b50f4d13","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":18,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1043,1553],[1080,1553],[1080,1587],[1043,1587]],"region":{"top_left_x":1043,"top_left_y":1552,"width":38,"height":36},"line":149,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f2a1101f241452d9b6d88887ff59637","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":18,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1147,1553],[1179,1553],[1179,1585],[1147,1585]],"region":{"top_left_x":1147,"top_left_y":1552,"width":33,"height":33},"line":150,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"712af175f93a4a61ac5b499ae5ef45b5","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":18,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1553],[1276,1553],[1276,1587],[1244,1587]],"region":{"top_left_x":1243,"top_left_y":1552,"width":33,"height":36},"line":151,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a72618f29ce6457a967d8e23c315dcfa","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":18,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1553],[1377,1553],[1377,1585],[1343,1585]],"region":{"top_left_x":1342,"top_left_y":1552,"width":36,"height":33},"line":152,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c46cd072e28b41ba9eb2e5ae51761b36","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":18,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1553],[1527,1553],[1527,1585],[1490,1585]],"region":{"top_left_x":1490,"top_left_y":1552,"width":37,"height":33},"line":153,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2da6eb99eb9443f6a78c29286e2cfad9","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":18,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1553],[1695,1553],[1695,1585],[1663,1585]],"region":{"top_left_x":1662,"top_left_y":1552,"width":33,"height":33},"line":154,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae66897260c14f749fc0d0697cfec7d0","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":18,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1792,1543],[1842,1543],[1842,1587],[1792,1587]],"region":{"top_left_x":1791,"top_left_y":1543,"width":52,"height":45},"line":155,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1ac5e166d0a4e25b8ac2fce5a125d89","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ D }\\)","text_display":"\\(X ^{ D }\\)","cell_row":18,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999674404968648},{"cnt":[[249,1622],[366,1622],[366,1656],[249,1656]],"region":{"top_left_x":249,"top_left_y":1621,"width":118,"height":36},"line":156,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb8b9e59da0d406ca58a1e6e8d08db11","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"UACR \\({ }^{\\text {Q }}\\)","text_display":"UACR \\({ }^{\\text {Q }}\\)","cell_row":19,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99853515625,"confidence_rate":0.9999333695979722},{"cnt":[[896,1612],[935,1612],[935,1645],[896,1645]],"region":{"top_left_x":896,"top_left_y":1612,"width":40,"height":33},"line":157,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"634361396acb4fd5a062acdc1b15c3a0","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":19,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1041,1608],[1087,1608],[1087,1645],[1041,1645]],"region":{"top_left_x":1041,"top_left_y":1607,"width":47,"height":38},"line":158,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3a10c7a64dd429eaf0f564fd6df2fa7","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ A }\\)","text_display":"\\(X ^{ A }\\)","cell_row":19,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.8721325397491455,"confidence_rate":0.9909205446920504},{"cnt":[[1244,1612],[1276,1612],[1276,1645],[1244,1645]],"region":{"top_left_x":1243,"top_left_y":1612,"width":33,"height":33},"line":159,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9833b2c0fa3a4358a72b36af1a16b8b5","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":19,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1483,1601],[1529,1601],[1529,1645],[1483,1645]],"region":{"top_left_x":1483,"top_left_y":1600,"width":47,"height":45},"line":160,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"233a27b3d2494495a0118500c8949e58","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ K }\\)","text_display":"\\(X ^{ K }\\)","cell_row":19,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":0.9951171875,"confidence_rate":0.9996737350775309},{"cnt":[[1663,1612],[1695,1612],[1695,1645],[1663,1645]],"region":{"top_left_x":1662,"top_left_y":1612,"width":33,"height":33},"line":161,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1bb35fea2a0f4b94ac6a501582490140","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":19,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1792,1601],[1842,1601],[1842,1645],[1792,1645]],"region":{"top_left_x":1791,"top_left_y":1600,"width":52,"height":45},"line":162,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0807fe5a1217468a95888ac96f9d2059","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ D }\\)","text_display":"\\(X ^{ D }\\)","cell_row":19,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1686],[341,1686],[341,1723],[249,1723]],"region":{"top_left_x":249,"top_left_y":1686,"width":93,"height":38},"line":163,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"adb4af7cfa1e4b91b084f0bc344554bd","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(HbA _{1 c }\\)","text_display":"\\(HbA _{1 c }\\)","cell_row":20,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.5289788246154785,"confidence_rate":0.9652403321083288},{"cnt":[[896,1672],[940,1672],[940,1709],[896,1709]],"region":{"top_left_x":896,"top_left_y":1672,"width":44,"height":38},"line":164,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d00b804ecb74dad97843e883ed50513","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":20,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1043,1672],[1080,1672],[1080,1709],[1043,1709]],"region":{"top_left_x":1043,"top_left_y":1672,"width":38,"height":38},"line":165,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04bd1fa431114b06b2a3203a88af84cc","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":20,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1147,1672],[1179,1672],[1179,1709],[1147,1709]],"region":{"top_left_x":1147,"top_left_y":1672,"width":33,"height":38},"line":166,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7e99eda1bfe45298020b2ab7c8e265c","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":20,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1672],[1276,1672],[1276,1709],[1244,1709]],"region":{"top_left_x":1243,"top_left_y":1672,"width":33,"height":38},"line":167,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da031bdce2df4399be4f283d56bd9efa","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":20,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1672],[1377,1672],[1377,1709],[1343,1709]],"region":{"top_left_x":1342,"top_left_y":1672,"width":36,"height":38},"line":168,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"264052a3944d49bfb939caac92b06aed","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":20,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1672],[1527,1672],[1527,1709],[1490,1709]],"region":{"top_left_x":1490,"top_left_y":1672,"width":37,"height":38},"line":169,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3cd73b7647f47e19ba0978a61120efe","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":20,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1672],[1695,1672],[1695,1709],[1663,1709]],"region":{"top_left_x":1662,"top_left_y":1672,"width":33,"height":38},"line":170,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f94206cf03b84f05b975a0152f03ea20","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":20,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1741],[413,1741],[413,1781],[249,1781]],"region":{"top_left_x":249,"top_left_y":1741,"width":164,"height":40},"line":171,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d9cda45874e48489122f014a718fb7f","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Lipid panel","text_display":"Lipid panel","cell_row":21,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1043,1730],[1080,1730],[1080,1767],[1043,1767]],"region":{"top_left_x":1043,"top_left_y":1729,"width":38,"height":38},"line":172,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c52d7f2307b4feea95fa0fd012c4c61","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":21,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1730],[1276,1730],[1276,1767],[1244,1767]],"region":{"top_left_x":1243,"top_left_y":1729,"width":33,"height":38},"line":173,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c724711c092d4c348af325cd092848f1","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":21,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1483,1723],[1529,1723],[1529,1767],[1483,1767]],"region":{"top_left_x":1483,"top_left_y":1723,"width":47,"height":44},"line":174,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54c76689ddff4c12b45d4b79bf980636","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ K }\\)","text_display":"\\(X ^{ K }\\)","cell_row":21,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":0.99853515625,"confidence_rate":0.9999022769297106},{"cnt":[[1663,1730],[1695,1730],[1695,1767],[1663,1767]],"region":{"top_left_x":1662,"top_left_y":1729,"width":33,"height":38},"line":175,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b970c6e78de4cd5917bff52e98b136a","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":21,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1792,1725],[1842,1725],[1842,1767],[1792,1767]],"region":{"top_left_x":1791,"top_left_y":1725,"width":52,"height":42},"line":176,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ac649ea37e44e799e3f4e692f367adb","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ D }\\)","text_display":"\\(X ^{ D }\\)","cell_row":21,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":0.9765625,"confidence_rate":0.9984201475084217},{"cnt":[[249,1794],[348,1794],[348,1831],[249,1831]],"region":{"top_left_x":249,"top_left_y":1794,"width":100,"height":38},"line":177,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a15fa50eb4374f3a99d174f08a19b0fa","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"eGFR \\({ }^{\\text {L }}\\)","text_display":"eGFR \\({ }^{\\text {L }}\\)","cell_row":22,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9970715045928955,"confidence_rate":0.9998667001652178},{"cnt":[[908,1785],[937,1785],[937,1822],[908,1822]],"region":{"top_left_x":907,"top_left_y":1785,"width":31,"height":38},"line":178,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9958152ab4cc4e5bb7e9bc12b17ace9b","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":22,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1043,1785],[1080,1785],[1080,1822],[1043,1822]],"region":{"top_left_x":1043,"top_left_y":1785,"width":38,"height":38},"line":179,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9bc57936902842a89521236f57ec9e92","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":22,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1147,1785],[1179,1785],[1179,1822],[1147,1822]],"region":{"top_left_x":1147,"top_left_y":1785,"width":33,"height":38},"line":180,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96655c7ce6b24a2faa60595a95cab680","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":22,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1785],[1276,1785],[1276,1822],[1244,1822]],"region":{"top_left_x":1243,"top_left_y":1785,"width":33,"height":38},"line":181,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae64c728c3614302a92696ab507dca78","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":22,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1785],[1377,1785],[1377,1822],[1343,1822]],"region":{"top_left_x":1342,"top_left_y":1785,"width":36,"height":38},"line":182,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac20c2aeedf84f7186a8a0d569621e96","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":22,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1785],[1527,1785],[1527,1822],[1490,1822]],"region":{"top_left_x":1490,"top_left_y":1785,"width":37,"height":38},"line":183,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c44408e148e467aa206a6658708e2e6","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":22,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1785],[1695,1785],[1695,1822],[1663,1822]],"region":{"top_left_x":1662,"top_left_y":1785,"width":33,"height":38},"line":184,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3929130932e649e0a1a689411e3176a5","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":22,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1792,1783],[1842,1783],[1842,1822],[1792,1822]],"region":{"top_left_x":1791,"top_left_y":1782,"width":52,"height":41},"line":185,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"931ca78840ce46b19cff4ad7f8557be7","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"\\(X ^{ D }\\)","text_display":"\\(X ^{ D }\\)","cell_row":22,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":0.9970703125,"confidence_rate":0.9998044199659498},{"cnt":[[249,1852],[638,1852],[638,1896],[249,1896]],"region":{"top_left_x":249,"top_left_y":1851,"width":390,"height":45},"line":186,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9c10a0e5a8d4502ad398b677251fca7","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Pharmacogenetic sampling \\({ }^{\\text {P }}\\)","text_display":"Pharmacogenetic sampling \\({ }^{\\text {P }}\\)","cell_row":23,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.8888011174276471,"confidence_rate":0.9971972259964398},{"cnt":[[1043,1850],[1080,1850],[1080,1882],[1043,1882]],"region":{"top_left_x":1043,"top_left_y":1849,"width":38,"height":33},"line":187,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79a0236fbc444012aef1c50d48b9b60a","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":23,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1912],[716,1912],[716,1951],[249,1951]],"region":{"top_left_x":249,"top_left_y":1911,"width":468,"height":40},"line":188,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61691aee66034550bb7e269dbeff48b0","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Adverse events/outcome events \\({ }^{\\text {M }}\\)","text_display":"Adverse events/outcome events \\({ }^{\\text {M }}\\)","cell_row":24,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.90966796875,"confidence_rate":0.997987652692209},{"cnt":[[896,1907],[937,1907],[937,1939],[896,1939]],"region":{"top_left_x":896,"top_left_y":1907,"width":42,"height":33},"line":189,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07150a25fe4c4307bbc1e0846ae90068","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":24,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1043,1907],[1080,1907],[1080,1939],[1043,1939]],"region":{"top_left_x":1043,"top_left_y":1907,"width":38,"height":33},"line":190,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e8ebedf4adc44c5ab8822f9b99ae877","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":24,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1147,1907],[1179,1907],[1179,1939],[1147,1939]],"region":{"top_left_x":1147,"top_left_y":1907,"width":33,"height":33},"line":191,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16078b9981aa433d982e1061b96e1dd5","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":24,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1907],[1276,1907],[1276,1939],[1244,1939]],"region":{"top_left_x":1243,"top_left_y":1907,"width":33,"height":33},"line":192,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"671d4700b63e4d63958acd0616b268d6","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":24,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1907],[1377,1907],[1377,1939],[1343,1939]],"region":{"top_left_x":1342,"top_left_y":1907,"width":36,"height":33},"line":193,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d001dbe84abe4dc19b290c69af30bc02","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":24,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1907],[1527,1907],[1527,1939],[1490,1939]],"region":{"top_left_x":1490,"top_left_y":1907,"width":37,"height":33},"line":194,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50f38b075f0c4eff9b80f8d9058ae1cb","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":24,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1907],[1695,1907],[1695,1939],[1663,1939]],"region":{"top_left_x":1662,"top_left_y":1907,"width":33,"height":33},"line":195,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44ad2f63ceab410aa719ee98e1002894","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":24,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1799,1907],[1842,1907],[1842,1939],[1799,1939]],"region":{"top_left_x":1798,"top_left_y":1907,"width":45,"height":33},"line":196,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb93796a4353453f8e4fa8b85db5ccd5","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":24,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1979],[544,1979],[544,2015],[249,2015]],"region":{"top_left_x":249,"top_left_y":1978,"width":295,"height":38},"line":197,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d124b73430d2459fb77089fb7aad605a","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Concomitant therapy","text_display":"Concomitant therapy","cell_row":25,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[896,1967],[940,1967],[940,2009],[896,2009]],"region":{"top_left_x":896,"top_left_y":1967,"width":44,"height":42},"line":198,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cef72754ea064f4e94b6c51841e1ced6","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":25,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1043,1967],[1080,1967],[1080,2009],[1043,2009]],"region":{"top_left_x":1043,"top_left_y":1967,"width":38,"height":42},"line":199,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6397d610bd846c4919333d0027bebe3","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":25,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1147,1967],[1179,1967],[1179,2009],[1147,2009]],"region":{"top_left_x":1147,"top_left_y":1967,"width":33,"height":42},"line":200,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ffc005bb074647b790e1a37b31fcf416","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":25,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,1967],[1276,1967],[1276,2009],[1244,2009]],"region":{"top_left_x":1243,"top_left_y":1967,"width":33,"height":42},"line":201,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6afeeac85d4d4237a5616465abf23f84","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":25,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,1967],[1377,1967],[1377,2006],[1343,2006]],"region":{"top_left_x":1342,"top_left_y":1967,"width":36,"height":40},"line":202,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3063b7fc25c41ebbea845fded89ff58","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":25,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,1967],[1527,1967],[1527,2009],[1490,2009]],"region":{"top_left_x":1490,"top_left_y":1967,"width":37,"height":42},"line":203,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf64de7c911046bc8f173e4501dcdcb8","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":25,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,1967],[1695,1967],[1695,2009],[1663,2009]],"region":{"top_left_x":1662,"top_left_y":1967,"width":33,"height":42},"line":204,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79b9780af62f4ee985e0c60cf28abcb1","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":25,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1796,1967],[1842,1967],[1842,2009],[1796,2009]],"region":{"top_left_x":1796,"top_left_y":1967,"width":47,"height":42},"line":205,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99b7c800e9b948a2b2e5dcc852455862","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":25,"cell_column":8,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,2027],[569,2027],[569,2075],[249,2075]],"region":{"top_left_x":249,"top_left_y":2026,"width":321,"height":50},"line":206,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6d61a2a889a4292ba53958fcb49b55c","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Randomization (IRT) \\({ }^{ N }\\)","text_display":"Randomization (IRT) \\({ }^{ N }\\)","cell_row":26,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99462890625,"confidence_rate":0.999846138411263},{"cnt":[[1043,2027],[1080,2027],[1080,2064],[1043,2064]],"region":{"top_left_x":1043,"top_left_y":2026,"width":38,"height":38},"line":207,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"208950f19fb94aa8b16c48723f75ec8b","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":26,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,2087],[730,2087],[730,2133],[249,2133]],"region":{"top_left_x":249,"top_left_y":2086,"width":482,"height":47},"line":208,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fda2f757a9f4e729c8ae24f95f03825","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"Dispense study medication (IRT) \\({ }^{ N }\\)","text_display":"Dispense study medication (IRT) \\({ }^{ N }\\)","cell_row":27,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.7119140625,"confidence_rate":0.992796325500242},{"cnt":[[1043,2087],[1080,2087],[1080,2119],[1043,2119]],"region":{"top_left_x":1043,"top_left_y":2086,"width":38,"height":34},"line":209,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58823c57407540b5ac11ba821794ca29","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":27,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1147,2087],[1179,2087],[1179,2119],[1147,2119]],"region":{"top_left_x":1147,"top_left_y":2086,"width":33,"height":34},"line":210,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae422bb29e2244ca95a8caee51a4f753","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":27,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,2087],[1276,2087],[1276,2119],[1244,2119]],"region":{"top_left_x":1243,"top_left_y":2086,"width":33,"height":34},"line":211,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"606fd09ab1524c57a2a1990bcb1a2c8b","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":27,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,2087],[1377,2087],[1377,2119],[1343,2119]],"region":{"top_left_x":1342,"top_left_y":2086,"width":36,"height":34},"line":212,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9dae2229a170488ba91245057abfb2b1","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":27,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,2082],[1527,2082],[1527,2119],[1490,2119]],"region":{"top_left_x":1490,"top_left_y":2082,"width":37,"height":38},"line":213,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c8acb3309a84627b29699588869537d","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":27,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[244,2156],[772,2156],[772,2236],[244,2236]],"region":{"top_left_x":244,"top_left_y":2155,"width":528,"height":82},"line":214,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77bf9c4c75e44c67aab6617a0a47ed8b","type":"complex_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","children_ids":["88416254bd65428c810f5df1c25dbffa","23a94cb776ff4c2ba509b664fd483b3e"],"text":"Return study medication/ medication compliance check","text_display":"Return study medication/ medication compliance check","cell_row":28,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.97705078125,"confidence_rate":0.9997098339616145},{"cnt":[[249,2156],[767,2156],[767,2195],[249,2195]],"region":{"top_left_x":249,"top_left_y":2155,"width":519,"height":41},"line":215,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"88416254bd65428c810f5df1c25dbffa","type":"text","conversion_output":false,"parent_id":"77bf9c4c75e44c67aab6617a0a47ed8b","text":"Return study medication/ medication","text_display":"Return study medication/ medication","confidence":0.97705078125,"confidence_rate":0.9994197521195588},{"cnt":[[249,2197],[505,2197],[505,2236],[249,2236]],"region":{"top_left_x":249,"top_left_y":2197,"width":256,"height":40},"line":216,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23a94cb776ff4c2ba509b664fd483b3e","type":"text","conversion_output":false,"parent_id":"77bf9c4c75e44c67aab6617a0a47ed8b","text":"compliance check","text_display":" compliance check","confidence":1,"confidence_rate":1},{"cnt":[[1147,2170],[1179,2170],[1179,2211],[1147,2211]],"region":{"top_left_x":1147,"top_left_y":2169,"width":33,"height":43},"line":217,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87fcc97c6e3e4adb87964f5823c1a6e1","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":28,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1244,2170],[1276,2170],[1276,2211],[1244,2211]],"region":{"top_left_x":1243,"top_left_y":2169,"width":33,"height":43},"line":218,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d18d1102fa64ccc81623ecb7913b01b","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":28,"cell_column":4,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1343,2170],[1377,2170],[1377,2211],[1343,2211]],"region":{"top_left_x":1342,"top_left_y":2169,"width":36,"height":43},"line":219,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c2578eb2ead4882afc8ee53bebc8820","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":28,"cell_column":5,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1490,2170],[1527,2170],[1527,2211],[1490,2211]],"region":{"top_left_x":1490,"top_left_y":2169,"width":37,"height":43},"line":220,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99e269abbe324869af02d8c3e76deaa0","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":28,"cell_column":6,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1663,2170],[1695,2170],[1695,2211],[1663,2211]],"region":{"top_left_x":1662,"top_left_y":2169,"width":33,"height":43},"line":221,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"700ee918c33b4c04b25f3314bb92c14c","type":"simple_cell","conversion_output":false,"parent_id":"49849896663d42aa920874818f1af4fb","text":"X","text_display":"X","cell_row":28,"cell_column":7,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":222,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b2064a052b684cbd91206ae30e7f9249","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":223,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"82ba03df45f449b9a047d3c02a7c7255","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1768,2668],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1473,"height":35},"line":224,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9d9d09630d5d462bbc146a4095757c42","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-009","page":9,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4b11f642bdb403c80ab6bb8f40941bd","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b0ae5c42a4d4e46b6277e0762c47daf","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5802fb4e57c041b8929908668af0a00e","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e103b90f17c940e28f81483be1b4782b","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91b60a73c5404a508319e4d7be119a82","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1594,210],[1816,210],[1816,254],[1594,254]],"region":{"top_left_x":1594,"top_left_y":210,"width":223,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55e39fb03bbc42a4b1ccedf71ef8fb09","type":"page_info","conversion_output":false,"text":"Page 9 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,334],[646,334],[646,393],[242,393]],"region":{"top_left_x":242,"top_left_y":333,"width":405,"height":60},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89e68812d44a45bd959ddb73d3205978","type":"section_header","conversion_output":false,"children_ids":["3abe5e1c019a4f80ac15447bb625169f"],"text":"","text_display":""},{"cnt":[[247,338],[644,338],[644,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":399,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3abe5e1c019a4f80ac15447bb625169f","type":"text","conversion_output":true,"parent_id":"89e68812d44a45bd959ddb73d3205978","text":"Flow Chart (continued)","text_display":"\n\n\\section*{Flow Chart (continued)}","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[247,420],[1802,420],[1802,464],[247,464]],"region":{"top_left_x":246,"top_left_y":420,"width":1557,"height":44},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"364d61cd5dd041ea863d2c042f06f196","type":"text","conversion_output":true,"text":"A Randomization may be done as soon as the visit 1 (safety) laboratory results and eGFR are known and","text_display":"\n\nA Randomization may be done as soon as the visit 1 (safety) laboratory results and eGFR are known and","confidence":1,"confidence_rate":1},{"cnt":[[370,461],[1800,461],[1800,505],[370,505]],"region":{"top_left_x":370,"top_left_y":461,"width":1431,"height":44},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7d6edeeb67d4856b8d4b7c7db85b4ba","type":"text","conversion_output":true,"text":"all other eligibility criteria are met. If the UACR result at visit 2 is required to fulfil inclusion criterion","text_display":" all other eligibility criteria are met. If the UACR result at visit 2 is required to fulfil inclusion criterion","confidence":1,"confidence_rate":1},{"cnt":[[370,503],[1775,503],[1775,546],[370,546]],"region":{"top_left_x":370,"top_left_y":502,"width":1405,"height":44},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ed3aa6657004927881914bc06b001d6","type":"text","conversion_output":true,"text":"8, randomization may be postponed until the laboratory results are known. It's not required to repeat","text_display":" 8, randomization may be postponed until the laboratory results are known. It's not required to repeat","confidence":0.81298828125,"confidence_rate":0.9980487120562032},{"cnt":[[370,544],[1368,544],[1368,587],[370,587]],"region":{"top_left_x":370,"top_left_y":543,"width":999,"height":45},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cac3df75e5ef4100bfaeadcad3ad556b","type":"text","conversion_output":true,"text":"visit 2 assessments if the patient returns to the clinic for randomization.","text_display":" visit 2 assessments if the patient returns to the clinic for randomization.","confidence":0.9990234375,"confidence_rate":0.9999882285072625},{"cnt":[[244,599],[1259,599],[1259,646],[244,646]],"region":{"top_left_x":244,"top_left_y":598,"width":1015,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"398247f600204eabbcc6f22fc6f9352c","type":"text","conversion_output":true,"text":"B A clinic visit will be scheduled every 24 weeks until study end.","text_display":"\nB A clinic visit will be scheduled every 24 weeks until study end.","confidence":1,"confidence_rate":1},{"cnt":[[244,662],[1725,662],[1725,706],[244,706]],"region":{"top_left_x":244,"top_left_y":662,"width":1481,"height":44},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0902cf912e0d42a48369651efb8b5b31","type":"text","conversion_output":true,"text":"C The study is event driven. The number of confirmed adjudicated primary endpoint events will be","text_display":"\nC The study is event driven. The number of confirmed adjudicated primary endpoint events will be","confidence":1,"confidence_rate":1},{"cnt":[[370,704],[1812,704],[1812,747],[370,747]],"region":{"top_left_x":370,"top_left_y":703,"width":1442,"height":44},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50f5002b933d4e6db2e0b799fc4b6754","type":"text","conversion_output":true,"text":"continuously monitored during the trial. Based on the available number of events the projected number","text_display":" continuously monitored during the trial. Based on the available number of events the projected number","confidence":1,"confidence_rate":1},{"cnt":[[370,742],[1775,742],[1775,788],[370,788]],"region":{"top_left_x":370,"top_left_y":742,"width":1405,"height":47},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aaff9b275d104a2fb9b83fc4b90ded9a","type":"text","conversion_output":true,"text":"of expected future events will be calculated. As soon as the projection reliably suggests that the total","text_display":" of expected future events will be calculated. As soon as the projection reliably suggests that the total","confidence":1,"confidence_rate":1},{"cnt":[[370,781],[1812,781],[1812,827],[370,827]],"region":{"top_left_x":370,"top_left_y":781,"width":1442,"height":46},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"659b2385b9394e57b3276156384d8022","type":"text","conversion_output":true,"text":"number of patients with a by adjudication confirmed primary endpoint event will reach 625611 within","text_display":" number of patients with a by adjudication confirmed primary endpoint event will reach 625611 within","confidence":0.9736328125,"confidence_rate":0.9997503018747429},{"cnt":[[370,822],[1789,822],[1789,866],[370,866]],"region":{"top_left_x":370,"top_left_y":822,"width":1419,"height":44},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"033d6757ae8e43f183687de43d2a7a62","type":"text","conversion_output":true,"text":"the next 24 weeks, the trial team will perform respective actions to stop the trial. From this time point","text_display":" the next 24 weeks, the trial team will perform respective actions to stop the trial. From this time point","confidence":1,"confidence_rate":1},{"cnt":[[370,863],[1761,863],[1761,905],[370,905]],"region":{"top_left_x":370,"top_left_y":863,"width":1392,"height":42},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5f476b2ef6247b197ab3dbff920412c","type":"text","conversion_output":true,"text":"on, all patients are expected to perform their last visit (EOT visit) within the regular proposed time","text_display":" on, all patients are expected to perform their last visit (EOT visit) within the regular proposed time","confidence":1,"confidence_rate":1},{"cnt":[[370,900],[1807,900],[1807,943],[370,943]],"region":{"top_left_x":370,"top_left_y":900,"width":1437,"height":44},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d037e0230f464391837a495338c99d0e","type":"text","conversion_output":true,"text":"schedule, which means within the next 24 weeks communicated via an investigator letter. A follow-","text_display":" schedule, which means within the next 24 weeks communicated via an investigator letter. A follow","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[370,941],[1489,941],[1489,985],[370,985]],"region":{"top_left_x":370,"top_left_y":941,"width":1120,"height":44},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"28d4fcb0c47e41e59acf5a38902e4dd2","type":"text","conversion_output":true,"text":"up visit will take place ene week \\(3 0\\) days after the end of treatment (EOT visit).","text_display":"up visit will take place ene week \\(3 0\\) days after the end of treatment (EOT visit).","confidence":0.4443046525120735,"confidence_rate":0.991220885233296},{"cnt":[[370,1001],[1766,1001],[1766,1046],[370,1046]],"region":{"top_left_x":370,"top_left_y":1000,"width":1396,"height":47},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"587c667cabb6486d8996bbfa466a4717","type":"text","conversion_output":true,"text":"Patients who discontinue study drug prematurely should continue study visits until study end. Study","text_display":"\n\nPatients who discontinue study drug prematurely should continue study visits until study end. Study","confidence":1,"confidence_rate":1},{"cnt":[[370,1042],[1693,1042],[1693,1085],[370,1085]],"region":{"top_left_x":370,"top_left_y":1041,"width":1323,"height":45},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9dabfc8ebd32495fa78e6c69820702c3","type":"text","conversion_output":true,"text":"assessments may be omitted if a patient is willing to return to the pre-defined study visits, with","text_display":" assessments may be omitted if a patient is willing to return to the pre-defined study visits, with","confidence":1,"confidence_rate":1},{"cnt":[[370,1083],[1711,1083],[1711,1126],[370,1126]],"region":{"top_left_x":370,"top_left_y":1082,"width":1341,"height":45},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3bd343cb6094566ae920bbbfc052b7e","type":"text","conversion_output":true,"text":"exception , collection of adverse events, outcome events, concomitant","text_display":" exception , collection of adverse events, outcome events, concomitant","confidence":0.9990234375,"confidence_rate":0.9999867968486782},{"cnt":[[370,1124],[1428,1124],[1428,1165],[370,1165]],"region":{"top_left_x":370,"top_left_y":1123,"width":1058,"height":43},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"407e17aaef96487298062249238ed84c","type":"text","conversion_output":true,"text":"therapy and laboratory testing of creatinine for the calculation of the eGFR.","text_display":" therapy and laboratory testing of creatinine for the calculation of the eGFR.","confidence":0.9697265625,"confidence_rate":0.9996251782930399},{"cnt":[[370,1202],[1775,1202],[1775,1245],[370,1245]],"region":{"top_left_x":370,"top_left_y":1201,"width":1405,"height":44},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c9f4df70e8741f3abafaf1aaf363013","type":"text","conversion_output":true,"text":"If a patient who prematurely discontinued study drug is not willing to return to the pre-defined study","text_display":"\n\nIf a patient who prematurely discontinued study drug is not willing to return to the pre-defined study","confidence":1,"confidence_rate":1},{"cnt":[[370,1243],[1818,1243],[1818,1286],[370,1286]],"region":{"top_left_x":370,"top_left_y":1242,"width":1449,"height":45},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"191bd142c11b4ad5b08a340eeb1994c1","type":"text","conversion_output":true,"text":"visits, at minimum a yearly telephone call (preferably every 6 months) and a telephone call at study end","text_display":" visits, at minimum a yearly telephone call (preferably every 6 months) and a telephone call at study end","confidence":1,"confidence_rate":1},{"cnt":[[370,1284],[1734,1284],[1734,1327],[370,1327]],"region":{"top_left_x":370,"top_left_y":1283,"width":1364,"height":45},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d19c76f602184b5c8774e98c3946bb26","type":"text","conversion_output":true,"text":"will be required, to document the occurrence of outcome events and vital status. If possible, other","text_display":" will be required, to document the occurrence of outcome events and vital status. If possible, other","confidence":1,"confidence_rate":1},{"cnt":[[370,1325],[1750,1325],[1750,1366],[370,1366]],"region":{"top_left_x":370,"top_left_y":1324,"width":1380,"height":43},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b192ce05f5ba4d07a9a941447ee7ccdd","type":"text","conversion_output":true,"text":"adverse events and concomitant therapy changes since last visit might should be recorded (refer to","text_display":" adverse events and concomitant therapy changes since last visit might should be recorded (refer to","confidence":1,"confidence_rate":1},{"cnt":[[370,1366],[573,1366],[573,1405],[370,1405]],"region":{"top_left_x":370,"top_left_y":1366,"width":204,"height":39},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8ade5203fef4441ae7b5bc2e383c21b","type":"text","conversion_output":true,"text":"section 3.3.4).","text_display":" section 3.3.4).","confidence":1,"confidence_rate":1},{"cnt":[[247,1444],[1814,1444],[1814,1487],[247,1487]],"region":{"top_left_x":246,"top_left_y":1443,"width":1568,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"93ff4f0ad0e647a9bce3928584df4e03","type":"text","conversion_output":true,"text":"D All patients will have a follow up visit eneek \\(3 0\\) days following regular or premature completion of","text_display":"\n\nD All patients will have a follow up visit eneek \\(3 0\\) days following regular or premature completion of","confidence":0.9719506056288745,"confidence_rate":0.9997460117866548},{"cnt":[[368,1485],[1770,1485],[1770,1528],[368,1528]],"region":{"top_left_x":367,"top_left_y":1484,"width":1404,"height":45},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5ed5dba27774f6a913ad8e0601269cf","type":"text","conversion_output":true,"text":"the treatment period. The follow-up visit may be performed as a phone visit for patients who did not","text_display":" the treatment period. The follow-up visit may be performed as a phone visit for patients who did not","confidence":1,"confidence_rate":1},{"cnt":[[370,1526],[1770,1526],[1770,1569],[370,1569]],"region":{"top_left_x":370,"top_left_y":1525,"width":1401,"height":45},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c42c006b132f47c2baef05756a839968","type":"text","conversion_output":true,"text":"prematurely discontinue study medication and who do not have abnormalities at the EOT visit (only","text_display":" prematurely discontinue study medication and who do not have abnormalities at the EOT visit (only","confidence":1,"confidence_rate":1},{"cnt":[[370,1567],[1540,1567],[1540,1610],[370,1610]],"region":{"top_left_x":370,"top_left_y":1567,"width":1170,"height":44},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c014a3f1e03442cb876f291cf67f60aa","type":"text","conversion_output":true,"text":"adverse events/outcome events and changes in concomitant therapy to be obtained).","text_display":" adverse events/outcome events and changes in concomitant therapy to be obtained).","confidence":1,"confidence_rate":1},{"cnt":[[247,1645],[1081,1645],[1081,1688],[247,1688]],"region":{"top_left_x":246,"top_left_y":1644,"width":835,"height":45},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b22c915afa874424a16ff573b5480b4e","type":"text","conversion_output":true,"text":"E Body Mass Index will be calculated automatically.","text_display":"\n\nE Body Mass Index will be calculated automatically.","confidence":0.99853515625,"confidence_rate":0.9999738232411441},{"cnt":[[247,1709],[1734,1709],[1734,1750],[247,1750]],"region":{"top_left_x":246,"top_left_y":1708,"width":1488,"height":42},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4744483ad2b44a08bf60c1815b367bb3","type":"text","conversion_output":true,"text":"F A complete, head-to-toe physical examination (e.g. evaluation of the body and its functions using","text_display":"\nF A complete, head-to-toe physical examination (e.g. evaluation of the body and its functions using","confidence":1,"confidence_rate":1},{"cnt":[[370,1750],[1277,1750],[1277,1793],[370,1793]],"region":{"top_left_x":370,"top_left_y":1749,"width":907,"height":45},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9779e054d3d4c94b1ffc850821acd39","type":"text","conversion_output":true,"text":"inspection, palpation, percussion, and auscultation) will be done.","text_display":" inspection, palpation, percussion, and auscultation) will be done.","confidence":0.99951171875,"confidence_rate":0.9999931211434043},{"cnt":[[240,1809],[279,1809],[279,1846],[240,1846]],"region":{"top_left_x":239,"top_left_y":1809,"width":40,"height":37},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c58c741d1ee4346b83db746717c1c5b","type":"text","conversion_output":true,"text":"G","text_display":"\n\nG","confidence":1,"confidence_rate":1},{"cnt":[[247,2108],[1770,2108],[1770,2150],[247,2150]],"region":{"top_left_x":246,"top_left_y":2108,"width":1525,"height":42},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e9cc08c4e2642cc9881a2aa736fe07b","type":"text","conversion_output":true,"text":"H In addition to the visits indicated, electrocardiogram (ECG) should be recorded in case of respective","text_display":"\n\nH In addition to the visits indicated, electrocardiogram (ECG) should be recorded in case of respective","confidence":1,"confidence_rate":1},{"cnt":[[370,2147],[1332,2147],[1332,2191],[370,2191]],"region":{"top_left_x":370,"top_left_y":2147,"width":962,"height":44},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e89a3d9ac2bd422b8179ee4e2d63b30b","type":"text","conversion_output":true,"text":"cardiac symptoms (indicating rhythm disorders or cardiac ischemia).","text_display":" cardiac symptoms (indicating rhythm disorders or cardiac ischemia).","confidence":1,"confidence_rate":1},{"cnt":[[244,2207],[1761,2207],[1761,2252],[244,2252]],"region":{"top_left_x":244,"top_left_y":2206,"width":1518,"height":47},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed183f93419a439781532a4da7f41a5a","type":"text","conversion_output":true,"text":"I For female patients (local urine pregnancy test in women of child bearing potential). More frequent","text_display":"\n\nI For female patients (local urine pregnancy test in women of child bearing potential). More frequent","confidence":1,"confidence_rate":1},{"cnt":[[370,2248],[1247,2248],[1247,2291],[370,2291]],"region":{"top_left_x":370,"top_left_y":2247,"width":878,"height":45},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8810cc5e84540439abf005eb39a4639","type":"text","conversion_output":true,"text":"testing can be done if required by local regulations/authorities.","text_display":" testing can be done if required by local regulations/authorities.","confidence":1,"confidence_rate":1},{"cnt":[[247,2310],[1798,2310],[1798,2351],[247,2351]],"region":{"top_left_x":246,"top_left_y":2309,"width":1552,"height":42},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e788309cb9141e7a011b886a2256b79","type":"text","conversion_output":true,"text":"J Distribution of glucometer and testing supplies with instructions at randomization (visit 2). During the","text_display":"\n\nJ Distribution of glucometer and testing supplies with instructions at randomization (visit 2). During the","confidence":1,"confidence_rate":1},{"cnt":[[368,2348],[1750,2348],[1750,2392],[368,2392]],"region":{"top_left_x":367,"top_left_y":2348,"width":1383,"height":44},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ce52ae21ba04eb78f66fd8931c4ba1a","type":"text","conversion_output":true,"text":"treatment period, weekly finger stick glucose measurements are recommended (fasted). During the","text_display":" treatment period, weekly finger stick glucose measurements are recommended (fasted). During the","confidence":1,"confidence_rate":1},{"cnt":[[370,2389],[1798,2389],[1798,2433],[370,2433]],"region":{"top_left_x":370,"top_left_y":2389,"width":1428,"height":44},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1c87df8df4043c3986add41c318b326","type":"text","conversion_output":true,"text":"whole trial participation, additional measurements should be done if necessary and in case of hypo- or","text_display":" whole trial participation, additional measurements should be done if necessary and in case of hypo- or","confidence":1,"confidence_rate":1},{"cnt":[[368,2431],[1780,2431],[1780,2474],[368,2474]],"region":{"top_left_x":367,"top_left_y":2430,"width":1413,"height":44},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1210d45589d54df090632b458ad51f0a","type":"text","conversion_output":true,"text":"hyperglycaemia related symptoms. The patient should be instructed to bring their HBGM device and","text_display":" hyperglycaemia related symptoms. The patient should be instructed to bring their HBGM device and","confidence":1,"confidence_rate":1},{"cnt":[[370,2472],[1176,2472],[1176,2511],[370,2511]],"region":{"top_left_x":370,"top_left_y":2471,"width":807,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"451d4c1dd9d14f93b5a667df2edb0d96","type":"text","conversion_output":true,"text":"diary to the clinic for an additional measurement (fasted).","text_display":" diary to the clinic for an additional measurement (fasted).","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c73044c031f8454ab1838db36031aebc","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99755859375,"confidence_rate":0.9999418018997234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4574e80d39e749f098b982c06ed22235","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.9912109375,"confidence_rate":0.9999258185992773},{"cnt":[[297,2664],[1770,2664],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1475,"height":40},"line":50,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c7222c35668143a19979bc4e98bce7a9","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-010","page":10,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7cd99cdcda574b1d87989380f6424d55","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3b5b0975aa442669798b85e4ac5add0","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d4b5da4d85e4d7093d8a3a7b426d86f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"daa71c61456646d18ac19328d55fb1d0","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2b9a10f71b04fbdb30c0399d4521204","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20767b85b35b4b65adf52846c1fc1fbc","type":"page_info","conversion_output":false,"text":"Page 10 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,336],[1720,336],[1720,381],[244,381]],"region":{"top_left_x":244,"top_left_y":335,"width":1477,"height":47},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24e86220965943199686196236494540","type":"text","conversion_output":true,"text":"K At visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for","text_display":"\n\nK At visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for","confidence":1,"confidence_rate":1},{"cnt":[[368,379],[1816,379],[1816,423],[368,423]],"region":{"top_left_x":367,"top_left_y":379,"width":1450,"height":44},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45885b3bb8b54f63a21d1d2e1d3e4194","type":"text","conversion_output":true,"text":"eligibility in addition to lipase, urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart.","text_display":" eligibility in addition to lipase, urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart.","confidence":1,"confidence_rate":1},{"cnt":[[370,420],[1752,420],[1752,459],[370,459]],"region":{"top_left_x":370,"top_left_y":420,"width":1383,"height":40},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15cb9bcb5ceb4eed91de7c7cc14b5899","type":"text","conversion_output":true,"text":"At randomization (visit 2) baseline laboratory will be obtained. See section 5.2.3 for to be obtained","text_display":" At randomization (visit 2) baseline laboratory will be obtained. See section 5.2.3 for to be obtained","confidence":1,"confidence_rate":1},{"cnt":[[370,457],[1748,457],[1748,500],[370,500]],"region":{"top_left_x":370,"top_left_y":456,"width":1378,"height":45},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1030745cfdc4ce8a2801618f69a2541","type":"text","conversion_output":true,"text":"laboratory parameters. As of visit 6: yearly (every other visit) lipid profile (Total cholesterol, HDL","text_display":" laboratory parameters. As of visit 6: yearly (every other visit) lipid profile (Total cholesterol, HDL","confidence":1,"confidence_rate":1},{"cnt":[[370,498],[1531,498],[1531,539],[370,539]],"region":{"top_left_x":370,"top_left_y":497,"width":1161,"height":43},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb598b422da84e95ae7b3f59ed7a9a03","type":"text","conversion_output":true,"text":"cholesterol, LDL cholesterol and triglycerides), urine albumin and urine creatinine.","text_display":" cholesterol, LDL cholesterol and triglycerides), urine albumin and urine creatinine.","confidence":1,"confidence_rate":1},{"cnt":[[247,557],[1807,557],[1807,601],[247,601]],"region":{"top_left_x":246,"top_left_y":557,"width":1561,"height":44},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e0f3b38d35048ea8f5bb7148bc4dbb2","type":"text","conversion_output":true,"text":"L Estimated ereatinine clearance glomerular filtration rate (eGFR) will be calculated using the MDRD","text_display":"\n\nL Estimated ereatinine clearance glomerular filtration rate (eGFR) will be calculated using the MDRD","confidence":0.7918077417657514,"confidence_rate":0.9977792631411039},{"cnt":[[370,599],[1761,599],[1761,642],[370,642]],"region":{"top_left_x":370,"top_left_y":598,"width":1392,"height":44},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cba0ac68919d4881ad754d98ceb70420","type":"text","conversion_output":true,"text":"formula. This formula considers the race as an adjustment factor, therefore, the race must be known","text_display":" formula. This formula considers the race as an adjustment factor, therefore, the race must be known","confidence":1,"confidence_rate":1},{"cnt":[[370,640],[1786,640],[1786,678],[370,678]],"region":{"top_left_x":370,"top_left_y":639,"width":1417,"height":40},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5428614656044baa01d7578e6124afc","type":"text","conversion_output":true,"text":"(and will be collected) for accurate estimation. In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline","text_display":" (and will be collected) for accurate estimation. In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline","confidence":1,"confidence_rate":1},{"cnt":[[370,678],[1812,678],[1812,720],[370,720]],"region":{"top_left_x":370,"top_left_y":678,"width":1442,"height":42},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f251a8deecf43188ce80248f260b54b","type":"text","conversion_output":true,"text":"(visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4-8","text_display":" (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4-8","confidence":0.7738208770751953,"confidence_rate":0.9977132003520551},{"cnt":[[370,717],[1766,717],[1766,761],[370,761]],"region":{"top_left_x":370,"top_left_y":717,"width":1396,"height":44},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b46b3f3c7a634c9ab47cfc830b2ba714","type":"text","conversion_output":true,"text":"weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine","text_display":" weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine","confidence":1,"confidence_rate":1},{"cnt":[[370,758],[1725,758],[1725,800],[370,800]],"region":{"top_left_x":370,"top_left_y":758,"width":1355,"height":42},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce0af481b9914592a669f0fe68606f87","type":"text","conversion_output":true,"text":"(eGFR). An additional sample of creatinine should also be taken between the visits if a signal of","text_display":" (eGFR). An additional sample of creatinine should also be taken between the visits if a signal of","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[370,800],[1567,800],[1567,843],[370,843]],"region":{"top_left_x":370,"top_left_y":799,"width":1198,"height":44},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3eb6cba872a417693afa47502e2652f","type":"text","conversion_output":true,"text":"increasing creatinine is reported to the study site by others (e.g., GPs from local labs).","text_display":" increasing creatinine is reported to the study site by others (e.g., GPs from local labs).","confidence":1,"confidence_rate":1},{"cnt":[[247,859],[1793,859],[1793,902],[247,902]],"region":{"top_left_x":246,"top_left_y":858,"width":1548,"height":45},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"209eb6252c2a4cb4b2d36be634073b18","type":"text","conversion_output":true,"text":"M In case of a stroke the reported value from the modified Rankin Scale will be collected approximately","text_display":"\n\nM In case of a stroke the reported value from the modified Rankin Scale will be collected approximately","confidence":1,"confidence_rate":1},{"cnt":[[368,900],[1784,900],[1784,943],[368,943]],"region":{"top_left_x":367,"top_left_y":900,"width":1418,"height":44},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e75bc8fe34843699e78d736809f5939","type":"text","conversion_output":true,"text":"one week after stroke onset and 3 months after stroke onset. This might require an additional contact.","text_display":" one week after stroke onset and 3 months after stroke onset. This might require an additional contact.","confidence":1,"confidence_rate":1},{"cnt":[[247,980],[1766,980],[1766,1021],[247,1021]],"region":{"top_left_x":246,"top_left_y":979,"width":1520,"height":43},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1bf060dbe7794816846c406a24ba9248","type":"text","conversion_output":true,"text":"N Interactive Response Technology (IRT) will allocate medication kit numbers at all study visits from","text_display":"\n\nN Interactive Response Technology (IRT) will allocate medication kit numbers at all study visits from","confidence":1,"confidence_rate":1},{"cnt":[[368,1019],[1816,1019],[1816,1062],[368,1062]],"region":{"top_left_x":367,"top_left_y":1018,"width":1450,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97a5e231833d4f768a8ba21f5cf92fd5","type":"text","conversion_output":true,"text":"visit 2 till study end. At visit 2 patients will receive one treatment box sufficient for 12 weeks treatment","text_display":" visit 2 till study end. At visit 2 patients will receive one treatment box sufficient for 12 weeks treatment","confidence":1,"confidence_rate":1},{"cnt":[[370,1060],[1732,1060],[1732,1103],[370,1103]],"region":{"top_left_x":370,"top_left_y":1059,"width":1362,"height":45},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fa2155cf4e143b68839aacf3e94258e","type":"text","conversion_output":true,"text":"(plus one week reserve). As of visit 3 patients will receive two medication boxes sufficient for 24","text_display":" (plus one week reserve). As of visit 3 patients will receive two medication boxes sufficient for 24","confidence":1,"confidence_rate":1},{"cnt":[[370,1101],[966,1101],[966,1144],[370,1144]],"region":{"top_left_x":370,"top_left_y":1101,"width":597,"height":44},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25e9b1e2fde64be2a932980eb3c0d062","type":"text","conversion_output":true,"text":"weeks treatment (plus two weeks reserve).","text_display":" weeks treatment (plus two weeks reserve).","confidence":1,"confidence_rate":1},{"cnt":[[247,1160],[1780,1160],[1780,1204],[247,1204]],"region":{"top_left_x":246,"top_left_y":1160,"width":1534,"height":44},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea0b2d33d599495cba7d7b357b1a1f13","type":"text","conversion_output":true,"text":"O The protocol allows a time window of +/- 7 days for visit 3 and +/- 14 days for all scheduled visits in","text_display":"\n\nO The protocol allows a time window of +/- 7 days for visit 3 and +/- 14 days for all scheduled visits in","confidence":0.67236328125,"confidence_rate":0.9966697886935868},{"cnt":[[370,1202],[1684,1202],[1684,1245],[370,1245]],"region":{"top_left_x":370,"top_left_y":1201,"width":1314,"height":44},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb0a84fe9c2347d1bb5f8301989e8b6f","type":"text","conversion_output":true,"text":"the treatment period after visit 3 . To ensure sufficient medication, visits after visit 3 should be","text_display":" the treatment period after visit 3 . To ensure sufficient medication, visits after visit 3 should be","confidence":0.7243895530700684,"confidence_rate":0.9970994761614345},{"cnt":[[370,1238],[1622,1238],[1622,1282],[370,1282]],"region":{"top_left_x":370,"top_left_y":1238,"width":1252,"height":44},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fdec4a78bb2419bb28c758787c86380","type":"text","conversion_output":true,"text":"scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2 .","text_display":" scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2 .","confidence":0.9931640625,"confidence_rate":0.9999376436755919},{"cnt":[[247,1302],[1789,1302],[1789,1343],[247,1343]],"region":{"top_left_x":246,"top_left_y":1302,"width":1543,"height":42},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f9d479715ce411ba2fc99798fd3b0a9","type":"text","conversion_output":true,"text":"P To allow possible retrospective pharmacogenetic analyses, all patients eligible for randomization will","text_display":"\n\nP To allow possible retrospective pharmacogenetic analyses, all patients eligible for randomization will","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[370,1341],[1761,1341],[1761,1382],[370,1382]],"region":{"top_left_x":370,"top_left_y":1340,"width":1392,"height":43},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"621af4d8bbb8415f9769fe32a8a63034","type":"text","conversion_output":true,"text":"be asked for a blood sample with a separate informed consent. The pharmacogenetic sample should","text_display":" be asked for a blood sample with a separate informed consent. The pharmacogenetic sample should","confidence":1,"confidence_rate":1},{"cnt":[[370,1380],[1802,1380],[1802,1423],[370,1423]],"region":{"top_left_x":370,"top_left_y":1379,"width":1433,"height":45},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad2399eba417477e80dc3b7ef3684804","type":"text","conversion_output":true,"text":"preferably be taken at visit 2 , but could also be taken at any later visit, depending on availability of the","text_display":" preferably be taken at visit 2 , but could also be taken at any later visit, depending on availability of the","confidence":0.97705078125,"confidence_rate":0.9998015867670594},{"cnt":[[370,1421],[1729,1421],[1729,1464],[370,1464]],"region":{"top_left_x":370,"top_left_y":1420,"width":1360,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4be863b1d3c46f69308cf3c8963f5dc","type":"text","conversion_output":true,"text":"respective informed consent. Pharmacogenetic sampling is voluntary and is not a prerequisite for","text_display":" respective informed consent. Pharmacogenetic sampling is voluntary and is not a prerequisite for","confidence":1,"confidence_rate":1},{"cnt":[[370,1462],[733,1462],[733,1505],[370,1505]],"region":{"top_left_x":370,"top_left_y":1462,"width":364,"height":44},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a612a30a802e4044a58f4b51d00a9a5a","type":"text","conversion_output":true,"text":"participation in the study.","text_display":" participation in the study.","confidence":1,"confidence_rate":1},{"cnt":[[247,1540],[1798,1540],[1798,1583],[247,1583]],"region":{"top_left_x":246,"top_left_y":1539,"width":1552,"height":45},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42a6aba1183945ca81034e9d72e76f2e","type":"text","conversion_output":true,"text":"Q Urine Albumin Creatinine Ratio (UACR) will be calculated at the central lab, and should be measured","text_display":"\n\nQ Urine Albumin Creatinine Ratio (UACR) will be calculated at the central lab, and should be measured","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[368,1581],[1103,1581],[1103,1624],[368,1624]],"region":{"top_left_x":367,"top_left_y":1580,"width":737,"height":45},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9faf554ed5d04621a8f3324e8af462be","type":"text","conversion_output":true,"text":"on a first morning void specimen wherever possible.","text_display":" on a first morning void specimen wherever possible.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2622],[793,2622]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":38},"line":35,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f1fe18f2a4b94a50973c3ba602798738","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999418018997234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":36,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fcea0570af5c46b4bb25ec2422b24759","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":37,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9c5f1ec924674a739c6e793a379f169f","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-011","page":11,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"703f45f856594efb829f3137e983fdd3","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8459c4ea23e24e9183f6005c189eb696","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,167],[599,167],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":166,"width":353,"height":38},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"575a00a9dc1644f0a06628e2c50c8712","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"edc64c520e134a108ad9b89c20c21fc6","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d7d833ba1334b9c958b6a5e16f0ccbf","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1576,210],[1814,210],[1814,254],[1576,254]],"region":{"top_left_x":1576,"top_left_y":210,"width":238,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e443cb9bb771410ba5e9e71508b20d47","type":"page_info","conversion_output":false,"text":"Page 11 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[781,338],[781,395],[242,395]],"region":{"top_left_x":242,"top_left_y":338,"width":540,"height":58},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d329c95b0076450c94380b2051313b01","type":"section_header","conversion_output":false,"children_ids":["f55cfddec17445b2abb5e8f5c267472b"],"text":"","text_display":""},{"cnt":[[247,343],[779,343],[779,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":533,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f55cfddec17445b2abb5e8f5c267472b","type":"text","conversion_output":true,"parent_id":"d329c95b0076450c94380b2051313b01","text":"TABLE OF CONTENTS","text_display":"\n\n\\section*{TABLE OF CONTENTS}","confidence":1,"confidence_rate":1},{"cnt":[[231,427],[1832,427],[1832,2716],[231,2716]],"region":{"top_left_x":230,"top_left_y":427,"width":1603,"height":2290},"line":9,"column":0,"font_size":29,"is_printed":true,"is_handwritten":false,"id":"d9322423409245b89412d63f0f1ad739","type":"table_of_contents_container","conversion_output":false,"children_ids":["266ccf86f277476ca852dfdff088091c","2a418a8424384a8a9481c01bdac52afd","e456a1ef94584085bc82ef8373b6511b","b2f422edb48245188b6f6abd7c19812a","6892e7b5b9e6418d8587150214d7980f","fd397fb0b68644e3abafd76958a04f79","e7d87fd1d20645c4a07699d420367e79","42162d044ab74bd28147ffb06d70e0db","fe3c09b1e7584d5d827d0b34fbba85f8","9dab1cf1858a444c97771ba678914f0e","28ace81386304e6ab262c5504f0e4498","a7c704b69ecb4885a3e122432c1ce59d","52fb66cc7add437aabefd9e67e48a01c","3cb928b6f2ba4306b7731b63328d950a","17998b82fde546e78e11efd91a39ba4e","6a0af005d26545faa3084b89f4c204fe","1c164fc5188f4324a4bcd1932628c221","8a80822deb734cb8921933da790df0cd","9569220fae604b6185e79358b55b9247","0979514932814b5c910cbb0b9a3035ff","f8794e7d50e4431598a25dea56447991","5d8a7ee17db243e7a067509cd32b1a7a","8380205949bd4b90ab4f9dca96136829","af8613bb80cd4510a7c4de4a873e7d99","4ba000d1dbbe4a9da0ad37e5770184c5","7d28363b46f84abd8b0b3d9647a41409","697401652c424d88bbc3a70517465fc5","c215c8b15ddd4284a5bcbe297ebb558c","efe71d7276ad43a7b3b1e97e26fd3f5e","80c5465edebc4adc89e1434c44421372","8b20913ab92a49209f6388e4bb6bffdb","91c060beabe14571ad528790136f5123","6820c075e83945c49b90b2b79eea2b96","5362803899094eab9cdc1c1bbb08fb18","e6c77465609b496d8f3eda4acece7af5","ef9f8e5b69314fb5a429a96fbdddf6ec"],"text":"","text_display":""},{"cnt":[[242,439],[1818,439],[1818,491],[242,491]],"region":{"top_left_x":242,"top_left_y":438,"width":1577,"height":54},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"266ccf86f277476ca852dfdff088091c","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["43dfbce76e114d64b8e03fb006b60b55","bedfe3d52a6a4c09ab1885423d8c4661"],"text":"","text_display":""},{"cnt":[[247,443],[546,443],[546,484],[247,484]],"region":{"top_left_x":246,"top_left_y":443,"width":300,"height":42},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"43dfbce76e114d64b8e03fb006b60b55","type":"table_of_contents_item","conversion_output":true,"parent_id":"266ccf86f277476ca852dfdff088091c","text":"TITLE PAGE","text_display":"\nTITLE PAGE","confidence":1,"confidence_rate":1},{"cnt":[[1786,441],[1823,441],[1823,484],[1786,484]],"region":{"top_left_x":1786,"top_left_y":440,"width":37,"height":45},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bedfe3d52a6a4c09ab1885423d8c4661","type":"table_of_contents_number","conversion_output":true,"parent_id":"266ccf86f277476ca852dfdff088091c","text":"1","text_display":" ..... 1","confidence":1,"confidence_rate":1},{"cnt":[[242,503],[1816,503],[1816,555],[242,555]],"region":{"top_left_x":242,"top_left_y":502,"width":1575,"height":54},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2a418a8424384a8a9481c01bdac52afd","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["c125fcbde9264efc8900fe22bb83783d","155718a890514f0297e63a9ba5467e61"],"text":"","text_display":""},{"cnt":[[247,507],[1202,507],[1202,551],[247,551]],"region":{"top_left_x":246,"top_left_y":507,"width":956,"height":44},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c125fcbde9264efc8900fe22bb83783d","type":"table_of_contents_item","conversion_output":true,"parent_id":"2a418a8424384a8a9481c01bdac52afd","text":"CLINICAL TRIAL PROTOCOL SYNOPSIS","text_display":"\nCLINICAL TRIAL PROTOCOL SYNOPSIS","confidence":1,"confidence_rate":1},{"cnt":[[1786,498],[1823,498],[1823,553],[1786,553]],"region":{"top_left_x":1786,"top_left_y":497,"width":37,"height":56},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"155718a890514f0297e63a9ba5467e61","type":"table_of_contents_number","conversion_output":true,"parent_id":"2a418a8424384a8a9481c01bdac52afd","text":"2","text_display":" ..... 2","confidence":1,"confidence_rate":1},{"cnt":[[242,569],[1821,569],[1821,624],[242,624]],"region":{"top_left_x":242,"top_left_y":568,"width":1579,"height":56},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e456a1ef94584085bc82ef8373b6511b","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["1c00f49b01884872844a91684815c49b","92bb8884805d44a687e7ae2412d754f4"],"text":"","text_display":""},{"cnt":[[247,576],[589,576],[589,619],[247,619]],"region":{"top_left_x":246,"top_left_y":575,"width":344,"height":45},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1c00f49b01884872844a91684815c49b","type":"table_of_contents_item","conversion_output":true,"parent_id":"e456a1ef94584085bc82ef8373b6511b","text":"FLOW CHART","text_display":"\nFLOW CHART","confidence":1,"confidence_rate":1},{"cnt":[[1786,569],[1823,569],[1823,617],[1786,617]],"region":{"top_left_x":1786,"top_left_y":568,"width":37,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"92bb8884805d44a687e7ae2412d754f4","type":"table_of_contents_number","conversion_output":true,"parent_id":"e456a1ef94584085bc82ef8373b6511b","text":"8","text_display":" ..... 8","confidence":1,"confidence_rate":1},{"cnt":[[242,635],[1816,635],[1816,690],[242,690]],"region":{"top_left_x":242,"top_left_y":635,"width":1575,"height":55},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b2f422edb48245188b6f6abd7c19812a","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["1d05f15a02c040d3a70ede7815b9a7f4","dc62b7d0e22946d4a543541ea75326c7"],"text":"","text_display":""},{"cnt":[[247,640],[777,640],[777,683],[247,683]],"region":{"top_left_x":246,"top_left_y":639,"width":531,"height":45},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1d05f15a02c040d3a70ede7815b9a7f4","type":"table_of_contents_item","conversion_output":true,"parent_id":"b2f422edb48245188b6f6abd7c19812a","text":"TABLE OF CONTENTS","text_display":"\nTABLE OF CONTENTS","confidence":1,"confidence_rate":1},{"cnt":[[1764,642],[1823,642],[1823,685],[1764,685]],"region":{"top_left_x":1763,"top_left_y":641,"width":60,"height":45},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dc62b7d0e22946d4a543541ea75326c7","type":"table_of_contents_number","conversion_output":true,"parent_id":"b2f422edb48245188b6f6abd7c19812a","text":"11","text_display":" ..... 11","confidence":1,"confidence_rate":1},{"cnt":[[242,701],[1821,701],[1821,756],[242,756]],"region":{"top_left_x":242,"top_left_y":701,"width":1579,"height":56},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6892e7b5b9e6418d8587150214d7980f","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["f374bae0ea5c46578ae3fcaa9a3df030","badae3e81e864e34b11d111d4176a869"],"text":"","text_display":""},{"cnt":[[247,708],[660,708],[660,752],[247,752]],"region":{"top_left_x":246,"top_left_y":708,"width":415,"height":44},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f374bae0ea5c46578ae3fcaa9a3df030","type":"table_of_contents_item","conversion_output":true,"parent_id":"6892e7b5b9e6418d8587150214d7980f","text":"ABBREVIATIONS","text_display":"\nABBREVIATIONS","confidence":1,"confidence_rate":1},{"cnt":[[1764,699],[1823,699],[1823,754],[1764,754]],"region":{"top_left_x":1763,"top_left_y":699,"width":60,"height":55},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"badae3e81e864e34b11d111d4176a869","type":"table_of_contents_number","conversion_output":true,"parent_id":"6892e7b5b9e6418d8587150214d7980f","text":"15","text_display":" ..... 15","confidence":1,"confidence_rate":1},{"cnt":[[242,768],[1821,768],[1821,825],[242,825]],"region":{"top_left_x":242,"top_left_y":767,"width":1579,"height":58},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fd397fb0b68644e3abafd76958a04f79","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["9988271b58624ef6b634c302995e93f5","fbc4306741114d47bbb4096d4acb26e7"],"text":"","text_display":""},{"cnt":[[247,772],[738,772],[738,818],[247,818]],"region":{"top_left_x":246,"top_left_y":772,"width":492,"height":46},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9988271b58624ef6b634c302995e93f5","type":"table_of_contents_item","conversion_output":true,"parent_id":"fd397fb0b68644e3abafd76958a04f79","text":"1. INTRODUCTION","text_display":"\n1. INTRODUCTION","confidence":1,"confidence_rate":1},{"cnt":[[1764,772],[1823,772],[1823,818],[1764,818]],"region":{"top_left_x":1763,"top_left_y":772,"width":60,"height":46},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fbc4306741114d47bbb4096d4acb26e7","type":"table_of_contents_number","conversion_output":true,"parent_id":"fd397fb0b68644e3abafd76958a04f79","text":"17","text_display":" ..... 17","confidence":1,"confidence_rate":1},{"cnt":[[338,832],[1821,832],[1821,884],[338,884]],"region":{"top_left_x":338,"top_left_y":831,"width":1483,"height":54},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e7d87fd1d20645c4a07699d420367e79","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["aa8c8e1a48864065951263cbfecd9268","bb7614e7219549a4b615db49665b341e"],"text":"","text_display":""},{"cnt":[[343,836],[975,836],[975,879],[343,879]],"region":{"top_left_x":342,"top_left_y":836,"width":634,"height":44},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"aa8c8e1a48864065951263cbfecd9268","type":"table_of_contents_item","conversion_output":true,"parent_id":"e7d87fd1d20645c4a07699d420367e79","text":"1.1 MEDICAL BACKGROUND","text_display":"\n1.1 MEDICAL BACKGROUND","confidence":1,"confidence_rate":1},{"cnt":[[1768,827],[1823,827],[1823,877],[1768,877]],"region":{"top_left_x":1768,"top_left_y":826,"width":55,"height":52},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bb7614e7219549a4b615db49665b341e","type":"table_of_contents_number","conversion_output":true,"parent_id":"e7d87fd1d20645c4a07699d420367e79","text":"17","text_display":" ..... 17","confidence":1,"confidence_rate":1},{"cnt":[[338,886],[1821,886],[1821,937],[338,937]],"region":{"top_left_x":338,"top_left_y":886,"width":1483,"height":51},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"42162d044ab74bd28147ffb06d70e0db","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["1b23069530c045ddbe9e7bc4806f1f1a","f03cb3d93ee4456ba214f34e49861c47"],"text":"","text_display":""},{"cnt":[[343,891],[779,891],[779,930],[343,930]],"region":{"top_left_x":342,"top_left_y":890,"width":437,"height":40},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1b23069530c045ddbe9e7bc4806f1f1a","type":"table_of_contents_item","conversion_output":true,"parent_id":"42162d044ab74bd28147ffb06d70e0db","text":"1.2 DRUG PROFILE","text_display":"\n1.2 DRUG PROFILE","confidence":1,"confidence_rate":1},{"cnt":[[1768,882],[1823,882],[1823,932],[1768,932]],"region":{"top_left_x":1768,"top_left_y":881,"width":55,"height":52},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f03cb3d93ee4456ba214f34e49861c47","type":"table_of_contents_number","conversion_output":true,"parent_id":"42162d044ab74bd28147ffb06d70e0db","text":"19","text_display":" ..... 19","confidence":1,"confidence_rate":1},{"cnt":[[242,946],[1821,946],[1821,1058],[242,1058]],"region":{"top_left_x":242,"top_left_y":945,"width":1579,"height":113},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fe3c09b1e7584d5d827d0b34fbba85f8","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["952d9b219fe843ebb9d5c24e7e353324","89e6b4f5c63840ac997bcb44c09da941","c3dcd0c86bd64a949e8996f7b124d5f1"],"text":"","text_display":""},{"cnt":[[247,950],[1492,950],[1492,1003],[247,1003]],"region":{"top_left_x":246,"top_left_y":950,"width":1246,"height":53},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"952d9b219fe843ebb9d5c24e7e353324","type":"table_of_contents_item","conversion_output":true,"parent_id":"fe3c09b1e7584d5d827d0b34fbba85f8","text":"2. RATIONALE, OBJECTIVES, AND BENEFIT - RISK","text_display":"\n2. RATIONALE, OBJECTIVES, AND BENEFIT - RISK","confidence":1,"confidence_rate":1},{"cnt":[[340,1010],[669,1010],[669,1053],[340,1053]],"region":{"top_left_x":340,"top_left_y":1009,"width":330,"height":45},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"89e6b4f5c63840ac997bcb44c09da941","type":"table_of_contents_item","conversion_output":true,"parent_id":"fe3c09b1e7584d5d827d0b34fbba85f8","text":"ASSESSMENT","text_display":" ASSESSMENT","confidence":1,"confidence_rate":1},{"cnt":[[1759,1010],[1823,1010],[1823,1051],[1759,1051]],"region":{"top_left_x":1758,"top_left_y":1009,"width":65,"height":42},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c3dcd0c86bd64a949e8996f7b124d5f1","type":"table_of_contents_number","conversion_output":true,"parent_id":"fe3c09b1e7584d5d827d0b34fbba85f8","text":"22","text_display":" ..... 22","confidence":1,"confidence_rate":1},{"cnt":[[333,1069],[1821,1067],[1821,1119],[334,1122]],"region":{"top_left_x":333,"top_left_y":1066,"width":1488,"height":56},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9dab1cf1858a444c97771ba678914f0e","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["5f7b7331138c45b595271fa38be47b14","eddd3a27d5e645e6968f863f277c443f"],"text":"","text_display":""},{"cnt":[[338,1074],[1345,1074],[1345,1112],[338,1112]],"region":{"top_left_x":338,"top_left_y":1073,"width":1008,"height":40},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5f7b7331138c45b595271fa38be47b14","type":"table_of_contents_item","conversion_output":true,"parent_id":"9dab1cf1858a444c97771ba678914f0e","text":"2.1 RATIONALE FOR PERFORMING THE TRIAL","text_display":"\n2.1 RATIONALE FOR PERFORMING THE TRIAL","confidence":0.984375,"confidence_rate":0.9996338261982728},{"cnt":[[1768,1067],[1823,1067],[1823,1115],[1768,1115]],"region":{"top_left_x":1768,"top_left_y":1066,"width":55,"height":49},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"eddd3a27d5e645e6968f863f277c443f","type":"table_of_contents_number","conversion_output":true,"parent_id":"9dab1cf1858a444c97771ba678914f0e","text":"22","text_display":" ..... 22","confidence":1,"confidence_rate":1},{"cnt":[[334,1124],[1821,1124],[1821,1172],[334,1172]],"region":{"top_left_x":333,"top_left_y":1123,"width":1488,"height":49},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"28ace81386304e6ab262c5504f0e4498","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["a1eef06f690e44f4b8a9bc17da951596","7a11e489f7ba4bbdbff4f01334c941e7"],"text":"","text_display":""},{"cnt":[[338,1128],[866,1128],[866,1167],[338,1167]],"region":{"top_left_x":338,"top_left_y":1128,"width":528,"height":40},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a1eef06f690e44f4b8a9bc17da951596","type":"table_of_contents_item","conversion_output":true,"parent_id":"28ace81386304e6ab262c5504f0e4498","text":"2.2 TRIAL OBJECTIVES","text_display":"\n2.2 TRIAL OBJECTIVES","confidence":1,"confidence_rate":1},{"cnt":[[1768,1122],[1823,1122],[1823,1170],[1768,1170]],"region":{"top_left_x":1768,"top_left_y":1121,"width":55,"height":49},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7a11e489f7ba4bbdbff4f01334c941e7","type":"table_of_contents_number","conversion_output":true,"parent_id":"28ace81386304e6ab262c5504f0e4498","text":"23","text_display":" ..... 23","confidence":1,"confidence_rate":1},{"cnt":[[334,1176],[1821,1176],[1821,1227],[334,1227]],"region":{"top_left_x":333,"top_left_y":1176,"width":1488,"height":51},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a7c704b69ecb4885a3e122432c1ce59d","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["9e51e0887c134509bc1c766a2f67e437","d5ea22a7fa804a79bb225bad7951fe0a"],"text":"","text_display":""},{"cnt":[[338,1183],[1067,1183],[1067,1222],[338,1222]],"region":{"top_left_x":338,"top_left_y":1183,"width":729,"height":40},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9e51e0887c134509bc1c766a2f67e437","type":"table_of_contents_item","conversion_output":true,"parent_id":"a7c704b69ecb4885a3e122432c1ce59d","text":"2.3 BENEFIT - RISK ASSESSMENT","text_display":"\n2.3 BENEFIT - RISK ASSESSMENT","confidence":0.9990234375,"confidence_rate":0.9999712639526579},{"cnt":[[1768,1176],[1823,1176],[1823,1220],[1768,1220]],"region":{"top_left_x":1768,"top_left_y":1176,"width":55,"height":44},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d5ea22a7fa804a79bb225bad7951fe0a","type":"table_of_contents_number","conversion_output":true,"parent_id":"a7c704b69ecb4885a3e122432c1ce59d","text":"24","text_display":" ..... 24","confidence":1,"confidence_rate":1},{"cnt":[[242,1236],[1821,1236],[1821,1293],[242,1293]],"region":{"top_left_x":242,"top_left_y":1235,"width":1579,"height":58},"line":47,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"52fb66cc7add437aabefd9e67e48a01c","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["0a4a069349984c618c8bc42cf1762a17","4fbdac1928cb4f5a9c05f1c1648ab8a9"],"text":"","text_display":""},{"cnt":[[247,1243],[1583,1243],[1583,1286],[247,1286]],"region":{"top_left_x":246,"top_left_y":1242,"width":1338,"height":45},"line":48,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0a4a069349984c618c8bc42cf1762a17","type":"table_of_contents_item","conversion_output":true,"parent_id":"52fb66cc7add437aabefd9e67e48a01c","text":"3. DESCRIPTION OF DESIGN AND TRIAL POPULATION","text_display":"\n3. DESCRIPTION OF DESIGN AND TRIAL POPULATION","confidence":1,"confidence_rate":1},{"cnt":[[1759,1243],[1823,1243],[1823,1288],[1759,1288]],"region":{"top_left_x":1758,"top_left_y":1242,"width":65,"height":47},"line":49,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4fbdac1928cb4f5a9c05f1c1648ab8a9","type":"table_of_contents_number","conversion_output":true,"parent_id":"52fb66cc7add437aabefd9e67e48a01c","text":"25","text_display":" ..... 25","confidence":1,"confidence_rate":1},{"cnt":[[334,1302],[1821,1302],[1821,1350],[334,1350]],"region":{"top_left_x":333,"top_left_y":1302,"width":1488,"height":49},"line":50,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3cb928b6f2ba4306b7731b63328d950a","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["57eb9e95ce3247e4a0dc46db3123b967","145cc01c5d45422ea9af91f1d71f3073"],"text":"","text_display":""},{"cnt":[[338,1307],[1204,1307],[1204,1345],[338,1345]],"region":{"top_left_x":338,"top_left_y":1306,"width":866,"height":40},"line":51,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"57eb9e95ce3247e4a0dc46db3123b967","type":"table_of_contents_item","conversion_output":true,"parent_id":"3cb928b6f2ba4306b7731b63328d950a","text":"3.1 OVERALL TRIAL DESIGN AND PLAN","text_display":"\n3.1 OVERALL TRIAL DESIGN AND PLAN","confidence":1,"confidence_rate":1},{"cnt":[[1768,1304],[1823,1304],[1823,1348],[1768,1348]],"region":{"top_left_x":1768,"top_left_y":1304,"width":55,"height":44},"line":52,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"145cc01c5d45422ea9af91f1d71f3073","type":"table_of_contents_number","conversion_output":true,"parent_id":"3cb928b6f2ba4306b7731b63328d950a","text":"25","text_display":" ..... 25","confidence":1,"confidence_rate":1},{"cnt":[[457,1357],[1821,1357],[1821,1409],[457,1409]],"region":{"top_left_x":456,"top_left_y":1356,"width":1365,"height":54},"line":53,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"17998b82fde546e78e11efd91a39ba4e","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["ac08d0fc1d0b4f71a739814a0f118ed3","261a7416eed846b1bfc070f1ca38d44f"],"text":"","text_display":""},{"cnt":[[464,1361],[1240,1361],[1240,1400],[464,1400]],"region":{"top_left_x":463,"top_left_y":1361,"width":778,"height":40},"line":54,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ac08d0fc1d0b4f71a739814a0f118ed3","type":"table_of_contents_item","conversion_output":true,"parent_id":"17998b82fde546e78e11efd91a39ba4e","text":"3.1.1 Administrative structure of the trial","text_display":"\n3.1.1 Administrative structure of the trial","confidence":1,"confidence_rate":1},{"cnt":[[1768,1359],[1823,1359],[1823,1403],[1768,1403]],"region":{"top_left_x":1768,"top_left_y":1359,"width":55,"height":44},"line":55,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"261a7416eed846b1bfc070f1ca38d44f","type":"table_of_contents_number","conversion_output":true,"parent_id":"17998b82fde546e78e11efd91a39ba4e","text":"26","text_display":" ..... 26","confidence":1,"confidence_rate":1},{"cnt":[[334,1412],[1821,1412],[1821,1515],[334,1515]],"region":{"top_left_x":333,"top_left_y":1411,"width":1488,"height":104},"line":56,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6a0af005d26545faa3084b89f4c204fe","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["d3b21e0318d94e0f8fcf8a5781266dbe","274bf39795694d7485d3d12edac31683","4efcdc6a5797470d882cc989e8caee2d"],"text":"","text_display":""},{"cnt":[[338,1416],[1706,1416],[1706,1460],[338,1460]],"region":{"top_left_x":338,"top_left_y":1416,"width":1369,"height":44},"line":57,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d3b21e0318d94e0f8fcf8a5781266dbe","type":"table_of_contents_item","conversion_output":true,"parent_id":"6a0af005d26545faa3084b89f4c204fe","text":"3.2 DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF","text_display":"\n3.2 DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[452,1467],[882,1467],[882,1510],[452,1510]],"region":{"top_left_x":452,"top_left_y":1466,"width":430,"height":44},"line":58,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"274bf39795694d7485d3d12edac31683","type":"table_of_contents_item","conversion_output":true,"parent_id":"6a0af005d26545faa3084b89f4c204fe","text":"CONTROL GROUP(S)","text_display":" CONTROL GROUP(S)","confidence":1,"confidence_rate":1},{"cnt":[[1768,1467],[1823,1467],[1823,1508],[1768,1508]],"region":{"top_left_x":1768,"top_left_y":1466,"width":55,"height":42},"line":59,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4efcdc6a5797470d882cc989e8caee2d","type":"table_of_contents_number","conversion_output":true,"parent_id":"6a0af005d26545faa3084b89f4c204fe","text":"27","text_display":" ..... 27","confidence":1,"confidence_rate":1},{"cnt":[[334,1512],[1821,1512],[1821,1565],[334,1565]],"region":{"top_left_x":333,"top_left_y":1512,"width":1488,"height":53},"line":60,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1c164fc5188f4324a4bcd1932628c221","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["5720e7085db4498591482c2c246654d5","63ac1b5cb07744cda7e0c01d8596e484"],"text":"","text_display":""},{"cnt":[[338,1517],[1204,1517],[1204,1560],[338,1560]],"region":{"top_left_x":338,"top_left_y":1516,"width":866,"height":45},"line":61,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5720e7085db4498591482c2c246654d5","type":"table_of_contents_item","conversion_output":true,"parent_id":"1c164fc5188f4324a4bcd1932628c221","text":"3.3 SELECTION OF TRIAL POPULATION","text_display":"\n3.3 SELECTION OF TRIAL POPULATION","confidence":1,"confidence_rate":1},{"cnt":[[1768,1521],[1823,1521],[1823,1563],[1768,1563]],"region":{"top_left_x":1768,"top_left_y":1521,"width":55,"height":42},"line":62,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"63ac1b5cb07744cda7e0c01d8596e484","type":"table_of_contents_number","conversion_output":true,"parent_id":"1c164fc5188f4324a4bcd1932628c221","text":"28","text_display":" ..... 28","confidence":1,"confidence_rate":1},{"cnt":[[459,1567],[1821,1567],[1821,1629],[459,1629]],"region":{"top_left_x":459,"top_left_y":1567,"width":1362,"height":62},"line":63,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8a80822deb734cb8921933da790df0cd","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["051b1de50d404b52888793b930ac995d","1c6e90ccee584aca8a49ba5b965b1ff3"],"text":"","text_display":""},{"cnt":[[464,1574],[1144,1574],[1144,1622],[464,1622]],"region":{"top_left_x":463,"top_left_y":1573,"width":682,"height":49},"line":64,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"051b1de50d404b52888793b930ac995d","type":"table_of_contents_item","conversion_output":true,"parent_id":"8a80822deb734cb8921933da790df0cd","text":"3.3.1 Main diagnosis for study entry","text_display":"\n3.3.1 Main diagnosis for study entry","confidence":1,"confidence_rate":1},{"cnt":[[1768,1576],[1823,1576],[1823,1617],[1768,1617]],"region":{"top_left_x":1768,"top_left_y":1576,"width":55,"height":42},"line":65,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1c6e90ccee584aca8a49ba5b965b1ff3","type":"table_of_contents_number","conversion_output":true,"parent_id":"8a80822deb734cb8921933da790df0cd","text":"29","text_display":" ..... 29","confidence":1,"confidence_rate":1},{"cnt":[[459,1622],[1821,1622],[1821,1670],[459,1670]],"region":{"top_left_x":459,"top_left_y":1621,"width":1362,"height":49},"line":66,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9569220fae604b6185e79358b55b9247","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["8342f00218b24c0688aa170f478bfe39","f641884874b14d2686e32c608e84d67b"],"text":"","text_display":""},{"cnt":[[466,1626],[902,1626],[902,1665],[466,1665]],"region":{"top_left_x":466,"top_left_y":1626,"width":437,"height":40},"line":67,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8342f00218b24c0688aa170f478bfe39","type":"table_of_contents_item","conversion_output":true,"parent_id":"9569220fae604b6185e79358b55b9247","text":"3.3.2 Inclusion criteria","text_display":"\n3.3.2 Inclusion criteria","confidence":1,"confidence_rate":1},{"cnt":[[1768,1626],[1823,1626],[1823,1672],[1768,1672]],"region":{"top_left_x":1768,"top_left_y":1626,"width":55,"height":47},"line":68,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f641884874b14d2686e32c608e84d67b","type":"table_of_contents_number","conversion_output":true,"parent_id":"9569220fae604b6185e79358b55b9247","text":"29","text_display":" ..... 29","confidence":1,"confidence_rate":1},{"cnt":[[461,1672],[1818,1672],[1818,1725],[461,1725]],"region":{"top_left_x":461,"top_left_y":1672,"width":1358,"height":53},"line":69,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0979514932814b5c910cbb0b9a3035ff","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["9965dcc2c37b412da2d70514f673c638","88ade6e469864fb8a3d4d8182c348cc2"],"text":"","text_display":""},{"cnt":[[466,1677],[911,1677],[911,1720],[466,1720]],"region":{"top_left_x":466,"top_left_y":1676,"width":446,"height":45},"line":70,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9965dcc2c37b412da2d70514f673c638","type":"table_of_contents_item","conversion_output":true,"parent_id":"0979514932814b5c910cbb0b9a3035ff","text":"3.3.3 Exclusion criteria","text_display":"\n3.3.3 Exclusion criteria","confidence":1,"confidence_rate":1},{"cnt":[[1768,1672],[1823,1672],[1823,1718],[1768,1718]],"region":{"top_left_x":1768,"top_left_y":1672,"width":55,"height":46},"line":71,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"88ade6e469864fb8a3d4d8182c348cc2","type":"table_of_contents_number","conversion_output":true,"parent_id":"0979514932814b5c910cbb0b9a3035ff","text":"31","text_display":" ..... 31","confidence":1,"confidence_rate":1},{"cnt":[[461,1722],[1821,1722],[1821,1780],[461,1780]],"region":{"top_left_x":461,"top_left_y":1722,"width":1360,"height":58},"line":72,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f8794e7d50e4431598a25dea56447991","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["b41a752a0644483c8b0368b618f748ed","0c4b528e142c4af497b843e9256ba39a"],"text":"","text_display":""},{"cnt":[[466,1729],[1469,1729],[1469,1775],[466,1775]],"region":{"top_left_x":466,"top_left_y":1729,"width":1003,"height":46},"line":73,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b41a752a0644483c8b0368b618f748ed","type":"table_of_contents_item","conversion_output":true,"parent_id":"f8794e7d50e4431598a25dea56447991","text":"3.3.4 Removal of patients from therapy or assessments","text_display":"\n3.3.4 Removal of patients from therapy or assessments","confidence":1,"confidence_rate":1},{"cnt":[[1768,1727],[1823,1727],[1823,1768],[1768,1768]],"region":{"top_left_x":1768,"top_left_y":1726,"width":55,"height":43},"line":74,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0c4b528e142c4af497b843e9256ba39a","type":"table_of_contents_number","conversion_output":true,"parent_id":"f8794e7d50e4431598a25dea56447991","text":"32","text_display":" ..... 32","confidence":1,"confidence_rate":1},{"cnt":[[589,1775],[1823,1775],[1823,1830],[589,1830]],"region":{"top_left_x":589,"top_left_y":1774,"width":1234,"height":56},"line":75,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5d8a7ee17db243e7a067509cd32b1a7a","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["67d2fce6b8154911a74fdbc526247a99","0d7d2a69cae74d0bb33e4d377006200c"],"text":"","text_display":""},{"cnt":[[596,1780],[1268,1780],[1268,1825],[596,1825]],"region":{"top_left_x":596,"top_left_y":1779,"width":672,"height":47},"line":76,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"67d2fce6b8154911a74fdbc526247a99","type":"table_of_contents_item","conversion_output":true,"parent_id":"5d8a7ee17db243e7a067509cd32b1a7a","text":"3.3.4.1 Removal of individual patients","text_display":"\n3.3.4.1 Removal of individual patients","confidence":1,"confidence_rate":1},{"cnt":[[1768,1782],[1823,1782],[1823,1818],[1768,1818]],"region":{"top_left_x":1768,"top_left_y":1781,"width":55,"height":38},"line":77,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0d7d2a69cae74d0bb33e4d377006200c","type":"table_of_contents_number","conversion_output":true,"parent_id":"5d8a7ee17db243e7a067509cd32b1a7a","text":"32","text_display":" ..... 32","confidence":0.99951171875,"confidence_rate":0.9997558295653994},{"cnt":[[592,1828],[1821,1828],[1821,1885],[592,1885]],"region":{"top_left_x":591,"top_left_y":1827,"width":1230,"height":58},"line":78,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8380205949bd4b90ab4f9dca96136829","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["6d1d4d865fb943f4b775db54692946ae","95d297d85b86418682d42ca1ea3006b6"],"text":"","text_display":""},{"cnt":[[599,1832],[1455,1832],[1455,1878],[599,1878]],"region":{"top_left_x":598,"top_left_y":1832,"width":858,"height":46},"line":79,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6d1d4d865fb943f4b775db54692946ae","type":"table_of_contents_item","conversion_output":true,"parent_id":"8380205949bd4b90ab4f9dca96136829","text":"3.3.4.2 Discontinuation of the trial by the sponsor","text_display":"\n3.3.4.2 Discontinuation of the trial by the sponsor","confidence":1,"confidence_rate":1},{"cnt":[[1768,1832],[1823,1832],[1823,1873],[1768,1873]],"region":{"top_left_x":1768,"top_left_y":1832,"width":55,"height":42},"line":80,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"95d297d85b86418682d42ca1ea3006b6","type":"table_of_contents_number","conversion_output":true,"parent_id":"8380205949bd4b90ab4f9dca96136829","text":"34","text_display":" ..... 34","confidence":0.99951171875,"confidence_rate":0.9997558295653994},{"cnt":[[240,1887],[1821,1887],[1821,1942],[240,1942]],"region":{"top_left_x":239,"top_left_y":1886,"width":1582,"height":56},"line":81,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"af8613bb80cd4510a7c4de4a873e7d99","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["cba0d314b8034cae8430016a52926b82","63ca564ea8ba4fe58e6fa5af8aca0f79"],"text":"","text_display":""},{"cnt":[[247,1891],[688,1891],[688,1935],[247,1935]],"region":{"top_left_x":246,"top_left_y":1891,"width":442,"height":44},"line":82,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cba0d314b8034cae8430016a52926b82","type":"table_of_contents_item","conversion_output":true,"parent_id":"af8613bb80cd4510a7c4de4a873e7d99","text":"4. TREATMENTS","text_display":"\n4. TREATMENTS","confidence":1,"confidence_rate":1},{"cnt":[[1761,1891],[1823,1891],[1823,1937],[1761,1937]],"region":{"top_left_x":1761,"top_left_y":1891,"width":62,"height":47},"line":83,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"63ca564ea8ba4fe58e6fa5af8aca0f79","type":"table_of_contents_number","conversion_output":true,"parent_id":"af8613bb80cd4510a7c4de4a873e7d99","text":"35","text_display":" ..... 35","confidence":0.9990234375,"confidence_rate":0.9995115994824673},{"cnt":[[334,1951],[1821,1951],[1821,2001],[334,2001]],"region":{"top_left_x":333,"top_left_y":1950,"width":1488,"height":52},"line":84,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4ba000d1dbbe4a9da0ad37e5770184c5","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["01bcb97330b64dbc821a5863ebf36d04","b4147551949447899c16b717dafd1a33"],"text":"","text_display":""},{"cnt":[[338,1955],[1227,1955],[1227,1994],[338,1994]],"region":{"top_left_x":338,"top_left_y":1955,"width":889,"height":40},"line":85,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"01bcb97330b64dbc821a5863ebf36d04","type":"table_of_contents_item","conversion_output":true,"parent_id":"4ba000d1dbbe4a9da0ad37e5770184c5","text":"4.1 TREATMENTS TO BE ADMINISTERED","text_display":"\n4.1 TREATMENTS TO BE ADMINISTERED","confidence":1,"confidence_rate":1},{"cnt":[[1768,1955],[1823,1955],[1823,2003],[1768,2003]],"region":{"top_left_x":1768,"top_left_y":1955,"width":55,"height":49},"line":86,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b4147551949447899c16b717dafd1a33","type":"table_of_contents_number","conversion_output":true,"parent_id":"4ba000d1dbbe4a9da0ad37e5770184c5","text":"35","text_display":" ..... 35","confidence":1,"confidence_rate":1},{"cnt":[[459,2006],[1821,2006],[1821,2111],[459,2111]],"region":{"top_left_x":459,"top_left_y":2005,"width":1362,"height":106},"line":87,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7d28363b46f84abd8b0b3d9647a41409","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["7bf10dcc92764e45920b3f7314bcc122","edbd98a09fd04f0981204c678506aa4c","a01e1a413da040c5903e2b35723c0f42"],"text":"","text_display":""},{"cnt":[[461,2010],[1556,2010],[1556,2058],[461,2058]],"region":{"top_left_x":461,"top_left_y":2010,"width":1095,"height":49},"line":88,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7bf10dcc92764e45920b3f7314bcc122","type":"table_of_contents_item","conversion_output":true,"parent_id":"7d28363b46f84abd8b0b3d9647a41409","text":"4.1.1 Identity of BI investigational product and comparator","text_display":"\n4.1.1 Identity of BI investigational product and comparator","confidence":1,"confidence_rate":1},{"cnt":[[589,2061],[779,2061],[779,2104],[589,2104]],"region":{"top_left_x":589,"top_left_y":2060,"width":190,"height":44},"line":89,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"edbd98a09fd04f0981204c678506aa4c","type":"table_of_contents_item","conversion_output":true,"parent_id":"7d28363b46f84abd8b0b3d9647a41409","text":"product(s)","text_display":" product(s)","confidence":1,"confidence_rate":1},{"cnt":[[1768,2058],[1823,2058],[1823,2097],[1768,2097]],"region":{"top_left_x":1768,"top_left_y":2058,"width":55,"height":40},"line":90,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a01e1a413da040c5903e2b35723c0f42","type":"table_of_contents_number","conversion_output":true,"parent_id":"7d28363b46f84abd8b0b3d9647a41409","text":"35","text_display":" ..... 35","confidence":1,"confidence_rate":1},{"cnt":[[459,2106],[1821,2106],[1821,2163],[459,2163]],"region":{"top_left_x":459,"top_left_y":2106,"width":1362,"height":58},"line":91,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"697401652c424d88bbc3a70517465fc5","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["f835e47935254a7a9d15da78b6fb6b62","6c8a7eed543f4122b0cd88cd0dd18fbc"],"text":"","text_display":""},{"cnt":[[464,2111],[1471,2111],[1471,2159],[464,2159]],"region":{"top_left_x":463,"top_left_y":2110,"width":1009,"height":49},"line":92,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f835e47935254a7a9d15da78b6fb6b62","type":"table_of_contents_item","conversion_output":true,"parent_id":"697401652c424d88bbc3a70517465fc5","text":"4.1.2 Method of assigning patients to treatment groups","text_display":"\n4.1.2 Method of assigning patients to treatment groups","confidence":1,"confidence_rate":1},{"cnt":[[1768,2111],[1823,2111],[1823,2152],[1768,2152]],"region":{"top_left_x":1768,"top_left_y":2110,"width":55,"height":42},"line":93,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6c8a7eed543f4122b0cd88cd0dd18fbc","type":"table_of_contents_number","conversion_output":true,"parent_id":"697401652c424d88bbc3a70517465fc5","text":"35","text_display":" ..... 35","confidence":1,"confidence_rate":1},{"cnt":[[459,2156],[1821,2156],[1821,2207],[459,2207]],"region":{"top_left_x":459,"top_left_y":2156,"width":1362,"height":51},"line":94,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c215c8b15ddd4284a5bcbe297ebb558c","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["1c14aa49980040d496672d8b902f511c","d1151a14e8e64a4ca144b484ff5526ca"],"text":"","text_display":""},{"cnt":[[464,2161],[1103,2161],[1103,2200],[464,2200]],"region":{"top_left_x":463,"top_left_y":2161,"width":641,"height":39},"line":95,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1c14aa49980040d496672d8b902f511c","type":"table_of_contents_item","conversion_output":true,"parent_id":"c215c8b15ddd4284a5bcbe297ebb558c","text":"4.1.3 Selection of doses in the trial","text_display":"\n4.1.3 Selection of doses in the trial","confidence":1,"confidence_rate":1},{"cnt":[[1768,2161],[1823,2161],[1823,2204],[1768,2204]],"region":{"top_left_x":1768,"top_left_y":2161,"width":55,"height":44},"line":96,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d1151a14e8e64a4ca144b484ff5526ca","type":"table_of_contents_number","conversion_output":true,"parent_id":"c215c8b15ddd4284a5bcbe297ebb558c","text":"35","text_display":" ..... 35","confidence":1,"confidence_rate":1},{"cnt":[[459,2207],[1821,2207],[1821,2264],[459,2264]],"region":{"top_left_x":459,"top_left_y":2206,"width":1362,"height":58},"line":97,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"efe71d7276ad43a7b3b1e97e26fd3f5e","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["18be528a5e3f40f8b15cb6c3a828c4fd","6b55b28ff8ae434ab571b092391a88cf"],"text":"","text_display":""},{"cnt":[[464,2211],[1693,2211],[1693,2259],[464,2259]],"region":{"top_left_x":463,"top_left_y":2211,"width":1230,"height":49},"line":98,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"18be528a5e3f40f8b15cb6c3a828c4fd","type":"table_of_contents_item","conversion_output":true,"parent_id":"efe71d7276ad43a7b3b1e97e26fd3f5e","text":"4.1.4 Drug assignment and administration of doses for each patient","text_display":"\n4.1.4 Drug assignment and administration of doses for each patient","confidence":0.9960966110229492,"confidence_rate":0.999944916628657},{"cnt":[[1768,2216],[1823,2216],[1823,2259],[1768,2259]],"region":{"top_left_x":1768,"top_left_y":2215,"width":55,"height":45},"line":99,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6b55b28ff8ae434ab571b092391a88cf","type":"table_of_contents_number","conversion_output":true,"parent_id":"efe71d7276ad43a7b3b1e97e26fd3f5e","text":"35","text_display":" ..... 35","confidence":1,"confidence_rate":1},{"cnt":[[459,2262],[1821,2262],[1821,2316],[459,2316]],"region":{"top_left_x":459,"top_left_y":2261,"width":1362,"height":56},"line":100,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"80c5465edebc4adc89e1434c44421372","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["2b354744fd4749d382495225733474e3","019b53fe7981408c9d40a3a9fb2f0b1c"],"text":"","text_display":""},{"cnt":[[466,2266],[1307,2266],[1307,2312],[466,2312]],"region":{"top_left_x":466,"top_left_y":2266,"width":841,"height":46},"line":101,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2b354744fd4749d382495225733474e3","type":"table_of_contents_item","conversion_output":true,"parent_id":"80c5465edebc4adc89e1434c44421372","text":"4.1.5 Blinding and procedures for unblinding","text_display":"\n4.1.5 Blinding and procedures for unblinding","confidence":1,"confidence_rate":1},{"cnt":[[1768,2266],[1823,2266],[1823,2314],[1768,2314]],"region":{"top_left_x":1768,"top_left_y":2266,"width":55,"height":49},"line":102,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"019b53fe7981408c9d40a3a9fb2f0b1c","type":"table_of_contents_number","conversion_output":true,"parent_id":"80c5465edebc4adc89e1434c44421372","text":"36","text_display":" ..... 36","confidence":0.99951171875,"confidence_rate":0.9997558295653994},{"cnt":[[589,2312],[1823,2312],[1823,2364],[589,2364]],"region":{"top_left_x":589,"top_left_y":2311,"width":1234,"height":54},"line":103,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8b20913ab92a49209f6388e4bb6bffdb","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["16e869759ee149ba90e3be9e0fe1bab1","02022186d3fe4f4089654116d6ce6607"],"text":"","text_display":""},{"cnt":[[594,2316],[900,2316],[900,2360],[594,2360]],"region":{"top_left_x":593,"top_left_y":2316,"width":308,"height":44},"line":104,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"16e869759ee149ba90e3be9e0fe1bab1","type":"table_of_contents_item","conversion_output":true,"parent_id":"8b20913ab92a49209f6388e4bb6bffdb","text":"4.1.5.1 Blinding","text_display":"\n4.1.5.1 Blinding","confidence":0.99755859375,"confidence_rate":0.9998836071864655},{"cnt":[[1768,2316],[1823,2316],[1823,2355],[1768,2355]],"region":{"top_left_x":1768,"top_left_y":2316,"width":55,"height":40},"line":105,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"02022186d3fe4f4089654116d6ce6607","type":"table_of_contents_number","conversion_output":true,"parent_id":"8b20913ab92a49209f6388e4bb6bffdb","text":"36","text_display":" ..... 36","confidence":1,"confidence_rate":1},{"cnt":[[589,2362],[1821,2362],[1821,2417],[589,2417]],"region":{"top_left_x":589,"top_left_y":2362,"width":1232,"height":55},"line":106,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"91c060beabe14571ad528790136f5123","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["460a96ea2144462cb82918861984be7a","1b038c9cb6ee4c3d9a24efe800778ce8"],"text":"","text_display":""},{"cnt":[[594,2367],[1382,2367],[1382,2415],[594,2415]],"region":{"top_left_x":593,"top_left_y":2366,"width":790,"height":49},"line":107,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"460a96ea2144462cb82918861984be7a","type":"table_of_contents_item","conversion_output":true,"parent_id":"91c060beabe14571ad528790136f5123","text":"4.1.5.2 Procedures for emergency unblinding","text_display":"\n4.1.5.2 Procedures for emergency unblinding","confidence":0.99951171875,"confidence_rate":0.999989825041388},{"cnt":[[1768,2367],[1823,2367],[1823,2408],[1768,2408]],"region":{"top_left_x":1768,"top_left_y":2366,"width":55,"height":42},"line":108,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1b038c9cb6ee4c3d9a24efe800778ce8","type":"table_of_contents_number","conversion_output":true,"parent_id":"91c060beabe14571ad528790136f5123","text":"37","text_display":" ..... 37","confidence":0.9990234375,"confidence_rate":0.9995115994824673},{"cnt":[[459,2415],[1821,2415],[1821,2469],[459,2469]],"region":{"top_left_x":459,"top_left_y":2414,"width":1362,"height":56},"line":109,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6820c075e83945c49b90b2b79eea2b96","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["2cf21252f49e4ffd992ae25c1a40fa17","2613eb99364743968cd0b8cd0eb4edf6"],"text":"","text_display":""},{"cnt":[[464,2421],[1222,2421],[1222,2465],[464,2465]],"region":{"top_left_x":463,"top_left_y":2421,"width":760,"height":44},"line":110,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2cf21252f49e4ffd992ae25c1a40fa17","type":"table_of_contents_item","conversion_output":true,"parent_id":"6820c075e83945c49b90b2b79eea2b96","text":"4.1.6 Packaging, labelling, and re-supply","text_display":"\n4.1.6 Packaging, labelling, and re-supply","confidence":1,"confidence_rate":1},{"cnt":[[1768,2421],[1823,2421],[1823,2463],[1768,2463]],"region":{"top_left_x":1768,"top_left_y":2421,"width":55,"height":42},"line":111,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2613eb99364743968cd0b8cd0eb4edf6","type":"table_of_contents_number","conversion_output":true,"parent_id":"6820c075e83945c49b90b2b79eea2b96","text":"37","text_display":" ..... 37","confidence":1,"confidence_rate":1},{"cnt":[[461,2467],[1821,2467],[1821,2520],[461,2520]],"region":{"top_left_x":461,"top_left_y":2467,"width":1360,"height":53},"line":112,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5362803899094eab9cdc1c1bbb08fb18","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["6b99106dae2a43f8b12a6ba69f7838f6","c9136beb0d8d43f2aa28dde41ed8744c"],"text":"","text_display":""},{"cnt":[[466,2472],[925,2472],[925,2515],[466,2515]],"region":{"top_left_x":466,"top_left_y":2471,"width":460,"height":45},"line":113,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6b99106dae2a43f8b12a6ba69f7838f6","type":"table_of_contents_item","conversion_output":true,"parent_id":"5362803899094eab9cdc1c1bbb08fb18","text":"4.1.7 Storage conditions","text_display":"\n4.1.7 Storage conditions","confidence":0.99951171875,"confidence_rate":0.999983158745329},{"cnt":[[1768,2472],[1823,2472],[1823,2517],[1768,2517]],"region":{"top_left_x":1768,"top_left_y":2471,"width":55,"height":47},"line":114,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c9136beb0d8d43f2aa28dde41ed8744c","type":"table_of_contents_number","conversion_output":true,"parent_id":"5362803899094eab9cdc1c1bbb08fb18","text":"37","text_display":" ..... 37","confidence":1,"confidence_rate":1},{"cnt":[[461,2517],[1821,2517],[1821,2572],[461,2572]],"region":{"top_left_x":461,"top_left_y":2517,"width":1360,"height":56},"line":115,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e6c77465609b496d8f3eda4acece7af5","type":"table_of_contents_row","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["d770ec67889b49f382dad05c258b2799","d1f12ef2f0114641b45da579a556e241"],"text":"","text_display":""},{"cnt":[[466,2522],[953,2522],[953,2568],[466,2568]],"region":{"top_left_x":466,"top_left_y":2521,"width":487,"height":47},"line":116,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d770ec67889b49f382dad05c258b2799","type":"table_of_contents_item","conversion_output":true,"parent_id":"e6c77465609b496d8f3eda4acece7af5","text":"4.1.8 Drug accountability","text_display":"\n4.1.8 Drug accountability","confidence":1,"confidence_rate":1},{"cnt":[[1768,2522],[1823,2522],[1823,2572],[1768,2572]],"region":{"top_left_x":1768,"top_left_y":2521,"width":55,"height":52},"line":117,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d1f12ef2f0114641b45da579a556e241","type":"table_of_contents_number","conversion_output":true,"parent_id":"e6c77465609b496d8f3eda4acece7af5","text":"38","text_display":" ..... 38","confidence":1,"confidence_rate":1},{"cnt":[[288,2620],[1805,2620],[1805,2670],[288,2670]],"region":{"top_left_x":287,"top_left_y":2620,"width":1518,"height":51},"line":118,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ef9f8e5b69314fb5a429a96fbdddf6ec","type":"footnote","conversion_output":false,"parent_id":"d9322423409245b89412d63f0f1ad739","children_ids":["53a9beb180ab4822872a9b6650cbde3c"],"text":"","text_display":""},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":119,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"53a9beb180ab4822872a9b6650cbde3c","type":"text","conversion_output":true,"parent_id":"ef9f8e5b69314fb5a429a96fbdddf6ec","text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n\n\\footnotetext{\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.\n}","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":120,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0397b908295b457bb076769c27cc5c56","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[297,2668],[1768,2668],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1473,"height":35},"line":121,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4dd9b2d9474d4017aa637f1483b0df94","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-012","page":12,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fba54de10704afeb387484e313ba310","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"09990401ac504904a0fd1834aa405ed5","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"832b313ad78043a4a05579c0acf40406","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01276718854b487cac4c10b5c2baba9f","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8bbfe73494ab46abb1facccc2e09e75e","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb5675cb933644dfbf3a7920dbe64661","type":"page_info","conversion_output":false,"text":"Page 12 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[231,324],[1832,324],[1832,2554],[231,2554]],"region":{"top_left_x":230,"top_left_y":324,"width":1603,"height":2230},"line":7,"column":0,"font_size":29,"is_printed":true,"is_handwritten":false,"id":"b77841c60d414d13863623cdf6c15e77","type":"table_of_contents_container","conversion_output":false,"children_ids":["a36e8d6167bd480e8a560ed9d9231a62","5808f1611e6243c9a454cc7c59a25bca","b332178ef168492aa81bf2af2f1d2f33","6c250bc957934003841ec850f739a1a6","642543e9aafc4dc5b21efb8d93d0d0e7","3198c2ee1cf74351872f98389e8d86d0","99760565d3e94035b2028bb1dcbdc30d","f6aa0d259bd04eeabb671ccdc61d72ac","1faaaf73ee6349a3a206f3caa90788a7","a0bd14b5ae2e4acba6e3829fcfee69f2","f747c0acf55244f2b679d4d14c3d4427","15c187b4270c4c7ea79d06be0a76a46e","6761aeba7c044e0bac1117fc2a77628c","cbda6a90fcb74a3e9816f9ecf745ac6f","ee8eb142002941a2b0531cbd9c68d59d","d47522e1cc8143ccad14454447e26dc9","d289412745554b21b7535d56598e9644","0ef91dfb780a4a95bf956039220f0a1a","23be4d2b5de445418c3fce34314db73f","6b78e8f0b20a486392ba4f61ab4c696c","45431d15d96e4bfa9555bdeb447a42ff","c9ccde9219c54e1eba4b86355d50fff5","4a1afcbcf8d84310ab091276834fa7e0","6403362f8adf49e99a62fcbf940f042f","f10ebc30fa2b48f1a2b5db78f8c2120f","cfc0c438a2294911b1b4e9bc861e76d3","d917320788ee42d3b2aa1fb504a471b7","e37855ebcb7b4ac0843a3d8ed29057e0","f4233189714047cf80629210802574dc","2e79ede41b55491f8325e85bede96a0f","4fa9431c5b9b41e78f045bc6b2063aa2","b532a4c0f0004d99a4ad18f2c2648863","3189205f3ea04865a623a3f8fd3dfec2","ded74589dcf04f89ac9b1dcfd52a8ea0","7843a03e231d43d9850b5c24ce7da37f","b3c93e34e2a042cebd7b82f15faff226"],"text":"","text_display":""},{"cnt":[[334,334],[1823,334],[1823,434],[334,434]],"region":{"top_left_x":333,"top_left_y":333,"width":1490,"height":102},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a36e8d6167bd480e8a560ed9d9231a62","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["9a46098aa9524040a8733946a297286b","b914fb07fc7a49dcb59e6aed58535f3e","db019196156548868c758f9d7b8055be"],"text":"","text_display":""},{"cnt":[[338,338],[1629,338],[1629,386],[338,386]],"region":{"top_left_x":338,"top_left_y":338,"width":1291,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a46098aa9524040a8733946a297286b","type":"table_of_contents_item","conversion_output":true,"parent_id":"a36e8d6167bd480e8a560ed9d9231a62","text":"4.2 CONCOMITANT THERAPY, RESTRICTIONS, AND RESCUE","text_display":"\n4.2 CONCOMITANT THERAPY, RESTRICTIONS, AND RESCUE","confidence":0.99560546875,"confidence_rate":0.9999184437780202},{"cnt":[[452,388],[729,388],[729,429],[452,429]],"region":{"top_left_x":452,"top_left_y":388,"width":277,"height":42},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b914fb07fc7a49dcb59e6aed58535f3e","type":"table_of_contents_item","conversion_output":true,"parent_id":"a36e8d6167bd480e8a560ed9d9231a62","text":"TREATMENT","text_display":" TREATMENT","confidence":1,"confidence_rate":1},{"cnt":[[1768,386],[1823,386],[1823,429],[1768,429]],"region":{"top_left_x":1768,"top_left_y":386,"width":55,"height":44},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db019196156548868c758f9d7b8055be","type":"table_of_contents_number","conversion_output":true,"parent_id":"a36e8d6167bd480e8a560ed9d9231a62","text":"39","text_display":" ..... 39","confidence":1,"confidence_rate":1},{"cnt":[[457,439],[1821,439],[1821,544],[457,544]],"region":{"top_left_x":456,"top_left_y":438,"width":1365,"height":106},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5808f1611e6243c9a454cc7c59a25bca","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["2b44881d7e3342628adcd36550ddc177","5ecb4b481789442cb43c55fb657c1190","7ebef9e7ee604f08b16852ac35f541ad"],"text":"","text_display":""},{"cnt":[[464,443],[1629,443],[1629,491],[464,491]],"region":{"top_left_x":463,"top_left_y":443,"width":1166,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b44881d7e3342628adcd36550ddc177","type":"table_of_contents_item","conversion_output":true,"parent_id":"5808f1611e6243c9a454cc7c59a25bca","text":"4.2.1 Glycaemic control, emergency procedures, and additional","text_display":"\n4.2.1 Glycaemic control, emergency procedures, and additional","confidence":1,"confidence_rate":1},{"cnt":[[589,493],[816,493],[816,539],[589,539]],"region":{"top_left_x":589,"top_left_y":493,"width":227,"height":47},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ecb4b481789442cb43c55fb657c1190","type":"table_of_contents_item","conversion_output":true,"parent_id":"5808f1611e6243c9a454cc7c59a25bca","text":"treatment(s)","text_display":" treatment(s)","confidence":1,"confidence_rate":1},{"cnt":[[1768,493],[1823,493],[1823,535],[1768,535]],"region":{"top_left_x":1768,"top_left_y":493,"width":55,"height":42},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ebef9e7ee604f08b16852ac35f541ad","type":"table_of_contents_number","conversion_output":true,"parent_id":"5808f1611e6243c9a454cc7c59a25bca","text":"39","text_display":" ..... 39","confidence":0.99951171875,"confidence_rate":0.9997558295653994},{"cnt":[[459,539],[1821,539],[1821,592],[459,592]],"region":{"top_left_x":459,"top_left_y":539,"width":1362,"height":53},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b332178ef168492aa81bf2af2f1d2f33","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["c87eb94157fc44ef836c1bb9810631f1","dae203e38d6d4534947503f3a8234b18"],"text":"","text_display":""},{"cnt":[[464,544],[811,544],[811,587],[464,587]],"region":{"top_left_x":463,"top_left_y":543,"width":348,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c87eb94157fc44ef836c1bb9810631f1","type":"table_of_contents_item","conversion_output":true,"parent_id":"b332178ef168492aa81bf2af2f1d2f33","text":"4.2.2 Restrictions","text_display":"\n4.2.2 Restrictions","confidence":1,"confidence_rate":1},{"cnt":[[1768,535],[1823,535],[1823,585],[1768,585]],"region":{"top_left_x":1768,"top_left_y":534,"width":55,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dae203e38d6d4534947503f3a8234b18","type":"table_of_contents_number","conversion_output":true,"parent_id":"b332178ef168492aa81bf2af2f1d2f33","text":"40","text_display":" ..... 40","confidence":1,"confidence_rate":1},{"cnt":[[589,589],[1823,589],[1823,646],[589,646]],"region":{"top_left_x":589,"top_left_y":589,"width":1234,"height":58},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c250bc957934003841ec850f739a1a6","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["3f52f745302c4088b77920189ed54f68","bfd29188147c4fbba43a4649a83b45d5"],"text":"","text_display":""},{"cnt":[[594,594],[1510,594],[1510,642],[594,642]],"region":{"top_left_x":593,"top_left_y":593,"width":917,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f52f745302c4088b77920189ed54f68","type":"table_of_contents_item","conversion_output":true,"parent_id":"6c250bc957934003841ec850f739a1a6","text":"4.2.2.1 Restrictions regarding concomitant treatment","text_display":"\n4.2.2.1 Restrictions regarding concomitant treatment","confidence":1,"confidence_rate":1},{"cnt":[[1768,587],[1823,587],[1823,635],[1768,635]],"region":{"top_left_x":1768,"top_left_y":587,"width":55,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bfd29188147c4fbba43a4649a83b45d5","type":"table_of_contents_number","conversion_output":true,"parent_id":"6c250bc957934003841ec850f739a1a6","text":"40","text_display":" ..... 40","confidence":1,"confidence_rate":1},{"cnt":[[334,644],[1823,644],[1823,697],[334,697]],"region":{"top_left_x":333,"top_left_y":644,"width":1490,"height":53},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"642543e9aafc4dc5b21efb8d93d0d0e7","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["b338777f1b7c45648b484eeb95020f23","34972fb95d8146fa8330edfe795656a3"],"text":"","text_display":""},{"cnt":[[338,649],[1030,649],[1030,690],[338,690]],"region":{"top_left_x":338,"top_left_y":648,"width":693,"height":42},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b338777f1b7c45648b484eeb95020f23","type":"table_of_contents_item","conversion_output":true,"parent_id":"642543e9aafc4dc5b21efb8d93d0d0e7","text":"4.3 TREATMENT COMPLIANCE","text_display":"\n4.3 TREATMENT COMPLIANCE","confidence":1,"confidence_rate":1},{"cnt":[[1768,644],[1823,644],[1823,690],[1768,690]],"region":{"top_left_x":1768,"top_left_y":644,"width":55,"height":46},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34972fb95d8146fa8330edfe795656a3","type":"table_of_contents_number","conversion_output":true,"parent_id":"642543e9aafc4dc5b21efb8d93d0d0e7","text":"40","text_display":" ..... 40","confidence":1,"confidence_rate":1},{"cnt":[[240,704],[1821,704],[1821,761],[240,761]],"region":{"top_left_x":239,"top_left_y":703,"width":1582,"height":58},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3198c2ee1cf74351872f98389e8d86d0","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["81e161438a894109a2741c4edaf4c2c8","c9fde08502f54b9db606a26efd0aeff6"],"text":"","text_display":""},{"cnt":[[244,708],[1254,708],[1254,756],[244,756]],"region":{"top_left_x":244,"top_left_y":708,"width":1011,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81e161438a894109a2741c4edaf4c2c8","type":"table_of_contents_item","conversion_output":true,"parent_id":"3198c2ee1cf74351872f98389e8d86d0","text":"5. VARIABLES AND THEIR ASSESSMENT","text_display":"\n5. VARIABLES AND THEIR ASSESSMENT","confidence":1,"confidence_rate":1},{"cnt":[[1759,713],[1816,713],[1816,754],[1759,754]],"region":{"top_left_x":1758,"top_left_y":712,"width":59,"height":42},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9fde08502f54b9db606a26efd0aeff6","type":"table_of_contents_number","conversion_output":true,"parent_id":"3198c2ee1cf74351872f98389e8d86d0","text":"41","text_display":" ..... 41","confidence":1,"confidence_rate":1},{"cnt":[[334,768],[1818,768],[1818,820],[334,820]],"region":{"top_left_x":333,"top_left_y":767,"width":1486,"height":54},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99760565d3e94035b2028bb1dcbdc30d","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["ca84273e70f84c0e82838ae7806f519a","d82bfd84e765479eb93885c064ee539d"],"text":"","text_display":""},{"cnt":[[338,772],[678,772],[678,816],[338,816]],"region":{"top_left_x":338,"top_left_y":772,"width":341,"height":44},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca84273e70f84c0e82838ae7806f519a","type":"table_of_contents_item","conversion_output":true,"parent_id":"99760565d3e94035b2028bb1dcbdc30d","text":"5.1 EFFICACY","text_display":"\n5.1 EFFICACY","confidence":0.9814453125,"confidence_rate":0.9988989016479037},{"cnt":[[1768,772],[1823,772],[1823,813],[1768,813]],"region":{"top_left_x":1768,"top_left_y":772,"width":55,"height":42},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d82bfd84e765479eb93885c064ee539d","type":"table_of_contents_number","conversion_output":true,"parent_id":"99760565d3e94035b2028bb1dcbdc30d","text":"41","text_display":" ..... 41","confidence":1,"confidence_rate":1},{"cnt":[[459,825],[1821,822],[1821,882],[459,884]],"region":{"top_left_x":459,"top_left_y":822,"width":1362,"height":63},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6aa0d259bd04eeabb671ccdc61d72ac","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["811ca1b8940d47dab71569813fbcaa9b","266688a57b2942c283761a46d045a134"],"text":"","text_display":""},{"cnt":[[464,827],[998,827],[998,879],[464,879]],"region":{"top_left_x":463,"top_left_y":826,"width":536,"height":54},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"811ca1b8940d47dab71569813fbcaa9b","type":"table_of_contents_item","conversion_output":true,"parent_id":"f6aa0d259bd04eeabb671ccdc61d72ac","text":"5.1.1 Endpoint(s) of efficacy","text_display":"\n5.1.1 Endpoint(s) of efficacy","confidence":0.99951171875,"confidence_rate":0.9999856353826395},{"cnt":[[1768,827],[1823,827],[1823,868],[1768,868]],"region":{"top_left_x":1768,"top_left_y":826,"width":55,"height":43},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"266688a57b2942c283761a46d045a134","type":"table_of_contents_number","conversion_output":true,"parent_id":"f6aa0d259bd04eeabb671ccdc61d72ac","text":"41","text_display":" ..... 41","confidence":1,"confidence_rate":1},{"cnt":[[459,877],[1821,877],[1821,934],[459,934]],"region":{"top_left_x":459,"top_left_y":877,"width":1362,"height":58},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1faaaf73ee6349a3a206f3caa90788a7","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["dd08f7c04b35445f9d3da1ffd6d985a7","d9084c67f94c43c0b50bd33e19779b3b"],"text":"","text_display":""},{"cnt":[[466,882],[994,882],[994,930],[466,930]],"region":{"top_left_x":466,"top_left_y":881,"width":528,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd08f7c04b35445f9d3da1ffd6d985a7","type":"table_of_contents_item","conversion_output":true,"parent_id":"1faaaf73ee6349a3a206f3caa90788a7","text":"5.1.2 Assessment of efficacy","text_display":"\n5.1.2 Assessment of efficacy","confidence":0.9980480668600649,"confidence_rate":0.9999407944604733},{"cnt":[[1768,882],[1823,882],[1823,921],[1768,921]],"region":{"top_left_x":1768,"top_left_y":881,"width":55,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9084c67f94c43c0b50bd33e19779b3b","type":"table_of_contents_number","conversion_output":true,"parent_id":"1faaaf73ee6349a3a206f3caa90788a7","text":"43","text_display":" ..... 43","confidence":1,"confidence_rate":1},{"cnt":[[334,932],[1821,932],[1821,980],[334,980]],"region":{"top_left_x":333,"top_left_y":932,"width":1488,"height":48},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0bd14b5ae2e4acba6e3829fcfee69f2","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["4cd60c1382814533b76821c2585c64d6","26a295f6f5874e3889916925ad54cf48"],"text":"","text_display":""},{"cnt":[[338,937],[624,937],[624,975],[338,975]],"region":{"top_left_x":338,"top_left_y":936,"width":286,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cd60c1382814533b76821c2585c64d6","type":"table_of_contents_item","conversion_output":true,"parent_id":"a0bd14b5ae2e4acba6e3829fcfee69f2","text":"5.2 SAFETY","text_display":"\n5.2 SAFETY","confidence":1,"confidence_rate":1},{"cnt":[[1768,937],[1823,937],[1823,978],[1768,978]],"region":{"top_left_x":1768,"top_left_y":936,"width":55,"height":42},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"26a295f6f5874e3889916925ad54cf48","type":"table_of_contents_number","conversion_output":true,"parent_id":"a0bd14b5ae2e4acba6e3829fcfee69f2","text":"43","text_display":" ..... 43","confidence":1,"confidence_rate":1},{"cnt":[[461,987],[1821,987],[1821,1044],[461,1044]],"region":{"top_left_x":461,"top_left_y":986,"width":1360,"height":58},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f747c0acf55244f2b679d4d14c3d4427","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["dc410f1c98d943d1a68a4eeba2edd88e","fa10812241ee479ab470fa5de34eee81"],"text":"","text_display":""},{"cnt":[[466,991],[971,991],[971,1039],[466,1039]],"region":{"top_left_x":466,"top_left_y":991,"width":505,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc410f1c98d943d1a68a4eeba2edd88e","type":"table_of_contents_item","conversion_output":true,"parent_id":"f747c0acf55244f2b679d4d14c3d4427","text":"5.2.1 Endpoint(s) of safety","text_display":"\n5.2.1 Endpoint(s) of safety","confidence":1,"confidence_rate":1},{"cnt":[[1768,991],[1823,991],[1823,1033],[1768,1033]],"region":{"top_left_x":1768,"top_left_y":991,"width":55,"height":42},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa10812241ee479ab470fa5de34eee81","type":"table_of_contents_number","conversion_output":true,"parent_id":"f747c0acf55244f2b679d4d14c3d4427","text":"43","text_display":" ..... 43","confidence":1,"confidence_rate":1},{"cnt":[[592,1037],[1821,1037],[1821,1094],[592,1094]],"region":{"top_left_x":591,"top_left_y":1037,"width":1230,"height":58},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15c187b4270c4c7ea79d06be0a76a46e","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["e606d4c4d9c946d781622a2d2e906f23","eeae622701204fde876ff7d8e57f406a"],"text":"","text_display":""},{"cnt":[[599,1042],[1629,1042],[1629,1090],[599,1090]],"region":{"top_left_x":598,"top_left_y":1041,"width":1031,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e606d4c4d9c946d781622a2d2e906f23","type":"table_of_contents_item","conversion_output":true,"parent_id":"15c187b4270c4c7ea79d06be0a76a46e","text":"5.2.1.1 Reporting waiver for cardiovascular-outcome events","text_display":"\n5.2.1.1 Reporting waiver for cardiovascular-outcome events","confidence":1,"confidence_rate":1},{"cnt":[[1768,1042],[1823,1042],[1823,1083],[1768,1083]],"region":{"top_left_x":1768,"top_left_y":1041,"width":55,"height":42},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eeae622701204fde876ff7d8e57f406a","type":"table_of_contents_number","conversion_output":true,"parent_id":"15c187b4270c4c7ea79d06be0a76a46e","text":"44","text_display":" ..... 44","confidence":1,"confidence_rate":1},{"cnt":[[461,1087],[1821,1087],[1821,1140],[461,1140]],"region":{"top_left_x":461,"top_left_y":1087,"width":1360,"height":53},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6761aeba7c044e0bac1117fc2a77628c","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["38f61e3eec584752ad96d72f2eb691af","0a0d49b451714840a36bce1350f7f808"],"text":"","text_display":""},{"cnt":[[466,1092],[1117,1092],[1117,1135],[466,1135]],"region":{"top_left_x":466,"top_left_y":1091,"width":652,"height":45},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38f61e3eec584752ad96d72f2eb691af","type":"table_of_contents_item","conversion_output":true,"parent_id":"6761aeba7c044e0bac1117fc2a77628c","text":"5.2.2 Assessment of adverse events","text_display":"\n5.2.2 Assessment of adverse events","confidence":0.9990234375,"confidence_rate":0.999974948015144},{"cnt":[[1768,1085],[1823,1085],[1823,1133],[1768,1133]],"region":{"top_left_x":1768,"top_left_y":1085,"width":55,"height":49},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a0d49b451714840a36bce1350f7f808","type":"table_of_contents_number","conversion_output":true,"parent_id":"6761aeba7c044e0bac1117fc2a77628c","text":"44","text_display":" ..... 44","confidence":1,"confidence_rate":1},{"cnt":[[592,1138],[1823,1138],[1823,1190],[592,1190]],"region":{"top_left_x":591,"top_left_y":1137,"width":1232,"height":54},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cbda6a90fcb74a3e9816f9ecf745ac6f","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["ddd152ea9a874feab83c6e495a182cf5","c38b6915b3274b2a889ec309f31d5638"],"text":"","text_display":""},{"cnt":[[596,1142],[1240,1142],[1240,1186],[596,1186]],"region":{"top_left_x":596,"top_left_y":1142,"width":645,"height":44},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ddd152ea9a874feab83c6e495a182cf5","type":"table_of_contents_item","conversion_output":true,"parent_id":"cbda6a90fcb74a3e9816f9ecf745ac6f","text":"5.2.2.1 Definitions of adverse events","text_display":"\n5.2.2.1 Definitions of adverse events","confidence":1,"confidence_rate":1},{"cnt":[[1768,1140],[1823,1140],[1823,1183],[1768,1183]],"region":{"top_left_x":1768,"top_left_y":1139,"width":55,"height":45},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c38b6915b3274b2a889ec309f31d5638","type":"table_of_contents_number","conversion_output":true,"parent_id":"cbda6a90fcb74a3e9816f9ecf745ac6f","text":"44","text_display":" ..... 44","confidence":1,"confidence_rate":1},{"cnt":[[594,1192],[1823,1192],[1823,1247],[594,1247]],"region":{"top_left_x":593,"top_left_y":1192,"width":1230,"height":56},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee8eb142002941a2b0531cbd9c68d59d","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["134fb9eccb7044e2967d326dffc9216f","9b68f90b162a443ab0af99780ecda958"],"text":"","text_display":""},{"cnt":[[596,1195],[1597,1195],[1597,1245],[596,1245]],"region":{"top_left_x":596,"top_left_y":1194,"width":1001,"height":51},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"134fb9eccb7044e2967d326dffc9216f","type":"table_of_contents_item","conversion_output":true,"parent_id":"ee8eb142002941a2b0531cbd9c68d59d","text":"5.2.2.2 Adverse event and serious adverse event reporting","text_display":"\n5.2.2.2 Adverse event and serious adverse event reporting","confidence":1,"confidence_rate":1},{"cnt":[[1768,1195],[1823,1195],[1823,1236],[1768,1236]],"region":{"top_left_x":1768,"top_left_y":1194,"width":55,"height":42},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b68f90b162a443ab0af99780ecda958","type":"table_of_contents_number","conversion_output":true,"parent_id":"ee8eb142002941a2b0531cbd9c68d59d","text":"48","text_display":" ..... 48","confidence":1,"confidence_rate":1},{"cnt":[[594,1243],[1821,1243],[1821,1300],[594,1300]],"region":{"top_left_x":593,"top_left_y":1242,"width":1228,"height":58},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d47522e1cc8143ccad14454447e26dc9","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["8da87d304a734d8396507f138d02da33","eb3a6c4146584bcea861221c5e36d66d"],"text":"","text_display":""},{"cnt":[[599,1247],[1186,1247],[1186,1295],[599,1295]],"region":{"top_left_x":598,"top_left_y":1247,"width":588,"height":49},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8da87d304a734d8396507f138d02da33","type":"table_of_contents_item","conversion_output":true,"parent_id":"d47522e1cc8143ccad14454447e26dc9","text":"5.2.2.3 Oncological adverse events","text_display":"\n5.2.2.3 Oncological adverse events","confidence":1,"confidence_rate":1},{"cnt":[[1768,1247],[1823,1247],[1823,1288],[1768,1288]],"region":{"top_left_x":1768,"top_left_y":1247,"width":55,"height":42},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb3a6c4146584bcea861221c5e36d66d","type":"table_of_contents_number","conversion_output":true,"parent_id":"d47522e1cc8143ccad14454447e26dc9","text":"49","text_display":" ..... 49","confidence":1,"confidence_rate":1},{"cnt":[[459,1293],[1821,1293],[1821,1350],[459,1350]],"region":{"top_left_x":459,"top_left_y":1292,"width":1362,"height":59},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d289412745554b21b7535d56598e9644","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["bb8d3cbca2f7422a924afb141b1560c8","4c723351e3604defbd10ab583ac62ffd"],"text":"","text_display":""},{"cnt":[[466,1298],[1373,1298],[1373,1345],[466,1345]],"region":{"top_left_x":466,"top_left_y":1297,"width":907,"height":49},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb8d3cbca2f7422a924afb141b1560c8","type":"table_of_contents_item","conversion_output":true,"parent_id":"d289412745554b21b7535d56598e9644","text":"5.2.3 Assessment of safety laboratory parameters","text_display":"\n5.2.3 Assessment of safety laboratory parameters","confidence":1,"confidence_rate":1},{"cnt":[[1768,1302],[1823,1302],[1823,1341],[1768,1341]],"region":{"top_left_x":1768,"top_left_y":1302,"width":55,"height":39},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c723351e3604defbd10ab583ac62ffd","type":"table_of_contents_number","conversion_output":true,"parent_id":"d289412745554b21b7535d56598e9644","text":"50","text_display":" ..... 50","confidence":1,"confidence_rate":1},{"cnt":[[592,1343],[1821,1343],[1821,1396],[592,1396]],"region":{"top_left_x":591,"top_left_y":1343,"width":1230,"height":53},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ef91dfb780a4a95bf956039220f0a1a","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["d3b2bf160b2146d59b883cb16833debe","88a6fd62b4804c6eb9096bef50c7b096"],"text":"","text_display":""},{"cnt":[[599,1348],[998,1348],[998,1391],[599,1391]],"region":{"top_left_x":598,"top_left_y":1347,"width":401,"height":45},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3b2bf160b2146d59b883cb16833debe","type":"table_of_contents_item","conversion_output":true,"parent_id":"0ef91dfb780a4a95bf956039220f0a1a","text":"5.2.3.1 Renal function","text_display":"\n5.2.3.1 Renal function","confidence":1,"confidence_rate":1},{"cnt":[[1773,1352],[1823,1352],[1823,1389],[1773,1389]],"region":{"top_left_x":1772,"top_left_y":1352,"width":51,"height":37},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"88a6fd62b4804c6eb9096bef50c7b096","type":"table_of_contents_number","conversion_output":true,"parent_id":"0ef91dfb780a4a95bf956039220f0a1a","text":"51","text_display":" ..... 51","confidence":1,"confidence_rate":1},{"cnt":[[459,1398],[1821,1398],[1821,1455],[459,1455]],"region":{"top_left_x":459,"top_left_y":1398,"width":1362,"height":58},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23be4d2b5de445418c3fce34314db73f","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["896f43f934004d28952024c842723976","9bf79afc685649269ea3b3c2639bcdfa"],"text":"","text_display":""},{"cnt":[[466,1403],[937,1403],[937,1451],[466,1451]],"region":{"top_left_x":466,"top_left_y":1402,"width":471,"height":49},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"896f43f934004d28952024c842723976","type":"table_of_contents_item","conversion_output":true,"parent_id":"23be4d2b5de445418c3fce34314db73f","text":"5.2.4 Electrocardiogram","text_display":"\n5.2.4 Electrocardiogram","confidence":1,"confidence_rate":1},{"cnt":[[1768,1398],[1823,1398],[1823,1444],[1768,1444]],"region":{"top_left_x":1768,"top_left_y":1398,"width":55,"height":46},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9bf79afc685649269ea3b3c2639bcdfa","type":"table_of_contents_number","conversion_output":true,"parent_id":"23be4d2b5de445418c3fce34314db73f","text":"51","text_display":" ..... 51","confidence":1,"confidence_rate":1},{"cnt":[[459,1448],[1821,1448],[1821,1505],[459,1505]],"region":{"top_left_x":459,"top_left_y":1448,"width":1362,"height":58},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b78e8f0b20a486392ba4f61ab4c696c","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["8c6ecee957e84ca7938fe4611bb208ce","361c1ba747ed43c1985709ba973f9dd8"],"text":"","text_display":""},{"cnt":[[466,1453],[1282,1453],[1282,1501],[466,1501]],"region":{"top_left_x":466,"top_left_y":1452,"width":816,"height":49},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c6ecee957e84ca7938fe4611bb208ce","type":"table_of_contents_item","conversion_output":true,"parent_id":"6b78e8f0b20a486392ba4f61ab4c696c","text":"5.2.5 Assessment of other safety parameters","text_display":"\n5.2.5 Assessment of other safety parameters","confidence":1,"confidence_rate":1},{"cnt":[[1768,1453],[1823,1453],[1823,1494],[1768,1494]],"region":{"top_left_x":1768,"top_left_y":1452,"width":55,"height":42},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"361c1ba747ed43c1985709ba973f9dd8","type":"table_of_contents_number","conversion_output":true,"parent_id":"6b78e8f0b20a486392ba4f61ab4c696c","text":"52","text_display":" ..... 52","confidence":1,"confidence_rate":1},{"cnt":[[334,1503],[1821,1503],[1821,1556],[334,1556]],"region":{"top_left_x":333,"top_left_y":1503,"width":1488,"height":53},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45431d15d96e4bfa9555bdeb447a42ff","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["1ba75a5b106c40c2a1ca9fc334506187","7aa4a59dad674a23b4783e47789ac01f"],"text":"","text_display":""},{"cnt":[[338,1508],[612,1508],[612,1549],[338,1549]],"region":{"top_left_x":338,"top_left_y":1507,"width":275,"height":42},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ba75a5b106c40c2a1ca9fc334506187","type":"table_of_contents_item","conversion_output":true,"parent_id":"45431d15d96e4bfa9555bdeb447a42ff","text":"5.3 OTHER","text_display":"\n5.3 OTHER","confidence":1,"confidence_rate":1},{"cnt":[[1768,1508],[1823,1508],[1823,1549],[1768,1549]],"region":{"top_left_x":1768,"top_left_y":1507,"width":55,"height":42},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7aa4a59dad674a23b4783e47789ac01f","type":"table_of_contents_number","conversion_output":true,"parent_id":"45431d15d96e4bfa9555bdeb447a42ff","text":"53","text_display":" ..... 53","confidence":1,"confidence_rate":1},{"cnt":[[459,1608],[1821,1608],[1821,1661],[459,1661]],"region":{"top_left_x":459,"top_left_y":1608,"width":1362,"height":53},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9ccde9219c54e1eba4b86355d50fff5","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["3804f6da3e184c1fb1e5c26bb3018329","49b4cdbdf37b45ae94197bf49e9ddce9"],"text":"","text_display":""},{"cnt":[[466,1613],[1190,1613],[1190,1656],[466,1656]],"region":{"top_left_x":466,"top_left_y":1612,"width":725,"height":45},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3804f6da3e184c1fb1e5c26bb3018329","type":"table_of_contents_item","conversion_output":true,"parent_id":"c9ccde9219c54e1eba4b86355d50fff5","text":"5.3.2 Post stroke functional assessment","text_display":"\n5.3.2 Post stroke functional assessment","confidence":1,"confidence_rate":1},{"cnt":[[1768,1617],[1823,1617],[1823,1654],[1768,1654]],"region":{"top_left_x":1768,"top_left_y":1617,"width":55,"height":37},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49b4cdbdf37b45ae94197bf49e9ddce9","type":"table_of_contents_number","conversion_output":true,"parent_id":"c9ccde9219c54e1eba4b86355d50fff5","text":"54","text_display":" ..... 54","confidence":1,"confidence_rate":1},{"cnt":[[461,1658],[1821,1658],[1821,1716],[461,1716]],"region":{"top_left_x":461,"top_left_y":1658,"width":1360,"height":58},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a1afcbcf8d84310ab091276834fa7e0","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["f90a6a2835834efc90452fd5f4376dd8","c14196db486e4822a83270afb758842e"],"text":"","text_display":""},{"cnt":[[466,1665],[1135,1665],[1135,1711],[466,1711]],"region":{"top_left_x":466,"top_left_y":1665,"width":670,"height":46},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f90a6a2835834efc90452fd5f4376dd8","type":"table_of_contents_item","conversion_output":true,"parent_id":"4a1afcbcf8d84310ab091276834fa7e0","text":"5.3.3 Pharmacogenomic evaluation","text_display":"\n5.3.3 Pharmacogenomic evaluation","confidence":1,"confidence_rate":1},{"cnt":[[1768,1668],[1823,1668],[1823,1709],[1768,1709]],"region":{"top_left_x":1768,"top_left_y":1667,"width":55,"height":42},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c14196db486e4822a83270afb758842e","type":"table_of_contents_number","conversion_output":true,"parent_id":"4a1afcbcf8d84310ab091276834fa7e0","text":"54","text_display":" ..... 54","confidence":1,"confidence_rate":1},{"cnt":[[592,1709],[1823,1709],[1823,1768],[592,1768]],"region":{"top_left_x":591,"top_left_y":1708,"width":1232,"height":61},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6403362f8adf49e99a62fcbf940f042f","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["19bb5c0fc5254a33950f4d9d90494802","d8e516b3536c4d92801c644486b09038"],"text":"","text_display":""},{"cnt":[[596,1713],[1752,1713],[1752,1764],[596,1764]],"region":{"top_left_x":596,"top_left_y":1713,"width":1157,"height":51},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19bb5c0fc5254a33950f4d9d90494802","type":"table_of_contents_item","conversion_output":true,"parent_id":"6403362f8adf49e99a62fcbf940f042f","text":"5.3.3.1 Methods and timing of Pharmacogenetics sample collection","text_display":"\n5.3.3.1 Methods and timing of Pharmacogenetics sample collection","confidence":1,"confidence_rate":1},{"cnt":[[1773,1718],[1823,1718],[1823,1764],[1773,1764]],"region":{"top_left_x":1772,"top_left_y":1717,"width":51,"height":47},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8e516b3536c4d92801c644486b09038","type":"table_of_contents_number","conversion_output":true,"parent_id":"6403362f8adf49e99a62fcbf940f042f","text":"54","text_display":" ..... 54","confidence":1,"confidence_rate":1},{"cnt":[[334,1764],[1821,1764],[1821,1816],[334,1816]],"region":{"top_left_x":333,"top_left_y":1763,"width":1488,"height":54},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f10ebc30fa2b48f1a2b5db78f8c2120f","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["3c837cfc0db14d4093356fe40237995b","7c52512bd0904c5d8bf701e90286aa09"],"text":"","text_display":""},{"cnt":[[338,1773],[1300,1773],[1300,1812],[338,1812]],"region":{"top_left_x":338,"top_left_y":1772,"width":962,"height":40},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c837cfc0db14d4093356fe40237995b","type":"table_of_contents_item","conversion_output":true,"parent_id":"f10ebc30fa2b48f1a2b5db78f8c2120f","text":"5.4 APPROPRIATENESS OF MEASUREMENTS","text_display":"\n5.4 APPROPRIATENESS OF MEASUREMENTS","confidence":1,"confidence_rate":1},{"cnt":[[1768,1773],[1823,1773],[1823,1818],[1768,1818]],"region":{"top_left_x":1768,"top_left_y":1772,"width":55,"height":47},"line":84,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c52512bd0904c5d8bf701e90286aa09","type":"table_of_contents_number","conversion_output":true,"parent_id":"f10ebc30fa2b48f1a2b5db78f8c2120f","text":"54","text_display":" ..... 54","confidence":1,"confidence_rate":1},{"cnt":[[334,1821],[1821,1821],[1821,1921],[334,1921]],"region":{"top_left_x":333,"top_left_y":1820,"width":1488,"height":102},"line":85,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfc0c438a2294911b1b4e9bc861e76d3","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["9578724983fa4992b9b0dc4d05ff04c7","a771d131a56247d9aeab6f6f5f95a967","05a6534e28214d3fbb3bd7c326f0baaa"],"text":"","text_display":""},{"cnt":[[338,1828],[1437,1828],[1437,1869],[338,1869]],"region":{"top_left_x":338,"top_left_y":1827,"width":1099,"height":42},"line":86,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9578724983fa4992b9b0dc4d05ff04c7","type":"table_of_contents_item","conversion_output":true,"parent_id":"cfc0c438a2294911b1b4e9bc861e76d3","text":"5.5 DRUG CONCENTRATION MEASUREMENTS AND","text_display":"\n5.5 DRUG CONCENTRATION MEASUREMENTS AND","confidence":1,"confidence_rate":1},{"cnt":[[452,1873],[916,1873],[916,1917],[452,1917]],"region":{"top_left_x":452,"top_left_y":1873,"width":465,"height":44},"line":87,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a771d131a56247d9aeab6f6f5f95a967","type":"table_of_contents_item","conversion_output":true,"parent_id":"cfc0c438a2294911b1b4e9bc861e76d3","text":"PHARMACOKINETICS","text_display":" PHARMACOKINETICS","confidence":1,"confidence_rate":1},{"cnt":[[1768,1875],[1823,1875],[1823,1914],[1768,1914]],"region":{"top_left_x":1768,"top_left_y":1875,"width":55,"height":40},"line":88,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"05a6534e28214d3fbb3bd7c326f0baaa","type":"table_of_contents_number","conversion_output":true,"parent_id":"cfc0c438a2294911b1b4e9bc861e76d3","text":"54","text_display":" ..... 54","confidence":1,"confidence_rate":1},{"cnt":[[334,1923],[1821,1923],[1821,1981],[334,1981]],"region":{"top_left_x":333,"top_left_y":1923,"width":1488,"height":58},"line":89,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d917320788ee42d3b2aa1fb504a471b7","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["102ad835897c4ac1b5d031647c37de2b","abe1f2e14504415499b9e0e03a21e53f"],"text":"","text_display":""},{"cnt":[[338,1928],[779,1928],[779,1976],[338,1976]],"region":{"top_left_x":338,"top_left_y":1928,"width":441,"height":48},"line":90,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"102ad835897c4ac1b5d031647c37de2b","type":"table_of_contents_item","conversion_output":true,"parent_id":"d917320788ee42d3b2aa1fb504a471b7","text":"5.6 BIOMARKER(S)","text_display":"\n5.6 BIOMARKER(S)","confidence":1,"confidence_rate":1},{"cnt":[[1768,1928],[1823,1928],[1823,1969],[1768,1969]],"region":{"top_left_x":1768,"top_left_y":1928,"width":55,"height":42},"line":91,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abe1f2e14504415499b9e0e03a21e53f","type":"table_of_contents_number","conversion_output":true,"parent_id":"d917320788ee42d3b2aa1fb504a471b7","text":"55","text_display":" ..... 55","confidence":1,"confidence_rate":1},{"cnt":[[334,1978],[1821,1978],[1821,2031],[334,2031]],"region":{"top_left_x":333,"top_left_y":1978,"width":1488,"height":53},"line":92,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e37855ebcb7b4ac0843a3d8ed29057e0","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["bbb02a4b01704d498f55ad6a8e778901","52cb780b012444fa996ec4f2d41cbfa1"],"text":"","text_display":""},{"cnt":[[338,1983],[939,1983],[939,2026],[338,2026]],"region":{"top_left_x":338,"top_left_y":1982,"width":601,"height":45},"line":93,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bbb02a4b01704d498f55ad6a8e778901","type":"table_of_contents_item","conversion_output":true,"parent_id":"e37855ebcb7b4ac0843a3d8ed29057e0","text":"5.7 PHARMACODYNAMICS","text_display":"\n5.7 PHARMACODYNAMICS","confidence":0.99951171875,"confidence_rate":0.9999804641709025},{"cnt":[[1768,1983],[1823,1983],[1823,2024],[1768,2024]],"region":{"top_left_x":1768,"top_left_y":1982,"width":55,"height":42},"line":94,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52cb780b012444fa996ec4f2d41cbfa1","type":"table_of_contents_number","conversion_output":true,"parent_id":"e37855ebcb7b4ac0843a3d8ed29057e0","text":"55","text_display":" ..... 55","confidence":1,"confidence_rate":1},{"cnt":[[334,2033],[1821,2033],[1821,2086],[334,2086]],"region":{"top_left_x":333,"top_left_y":2033,"width":1488,"height":53},"line":95,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4233189714047cf80629210802574dc","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["fefd82d6ef1d4e41b4bec6904f2a5d2a","3866d97314c34f1485b853d8794fc378"],"text":"","text_display":""},{"cnt":[[338,2038],[1716,2038],[1716,2081],[338,2081]],"region":{"top_left_x":338,"top_left_y":2037,"width":1378,"height":45},"line":96,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fefd82d6ef1d4e41b4bec6904f2a5d2a","type":"table_of_contents_item","conversion_output":true,"parent_id":"f4233189714047cf80629210802574dc","text":"5.8 PHARMACOKINETIC - PHARMACODYNAMIC RELATIONSHIP","text_display":"\n5.8 PHARMACOKINETIC - PHARMACODYNAMIC RELATIONSHIP","confidence":0.99853515625,"confidence_rate":0.9999733473064166},{"cnt":[[1768,2038],[1823,2038],[1823,2079],[1768,2079]],"region":{"top_left_x":1768,"top_left_y":2037,"width":55,"height":42},"line":97,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3866d97314c34f1485b853d8794fc378","type":"table_of_contents_number","conversion_output":true,"parent_id":"f4233189714047cf80629210802574dc","text":"55","text_display":" ..... 55","confidence":1,"confidence_rate":1},{"cnt":[[242,2092],[1821,2092],[1821,2150],[242,2150]],"region":{"top_left_x":242,"top_left_y":2092,"width":1579,"height":58},"line":98,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e79ede41b55491f8325e85bede96a0f","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["3b6e52b8213c43bbbc02487f6e214d9e","ff67067e63ca43098d2e9a1cf3ad8f43"],"text":"","text_display":""},{"cnt":[[247,2097],[957,2097],[957,2145],[247,2145]],"region":{"top_left_x":246,"top_left_y":2097,"width":712,"height":49},"line":99,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b6e52b8213c43bbbc02487f6e214d9e","type":"table_of_contents_item","conversion_output":true,"parent_id":"2e79ede41b55491f8325e85bede96a0f","text":"6. INVESTIGATIONAL PLAN","text_display":"\n6. INVESTIGATIONAL PLAN","confidence":0.99951171875,"confidence_rate":0.9999825572771935},{"cnt":[[1759,2097],[1818,2097],[1818,2145],[1759,2145]],"region":{"top_left_x":1758,"top_left_y":2097,"width":61,"height":49},"line":100,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff67067e63ca43098d2e9a1cf3ad8f43","type":"table_of_contents_number","conversion_output":true,"parent_id":"2e79ede41b55491f8325e85bede96a0f","text":"56","text_display":" ..... 56","confidence":1,"confidence_rate":1},{"cnt":[[334,2159],[1821,2159],[1821,2209],[334,2209]],"region":{"top_left_x":333,"top_left_y":2158,"width":1488,"height":51},"line":101,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4fa9431c5b9b41e78f045bc6b2063aa2","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["f1862a9015d8478f97d4ee83cfc240e0","7b4adf059971483787f017075cdb1700"],"text":"","text_display":""},{"cnt":[[338,2163],[816,2163],[816,2204],[338,2204]],"region":{"top_left_x":338,"top_left_y":2163,"width":478,"height":42},"line":102,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1862a9015d8478f97d4ee83cfc240e0","type":"table_of_contents_item","conversion_output":true,"parent_id":"4fa9431c5b9b41e78f045bc6b2063aa2","text":"6.1 VISIT SCHEDULE","text_display":"\n6.1 VISIT SCHEDULE","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[1768,2166],[1823,2166],[1823,2204],[1768,2204]],"region":{"top_left_x":1768,"top_left_y":2165,"width":55,"height":40},"line":103,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b4adf059971483787f017075cdb1700","type":"table_of_contents_number","conversion_output":true,"parent_id":"4fa9431c5b9b41e78f045bc6b2063aa2","text":"56","text_display":" ..... 56","confidence":1,"confidence_rate":1},{"cnt":[[334,2211],[1821,2211],[1821,2264],[334,2264]],"region":{"top_left_x":333,"top_left_y":2211,"width":1488,"height":53},"line":104,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b532a4c0f0004d99a4ad18f2c2648863","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["3939a3d1ce4e4497b73d87b23a8a6ddb","7880a0ba28e04e8d95fe55711d1c78af"],"text":"","text_display":""},{"cnt":[[338,2216],[1601,2216],[1601,2259],[338,2259]],"region":{"top_left_x":338,"top_left_y":2215,"width":1264,"height":45},"line":105,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3939a3d1ce4e4497b73d87b23a8a6ddb","type":"table_of_contents_item","conversion_output":true,"parent_id":"b532a4c0f0004d99a4ad18f2c2648863","text":"6.2 DETAILS OF TRIAL PROCEDURES AT SELECTED VISITS","text_display":"\n6.2 DETAILS OF TRIAL PROCEDURES AT SELECTED VISITS","confidence":0.99365234375,"confidence_rate":0.9998842269152626},{"cnt":[[1768,2220],[1823,2220],[1823,2259],[1768,2259]],"region":{"top_left_x":1768,"top_left_y":2220,"width":55,"height":40},"line":106,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7880a0ba28e04e8d95fe55711d1c78af","type":"table_of_contents_number","conversion_output":true,"parent_id":"b532a4c0f0004d99a4ad18f2c2648863","text":"56","text_display":" ..... 56","confidence":1,"confidence_rate":1},{"cnt":[[459,2266],[1821,2266],[1821,2325],[459,2325]],"region":{"top_left_x":459,"top_left_y":2266,"width":1362,"height":60},"line":107,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3189205f3ea04865a623a3f8fd3dfec2","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["cba9fdb2923641fa8b58677da025261b","bc0f0e84021b4bc680b934cc21faf4aa"],"text":"","text_display":""},{"cnt":[[466,2273],[900,2273],[900,2323],[466,2323]],"region":{"top_left_x":466,"top_left_y":2272,"width":435,"height":52},"line":108,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cba9fdb2923641fa8b58677da025261b","type":"table_of_contents_item","conversion_output":true,"parent_id":"3189205f3ea04865a623a3f8fd3dfec2","text":"6.2.1 Screening period","text_display":"\n6.2.1 Screening period","confidence":0.9975595474243164,"confidence_rate":0.999909506489825},{"cnt":[[1768,2275],[1823,2275],[1823,2316],[1768,2316]],"region":{"top_left_x":1768,"top_left_y":2275,"width":55,"height":42},"line":109,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc0f0e84021b4bc680b934cc21faf4aa","type":"table_of_contents_number","conversion_output":true,"parent_id":"3189205f3ea04865a623a3f8fd3dfec2","text":"56","text_display":" ..... 56","confidence":1,"confidence_rate":1},{"cnt":[[461,2321],[1821,2321],[1821,2378],[461,2378]],"region":{"top_left_x":461,"top_left_y":2320,"width":1360,"height":59},"line":110,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ded74589dcf04f89ac9b1dcfd52a8ea0","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["19aeebca70bc416a9aa604c2ec28fef7","a7092b4986ab43778cbce26aab6a1bc0"],"text":"","text_display":""},{"cnt":[[466,2325],[916,2325],[916,2373],[466,2373]],"region":{"top_left_x":466,"top_left_y":2325,"width":451,"height":49},"line":111,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19aeebca70bc416a9aa604c2ec28fef7","type":"table_of_contents_item","conversion_output":true,"parent_id":"ded74589dcf04f89ac9b1dcfd52a8ea0","text":"6.2.2 Treatment period","text_display":"\n6.2.2 Treatment period","confidence":1,"confidence_rate":1},{"cnt":[[1768,2325],[1823,2325],[1823,2371],[1768,2371]],"region":{"top_left_x":1768,"top_left_y":2325,"width":55,"height":47},"line":112,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7092b4986ab43778cbce26aab6a1bc0","type":"table_of_contents_number","conversion_output":true,"parent_id":"ded74589dcf04f89ac9b1dcfd52a8ea0","text":"56","text_display":" ..... 56","confidence":1,"confidence_rate":1},{"cnt":[[461,2371],[1821,2371],[1821,2428],[461,2428]],"region":{"top_left_x":461,"top_left_y":2371,"width":1360,"height":58},"line":113,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7843a03e231d43d9850b5c24ce7da37f","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["d05c971d5f0944bab913debb6dbb00e6","ae9a80ae7bb2480b90a7d26c6f44a957"],"text":"","text_display":""},{"cnt":[[466,2376],[1286,2376],[1286,2424],[466,2424]],"region":{"top_left_x":466,"top_left_y":2375,"width":821,"height":49},"line":114,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d05c971d5f0944bab913debb6dbb00e6","type":"table_of_contents_item","conversion_output":true,"parent_id":"7843a03e231d43d9850b5c24ce7da37f","text":"6.2.3 End of treatment and follow-up period","text_display":"\n6.2.3 End of treatment and follow-up period","confidence":1,"confidence_rate":1},{"cnt":[[1768,2378],[1823,2378],[1823,2426],[1768,2426]],"region":{"top_left_x":1768,"top_left_y":2378,"width":55,"height":49},"line":115,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae9a80ae7bb2480b90a7d26c6f44a957","type":"table_of_contents_number","conversion_output":true,"parent_id":"7843a03e231d43d9850b5c24ce7da37f","text":"57","text_display":" ..... 57","confidence":1,"confidence_rate":1},{"cnt":[[242,2431],[1821,2431],[1821,2543],[242,2543]],"region":{"top_left_x":242,"top_left_y":2430,"width":1579,"height":113},"line":116,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b3c93e34e2a042cebd7b82f15faff226","type":"table_of_contents_row","conversion_output":false,"parent_id":"b77841c60d414d13863623cdf6c15e77","children_ids":["0c598130b1b74387bc5800a6b99d3534","6af8d623ad8a46d6a7947b63b249f3f7","1f4c1897c22f4864b7ddaeeda3c089f4"],"text":"","text_display":""},{"cnt":[[247,2435],[1574,2435],[1574,2483],[247,2483]],"region":{"top_left_x":246,"top_left_y":2435,"width":1328,"height":49},"line":117,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0c598130b1b74387bc5800a6b99d3534","type":"table_of_contents_item","conversion_output":true,"parent_id":"b3c93e34e2a042cebd7b82f15faff226","text":"7. STATISTICAL METHODS AND DETERMINATION OF","text_display":"\n7. STATISTICAL METHODS AND DETERMINATION OF","confidence":1,"confidence_rate":1},{"cnt":[[340,2490],[674,2490],[674,2538],[340,2538]],"region":{"top_left_x":340,"top_left_y":2489,"width":334,"height":49},"line":118,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6af8d623ad8a46d6a7947b63b249f3f7","type":"table_of_contents_item","conversion_output":true,"parent_id":"b3c93e34e2a042cebd7b82f15faff226","text":"SAMPLE SIZE","text_display":" SAMPLE SIZE","confidence":1,"confidence_rate":1},{"cnt":[[1761,2495],[1818,2495],[1818,2536],[1761,2536]],"region":{"top_left_x":1761,"top_left_y":2494,"width":58,"height":42},"line":119,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f4c1897c22f4864b7ddaeeda3c089f4","type":"table_of_contents_number","conversion_output":true,"parent_id":"b3c93e34e2a042cebd7b82f15faff226","text":"59","text_display":" ..... 59","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":120,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"222a8c47e268424b92fa3144c5f10357","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":121,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2c88c8b7f67e49239db7be4a1715ae7d","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.9912109375,"confidence_rate":0.9999258185992773},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":122,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0e1cbfe9d67b47ce9223aabed3e22333","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-013","page":13,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c99be1140f524332826eebf443717709","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70977c1814f5453eaee91093325c0e87","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92a706e1dcdd4e41a9f1dc8524d8d21c","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51d006e33fc44b62a06ceec53ce789ea","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7761abe694fe456cb6040c2045592a34","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1576,210],[1816,210],[1816,254],[1576,254]],"region":{"top_left_x":1576,"top_left_y":210,"width":241,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78015ec777084b3a8a147a901d1c9660","type":"page_info","conversion_output":false,"text":"Page 13 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[231,331],[1830,331],[1830,2716],[231,2716]],"region":{"top_left_x":230,"top_left_y":331,"width":1600,"height":2386},"line":7,"column":0,"font_size":29,"is_printed":true,"is_handwritten":false,"id":"b90288381ef049f7ac5f73e2b27ae3ee","type":"table_of_contents_container","conversion_output":false,"children_ids":["d459c8e633514bd49ce903959d38ca9e","638b1d0ce0194f5293313c222a9eebf5","24adc957d8ca42ed821d4113b09ff69e","399d940dc6284a9b929a7d7a4e2f26bf","518c54ef037d4e36975774719fd807a1","bfece0bae19b4805850a09268225a539","5f7d2f366c3e497a8e31173e0a16ab7c","2fe558134f9b4ceb8ace1ec0ea88c918","48900f797895401aab5ba8953f2045eb","201a97a0710a4766ba56fd8620321db4","6473cb60565446df9bb8ca5798568702","026fa852196e4e51a4927c96054ecdf2","e7f4a23ac4234b3eb87ca4d1251a948c","0f86fc38788c464ba7cdde1e1b0ddc70","9921efc2fe7148fabb59b3eb66deb3bd","ebb8c120773f4084bf87530cb03b9cf3","b7cbdcf3c5154d33b1790abd18e82531","8e7ed1057e044dc78c323714a671ab6b","2f46a6dda70348de914cfad815f69aa9","18d11640c32d40c8bea621b9c76c4e91","37258037b48848528ea365687c948a79","54aa2ff3ae464c42a3d212ea5ad1ce00","827e0353230e473a8d6f2ee22067c991","da9cf917ec6445348ce161d4838f6993","e1a529907bac4919bcac1a6bfb369135","2db8815aad8e498298cf6feb15b439f0","1d28489ccdea45729c591d516566fd63","746ddcaaf66e48bda58f44d5723a26b0","e3893d726ffb448f88868399edb618ec","984cdb92744f48b2af8316b11c88bc0f","ba9a13b06c894547b66bcf0443077970","019f0b9bca134846ac4972e9230d6e0c","8b57e1f91d1044169940466771576004","d2a0d24e0bfb491ca53451b47936a8dd","08256c206d50401888217f21cd80a26e","49a6b4e642b6452d927e2add47f94a04","1133b10a6d58446ab853f12b4aa0d53c"],"text":"","text_display":""},{"cnt":[[334,336],[1821,336],[1821,386],[334,386]],"region":{"top_left_x":333,"top_left_y":335,"width":1488,"height":52},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d459c8e633514bd49ce903959d38ca9e","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["f1a092dbc178470ab5596f0e5a37bd91","6b35335ff4be4bf19437afc2bf5a960c"],"text":"","text_display":""},{"cnt":[[338,343],[1099,343],[1099,381],[338,381]],"region":{"top_left_x":338,"top_left_y":342,"width":761,"height":40},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1a092dbc178470ab5596f0e5a37bd91","type":"table_of_contents_item","conversion_output":true,"parent_id":"d459c8e633514bd49ce903959d38ca9e","text":"7.1 STATISTICAL DESIGN - MODEL","text_display":"\n7.1 STATISTICAL DESIGN - MODEL","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[1768,331],[1823,331],[1823,384],[1768,384]],"region":{"top_left_x":1768,"top_left_y":331,"width":55,"height":53},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b35335ff4be4bf19437afc2bf5a960c","type":"table_of_contents_number","conversion_output":true,"parent_id":"d459c8e633514bd49ce903959d38ca9e","text":"59","text_display":" ..... 59","confidence":1,"confidence_rate":1},{"cnt":[[334,393],[1818,393],[1818,441],[334,441]],"region":{"top_left_x":333,"top_left_y":392,"width":1486,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"638b1d0ce0194f5293313c222a9eebf5","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["46282923f1ff4d1485e49f66a13fb397","1082d639a4e741f5b99f0d30821dd254"],"text":"","text_display":""},{"cnt":[[338,397],[1286,397],[1286,436],[338,436]],"region":{"top_left_x":338,"top_left_y":397,"width":949,"height":40},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"46282923f1ff4d1485e49f66a13fb397","type":"table_of_contents_item","conversion_output":true,"parent_id":"638b1d0ce0194f5293313c222a9eebf5","text":"7.2 NULL AND ALTERNATIVE HYPOTHESES","text_display":"\n7.2 NULL AND ALTERNATIVE HYPOTHESES","confidence":1,"confidence_rate":1},{"cnt":[[1768,386],[1823,386],[1823,436],[1768,436]],"region":{"top_left_x":1768,"top_left_y":386,"width":55,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1082d639a4e741f5b99f0d30821dd254","type":"table_of_contents_number","conversion_output":true,"parent_id":"638b1d0ce0194f5293313c222a9eebf5","text":"59","text_display":" ..... 59","confidence":1,"confidence_rate":1},{"cnt":[[334,445],[1821,445],[1821,496],[334,496]],"region":{"top_left_x":333,"top_left_y":445,"width":1488,"height":51},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24adc957d8ca42ed821d4113b09ff69e","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["8fc9a346499045cfa696afcd50b5e528","b32ccf561e274cea813f0eb1b7e8b85d"],"text":"","text_display":""},{"cnt":[[340,452],[893,452],[893,491],[340,491]],"region":{"top_left_x":340,"top_left_y":452,"width":554,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fc9a346499045cfa696afcd50b5e528","type":"table_of_contents_item","conversion_output":true,"parent_id":"24adc957d8ca42ed821d4113b09ff69e","text":"7.3 PLANNED ANALYSES","text_display":"\n7.3 PLANNED ANALYSES","confidence":1,"confidence_rate":1},{"cnt":[[1768,441],[1823,441],[1823,489],[1768,489]],"region":{"top_left_x":1768,"top_left_y":440,"width":55,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b32ccf561e274cea813f0eb1b7e8b85d","type":"table_of_contents_number","conversion_output":true,"parent_id":"24adc957d8ca42ed821d4113b09ff69e","text":"62","text_display":" ..... 62","confidence":1,"confidence_rate":1},{"cnt":[[459,503],[1821,503],[1821,557],[459,557]],"region":{"top_left_x":459,"top_left_y":502,"width":1362,"height":56},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"399d940dc6284a9b929a7d7a4e2f26bf","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["85660926b8b043d2afa069f103e04c82","8083f57a4b9741f291cf6af7db6a8961"],"text":"","text_display":""},{"cnt":[[466,507],[905,507],[905,553],[466,553]],"region":{"top_left_x":466,"top_left_y":507,"width":439,"height":46},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85660926b8b043d2afa069f103e04c82","type":"table_of_contents_item","conversion_output":true,"parent_id":"399d940dc6284a9b929a7d7a4e2f26bf","text":"7.3.1 Primary analyses","text_display":"\n7.3.1 Primary analyses","confidence":1,"confidence_rate":1},{"cnt":[[1768,496],[1823,496],[1823,548],[1768,548]],"region":{"top_left_x":1768,"top_left_y":495,"width":55,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8083f57a4b9741f291cf6af7db6a8961","type":"table_of_contents_number","conversion_output":true,"parent_id":"399d940dc6284a9b929a7d7a4e2f26bf","text":"63","text_display":" ..... 63","confidence":1,"confidence_rate":1},{"cnt":[[461,553],[1821,553],[1821,610],[461,610]],"region":{"top_left_x":461,"top_left_y":552,"width":1360,"height":58},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"518c54ef037d4e36975774719fd807a1","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["18dc4d59f2424b2285ad465b66a1160c","a8e65e56c03541f5aecdc5aadd9b5a2e"],"text":"","text_display":""},{"cnt":[[466,557],[943,557],[943,605],[466,605]],"region":{"top_left_x":466,"top_left_y":557,"width":478,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18dc4d59f2424b2285ad465b66a1160c","type":"table_of_contents_item","conversion_output":true,"parent_id":"518c54ef037d4e36975774719fd807a1","text":"7.3.2 Secondary analyses","text_display":"\n7.3.2 Secondary analyses","confidence":1,"confidence_rate":1},{"cnt":[[1768,551],[1823,551],[1823,599],[1768,599]],"region":{"top_left_x":1768,"top_left_y":550,"width":55,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8e65e56c03541f5aecdc5aadd9b5a2e","type":"table_of_contents_number","conversion_output":true,"parent_id":"518c54ef037d4e36975774719fd807a1","text":"64","text_display":" ..... 64","confidence":1,"confidence_rate":1},{"cnt":[[461,605],[1821,605],[1821,660],[461,660]],"region":{"top_left_x":461,"top_left_y":605,"width":1360,"height":56},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bfece0bae19b4805850a09268225a539","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["6f00bc5cd8cc4e9eb5cdd63bfa0852b7","3a90c84027b64d919530863dbe84f4bd"],"text":"","text_display":""},{"cnt":[[466,612],[866,612],[866,656],[466,656]],"region":{"top_left_x":466,"top_left_y":612,"width":400,"height":44},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f00bc5cd8cc4e9eb5cdd63bfa0852b7","type":"table_of_contents_item","conversion_output":true,"parent_id":"bfece0bae19b4805850a09268225a539","text":"7.3.3 Safety analyses","text_display":"\n7.3.3 Safety analyses","confidence":0.99951171875,"confidence_rate":0.9999812155418875},{"cnt":[[1768,605],[1823,605],[1823,649],[1768,649]],"region":{"top_left_x":1768,"top_left_y":605,"width":55,"height":44},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a90c84027b64d919530863dbe84f4bd","type":"table_of_contents_number","conversion_output":true,"parent_id":"bfece0bae19b4805850a09268225a539","text":"66","text_display":" ..... 66","confidence":1,"confidence_rate":1},{"cnt":[[461,658],[1821,658],[1821,710],[461,710]],"region":{"top_left_x":461,"top_left_y":657,"width":1360,"height":54},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f7d2f366c3e497a8e31173e0a16ab7c","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["5cbbf566c94f4de0adecc59920775aba","917630c379a349789fb38c96ac5d308b"],"text":"","text_display":""},{"cnt":[[466,662],[891,662],[891,706],[466,706]],"region":{"top_left_x":466,"top_left_y":662,"width":425,"height":44},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cbbf566c94f4de0adecc59920775aba","type":"table_of_contents_item","conversion_output":true,"parent_id":"5f7d2f366c3e497a8e31173e0a16ab7c","text":"7.3.4 Interim analyses","text_display":"\n7.3.4 Interim analyses","confidence":1,"confidence_rate":1},{"cnt":[[1768,660],[1823,660],[1823,699],[1768,699]],"region":{"top_left_x":1768,"top_left_y":660,"width":55,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"917630c379a349789fb38c96ac5d308b","type":"table_of_contents_number","conversion_output":true,"parent_id":"5f7d2f366c3e497a8e31173e0a16ab7c","text":"66","text_display":" ..... 66","confidence":1,"confidence_rate":1},{"cnt":[[461,708],[1821,708],[1821,763],[461,763]],"region":{"top_left_x":461,"top_left_y":708,"width":1360,"height":55},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fe558134f9b4ceb8ace1ec0ea88c918","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["3daa6c02f1c54146a904e121f8f7137b","20539b6787504c6e88be77402614ead6"],"text":"","text_display":""},{"cnt":[[466,713],[1058,713],[1058,758],[466,758]],"region":{"top_left_x":466,"top_left_y":712,"width":592,"height":47},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3daa6c02f1c54146a904e121f8f7137b","type":"table_of_contents_item","conversion_output":true,"parent_id":"2fe558134f9b4ceb8ace1ec0ea88c918","text":"7.3.5 Pharmacokinetic analyses","text_display":"\n7.3.5 Pharmacokinetic analyses","confidence":1,"confidence_rate":1},{"cnt":[[1768,713],[1823,713],[1823,754],[1768,754]],"region":{"top_left_x":1768,"top_left_y":712,"width":55,"height":42},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20539b6787504c6e88be77402614ead6","type":"table_of_contents_number","conversion_output":true,"parent_id":"2fe558134f9b4ceb8ace1ec0ea88c918","text":"67","text_display":" ..... 67","confidence":1,"confidence_rate":1},{"cnt":[[461,758],[1821,758],[1821,813],[461,813]],"region":{"top_left_x":461,"top_left_y":758,"width":1360,"height":56},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48900f797895401aab5ba8953f2045eb","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["4a8824dd96134515b3880a381f7eaa3b","4120f9e13b8a4bd0b3d13d7174a77fd2"],"text":"","text_display":""},{"cnt":[[466,763],[1090,763],[1090,811],[466,811]],"region":{"top_left_x":466,"top_left_y":762,"width":624,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a8824dd96134515b3880a381f7eaa3b","type":"table_of_contents_item","conversion_output":true,"parent_id":"48900f797895401aab5ba8953f2045eb","text":"7.3.6 Pharmacodynamic analyses","text_display":"\n7.3.6 Pharmacodynamic analyses","confidence":1,"confidence_rate":1},{"cnt":[[1768,754],[1823,754],[1823,804],[1768,804]],"region":{"top_left_x":1768,"top_left_y":753,"width":55,"height":52},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4120f9e13b8a4bd0b3d13d7174a77fd2","type":"table_of_contents_number","conversion_output":true,"parent_id":"48900f797895401aab5ba8953f2045eb","text":"67","text_display":" ..... 67","confidence":1,"confidence_rate":1},{"cnt":[[459,811],[1821,811],[1821,866],[459,866]],"region":{"top_left_x":459,"top_left_y":810,"width":1362,"height":56},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"201a97a0710a4766ba56fd8620321db4","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["a579a1d4018c4981b883b800b9c31dde","8243201d731d4322a9ada3f247969143"],"text":"","text_display":""},{"cnt":[[466,816],[1085,816],[1085,861],[466,861]],"region":{"top_left_x":466,"top_left_y":815,"width":620,"height":47},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a579a1d4018c4981b883b800b9c31dde","type":"table_of_contents_item","conversion_output":true,"parent_id":"201a97a0710a4766ba56fd8620321db4","text":"7.3.7 Pharmacogenomic analyses","text_display":"\n7.3.7 Pharmacogenomic analyses","confidence":1,"confidence_rate":1},{"cnt":[[1768,809],[1823,809],[1823,854],[1768,854]],"region":{"top_left_x":1768,"top_left_y":808,"width":55,"height":47},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8243201d731d4322a9ada3f247969143","type":"table_of_contents_number","conversion_output":true,"parent_id":"201a97a0710a4766ba56fd8620321db4","text":"67","text_display":" ..... 67","confidence":1,"confidence_rate":1},{"cnt":[[334,863],[1821,863],[1821,916],[334,916]],"region":{"top_left_x":333,"top_left_y":863,"width":1488,"height":54},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6473cb60565446df9bb8ca5798568702","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["e45c8b15d8e24a2db1db5e8329694b4b","a47dbc23e6024645a137654abdce134d"],"text":"","text_display":""},{"cnt":[[340,868],[1076,868],[1076,907],[340,907]],"region":{"top_left_x":340,"top_left_y":868,"width":736,"height":39},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e45c8b15d8e24a2db1db5e8329694b4b","type":"table_of_contents_item","conversion_output":true,"parent_id":"6473cb60565446df9bb8ca5798568702","text":"7.4 HANDLING OF MISSING DATA","text_display":"\n7.4 HANDLING OF MISSING DATA","confidence":1,"confidence_rate":1},{"cnt":[[1768,863],[1823,863],[1823,909],[1768,909]],"region":{"top_left_x":1768,"top_left_y":863,"width":55,"height":47},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a47dbc23e6024645a137654abdce134d","type":"table_of_contents_number","conversion_output":true,"parent_id":"6473cb60565446df9bb8ca5798568702","text":"67","text_display":" ..... 67","confidence":1,"confidence_rate":1},{"cnt":[[334,918],[1821,918],[1821,971],[334,971]],"region":{"top_left_x":333,"top_left_y":918,"width":1488,"height":53},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"026fa852196e4e51a4927c96054ecdf2","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["20a5e6f606694458bed5de5ec3c77097","0d30271f2fcf4d6285eb7f436a4d08b0"],"text":"","text_display":""},{"cnt":[[340,923],[834,923],[834,962],[340,962]],"region":{"top_left_x":340,"top_left_y":922,"width":494,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20a5e6f606694458bed5de5ec3c77097","type":"table_of_contents_item","conversion_output":true,"parent_id":"026fa852196e4e51a4927c96054ecdf2","text":"7.5 RANDOMIZATION","text_display":"\n7.5 RANDOMIZATION","confidence":1,"confidence_rate":1},{"cnt":[[1768,918],[1823,918],[1823,964],[1768,964]],"region":{"top_left_x":1768,"top_left_y":918,"width":55,"height":47},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d30271f2fcf4d6285eb7f436a4d08b0","type":"table_of_contents_number","conversion_output":true,"parent_id":"026fa852196e4e51a4927c96054ecdf2","text":"68","text_display":" ..... 68","confidence":1,"confidence_rate":1},{"cnt":[[334,973],[1821,973],[1821,1026],[334,1026]],"region":{"top_left_x":333,"top_left_y":973,"width":1488,"height":53},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7f4a23ac4234b3eb87ca4d1251a948c","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["99cb016d707d489b8f615d06b5204258","290a90652be443be813a8d52c0f4daa4"],"text":"","text_display":""},{"cnt":[[338,978],[1181,978],[1181,1017],[338,1017]],"region":{"top_left_x":338,"top_left_y":977,"width":844,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99cb016d707d489b8f615d06b5204258","type":"table_of_contents_item","conversion_output":true,"parent_id":"e7f4a23ac4234b3eb87ca4d1251a948c","text":"7.6 DETERMINATION OF SAMPLE SIZE","text_display":"\n7.6 DETERMINATION OF SAMPLE SIZE","confidence":0.9931640625,"confidence_rate":0.9998146277362402},{"cnt":[[1768,973],[1823,973],[1823,1019],[1768,1019]],"region":{"top_left_x":1768,"top_left_y":973,"width":55,"height":46},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"290a90652be443be813a8d52c0f4daa4","type":"table_of_contents_number","conversion_output":true,"parent_id":"e7f4a23ac4234b3eb87ca4d1251a948c","text":"68","text_display":" ..... 68","confidence":1,"confidence_rate":1},{"cnt":[[242,1033],[1821,1033],[1821,1144],[242,1144]],"region":{"top_left_x":242,"top_left_y":1032,"width":1579,"height":113},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f86fc38788c464ba7cdde1e1b0ddc70","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["a7c814f7f7184c83938b74e64b2809f4","5274e1117ef74d908af042ee0780b5f4","8f2e93b432774098bd3ede80dff45822"],"text":"","text_display":""},{"cnt":[[247,1037],[1547,1037],[1547,1090],[247,1090]],"region":{"top_left_x":246,"top_left_y":1037,"width":1301,"height":53},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7c814f7f7184c83938b74e64b2809f4","type":"table_of_contents_item","conversion_output":true,"parent_id":"0f86fc38788c464ba7cdde1e1b0ddc70","text":"8. INFORMED CONSENT, DATA PROTECTION, TRIAL","text_display":"\n8. INFORMED CONSENT, DATA PROTECTION, TRIAL","confidence":1,"confidence_rate":1},{"cnt":[[343,1096],[587,1096],[587,1140],[343,1140]],"region":{"top_left_x":342,"top_left_y":1096,"width":246,"height":44},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5274e1117ef74d908af042ee0780b5f4","type":"table_of_contents_item","conversion_output":true,"parent_id":"0f86fc38788c464ba7cdde1e1b0ddc70","text":"RECORDS","text_display":" RECORDS","confidence":1,"confidence_rate":1},{"cnt":[[1764,1096],[1814,1096],[1814,1140],[1764,1140]],"region":{"top_left_x":1763,"top_left_y":1096,"width":51,"height":44},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f2e93b432774098bd3ede80dff45822","type":"table_of_contents_number","conversion_output":true,"parent_id":"0f86fc38788c464ba7cdde1e1b0ddc70","text":"71","text_display":" ..... 71","confidence":1,"confidence_rate":1},{"cnt":[[334,1154],[1821,1154],[1821,1254],[334,1254]],"region":{"top_left_x":333,"top_left_y":1153,"width":1488,"height":102},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9921efc2fe7148fabb59b3eb66deb3bd","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["ef53169c9b8a4ff6ab76df42b171181a","82fed2e7eeac4cfe9f87cde5756a70ea","c00cea1f3f0748cda95381de3e577042"],"text":"","text_display":""},{"cnt":[[340,1160],[1725,1160],[1725,1204],[340,1204]],"region":{"top_left_x":340,"top_left_y":1160,"width":1385,"height":44},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef53169c9b8a4ff6ab76df42b171181a","type":"table_of_contents_item","conversion_output":true,"parent_id":"9921efc2fe7148fabb59b3eb66deb3bd","text":"8.1 STUDY APPROVAL, PATIENT INFORMATION, AND INFORMED","text_display":"\n8.1 STUDY APPROVAL, PATIENT INFORMATION, AND INFORMED","confidence":1,"confidence_rate":1},{"cnt":[[452,1211],[662,1211],[662,1247],[452,1247]],"region":{"top_left_x":452,"top_left_y":1210,"width":211,"height":38},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"82fed2e7eeac4cfe9f87cde5756a70ea","type":"table_of_contents_item","conversion_output":true,"parent_id":"9921efc2fe7148fabb59b3eb66deb3bd","text":"CONSENT","text_display":" CONSENT","confidence":1,"confidence_rate":1},{"cnt":[[1768,1211],[1823,1211],[1823,1250],[1768,1250]],"region":{"top_left_x":1768,"top_left_y":1210,"width":55,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c00cea1f3f0748cda95381de3e577042","type":"table_of_contents_number","conversion_output":true,"parent_id":"9921efc2fe7148fabb59b3eb66deb3bd","text":"71","text_display":" ..... 71","confidence":1,"confidence_rate":1},{"cnt":[[334,1256],[1821,1256],[1821,1314],[334,1314]],"region":{"top_left_x":333,"top_left_y":1256,"width":1488,"height":58},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ebb8c120773f4084bf87530cb03b9cf3","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["e40213f24f3441678cf29b40fc3b518c","08eb0bd7ca204ef7a928392b00c3897c"],"text":"","text_display":""},{"cnt":[[340,1263],[1049,1263],[1049,1309],[340,1309]],"region":{"top_left_x":340,"top_left_y":1263,"width":709,"height":46},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e40213f24f3441678cf29b40fc3b518c","type":"table_of_contents_item","conversion_output":true,"parent_id":"ebb8c120773f4084bf87530cb03b9cf3","text":"8.2 DATA QUALITY ASSURANCE","text_display":"\n8.2 DATA QUALITY ASSURANCE","confidence":1,"confidence_rate":1},{"cnt":[[1768,1266],[1823,1266],[1823,1304],[1768,1304]],"region":{"top_left_x":1768,"top_left_y":1265,"width":55,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08eb0bd7ca204ef7a928392b00c3897c","type":"table_of_contents_number","conversion_output":true,"parent_id":"ebb8c120773f4084bf87530cb03b9cf3","text":"72","text_display":" ..... 72","confidence":1,"confidence_rate":1},{"cnt":[[334,1311],[1821,1311],[1821,1364],[334,1364]],"region":{"top_left_x":333,"top_left_y":1311,"width":1488,"height":53},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7cbdcf3c5154d33b1790abd18e82531","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["02817f8cb58342aaacd96ef77d70bc1e","6df458cdb3a54ad0bce4698bcff54088"],"text":"","text_display":""},{"cnt":[[338,1316],[665,1316],[665,1355],[338,1355]],"region":{"top_left_x":338,"top_left_y":1315,"width":327,"height":40},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02817f8cb58342aaacd96ef77d70bc1e","type":"table_of_contents_item","conversion_output":true,"parent_id":"b7cbdcf3c5154d33b1790abd18e82531","text":"8.3 RECORDS","text_display":"\n8.3 RECORDS","confidence":1,"confidence_rate":1},{"cnt":[[1768,1320],[1823,1320],[1823,1359],[1768,1359]],"region":{"top_left_x":1768,"top_left_y":1320,"width":55,"height":40},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6df458cdb3a54ad0bce4698bcff54088","type":"table_of_contents_number","conversion_output":true,"parent_id":"b7cbdcf3c5154d33b1790abd18e82531","text":"72","text_display":" ..... 72","confidence":1,"confidence_rate":1},{"cnt":[[459,1366],[1821,1366],[1821,1419],[459,1419]],"region":{"top_left_x":459,"top_left_y":1366,"width":1362,"height":53},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e7ed1057e044dc78c323714a671ab6b","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["c5daeaf0236d4bd38b75dff52767595a","85fb67c0d07a474499a31d40766ead8c"],"text":"","text_display":""},{"cnt":[[466,1373],[921,1373],[921,1414],[466,1414]],"region":{"top_left_x":466,"top_left_y":1372,"width":455,"height":43},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5daeaf0236d4bd38b75dff52767595a","type":"table_of_contents_item","conversion_output":true,"parent_id":"8e7ed1057e044dc78c323714a671ab6b","text":"8.3.1 Source documents","text_display":"\n8.3.1 Source documents","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[1768,1375],[1823,1375],[1823,1414],[1768,1414]],"region":{"top_left_x":1768,"top_left_y":1375,"width":55,"height":40},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85fb67c0d07a474499a31d40766ead8c","type":"table_of_contents_number","conversion_output":true,"parent_id":"8e7ed1057e044dc78c323714a671ab6b","text":"73","text_display":" ..... 73","confidence":1,"confidence_rate":1},{"cnt":[[461,1419],[1821,1419],[1821,1469],[461,1469]],"region":{"top_left_x":461,"top_left_y":1418,"width":1360,"height":51},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f46a6dda70348de914cfad815f69aa9","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["2b4ddfd6e5a34443ba4f4de31574e7e2","702c4edd7fd343d6a6fa52b1c051a02b"],"text":"","text_display":""},{"cnt":[[466,1425],[1366,1425],[1366,1464],[466,1464]],"region":{"top_left_x":466,"top_left_y":1425,"width":901,"height":40},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b4ddfd6e5a34443ba4f4de31574e7e2","type":"table_of_contents_item","conversion_output":true,"parent_id":"2f46a6dda70348de914cfad815f69aa9","text":"8.3.2 Direct access to source data and documents","text_display":"\n8.3.2 Direct access to source data and documents","confidence":1,"confidence_rate":1},{"cnt":[[1768,1425],[1823,1425],[1823,1469],[1768,1469]],"region":{"top_left_x":1768,"top_left_y":1425,"width":55,"height":44},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"702c4edd7fd343d6a6fa52b1c051a02b","type":"table_of_contents_number","conversion_output":true,"parent_id":"2f46a6dda70348de914cfad815f69aa9","text":"73","text_display":" ..... 73","confidence":1,"confidence_rate":1},{"cnt":[[459,1471],[1821,1471],[1821,1528],[459,1528]],"region":{"top_left_x":459,"top_left_y":1471,"width":1362,"height":58},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18d11640c32d40c8bea621b9c76c4e91","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["9c627dc4744941f59fd6d7cfeba3c1af","4103d7e26ed149a783ccd741b770100c"],"text":"","text_display":""},{"cnt":[[466,1476],[934,1476],[934,1524],[466,1524]],"region":{"top_left_x":466,"top_left_y":1475,"width":469,"height":49},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c627dc4744941f59fd6d7cfeba3c1af","type":"table_of_contents_item","conversion_output":true,"parent_id":"18d11640c32d40c8bea621b9c76c4e91","text":"8.3.3 Storage of records","text_display":"\n8.3.3 Storage of records","confidence":1,"confidence_rate":1},{"cnt":[[1768,1471],[1823,1471],[1823,1517],[1768,1517]],"region":{"top_left_x":1768,"top_left_y":1471,"width":55,"height":46},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4103d7e26ed149a783ccd741b770100c","type":"table_of_contents_number","conversion_output":true,"parent_id":"18d11640c32d40c8bea621b9c76c4e91","text":"73","text_display":" ..... 73","confidence":1,"confidence_rate":1},{"cnt":[[334,1526],[1821,1526],[1821,1624],[334,1624]],"region":{"top_left_x":333,"top_left_y":1525,"width":1488,"height":100},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37258037b48848528ea365687c948a79","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["a3a114fd185b4a0489f672932e5a444e","178e7e2f85074fa5afce40620bae32e5","d6d22ab2ed7e4a5c81e9583ff359440d"],"text":"","text_display":""},{"cnt":[[340,1531],[1610,1531],[1610,1569],[340,1569]],"region":{"top_left_x":340,"top_left_y":1530,"width":1271,"height":40},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3a114fd185b4a0489f672932e5a444e","type":"table_of_contents_item","conversion_output":true,"parent_id":"37258037b48848528ea365687c948a79","text":"8.4 LISTEDNESS AND EXPEDITED REPORTING OF ADVERSE","text_display":"\n8.4 LISTEDNESS AND EXPEDITED REPORTING OF ADVERSE","confidence":0.99951171875,"confidence_rate":0.9999909555872323},{"cnt":[[452,1579],[628,1579],[628,1615],[452,1615]],"region":{"top_left_x":452,"top_left_y":1578,"width":177,"height":38},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"178e7e2f85074fa5afce40620bae32e5","type":"table_of_contents_item","conversion_output":true,"parent_id":"37258037b48848528ea365687c948a79","text":"EVENTS","text_display":" EVENTS","confidence":0.99951171875,"confidence_rate":0.9999556009403848},{"cnt":[[1768,1581],[1823,1581],[1823,1617],[1768,1617]],"region":{"top_left_x":1768,"top_left_y":1580,"width":55,"height":38},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6d22ab2ed7e4a5c81e9583ff359440d","type":"table_of_contents_number","conversion_output":true,"parent_id":"37258037b48848528ea365687c948a79","text":"73","text_display":" ..... 73","confidence":1,"confidence_rate":1},{"cnt":[[457,1626],[1821,1626],[1821,1677],[457,1677]],"region":{"top_left_x":456,"top_left_y":1626,"width":1365,"height":51},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54aa2ff3ae464c42a3d212ea5ad1ce00","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["1a3c3a9591cb4b1d88e623feda769b84","2f5861b64db9442d91f678f12d9729fe"],"text":"","text_display":""},{"cnt":[[466,1636],[779,1636],[779,1670],[466,1670]],"region":{"top_left_x":466,"top_left_y":1635,"width":313,"height":35},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a3c3a9591cb4b1d88e623feda769b84","type":"table_of_contents_item","conversion_output":true,"parent_id":"54aa2ff3ae464c42a3d212ea5ad1ce00","text":"8.4.1 Listedness","text_display":"\n8.4.1 Listedness","confidence":1,"confidence_rate":1},{"cnt":[[1768,1636],[1823,1636],[1823,1672],[1768,1672]],"region":{"top_left_x":1768,"top_left_y":1635,"width":55,"height":38},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f5861b64db9442d91f678f12d9729fe","type":"table_of_contents_number","conversion_output":true,"parent_id":"54aa2ff3ae464c42a3d212ea5ad1ce00","text":"73","text_display":" ..... 73","confidence":1,"confidence_rate":1},{"cnt":[[461,1677],[1821,1677],[1821,1734],[461,1734]],"region":{"top_left_x":461,"top_left_y":1676,"width":1360,"height":58},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"827e0353230e473a8d6f2ee22067c991","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["7bd7a3fb24bb4128ae6b661c6d2629c5","fd7ea05fcc1e490581b482bd7bef2086"],"text":"","text_display":""},{"cnt":[[466,1684],[1606,1684],[1606,1729],[466,1729]],"region":{"top_left_x":466,"top_left_y":1683,"width":1140,"height":47},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7bd7a3fb24bb4128ae6b661c6d2629c5","type":"table_of_contents_item","conversion_output":true,"parent_id":"827e0353230e473a8d6f2ee22067c991","text":"8.4.2 Expedited reporting to health authorities and IECs/IRBs","text_display":"\n8.4.2 Expedited reporting to health authorities and IECs/IRBs","confidence":0.99951171875,"confidence_rate":0.9999926000198329},{"cnt":[[1768,1686],[1823,1686],[1823,1727],[1768,1727]],"region":{"top_left_x":1768,"top_left_y":1685,"width":55,"height":42},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd7ea05fcc1e490581b482bd7bef2086","type":"table_of_contents_number","conversion_output":true,"parent_id":"827e0353230e473a8d6f2ee22067c991","text":"74","text_display":" ..... 74","confidence":1,"confidence_rate":1},{"cnt":[[334,1732],[1821,1732],[1821,1784],[334,1784]],"region":{"top_left_x":333,"top_left_y":1731,"width":1488,"height":54},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da9cf917ec6445348ce161d4838f6993","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["a3b2eed270204c0699cda0a34cd25d03","8a19a97f3d8f4396bba715901f21f4cb"],"text":"","text_display":""},{"cnt":[[340,1738],[1199,1738],[1199,1780],[340,1780]],"region":{"top_left_x":340,"top_left_y":1738,"width":860,"height":42},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3b2eed270204c0699cda0a34cd25d03","type":"table_of_contents_item","conversion_output":true,"parent_id":"da9cf917ec6445348ce161d4838f6993","text":"8.5 STATEMENT OF CONFIDENTIALITY","text_display":"\n8.5 STATEMENT OF CONFIDENTIALITY","confidence":1,"confidence_rate":1},{"cnt":[[1768,1741],[1823,1741],[1823,1782],[1768,1782]],"region":{"top_left_x":1768,"top_left_y":1740,"width":55,"height":42},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a19a97f3d8f4396bba715901f21f4cb","type":"table_of_contents_number","conversion_output":true,"parent_id":"da9cf917ec6445348ce161d4838f6993","text":"74","text_display":" ..... 74","confidence":1,"confidence_rate":1},{"cnt":[[334,1786],[1821,1786],[1821,1839],[334,1839]],"region":{"top_left_x":333,"top_left_y":1786,"width":1488,"height":53},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1a529907bac4919bcac1a6bfb369135","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["fe557db5c83a43f8ad4a6a38ed85f819","056a934be7604329b8a8dbe362c9ca11"],"text":"","text_display":""},{"cnt":[[340,1796],[955,1796],[955,1834],[340,1834]],"region":{"top_left_x":340,"top_left_y":1795,"width":615,"height":40},"line":84,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe557db5c83a43f8ad4a6a38ed85f819","type":"table_of_contents_item","conversion_output":true,"parent_id":"e1a529907bac4919bcac1a6bfb369135","text":"8.6 COMPLETION OF TRIAL","text_display":"\n8.6 COMPLETION OF TRIAL","confidence":1,"confidence_rate":1},{"cnt":[[1768,1796],[1823,1796],[1823,1837],[1768,1837]],"region":{"top_left_x":1768,"top_left_y":1795,"width":55,"height":42},"line":85,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"056a934be7604329b8a8dbe362c9ca11","type":"table_of_contents_number","conversion_output":true,"parent_id":"e1a529907bac4919bcac1a6bfb369135","text":"74","text_display":" ..... 74","confidence":1,"confidence_rate":1},{"cnt":[[334,1841],[1821,1841],[1821,1894],[334,1894]],"region":{"top_left_x":333,"top_left_y":1841,"width":1488,"height":53},"line":86,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2db8815aad8e498298cf6feb15b439f0","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["c23f6bb8d09e4e8dbcf1441f919fe119","547a1f589efe451aa81ba53b5f6a292b"],"text":"","text_display":""},{"cnt":[[338,1850],[975,1850],[975,1889],[338,1889]],"region":{"top_left_x":338,"top_left_y":1850,"width":638,"height":40},"line":87,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c23f6bb8d09e4e8dbcf1441f919fe119","type":"table_of_contents_item","conversion_output":true,"parent_id":"2db8815aad8e498298cf6feb15b439f0","text":"8.7 PROTOCOL VIOLATIONS","text_display":"\n8.7 PROTOCOL VIOLATIONS","confidence":0.98583984375,"confidence_rate":0.9994907951228822},{"cnt":[[1768,1850],[1823,1850],[1823,1891],[1768,1891]],"region":{"top_left_x":1768,"top_left_y":1850,"width":55,"height":42},"line":88,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"547a1f589efe451aa81ba53b5f6a292b","type":"table_of_contents_number","conversion_output":true,"parent_id":"2db8815aad8e498298cf6feb15b439f0","text":"74","text_display":" ..... 74","confidence":1,"confidence_rate":1},{"cnt":[[334,1896],[1821,1896],[1821,1997],[334,1997]],"region":{"top_left_x":333,"top_left_y":1896,"width":1488,"height":101},"line":89,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d28489ccdea45729c591d516566fd63","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["db1a9f147c95417c8b3051a139919e4e","9ac9c688f55b44d285c36f74d558dda4","2d1ef63b85dc4b79b182711b1cd6b2f2"],"text":"","text_display":""},{"cnt":[[338,1903],[1738,1903],[1738,1944],[338,1944]],"region":{"top_left_x":338,"top_left_y":1902,"width":1401,"height":43},"line":90,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db1a9f147c95417c8b3051a139919e4e","type":"table_of_contents_item","conversion_output":true,"parent_id":"1d28489ccdea45729c591d516566fd63","text":"8.8 COMPENSATION AVAILABLE TO THE PATIENT IN THE EVENT","text_display":"\n8.8 COMPENSATION AVAILABLE TO THE PATIENT IN THE EVENT","confidence":1,"confidence_rate":1},{"cnt":[[452,1951],[1044,1951],[1044,1990],[452,1990]],"region":{"top_left_x":452,"top_left_y":1950,"width":592,"height":40},"line":91,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ac9c688f55b44d285c36f74d558dda4","type":"table_of_contents_item","conversion_output":true,"parent_id":"1d28489ccdea45729c591d516566fd63","text":"OF TRIAL RELATED INJURY","text_display":" OF TRIAL RELATED INJURY","confidence":1,"confidence_rate":1},{"cnt":[[1768,1949],[1823,1949],[1823,1992],[1768,1992]],"region":{"top_left_x":1768,"top_left_y":1948,"width":55,"height":44},"line":92,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d1ef63b85dc4b79b182711b1cd6b2f2","type":"table_of_contents_number","conversion_output":true,"parent_id":"1d28489ccdea45729c591d516566fd63","text":"74","text_display":" ..... 74","confidence":1,"confidence_rate":1},{"cnt":[[242,2006],[1821,2006],[1821,2063],[242,2063]],"region":{"top_left_x":242,"top_left_y":2005,"width":1579,"height":58},"line":93,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"746ddcaaf66e48bda58f44d5723a26b0","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["16b337a7ce8b4e5ebd73b2908cfc839d","510884144fba480590753014b092395c"],"text":"","text_display":""},{"cnt":[[247,2010],[674,2010],[674,2054],[247,2054]],"region":{"top_left_x":246,"top_left_y":2010,"width":428,"height":44},"line":94,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16b337a7ce8b4e5ebd73b2908cfc839d","type":"table_of_contents_item","conversion_output":true,"parent_id":"746ddcaaf66e48bda58f44d5723a26b0","text":"9. REFERENCES","text_display":"\n9. REFERENCES","confidence":0.99951171875,"confidence_rate":0.9999728670071003},{"cnt":[[1764,2015],[1818,2015],[1818,2056],[1764,2056]],"region":{"top_left_x":1763,"top_left_y":2014,"width":56,"height":42},"line":95,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"510884144fba480590753014b092395c","type":"table_of_contents_number","conversion_output":true,"parent_id":"746ddcaaf66e48bda58f44d5723a26b0","text":"75","text_display":" ..... 75","confidence":1,"confidence_rate":1},{"cnt":[[334,2070],[1821,2070],[1821,2122],[334,2122]],"region":{"top_left_x":333,"top_left_y":2069,"width":1488,"height":54},"line":96,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3893d726ffb448f88868399edb618ec","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["618925f6c8af4eb0a8fe4fa015b0482c","a1bb731fd8214fb59c990b2c96611da4"],"text":"","text_display":""},{"cnt":[[338,2074],[991,2074],[991,2113],[338,2113]],"region":{"top_left_x":338,"top_left_y":2074,"width":654,"height":40},"line":97,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"618925f6c8af4eb0a8fe4fa015b0482c","type":"table_of_contents_item","conversion_output":true,"parent_id":"e3893d726ffb448f88868399edb618ec","text":"9.1 PUBLISHED REFERENCES","text_display":"\n9.1 PUBLISHED REFERENCES","confidence":1,"confidence_rate":1},{"cnt":[[1768,2076],[1823,2076],[1823,2115],[1768,2115]],"region":{"top_left_x":1768,"top_left_y":2076,"width":55,"height":40},"line":98,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a1bb731fd8214fb59c990b2c96611da4","type":"table_of_contents_number","conversion_output":true,"parent_id":"e3893d726ffb448f88868399edb618ec","text":"75","text_display":" ..... 75","confidence":1,"confidence_rate":1},{"cnt":[[334,2124],[1821,2124],[1821,2177],[334,2177]],"region":{"top_left_x":333,"top_left_y":2124,"width":1488,"height":54},"line":99,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"984cdb92744f48b2af8316b11c88bc0f","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["344a796194b34998b594d40eeac38bd3","d755ba0a303f46cf99738c4941df3b0a"],"text":"","text_display":""},{"cnt":[[338,2129],[1053,2129],[1053,2170],[338,2170]],"region":{"top_left_x":338,"top_left_y":2129,"width":716,"height":42},"line":100,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"344a796194b34998b594d40eeac38bd3","type":"table_of_contents_item","conversion_output":true,"parent_id":"984cdb92744f48b2af8316b11c88bc0f","text":"9.2 UNPUBLISHED REFERENCES","text_display":"\n9.2 UNPUBLISHED REFERENCES","confidence":1,"confidence_rate":1},{"cnt":[[1768,2131],[1823,2131],[1823,2170],[1768,2170]],"region":{"top_left_x":1768,"top_left_y":2131,"width":55,"height":40},"line":101,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d755ba0a303f46cf99738c4941df3b0a","type":"table_of_contents_number","conversion_output":true,"parent_id":"984cdb92744f48b2af8316b11c88bc0f","text":"78","text_display":" ..... 78","confidence":1,"confidence_rate":1},{"cnt":[[242,2184],[1821,2184],[1821,2241],[242,2241]],"region":{"top_left_x":242,"top_left_y":2183,"width":1579,"height":58},"line":102,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba9a13b06c894547b66bcf0443077970","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["9da11e3514984b0689998906b6aa9e3d","0048966cfc2d47c79ff5c261c1b51d41"],"text":"","text_display":""},{"cnt":[[247,2188],[660,2188],[660,2236],[247,2236]],"region":{"top_left_x":246,"top_left_y":2188,"width":415,"height":49},"line":103,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9da11e3514984b0689998906b6aa9e3d","type":"table_of_contents_item","conversion_output":true,"parent_id":"ba9a13b06c894547b66bcf0443077970","text":"10. APPENDICES","text_display":"\n10. APPENDICES","confidence":0.99560546875,"confidence_rate":0.9997682260434743},{"cnt":[[1764,2193],[1818,2193],[1818,2236],[1764,2236]],"region":{"top_left_x":1763,"top_left_y":2193,"width":56,"height":44},"line":104,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0048966cfc2d47c79ff5c261c1b51d41","type":"table_of_contents_number","conversion_output":true,"parent_id":"ba9a13b06c894547b66bcf0443077970","text":"79","text_display":" ..... 79","confidence":1,"confidence_rate":1},{"cnt":[[336,2250],[1821,2250],[1821,2300],[336,2300]],"region":{"top_left_x":335,"top_left_y":2250,"width":1486,"height":51},"line":105,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"019f0b9bca134846ac4972e9230d6e0c","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["ed79919af3e04ba987ea10a5ad8465be","5182236df4c345dcaf6770d802baa6b1"],"text":"","text_display":""},{"cnt":[[343,2257],[1254,2257],[1254,2296],[343,2296]],"region":{"top_left_x":342,"top_left_y":2256,"width":913,"height":40},"line":106,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed79919af3e04ba987ea10a5ad8465be","type":"table_of_contents_item","conversion_output":true,"parent_id":"019f0b9bca134846ac4972e9230d6e0c","text":"10.1 INCLUSION OF ILLITERATE PATIENTS","text_display":"\n10.1 INCLUSION OF ILLITERATE PATIENTS","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[1768,2257],[1823,2257],[1823,2298],[1768,2298]],"region":{"top_left_x":1768,"top_left_y":2256,"width":55,"height":43},"line":107,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5182236df4c345dcaf6770d802baa6b1","type":"table_of_contents_number","conversion_output":true,"parent_id":"019f0b9bca134846ac4972e9230d6e0c","text":"79","text_display":" ..... 79","confidence":1,"confidence_rate":1},{"cnt":[[461,2307],[1821,2305],[1821,2364],[461,2367]],"region":{"top_left_x":461,"top_left_y":2304,"width":1360,"height":63},"line":108,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b57e1f91d1044169940466771576004","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["85d2f8a969f943cea50a02c418b08b5e","5d00d958464c455c90139e44da61b7a7"],"text":"","text_display":""},{"cnt":[[466,2312],[1167,2312],[1167,2360],[466,2360]],"region":{"top_left_x":466,"top_left_y":2311,"width":702,"height":49},"line":109,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85d2f8a969f943cea50a02c418b08b5e","type":"table_of_contents_item","conversion_output":true,"parent_id":"8b57e1f91d1044169940466771576004","text":"10.1.1 Home blood glucose monitoring","text_display":"\n10.1.1 Home blood glucose monitoring","confidence":1,"confidence_rate":1},{"cnt":[[1768,2312],[1823,2312],[1823,2353],[1768,2353]],"region":{"top_left_x":1768,"top_left_y":2311,"width":55,"height":42},"line":110,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d00d958464c455c90139e44da61b7a7","type":"table_of_contents_number","conversion_output":true,"parent_id":"8b57e1f91d1044169940466771576004","text":"79","text_display":" ..... 79","confidence":1,"confidence_rate":1},{"cnt":[[461,2357],[1821,2357],[1821,2408],[461,2408]],"region":{"top_left_x":461,"top_left_y":2357,"width":1360,"height":51},"line":111,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2a0d24e0bfb491ca53451b47936a8dd","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["be8438ffa2f5433189e9934eacad53e2","866208f4bd9f480da06dbbc7323a1ea4"],"text":"","text_display":""},{"cnt":[[466,2362],[1345,2362],[1345,2401],[466,2401]],"region":{"top_left_x":466,"top_left_y":2362,"width":880,"height":39},"line":112,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be8438ffa2f5433189e9934eacad53e2","type":"table_of_contents_item","conversion_output":true,"parent_id":"d2a0d24e0bfb491ca53451b47936a8dd","text":"10.1.2 Patient information and informed consent","text_display":"\n10.1.2 Patient information and informed consent","confidence":1,"confidence_rate":1},{"cnt":[[1768,2362],[1823,2362],[1823,2408],[1768,2408]],"region":{"top_left_x":1768,"top_left_y":2362,"width":55,"height":46},"line":113,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"866208f4bd9f480da06dbbc7323a1ea4","type":"table_of_contents_number","conversion_output":true,"parent_id":"d2a0d24e0bfb491ca53451b47936a8dd","text":"79","text_display":" ..... 79","confidence":1,"confidence_rate":1},{"cnt":[[336,2408],[1821,2408],[1821,2460],[336,2460]],"region":{"top_left_x":335,"top_left_y":2407,"width":1486,"height":54},"line":114,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08256c206d50401888217f21cd80a26e","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["83a19e518455407cb2010a603499612f","c0a361e66556497c94a894ef1fc975c3"],"text":"","text_display":""},{"cnt":[[343,2417],[1213,2417],[1213,2456],[343,2456]],"region":{"top_left_x":342,"top_left_y":2416,"width":872,"height":40},"line":115,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83a19e518455407cb2010a603499612f","type":"table_of_contents_item","conversion_output":true,"parent_id":"08256c206d50401888217f21cd80a26e","text":"10.2 DEFINITIONS OF ENDPOINT EVENTS","text_display":"\n10.2 DEFINITIONS OF ENDPOINT EVENTS","confidence":0.99755859375,"confidence_rate":0.9999388920836204},{"cnt":[[1768,2417],[1823,2417],[1823,2463],[1768,2463]],"region":{"top_left_x":1768,"top_left_y":2416,"width":55,"height":47},"line":116,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0a361e66556497c94a894ef1fc975c3","type":"table_of_contents_number","conversion_output":true,"parent_id":"08256c206d50401888217f21cd80a26e","text":"80","text_display":" ..... 80","confidence":1,"confidence_rate":1},{"cnt":[[336,2463],[1821,2463],[1821,2517],[336,2517]],"region":{"top_left_x":335,"top_left_y":2462,"width":1486,"height":56},"line":117,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49a6b4e642b6452d927e2add47f94a04","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["aa20a62a65b94ca9af0f7f22f027c2d7","bc6e87ce6b9645338277be91f1fbc980"],"text":"","text_display":""},{"cnt":[[343,2472],[1455,2472],[1455,2511],[343,2511]],"region":{"top_left_x":342,"top_left_y":2471,"width":1114,"height":40},"line":118,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa20a62a65b94ca9af0f7f22f027c2d7","type":"table_of_contents_item","conversion_output":true,"parent_id":"49a6b4e642b6452d927e2add47f94a04","text":"10.3 BLOOD PRESSURE MEASUREMENT PROCEDURE","text_display":"\n10.3 BLOOD PRESSURE MEASUREMENT PROCEDURE","confidence":1,"confidence_rate":1},{"cnt":[[1768,2472],[1823,2472],[1823,2517],[1768,2517]],"region":{"top_left_x":1768,"top_left_y":2471,"width":55,"height":47},"line":119,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc6e87ce6b9645338277be91f1fbc980","type":"table_of_contents_number","conversion_output":true,"parent_id":"49a6b4e642b6452d927e2add47f94a04","text":"80","text_display":" ..... 80","confidence":1,"confidence_rate":1},{"cnt":[[336,2517],[1821,2517],[1821,2572],[336,2572]],"region":{"top_left_x":335,"top_left_y":2517,"width":1486,"height":56},"line":120,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1133b10a6d58446ab853f12b4aa0d53c","type":"table_of_contents_row","conversion_output":false,"parent_id":"b90288381ef049f7ac5f73e2b27ae3ee","children_ids":["71a008d34e5646b1a7ab51796ba40dbb","c59beea003d24ecdb83f3d37da6aa686"],"text":"","text_display":""},{"cnt":[[343,2527],[1208,2527],[1208,2565],[343,2565]],"region":{"top_left_x":342,"top_left_y":2526,"width":867,"height":40},"line":121,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71a008d34e5646b1a7ab51796ba40dbb","type":"table_of_contents_item","conversion_output":true,"parent_id":"1133b10a6d58446ab853f12b4aa0d53c","text":"10.4 SILENT MYOCARDIAL INFARCTION","text_display":"\n10.4 SILENT MYOCARDIAL INFARCTION","confidence":1,"confidence_rate":1},{"cnt":[[1768,2527],[1823,2527],[1823,2572],[1768,2572]],"region":{"top_left_x":1768,"top_left_y":2526,"width":55,"height":47},"line":122,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c59beea003d24ecdb83f3d37da6aa686","type":"table_of_contents_number","conversion_output":true,"parent_id":"1133b10a6d58446ab853f12b4aa0d53c","text":"81","text_display":" ..... 81","confidence":1,"confidence_rate":1},{"cnt":[[788,2581],[1302,2581],[1302,2625],[788,2625]],"region":{"top_left_x":788,"top_left_y":2581,"width":515,"height":44},"line":123,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1c53f6d7699d4e1bbc9340b8f630960b","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[288,2622],[1798,2622],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2622,"width":1511,"height":40},"line":124,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bc8794e301254e8e9975fc55711d070d","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.98583984375,"confidence_rate":0.9998801637536546},{"cnt":[[297,2666],[1770,2666],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2665,"width":1475,"height":38},"line":125,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fcab35a2777c493b9bb78fa5fd89d06f","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-014","page":14,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4752ef75d1054f5d9055591d336a1d57","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef254180eb844b03a8fad2dd256653c3","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b2d2b5402a547c298014a154b18eb4a","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,208],[637,208],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":207,"width":394,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6c8a470922943f08fb75cedf1460938","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12fb160b59c54d9490acfc91ac805c70","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f508e5df89241e8825bb48b864b0b03","type":"page_info","conversion_output":false,"text":"Page 14 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[240,334],[1823,334],[1823,404],[240,404]],"region":{"top_left_x":239,"top_left_y":333,"width":1584,"height":72},"line":7,"column":0,"font_size":29,"is_printed":true,"is_handwritten":false,"id":"a29fc8f39d5b495da6a7610039c55cad","type":"table_of_contents_container","conversion_output":false,"children_ids":["2c4c6871f4034b89b7f77086881cf1e2"],"text":"","text_display":""},{"cnt":[[242,334],[1823,334],[1823,404],[242,404]],"region":{"top_left_x":242,"top_left_y":333,"width":1581,"height":72},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2c4c6871f4034b89b7f77086881cf1e2","type":"table_of_contents_row","conversion_output":false,"parent_id":"a29fc8f39d5b495da6a7610039c55cad","children_ids":["29a3488d2962436680a7d6ba0c2ef4cc","dacf4d356f97419cbb9c765c0b808c75"],"text":"","text_display":""},{"cnt":[[247,343],[1387,343],[1387,400],[247,400]],"region":{"top_left_x":246,"top_left_y":342,"width":1141,"height":58},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"29a3488d2962436680a7d6ba0c2ef4cc","type":"table_of_contents_item","conversion_output":true,"parent_id":"2c4c6871f4034b89b7f77086881cf1e2","text":"11. DESCRIPTION OF GLOBAL AMENDMENT(S)","text_display":"\n11. DESCRIPTION OF GLOBAL AMENDMENT(S)","confidence":1,"confidence_rate":1},{"cnt":[[1759,331],[1823,331],[1823,388],[1759,388]],"region":{"top_left_x":1758,"top_left_y":331,"width":65,"height":58},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dacf4d356f97419cbb9c765c0b808c75","type":"table_of_contents_number","conversion_output":true,"parent_id":"2c4c6871f4034b89b7f77086881cf1e2","text":"82","text_display":" ..... 82","confidence":1,"confidence_rate":1},{"cnt":[[790,2586],[1300,2586],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2585,"width":510,"height":40},"line":11,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"18e8da6ffdca4a3092f7d72bac61cc31","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.9833984375,"confidence_rate":0.9996014862638709},{"cnt":[[292,2620],[1798,2620],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2620,"width":1506,"height":42},"line":12,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4438827afd9b440cac3a4a2c8f9046e2","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.99658203125,"confidence_rate":0.999971228789113},{"cnt":[[297,2664],[1770,2664],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1475,"height":40},"line":13,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c13a1170a63c41cbad7c6f8167f7dee6","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-015","page":15,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6e55ae83aa245b998e810b0b9971dd8","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"482be7037639467e97a21b2bb8fb0e78","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22889de6fdec41a5979c48ec88e00531","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1bd74badd764e578505c9b6dac956a5","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,247],[868,247]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":37},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e35159951c3e4addb3d8fcc09c9561af","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4c08e81d6494bf78a7a64660b6b22fb","type":"page_info","conversion_output":false,"text":"Page 15 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,340],[665,340],[665,391],[242,391]],"region":{"top_left_x":242,"top_left_y":340,"width":423,"height":51},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"67a0ec9f98164c5ab6656d64c5348ce7","type":"section_header","conversion_output":false,"children_ids":["57181459c6914b7a9bdeeb2e0dd23a9e"],"text":"","text_display":""},{"cnt":[[247,343],[662,343],[662,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":417,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"57181459c6914b7a9bdeeb2e0dd23a9e","type":"text","conversion_output":true,"parent_id":"67a0ec9f98164c5ab6656d64c5348ce7","text":"ABBREVIATIONS","text_display":"\n\n\\section*{ABBREVIATIONS}","confidence":1,"confidence_rate":1},{"cnt":[[240,434],[1704,434],[1704,2549],[240,2549]],"region":{"top_left_x":239,"top_left_y":434,"width":1466,"height":2116},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c08ec4d40905488ea6ad7d639cbe2d25","type":"table","conversion_output":true,"children_ids":["2bde43ed91e749539d57d7cc258012a2","42e7cce22de242c0b8351b3c082edad8","edde66684dde41e9aa0cf23726a32319","e6021297e2a841e387d3a3397b11bdb3","094d6b4144c1499c9a713245ad5471ca","a99544fe3b5844cc90c41c00e2a80690","b4047029cb82410cb141dea869009e27","d21a7c42c2c147b79d5bd748cbfabe1e","068072032e0d449c9047d4217c128739","239913be6e2e42ff98e91b8b7d8bb3eb","78637a4cb0e648fbae868b1f8e02d228","10d978a5e6e24ff3b183e36c5e531769","4aff32160906474d90e2b0e972093fa4","f5c8a65c98c046b09f8b2723c0aa7946","5220e97a0040427b876268c99941442b","7b2144b12ca0432c9bdeef15a0a45c86","efd49cb299cc40a497e8e6577cb32fb6","d4bae80653aa424b8446183060ecb900","976335907bc4443c84e53be57a2af11a","7aa7b4151a0f4a12861630e0b9782fef","5295542dc06a45fd9e79ee08e372fcb8","7a9c92b5050c479abfd31cafc09bdc32","561ba76b9fe349d28567190932ba0bb4","84c183cb3a8c4a1abfbb42ce2ba2008f","b9d1e0b077b8492e8a5909f4ef70f910","4fd8afbe6f914a4eb8d928f33f3da974","a846adaa1acc4dae962282657dba27cd","6991a349e72745d9b20bd9dda49cb329","bb55bfb56c844844afb47a85059058e1","806cc2724901405991e1b88a95f97c1f","215cf7840a7143b0b9e947ec7f7d12a0","145f25d78314407db7cc4c0659849129","ef81a563135144ad9a13159ee116d871","7570115222254c3f84d13b12787f7c87","fc7ecd5236db4e18905c4050a2be0f2a","cef20bbb57414da0996b96ebd56757d7","3c31f45a842f43d982d597833ee6a0b2","07f229dd62d64216af418a250afc425d","4be65b4be72141bbba10a2939b937f2f","69f44fba1a994c478e9d9c4b5276966b","aeb24b10be7b4d51b8e1b67c0bf9204b","2507b20b72e54f05b8754b233616e38d","88af9fddcfff44a59d3fca3637eb8e7d","42aec36220954672803e2e630283337d","f58bfbe784fc4539915ec6a0dd23ee6e","0c26bc08379a4242916c383d9e958e61","5010e84e544e41b7bc848c33e2e31214","a8330936503a4b42ab2d83bed5241d10","fb7ba2a92c90492db158b2259191b7ea","a9b6273c1a40429993602564dacfb34c","299b93223ba844a899358163620c0ab9","1370a56242014fa49cd7d04f605f151e","37cb0644810544e3ab3469cf438b46e8","f23fafdb7f1c4550a0525fb230181dc0","6aeacf8a0bb840fd8ccec0cb10f90390","0247be583125483c885e5cfd06cf479b","1c4f9658634046c7b26cd0390ba1bd69","672dd283584b4802833d4c996096488e","082e093cdb1a4151bd81a71f372c1dbb","bbc2d02ee65d4c0cb56c3a258fc95c77","3529c11f69a74443918ae04792a93422","81122dd851554f169f1c72fb52b296e1","279b07e2d46c49cfb04772371cbfc5e3","09846101a6144cd3856a4f9837247d55","0a83f9297b3d41a29390e9d406e05666","b7a3df18bb844d15b94c387e39dbce9c","1e7c83e8da4048df9b0965a449266993","1ea3dddbe6a64ef588d1d2b31bcc68fb","4ebdaaa7c83a4796aefbaa6686a593ff","54caf4f6339b4b19a0a9c20d7b1fd30a","109dbf76bab7477db76a85a6181dffe3","210980b56d9841d1af4d62dd5ff49c98","d19b2a0c603a407b95b24133c20ff8a3","0cbd15386644419db264cc15f5f495b5","5fc8a9d8fe3c47f8a9d480fc5f1782e1","09e79a4a1476487da58ad56a89cf6399","67c909219fc64176838c58594b0323c0","51b5bce372bb46e19b61d7bb9a451e9c","c7546b9477944ef38b3d0a14021d4527","e28305884e234b1e9fba7a8dc1958e71","3e0d6e72b3094179a82c7d3bacc55aab","57392c4776d24c08bffc75c45f36c7de","62412390cea84fe7879c61e5f588599b","ec2918bfb24148b6a85bb99fc922a5a4","1be2f099a1d34d25bd5bb1d6f1de0311","2837a5f1f4694be98bcaf80676b129f3","828338de28bd4723952ee946446277b4","35e15e47b2424cc999d1714d5ea6d456","2333300f68954ab2980fc810455e7649","493c9e2c1bc2429e87c3379a2c45cee6","52926237a0ab4f47b209faf1d99ead06","2e6f757a22f34deca4867c39e018c358","7077e6983b7747d5a22ac73e8e44c2fb","7217406f934841bea9fab73d08174a24","30347af3d4f74ab3b2aeb6e84a5d2fa8","b7c9761be8074045b57395513549221e","d3d303b3e7874d9996f86dbff06a0bb3","1d27c2a9654d4ccb815811a8cba668ca","1edeb2303ddb42948b13cd9649acde64","ff33fdec999e4486b228e1da87cc8be3","2e2ee8478f4b4fd19baf349f9d1a7c93","99269d7b9e234846ba6673ede106bc62","989b3a69f51f4daa8013e368030dbc05","4cf0c70a1fe8448dbd25084e2f972962","cd4129ddc09045579059be59c8eefeb7","6e192f37eb104d75aa4fbc120fd3f19c","c4cd7cc1de7b440599c13760de1020b3","9e71bc2c615f4607a09b904ed6633c21","e19ee0dcc93f43cf823e8d711ffe2dbf","895f72e1ea984144a4be29dc090d3f64","71bebde76bcf49598b8b6a9c8f4daab9","2ce3e6e9219145bb8e3b1da76bcba4ea","fe36ef68ad1a45bbb3c8bcbc9041360a","dc7037f5aca14f2ebd85231a798554c1","f71ea28d4bad46089f50f893165bea36","7ec1c63e9aab49029470d6ae5945fdfd","136e3d52bdde4965b5935b28b7045c5e","ef4bc74c460e43d6a187c893e4514d5c","b8ce1cfe23d342e38a52b2441b9d4f7b","59e508dde71b45a18c4cc80c12c7ebc6","503f733678584fc1b34fb09335fd04dc","9274984ad85f4d4190c8a8a473a6d8fe","5533ff93bb9b493fa2877bce25d32e45","4be09db10a724feb9b007171ea720fbb","031bfd5cfc534962bb902c470bd06e4e","d1a2c6096f15414ea7c27d6aa65d8c39","03293b91d52541059a3824612a82dec8","24f4440ff4094aa48bfdafe624ac84c8","f1acb203b1e04c96a4d27f811aa639d1","2069746751284607854010142a381751","ee0034cd8daf4614a58edafbd044023b","587c06a260f641bc91679886f4f17140","0d89d18540ea413482960fcc367907d6","a36876066bc240fab956af1298e80737"],"text":"\\begin{tabular}{|l|l|}\n\\hline ACEi & Angiotensin Converting Enzyme inhibitor \\\\\n\\hline AE & Adverse Event \\\\\n\\hline AESI & Adverse Event of Special Interest \\\\\n\\hline ALD & Approximate Lethal Dose \\\\\n\\hline ALT & Alanine Transaminase (SGPT) \\\\\n\\hline AP & Alkaline Phosphatase \\\\\n\\hline ARB & Angiotensin Receptor Blocker \\\\\n\\hline AST & Aspartate transaminase (SGOT) \\\\\n\\hline BI & Boehringer Ingelheim \\\\\n\\hline BMI & Body Mass Index (weight in kg divided by height in meters squared) \\\\\n\\hline BP & Blood Pressure \\\\\n\\hline CA & Competent Authority \\\\\n\\hline CABG & Coronary Artery Bypass Graft \\\\\n\\hline CCDS & Company Core Data Sheet \\\\\n\\hline CEC & Clinical Event Committee \\\\\n\\hline CES-D & Center for Epidemiologic Studies Depression scale \\\\\n\\hline CHF & Congestive Heart Failure \\\\\n\\hline CKD & Chronic Kidney Disease \\\\\n\\hline CRA & Clinical Research Associate \\\\\n\\hline CRO & Contract Research Organisation \\\\\n\\hline CRF & Case Report Form \\\\\n\\hline CTMF & Clinical Trial Master File \\\\\n\\hline CTP & Clinical Trial Protocol \\\\\n\\hline CTSU & Clinical Trial Supply Unit \\\\\n\\hline CV & Cardiovascular \\\\\n\\hline DBP & Diastolic Blood Pressure \\\\\n\\hline DMC & Data Monitoring Committee \\\\\n\\hline DNA & Deoxyribonucleic Acid \\\\\n\\hline DPP-4 & Dipeptidyl-peptidase 4 \\\\\n\\hline ECG & Electrocardiogram \\\\\n\\hline eCRF & Electronic Case Report Form \\\\\n\\hline eGFR & Estimated Glomerular filtration Rate \\\\\n\\hline EOT & End of Treatment \\\\\n\\hline ESRD & End Stage Renal Disease \\\\\n\\hline EudraCT & European Clinical Trials Database \\\\\n\\hline FAS & Full Analysis Set \\\\\n\\hline FDA & Food and Drug Administration \\\\\n\\hline FPG & Fasting Plasma Glucose \\\\\n\\hline GCP & Good Clinical Practice \\\\\n\\hline \\(\\gamma\\)-GT & Gamma-glutamyl-transferase (GGT) \\\\\n\\hline GI & GastroIntestinal \\\\\n\\hline GIP & Glucose-dependent Insulinotropic Peptide \\\\\n\\hline GLP-1 & Glucagon-like Peptide 1 \\\\\n\\hline \\(HbA _{1 c }\\) & Glycosylated Haemoglobin \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline ACEi & Angiotensin Converting Enzyme inhibitor \\\\\n\\hline AE & Adverse Event \\\\\n\\hline AESI & Adverse Event of Special Interest \\\\\n\\hline ALD & Approximate Lethal Dose \\\\\n\\hline ALT & Alanine Transaminase (SGPT) \\\\\n\\hline AP & Alkaline Phosphatase \\\\\n\\hline ARB & Angiotensin Receptor Blocker \\\\\n\\hline AST & Aspartate transaminase (SGOT) \\\\\n\\hline BI & Boehringer Ingelheim \\\\\n\\hline BMI & Body Mass Index (weight in kg divided by height in meters squared) \\\\\n\\hline BP & Blood Pressure \\\\\n\\hline CA & Competent Authority \\\\\n\\hline CABG & Coronary Artery Bypass Graft \\\\\n\\hline CCDS & Company Core Data Sheet \\\\\n\\hline CEC & Clinical Event Committee \\\\\n\\hline CES-D & Center for Epidemiologic Studies Depression scale \\\\\n\\hline CHF & Congestive Heart Failure \\\\\n\\hline CKD & Chronic Kidney Disease \\\\\n\\hline CRA & Clinical Research Associate \\\\\n\\hline CRO & Contract Research Organisation \\\\\n\\hline CRF & Case Report Form \\\\\n\\hline CTMF & Clinical Trial Master File \\\\\n\\hline CTP & Clinical Trial Protocol \\\\\n\\hline CTSU & Clinical Trial Supply Unit \\\\\n\\hline CV & Cardiovascular \\\\\n\\hline DBP & Diastolic Blood Pressure \\\\\n\\hline DMC & Data Monitoring Committee \\\\\n\\hline DNA & Deoxyribonucleic Acid \\\\\n\\hline DPP-4 & Dipeptidyl-peptidase 4 \\\\\n\\hline ECG & Electrocardiogram \\\\\n\\hline eCRF & Electronic Case Report Form \\\\\n\\hline eGFR & Estimated Glomerular filtration Rate \\\\\n\\hline EOT & End of Treatment \\\\\n\\hline ESRD & End Stage Renal Disease \\\\\n\\hline EudraCT & European Clinical Trials Database \\\\\n\\hline FAS & Full Analysis Set \\\\\n\\hline FDA & Food and Drug Administration \\\\\n\\hline FPG & Fasting Plasma Glucose \\\\\n\\hline GCP & Good Clinical Practice \\\\\n\\hline \\(\\gamma\\)-GT & Gamma-glutamyl-transferase (GGT) \\\\\n\\hline GI & GastroIntestinal \\\\\n\\hline GIP & Glucose-dependent Insulinotropic Peptide \\\\\n\\hline GLP-1 & Glucagon-like Peptide 1 \\\\\n\\hline \\(HbA _{1 c }\\) & Glycosylated Haemoglobin \\\\\n\\hline\n\\end{tabular}","confidence":0.9765625,"confidence_rate":0.9999861745990059},{"cnt":[[239,434],[412,434],[412,2548],[239,2548]],"region":{"top_left_x":239,"top_left_y":434,"width":173,"height":2114},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2bde43ed91e749539d57d7cc258012a2","type":"table_column","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[541,434],[1703,434],[1703,2552],[541,2552]],"region":{"top_left_x":540,"top_left_y":434,"width":1164,"height":2119},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42e7cce22de242c0b8351b3c082edad8","type":"table_column","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,434],[1710,434],[1710,485],[239,485]],"region":{"top_left_x":239,"top_left_y":434,"width":1472,"height":51},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"edde66684dde41e9aa0cf23726a32319","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,485],[1710,485],[1710,528],[239,528]],"region":{"top_left_x":239,"top_left_y":484,"width":1472,"height":45},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e6021297e2a841e387d3a3397b11bdb3","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,531],[1708,531],[1708,579],[239,579]],"region":{"top_left_x":239,"top_left_y":530,"width":1469,"height":50},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"094d6b4144c1499c9a713245ad5471ca","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,581],[1708,581],[1708,630],[239,630]],"region":{"top_left_x":239,"top_left_y":581,"width":1469,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a99544fe3b5844cc90c41c00e2a80690","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,627],[1708,627],[1708,678],[239,678]],"region":{"top_left_x":239,"top_left_y":627,"width":1469,"height":52},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b4047029cb82410cb141dea869009e27","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,678],[1708,678],[1708,724],[239,724]],"region":{"top_left_x":239,"top_left_y":678,"width":1469,"height":47},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d21a7c42c2c147b79d5bd748cbfabe1e","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,724],[1710,724],[1710,772],[239,772]],"region":{"top_left_x":239,"top_left_y":724,"width":1472,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"068072032e0d449c9047d4217c128739","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,772],[1706,772],[1706,823],[239,823]],"region":{"top_left_x":239,"top_left_y":772,"width":1467,"height":52},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"239913be6e2e42ff98e91b8b7d8bb3eb","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,821],[1708,821],[1708,869],[239,869]],"region":{"top_left_x":239,"top_left_y":820,"width":1469,"height":50},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78637a4cb0e648fbae868b1f8e02d228","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,867],[1710,867],[1710,920],[239,920]],"region":{"top_left_x":239,"top_left_y":866,"width":1472,"height":54},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10d978a5e6e24ff3b183e36c5e531769","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,918],[1708,918],[1708,961],[239,961]],"region":{"top_left_x":239,"top_left_y":917,"width":1469,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4aff32160906474d90e2b0e972093fa4","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,964],[1710,964],[1710,1014],[239,1014]],"region":{"top_left_x":239,"top_left_y":963,"width":1472,"height":52},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5c8a65c98c046b09f8b2723c0aa7946","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1012],[1710,1012],[1710,1063],[239,1063]],"region":{"top_left_x":239,"top_left_y":1011,"width":1472,"height":52},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5220e97a0040427b876268c99941442b","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1060],[1708,1060],[1708,1109],[239,1109]],"region":{"top_left_x":239,"top_left_y":1060,"width":1469,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b2144b12ca0432c9bdeef15a0a45c86","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1106],[1706,1106],[1706,1150],[239,1150]],"region":{"top_left_x":239,"top_left_y":1106,"width":1467,"height":45},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"efd49cb299cc40a497e8e6577cb32fb6","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1155],[1708,1152],[1708,1205],[239,1208]],"region":{"top_left_x":238,"top_left_y":1152,"width":1471,"height":56},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4bae80653aa424b8446183060ecb900","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1203],[1708,1203],[1708,1251],[239,1251]],"region":{"top_left_x":239,"top_left_y":1203,"width":1469,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"976335907bc4443c84e53be57a2af11a","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1251],[1706,1251],[1706,1302],[239,1302]],"region":{"top_left_x":239,"top_left_y":1251,"width":1467,"height":52},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7aa7b4151a0f4a12861630e0b9782fef","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1300],[1706,1300],[1706,1343],[239,1343]],"region":{"top_left_x":239,"top_left_y":1299,"width":1467,"height":45},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5295542dc06a45fd9e79ee08e372fcb8","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1346],[1708,1346],[1708,1399],[239,1399]],"region":{"top_left_x":239,"top_left_y":1345,"width":1469,"height":54},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a9c92b5050c479abfd31cafc09bdc32","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1396],[1706,1396],[1706,1445],[239,1445]],"region":{"top_left_x":239,"top_left_y":1396,"width":1467,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"561ba76b9fe349d28567190932ba0bb4","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1442],[1708,1442],[1708,1489],[239,1489]],"region":{"top_left_x":239,"top_left_y":1442,"width":1469,"height":47},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84c183cb3a8c4a1abfbb42ce2ba2008f","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1492],[1706,1489],[1706,1535],[239,1538]],"region":{"top_left_x":238,"top_left_y":1489,"width":1468,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b9d1e0b077b8492e8a5909f4ef70f910","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1539],[1708,1539],[1708,1588],[239,1588]],"region":{"top_left_x":239,"top_left_y":1539,"width":1469,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4fd8afbe6f914a4eb8d928f33f3da974","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1588],[1706,1588],[1706,1634],[239,1634]],"region":{"top_left_x":239,"top_left_y":1587,"width":1467,"height":47},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a846adaa1acc4dae962282657dba27cd","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1634],[1706,1634],[1706,1680],[239,1680]],"region":{"top_left_x":239,"top_left_y":1633,"width":1467,"height":47},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6991a349e72745d9b20bd9dda49cb329","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1682],[1710,1682],[1710,1733],[239,1733]],"region":{"top_left_x":239,"top_left_y":1681,"width":1472,"height":52},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb55bfb56c844844afb47a85059058e1","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1733],[1710,1733],[1710,1781],[239,1781]],"region":{"top_left_x":239,"top_left_y":1732,"width":1472,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"806cc2724901405991e1b88a95f97c1f","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1779],[1708,1779],[1708,1827],[239,1827]],"region":{"top_left_x":239,"top_left_y":1778,"width":1469,"height":50},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"215cf7840a7143b0b9e947ec7f7d12a0","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1827],[1708,1827],[1708,1878],[239,1878]],"region":{"top_left_x":239,"top_left_y":1827,"width":1469,"height":51},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"145f25d78314407db7cc4c0659849129","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1875],[1706,1875],[1706,1924],[239,1924]],"region":{"top_left_x":239,"top_left_y":1875,"width":1467,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef81a563135144ad9a13159ee116d871","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1921],[1708,1921],[1708,1970],[239,1970]],"region":{"top_left_x":239,"top_left_y":1921,"width":1469,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7570115222254c3f84d13b12787f7c87","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,1970],[1706,1970],[1706,2014],[239,2014]],"region":{"top_left_x":239,"top_left_y":1969,"width":1467,"height":45},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc7ecd5236db4e18905c4050a2be0f2a","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2018],[1706,2018],[1706,2066],[239,2066]],"region":{"top_left_x":239,"top_left_y":2018,"width":1467,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cef20bbb57414da0996b96ebd56757d7","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2066],[1710,2066],[1710,2117],[239,2117]],"region":{"top_left_x":239,"top_left_y":2066,"width":1472,"height":52},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c31f45a842f43d982d597833ee6a0b2","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2115],[1706,2115],[1706,2163],[239,2163]],"region":{"top_left_x":239,"top_left_y":2114,"width":1467,"height":50},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07f229dd62d64216af418a250afc425d","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2161],[1708,2161],[1708,2212],[239,2212]],"region":{"top_left_x":239,"top_left_y":2160,"width":1469,"height":52},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4be65b4be72141bbba10a2939b937f2f","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2212],[1706,2212],[1706,2260],[239,2260]],"region":{"top_left_x":239,"top_left_y":2211,"width":1467,"height":49},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69f44fba1a994c478e9d9c4b5276966b","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2258],[1706,2258],[1706,2301],[239,2301]],"region":{"top_left_x":239,"top_left_y":2257,"width":1467,"height":45},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aeb24b10be7b4d51b8e1b67c0bf9204b","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2304],[1710,2304],[1710,2357],[239,2357]],"region":{"top_left_x":239,"top_left_y":2303,"width":1472,"height":54},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2507b20b72e54f05b8754b233616e38d","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2354],[1706,2354],[1706,2398],[239,2398]],"region":{"top_left_x":239,"top_left_y":2354,"width":1467,"height":45},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"88af9fddcfff44a59d3fca3637eb8e7d","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2400],[1708,2400],[1708,2453],[239,2453]],"region":{"top_left_x":239,"top_left_y":2400,"width":1469,"height":54},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42aec36220954672803e2e630283337d","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2451],[1706,2451],[1706,2499],[239,2499]],"region":{"top_left_x":239,"top_left_y":2450,"width":1467,"height":50},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f58bfbe784fc4539915ec6a0dd23ee6e","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[239,2497],[1706,2497],[1706,2548],[239,2548]],"region":{"top_left_x":239,"top_left_y":2497,"width":1467,"height":51},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c26bc08379a4242916c383d9e958e61","type":"table_row","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"","text_display":""},{"cnt":[[246,439],[347,439],[347,478],[246,478]],"region":{"top_left_x":245,"top_left_y":438,"width":103,"height":40},"line":56,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"5010e84e544e41b7bc848c33e2e31214","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"ACEi","text_display":"ACEi","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,439],[1259,439],[1259,482],[548,482]],"region":{"top_left_x":547,"top_left_y":438,"width":713,"height":45},"line":57,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"a8330936503a4b42ab2d83bed5241d10","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Angiotensin Converting Enzyme inhibitor","text_display":"Angiotensin Converting Enzyme inhibitor","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,489],[308,489],[308,526],[239,526]],"region":{"top_left_x":239,"top_left_y":489,"width":70,"height":38},"line":58,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"fb7ba2a92c90492db158b2259191b7ea","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"AE","text_display":"AE","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,489],[799,489],[799,524],[548,524]],"region":{"top_left_x":547,"top_left_y":489,"width":252,"height":35},"line":59,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"a9b6273c1a40429993602564dacfb34c","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Adverse Event","text_display":"Adverse Event","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,526],[347,526],[347,570],[239,570]],"region":{"top_left_x":239,"top_left_y":526,"width":109,"height":44},"line":60,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"299b93223ba844a899358163620c0ab9","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"AESI","text_display":"AESI","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,535],[1112,535],[1112,579],[548,579]],"region":{"top_left_x":547,"top_left_y":535,"width":565,"height":45},"line":61,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1370a56242014fa49cd7d04f605f151e","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Adverse Event of Special Interest","text_display":"Adverse Event of Special Interest","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,581],[340,581],[340,623],[239,623]],"region":{"top_left_x":239,"top_left_y":581,"width":102,"height":42},"line":62,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"37cb0644810544e3ab3469cf438b46e8","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"ALD","text_display":"ALD","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,584],[985,584],[985,625],[548,625]],"region":{"top_left_x":547,"top_left_y":583,"width":439,"height":43},"line":63,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"f23fafdb7f1c4550a0525fb230181dc0","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Approximate Lethal Dose","text_display":"Approximate Lethal Dose","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,621],[336,621],[336,669],[239,669]],"region":{"top_left_x":239,"top_left_y":620,"width":97,"height":49},"line":64,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"6aeacf8a0bb840fd8ccec0cb10f90390","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"ALT","text_display":"ALT","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,632],[1066,632],[1066,676],[548,676]],"region":{"top_left_x":547,"top_left_y":632,"width":519,"height":44},"line":65,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"0247be583125483c885e5cfd06cf479b","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Alanine Transaminase (SGPT)","text_display":"Alanine Transaminase (SGPT)","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,676],[308,676],[308,717],[239,717]],"region":{"top_left_x":239,"top_left_y":675,"width":70,"height":43},"line":66,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1c4f9658634046c7b26cd0390ba1bd69","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"AP","text_display":"AP","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,678],[914,678],[914,722],[548,722]],"region":{"top_left_x":547,"top_left_y":678,"width":367,"height":44},"line":67,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"672dd283584b4802833d4c996096488e","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Alkaline Phosphatase","text_display":"Alkaline Phosphatase","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,729],[336,729],[336,766],[239,766]],"region":{"top_left_x":239,"top_left_y":728,"width":97,"height":38},"line":68,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"082e093cdb1a4151bd81a71f372c1dbb","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"ARB","text_display":"ARB","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,729],[1061,729],[1061,772],[548,772]],"region":{"top_left_x":547,"top_left_y":728,"width":514,"height":45},"line":69,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"bbc2d02ee65d4c0cb56c3a258fc95c77","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Angiotensin Receptor Blocker","text_display":"Angiotensin Receptor Blocker","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,768],[336,768],[336,812],[239,812]],"region":{"top_left_x":239,"top_left_y":767,"width":97,"height":45},"line":70,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"3529c11f69a74443918ae04792a93422","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"AST","text_display":"AST","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,775],[1089,775],[1089,819],[548,819]],"region":{"top_left_x":547,"top_left_y":774,"width":542,"height":45},"line":71,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"81122dd851554f169f1c72fb52b296e1","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Aspartate transaminase (SGOT)","text_display":"Aspartate transaminase (SGOT)","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,823],[294,823],[294,862],[239,862]],"region":{"top_left_x":239,"top_left_y":823,"width":56,"height":40},"line":72,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"279b07e2d46c49cfb04772371cbfc5e3","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"BI","text_display":"BI","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,823],[923,823],[923,867],[548,867]],"region":{"top_left_x":547,"top_left_y":823,"width":376,"height":44},"line":73,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"09846101a6144cd3856a4f9837247d55","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Boehringer Ingelheim","text_display":"Boehringer Ingelheim","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,862],[336,862],[336,908],[239,908]],"region":{"top_left_x":239,"top_left_y":862,"width":97,"height":47},"line":74,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"0a83f9297b3d41a29390e9d406e05666","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"BMI","text_display":"BMI","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,871],[1701,871],[1701,915],[548,915]],"region":{"top_left_x":547,"top_left_y":871,"width":1155,"height":45},"line":75,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"b7a3df18bb844d15b94c387e39dbce9c","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Body Mass Index (weight in kg divided by height in meters squared)","text_display":"Body Mass Index (weight in kg divided by height in meters squared)","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9765625,"confidence_rate":0.9996660201975156},{"cnt":[[239,918],[303,918],[303,959],[239,959]],"region":{"top_left_x":239,"top_left_y":917,"width":65,"height":42},"line":76,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1e7c83e8da4048df9b0965a449266993","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"BP","text_display":"BP","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,920],[808,920],[808,957],[548,957]],"region":{"top_left_x":547,"top_left_y":919,"width":261,"height":38},"line":77,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1ea3dddbe6a64ef588d1d2b31bcc68fb","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Blood Pressure","text_display":"Blood Pressure","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,968],[313,968],[313,1005],[239,1005]],"region":{"top_left_x":239,"top_left_y":968,"width":74,"height":38},"line":78,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"4ebdaaa7c83a4796aefbaa6686a593ff","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CA","text_display":"CA","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,968],[909,968],[909,1012],[548,1012]],"region":{"top_left_x":547,"top_left_y":968,"width":363,"height":44},"line":79,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"54caf4f6339b4b19a0a9c20d7b1fd30a","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Competent Authority","text_display":"Competent Authority","cell_row":11,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1014],[370,1014],[370,1053],[248,1053]],"region":{"top_left_x":248,"top_left_y":1014,"width":123,"height":40},"line":80,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"109dbf76bab7477db76a85a6181dffe3","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CABG","text_display":"CABG","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1014],[1061,1014],[1061,1058],[548,1058]],"region":{"top_left_x":547,"top_left_y":1014,"width":514,"height":44},"line":81,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"210980b56d9841d1af4d62dd5ff49c98","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Coronary Artery Bypass Graft","text_display":"Coronary Artery Bypass Graft","cell_row":12,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1063],[361,1063],[361,1099],[248,1099]],"region":{"top_left_x":248,"top_left_y":1062,"width":114,"height":38},"line":82,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"d19b2a0c603a407b95b24133c20ff8a3","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CCDS","text_display":"CCDS","cell_row":13,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1063],[1001,1063],[1001,1104],[548,1104]],"region":{"top_left_x":547,"top_left_y":1062,"width":455,"height":43},"line":83,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"0cbd15386644419db264cc15f5f495b5","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Company Core Data Sheet","text_display":"Company Core Data Sheet","cell_row":13,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,1102],[336,1102],[336,1148],[239,1148]],"region":{"top_left_x":239,"top_left_y":1101,"width":97,"height":47},"line":84,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"5fc8a9d8fe3c47f8a9d480fc5f1782e1","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CEC","text_display":"CEC","cell_row":14,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1111],[987,1111],[987,1148],[548,1148]],"region":{"top_left_x":547,"top_left_y":1110,"width":441,"height":38},"line":85,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"09e79a4a1476487da58ad56a89cf6399","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Clinical Event Committee","text_display":"Clinical Event Committee","cell_row":14,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1157],[370,1157],[370,1196],[248,1196]],"region":{"top_left_x":248,"top_left_y":1156,"width":123,"height":41},"line":86,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"67c909219fc64176838c58594b0323c0","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CES-D","text_display":"CES-D","cell_row":15,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1157],[1406,1157],[1406,1201],[548,1201]],"region":{"top_left_x":547,"top_left_y":1156,"width":860,"height":45},"line":87,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"51b5bce372bb46e19b61d7bb9a451e9c","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Center for Epidemiologic Studies Depression scale","text_display":"Center for Epidemiologic Studies Depression scale","cell_row":15,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,1196],[333,1196],[333,1242],[239,1242]],"region":{"top_left_x":239,"top_left_y":1196,"width":95,"height":47},"line":88,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"c7546b9477944ef38b3d0a14021d4527","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CHF","text_display":"CHF","cell_row":16,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9951171875,"confidence_rate":0.9993883405928387},{"cnt":[[548,1203],[973,1203],[973,1251],[548,1251]],"region":{"top_left_x":547,"top_left_y":1203,"width":427,"height":49},"line":89,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"e28305884e234b1e9fba7a8dc1958e71","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Congestive Heart Failure","text_display":"Congestive Heart Failure","cell_row":16,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99609375,"confidence_rate":0.9998650470614108},{"cnt":[[239,1251],[340,1251],[340,1291],[239,1291]],"region":{"top_left_x":239,"top_left_y":1251,"width":102,"height":40},"line":90,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"3e0d6e72b3094179a82c7d3bacc55aab","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CKD","text_display":"CKD","cell_row":17,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1254],[960,1254],[960,1297],[548,1297]],"region":{"top_left_x":547,"top_left_y":1253,"width":413,"height":45},"line":91,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"57392c4776d24c08bffc75c45f36c7de","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Chronic Kidney Disease","text_display":"Chronic Kidney Disease","cell_row":17,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,1304],[340,1304],[340,1343],[239,1343]],"region":{"top_left_x":239,"top_left_y":1304,"width":102,"height":40},"line":92,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"62412390cea84fe7879c61e5f588599b","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CRA","text_display":"CRA","cell_row":18,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1302],[1020,1302],[1020,1339],[548,1339]],"region":{"top_left_x":547,"top_left_y":1302,"width":473,"height":37},"line":93,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ec2918bfb24148b6a85bb99fc922a5a4","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Clinical Research Associate","text_display":"Clinical Research Associate","cell_row":18,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,1343],[340,1343],[340,1387],[239,1387]],"region":{"top_left_x":239,"top_left_y":1343,"width":102,"height":45},"line":94,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1be2f099a1d34d25bd5bb1d6f1de0311","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CRO","text_display":"CRO","cell_row":19,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1350],[1089,1350],[1089,1394],[548,1394]],"region":{"top_left_x":547,"top_left_y":1350,"width":542,"height":45},"line":95,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2837a5f1f4694be98bcaf80676b129f3","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Contract Research Organisation","text_display":"Contract Research Organisation","cell_row":19,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1399],[336,1399],[336,1438],[248,1438]],"region":{"top_left_x":248,"top_left_y":1398,"width":88,"height":40},"line":96,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"828338de28bd4723952ee946446277b4","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CRF","text_display":"CRF","cell_row":20,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1399],[858,1399],[858,1442],[548,1442]],"region":{"top_left_x":547,"top_left_y":1398,"width":312,"height":45},"line":97,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"35e15e47b2424cc999d1714d5ea6d456","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Case Report Form","text_display":"Case Report Form","cell_row":20,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1447],[366,1447],[366,1482],[248,1482]],"region":{"top_left_x":248,"top_left_y":1447,"width":118,"height":35},"line":98,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2333300f68954ab2980fc810455e7649","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CTMF","text_display":"CTMF","cell_row":21,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1447],[978,1447],[978,1486],[548,1486]],"region":{"top_left_x":547,"top_left_y":1447,"width":432,"height":40},"line":99,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"493c9e2c1bc2429e87c3379a2c45cee6","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Clinical Trial Master File","text_display":"Clinical Trial Master File","cell_row":21,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,1491],[331,1491],[331,1535],[239,1535]],"region":{"top_left_x":239,"top_left_y":1490,"width":93,"height":45},"line":100,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"52926237a0ab4f47b209faf1d99ead06","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CTP","text_display":"CTP","cell_row":22,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1493],[927,1493],[927,1532],[548,1532]],"region":{"top_left_x":547,"top_left_y":1493,"width":381,"height":40},"line":101,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2e6f757a22f34deca4867c39e018c358","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Clinical Trial Protocol","text_display":"Clinical Trial Protocol","cell_row":22,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1544],[359,1544],[359,1578],[248,1578]],"region":{"top_left_x":248,"top_left_y":1543,"width":111,"height":36},"line":102,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"7077e6983b7747d5a22ac73e8e44c2fb","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CTSU","text_display":"CTSU","cell_row":23,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1542],[992,1542],[992,1588],[548,1588]],"region":{"top_left_x":547,"top_left_y":1541,"width":445,"height":47},"line":103,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"7217406f934841bea9fab73d08174a24","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Clinical Trial Supply Unit","text_display":"Clinical Trial Supply Unit","cell_row":23,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,1585],[313,1585],[313,1627],[239,1627]],"region":{"top_left_x":239,"top_left_y":1585,"width":74,"height":42},"line":104,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"30347af3d4f74ab3b2aeb6e84a5d2fa8","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"CV","text_display":"CV","cell_row":24,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1590],[808,1590],[808,1629],[548,1629]],"region":{"top_left_x":547,"top_left_y":1589,"width":261,"height":41},"line":105,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"b7c9761be8074045b57395513549221e","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Cardiovascular","text_display":"Cardiovascular","cell_row":24,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1638],[336,1638],[336,1677],[248,1677]],"region":{"top_left_x":248,"top_left_y":1638,"width":88,"height":40},"line":106,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"d3d303b3e7874d9996f86dbff06a0bb3","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"DBP","text_display":"DBP","cell_row":25,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1636],[969,1636],[969,1675],[548,1675]],"region":{"top_left_x":547,"top_left_y":1635,"width":422,"height":41},"line":107,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1d27c2a9654d4ccb815811a8cba668ca","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Diastolic Blood Pressure","text_display":"Diastolic Blood Pressure","cell_row":25,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1687],[347,1687],[347,1726],[248,1726]],"region":{"top_left_x":248,"top_left_y":1686,"width":100,"height":40},"line":108,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1edeb2303ddb42948b13cd9649acde64","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"DMC","text_display":"DMC","cell_row":26,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1687],[1029,1687],[1029,1730],[548,1730]],"region":{"top_left_x":547,"top_left_y":1686,"width":482,"height":45},"line":109,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ff33fdec999e4486b228e1da87cc8be3","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Data Monitoring Committee","text_display":"Data Monitoring Committee","cell_row":26,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1733],[343,1733],[343,1772],[248,1772]],"region":{"top_left_x":248,"top_left_y":1732,"width":95,"height":40},"line":110,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2e2ee8478f4b4fd19baf349f9d1a7c93","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"DNA","text_display":"DNA","cell_row":27,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1733],[944,1733],[944,1776],[548,1776]],"region":{"top_left_x":547,"top_left_y":1732,"width":397,"height":45},"line":111,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"99269d7b9e234846ba6673ede106bc62","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Deoxyribonucleic Acid","text_display":"Deoxyribonucleic Acid","cell_row":27,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1783],[363,1783],[363,1818],[248,1818]],"region":{"top_left_x":248,"top_left_y":1783,"width":116,"height":35},"line":112,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"989b3a69f51f4daa8013e368030dbc05","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"DPP-4","text_display":"DPP-4","cell_row":28,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1781],[934,1781],[934,1827],[548,1827]],"region":{"top_left_x":547,"top_left_y":1780,"width":388,"height":48},"line":113,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"4cf0c70a1fe8448dbd25084e2f972962","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Dipeptidyl-peptidase 4","text_display":"Dipeptidyl-peptidase 4","cell_row":28,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1829],[336,1829],[336,1868],[248,1868]],"region":{"top_left_x":248,"top_left_y":1829,"width":88,"height":40},"line":114,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"cd4129ddc09045579059be59c8eefeb7","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"ECG","text_display":"ECG","cell_row":29,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1829],[863,1829],[863,1873],[548,1873]],"region":{"top_left_x":547,"top_left_y":1829,"width":316,"height":45},"line":115,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"6e192f37eb104d75aa4fbc120fd3f19c","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Electrocardiogram","text_display":"Electrocardiogram","cell_row":29,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1880],[352,1880],[352,1915],[248,1915]],"region":{"top_left_x":248,"top_left_y":1879,"width":104,"height":36},"line":116,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"c4cd7cc1de7b440599c13760de1020b3","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"eCRF","text_display":"eCRF","cell_row":30,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1878],[1043,1878],[1043,1921],[548,1921]],"region":{"top_left_x":547,"top_left_y":1877,"width":496,"height":45},"line":117,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"9e71bc2c615f4607a09b904ed6633c21","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Electronic Case Report Form","text_display":"Electronic Case Report Form","cell_row":30,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1926],[352,1926],[352,1965],[248,1965]],"region":{"top_left_x":248,"top_left_y":1926,"width":104,"height":40},"line":118,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"e19ee0dcc93f43cf823e8d711ffe2dbf","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"eGFR","text_display":"eGFR","cell_row":31,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1926],[1167,1926],[1167,1965],[548,1965]],"region":{"top_left_x":547,"top_left_y":1926,"width":620,"height":40},"line":119,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"895f72e1ea984144a4be29dc090d3f64","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Estimated Glomerular filtration Rate","text_display":"Estimated Glomerular filtration Rate","cell_row":31,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,1972],[333,1972],[333,2011],[239,2011]],"region":{"top_left_x":239,"top_left_y":1972,"width":95,"height":40},"line":120,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"71bebde76bcf49598b8b6a9c8f4daab9","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"EOT","text_display":"EOT","cell_row":32,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1972],[849,1972],[849,2011],[548,2011]],"region":{"top_left_x":547,"top_left_y":1972,"width":303,"height":40},"line":121,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2ce3e6e9219145bb8e3b1da76bcba4ea","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"End of Treatment","text_display":"End of Treatment","cell_row":32,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,2023],[356,2023],[356,2057],[248,2057]],"region":{"top_left_x":248,"top_left_y":2022,"width":109,"height":36},"line":122,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"fe36ef68ad1a45bbb3c8bcbc9041360a","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"ESRD","text_display":"ESRD","cell_row":33,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2023],[973,2023],[973,2066],[548,2066]],"region":{"top_left_x":547,"top_left_y":2022,"width":427,"height":45},"line":123,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"dc7037f5aca14f2ebd85231a798554c1","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"End Stage Renal Disease","text_display":"End Stage Renal Disease","cell_row":33,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,2069],[407,2069],[407,2108],[248,2108]],"region":{"top_left_x":248,"top_left_y":2068,"width":160,"height":40},"line":124,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"f71ea28d4bad46089f50f893165bea36","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"EudraCT","text_display":"EudraCT","cell_row":34,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2069],[1125,2069],[1125,2113],[548,2113]],"region":{"top_left_x":547,"top_left_y":2068,"width":579,"height":45},"line":125,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"7ec1c63e9aab49029470d6ae5945fdfd","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"European Clinical Trials Database","text_display":"European Clinical Trials Database","cell_row":34,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,2119],[331,2119],[331,2159],[239,2159]],"region":{"top_left_x":239,"top_left_y":2119,"width":93,"height":40},"line":126,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"136e3d52bdde4965b5935b28b7045c5e","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"FAS","text_display":"FAS","cell_row":35,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2119],[842,2119],[842,2163],[548,2163]],"region":{"top_left_x":547,"top_left_y":2119,"width":296,"height":45},"line":127,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ef4bc74c460e43d6a187c893e4514d5c","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Full Analysis Set","text_display":"Full Analysis Set","cell_row":35,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,2165],[333,2165],[333,2214],[239,2214]],"region":{"top_left_x":239,"top_left_y":2165,"width":95,"height":49},"line":128,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"b8ce1cfe23d342e38a52b2441b9d4f7b","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"FDA","text_display":"FDA","cell_row":36,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2165],[1070,2165],[1070,2209],[548,2209]],"region":{"top_left_x":547,"top_left_y":2165,"width":524,"height":45},"line":129,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"59e508dde71b45a18c4cc80c12c7ebc6","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Food and Drug Administration","text_display":"Food and Drug Administration","cell_row":36,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,2212],[331,2212],[331,2253],[248,2253]],"region":{"top_left_x":248,"top_left_y":2211,"width":84,"height":42},"line":130,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"503f733678584fc1b34fb09335fd04dc","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"FPG","text_display":"FPG","cell_row":37,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2212],[955,2212],[955,2258],[548,2258]],"region":{"top_left_x":547,"top_left_y":2211,"width":409,"height":47},"line":131,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"9274984ad85f4d4190c8a8a473a6d8fe","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Fasting Plasma Glucose","text_display":"Fasting Plasma Glucose","cell_row":37,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,2260],[336,2260],[336,2299],[248,2299]],"region":{"top_left_x":248,"top_left_y":2259,"width":88,"height":41},"line":132,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"5533ff93bb9b493fa2877bce25d32e45","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"GCP","text_display":"GCP","cell_row":38,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2260],[932,2260],[932,2299],[548,2299]],"region":{"top_left_x":547,"top_left_y":2259,"width":386,"height":41},"line":133,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"4be09db10a724feb9b007171ea720fbb","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Good Clinical Practice","text_display":"Good Clinical Practice","cell_row":38,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[244,2308],[343,2308],[343,2352],[244,2352]],"region":{"top_left_x":243,"top_left_y":2308,"width":100,"height":44},"line":134,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"031bfd5cfc534962bb902c470bd06e4e","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"\\(\\gamma\\)-GT","text_display":"\\(\\gamma\\)-GT","cell_row":39,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2308],[1165,2308],[1165,2352],[548,2352]],"region":{"top_left_x":547,"top_left_y":2308,"width":618,"height":44},"line":135,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"d1a2c6096f15414ea7c27d6aa65d8c39","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Gamma-glutamyl-transferase (GGT)","text_display":"Gamma-glutamyl-transferase (GGT)","cell_row":39,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,2354],[299,2354],[299,2400],[239,2400]],"region":{"top_left_x":239,"top_left_y":2354,"width":60,"height":47},"line":136,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"03293b91d52541059a3824612a82dec8","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"GI","text_display":"GI","cell_row":40,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2357],[822,2357],[822,2393],[548,2393]],"region":{"top_left_x":547,"top_left_y":2356,"width":275,"height":38},"line":137,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"24f4440ff4094aa48bfdafe624ac84c8","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"GastroIntestinal","text_display":"GastroIntestinal","cell_row":40,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[239,2405],[322,2405],[322,2456],[239,2456]],"region":{"top_left_x":239,"top_left_y":2404,"width":83,"height":52},"line":138,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"f1acb203b1e04c96a4d27f811aa639d1","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"GIP","text_display":"GIP","cell_row":41,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2405],[1254,2405],[1254,2451],[548,2451]],"region":{"top_left_x":547,"top_left_y":2404,"width":708,"height":47},"line":139,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2069746751284607854010142a381751","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Glucose-dependent Insulinotropic Peptide","text_display":"Glucose-dependent Insulinotropic Peptide","cell_row":41,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,2451],[361,2451],[361,2490],[248,2490]],"region":{"top_left_x":248,"top_left_y":2450,"width":114,"height":41},"line":140,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ee0034cd8daf4614a58edafbd044023b","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"GLP-1","text_display":"GLP-1","cell_row":42,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2451],[955,2451],[955,2499],[548,2499]],"region":{"top_left_x":547,"top_left_y":2450,"width":409,"height":50},"line":141,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"587c06a260f641bc91679886f4f17140","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Glucagon-like Peptide 1","text_display":"Glucagon-like Peptide 1","cell_row":42,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[246,2502],[361,2502],[361,2541],[246,2541]],"region":{"top_left_x":245,"top_left_y":2501,"width":117,"height":40},"line":142,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"0d89d18540ea413482960fcc367907d6","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"\\(HbA _{1 c }\\)","text_display":"\\(HbA _{1 c }\\)","cell_row":43,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99755859375,"confidence_rate":0.9998642097013497},{"cnt":[[548,2499],[1013,2499],[1013,2545],[548,2545]],"region":{"top_left_x":547,"top_left_y":2499,"width":466,"height":47},"line":143,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"a36876066bc240fab956af1298e80737","type":"simple_cell","conversion_output":false,"parent_id":"c08ec4d40905488ea6ad7d639cbe2d25","text":"Glycosylated Haemoglobin","text_display":"Glycosylated Haemoglobin","cell_row":43,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":144,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ca73e10b0be746a2aba4e009c183db37","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2659],[292,2659]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":38},"line":145,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7b3859d697ad42f2b69339f5159e5773","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999876814398867},{"cnt":[[297,2668],[1768,2668],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1473,"height":35},"line":146,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7c33eb8bd37f465899b269371e9429b5","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-016","page":16,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f6c05da9e1b4b65a2dfb8dfb82c54fb","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1505,121],[1816,121],[1816,160],[1505,160]],"region":{"top_left_x":1505,"top_left_y":121,"width":312,"height":39},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52faccbb4dde4900bfe6db28bef3ecac","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"edca333b61db48628949a048482afd69","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d81fdd8ad4354f5d9f49b0683528501b","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c54e982de13d49efb2bec88ac515a132","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b2b62fc8a1ad47f6a8d13e91c04d0809","type":"page_info","conversion_output":false,"text":"Page 16 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1439,338],[1439,2353],[242,2353]],"region":{"top_left_x":242,"top_left_y":338,"width":1198,"height":2015},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57705fdc55454b6f955ce3c308323284","type":"table","conversion_output":true,"children_ids":["5a1fe64cccfd4ce8ad3d9c95ee919688","4cc4baff9ef649908731a2e1b691f33a","abbe0f0678c34544bfacf393c6bcfe23","2708dd4826f64bbc8822f456ca92b03f","ba5765afe390404aaeab0fe7b68f94c2","c03527b30a2b426b9b9bf1e29ad73392","20398c3092984f5e873b48820f8538ff","f57f8259a03a4732937c70cf97b13f49","391147385ffe494990af4f7cd018d140","06da4616d9074f91b26f030b9815568f","9f324824ee204810ac282662ebad1f13","6188b97e7b3541af8481263486faa3a9","98fe9171b2974d10a994362d6c8812d8","65e5ba6ff3a44f5f863219d9d1da117c","98af022e66974f66baf3b65917c00856","dc7ad2aebfec4d6a9d601e5542829b60","c1ad913ad24d43fbb954d7b8fc1fe2c2","348419a27a1744e99414887fa40ee6e0","84732df48c4a404588fa57dd8f2e0563","dbc66b8d4f2b4deb80da3037bc69c5d5","0d95894a1211431b85e6e35d9aba5bfb","a8e86f7b77c5407483c6fbc705f67f8e","ca371e6349484eaba186fce34ad8ea7f","9f2b7af38f5144cd891d59872276c6ad","96e052bed2424380a3e8e83276f55248","92e509f150d84b1b846db61ef84d3f7a","2838e1f85acc46b9853be4e854d87485","5cb9fcb7a815408b8e31dda1f9e4d537","fc2eac76fdd04e71804bf0b89a6091b6","7cde0cc8771044f7ba1d02600e895b82","537720fd1c904522bf13cd702a83de7b","7b57887fdeb940208f68b86bcfe3500f","3750ae42e19c416c8557d2d2774b0304","0047402b8bd64803bee74f6629fbb56e","b97f0bc408714c32abd6803c631cb7cf","c29050289061497392d22ded02f1cd7e","5a63163d66d043f68444662bfc57f532","74b811780cb94a109090e4fc5aa5e4c9","d68476785fdf41309348535c2b5a9695","13337c3acb80410587dac7190d9809ec","425de651fff7485ea4206e3bcdc26b60","05d30197a7f248b1bb6f79e88e65fc66","e639398594e0473388e1cc80d0fc6901","ab525ce193274d45b542c01d9a29b359","210b7e90d39148269a3a150fd79f4d6c","ef6c8fb9d4994b9683f4913bbe9d7f64","53aacb6237884bfda10fda0a468dc8f8","2bb9f53640434519a6d8a753f771e766","13fefe59913d42e1849045007d0beff8","0af26e07d7414cf0a03650b504736a2d","c94c6f9b73c94e60b9815c1bcd8cf13e","43e2f6914fc940b0a260cada1e402158","9f9eb4edcd6d4a0b98ea308184a6cbea","dbb4fba8f98d4c31ac471bb7bc70ae52","b72512c1ece8417c8c85a7a8167bce0f","08de3ed09905401f88f0c74280ce2247","1e2cbac2c465417797d1856295a08d86","a89ca19ea8594beabb1d2e8c80f102a4","1a36323700f84458a03c7f9a711816b6","559bb3aa0fa64dd785cd9b9932762f88","27d11812b5f240f190f28afc8efd534e","f93424453574485d80b2351d28bb12f8","26ba8a8dfc874bb2855ee8e21a0e318d","184dac556deb4042b86ef1790e3d6fc4","67d86b5c766044bea2d39397c115f8a8","e3bd6d2d06014c9e85b1352b42e8a0c5","f5cfedf8d915480688811bc38da19b4c","b69ccb13999b4b6fadc346b9545ebad3","66cc346780974d11bf6c7382f4800f0c","20a109f827634bfa8503b79fc63ab041","0b5f154a702f497ba611d13471e9e9c6","ce9f0f4787cd4ab8a5e110a2d5af5f0f","85c0f0e45f854f7bb0036ff3ad1bd663","7972860b39e24f368d897862550936fc","ace16433922441568b8d2676d6c132d2","3d228da9dae0436baaa3f2dc6938486d","1b0a1609ab30477d9c2219bc9d4f0ddf","540aae68a64b455e894e7a0b4a5930d5","69404dba85264b6ca2bf21e23cb06c75","38311fc3752c4096b254cfcf77317a2d","8f070f2d47ca485f801095c69f6e1888","113a034308284066b81c3497be13f3d3","2f02085c1f004ad6942bb09c0c7360d4","97d2ea26e8f54151995cb8e12df86e15","0bfa2ee07f5d4dc8bb43a92c3e796a85","3521757f49424bbf82db60e48643f3be","e95f8d8c9035400c9ac9fb57f14637f9","9a60bc007a644a38a388d4f9bf28e9a0","06d93d453ade4f4cb0e50adf2827a443","7479c397b4af4689adcd58841a4d0e7f","6a5ca3e878c94f3aadb060e6d8e45bf9","b497cb7418d94be0b3dc9462bd66eb59","12751d2456494ca985940ab23c3a24d5","9ecf373abf0d4bccab40ddabb2001047","3d211f99e56d47ac9ad10d94d59b4653","9d46f1d91c374e87b000e3c618c30c62","f8cfc2210fbd4c009ba7ac88c2e586ac","9f6aef1a265d4434a40be3223f44d60c","b046702d31c840e59f2bdf9a335311c1","08917ffab4fa42a596c0b5939172a8f5","4d0ff2df8a7c4e9d965b095b959111dd","440b392d84d04eda83aef742da94d022","a07886ab132045f88929c48d80b887e5","91fc16a17848463fa65c636165db1dd3","115c8b624eca40f9b7c3e271cfc46ead","12ce4abd59084fd0b44d469fb43be162","388f4419ade24cc4a9a0b7b9a1182759","4621f9b5a6f848bfbfbfd467d8235f3b","b23be064bbba43cbac53fa6edf010c87","62748a19c94c4e8da531e207d4f1932d","72ea5b848c3b45f8b923b8cd27a860c5","2a82a071cff94d8699b82fdb9ce36893","cc43e827826b43ccb2ae71dc43b72d7c","19c425dfa66a4cdea93c155c9ab16e3d","57d25369f7cf4f93b663b669b0b4af4c","77a842f53a3041a899990cec3a6a23bd","672d3a7006ed4a45bea5b4b78b368992","2168c59dd74a486591821c08398df2e3","01af53c4e32d4ef99db9797aa1d6478b","4b010dd17cee40a3acb049e11ee2af31","edf83d2e98d749e2bb3bd5c67842e214","2e72bb8cba034eacb2d1f3419dc7dceb","1ae7882b21e645409dc79ec48d084904","ada73e65033048cd9cc4ed0601010e2b","5b351edfe4614d3997de29280471e484"],"text":"\\begin{tabular}{|l|l|}\n\\hline HBGM & Home Blood Glucose Monitoring \\\\\n\\hline HDL & High Density Lipoprotein \\\\\n\\hline HR & Hazard Ratio \\\\\n\\hline ICH & International Conference of Harmonisation \\\\\n\\hline IEC & Independent Ethics Committee \\\\\n\\hline IRB & Institutional Review Board \\\\\n\\hline IRT & Interactive Response Technology \\\\\n\\hline ISF & Investigator Site File \\\\\n\\hline ITT & Intention To Treat \\\\\n\\hline IUDs/IUSs & Intra Uterine Devices/Systems \\\\\n\\hline LDL & Low Density Lipoprotein \\\\\n\\hline LDH & Lactate Dehydrogenase \\\\\n\\hline MACE & Major Adverse Cardiovascular Events \\\\\n\\hline MDRD & Modification of Diet in Renal Disease \\\\\n\\hline MedDRA & Medical Dictionary for Drug Regulatory Activities \\\\\n\\hline MI & Myocardial infarction \\\\\n\\hline MMSE & Mini-Mental State Examination \\\\\n\\hline NGSP & National Glycohemoglobin Standardization Program \\\\\n\\hline NI & Non-Inferiority \\\\\n\\hline OAD & Oral antidiabetic drug \\\\\n\\hline OS & On-treatment Set \\\\\n\\hline PCI & Percutaneous Coronary Intervention \\\\\n\\hline p.o. & per os (oral) \\\\\n\\hline PPS & Per Protocol Set \\\\\n\\hline PR & Pulse Rate \\\\\n\\hline PV & Protocol Violation \\\\\n\\hline SAE & Serious Adverse Event \\\\\n\\hline SC & Steering Committee \\\\\n\\hline SGLT-2 & Sodium Glucose Linked Transporter \\\\\n\\hline SOP & Standard Operating Procedure \\\\\n\\hline SU & Sulfonylurea \\\\\n\\hline SUSAR & Suspected Unexpected Serious Adverse Reactions \\\\\n\\hline T2DM & Type 2 diabetes mellitus \\\\\n\\hline TIA & Transient Ischemic Attack \\\\\n\\hline TMT & Trial Making Test \\\\\n\\hline TS & Treated Set \\\\\n\\hline TSAP & Trial Statistical Analysis Plan \\\\\n\\hline UACR & Urine Albumin Creatinine Ratio \\\\\n\\hline ULN & Upper Limit of Normal \\\\\n\\hline VEGF & Vascular endothelial growth factor \\\\\n\\hline VFT & Verbal Fluency Test \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline HBGM & Home Blood Glucose Monitoring \\\\\n\\hline HDL & High Density Lipoprotein \\\\\n\\hline HR & Hazard Ratio \\\\\n\\hline ICH & International Conference of Harmonisation \\\\\n\\hline IEC & Independent Ethics Committee \\\\\n\\hline IRB & Institutional Review Board \\\\\n\\hline IRT & Interactive Response Technology \\\\\n\\hline ISF & Investigator Site File \\\\\n\\hline ITT & Intention To Treat \\\\\n\\hline IUDs/IUSs & Intra Uterine Devices/Systems \\\\\n\\hline LDL & Low Density Lipoprotein \\\\\n\\hline LDH & Lactate Dehydrogenase \\\\\n\\hline MACE & Major Adverse Cardiovascular Events \\\\\n\\hline MDRD & Modification of Diet in Renal Disease \\\\\n\\hline MedDRA & Medical Dictionary for Drug Regulatory Activities \\\\\n\\hline MI & Myocardial infarction \\\\\n\\hline MMSE & Mini-Mental State Examination \\\\\n\\hline NGSP & National Glycohemoglobin Standardization Program \\\\\n\\hline NI & Non-Inferiority \\\\\n\\hline OAD & Oral antidiabetic drug \\\\\n\\hline OS & On-treatment Set \\\\\n\\hline PCI & Percutaneous Coronary Intervention \\\\\n\\hline p.o. & per os (oral) \\\\\n\\hline PPS & Per Protocol Set \\\\\n\\hline PR & Pulse Rate \\\\\n\\hline PV & Protocol Violation \\\\\n\\hline SAE & Serious Adverse Event \\\\\n\\hline SC & Steering Committee \\\\\n\\hline SGLT-2 & Sodium Glucose Linked Transporter \\\\\n\\hline SOP & Standard Operating Procedure \\\\\n\\hline SU & Sulfonylurea \\\\\n\\hline SUSAR & Suspected Unexpected Serious Adverse Reactions \\\\\n\\hline T2DM & Type 2 diabetes mellitus \\\\\n\\hline TIA & Transient Ischemic Attack \\\\\n\\hline TMT & Trial Making Test \\\\\n\\hline TS & Treated Set \\\\\n\\hline TSAP & Trial Statistical Analysis Plan \\\\\n\\hline UACR & Urine Albumin Creatinine Ratio \\\\\n\\hline ULN & Upper Limit of Normal \\\\\n\\hline VEGF & Vascular endothelial growth factor \\\\\n\\hline VFT & Verbal Fluency Test \\\\\n\\hline\n\\end{tabular}","confidence":0.9833984375,"confidence_rate":0.9999916136025454},{"cnt":[[242,338],[440,338],[440,2353],[242,2353]],"region":{"top_left_x":242,"top_left_y":338,"width":199,"height":2015},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a1fe64cccfd4ce8ad3d9c95ee919688","type":"table_column","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[539,338],[1437,338],[1437,2355],[539,2355]],"region":{"top_left_x":539,"top_left_y":338,"width":899,"height":2017},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cc4baff9ef649908731a2e1b691f33a","type":"table_column","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,338],[1437,338],[1437,437],[242,437]],"region":{"top_left_x":242,"top_left_y":338,"width":1196,"height":100},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abbe0f0678c34544bfacf393c6bcfe23","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,435],[1437,435],[1437,488],[242,488]],"region":{"top_left_x":242,"top_left_y":434,"width":1196,"height":54},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2708dd4826f64bbc8822f456ca92b03f","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,485],[1437,485],[1437,527],[242,527]],"region":{"top_left_x":242,"top_left_y":485,"width":1196,"height":42},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba5765afe390404aaeab0fe7b68f94c2","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,531],[1437,531],[1437,575],[242,575]],"region":{"top_left_x":242,"top_left_y":531,"width":1196,"height":45},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c03527b30a2b426b9b9bf1e29ad73392","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,577],[1437,577],[1437,628],[242,628]],"region":{"top_left_x":242,"top_left_y":577,"width":1196,"height":52},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20398c3092984f5e873b48820f8538ff","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,628],[1437,628],[1437,672],[242,672]],"region":{"top_left_x":242,"top_left_y":628,"width":1196,"height":44},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f57f8259a03a4732937c70cf97b13f49","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,674],[1437,674],[1437,723],[242,723]],"region":{"top_left_x":242,"top_left_y":674,"width":1196,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"391147385ffe494990af4f7cd018d140","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,720],[1437,720],[1437,773],[242,773]],"region":{"top_left_x":242,"top_left_y":720,"width":1196,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06da4616d9074f91b26f030b9815568f","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,771],[1437,771],[1437,815],[242,815]],"region":{"top_left_x":242,"top_left_y":770,"width":1196,"height":45},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f324824ee204810ac282662ebad1f13","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,817],[1437,817],[1437,868],[242,868]],"region":{"top_left_x":242,"top_left_y":816,"width":1196,"height":52},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6188b97e7b3541af8481263486faa3a9","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,868],[1437,868],[1437,916],[242,916]],"region":{"top_left_x":242,"top_left_y":867,"width":1196,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98fe9171b2974d10a994362d6c8812d8","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,916],[1437,916],[1437,962],[242,962]],"region":{"top_left_x":242,"top_left_y":915,"width":1196,"height":47},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65e5ba6ff3a44f5f863219d9d1da117c","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,964],[1437,964],[1437,1013],[242,1013]],"region":{"top_left_x":242,"top_left_y":964,"width":1196,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98af022e66974f66baf3b65917c00856","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1010],[1437,1010],[1437,1054],[242,1054]],"region":{"top_left_x":242,"top_left_y":1010,"width":1196,"height":45},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc7ad2aebfec4d6a9d601e5542829b60","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1056],[1437,1056],[1437,1107],[242,1107]],"region":{"top_left_x":242,"top_left_y":1056,"width":1196,"height":52},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1ad913ad24d43fbb954d7b8fc1fe2c2","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1107],[1437,1107],[1437,1155],[242,1155]],"region":{"top_left_x":242,"top_left_y":1107,"width":1196,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"348419a27a1744e99414887fa40ee6e0","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1155],[1437,1155],[1437,1197],[242,1197]],"region":{"top_left_x":242,"top_left_y":1155,"width":1196,"height":42},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84732df48c4a404588fa57dd8f2e0563","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1204],[1437,1204],[1437,1252],[242,1252]],"region":{"top_left_x":242,"top_left_y":1203,"width":1196,"height":50},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dbc66b8d4f2b4deb80da3037bc69c5d5","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1250],[1437,1250],[1437,1298],[242,1298]],"region":{"top_left_x":242,"top_left_y":1249,"width":1196,"height":50},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d95894a1211431b85e6e35d9aba5bfb","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1298],[1437,1298],[1437,1346],[242,1346]],"region":{"top_left_x":242,"top_left_y":1298,"width":1196,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8e86f7b77c5407483c6fbc705f67f8e","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1346],[1437,1346],[1437,1390],[242,1390]],"region":{"top_left_x":242,"top_left_y":1346,"width":1196,"height":45},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca371e6349484eaba186fce34ad8ea7f","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1393],[1437,1393],[1437,1441],[242,1441]],"region":{"top_left_x":242,"top_left_y":1392,"width":1196,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f2b7af38f5144cd891d59872276c6ad","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1443],[1437,1443],[1437,1492],[242,1492]],"region":{"top_left_x":242,"top_left_y":1443,"width":1196,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96e052bed2424380a3e8e83276f55248","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1489],[1437,1489],[1437,1533],[242,1533]],"region":{"top_left_x":242,"top_left_y":1489,"width":1196,"height":45},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92e509f150d84b1b846db61ef84d3f7a","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1540],[1437,1540],[1437,1579],[242,1579]],"region":{"top_left_x":242,"top_left_y":1539,"width":1196,"height":41},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2838e1f85acc46b9853be4e854d87485","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1586],[1437,1586],[1437,1630],[242,1630]],"region":{"top_left_x":242,"top_left_y":1585,"width":1196,"height":45},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cb9fcb7a815408b8e31dda1f9e4d537","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1632],[1437,1632],[1437,1676],[242,1676]],"region":{"top_left_x":242,"top_left_y":1632,"width":1196,"height":44},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc2eac76fdd04e71804bf0b89a6091b6","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1683],[1437,1683],[1437,1731],[242,1731]],"region":{"top_left_x":242,"top_left_y":1682,"width":1196,"height":50},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7cde0cc8771044f7ba1d02600e895b82","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1729],[1437,1729],[1437,1777],[242,1777]],"region":{"top_left_x":242,"top_left_y":1728,"width":1196,"height":50},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"537720fd1c904522bf13cd702a83de7b","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1777],[1437,1777],[1437,1825],[242,1825]],"region":{"top_left_x":242,"top_left_y":1777,"width":1196,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b57887fdeb940208f68b86bcfe3500f","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1825],[1437,1825],[1437,1874],[242,1874]],"region":{"top_left_x":242,"top_left_y":1825,"width":1196,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3750ae42e19c416c8557d2d2774b0304","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1871],[1437,1871],[1437,1920],[242,1920]],"region":{"top_left_x":242,"top_left_y":1871,"width":1196,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0047402b8bd64803bee74f6629fbb56e","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1918],[1437,1918],[1437,1970],[242,1970]],"region":{"top_left_x":242,"top_left_y":1917,"width":1196,"height":54},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b97f0bc408714c32abd6803c631cb7cf","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,1968],[1437,1968],[1437,2012],[242,2012]],"region":{"top_left_x":242,"top_left_y":1968,"width":1196,"height":44},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c29050289061497392d22ded02f1cd7e","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,2063],[242,2014],[1437,2017],[1437,2065]],"region":{"top_left_x":241,"top_left_y":2014,"width":1197,"height":51},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a63163d66d043f68444662bfc57f532","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,2065],[1437,2065],[1437,2109],[242,2109]],"region":{"top_left_x":242,"top_left_y":2064,"width":1196,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74b811780cb94a109090e4fc5aa5e4c9","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,2111],[1437,2111],[1437,2159],[242,2159]],"region":{"top_left_x":242,"top_left_y":2110,"width":1196,"height":50},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d68476785fdf41309348535c2b5a9695","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,2162],[1437,2162],[1437,2205],[242,2205]],"region":{"top_left_x":242,"top_left_y":2161,"width":1196,"height":45},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13337c3acb80410587dac7190d9809ec","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,2208],[1437,2208],[1437,2256],[242,2256]],"region":{"top_left_x":242,"top_left_y":2207,"width":1196,"height":49},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"425de651fff7485ea4206e3bcdc26b60","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,2256],[1437,2256],[1437,2304],[242,2304]],"region":{"top_left_x":242,"top_left_y":2255,"width":1196,"height":50},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"05d30197a7f248b1bb6f79e88e65fc66","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[242,2304],[1437,2304],[1437,2353],[242,2353]],"region":{"top_left_x":242,"top_left_y":2304,"width":1196,"height":49},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e639398594e0473388e1cc80d0fc6901","type":"table_row","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"","text_display":""},{"cnt":[[247,343],[378,343],[378,382],[247,382]],"region":{"top_left_x":246,"top_left_y":342,"width":132,"height":40},"line":51,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ab525ce193274d45b542c01d9a29b359","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"HBGM","text_display":"HBGM","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[546,343],[1115,343],[1115,386],[546,386]],"region":{"top_left_x":545,"top_left_y":342,"width":570,"height":45},"line":52,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"210b7e90d39148269a3a150fd79f4d6c","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Home Blood Glucose Monitoring","text_display":"Home Blood Glucose Monitoring","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,430],[339,430],[339,476],[242,476]],"region":{"top_left_x":242,"top_left_y":430,"width":97,"height":47},"line":53,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ef6c8fb9d4994b9683f4913bbe9d7f64","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"HDL","text_display":"HDL","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,439],[981,439],[981,483],[548,483]],"region":{"top_left_x":548,"top_left_y":439,"width":434,"height":45},"line":54,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"53aacb6237884bfda10fda0a468dc8f8","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"High Density Lipoprotein","text_display":"High Density Lipoprotein","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,485],[311,485],[311,522],[242,522]],"region":{"top_left_x":242,"top_left_y":485,"width":70,"height":38},"line":55,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2bb9f53640434519a6d8a753f771e766","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"HR","text_display":"HR","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,485],[772,485],[772,525],[548,525]],"region":{"top_left_x":548,"top_left_y":485,"width":224,"height":40},"line":56,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"13fefe59913d42e1849045007d0beff8","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Hazard Ratio","text_display":"Hazard Ratio","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,525],[325,525],[325,573],[242,573]],"region":{"top_left_x":242,"top_left_y":524,"width":83,"height":49},"line":57,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"0af26e07d7414cf0a03650b504736a2d","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"ICH","text_display":"ICH","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,534],[1271,534],[1271,571],[548,571]],"region":{"top_left_x":548,"top_left_y":533,"width":724,"height":38},"line":58,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"c94c6f9b73c94e60b9815c1bcd8cf13e","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"International Conference of Harmonisation","text_display":"International Conference of Harmonisation","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,580],[320,580],[320,619],[242,619]],"region":{"top_left_x":242,"top_left_y":579,"width":79,"height":40},"line":59,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"43e2f6914fc940b0a260cada1e402158","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"IEC","text_display":"IEC","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,582],[1069,582],[1069,626],[548,626]],"region":{"top_left_x":548,"top_left_y":582,"width":521,"height":44},"line":60,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"9f9eb4edcd6d4a0b98ea308184a6cbea","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Independent Ethics Committee","text_display":"Independent Ethics Committee","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,633],[320,633],[320,670],[242,670]],"region":{"top_left_x":242,"top_left_y":632,"width":79,"height":38},"line":61,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"dbb4fba8f98d4c31ac471bb7bc70ae52","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"IRB","text_display":"IRB","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,628],[1004,628],[1004,667],[548,667]],"region":{"top_left_x":548,"top_left_y":628,"width":457,"height":40},"line":62,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"b72512c1ece8417c8c85a7a8167bce0f","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Institutional Review Board","text_display":"Institutional Review Board","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,672],[320,672],[320,716],[242,716]],"region":{"top_left_x":242,"top_left_y":671,"width":79,"height":45},"line":63,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"08de3ed09905401f88f0c74280ce2247","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"IRT","text_display":"IRT","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,679],[1110,679],[1110,720],[548,720]],"region":{"top_left_x":548,"top_left_y":678,"width":563,"height":43},"line":64,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1e2cbac2c465417797d1856295a08d86","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Interactive Response Technology","text_display":"Interactive Response Technology","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,725],[316,725],[316,766],[242,766]],"region":{"top_left_x":242,"top_left_y":724,"width":74,"height":43},"line":65,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"a89ca19ea8594beabb1d2e8c80f102a4","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"ISF","text_display":"ISF","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,725],[903,725],[903,769],[548,769]],"region":{"top_left_x":548,"top_left_y":724,"width":355,"height":45},"line":66,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1a36323700f84458a03c7f9a711816b6","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Investigator Site File","text_display":"Investigator Site File","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,766],[320,766],[320,812],[242,812]],"region":{"top_left_x":242,"top_left_y":766,"width":79,"height":47},"line":67,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"559bb3aa0fa64dd785cd9b9932762f88","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"ITT","text_display":"ITT","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,775],[859,775],[859,810],[548,810]],"region":{"top_left_x":548,"top_left_y":775,"width":312,"height":36},"line":68,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"27d11812b5f240f190f28afc8efd534e","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Intention To Treat","text_display":"Intention To Treat","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,822],[435,822],[435,856],[247,856]],"region":{"top_left_x":246,"top_left_y":821,"width":190,"height":36},"line":69,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"f93424453574485d80b2351d28bb12f8","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"IUDs/IUSs","text_display":"IUDs/IUSs","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,822],[1059,822],[1059,865],[548,865]],"region":{"top_left_x":548,"top_left_y":821,"width":512,"height":45},"line":70,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"26ba8a8dfc874bb2855ee8e21a0e318d","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Intra Uterine Devices/Systems","text_display":"Intra Uterine Devices/Systems","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99853515625,"confidence_rate":0.9999568857034922},{"cnt":[[247,868],[334,868],[334,907],[247,907]],"region":{"top_left_x":246,"top_left_y":867,"width":89,"height":40},"line":71,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"184dac556deb4042b86ef1790e3d6fc4","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"LDL","text_display":"LDL","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,868],[976,868],[976,914],[548,914]],"region":{"top_left_x":548,"top_left_y":867,"width":429,"height":47},"line":72,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"67d86b5c766044bea2d39397c115f8a8","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Low Density Lipoprotein","text_display":"Low Density Lipoprotein","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,914],[339,914],[339,955],[242,955]],"region":{"top_left_x":242,"top_left_y":913,"width":97,"height":43},"line":73,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"e3bd6d2d06014c9e85b1352b42e8a0c5","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"LDH","text_display":"LDH","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,918],[944,918],[944,962],[548,962]],"region":{"top_left_x":548,"top_left_y":918,"width":397,"height":44},"line":74,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"f5cfedf8d915480688811bc38da19b4c","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Lactate Dehydrogenase","text_display":"Lactate Dehydrogenase","cell_row":11,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,967],[373,967],[373,1003],[247,1003]],"region":{"top_left_x":246,"top_left_y":966,"width":128,"height":38},"line":75,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"b69ccb13999b4b6fadc346b9545ebad3","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"MACE","text_display":"MACE","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,964],[1188,964],[1188,1008],[548,1008]],"region":{"top_left_x":548,"top_left_y":964,"width":641,"height":45},"line":76,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"66cc346780974d11bf6c7382f4800f0c","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Major Adverse Cardiovascular Events","text_display":"Major Adverse Cardiovascular Events","cell_row":12,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,1015],[376,1015],[376,1049],[247,1049]],"region":{"top_left_x":246,"top_left_y":1014,"width":130,"height":36},"line":77,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"20a109f827634bfa8503b79fc63ab041","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"MDRD","text_display":"MDRD","cell_row":13,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1015],[1188,1015],[1188,1049],[548,1049]],"region":{"top_left_x":548,"top_left_y":1014,"width":641,"height":36},"line":78,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"0b5f154a702f497ba611d13471e9e9c6","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Modification of Diet in Renal Disease","text_display":"Modification of Diet in Renal Disease","cell_row":13,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,1061],[415,1061],[415,1096],[247,1096]],"region":{"top_left_x":246,"top_left_y":1060,"width":169,"height":36},"line":79,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ce9f0f4787cd4ab8a5e110a2d5af5f0f","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"MedDRA","text_display":"MedDRA","cell_row":14,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.998046875,"confidence_rate":0.9998222853535005},{"cnt":[[548,1061],[1400,1061],[1400,1105],[548,1105]],"region":{"top_left_x":548,"top_left_y":1060,"width":853,"height":45},"line":80,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"85c0f0e45f854f7bb0036ff3ad1bd663","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Medical Dictionary for Drug Regulatory Activities","text_display":"Medical Dictionary for Drug Regulatory Activities","cell_row":14,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1112],[306,1112],[306,1148],[242,1148]],"region":{"top_left_x":242,"top_left_y":1111,"width":65,"height":38},"line":81,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"7972860b39e24f368d897862550936fc","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"MI","text_display":"MI","cell_row":15,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[546,1107],[917,1107],[917,1151],[546,1151]],"region":{"top_left_x":545,"top_left_y":1107,"width":372,"height":44},"line":82,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ace16433922441568b8d2676d6c132d2","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Myocardial infarction","text_display":"Myocardial infarction","cell_row":15,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,1158],[373,1158],[373,1192],[247,1192]],"region":{"top_left_x":246,"top_left_y":1157,"width":128,"height":36},"line":83,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"3d228da9dae0436baaa3f2dc6938486d","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"MMSE","text_display":"MMSE","cell_row":16,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1158],[1082,1158],[1082,1192],[548,1192]],"region":{"top_left_x":548,"top_left_y":1157,"width":535,"height":36},"line":84,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1b0a1609ab30477d9c2219bc9d4f0ddf","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Mini-Mental State Examination","text_display":"Mini-Mental State Examination","cell_row":16,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,1206],[359,1206],[359,1243],[247,1243]],"region":{"top_left_x":246,"top_left_y":1206,"width":114,"height":37},"line":85,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"540aae68a64b455e894e7a0b4a5930d5","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"NGSP","text_display":"NGSP","cell_row":17,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[546,1204],[1432,1204],[1432,1247],[546,1247]],"region":{"top_left_x":545,"top_left_y":1203,"width":888,"height":45},"line":86,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"69404dba85264b6ca2bf21e23cb06c75","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"National Glycohemoglobin Standardization Program","text_display":"National Glycohemoglobin Standardization Program","cell_row":17,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1247],[297,1247],[297,1289],[242,1289]],"region":{"top_left_x":242,"top_left_y":1247,"width":56,"height":42},"line":87,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"38311fc3752c4096b254cfcf77317a2d","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"NI","text_display":"NI","cell_row":18,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[546,1254],[811,1254],[811,1298],[546,1298]],"region":{"top_left_x":545,"top_left_y":1254,"width":266,"height":45},"line":88,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"8f070f2d47ca485f801095c69f6e1888","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Non-Inferiority","text_display":"Non-Inferiority","cell_row":18,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1300],[341,1300],[341,1340],[242,1340]],"region":{"top_left_x":242,"top_left_y":1300,"width":100,"height":40},"line":89,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"113a034308284066b81c3497be13f3d3","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"OAD","text_display":"OAD","cell_row":19,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1300],[917,1300],[917,1344],[548,1344]],"region":{"top_left_x":548,"top_left_y":1300,"width":369,"height":45},"line":90,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2f02085c1f004ad6942bb09c0c7360d4","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Oral antidiabetic drug","text_display":"Oral antidiabetic drug","cell_row":19,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1342],[311,1342],[311,1388],[242,1388]],"region":{"top_left_x":242,"top_left_y":1341,"width":70,"height":47},"line":91,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"97d2ea26e8f54151995cb8e12df86e15","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"OS","text_display":"OS","cell_row":20,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1346],[864,1346],[864,1386],[548,1386]],"region":{"top_left_x":548,"top_left_y":1346,"width":316,"height":40},"line":92,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"0bfa2ee07f5d4dc8bb43a92c3e796a85","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"On-treatment Set","text_display":"On-treatment Set","cell_row":20,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1397],[320,1397],[320,1434],[242,1434]],"region":{"top_left_x":242,"top_left_y":1397,"width":79,"height":37},"line":93,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"3521757f49424bbf82db60e48643f3be","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"PCI","text_display":"PCI","cell_row":21,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1397],[1156,1397],[1156,1441],[548,1441]],"region":{"top_left_x":548,"top_left_y":1397,"width":609,"height":44},"line":94,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"e95f8d8c9035400c9ac9fb57f14637f9","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Percutaneous Coronary Intervention","text_display":"Percutaneous Coronary Intervention","cell_row":21,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99853515625,"confidence_rate":0.9999624130735217},{"cnt":[[242,1452],[316,1452],[316,1489],[242,1489]],"region":{"top_left_x":242,"top_left_y":1452,"width":74,"height":38},"line":95,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"9a60bc007a644a38a388d4f9bf28e9a0","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"p.o.","text_display":"p.o.","cell_row":22,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[546,1443],[755,1443],[755,1487],[546,1487]],"region":{"top_left_x":545,"top_left_y":1443,"width":211,"height":44},"line":96,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"06d93d453ade4f4cb0e50adf2827a443","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"per os (oral)","text_display":"per os (oral)","cell_row":22,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1489],[320,1489],[320,1531],[242,1531]],"region":{"top_left_x":242,"top_left_y":1489,"width":79,"height":42},"line":97,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"7479c397b4af4689adcd58841a4d0e7f","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"PPS","text_display":"PPS","cell_row":23,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[551,1494],[825,1494],[825,1528],[551,1528]],"region":{"top_left_x":550,"top_left_y":1493,"width":275,"height":36},"line":98,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"6a5ca3e878c94f3aadb060e6d8e45bf9","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Per Protocol Set","text_display":"Per Protocol Set","cell_row":23,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1542],[306,1542],[306,1581],[242,1581]],"region":{"top_left_x":242,"top_left_y":1542,"width":65,"height":40},"line":99,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"b497cb7418d94be0b3dc9462bd66eb59","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"PR","text_display":"PR","cell_row":24,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1540],[728,1540],[728,1574],[548,1574]],"region":{"top_left_x":548,"top_left_y":1539,"width":180,"height":36},"line":100,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"12751d2456494ca985940ab23c3a24d5","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Pulse Rate","text_display":"Pulse Rate","cell_row":24,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1584],[306,1584],[306,1627],[242,1627]],"region":{"top_left_x":242,"top_left_y":1583,"width":65,"height":45},"line":101,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"9ecf373abf0d4bccab40ddabb2001047","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"PV","text_display":"PV","cell_row":25,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1586],[861,1586],[861,1625],[548,1625]],"region":{"top_left_x":548,"top_left_y":1585,"width":314,"height":41},"line":102,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"3d211f99e56d47ac9ad10d94d59b4653","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Protocol Violation","text_display":"Protocol Violation","cell_row":25,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1637],[334,1637],[334,1676],[242,1676]],"region":{"top_left_x":242,"top_left_y":1636,"width":93,"height":40},"line":103,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"9d46f1d91c374e87b000e3c618c30c62","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"SAE","text_display":"SAE","cell_row":26,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[551,1637],[935,1637],[935,1671],[551,1671]],"region":{"top_left_x":550,"top_left_y":1636,"width":386,"height":36},"line":104,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"f8cfc2210fbd4c009ba7ac88c2e586ac","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Serious Adverse Event","text_display":"Serious Adverse Event","cell_row":26,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1685],[306,1685],[306,1729],[242,1729]],"region":{"top_left_x":242,"top_left_y":1684,"width":65,"height":45},"line":105,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"9f6aef1a265d4434a40be3223f44d60c","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"SC","text_display":"SC","cell_row":27,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[551,1683],[889,1683],[889,1726],[551,1726]],"region":{"top_left_x":550,"top_left_y":1682,"width":340,"height":45},"line":106,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"b046702d31c840e59f2bdf9a335311c1","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Steering Committee","text_display":"Steering Committee","cell_row":27,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,1733],[392,1733],[392,1768],[247,1768]],"region":{"top_left_x":246,"top_left_y":1733,"width":146,"height":35},"line":107,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"08917ffab4fa42a596c0b5939172a8f5","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"SGLT-2","text_display":"SGLT-2","cell_row":28,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1733],[1165,1733],[1165,1777],[548,1777]],"region":{"top_left_x":548,"top_left_y":1733,"width":618,"height":45},"line":108,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"4d0ff2df8a7c4e9d965b095b959111dd","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Sodium Glucose Linked Transporter","text_display":"Sodium Glucose Linked Transporter","cell_row":28,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1779],[329,1779],[329,1823],[242,1823]],"region":{"top_left_x":242,"top_left_y":1779,"width":88,"height":45},"line":109,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"440b392d84d04eda83aef742da94d022","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"SOP","text_display":"SOP","cell_row":29,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[551,1779],[1055,1779],[1055,1823],[551,1823]],"region":{"top_left_x":550,"top_left_y":1779,"width":505,"height":45},"line":110,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"a07886ab132045f88929c48d80b887e5","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Standard Operating Procedure","text_display":"Standard Operating Procedure","cell_row":29,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1823],[306,1823],[306,1867],[242,1867]],"region":{"top_left_x":242,"top_left_y":1823,"width":65,"height":44},"line":111,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"91fc16a17848463fa65c636165db1dd3","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"SU","text_display":"SU","cell_row":30,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[551,1825],[769,1825],[769,1869],[551,1869]],"region":{"top_left_x":550,"top_left_y":1825,"width":220,"height":45},"line":112,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"115c8b624eca40f9b7c3e271cfc46ead","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Sulfonylurea","text_display":"Sulfonylurea","cell_row":30,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[249,1876],[387,1876],[387,1911],[249,1911]],"region":{"top_left_x":248,"top_left_y":1876,"width":140,"height":35},"line":113,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"12ce4abd59084fd0b44d469fb43be162","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"SUSAR","text_display":"SUSAR","cell_row":31,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,1876],[1391,1876],[1391,1920],[548,1920]],"region":{"top_left_x":548,"top_left_y":1876,"width":843,"height":44},"line":114,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"388f4419ade24cc4a9a0b7b9a1182759","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Suspected Unexpected Serious Adverse Reactions","text_display":"Suspected Unexpected Serious Adverse Reactions","cell_row":31,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,1924],[364,1924],[364,1961],[247,1961]],"region":{"top_left_x":246,"top_left_y":1924,"width":119,"height":38},"line":115,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"4621f9b5a6f848bfbfbfd467d8235f3b","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"T2DM","text_display":"T2DM","cell_row":32,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[546,1922],[963,1922],[963,1966],[546,1966]],"region":{"top_left_x":545,"top_left_y":1922,"width":418,"height":44},"line":116,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"b23be064bbba43cbac53fa6edf010c87","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Type 2 diabetes mellitus","text_display":"Type 2 diabetes mellitus","cell_row":32,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1973],[325,1973],[325,2010],[242,2010]],"region":{"top_left_x":242,"top_left_y":1972,"width":83,"height":38},"line":117,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"62748a19c94c4e8da531e207d4f1932d","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"TIA","text_display":"TIA","cell_row":33,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[546,1970],[993,1970],[993,2007],[546,2007]],"region":{"top_left_x":545,"top_left_y":1970,"width":448,"height":38},"line":118,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"72ea5b848c3b45f8b923b8cd27a860c5","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Transient Ischemic Attack","text_display":"Transient Ischemic Attack","cell_row":33,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,2019],[343,2019],[343,2056],[247,2056]],"region":{"top_left_x":246,"top_left_y":2018,"width":98,"height":38},"line":119,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2a82a071cff94d8699b82fdb9ce36893","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"TMT","text_display":"TMT","cell_row":34,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2019],[857,2019],[857,2063],[548,2063]],"region":{"top_left_x":548,"top_left_y":2018,"width":309,"height":45},"line":120,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"cc43e827826b43ccb2ae71dc43b72d7c","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Trial Making Test","text_display":"Trial Making Test","cell_row":34,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,2065],[306,2065],[306,2106],[242,2106]],"region":{"top_left_x":242,"top_left_y":2064,"width":65,"height":43},"line":121,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"19c425dfa66a4cdea93c155c9ab16e3d","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"TS","text_display":"TS","cell_row":35,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2069],[760,2069],[760,2104],[548,2104]],"region":{"top_left_x":548,"top_left_y":2069,"width":213,"height":36},"line":122,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"57d25369f7cf4f93b663b669b0b4af4c","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Treated Set","text_display":"Treated Set","cell_row":35,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,2116],[355,2116],[355,2150],[247,2150]],"region":{"top_left_x":246,"top_left_y":2115,"width":109,"height":36},"line":123,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"77a842f53a3041a899990cec3a6a23bd","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"TSAP","text_display":"TSAP","cell_row":36,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[546,2116],[1050,2116],[1050,2159],[546,2159]],"region":{"top_left_x":545,"top_left_y":2115,"width":506,"height":45},"line":124,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"672d3a7006ed4a45bea5b4b78b368992","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Trial Statistical Analysis Plan","text_display":"Trial Statistical Analysis Plan","cell_row":36,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,2164],[369,2164],[369,2201],[247,2201]],"region":{"top_left_x":246,"top_left_y":2163,"width":123,"height":38},"line":125,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2168c59dd74a486591821c08398df2e3","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"UACR","text_display":"UACR","cell_row":37,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2162],[1092,2162],[1092,2201],[548,2201]],"region":{"top_left_x":548,"top_left_y":2161,"width":544,"height":40},"line":126,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"01af53c4e32d4ef99db9797aa1d6478b","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Urine Albumin Creatinine Ratio","text_display":"Urine Albumin Creatinine Ratio","cell_row":37,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,2212],[339,2212],[339,2251],[242,2251]],"region":{"top_left_x":242,"top_left_y":2212,"width":97,"height":40},"line":127,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"4b010dd17cee40a3acb049e11ee2af31","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"ULN","text_display":"ULN","cell_row":38,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2212],[944,2212],[944,2256],[548,2256]],"region":{"top_left_x":548,"top_left_y":2212,"width":397,"height":44},"line":128,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"edf83d2e98d749e2bb3bd5c67842e214","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Upper Limit of Normal","text_display":"Upper Limit of Normal","cell_row":38,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[247,2258],[364,2258],[364,2295],[247,2295]],"region":{"top_left_x":246,"top_left_y":2258,"width":119,"height":38},"line":129,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2e72bb8cba034eacb2d1f3419dc7dceb","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"VEGF","text_display":"VEGF","cell_row":39,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[546,2258],[1133,2258],[1133,2302],[546,2302]],"region":{"top_left_x":545,"top_left_y":2258,"width":589,"height":45},"line":130,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1ae7882b21e645409dc79ec48d084904","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Vascular endothelial growth factor","text_display":"Vascular endothelial growth factor","cell_row":39,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9833984375,"confidence_rate":0.9995708379399599},{"cnt":[[242,2309],[332,2309],[332,2346],[242,2346]],"region":{"top_left_x":242,"top_left_y":2308,"width":90,"height":38},"line":131,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ada73e65033048cd9cc4ed0601010e2b","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"VFT","text_display":"VFT","cell_row":40,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[548,2309],[894,2309],[894,2353],[548,2353]],"region":{"top_left_x":548,"top_left_y":2308,"width":346,"height":45},"line":132,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"5b351edfe4614d3997de29280471e484","type":"simple_cell","conversion_output":false,"parent_id":"57705fdc55454b6f955ce3c308323284","text":"Verbal Fluency Test","text_display":"Verbal Fluency Test","cell_row":40,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[795,2586],[1300,2586],[1300,2620],[795,2620]],"region":{"top_left_x":794,"top_left_y":2585,"width":506,"height":36},"line":133,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5beb9e2543554f7e9f35776523eb47f0","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[292,2622],[1798,2622],[1798,2659],[292,2659]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":38},"line":134,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0d6f0d1452da4561bb27f907d3b09293","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999876814398867},{"cnt":[[297,2668],[1768,2668],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1473,"height":35},"line":135,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"819f69f9b97b4ce78109e68961f49f58","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-017","page":17,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ce7a2f39f4b464e84a23aee8abc684a","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b90be3abfca64d45a7cf14457f8c2444","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a245f9118664540ae59ca8fa6e1dec0","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0e19814e6164177b0021f348406712e","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7dbefc047afb44788a778c246f45bf5b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1576,210],[1816,210],[1816,254],[1576,254]],"region":{"top_left_x":1576,"top_left_y":210,"width":241,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e48a2bcb22494e569712d97957f23ecd","type":"page_info","conversion_output":false,"text":"Page 17 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[806,338],[806,393],[242,393]],"region":{"top_left_x":242,"top_left_y":338,"width":565,"height":55},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"513909d4227043d3bc820acdaee3b356","type":"section_header","conversion_output":false,"children_ids":["6d91810e167941e580ebd4fbcf0962b9"],"text":"","text_display":""},{"cnt":[[247,343],[800,343],[800,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":554,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6d91810e167941e580ebd4fbcf0962b9","type":"text","conversion_output":true,"parent_id":"513909d4227043d3bc820acdaee3b356","text":"1. INTRODUCTION","text_display":"\n\n\\section*{1. INTRODUCTION}","confidence":1,"confidence_rate":1},{"cnt":[[247,439],[1750,439],[1750,487],[247,487]],"region":{"top_left_x":246,"top_left_y":438,"width":1504,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"59256f47fc9341f682a2c05b705d38ea","type":"text","conversion_output":true,"text":"Linagliptin is an orally available inhibitor of the enzyme dipeptidyl-peptidase IV (DPP-4)","text_display":"\n\nLinagliptin is an orally available inhibitor of the enzyme dipeptidyl-peptidase IV (DPP-4)","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1684,484],[1684,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1438,"height":49},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"00b19691a0de4fe5b59d297df4b2408c","type":"text","conversion_output":true,"text":"facilitating a decrease of blood glucose levels in patients with type 2 diabetes mellitus","text_display":" facilitating a decrease of blood glucose levels in patients with type 2 diabetes mellitus","confidence":0.9970703125,"confidence_rate":0.9999697531643026},{"cnt":[[247,535],[404,535],[404,580],[247,580]],"region":{"top_left_x":246,"top_left_y":534,"width":159,"height":47},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"34cf2ea90b064a26b74dee9bed087450","type":"text","conversion_output":true,"text":"(T2DM).","text_display":" (T2DM).","confidence":0.83984375,"confidence_rate":0.9855603154574818},{"cnt":[[244,621],[930,621],[930,667],[244,667]],"region":{"top_left_x":244,"top_left_y":621,"width":686,"height":47},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0d423401b0f5450a978bca1f796f0aa4","type":"section_header","conversion_output":false,"children_ids":["85135a12e5f64ae6abd06347abb2b2c2"],"text":"","text_display":""},{"cnt":[[247,626],[925,626],[925,665],[247,665]],"region":{"top_left_x":246,"top_left_y":625,"width":680,"height":40},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"85135a12e5f64ae6abd06347abb2b2c2","type":"text","conversion_output":true,"parent_id":"0d423401b0f5450a978bca1f796f0aa4","text":"1.1 MEDICAL BACKGROUND","text_display":"\n\n\\subsection*{1.1 MEDICAL BACKGROUND}","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[247,713],[1750,713],[1750,761],[247,761]],"region":{"top_left_x":246,"top_left_y":712,"width":1504,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"50b047a4ee5f447d8f3953b18312416f","type":"text","conversion_output":true,"text":"T2DM is a chronic metabolic disease defined by elevated glucose levels that is associated","text_display":"\n\nT2DM is a chronic metabolic disease defined by elevated glucose levels that is associated","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[247,761],[1629,761],[1629,806],[247,806]],"region":{"top_left_x":246,"top_left_y":760,"width":1383,"height":47},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"31b22ca71c384cb680063dd66b3fab7d","type":"text","conversion_output":true,"text":"with an increased risk for acute and/or late complications related to the micro- and","text_display":" with an increased risk for acute and/or late complications related to the micro- and","confidence":1,"confidence_rate":1},{"cnt":[[247,809],[1702,809],[1702,857],[247,857]],"region":{"top_left_x":246,"top_left_y":808,"width":1456,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4cd39c2b618d4450a09f3b1e6389e420","type":"text","conversion_output":true,"text":"macrovascular circulation. For instance, T2DM is the leading cause for end stage renal","text_display":" macrovascular circulation. For instance, T2DM is the leading cause for end stage renal","confidence":1,"confidence_rate":1},{"cnt":[[247,854],[1633,854],[1633,902],[247,902]],"region":{"top_left_x":246,"top_left_y":854,"width":1388,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1d3f4cf3144a45ca8720acb22064dd82","type":"text","conversion_output":true,"text":"disease (ESRD) worldwide and a major cause of new cases of blindness and visual","text_display":" disease (ESRD) worldwide and a major cause of new cases of blindness and visual","confidence":1,"confidence_rate":1},{"cnt":[[247,905],[1812,905],[1812,953],[247,953]],"region":{"top_left_x":246,"top_left_y":904,"width":1566,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"515f764d1f8e429096688fd1eb4325d1","type":"text","conversion_output":true,"text":"impairment. The elevated risk for macrovascular disease is primarily related to increased risk","text_display":" impairment. The elevated risk for macrovascular disease is primarily related to increased risk","confidence":1,"confidence_rate":1},{"cnt":[[247,953],[1674,953],[1674,998],[247,998]],"region":{"top_left_x":246,"top_left_y":952,"width":1429,"height":47},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"76fa4261477b463db26dfbef503161af","type":"text","conversion_output":true,"text":"for athero-thrombosis that leads to increased morbidity and premature mortality from","text_display":" for athero-thrombosis that leads to increased morbidity and premature mortality from","confidence":1,"confidence_rate":1},{"cnt":[[247,1001],[1713,1001],[1713,1049],[247,1049]],"region":{"top_left_x":246,"top_left_y":1000,"width":1468,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bb1c384af5ab45cc8baaf59d044347a2","type":"text","conversion_output":true,"text":"cardiovascular (CV) disease [R10-0116, P08-06509] and an important predictor for CV","text_display":" cardiovascular (CV) disease [R10-0116, P08-06509] and an important predictor for CV","confidence":0.9882962703704834,"confidence_rate":0.9998662276143475},{"cnt":[[247,1049],[1789,1049],[1789,1094],[247,1094]],"region":{"top_left_x":246,"top_left_y":1048,"width":1543,"height":47},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"73397383f7134a729d0854ca8f2e675b","type":"text","conversion_output":true,"text":"diseases is chronic kidney disease (CKD) which often co-exist. Studies suggest that 70-75\\%","text_display":" diseases is chronic kidney disease (CKD) which often co-exist. Studies suggest that 70-75\\%","confidence":0.7744140625,"confidence_rate":0.9973125798703211},{"cnt":[[247,1096],[1711,1096],[1711,1144],[247,1144]],"region":{"top_left_x":246,"top_left_y":1096,"width":1465,"height":49},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"521b96f144be4dc888e9f992eb4df8ff","type":"text","conversion_output":true,"text":"of all deaths in people with diabetes can be attributed to CV complications [R10-0117].","text_display":" of all deaths in people with diabetes can be attributed to CV complications [R10-0117].","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[242,1183],[1505,1183],[1505,1236],[242,1236]],"region":{"top_left_x":242,"top_left_y":1183,"width":1264,"height":53},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8b42322822c546d38888e407763bde0f","type":"section_header","conversion_output":false,"children_ids":["4fc0ded160714adf876ae01904c46756"],"text":"","text_display":""},{"cnt":[[247,1186],[1501,1186],[1501,1231],[247,1231]],"region":{"top_left_x":246,"top_left_y":1185,"width":1255,"height":47},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4fc0ded160714adf876ae01904c46756","type":"text","conversion_output":true,"parent_id":"8b42322822c546d38888e407763bde0f","text":"Strategies for glycaemic management of T2DM; guidelines and limitations","text_display":"\n\n\\section*{Strategies for glycaemic management of T2DM; guidelines and limitations}","confidence":1,"confidence_rate":1},{"cnt":[[247,1275],[1745,1275],[1745,1323],[247,1323]],"region":{"top_left_x":246,"top_left_y":1274,"width":1500,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c9d3b51f9f92422b95b4b9495dbff79d","type":"text","conversion_output":true,"text":"Patients with T2DM are usually treated by combinations of lifestyle and pharmacological","text_display":"\n\nPatients with T2DM are usually treated by combinations of lifestyle and pharmacological","confidence":1,"confidence_rate":1},{"cnt":[[247,1325],[1709,1325],[1709,1368],[247,1368]],"region":{"top_left_x":246,"top_left_y":1324,"width":1463,"height":45},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"807f75d5a78f406b94fbdf013b7a32af","type":"text","conversion_output":true,"text":"interventions and several international guidelines for the treatment of T2DM have been","text_display":" interventions and several international guidelines for the treatment of T2DM have been","confidence":1,"confidence_rate":1},{"cnt":[[247,1371],[1816,1371],[1816,1419],[247,1419]],"region":{"top_left_x":246,"top_left_y":1370,"width":1571,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ea371256237146e59a56b5ecc5aff8ff","type":"text","conversion_output":true,"text":"issued [R07-1076, P10-00533, R09-1164, R09-6397, R08-1310, R10-4077, P08-01788]. Most","text_display":" issued [R07-1076, P10-00533, R09-1164, R09-6397, R08-1310, R10-4077, P08-01788]. Most","confidence":0.9956090442137793,"confidence_rate":0.9999511053693173},{"cnt":[[247,1421],[1812,1421],[1812,1467],[247,1467]],"region":{"top_left_x":246,"top_left_y":1420,"width":1566,"height":47},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f118fa4dfd4b434aa439c928b51ef8a0","type":"text","conversion_output":true,"text":"guidelines suggest that the therapeutic goal for glycosylated haemoglobin ( HbA 1 c ) should be","text_display":" guidelines suggest that the therapeutic goal for glycosylated haemoglobin ( HbA 1 c ) should be","confidence":0.9863831238144485,"confidence_rate":0.9998718732916896},{"cnt":[[247,1467],[1793,1467],[1793,1515],[247,1515]],"region":{"top_left_x":246,"top_left_y":1466,"width":1548,"height":49},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6e2731679a714c3dbd245948e3259c4d","type":"text","conversion_output":true,"text":"6.5-7.0\\%, which by the use of available tools seem hard to obtain after more than 5-10 years","text_display":" 6.5-7.0\\%, which by the use of available tools seem hard to obtain after more than 5-10 years","confidence":0.9529609680175781,"confidence_rate":0.9995034085678637},{"cnt":[[247,1517],[1800,1517],[1800,1560],[247,1560]],"region":{"top_left_x":246,"top_left_y":1516,"width":1555,"height":45},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0bf5d94ab14e442f9d036942545aee50","type":"text","conversion_output":true,"text":"of diabetes duration. A survey in the US (National Health and Nutrition Examination Survey","text_display":" of diabetes duration. A survey in the US (National Health and Nutrition Examination Survey","confidence":1,"confidence_rate":1},{"cnt":[[247,1563],[1802,1563],[1802,1610],[247,1610]],"region":{"top_left_x":246,"top_left_y":1562,"width":1557,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b3fc7ae813c24980835a20cb4e145014","type":"text","conversion_output":true,"text":"[NHANES] 2003-2004) found that only \\(57 \\%\\) of participants had \\(HbA 1 c <7.0 \\%\\) [R10-0133].","text_display":" [NHANES] 2003-2004) found that only \\(57 \\%\\) of participants had \\(HbA 1 c <7.0 \\%\\) [R10-0133].","confidence":0.9825151692038043,"confidence_rate":0.9998218391456138},{"cnt":[[247,1610],[1793,1610],[1793,1656],[247,1656]],"region":{"top_left_x":246,"top_left_y":1610,"width":1548,"height":47},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a69e4383ffa446d686afcba657d70c7c","type":"text","conversion_output":true,"text":"Poor control was also noted among the 7000 individuals with T2DM in the Cost of Diabetes","text_display":" Poor control was also noted among the 7000 individuals with T2DM in the Cost of Diabetes","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[247,1658],[1821,1658],[1821,1706],[247,1706]],"region":{"top_left_x":246,"top_left_y":1658,"width":1575,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6bd0fb9b3249473db56d9239cf5391a0","type":"text","conversion_output":true,"text":"in Europe - Type 2 study where only \\(31 \\%\\) achieved the \\(<6.5 \\% HbA\\) 1c goal for HbA 1c [R10-","text_display":" in Europe - Type 2 study where only \\(31 \\%\\) achieved the \\(<6.5 \\% HbA\\) 1c goal for HbA 1c [R10","confidence":0.7515818414629456,"confidence_rate":0.9973834733860651},{"cnt":[[247,1706],[1711,1706],[1711,1752],[247,1752]],"region":{"top_left_x":246,"top_left_y":1706,"width":1465,"height":47},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a7e0f0e61da64b3b818e53e33e03c80a","type":"text","conversion_output":true,"text":"0134]. Reasons for this are, amongst other factors, related to a progressive failure of the","text_display":"0134]. Reasons for this are, amongst other factors, related to a progressive failure of the","confidence":1,"confidence_rate":1},{"cnt":[[247,1754],[1706,1754],[1706,1802],[247,1802]],"region":{"top_left_x":246,"top_left_y":1754,"width":1461,"height":49},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c8f96ec7e4c44a2996f2c42385202632","type":"text","conversion_output":true,"text":"pancreatic \\(\\beta\\)-cells to compensate for an endogenous insulin resistance by an adequately","text_display":" pancreatic \\(\\beta\\)-cells to compensate for an endogenous insulin resistance by an adequately","confidence":0.93603515625,"confidence_rate":0.9993044289363797},{"cnt":[[247,1802],[1665,1802],[1665,1848],[247,1848]],"region":{"top_left_x":246,"top_left_y":1802,"width":1420,"height":47},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f0ba888a60d5425f80daa3d317a310b0","type":"text","conversion_output":true,"text":"increased insulin secretion, and the lack of treatment with sustainable effects. Ample","text_display":" increased insulin secretion, and the lack of treatment with sustainable effects. Ample","confidence":1,"confidence_rate":1},{"cnt":[[247,1850],[1729,1850],[1729,1898],[247,1898]],"region":{"top_left_x":246,"top_left_y":1850,"width":1484,"height":49},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"971b0d7a67784ca09fa4ec11f76caf4f","type":"text","conversion_output":true,"text":"evidence tells that lifestyle modification alone, or oral monotherapy, are not sufficient to","text_display":" evidence tells that lifestyle modification alone, or oral monotherapy, are not sufficient to","confidence":1,"confidence_rate":1},{"cnt":[[247,1901],[1748,1901],[1748,1944],[247,1944]],"region":{"top_left_x":246,"top_left_y":1900,"width":1502,"height":45},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"93aef5ad5e734e8f85d2949c0e3555a6","type":"text","conversion_output":true,"text":"maintain target levels of glycaemic control in most patients over time. In guidance for the","text_display":" maintain target levels of glycaemic control in most patients over time. In guidance for the","confidence":1,"confidence_rate":1},{"cnt":[[247,1946],[1775,1946],[1775,1994],[247,1994]],"region":{"top_left_x":246,"top_left_y":1946,"width":1529,"height":49},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"caab87fbe17e4474b39fde18d1413cd3","type":"text","conversion_output":true,"text":"clinician on which pharmacological compounds to use to achieve glycaemic goals amongst","text_display":" clinician on which pharmacological compounds to use to achieve glycaemic goals amongst","confidence":1,"confidence_rate":1},{"cnt":[[247,1994],[1812,1994],[1812,2040],[247,2040]],"region":{"top_left_x":246,"top_left_y":1994,"width":1566,"height":46},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"601550b676a140e2b9d2ab6e07109389","type":"text","conversion_output":true,"text":"patients with T2DM the international guidelines differs slightly [R07-1076, P10-00533, R09-","text_display":" patients with T2DM the international guidelines differs slightly [R07-1076, P10-00533, R09","confidence":0.9912188034504652,"confidence_rate":0.9999081294447617},{"cnt":[[247,2042],[1642,2042],[1642,2090],[247,2090]],"region":{"top_left_x":246,"top_left_y":2042,"width":1397,"height":49},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ebd3c15e94924504a755065c8e75bac5","type":"text","conversion_output":true,"text":"1164, R09-6397, R08-1310, R10-4077, P08-01788]. In general however, all bodies","text_display":"1164, R09-6397, R08-1310, R10-4077, P08-01788]. In general however, all bodies","confidence":0.9970703125,"confidence_rate":0.9999646513785749},{"cnt":[[247,2090],[1716,2090],[1716,2136],[247,2136]],"region":{"top_left_x":246,"top_left_y":2090,"width":1470,"height":46},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ae4ae10c98ec4e0abe2567edf551b289","type":"text","conversion_output":true,"text":"recommend that metformin should be first line treatment. Despite some limitations, this","text_display":" recommend that metformin should be first line treatment. Despite some limitations, this","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[247,2138],[1812,2138],[1812,2186],[247,2186]],"region":{"top_left_x":246,"top_left_y":2138,"width":1566,"height":49},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"464f445e0f064db1811ac55f4ec3ee15","type":"text","conversion_output":true,"text":"compound is the most widely used with a good safety profile, with some evidence suggesting","text_display":" compound is the most widely used with a good safety profile, with some evidence suggesting","confidence":1,"confidence_rate":1},{"cnt":[[247,2186],[1757,2186],[1757,2232],[247,2232]],"region":{"top_left_x":246,"top_left_y":2186,"width":1511,"height":46},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"281decb9e9b04f949998ce82a7512607","type":"text","conversion_output":true,"text":"cardio protective properties [R09-6405, R09-6406], and without associated cardiotoxicity.","text_display":" cardio protective properties [R09-6405, R09-6406], and without associated cardiotoxicity.","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[247,2234],[1213,2234],[1213,2280],[247,2280]],"region":{"top_left_x":246,"top_left_y":2234,"width":968,"height":46},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"147b8a77fcee44b781315aac516a7d67","type":"text","conversion_output":true,"text":"Most other drugs on the market lack such documentation.","text_display":" Most other drugs on the market lack such documentation.","confidence":1,"confidence_rate":1},{"cnt":[[247,2330],[1800,2330],[1800,2378],[247,2378]],"region":{"top_left_x":246,"top_left_y":2330,"width":1555,"height":49},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"be7677f189da4ac9a447b5da8aa1eabd","type":"text","conversion_output":true,"text":"As a second line treatment, because of the progressive loss of \\(\\beta\\)-cell function in patients with","text_display":"\n\nAs a second line treatment, because of the progressive loss of \\(\\beta\\)-cell function in patients with","confidence":0.5256221294403076,"confidence_rate":0.9938347307744111},{"cnt":[[247,2378],[1713,2378],[1713,2424],[247,2424]],"region":{"top_left_x":246,"top_left_y":2378,"width":1468,"height":46},"line":47,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2d02876e0551460ebce103cb50c58741","type":"text","conversion_output":true,"text":"T2DM, traditional insulin secretagogues such as the sulfonylurea's (SUs) that stimulate","text_display":" T2DM, traditional insulin secretagogues such as the sulfonylurea's (SUs) that stimulate","confidence":1,"confidence_rate":1},{"cnt":[[247,2426],[1748,2426],[1748,2472],[247,2472]],"region":{"top_left_x":246,"top_left_y":2426,"width":1502,"height":46},"line":48,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"216b985ce6254deea4b8cf50879046fe","type":"text","conversion_output":true,"text":"insulin secretion in a non-glucose-dependent manner are widely used; in fact, they are the","text_display":" insulin secretion in a non-glucose-dependent manner are widely used; in fact, they are the","confidence":1,"confidence_rate":1},{"cnt":[[247,2474],[1802,2474],[1802,2520],[247,2520]],"region":{"top_left_x":246,"top_left_y":2473,"width":1557,"height":47},"line":49,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4bd3a1c860fc4604a5a50bf21b8dabbc","type":"text","conversion_output":true,"text":"most commonly used second line therapy. However, treatment with SUs carries an increased","text_display":" most commonly used second line therapy. However, treatment with SUs carries an increased","confidence":1,"confidence_rate":1},{"cnt":[[247,2522],[1748,2522],[1748,2570],[247,2570]],"region":{"top_left_x":246,"top_left_y":2521,"width":1502,"height":49},"line":50,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"53b252292cf5403ebeed2161514fc942","type":"text","conversion_output":true,"text":"risk for hypoglycaemia and weight gain [R09-6400], and as is the case for metformin, are","text_display":" risk for hypoglycaemia and weight gain [R09-6400], and as is the case for metformin, are","confidence":0.990234375,"confidence_rate":0.9998944827560637},{"cnt":[[790,2586],[1300,2586],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2585,"width":510,"height":38},"line":51,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8223880b9a2a47fcb77ff82747569916","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.986328125,"confidence_rate":0.9996722871437795},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":52,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f80474c159344c5d9781bb961d544d72","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":53,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a7e684406f8b411897aedd846da74272","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-018","page":18,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f61c1850189744128423605f3361ec75","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"05ee1f7a5e8648be8f46b5639dd58039","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fee067e73514350a533568ea3f9a267","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58b2b5430efa4053925f442c79cd727f","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3c2d9f6c7354a19b3a7c01c0bf82906","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fd899a6a3954469800a28d44c4b711e","type":"page_info","conversion_output":false,"text":"Page 18 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1665,338],[1665,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":1420,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d37c9a2630db415091b9ae0a2bfbe30e","type":"text","conversion_output":true,"text":"also associated with a lack of sustainable effect [R09-6400]. Therefore, international","text_display":"\nalso associated with a lack of sustainable effect [R09-6400]. Therefore, international","confidence":1,"confidence_rate":1},{"cnt":[[247,386],[1789,386],[1789,436],[247,436]],"region":{"top_left_x":246,"top_left_y":386,"width":1543,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0724549a00ce41178b27e2d008a605ec","type":"text","conversion_output":true,"text":"treatment guidelines have endorsed use of other drugs, e.g. insulins, glitazones, glinides and","text_display":" treatment guidelines have endorsed use of other drugs, e.g. insulins, glitazones, glinides and","confidence":1,"confidence_rate":1},{"cnt":[[247,429],[1748,429],[1748,482],[247,482]],"region":{"top_left_x":246,"top_left_y":429,"width":1502,"height":54},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ccaedaaef499405cac2d0d8186426c85","type":"text","conversion_output":true,"text":"alpha-glucosidase inhibitors, to be used as \\(2^{\\text {nd }}\\) line or \\(3^{\\text {rd }}\\) line in certain settings. However,","text_display":" alpha-glucosidase inhibitors, to be used as \\(2^{\\text {nd }}\\) line or \\(3^{\\text {rd }}\\) line in certain settings. However,","confidence":0.7642428874969482,"confidence_rate":0.9979179099058578},{"cnt":[[247,484],[1802,484],[1802,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1557,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d20f64a927494177bb6b73e36478b9c0","type":"text","conversion_output":true,"text":"most of these drugs also have side effects that limit their use, such as hypoglycaemia, weight","text_display":" most of these drugs also have side effects that limit their use, such as hypoglycaemia, weight","confidence":1,"confidence_rate":1},{"cnt":[[247,532],[1693,532],[1693,580],[247,580]],"region":{"top_left_x":246,"top_left_y":532,"width":1447,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9164670c38b4850a8d8ef93e20846c3","type":"text","conversion_output":true,"text":"gain, gastrointestinal (GI) side effects and peripheral oedema. In addition to morbidity","text_display":" gain, gastrointestinal (GI) side effects and peripheral oedema. In addition to morbidity","confidence":1,"confidence_rate":1},{"cnt":[[247,580],[1729,580],[1729,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1484,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68f70793f90943099c1e99f251c29010","type":"text","conversion_output":true,"text":"associated with each of these side effects, they could also have adverse CV implications.","text_display":" associated with each of these side effects, they could also have adverse CV implications.","confidence":1,"confidence_rate":1},{"cnt":[[247,626],[1711,626],[1711,676],[247,676]],"region":{"top_left_x":246,"top_left_y":625,"width":1465,"height":52},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42c0650ce7414f4f9316439f0e793036","type":"text","conversion_output":true,"text":"Hypoglycaemia and weight gain were recently postulated as contributors to the adverse","text_display":" Hypoglycaemia and weight gain were recently postulated as contributors to the adverse","confidence":1,"confidence_rate":1},{"cnt":[[247,672],[1784,672],[1784,724],[247,724]],"region":{"top_left_x":246,"top_left_y":671,"width":1539,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1b2ce6f99aa40c185e60af85d145c8d","type":"text","conversion_output":true,"text":"mortality outcomes in the \"Action to Control Cardiovascular Risk in Diabetes\" (ACCORD)","text_display":" mortality outcomes in the \"Action to Control Cardiovascular Risk in Diabetes\" (ACCORD)","confidence":1,"confidence_rate":1},{"cnt":[[244,717],[1720,717],[1720,770],[244,770]],"region":{"top_left_x":244,"top_left_y":717,"width":1477,"height":53},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"397648f9e093408fa8cfb098be3d803c","type":"text","conversion_output":true,"text":"trial [R09-6407]. In addition, serious hypoglycaemia was the \\(2^{\\text {nd }}\\) strongest predictor for","text_display":" trial [R09-6407]. In addition, serious hypoglycaemia was the \\(2^{\\text {nd }}\\) strongest predictor for","confidence":0.81982421875,"confidence_rate":0.9981621970439856},{"cnt":[[247,770],[1725,768],[1725,818],[247,820]],"region":{"top_left_x":246,"top_left_y":767,"width":1479,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b25cbbd6bc8d42c1976cf08e583d9971","type":"text","conversion_output":true,"text":"incident myocardial infarction (MI) in the Veterans Affairs Diabetes trial (VADT)[R09-","text_display":" incident myocardial infarction (MI) in the Veterans Affairs Diabetes trial (VADT)[R09","confidence":1,"confidence_rate":1},{"cnt":[[247,818],[359,818],[359,866],[247,866]],"region":{"top_left_x":246,"top_left_y":817,"width":113,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6aedea22cb164c59b4c7404b275de214","type":"text","conversion_output":true,"text":"6408].","text_display":"6408].","confidence":1,"confidence_rate":1},{"cnt":[[247,907],[1798,907],[1798,957],[247,957]],"region":{"top_left_x":246,"top_left_y":906,"width":1552,"height":52},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6041ab8a8b374aec8b47d268945e9e8f","type":"text","conversion_output":true,"text":"Since CV risk signals with drugs to treat T2DM have historically been observed at relatively","text_display":"\n\nSince CV risk signals with drugs to treat T2DM have historically been observed at relatively","confidence":1,"confidence_rate":1},{"cnt":[[247,955],[1802,955],[1802,1007],[247,1007]],"region":{"top_left_x":246,"top_left_y":954,"width":1557,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8cdf7f9572b24f0fb5d08727013b7bd2","type":"text","conversion_output":true,"text":"late stages, just before or even after the drugs have reached the market, regulatory authorities","text_display":" late stages, just before or even after the drugs have reached the market, regulatory authorities","confidence":1,"confidence_rate":1},{"cnt":[[247,1005],[1793,1005],[1793,1053],[247,1053]],"region":{"top_left_x":246,"top_left_y":1005,"width":1548,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fc825ab10c346b0aafbf05a66a8c1f2","type":"text","conversion_output":true,"text":"such as the US Food and Drugs Administration (FDA) have issued a guidance to industry in","text_display":" such as the US Food and Drugs Administration (FDA) have issued a guidance to industry in","confidence":1,"confidence_rate":1},{"cnt":[[247,1051],[1725,1051],[1725,1101],[247,1101]],"region":{"top_left_x":246,"top_left_y":1050,"width":1479,"height":52},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"351b2304ba14416dbbd59999f8fafdbc","type":"text","conversion_output":true,"text":"order to rule out potential excessive CV morbidity and mortality associated with all new","text_display":" order to rule out potential excessive CV morbidity and mortality associated with all new","confidence":1,"confidence_rate":1},{"cnt":[[247,1096],[1768,1096],[1768,1149],[247,1149]],"region":{"top_left_x":246,"top_left_y":1096,"width":1523,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5413fd46ab1b40de955f692b75ddbe4e","type":"text","conversion_output":true,"text":"drugs for the treatment of T2DM [R09-2151]. Such an assessment could involve dedicated","text_display":" drugs for the treatment of T2DM [R09-2151]. Such an assessment could involve dedicated","confidence":1,"confidence_rate":1},{"cnt":[[247,1147],[1688,1147],[1688,1197],[247,1197]],"region":{"top_left_x":246,"top_left_y":1146,"width":1443,"height":52},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7a4a29ac5914a50ab5eaceb4ebdae55","type":"text","conversion_output":true,"text":"trials. It is therefore of interest to explore novel treatment options that offer glycaemic","text_display":" trials. It is therefore of interest to explore novel treatment options that offer glycaemic","confidence":1,"confidence_rate":1},{"cnt":[[247,1192],[1099,1192],[1099,1240],[247,1240]],"region":{"top_left_x":246,"top_left_y":1192,"width":853,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08e6a667ef6d47ecb4c60966940481ad","type":"text","conversion_output":true,"text":"reduction without an associated increased CV risk.","text_display":" reduction without an associated increased CV risk.","confidence":1,"confidence_rate":1},{"cnt":[[247,1284],[1782,1284],[1782,1336],[247,1336]],"region":{"top_left_x":246,"top_left_y":1283,"width":1536,"height":54},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4dbf85356b754ca9a10ef51d164d8e0a","type":"text","conversion_output":true,"text":"Of note is that data from recent years indicates a decrease in the age-specific mortality rates","text_display":"\n\nOf note is that data from recent years indicates a decrease in the age-specific mortality rates","confidence":1,"confidence_rate":1},{"cnt":[[247,1330],[1821,1330],[1821,1382],[247,1382]],"region":{"top_left_x":246,"top_left_y":1329,"width":1575,"height":54},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54188d35d7bf4404b8af19f39807f70e","type":"text","conversion_output":true,"text":"due to CV diseases (although the increased relative CV risk between subjects with T2DM and","text_display":" due to CV diseases (although the increased relative CV risk between subjects with T2DM and","confidence":1,"confidence_rate":1},{"cnt":[[247,1380],[1780,1380],[1780,1432],[247,1432]],"region":{"top_left_x":246,"top_left_y":1379,"width":1534,"height":54},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f810f2e32c694ca0a8f14a67dcaa508e","type":"text","conversion_output":true,"text":"without still is high and increased 2-4 fold), a reduction in renal complications seems not to","text_display":" without still is high and increased 2-4 fold), a reduction in renal complications seems not to","confidence":0.8755488395690918,"confidence_rate":0.998658432585623},{"cnt":[[247,1430],[1713,1430],[1713,1478],[247,1478]],"region":{"top_left_x":246,"top_left_y":1430,"width":1468,"height":48},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"46dde7c900b94e54831afa34301b4608","type":"text","conversion_output":true,"text":"occur. Establishing treatment options for T2DM that potentially not only reduce overall","text_display":" occur. Establishing treatment options for T2DM that potentially not only reduce overall","confidence":1,"confidence_rate":1},{"cnt":[[247,1476],[1647,1476],[1647,1528],[247,1528]],"region":{"top_left_x":246,"top_left_y":1475,"width":1402,"height":54},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"041f362bf53a4359a1ed1896f210feba","type":"text","conversion_output":true,"text":"glycaemic burden, but also potentially could address current unmet medical need in","text_display":" glycaemic burden, but also potentially could address current unmet medical need in","confidence":1,"confidence_rate":1},{"cnt":[[244,1524],[1738,1524],[1738,1574],[244,1574]],"region":{"top_left_x":244,"top_left_y":1523,"width":1495,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65e14c219563445caf7e6180ff3623ed","type":"text","conversion_output":true,"text":"prevention and/or treatment of macro-/microvascular complications could therefore have","text_display":" prevention and/or treatment of macro-/microvascular complications could therefore have","confidence":1,"confidence_rate":1},{"cnt":[[247,1572],[1775,1572],[1775,1622],[247,1622]],"region":{"top_left_x":246,"top_left_y":1571,"width":1529,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b03051d58524abb865f7c21e368ec95","type":"text","conversion_output":true,"text":"huge implications for T2DM patient care as there currently are insufficient and low-quality","text_display":" huge implications for T2DM patient care as there currently are insufficient and low-quality","confidence":1,"confidence_rate":1},{"cnt":[[247,1620],[1610,1620],[1610,1670],[247,1670]],"region":{"top_left_x":246,"top_left_y":1619,"width":1365,"height":51},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70ad4f5b6483469697d19b2db9e2c9ca","type":"text","conversion_output":true,"text":"evidence on the effectiveness of individual oral antidiabetic drugs (OADs) on the","text_display":" evidence on the effectiveness of individual oral antidiabetic drugs (OADs) on the","confidence":1,"confidence_rate":1},{"cnt":[[244,1668],[1818,1668],[1818,1720],[244,1720]],"region":{"top_left_x":244,"top_left_y":1667,"width":1575,"height":54},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c15d16a2ab04bfbb0547827c4b7cd15","type":"text","conversion_output":true,"text":"development or progression of CV complications and nephropathy, as underscored also in the","text_display":" development or progression of CV complications and nephropathy, as underscored also in the","confidence":1,"confidence_rate":1},{"cnt":[[244,1713],[1727,1713],[1727,1766],[244,1766]],"region":{"top_left_x":244,"top_left_y":1713,"width":1483,"height":53},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9af379648faa4ee284b63f97895f3dc6","type":"text","conversion_output":true,"text":"recent systematic review on the 'Comparative Effectiveness and Safety of Oral Diabetes","text_display":" recent systematic review on the 'Comparative Effectiveness and Safety of Oral Diabetes","confidence":1,"confidence_rate":1},{"cnt":[[247,1764],[1716,1764],[1716,1814],[247,1814]],"region":{"top_left_x":246,"top_left_y":1763,"width":1470,"height":51},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8db62a4e535a41fabfbf58e3ca4c6ddd","type":"text","conversion_output":true,"text":"Medications for Adults with Type 2 Diabetes', sponsored by the Agency for Healthcare","text_display":" Medications for Adults with Type 2 Diabetes', sponsored by the Agency for Healthcare","confidence":1,"confidence_rate":1},{"cnt":[[247,1812],[825,1812],[825,1862],[247,1862]],"region":{"top_left_x":246,"top_left_y":1811,"width":579,"height":51},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b840a45524544669a352736ae13b78d","type":"text","conversion_output":true,"text":"Research and Quality [R11-4860].","text_display":" Research and Quality [R11-4860].","confidence":0.99951171875,"confidence_rate":0.9999868000736574},{"cnt":[[242,1896],[1094,1896],[1094,1958],[242,1958]],"region":{"top_left_x":242,"top_left_y":1896,"width":853,"height":62},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9e59755dbad4add98b314e950fb7773","type":"section_header","conversion_output":false,"children_ids":["ada9b6fc0a894895a9f0a4d1683cf7b4"],"text":"","text_display":""},{"cnt":[[247,1901],[1090,1901],[1090,1951],[247,1951]],"region":{"top_left_x":246,"top_left_y":1900,"width":844,"height":51},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ada9b6fc0a894895a9f0a4d1683cf7b4","type":"text","conversion_output":true,"parent_id":"e9e59755dbad4add98b314e950fb7773","text":"Emerging treatment for T2DM; DPP- 4 inhibitors","text_display":"\n\n\\section*{Emerging treatment for T2DM; DPP- 4 inhibitors}","confidence":0.92431640625,"confidence_rate":0.9985436386555048},{"cnt":[[247,1987],[1807,1987],[1807,2040],[247,2040]],"region":{"top_left_x":246,"top_left_y":1987,"width":1561,"height":53},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c4ba50c4cbc4a0586ea6829e78c6b7e","type":"text","conversion_output":true,"text":"The incretin effect is a phenomenon where glucose-dependent insulin secretion is augmented","text_display":"\n\nThe incretin effect is a phenomenon where glucose-dependent insulin secretion is augmented","confidence":1,"confidence_rate":1},{"cnt":[[247,2038],[1793,2038],[1793,2090],[247,2090]],"region":{"top_left_x":246,"top_left_y":2037,"width":1548,"height":54},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80912b8c0f9b4544a9cb55ab511e6ec7","type":"text","conversion_output":true,"text":"by intestinally derived peptides (i.e. incretins) that are released in the presence of glucose or","text_display":" by intestinally derived peptides (i.e. incretins) that are released in the presence of glucose or","confidence":1,"confidence_rate":1},{"cnt":[[247,2088],[1741,2088],[1741,2136],[247,2136]],"region":{"top_left_x":246,"top_left_y":2087,"width":1495,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b63100c2ba4479e88f91c8268bad84d","type":"text","conversion_output":true,"text":"nutrients in the gut and thereby contribute to the maintenance of long term and post-meal","text_display":" nutrients in the gut and thereby contribute to the maintenance of long term and post-meal","confidence":1,"confidence_rate":1},{"cnt":[[247,2134],[1748,2134],[1748,2186],[247,2186]],"region":{"top_left_x":246,"top_left_y":2133,"width":1502,"height":54},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85f0ec5736dc48668ab57885ac0afd0c","type":"text","conversion_output":true,"text":"glycaemic control in a glucose-dependent manner. Glucagon-like peptide 1 (GLP-1) is an","text_display":" glycaemic control in a glucose-dependent manner. Glucagon-like peptide 1 (GLP-1) is an","confidence":1,"confidence_rate":1},{"cnt":[[247,2184],[1720,2184],[1720,2232],[247,2232]],"region":{"top_left_x":246,"top_left_y":2183,"width":1475,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"088c6b30285a4a5aaa59063ec86bf22f","type":"text","conversion_output":true,"text":"important member of the incretin hormone family, and together with glucose-dependent","text_display":" important member of the incretin hormone family, and together with glucose-dependent","confidence":1,"confidence_rate":1},{"cnt":[[247,2230],[1745,2230],[1745,2280],[247,2280]],"region":{"top_left_x":246,"top_left_y":2229,"width":1500,"height":51},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91235a8899244fe39ebbe3e1ee5bd96d","type":"text","conversion_output":true,"text":"insulinotropic peptide (GIP), accounts for more than \\(50 \\%\\) of the incretin effect in humans","text_display":" insulinotropic peptide (GIP), accounts for more than \\(50 \\%\\) of the incretin effect in humans","confidence":0.6754512786865234,"confidence_rate":0.9959630750121218},{"cnt":[[247,2278],[1775,2278],[1775,2328],[247,2328]],"region":{"top_left_x":246,"top_left_y":2277,"width":1529,"height":51},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29e5d0ada5ee40628d01f1ea0b58aa95","type":"text","conversion_output":true,"text":"[R09-6409]. These hormones are almost instantaneously inactivated by the enzyme DPP-4.","text_display":" [R09-6409]. These hormones are almost instantaneously inactivated by the enzyme DPP-4.","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[247,2325],[1757,2325],[1757,2378],[247,2378]],"region":{"top_left_x":246,"top_left_y":2325,"width":1511,"height":54},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b952a956f3f48d0ba986dabcd4e9231","type":"text","conversion_output":true,"text":"DPP-4 is widely expressed in many tissues including kidney, liver, intestine, lymphocytes","text_display":" DPP-4 is widely expressed in many tissues including kidney, liver, intestine, lymphocytes","confidence":1,"confidence_rate":1},{"cnt":[[247,2376],[1757,2376],[1757,2424],[247,2424]],"region":{"top_left_x":246,"top_left_y":2375,"width":1511,"height":49},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8961c45e9dc94e70be101ce510407f06","type":"text","conversion_output":true,"text":"and vascular endothelial cells. Since postprandial GLP-1 secretion has been reported to be","text_display":" and vascular endothelial cells. Since postprandial GLP-1 secretion has been reported to be","confidence":1,"confidence_rate":1},{"cnt":[[247,2421],[1652,2421],[1652,2469],[247,2469]],"region":{"top_left_x":246,"top_left_y":2421,"width":1406,"height":49},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52c85eabe9394357ab06a27a719b1271","type":"text","conversion_output":true,"text":"attenuated in T2DM [R09-6409], a prolongation of the half life of GLP-1 by DPP-4","text_display":" attenuated in T2DM [R09-6409], a prolongation of the half life of GLP-1 by DPP-4","confidence":1,"confidence_rate":1},{"cnt":[[247,2469],[1757,2469],[1757,2520],[247,2520]],"region":{"top_left_x":246,"top_left_y":2469,"width":1511,"height":51},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b8a4f9b6b0e4c06a46bdfbef50a457c","type":"text","conversion_output":true,"text":"inhibition has been proven as a therapeutic target to improve glycaemic control in patients","text_display":" inhibition has been proven as a therapeutic target to improve glycaemic control in patients","confidence":1,"confidence_rate":1},{"cnt":[[247,2517],[1716,2517],[1716,2568],[247,2568]],"region":{"top_left_x":246,"top_left_y":2517,"width":1470,"height":51},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6efb43b83f8b41cbb33da1ad2e6f4354","type":"text","conversion_output":true,"text":"with T2DM. Besides its stimulatory effects on insulin secretion dependent on the actual","text_display":" with T2DM. Besides its stimulatory effects on insulin secretion dependent on the actual","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":51,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"57ee6efe71694117bfd21a2b356f1fe8","type":"section_header","conversion_output":false,"children_ids":["efe3aef2ae1b44ed9dd5c7a139eaa60d"],"text":"","text_display":""},{"cnt":[[795,2586],[1300,2586],[1300,2620],[795,2620]],"region":{"top_left_x":794,"top_left_y":2585,"width":506,"height":36},"line":52,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"efe3aef2ae1b44ed9dd5c7a139eaa60d","type":"text","conversion_output":true,"parent_id":"57ee6efe71694117bfd21a2b356f1fe8","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":53,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"668024bf21e24f509d6cd389e53da7cd","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2664],[1770,2664],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1475,"height":40},"line":54,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"219e1f192365420cba237fee6e95cc6d","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-019","page":19,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f6ae1af975d4a7fa9c23034d7978437","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"df5278153dc44639a97920a8a70d2538","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2b498a180a14f738db6d1bede2be99b","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cdc2bbb6cff4933abd0e2d97ed2a932","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"039d736086ba4377af45df60b8f5e790","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c7629d7e0f24c1c8deb23f1a003ba75","type":"page_info","conversion_output":false,"text":"Page 19 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1798,338],[1798,386],[244,386]],"region":{"top_left_x":244,"top_left_y":338,"width":1554,"height":49},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2126f4906c9147dcb6ddff62f0f73813","type":"text","conversion_output":true,"text":"plasma glucose concentration [R09-6409], resulting in a reduction of \\(HbA _{1 c }\\), GLP-1 has also","text_display":"\nplasma glucose concentration [R09-6409], resulting in a reduction of \\(HbA _{1 c }\\), GLP-1 has also","confidence":0.99853515625,"confidence_rate":0.9999869115349181},{"cnt":[[247,388],[1727,388],[1727,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1481,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bc7ebebb93d447d2892f1151e0079110","type":"text","conversion_output":true,"text":"been shown to inhibit glucagon secretion, to delay gastric emptying, to induce satiety, to","text_display":" been shown to inhibit glucagon secretion, to delay gastric emptying, to induce satiety, to","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1816,434],[1816,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1571,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"61058e6fca6d46a78f24dc312ae23d21","type":"text","conversion_output":true,"text":"affect weight loss, and, in animal models, to maintain long-term \\(\\beta\\)-cell function. The potential","text_display":" affect weight loss, and, in animal models, to maintain long-term \\(\\beta\\)-cell function. The potential","confidence":0.6668286323547363,"confidence_rate":0.9961112137866631},{"cnt":[[247,484],[1704,484],[1704,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1459,"height":49},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"863ff39e2b6343739754e66de611dd01","type":"text","conversion_output":true,"text":"benefit of maintenance of \\(\\beta\\)-cell function is of particular interest, that if also the case in","text_display":" benefit of maintenance of \\(\\beta\\)-cell function is of particular interest, that if also the case in","confidence":0.734440803527832,"confidence_rate":0.9969786335337846},{"cnt":[[247,532],[1738,532],[1738,578],[247,578]],"region":{"top_left_x":246,"top_left_y":532,"width":1493,"height":46},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fcd12427f29e4ce1a407fe3ab5b79e21","type":"text","conversion_output":true,"text":"humans, would represent an important clinical finding. However, no long term studies in","text_display":" humans, would represent an important clinical finding. However, no long term studies in","confidence":1,"confidence_rate":1},{"cnt":[[247,580],[1793,580],[1793,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1548,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"32498dd0253144b9b66acfa2cef54979","type":"text","conversion_output":true,"text":"humans have confirmed this. An added interesting feature of this therapeutic option is that it","text_display":" humans have confirmed this. An added interesting feature of this therapeutic option is that it","confidence":1,"confidence_rate":1},{"cnt":[[247,626],[1622,626],[1622,678],[247,678]],"region":{"top_left_x":246,"top_left_y":625,"width":1376,"height":54},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"113ff4000d2c466cbfb76c142fb55839","type":"text","conversion_output":true,"text":"seems to be associated with no weight gain and a very low risk of hypoglycaemia.","text_display":" seems to be associated with no weight gain and a very low risk of hypoglycaemia.","confidence":0.99853515625,"confidence_rate":0.9999827540583306},{"cnt":[[242,713],[509,713],[509,770],[242,770]],"region":{"top_left_x":242,"top_left_y":712,"width":268,"height":58},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f0d485d0865a431cbe8338a0d473d943","type":"section_header","conversion_output":false,"children_ids":["28306a41304e4c758b6a86ee8af8f732"],"text":"","text_display":""},{"cnt":[[247,717],[505,717],[505,765],[247,765]],"region":{"top_left_x":246,"top_left_y":717,"width":259,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"28306a41304e4c758b6a86ee8af8f732","type":"text","conversion_output":true,"parent_id":"f0d485d0865a431cbe8338a0d473d943","text":"Study proposal","text_display":"\n\n\\section*{Study proposal}","confidence":1,"confidence_rate":1},{"cnt":[[247,806],[1706,806],[1706,854],[247,854]],"region":{"top_left_x":246,"top_left_y":806,"width":1461,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"538bb5c084c242ed828fa00de2c0a98f","type":"text","conversion_output":true,"text":"In this large-scale intervention trial we will test the impact of treatment with the DPP-4","text_display":"\n\nIn this large-scale intervention trial we will test the impact of treatment with the DPP-4","confidence":1,"confidence_rate":1},{"cnt":[[247,854],[1702,854],[1702,902],[247,902]],"region":{"top_left_x":246,"top_left_y":854,"width":1456,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f82bdf593ed548d4b5f30d1dddf0d940","type":"text","conversion_output":true,"text":"inhibitor linagliptin head-to-head versus placebo on long-term CV safety as well as the","text_display":" inhibitor linagliptin head-to-head versus placebo on long-term CV safety as well as the","confidence":1,"confidence_rate":1},{"cnt":[[247,902],[1711,902],[1711,953],[247,953]],"region":{"top_left_x":246,"top_left_y":902,"width":1465,"height":51},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"01b0e9b61b754c29b12235706b03e201","type":"text","conversion_output":true,"text":"potential preventive impact on CV and renal complications. The study will be given the","text_display":" potential preventive impact on CV and renal complications. The study will be given the","confidence":0.9682769775390625,"confidence_rate":0.9996458089073738},{"cnt":[[247,950],[1711,950],[1711,998],[247,998]],"region":{"top_left_x":246,"top_left_y":950,"width":1465,"height":49},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ca8b96b17a084550a252910a734b931d","type":"text","conversion_output":true,"text":"acronym CARMELINA (CArdiovascular Safety \\& Renal Microvascular outcomE with","text_display":" acronym CARMELINA (CArdiovascular Safety \\& Renal Microvascular outcomE with","confidence":1,"confidence_rate":1},{"cnt":[[247,996],[1503,996],[1503,1046],[247,1046]],"region":{"top_left_x":246,"top_left_y":995,"width":1258,"height":52},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cd77ef507dc74f02b023a474329e686b","type":"text","conversion_output":true,"text":"LINAgliptin in patients with type 2 diabetes mellitus at high vascular risk).","text_display":" LINAgliptin in patients with type 2 diabetes mellitus at high vascular risk).","confidence":1,"confidence_rate":1},{"cnt":[[242,1083],[733,1083],[733,1135],[242,1135]],"region":{"top_left_x":242,"top_left_y":1082,"width":492,"height":54},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b412c73ca03c489990e6eca5d0ac7fbf","type":"section_header","conversion_output":false,"children_ids":["dfb66a2a602f400fb27e1475730d8f77"],"text":"","text_display":""},{"cnt":[[247,1087],[729,1087],[729,1131],[247,1131]],"region":{"top_left_x":246,"top_left_y":1087,"width":483,"height":44},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dfb66a2a602f400fb27e1475730d8f77","type":"text","conversion_output":true,"parent_id":"b412c73ca03c489990e6eca5d0ac7fbf","text":"1.2 DRUG PROFILE","text_display":"\n\n\\subsection*{1.2 DRUG PROFILE}","confidence":0.99951171875,"confidence_rate":0.9999767431038692},{"cnt":[[247,1179],[1796,1179],[1796,1227],[247,1227]],"region":{"top_left_x":246,"top_left_y":1178,"width":1550,"height":49},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"91c80a2a5b8542d5a5b449f13ddf72cb","type":"text","conversion_output":true,"text":"The DPP-4 inhibitor compound linagliptin was discovered by Boehringer Ingelheim Pharma","text_display":"\n\nThe DPP-4 inhibitor compound linagliptin was discovered by Boehringer Ingelheim Pharma","confidence":1,"confidence_rate":1},{"cnt":[[247,1224],[733,1224],[733,1272],[247,1272]],"region":{"top_left_x":246,"top_left_y":1224,"width":488,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"501a4c6b77344fc29bd99b5e1f085465","type":"text","conversion_output":true,"text":"GmbH \\& Co. KG, Germany.","text_display":" GmbH \\& Co. KG, Germany.","confidence":0.9239730834960938,"confidence_rate":0.9971799716932874},{"cnt":[[247,1316],[1775,1316],[1775,1364],[247,1364]],"region":{"top_left_x":246,"top_left_y":1315,"width":1529,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9882f9a24ebd4736a9ba86ba2b7c78cf","type":"text","conversion_output":true,"text":"Linagliptin is a potent inhibitor of DPP-4 activity and prolongs the half-life of GLP-1. This","text_display":"\n\nLinagliptin is a potent inhibitor of DPP-4 activity and prolongs the half-life of GLP-1. This","confidence":1,"confidence_rate":1},{"cnt":[[247,1361],[1738,1361],[1738,1409],[247,1409]],"region":{"top_left_x":246,"top_left_y":1361,"width":1493,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5745046e2ada415fbfa7b2c5bb0c5a5e","type":"text","conversion_output":true,"text":"has been shown in vitro, in various animal models, and in clinical trials. Linagliptin is an","text_display":" has been shown in vitro, in various animal models, and in clinical trials. Linagliptin is an","confidence":1,"confidence_rate":1},{"cnt":[[247,1412],[1652,1412],[1652,1460],[247,1460]],"region":{"top_left_x":246,"top_left_y":1411,"width":1406,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b7d2e929bd454ddabe3f51ea21a383eb","type":"text","conversion_output":true,"text":"orally available compound with a low risk for hypoglycaemic episodes [U04-1767].","text_display":" orally available compound with a low risk for hypoglycaemic episodes [U04-1767].","confidence":0.99853515625,"confidence_rate":0.9999827540583306},{"cnt":[[247,1508],[1688,1508],[1688,1556],[247,1556]],"region":{"top_left_x":246,"top_left_y":1507,"width":1443,"height":49},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e447ddb11cf54ea7a650f36494b539b1","type":"text","conversion_output":true,"text":"In general pharmacological tests, linagliptin exhibited good tolerability in a variety of","text_display":"\n\nIn general pharmacological tests, linagliptin exhibited good tolerability in a variety of","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[247,1556],[1784,1556],[1784,1601],[247,1601]],"region":{"top_left_x":246,"top_left_y":1555,"width":1539,"height":47},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7d7e48c7e7184d3ea05895170f1014d1","type":"text","conversion_output":true,"text":"physiological systems. No genotoxic effect was observed in any of the tests performed with","text_display":" physiological systems. No genotoxic effect was observed in any of the tests performed with","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[247,1604],[1656,1604],[1656,1652],[247,1652]],"region":{"top_left_x":246,"top_left_y":1603,"width":1411,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dd52657d2aa049f4971d14589634eda9","type":"text","conversion_output":true,"text":"linagliptin or with its major metabolite CD 1790. The single dose (acute) toxicity of","text_display":" linagliptin or with its major metabolite CD 1790. The single dose (acute) toxicity of","confidence":0.9965846532722935,"confidence_rate":0.9999619874742944},{"cnt":[[247,1649],[1738,1649],[1738,1697],[247,1697]],"region":{"top_left_x":246,"top_left_y":1649,"width":1493,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c2b305323a604823ac2b4e22a39d56d6","type":"text","conversion_output":true,"text":"linagliptin after oral administration was low as indicated by an Approximate Lethal Dose","text_display":" linagliptin after oral administration was low as indicated by an Approximate Lethal Dose","confidence":1,"confidence_rate":1},{"cnt":[[247,1695],[1761,1695],[1761,1745],[247,1745]],"region":{"top_left_x":246,"top_left_y":1695,"width":1516,"height":51},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7baccf8c73684e608a5e2da88bf73643","type":"text","conversion_output":true,"text":"(ALD50) between 1000 and \\(2000 mg / kg\\). In repeat dose toxicity studies, a wide margin of","text_display":" (ALD50) between 1000 and \\(2000 mg / kg\\). In repeat dose toxicity studies, a wide margin of","confidence":0.8663406372070312,"confidence_rate":0.9986079881732094},{"cnt":[[247,1745],[1802,1745],[1802,1793],[247,1793]],"region":{"top_left_x":246,"top_left_y":1745,"width":1557,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f8b8575d7f1e4064a7f0245defd8ab75","type":"text","conversion_output":true,"text":"safety was demonstrated. This was also true with respect to exposure to the major metabolite","text_display":" safety was demonstrated. This was also true with respect to exposure to the major metabolite","confidence":0.9990236759185791,"confidence_rate":0.9999899299373404},{"cnt":[[247,1796],[416,1796],[416,1834],[247,1834]],"region":{"top_left_x":246,"top_left_y":1795,"width":170,"height":40},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8fd5f6ddba21496ca47dcfbc3df015b7","type":"text","conversion_output":true,"text":"CD 1750.","text_display":" CD 1750.","confidence":0.996584415435791,"confidence_rate":0.9997149213934967},{"cnt":[[247,1891],[1812,1891],[1812,1939],[247,1939]],"region":{"top_left_x":246,"top_left_y":1891,"width":1566,"height":49},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"86388d02da1e459180af9de23ca348ee","type":"text","conversion_output":true,"text":"Linagliptin shows nonlinear pharmacokinetics, both after oral and intravenous administration","text_display":"\n\nLinagliptin shows nonlinear pharmacokinetics, both after oral and intravenous administration","confidence":0.9209747314453125,"confidence_rate":0.9991516726198834},{"cnt":[[247,1937],[1638,1937],[1638,1985],[247,1985]],"region":{"top_left_x":246,"top_left_y":1937,"width":1392,"height":49},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8f203fe472514c079cef0d3b59f7a68f","type":"text","conversion_output":true,"text":"in the therapeutic dose range, with a less than dose proportional increase in plasma","text_display":" in the therapeutic dose range, with a less than dose proportional increase in plasma","confidence":1,"confidence_rate":1},{"cnt":[[247,1985],[1805,1985],[1805,2035],[247,2035]],"region":{"top_left_x":246,"top_left_y":1985,"width":1559,"height":51},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b8b4dad79fc44c789060366b3118e383","type":"text","conversion_output":true,"text":"concentrations. After oral administration of a 5 mg dose, linagliptin is rapidly absorbed, with","text_display":" concentrations. After oral administration of a 5 mg dose, linagliptin is rapidly absorbed, with","confidence":0.980478048324585,"confidence_rate":0.9998122555134159},{"cnt":[[244,2033],[1748,2033],[1748,2086],[244,2086]],"region":{"top_left_x":244,"top_left_y":2033,"width":1504,"height":53},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f53d4582fc6343cd825957fbb21c27ea","type":"text","conversion_output":true,"text":"peak plasma concentrations (median Tmax) occurring approximately 1.5 hours post dose.","text_display":" peak plasma concentrations (median Tmax) occurring approximately 1.5 hours post dose.","confidence":0.9719226722546975,"confidence_rate":0.9996938207213709},{"cnt":[[247,2122],[1743,2122],[1743,2170],[247,2170]],"region":{"top_left_x":246,"top_left_y":2122,"width":1497,"height":49},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1c8d1cf41d614b3fb8f2736a0c9e6aa7","type":"text","conversion_output":true,"text":"Clearance, volume of distribution, and amount excreted unchanged in urine increase with","text_display":"\n\nClearance, volume of distribution, and amount excreted unchanged in urine increase with","confidence":1,"confidence_rate":1},{"cnt":[[247,2170],[1693,2170],[1693,2218],[247,2218]],"region":{"top_left_x":246,"top_left_y":2170,"width":1447,"height":49},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2f80ca57214f4a068862cd6bdbd171be","type":"text","conversion_output":true,"text":"increasing doses, which may be a result of nonlinear protein binding in the therapeutic","text_display":" increasing doses, which may be a result of nonlinear protein binding in the therapeutic","confidence":1,"confidence_rate":1},{"cnt":[[247,2220],[1720,2220],[1720,2268],[247,2268]],"region":{"top_left_x":246,"top_left_y":2220,"width":1475,"height":49},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e1419c579ba44a78b9925018b2377187","type":"text","conversion_output":true,"text":"plasma concentration range. Linagliptin is predominantly excreted unchanged in faeces.","text_display":" plasma concentration range. Linagliptin is predominantly excreted unchanged in faeces.","confidence":0.921875,"confidence_rate":0.9991064912909783},{"cnt":[[247,2266],[1793,2266],[1793,2314],[247,2314]],"region":{"top_left_x":246,"top_left_y":2266,"width":1548,"height":49},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"995984ee75124d9da9e6057118b266d2","type":"text","conversion_output":true,"text":"Renal excretion is considered to be a minor elimination pathway of linagliptin at therapeutic","text_display":" Renal excretion is considered to be a minor elimination pathway of linagliptin at therapeutic","confidence":0.7607259750366211,"confidence_rate":0.9972132568168423},{"cnt":[[247,2316],[448,2316],[448,2355],[247,2355]],"region":{"top_left_x":246,"top_left_y":2316,"width":202,"height":40},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c04f607f01e44d42b8b3ca704aa8af0b","type":"text","conversion_output":true,"text":"dose levels.","text_display":" dose levels.","confidence":0.998046875,"confidence_rate":0.9998850045633173},{"cnt":[[247,2410],[1743,2410],[1743,2460],[247,2460]],"region":{"top_left_x":246,"top_left_y":2410,"width":1497,"height":51},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c3cf3d2c094246bab57d3019904c32a1","type":"text","conversion_output":true,"text":"The long terminal half life of \\(>100\\) hours does not reflect the effective half life, as steady","text_display":"\n\nThe long terminal half life of \\(>100\\) hours does not reflect the effective half life, as steady","confidence":0.9931697845458984,"confidence_rate":0.9999321443999507},{"cnt":[[795,2586],[1300,2586],[1300,2625],[795,2625]],"region":{"top_left_x":794,"top_left_y":2585,"width":506,"height":40},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e876cb096b5e4983a2a5edbb01561382","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99267578125,"confidence_rate":0.9998249873990863},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bdd1d3bed2c94819bb044d57c3390211","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7cce84b347ae453b85b0f8527cfcc5cd","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-020","page":20,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e13830f1da6b4a1cbdc57e16d132da11","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f46166e7251f414f8040d8fa1e4258dd","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f3e70cd62c0421f84b4cb6d8f70125d","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff195e3d7f7b490dbc57ca45ad11d0f6","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011059},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71523878c4fe47d19e3f165e214400d1","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"848da8cfb6e342b0aee2db44583a7dd4","type":"page_info","conversion_output":false,"text":"Page 20 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1807,338],[1807,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":1561,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e552f28b2b534fafb3bf80b2d6fdb492","type":"text","conversion_output":true,"text":"days to 2 days for once daily dosing of \\(1-10 mg\\) linagliptin. The accumulation factors of \\(C _{\\max }\\)","text_display":"\ndays to 2 days for once daily dosing of \\(1-10 mg\\) linagliptin. The accumulation factors of \\(C _{\\max }\\)","confidence":0.9791189645411578,"confidence_rate":0.9998211844008654},{"cnt":[[247,388],[1081,388],[1081,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":835,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fba16586cbf492c85aed8869d02961a","type":"text","conversion_output":true,"text":"and AUC range from 1.2-2 upon multiple dosing.","text_display":" and AUC range from 1.2-2 upon multiple dosing.","confidence":0.9578697038814425,"confidence_rate":0.999156365496412},{"cnt":[[247,434],[1780,434],[1780,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1534,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ec11f77047646239083734ec47538e4","type":"text","conversion_output":true,"text":"No adjustment of linagliptin dosage based on the intrinsic factors age, BMI, weight, gender","text_display":"\nNo adjustment of linagliptin dosage based on the intrinsic factors age, BMI, weight, gender","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[247,484],[1748,484],[1748,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1502,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15e607a7b3d946939261ec5e3ccf9d67","type":"text","conversion_output":true,"text":"or race is considered necessary. Linagliptin showed no clinically relevant interaction with","text_display":" or race is considered necessary. Linagliptin showed no clinically relevant interaction with","confidence":0.9956116636761293,"confidence_rate":0.9999541886188087},{"cnt":[[247,532],[1688,532],[1688,578],[247,578]],"region":{"top_left_x":246,"top_left_y":532,"width":1443,"height":46},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10f6f706c2fb41ff8dac4a8805408fbd","type":"text","conversion_output":true,"text":"either the CYP 3A4 substrate simvastatin, with metformin, pioglitazone, glyburide, or","text_display":" either the CYP 3A4 substrate simvastatin, with metformin, pioglitazone, glyburide, or","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[247,580],[1661,580],[1661,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1415,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d58a62fe3f824e33abd8ddc57bddc110","type":"text","conversion_output":true,"text":"empagliflozin (BI 10773). After strong inhibition of P-gp and CYP 3A4 by ritonavir","text_display":" empagliflozin (BI 10773). After strong inhibition of P-gp and CYP 3A4 by ritonavir","confidence":0.7328260984262678,"confidence_rate":0.9964334230817249},{"cnt":[[244,626],[1727,626],[1727,678],[244,678]],"region":{"top_left_x":244,"top_left_y":625,"width":1483,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19701dcc3e044466a63085bb0bc6f55f","type":"text","conversion_output":true,"text":"linagliptin AUC and Cmax increased approximately twofold and threefold, respectively.","text_display":" linagliptin AUC and Cmax increased approximately twofold and threefold, respectively.","confidence":0.9557666206018212,"confidence_rate":0.9994974428081637},{"cnt":[[247,676],[1777,676],[1777,724],[247,724]],"region":{"top_left_x":246,"top_left_y":676,"width":1532,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41167816860b4b53adbcc6ffd70f14e2","type":"text","conversion_output":true,"text":"Since linagliptin has a large safety window and no obvious change in the safety profile was","text_display":" Since linagliptin has a large safety window and no obvious change in the safety profile was","confidence":0.998535871389322,"confidence_rate":0.9999847376009057},{"cnt":[[247,722],[1805,722],[1805,772],[247,772]],"region":{"top_left_x":246,"top_left_y":721,"width":1559,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a49652ecf35849b9b08beccb32f61d28","type":"text","conversion_output":true,"text":"seen under concomitant administration of P gp and/or CYP3A4 inhibitors in phase H and HI ,","text_display":" seen under concomitant administration of P gp and/or CYP3A4 inhibitors in phase H and HI ,","confidence":0.7213248472322953,"confidence_rate":0.9971133276403591},{"cnt":[[244,770],[1213,770],[1213,820],[244,820]],"region":{"top_left_x":244,"top_left_y":769,"width":970,"height":52},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abd4cbe43c9d4290a11725945a6bef16","type":"text","conversion_output":true,"text":"these changes are considered to be not clinically relevant.","text_display":" these changes are considered to be not clinically relevant.","confidence":1,"confidence_rate":1},{"cnt":[[244,866],[1816,866],[1816,916],[244,916]],"region":{"top_left_x":244,"top_left_y":865,"width":1573,"height":52},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bfcf5fc0362f467bb115dcc206274deb","type":"text","conversion_output":true,"text":"There is no effect of food on the extent of absorption. Only the rate of absorption was slightly","text_display":"\n\nThere is no effect of food on the extent of absorption. Only the rate of absorption was slightly","confidence":0.998535871389322,"confidence_rate":0.9999854931597368},{"cnt":[[244,914],[1793,914],[1793,962],[244,962]],"region":{"top_left_x":244,"top_left_y":913,"width":1550,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2eda693a1f3941fc8e56ff02723ab04b","type":"text","conversion_output":true,"text":"reduced (median Tmax increased from 1.02 to 2.99 hours and Cmax reduced by about \\(15 \\%\\) )","text_display":" reduced (median Tmax increased from 1.02 to 2.99 hours and Cmax reduced by about \\(15 \\%\\) )","confidence":0.95654296875,"confidence_rate":0.9995558030025624},{"cnt":[[247,962],[1766,962],[1766,1012],[247,1012]],"region":{"top_left_x":246,"top_left_y":961,"width":1520,"height":51},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51cfad743b06465991a7b381e28c2ad5","type":"text","conversion_output":true,"text":"when linagliptin was given with food, which was considered to be of no clinical relevance.","text_display":" when linagliptin was given with food, which was considered to be of no clinical relevance.","confidence":1,"confidence_rate":1},{"cnt":[[244,1010],[1789,1010],[1789,1062],[244,1062]],"region":{"top_left_x":244,"top_left_y":1009,"width":1545,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9b732f2987b4e5ead24e4685cb2eb3b","type":"text","conversion_output":true,"text":"No dose adjustment of linagliptin in patients with any degree of hepatic or renal impairment","text_display":" No dose adjustment of linagliptin in patients with any degree of hepatic or renal impairment","confidence":1,"confidence_rate":1},{"cnt":[[244,1055],[1802,1055],[1802,1108],[244,1108]],"region":{"top_left_x":244,"top_left_y":1055,"width":1559,"height":53},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e2c05d0810f41609e6554670aaffd22","type":"text","conversion_output":true,"text":"is suggested as the pharmacokineties of linagliptin did not relevantly change with decreasing","text_display":" is suggested as the pharmacokineties of linagliptin did not relevantly change with decreasing","confidence":0.86763287867464,"confidence_rate":0.9985522061618246},{"cnt":[[247,1106],[1743,1106],[1743,1156],[247,1156]],"region":{"top_left_x":246,"top_left_y":1105,"width":1497,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61e865b373ed4cf19a9ef946bd066c5a","type":"text","conversion_output":true,"text":"hepatic function and the exposure changes seen at steady state in patients decreased renal","text_display":" hepatic function and the exposure changes seen at steady state in patients decreased renal","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[244,1154],[1074,1154],[1074,1204],[244,1204]],"region":{"top_left_x":244,"top_left_y":1153,"width":830,"height":51},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a8d8753b3854bf5a096401275ed486c","type":"text","conversion_output":true,"text":"function are considered as not clinically relevant.","text_display":" function are considered as not clinically relevant.","confidence":0.99755859375,"confidence_rate":0.9999563511072518},{"cnt":[[247,1250],[1793,1250],[1793,1300],[247,1300]],"region":{"top_left_x":246,"top_left_y":1249,"width":1548,"height":51},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"021735c24ec44d1281b5db01a75a34a2","type":"text","conversion_output":true,"text":"In all trials to date in patients with T2DM, more than 5955 patients have received linagliptin","text_display":"\n\nIn all trials to date in patients with T2DM, more than 5955 patients have received linagliptin","confidence":1,"confidence_rate":1},{"cnt":[[247,1298],[1752,1298],[1752,1345],[247,1345]],"region":{"top_left_x":246,"top_left_y":1297,"width":1507,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9e517c2dc1e479eb8a885ec56495bc4","type":"text","conversion_output":true,"text":"5 mg . Inhibition of DPP-4 activity by linagliptin also translated into an increase in plasma","text_display":" 5 mg . Inhibition of DPP-4 activity by linagliptin also translated into an increase in plasma","confidence":0.9825085330050327,"confidence_rate":0.9998217709323237},{"cnt":[[247,1343],[1720,1343],[1720,1396],[247,1396]],"region":{"top_left_x":246,"top_left_y":1343,"width":1475,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04216f370f14417fa2780380c8497038","type":"text","conversion_output":true,"text":"GLP-1 levels. In addition, linagliptin exhibited excellent tolerability at all dose levels in","text_display":" GLP-1 levels. In addition, linagliptin exhibited excellent tolerability at all dose levels in","confidence":1,"confidence_rate":1},{"cnt":[[244,1393],[1588,1393],[1588,1441],[244,1441]],"region":{"top_left_x":244,"top_left_y":1393,"width":1344,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7558e5b5cd374e8185d5b0053d1dd3d3","type":"text","conversion_output":true,"text":"phase \\(I\\) studies with an absence of a dose dependent increase in adverse events.","text_display":" phase \\(I\\) studies with an absence of a dose dependent increase in adverse events.","confidence":0.4739003781368982,"confidence_rate":0.9914533054025301},{"cnt":[[247,1439],[1722,1439],[1722,1492],[247,1492]],"region":{"top_left_x":246,"top_left_y":1439,"width":1477,"height":53},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7b7df07a77a43d691cd89cecb412621","type":"text","conversion_output":true,"text":"In phase II and III clinical trials in patients with T2DM, the overall incidence of adverse","text_display":" In phase II and III clinical trials in patients with T2DM, the overall incidence of adverse","confidence":0.8042783816345036,"confidence_rate":0.9977337195675156},{"cnt":[[247,1489],[1725,1489],[1725,1537],[247,1537]],"region":{"top_left_x":246,"top_left_y":1489,"width":1479,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f14fe10558d4a4886d371d977a0960c","type":"text","conversion_output":true,"text":"events (AEs) with linagliptin 5 mg was comparable to placebo (linagliptin 5 mg : 52.5\\%,","text_display":" events (AEs) with linagliptin 5 mg was comparable to placebo (linagliptin 5 mg : 52.5\\%,","confidence":0.9965860823871253,"confidence_rate":0.999966473519608},{"cnt":[[244,1535],[1784,1535],[1784,1588],[244,1588]],"region":{"top_left_x":244,"top_left_y":1535,"width":1541,"height":53},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0d0ff207338468a9ba036db2b1ead56","type":"text","conversion_output":true,"text":"placebo: \\(51.6 \\%\\) ). In addition, the number of patients with AEs leading to discontinuation of","text_display":" placebo: \\(51.6 \\%\\) ). In addition, the number of patients with AEs leading to discontinuation of","confidence":0.87939453125,"confidence_rate":0.9987156091270732},{"cnt":[[247,1585],[1793,1585],[1793,1633],[247,1633]],"region":{"top_left_x":246,"top_left_y":1585,"width":1548,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92d9316940624e22ad2e401e6c537bcd","type":"text","conversion_output":true,"text":"trial drug (linagliptin \\(5 mg : 2.3 \\%\\), placebo: \\(2.8 \\%\\) ) and with investigator defined drug-related","text_display":" trial drug (linagliptin \\(5 mg : 2.3 \\%\\), placebo: \\(2.8 \\%\\) ) and with investigator defined drug-related","confidence":0.6617668167564261,"confidence_rate":0.9961490971289269},{"cnt":[[244,1631],[1780,1631],[1780,1684],[244,1684]],"region":{"top_left_x":244,"top_left_y":1631,"width":1536,"height":53},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63d6571ec8374295a643f69398fe2164","type":"text","conversion_output":true,"text":"AEs (linagliptin \\(5 mg : 8.3 \\%\\), placebo: \\(9.1 \\%\\) ) did not differ significantly between linagliptin","text_display":" AEs (linagliptin \\(5 mg : 8.3 \\%\\), placebo: \\(9.1 \\%\\) ) did not differ significantly between linagliptin","confidence":0.8174595229872824,"confidence_rate":0.998100354816094},{"cnt":[[247,1681],[464,1681],[464,1729],[247,1729]],"region":{"top_left_x":246,"top_left_y":1681,"width":218,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08e74b244ec24ac488875357d7a1adbb","type":"text","conversion_output":true,"text":"and placebo.","text_display":" and placebo.","confidence":0.99169921875,"confidence_rate":0.9995098010938792},{"cnt":[[244,1777],[1633,1777],[1633,1825],[244,1825]],"region":{"top_left_x":244,"top_left_y":1777,"width":1390,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2e6f85ef0ad48d2b20f0c8d5c1b28f2","type":"text","conversion_output":true,"text":"The most frequently reported adverse events ( \\(\\geq 5 \\%\\) ) in both treatment groups were","text_display":"\n\nThe most frequently reported adverse events ( \\(\\geq 5 \\%\\) ) in both treatment groups were","confidence":0.9921944125089794,"confidence_rate":0.9999119565665325},{"cnt":[[247,1823],[1738,1823],[1738,1873],[247,1873]],"region":{"top_left_x":246,"top_left_y":1822,"width":1493,"height":52},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cdac9921bf174b0fa65e0607dbb0a8d5","type":"text","conversion_output":true,"text":"nasopharyngitis ( \\(4.7 \\%\\) placebo, \\(5.9 \\%\\) linagliptin 5 mg ), hyperglycaemia ( \\(10.6 \\%\\) placebo,","text_display":" nasopharyngitis ( \\(4.7 \\%\\) placebo, \\(5.9 \\%\\) linagliptin 5 mg ), hyperglycaemia ( \\(10.6 \\%\\) placebo,","confidence":0.8246437161246065,"confidence_rate":0.9981997173613034},{"cnt":[[247,1873],[1679,1873],[1679,1921],[247,1921]],"region":{"top_left_x":246,"top_left_y":1873,"width":1434,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45253f5122dd44efb03a04da272a3b60","type":"text","conversion_output":true,"text":"\\(5.1 \\%\\) linagliptin 5 mg ) and hypoglycaemia ( \\(5.1 \\%\\) placebo and \\(7.8 \\%\\) linagliptin 5 mg )","text_display":" \\(5.1 \\%\\) linagliptin 5 mg ) and hypoglycaemia ( \\(5.1 \\%\\) placebo and \\(7.8 \\%\\) linagliptin 5 mg )","confidence":0.625913182861537,"confidence_rate":0.9955049063594525},{"cnt":[[247,1969],[1738,1969],[1738,2017],[247,2017]],"region":{"top_left_x":246,"top_left_y":1969,"width":1493,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e97513bb02d450d9b6e7fd2d2aa48f0","type":"text","conversion_output":true,"text":"The increased incidence of hypoglycaemia observed in the phase \\(\\amalg\\) and II studies nearly","text_display":"\n\nThe increased incidence of hypoglycaemia observed in the phase \\(\\amalg\\) and II studies nearly","confidence":0.26090922744609596,"confidence_rate":0.9863835266458071},{"cnt":[[247,2015],[1798,2015],[1798,2067],[247,2067]],"region":{"top_left_x":246,"top_left_y":2014,"width":1552,"height":54},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9af23905ea914121b470e3d7f68a2a61","type":"text","conversion_output":true,"text":"exclusively came from trial 1218.18 where linagliptin was added to a background therapy of","text_display":" exclusively came from trial 1218.18 where linagliptin was added to a background therapy of","confidence":0.93896484375,"confidence_rate":0.9993575815353783},{"cnt":[[247,2065],[1789,2065],[1789,2113],[247,2113]],"region":{"top_left_x":246,"top_left_y":2065,"width":1543,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"628f60491cd046169f93f74f860543f9","type":"text","conversion_output":true,"text":"metformin and SU where hypoglycemia rates after 24 weeks were observed to be \\(14.8 \\%\\) for","text_display":" metformin and SU where hypoglycemia rates after 24 weeks were observed to be \\(14.8 \\%\\) for","confidence":1,"confidence_rate":1},{"cnt":[[247,2111],[1798,2111],[1798,2163],[247,2163]],"region":{"top_left_x":246,"top_left_y":2110,"width":1552,"height":54},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f8afabd50b14173a0f876569502ba62","type":"text","conversion_output":true,"text":"placebo, and \\(22.8 \\%\\) for linagliptin 5 mg . When linagliptin was administered as monotherapy","text_display":" placebo, and \\(22.8 \\%\\) for linagliptin 5 mg . When linagliptin was administered as monotherapy","confidence":0.9795379333726828,"confidence_rate":0.9997992986377238},{"cnt":[[244,2161],[1661,2161],[1661,2209],[244,2209]],"region":{"top_left_x":244,"top_left_y":2161,"width":1417,"height":48},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f569dc53fa4d40dba1ac0c931cb18467","type":"text","conversion_output":true,"text":"there was no difference between the placebo group and linagliptin with regard to the","text_display":" there was no difference between the placebo group and linagliptin with regard to the","confidence":1,"confidence_rate":1},{"cnt":[[247,2207],[1775,2207],[1775,2257],[247,2257]],"region":{"top_left_x":246,"top_left_y":2206,"width":1529,"height":51},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2ee7112c7fd4211b8bbcb6c6a2b870a","type":"text","conversion_output":true,"text":"eccurrence of 'hypoglycaemia'. Also the addition of linagliptin to a metformin background","text_display":" eccurrence of 'hypoglycaemia'. Also the addition of linagliptin to a metformin background","confidence":0.5982389664653666,"confidence_rate":0.994549324078023},{"cnt":[[247,2257],[1240,2257],[1240,2305],[247,2305]],"region":{"top_left_x":246,"top_left_y":2256,"width":995,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78f309e8aeef488e918c8c7a41314d85","type":"text","conversion_output":true,"text":"did not appear to increase the frequency of hypoglycaemia.","text_display":" did not appear to increase the frequency of hypoglycaemia.","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[247,2353],[1761,2353],[1761,2401],[247,2401]],"region":{"top_left_x":246,"top_left_y":2352,"width":1516,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b957c3bbc93b4894b7aeb8a62985f4a7","type":"text","conversion_output":true,"text":"The incidence of serious adverse events (SAEs) in the phase H and HI studies was \\(3.1 \\%\\) in","text_display":"\n\nThe incidence of serious adverse events (SAEs) in the phase H and HI studies was \\(3.1 \\%\\) in","confidence":0.11135604141507241,"confidence_rate":0.9798808624685382},{"cnt":[[244,2399],[1579,2399],[1579,2451],[244,2451]],"region":{"top_left_x":244,"top_left_y":2398,"width":1335,"height":54},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37b881800da54c33b959c7ef60a50a5f","type":"text","conversion_output":true,"text":"patients treated with linagliptin 5 mg and \\(3.8 \\%\\) in patients treated with placebo.","text_display":" patients treated with linagliptin 5 mg and \\(3.8 \\%\\) in patients treated with placebo.","confidence":0.9385645389556885,"confidence_rate":0.9993257204380649},{"cnt":[[247,2495],[1780,2495],[1780,2545],[247,2545]],"region":{"top_left_x":246,"top_left_y":2494,"width":1534,"height":51},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a246c002153649dc89e3f76d3010183b","type":"text","conversion_output":true,"text":"Consistency of efficacy of linagliptin 5 mg has been shown in a number of phase ШД double","text_display":"\n\nConsistency of efficacy of linagliptin 5 mg has been shown in a number of phase ШД double","confidence":0.14506276372374682,"confidence_rate":0.9814309881624377},{"cnt":[[790,2584],[1300,2584],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":42},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4c0c1f65a70c4d80a20671605d3d44eb","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.98974609375,"confidence_rate":0.9997546291629348},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"895c4ebf65db4eb1b0a4e30d7b5be866","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.9912109375,"confidence_rate":0.9999258185992773},{"cnt":[[297,2668],[1770,2668],[1770,2707],[297,2707]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":39},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9765539eecbe4d89bfbc24fd6b29ce78","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-021","page":21,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6cf84a50963a4642bd7cf5861f87f4d6","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,158],[1503,158]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":40},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22ec5c3658584d9e86da23740b43b35e","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,167],[599,167],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":166,"width":353,"height":38},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ac7908963da4f2f8504fe06934ac2fe","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f5166c9c1f24d60b1ce86ac3805166c","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,247],[868,247]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":37},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b196fd48b8bb4aeca3ab0386e489be16","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f03b01f89b7742b494c436437037e856","type":"page_info","conversion_output":false,"text":"Page 21 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1697,338],[1697,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":1452,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6c33e52a23c41d5991801802a2f30c9","type":"text","conversion_output":true,"text":"blind placebo-controlled efficacy trials, in reduction of HbA1c, fasting plasma glucose","text_display":"\nblind placebo-controlled efficacy trials, in reduction of HbA1c, fasting plasma glucose","confidence":0.5395316339743772,"confidence_rate":0.9933153352637722},{"cnt":[[247,388],[1789,388],[1789,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1543,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fafc1190071749a7bd3b5342069e15d0","type":"text","conversion_output":true,"text":"(FPG), postprandial plasma glucose etc. These trials have tested linagliptin as monotherapy,","text_display":" (FPG), postprandial plasma glucose etc. These trials have tested linagliptin as monotherapy,","confidence":0.9980480668600649,"confidence_rate":0.9999798575158105},{"cnt":[[247,434],[1702,434],[1702,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1456,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3dd6b204e8694047a533ee2465e7f427","type":"text","conversion_output":true,"text":"on a background of metformin, and as add on therapy to metformin plus SU and initial","text_display":" on a background of metformin, and as add on therapy to metformin plus SU and initial","confidence":0.94677734375,"confidence_rate":0.9993856794360495},{"cnt":[[247,484],[1195,484],[1195,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":949,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87ae138c4f1941c2a2f5473156781b18","type":"text","conversion_output":true,"text":"combination with metformin in the factorial design trial.","text_display":" combination with metformin in the factorial design trial.","confidence":0.8586037158966064,"confidence_rate":0.9975441850508708},{"cnt":[[247,580],[1821,580],[1821,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1575,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67a592613972448384266e42ffb8e71d","type":"text","conversion_output":true,"text":"For further information about the drug profile of linagliptin, please refer to EU SPC or US-PI,","text_display":"\n\nFor further information about the drug profile of linagliptin, please refer to EU SPC or US-PI,","confidence":0.9975595474243164,"confidence_rate":0.9999755659451772},{"cnt":[[247,628],[879,628],[879,674],[247,674]],"region":{"top_left_x":246,"top_left_y":628,"width":634,"height":46},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0bcf3a469c04dff8795d4dd96899920","type":"text","conversion_output":true,"text":"or another regulatory label document.","text_display":" or another regulatory label document.","confidence":0.9990236759185791,"confidence_rate":0.9999767431038692},{"cnt":[[242,720],[726,720],[726,770],[242,770]],"region":{"top_left_x":242,"top_left_y":719,"width":485,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e8e8c7932c744c397ac96661b864a50","type":"section_header","conversion_output":false,"children_ids":["60e4fd768a7f41a49db56a6e326b4ade"],"text":"","text_display":""},{"cnt":[[247,726],[722,726],[722,765],[247,765]],"region":{"top_left_x":246,"top_left_y":726,"width":476,"height":40},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60e4fd768a7f41a49db56a6e326b4ade","type":"text","conversion_output":true,"parent_id":"4e8e8c7932c744c397ac96661b864a50","text":"Clinical Pharmacokinetics","text_display":"\n\n\\section*{Clinical Pharmacokinetics}","confidence":1,"confidence_rate":1},{"cnt":[[247,772],[1814,772],[1814,820],[247,820]],"region":{"top_left_x":246,"top_left_y":772,"width":1568,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef6854ca070441edbda8c264130ec922","type":"text","conversion_output":true,"text":"In earlier PK trials, linagliptin showed nonlinear PK in the therapeutic dose range, with","text_display":"\n\nIn earlier PK trials, linagliptin showed nonlinear PK in the therapeutic dose range, with","confidence":1,"confidence_rate":1},{"cnt":[[247,818],[1777,818],[1777,866],[247,866]],"region":{"top_left_x":246,"top_left_y":817,"width":1532,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f02b1575fff4b3b93558de2e38ce6f9","type":"text","conversion_output":true,"text":"a less than dose proportional increase in plasma concentrations. Clearance, volume of","text_display":" a less than dose proportional increase in plasma concentrations. Clearance, volume of","confidence":1,"confidence_rate":1},{"cnt":[[247,868],[1793,868],[1793,916],[247,916]],"region":{"top_left_x":246,"top_left_y":868,"width":1548,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"955bb9d06d794d9a8341d42f152ed2d4","type":"text","conversion_output":true,"text":"distribution, and amount excreted unchanged in urine increased with increasing doses,","text_display":" distribution, and amount excreted unchanged in urine increased with increasing doses,","confidence":1,"confidence_rate":1},{"cnt":[[247,916],[1720,916],[1720,964],[247,964]],"region":{"top_left_x":246,"top_left_y":916,"width":1475,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dda4f1717bd94632a0224f72d9b0b8ad","type":"text","conversion_output":true,"text":"possibly due to nonlinear protein binding. Linagliptin was predominantly excreted","text_display":" possibly due to nonlinear protein binding. Linagliptin was predominantly excreted","confidence":0.9985356330871582,"confidence_rate":0.9999829601434831},{"cnt":[[247,964],[1649,964],[1649,1012],[247,1012]],"region":{"top_left_x":246,"top_left_y":964,"width":1404,"height":48},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1457068542046e9bc872935e3be349c","type":"text","conversion_output":true,"text":"unchanged in faeces. Renal excretion was considered to be a minor elimination","text_display":" unchanged in faeces. Renal excretion was considered to be a minor elimination","confidence":0.9605226516723633,"confidence_rate":0.9995089289826352},{"cnt":[[247,1012],[1658,1012],[1658,1062],[247,1062]],"region":{"top_left_x":246,"top_left_y":1011,"width":1413,"height":52},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f286ab67397f43828a688d86503d29a4","type":"text","conversion_output":true,"text":"pathway. No dose adjustment of linagliptin based on hepatic impairment, renal","text_display":" pathway. No dose adjustment of linagliptin based on hepatic impairment, renal","confidence":1,"confidence_rate":1},{"cnt":[[247,1060],[1652,1060],[1652,1108],[247,1108]],"region":{"top_left_x":246,"top_left_y":1059,"width":1406,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1bc634869c30405596b3943d002e0bbf","type":"text","conversion_output":true,"text":"impairment, age, body mass index (BMI), weight, gender, or race is considered","text_display":" impairment, age, body mass index (BMI), weight, gender, or race is considered","confidence":1,"confidence_rate":1},{"cnt":[[247,1108],[1672,1108],[1672,1156],[247,1156]],"region":{"top_left_x":246,"top_left_y":1107,"width":1427,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b9c1bf86886f4e1982a95fe9ac79c6f2","type":"text","conversion_output":true,"text":"necessary. Linagliptin showed no clinically relevant interaction with metformin,","text_display":" necessary. Linagliptin showed no clinically relevant interaction with metformin,","confidence":1,"confidence_rate":1},{"cnt":[[247,1156],[971,1156],[971,1204],[247,1204]],"region":{"top_left_x":246,"top_left_y":1155,"width":725,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"566a565618d741c3bace0383e2637438","type":"text","conversion_output":true,"text":"pioglitazone, glyburide or empagliflozin.","text_display":" pioglitazone, glyburide or empagliflozin.","confidence":1,"confidence_rate":1},{"cnt":[[244,1247],[733,1247],[733,1300],[244,1300]],"region":{"top_left_x":244,"top_left_y":1247,"width":490,"height":53},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a15289d41f14e2783fab0933d969d94","type":"section_header","conversion_output":false,"children_ids":["7ee9923f5c694a1094e02b72ff81b6d6"],"text":"","text_display":""},{"cnt":[[247,1252],[729,1252],[729,1295],[247,1295]],"region":{"top_left_x":246,"top_left_y":1251,"width":483,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ee9923f5c694a1094e02b72ff81b6d6","type":"text","conversion_output":true,"parent_id":"6a15289d41f14e2783fab0933d969d94","text":"Clinical efficacy and safety","text_display":"\n\n\\section*{Clinical efficacy and safety}","confidence":1,"confidence_rate":1},{"cnt":[[247,1300],[1743,1300],[1743,1345],[247,1345]],"region":{"top_left_x":246,"top_left_y":1299,"width":1497,"height":47},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad71b02b4148477ca8d19ec50c4212f7","type":"text","conversion_output":true,"text":"Treatment with 5 mg linagliptin once daily has resulted in clinically meaningful and","text_display":"\n\nTreatment with 5 mg linagliptin once daily has resulted in clinically meaningful and","confidence":0.5746869519352913,"confidence_rate":0.9941244585023379},{"cnt":[[247,1348],[1780,1348],[1780,1396],[247,1396]],"region":{"top_left_x":246,"top_left_y":1347,"width":1534,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecc5956579a5403783ee20dfb25079ab","type":"text","conversion_output":true,"text":"statistically significant reductions in \\(HbA _{1 c}, FPG\\), and postprandial glucose. There is a","text_display":" statistically significant reductions in \\(HbA _{1 c}, FPG\\), and postprandial glucose. There is a","confidence":0.38017218048351414,"confidence_rate":0.9911664851153607},{"cnt":[[247,1396],[1720,1396],[1720,1441],[247,1441]],"region":{"top_left_x":246,"top_left_y":1395,"width":1475,"height":47},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8ae039168f5446d910e0018e0696a44","type":"text","conversion_output":true,"text":"consistent pattern in the improvement in \\(HbA _{1 c }\\) levels when linagliptin was used in","text_display":" consistent pattern in the improvement in \\(HbA _{1 c }\\) levels when linagliptin was used in","confidence":0.99609375,"confidence_rate":0.9999620016994184},{"cnt":[[247,1444],[1770,1444],[1770,1492],[247,1492]],"region":{"top_left_x":246,"top_left_y":1443,"width":1525,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a303191d22bc4907b5e77ed4422d5777","type":"text","conversion_output":true,"text":"patients with different background therapies. These findings demonstrate efficacy for","text_display":" patients with different background therapies. These findings demonstrate efficacy for","confidence":1,"confidence_rate":1},{"cnt":[[247,1492],[1693,1492],[1693,1537],[247,1537]],"region":{"top_left_x":246,"top_left_y":1491,"width":1447,"height":47},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ddf0e15bfa0b4e988137a4c118de59c4","type":"text","conversion_output":true,"text":"up to 18 to 24 weeks duration for different background therapies and are further","text_display":" up to 18 to 24 weeks duration for different background therapies and are further","confidence":0.9975605006329715,"confidence_rate":0.9999731599229073},{"cnt":[[247,1540],[1227,1540],[1227,1588],[247,1588]],"region":{"top_left_x":246,"top_left_y":1539,"width":981,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7600d9318ce84575b52ff8caf1d6ad58","type":"text","conversion_output":true,"text":"supported by trials of longer duration up to 104 weeks.","text_display":" supported by trials of longer duration up to 104 weeks.","confidence":0.530731201171875,"confidence_rate":0.9899948388194132},{"cnt":[[247,1636],[1789,1636],[1789,1684],[247,1684]],"region":{"top_left_x":246,"top_left_y":1635,"width":1543,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d63d58b573744143abf45fba5b671ec9","type":"text","conversion_output":true,"text":"Overall, in phase III studies the overall incidence of adverse events (AEs), drug related","text_display":"\n\nOverall, in phase III studies the overall incidence of adverse events (AEs), drug related","confidence":1,"confidence_rate":1},{"cnt":[[247,1684],[1784,1684],[1784,1729],[247,1729]],"region":{"top_left_x":246,"top_left_y":1683,"width":1539,"height":47},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"df61991b07eb471b99ca33fd316ea894","type":"text","conversion_output":true,"text":"AEs, AEs of severe intensity, AEs leading to discontinuation, and serious AEs (Serious","text_display":" AEs, AEs of severe intensity, AEs leading to discontinuation, and serious AEs (Serious","confidence":1,"confidence_rate":1},{"cnt":[[247,1732],[1748,1732],[1748,1780],[247,1780]],"region":{"top_left_x":246,"top_left_y":1731,"width":1502,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c9fe6a0d56f4114b074351e92fc27bb","type":"text","conversion_output":true,"text":"Adverse Event, SAEs) were very similar across studies, with linagliptin being mostly","text_display":" Adverse Event, SAEs) were very similar across studies, with linagliptin being mostly","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[247,1777],[1693,1777],[1693,1825],[247,1825]],"region":{"top_left_x":246,"top_left_y":1777,"width":1447,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac243ac4dfd34e6a9bafb92776394a54","type":"text","conversion_output":true,"text":"comparable with placebo. For description of side effects of linagliptin refer to the","text_display":" comparable with placebo. For description of side effects of linagliptin refer to the","confidence":1,"confidence_rate":1},{"cnt":[[247,1828],[1768,1828],[1768,1873],[247,1873]],"region":{"top_left_x":246,"top_left_y":1827,"width":1523,"height":47},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b45fec570354d37bb6a318a52377048","type":"text","conversion_output":true,"text":"current Investigator's Brochure [U04-1767] and the local prescribing information for","text_display":" current Investigator's Brochure [U04-1767] and the local prescribing information for","confidence":0.9604682922363281,"confidence_rate":0.9995469081934534},{"cnt":[[247,1873],[445,1873],[445,1921],[247,1921]],"region":{"top_left_x":246,"top_left_y":1873,"width":200,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e908ce55d914ddfa26558f715b93a8c","type":"text","conversion_output":true,"text":"linagliptin.","text_display":" linagliptin.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":38,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c7d5e7505032419bae7fa5ee3e8b7392","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":39,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5c470a1d986a4d5fa3adba6977c45dd9","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1768,2668],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1473,"height":35},"line":40,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6544cc9a1ac54f90ae5c7c45546f154d","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-022","page":22,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"997d35997c4a49dc9b5fa4735bf55ad5","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b321a8dfd104ae58560dce6a485901a","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9005cb0cd5c4d1aa6f134ea651a675f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e99b60c61ff46f09305225e5e188e87","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,247],[868,247]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":37},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4505a0d0f7544989f8a963a704c2b9b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2eb5d21ea59414bbfa8dc6b08bb796a","type":"page_info","conversion_output":false,"text":"Page 22 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1560,338],[1560,448],[242,448]],"region":{"top_left_x":242,"top_left_y":338,"width":1319,"height":110},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3c063f2ce9294cf7bacf0b7720a98a37","type":"section_header","conversion_output":false,"children_ids":["d2a6cf5ca2514bfd937e24a9318e81b0","84fdeeb68b6a4813936648702f925f93"],"text":"","text_display":""},{"cnt":[[247,343],[1556,343],[1556,395],[247,395]],"region":{"top_left_x":246,"top_left_y":342,"width":1310,"height":54},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d2a6cf5ca2514bfd937e24a9318e81b0","type":"text","conversion_output":true,"parent_id":"3c063f2ce9294cf7bacf0b7720a98a37","text":"2. RATIONALE, OBJECTIVES, AND BENEFIT - RISK","text_display":"\n\n\\section*{2. RATIONALE, OBJECTIVES, AND BENEFIT - RISK","confidence":1,"confidence_rate":1},{"cnt":[[402,397],[733,397],[733,445],[402,445]],"region":{"top_left_x":402,"top_left_y":397,"width":332,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"84fdeeb68b6a4813936648702f925f93","type":"text","conversion_output":true,"parent_id":"3c063f2ce9294cf7bacf0b7720a98a37","text":"ASSESSMENT","text_display":" ASSESSMENT}","confidence":1,"confidence_rate":1},{"cnt":[[242,489],[1307,489],[1307,541],[242,541]],"region":{"top_left_x":242,"top_left_y":488,"width":1065,"height":54},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f758f8a9195241a9a42bddac53dedea6","type":"section_header","conversion_output":false,"children_ids":["59619991591a4d85ad6c68cca5620a65"],"text":"","text_display":""},{"cnt":[[247,493],[1304,493],[1304,537],[247,537]],"region":{"top_left_x":246,"top_left_y":493,"width":1059,"height":44},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"59619991591a4d85ad6c68cca5620a65","type":"text","conversion_output":true,"parent_id":"f758f8a9195241a9a42bddac53dedea6","text":"2.1 RATIONALE FOR PERFORMING THE TRIAL","text_display":"\n\n\\subsection*{2.1 RATIONALE FOR PERFORMING THE TRIAL}","confidence":0.99951171875,"confidence_rate":0.9999886419133848},{"cnt":[[247,580],[1734,580],[1734,630],[247,630]],"region":{"top_left_x":246,"top_left_y":580,"width":1488,"height":51},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0b648f10606648c0b5470a7becc21a5a","type":"text","conversion_output":true,"text":"The aim of the present study is to investigate the long-term impact on CV morbidity and","text_display":"\n\nThe aim of the present study is to investigate the long-term impact on CV morbidity and","confidence":1,"confidence_rate":1},{"cnt":[[247,630],[1757,630],[1757,678],[247,678]],"region":{"top_left_x":246,"top_left_y":630,"width":1511,"height":49},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fd29ebb77ad645bf84ca3b2570dc6bed","type":"text","conversion_output":true,"text":"mortality of treatment with linagliptin in a selected population of patients with T2DM and","text_display":" mortality of treatment with linagliptin in a selected population of patients with T2DM and","confidence":1,"confidence_rate":1},{"cnt":[[247,678],[1814,678],[1814,726],[247,726]],"region":{"top_left_x":246,"top_left_y":678,"width":1568,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e60aa1099c3347809192c01f934f371a","type":"text","conversion_output":true,"text":"compare outcomes against placebo, on a background of standard of care. To date, this has not","text_display":" compare outcomes against placebo, on a background of standard of care. To date, this has not","confidence":1,"confidence_rate":1},{"cnt":[[247,726],[1793,726],[1793,774],[247,774]],"region":{"top_left_x":246,"top_left_y":726,"width":1548,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0579d1add02f41f2b51b22f5a4a276e4","type":"text","conversion_output":true,"text":"been tested in long-term trials of linagliptin. Since this is the case for other DPP-4 inhibitors","text_display":" been tested in long-term trials of linagliptin. Since this is the case for other DPP-4 inhibitors","confidence":1,"confidence_rate":1},{"cnt":[[247,774],[1796,774],[1796,825],[247,825]],"region":{"top_left_x":246,"top_left_y":774,"width":1550,"height":51},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"15968501d1be42c5a55e7b203129b6ec","type":"text","conversion_output":true,"text":"approved for the treatment of T2DM, several long-term studies are presently ongoing. There","text_display":" approved for the treatment of T2DM, several long-term studies are presently ongoing. There","confidence":1,"confidence_rate":1},{"cnt":[[247,822],[1798,822],[1798,870],[247,870]],"region":{"top_left_x":246,"top_left_y":822,"width":1552,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"91f566cd900040ea8ae0695097353ba9","type":"text","conversion_output":true,"text":"are currently no safety signals that indicate that linagliptin should be inferior to placebo with","text_display":" are currently no safety signals that indicate that linagliptin should be inferior to placebo with","confidence":1,"confidence_rate":1},{"cnt":[[247,870],[1793,870],[1793,918],[247,918]],"region":{"top_left_x":246,"top_left_y":870,"width":1548,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"31925b8b208b45f2b12bb5e245f09f25","type":"text","conversion_output":true,"text":"respect to CV safety [P12-00933]. A recent meta-analysis of the marketed DPP-4 inhibitors,","text_display":" respect to CV safety [P12-00933]. A recent meta-analysis of the marketed DPP-4 inhibitors,","confidence":1,"confidence_rate":1},{"cnt":[[247,918],[1761,918],[1761,966],[247,966]],"region":{"top_left_x":246,"top_left_y":918,"width":1516,"height":49},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a985ed87e61247d5b14623bb3d440acd","type":"text","conversion_output":true,"text":"on the contrary, indicates actually a potential beneficial CV effect of DPP-4 inhibitors as a","text_display":" on the contrary, indicates actually a potential beneficial CV effect of DPP-4 inhibitors as a","confidence":1,"confidence_rate":1},{"cnt":[[247,964],[1812,964],[1812,1012],[247,1012]],"region":{"top_left_x":246,"top_left_y":964,"width":1566,"height":48},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"849fe96413bf4814aa45bb9fb98952df","type":"text","conversion_output":true,"text":"class, although this meta-analysis mainly included trials of shorter duration with patients who","text_display":" class, although this meta-analysis mainly included trials of shorter duration with patients who","confidence":1,"confidence_rate":1},{"cnt":[[247,1014],[1752,1014],[1752,1062],[247,1062]],"region":{"top_left_x":246,"top_left_y":1014,"width":1507,"height":49},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"10ce30af072a4481b96a5851ca69d995","type":"text","conversion_output":true,"text":"were not at a particular high CV risk, limiting the findings to hypothesis generation [R09-","text_display":" were not at a particular high CV risk, limiting the findings to hypothesis generation [R09","confidence":0.97412109375,"confidence_rate":0.9997269158688921},{"cnt":[[247,1062],[916,1062],[916,1108],[247,1108]],"region":{"top_left_x":246,"top_left_y":1062,"width":671,"height":46},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1cbd9f04a5284316aeb9c39b5163bc8a","type":"text","conversion_output":true,"text":"6410]; thus this requires further studies.","text_display":"6410]; thus this requires further studies.","confidence":1,"confidence_rate":1},{"cnt":[[247,1151],[1743,1151],[1743,1199],[247,1199]],"region":{"top_left_x":246,"top_left_y":1151,"width":1497,"height":49},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"24bcea4fed564778b0a0eb7dd712c36a","type":"text","conversion_output":true,"text":"The rationale to assess microvascular outcomes, in particular renal safety with the aim of","text_display":"\n\nThe rationale to assess microvascular outcomes, in particular renal safety with the aim of","confidence":1,"confidence_rate":1},{"cnt":[[247,1199],[1812,1199],[1812,1247],[247,1247]],"region":{"top_left_x":246,"top_left_y":1199,"width":1566,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7c21c0f341584189addab8ae1fe8ffb3","type":"text","conversion_output":true,"text":"demonstrating renal benefits, is derived from the hypothesis based on pre-clinical and limited","text_display":" demonstrating renal benefits, is derived from the hypothesis based on pre-clinical and limited","confidence":1,"confidence_rate":1},{"cnt":[[247,1247],[1722,1247],[1722,1295],[247,1295]],"region":{"top_left_x":246,"top_left_y":1247,"width":1477,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4bf7e18195bb427a82ac0dd415c23385","type":"text","conversion_output":true,"text":"clinical data, that GLP-1 based therapies, and in particular linagliptin, may have a direct","text_display":" clinical data, that GLP-1 based therapies, and in particular linagliptin, may have a direct","confidence":1,"confidence_rate":1},{"cnt":[[247,1293],[1784,1293],[1784,1341],[247,1341]],"region":{"top_left_x":246,"top_left_y":1292,"width":1539,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5f892fd1808e4a569293eb4cb81f9dc1","type":"text","conversion_output":true,"text":"impact on the integrity of the endothelium and podocytes of the glomerula and the proximal","text_display":" impact on the integrity of the endothelium and podocytes of the glomerula and the proximal","confidence":1,"confidence_rate":1},{"cnt":[[247,1343],[1725,1343],[1725,1391],[247,1391]],"region":{"top_left_x":246,"top_left_y":1343,"width":1479,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"113ca09a12b64588a34e8e3a00f3a9f2","type":"text","conversion_output":true,"text":"tubular cells as well as endothelial function and last, that linagliptin has a relatively high","text_display":" tubular cells as well as endothelial function and last, that linagliptin has a relatively high","confidence":1,"confidence_rate":1},{"cnt":[[247,1391],[1757,1391],[1757,1437],[247,1437]],"region":{"top_left_x":246,"top_left_y":1391,"width":1511,"height":46},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"080e85aea0b84eb0ba12d9df9cb86809","type":"text","conversion_output":true,"text":"tissue distribution, including in the kidney, albeit all these features currently remains to be","text_display":" tissue distribution, including in the kidney, albeit all these features currently remains to be","confidence":1,"confidence_rate":1},{"cnt":[[247,1439],[487,1439],[487,1483],[247,1483]],"region":{"top_left_x":246,"top_left_y":1439,"width":241,"height":44},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8d197c6c37c648dc984287666eeaa727","type":"text","conversion_output":true,"text":"demonstrated.","text_display":" demonstrated.","confidence":1,"confidence_rate":1},{"cnt":[[247,1528],[1823,1528],[1823,1576],[247,1576]],"region":{"top_left_x":246,"top_left_y":1528,"width":1577,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"39c8fa860724444fa544b9b5ea59ff4c","type":"text","conversion_output":true,"text":"As the study population of this trial are patients with high CV risk, all with various degrees of","text_display":"\n\nAs the study population of this trial are patients with high CV risk, all with various degrees of","confidence":1,"confidence_rate":1},{"cnt":[[247,1576],[1684,1576],[1684,1624],[247,1624]],"region":{"top_left_x":246,"top_left_y":1576,"width":1438,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5f2a9b7e42f945908c877271f3ab4766","type":"text","conversion_output":true,"text":"end-organ damage (i.e., renal impairment) it is conceivable that the study will include","text_display":" end-organ damage (i.e., renal impairment) it is conceivable that the study will include","confidence":1,"confidence_rate":1},{"cnt":[[247,1622],[1789,1622],[1789,1672],[247,1672]],"region":{"top_left_x":246,"top_left_y":1621,"width":1543,"height":52},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f1851f2127d14e1cae0d3c433976e78b","type":"text","conversion_output":true,"text":"patients at all stages of T2DM duration since in fact many patients are being diagnosed with","text_display":" patients at all stages of T2DM duration since in fact many patients are being diagnosed with","confidence":1,"confidence_rate":1},{"cnt":[[247,1672],[1757,1672],[1757,1720],[247,1720]],"region":{"top_left_x":246,"top_left_y":1672,"width":1511,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"060c9ff85d7147c2945ee69cb8115345","type":"text","conversion_output":true,"text":"T2DM for the first time at the occasion of a CV event [R12-1135]. Therefore, antidiabetic","text_display":" T2DM for the first time at the occasion of a CV event [R12-1135]. Therefore, antidiabetic","confidence":1,"confidence_rate":1},{"cnt":[[247,1720],[1679,1720],[1679,1766],[247,1766]],"region":{"top_left_x":246,"top_left_y":1720,"width":1434,"height":46},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"496bd565f39a404788d623a91597583a","type":"text","conversion_output":true,"text":"treatment naïve, as well as patients with all kind of approved background antidiabetic","text_display":" treatment naïve, as well as patients with all kind of approved background antidiabetic","confidence":1,"confidence_rate":1},{"cnt":[[247,1768],[1679,1768],[1679,1816],[247,1816]],"region":{"top_left_x":246,"top_left_y":1768,"width":1434,"height":49},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"63454b2261014ea8bbff0079e3556e7d","type":"text","conversion_output":true,"text":"treatment (including insulins) are eligible. The only exceptions are patients on DPP-4","text_display":" treatment (including insulins) are eligible. The only exceptions are patients on DPP-4","confidence":1,"confidence_rate":1},{"cnt":[[247,1814],[1816,1814],[1816,1864],[247,1864]],"region":{"top_left_x":246,"top_left_y":1813,"width":1571,"height":52},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e83f736ca7d54203bfbc8ad42748e936","type":"text","conversion_output":true,"text":"inhibitors and/or GLP-1 receptor agonists and/or sodium glucose linked transporter (SGLT-2)","text_display":" inhibitors and/or GLP-1 receptor agonists and/or sodium glucose linked transporter (SGLT-2)","confidence":1,"confidence_rate":1},{"cnt":[[247,1864],[1807,1864],[1807,1912],[247,1912]],"region":{"top_left_x":246,"top_left_y":1864,"width":1561,"height":49},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"23527554255e404fafce21af41c3953a","type":"text","conversion_output":true,"text":"inhibitors. Taking into consideration linagliptins mode of action, there is not an option in this","text_display":" inhibitors. Taking into consideration linagliptins mode of action, there is not an option in this","confidence":1,"confidence_rate":1},{"cnt":[[247,1912],[1761,1912],[1761,1960],[247,1960]],"region":{"top_left_x":246,"top_left_y":1912,"width":1516,"height":48},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1311616a8157493aaa42d02593df6d21","type":"text","conversion_output":true,"text":"trial to combine study drug (i.e., placebo or linagliptin) with a GLP-1 receptor analogue as","text_display":" trial to combine study drug (i.e., placebo or linagliptin) with a GLP-1 receptor analogue as","confidence":1,"confidence_rate":1},{"cnt":[[247,1960],[1750,1960],[1750,2008],[247,2008]],"region":{"top_left_x":246,"top_left_y":1959,"width":1504,"height":49},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"58a47923b33740aa9fab0907c2e7b0b0","type":"text","conversion_output":true,"text":"the DPP4 inhibitor and GLP1 receptor analogue combination is not approved or indicated","text_display":" the DPP4 inhibitor and GLP1 receptor analogue combination is not approved or indicated","confidence":1,"confidence_rate":1},{"cnt":[[247,2006],[1775,2006],[1775,2054],[247,2054]],"region":{"top_left_x":246,"top_left_y":2005,"width":1529,"height":49},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6b1e8c5366344bc5aec6143ed868b8b5","type":"text","conversion_output":true,"text":"(per label of all GLP-1 products and DPP4 inhibitors). Also concomitant use of an SGLT-2","text_display":" (per label of all GLP-1 products and DPP4 inhibitors). Also concomitant use of an SGLT-2","confidence":1,"confidence_rate":1},{"cnt":[[247,2056],[1775,2056],[1775,2104],[247,2104]],"region":{"top_left_x":246,"top_left_y":2055,"width":1529,"height":49},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7627f2459aa94466b7e1b3b1df241ecb","type":"text","conversion_output":true,"text":"inhibitor is not allowed since this is a new class of drug that is and hithereto undescribed in","text_display":" inhibitor is not allowed since this is a new class of drug that is and hithereto undescribed in","confidence":1,"confidence_rate":1},{"cnt":[[247,2104],[1679,2104],[1679,2150],[247,2150]],"region":{"top_left_x":246,"top_left_y":2103,"width":1434,"height":47},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f27fe3cda33645439a902d8acd8045f5","type":"text","conversion_output":true,"text":"terms of CV benefit-risk ratio in order to reduce complexity of interpretation of study","text_display":" terms of CV benefit-risk ratio in order to reduce complexity of interpretation of study","confidence":1,"confidence_rate":1},{"cnt":[[247,2152],[1814,2152],[1814,2200],[247,2200]],"region":{"top_left_x":246,"top_left_y":2151,"width":1568,"height":49},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"318f5a6191c84daf8ec2cb545e361e01","type":"text","conversion_output":true,"text":"outcome. Further, as this trial would like to address the impact on CV outcomes of linagliptin","text_display":" outcome. Further, as this trial would like to address the impact on CV outcomes of linagliptin","confidence":1,"confidence_rate":1},{"cnt":[[247,2198],[1624,2198],[1624,2248],[247,2248]],"region":{"top_left_x":246,"top_left_y":2197,"width":1379,"height":51},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"340d95afa90d4adbacbc9314d9a61ecc","type":"text","conversion_output":true,"text":"compared to placebo in a high CV risk population, some with high degree of renal","text_display":" compared to placebo in a high CV risk population, some with high degree of renal","confidence":1,"confidence_rate":1},{"cnt":[[247,2248],[1706,2248],[1706,2296],[247,2296]],"region":{"top_left_x":246,"top_left_y":2247,"width":1461,"height":49},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7f3e699254254e8bab0e9f17f07d1cf1","type":"text","conversion_output":true,"text":"impairment, where most likely the use of SGLT-2 inhibitors will be restricted, SGLT-2","text_display":" impairment, where most likely the use of SGLT-2 inhibitors will be restricted, SGLT-2","confidence":1,"confidence_rate":1},{"cnt":[[247,2294],[1565,2294],[1565,2341],[247,2341]],"region":{"top_left_x":246,"top_left_y":2293,"width":1319,"height":49},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"69c4e87e077e4910988edc9122d41b2e","type":"text","conversion_output":true,"text":"inhibitors would only be an applicable therapy for a subset of the study cohort.","text_display":" inhibitors would only be an applicable therapy for a subset of the study cohort.","confidence":1,"confidence_rate":1},{"cnt":[[247,2389],[1716,2389],[1716,2437],[247,2437]],"region":{"top_left_x":246,"top_left_y":2389,"width":1470,"height":49},"line":47,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0c6f315496da41e9a5157a22d7dca228","type":"text","conversion_output":true,"text":"The study has two arms: linagliptin or placebo as add-on to antidiabetic treatment naive","text_display":"\n\nThe study has two arms: linagliptin or placebo as add-on to antidiabetic treatment naive","confidence":1,"confidence_rate":1},{"cnt":[[247,2440],[1812,2440],[1812,2488],[247,2488]],"region":{"top_left_x":246,"top_left_y":2439,"width":1566,"height":49},"line":48,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ad1cd376cbf148999a76d8b13b32315b","type":"text","conversion_output":true,"text":"patients or other allowed antidiabetic treatments. The study design is described in more detail","text_display":" patients or other allowed antidiabetic treatments. The study design is described in more detail","confidence":1,"confidence_rate":1},{"cnt":[[247,2485],[491,2485],[491,2533],[247,2533]],"region":{"top_left_x":246,"top_left_y":2485,"width":246,"height":49},"line":49,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"12c158d0db7e42b696f02fdae5846910","type":"text","conversion_output":true,"text":"in Section 3.1.","text_display":" in Section 3.1.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2622],[793,2622]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":38},"line":50,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4bd97b3f670d41db8ea6efd81b96b6da","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99755859375,"confidence_rate":0.9999418018997234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":51,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c365bc4d53e249f7a672339edc3de528","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":52,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1032d1b6477542faa52b679322f6bdbb","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-023","page":23,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"46ccb1ab5cba45078ff6ddee055fcd7d","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07a2779f9285462ab6b846cf8e48f1db","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50f905f6bdb64dee92db37158a04f65d","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"199c843dbf844b91833a378ece88be57","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ddbf2ec96c2d4936a3efdf6d0b24d7b1","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25454b32bcdc4d00bc0fd53cb27dabb7","type":"page_info","conversion_output":false,"text":"Page 23 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1802,338],[1802,388],[244,388]],"region":{"top_left_x":244,"top_left_y":338,"width":1559,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e13b077fcf1a411fbc3e2880495fdcb1","type":"text","conversion_output":true,"text":"The planned eligibility criteria will hence target a trial population with a short to long T2DM","text_display":"\n\nThe planned eligibility criteria will hence target a trial population with a short to long T2DM","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[247,388],[1761,388],[1761,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1516,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d99536784f204037a81b7317aab27424","type":"text","conversion_output":true,"text":"duration with a high CV risk (e.g., due to previous macrovascular disease and albuminuria","text_display":" duration with a high CV risk (e.g., due to previous macrovascular disease and albuminuria","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1716,434],[1716,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1470,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ca5a0ef58ee415394994793ed47d302","type":"text","conversion_output":true,"text":"(micro or macro) and/or renal impairment and predefined urine albumin creatinine ratio","text_display":" (micro or macro) and/or renal impairment and predefined urine albumin creatinine ratio","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1693,484],[1693,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1447,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee5de86853664f91b2eeff522dec75d6","type":"text","conversion_output":true,"text":"[UACR]). Thereby, it will assess the CV safety profile of linagliptin as compared with","text_display":" [UACR]). Thereby, it will assess the CV safety profile of linagliptin as compared with","confidence":1,"confidence_rate":1},{"cnt":[[244,532],[1818,532],[1818,578],[244,578]],"region":{"top_left_x":244,"top_left_y":532,"width":1575,"height":46},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9c5492fe0d4446db19f4bb408c602d0","type":"text","conversion_output":true,"text":"placebo in a broad (> 50\\% of patients with T2DM and CV complications are assumed to have","text_display":" placebo in a broad (> 50\\% of patients with T2DM and CV complications are assumed to have","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[247,580],[1775,580],[1775,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1529,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80ba8cb66bba4271a992867934e8170b","type":"text","conversion_output":true,"text":"some degree of renal impairment and some others \\(>20 \\%\\) have renal impairment alone) and","text_display":" some degree of renal impairment and some others \\(>20 \\%\\) have renal impairment alone) and","confidence":0.55029296875,"confidence_rate":0.9935979522625129},{"cnt":[[247,626],[1734,626],[1734,674],[247,674]],"region":{"top_left_x":246,"top_left_y":625,"width":1488,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d10585675c0c4307b8cc38506790bfbe","type":"text","conversion_output":true,"text":"relevant population of patients with T2DM. This study design therefore concurs with the","text_display":" relevant population of patients with T2DM. This study design therefore concurs with the","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[244,672],[1821,672],[1821,724],[244,724]],"region":{"top_left_x":244,"top_left_y":671,"width":1577,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cda444f66cd14dd6a53b489ba9ceb1bb","type":"text","conversion_output":true,"text":"recent FDA guidance for target populations in whom to specifically assess CV safety of novel","text_display":" recent FDA guidance for target populations in whom to specifically assess CV safety of novel","confidence":1,"confidence_rate":1},{"cnt":[[247,722],[1789,722],[1789,770],[247,770]],"region":{"top_left_x":246,"top_left_y":721,"width":1543,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c0a49e5d64d4389a363825d7f8d349f","type":"text","conversion_output":true,"text":"OADs for the treatment of T2DM [R09-2151]. This study will also be an integral part of the","text_display":" OADs for the treatment of T2DM [R09-2151]. This study will also be an integral part of the","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[247,770],[1727,770],[1727,820],[247,820]],"region":{"top_left_x":246,"top_left_y":769,"width":1481,"height":52},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2be09a76bf34e5b9e0b3038d1889cf9","type":"text","conversion_output":true,"text":"ongoing CV safety assessment for linagliptin and data will be used to support regulatory","text_display":" ongoing CV safety assessment for linagliptin and data will be used to support regulatory","confidence":1,"confidence_rate":1},{"cnt":[[247,818],[450,818],[450,861],[247,861]],"region":{"top_left_x":246,"top_left_y":817,"width":205,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e17fdcd8ee9d4adc9ef20c7b5f4b206b","type":"text","conversion_output":true,"text":"submission.","text_display":" submission.","confidence":1,"confidence_rate":1},{"cnt":[[1163,955],[1784,955],[1784,1003],[1163,1003]],"region":{"top_left_x":1162,"top_left_y":954,"width":623,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d0a06bcd41d4128a0ee0b69ce3bf215","type":"text","conversion_output":true,"text":"Functional assessment of post-stroke","text_display":"\n\nFunctional assessment of post-stroke","confidence":0.9990234375,"confidence_rate":0.9999761700486249},{"cnt":[[244,1001],[1812,1001],[1812,1053],[244,1053]],"region":{"top_left_x":244,"top_left_y":1000,"width":1568,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d81fdbefc79e4007840bf018eaf9d6d6","type":"text","conversion_output":true,"text":"recovery outcome of linagliptin versus placebo when provided on top of standard of care will","text_display":" recovery outcome of linagliptin versus placebo when provided on top of standard of care will","confidence":0.998046875,"confidence_rate":0.9999798452048033},{"cnt":[[247,1051],[1738,1051],[1738,1099],[247,1099]],"region":{"top_left_x":246,"top_left_y":1050,"width":1493,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42767d0b8463454286c503798909be0d","type":"text","conversion_output":true,"text":"also be evaluated using a simple one-tick box questionnaire (Rankin modified test scale),","text_display":" also be evaluated using a simple one-tick box questionnaire (Rankin modified test scale),","confidence":1,"confidence_rate":1},{"cnt":[[244,1099],[1745,1099],[1745,1147],[244,1147]],"region":{"top_left_x":244,"top_left_y":1098,"width":1502,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45546f55f11049d8b5f44ddd568d0564","type":"text","conversion_output":true,"text":"which could further advance our understanding of important issues in the management of","text_display":" which could further advance our understanding of important issues in the management of","confidence":1,"confidence_rate":1},{"cnt":[[247,1147],[857,1147],[857,1195],[247,1195]],"region":{"top_left_x":246,"top_left_y":1146,"width":611,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1cf3c597d509409aaef62d77bdd1ca6e","type":"text","conversion_output":true,"text":"patients with T2DM (Section 5.3.2).","text_display":" patients with T2DM (Section 5.3.2).","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[242,1238],[820,1238],[820,1291],[242,1291]],"region":{"top_left_x":242,"top_left_y":1238,"width":579,"height":53},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e0434612fa5496083ba0e0a0ad6b98c","type":"section_header","conversion_output":false,"children_ids":["db9a104c5f364644be19f8f30c44794c"],"text":"","text_display":""},{"cnt":[[247,1243],[816,1243],[816,1286],[247,1286]],"region":{"top_left_x":246,"top_left_y":1242,"width":570,"height":45},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db9a104c5f364644be19f8f30c44794c","type":"text","conversion_output":true,"parent_id":"4e0434612fa5496083ba0e0a0ad6b98c","text":"2.2 TRIAL OBJECTIVES","text_display":"\n\n\\subsection*{2.2 TRIAL OBJECTIVES}","confidence":0.97216796875,"confidence_rate":0.9988715698728374},{"cnt":[[247,1334],[1757,1334],[1757,1382],[247,1382]],"region":{"top_left_x":246,"top_left_y":1334,"width":1511,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ccea9d7cf290426ebd7d7a547f91605a","type":"text","conversion_output":true,"text":"The primary objective is to demonstrate non-inferiority (by means of comparing the upper","text_display":"\n\nThe primary objective is to demonstrate non-inferiority (by means of comparing the upper","confidence":1,"confidence_rate":1},{"cnt":[[247,1380],[1702,1380],[1702,1428],[247,1428]],"region":{"top_left_x":246,"top_left_y":1379,"width":1456,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ede8de003afa4d158683224343f3f353","type":"text","conversion_output":true,"text":"limit of a two-sided \\(95 \\%\\) confidence interval with the non-inferiority margin of 1.3 ) of","text_display":" limit of a two-sided \\(95 \\%\\) confidence interval with the non-inferiority margin of 1.3 ) of","confidence":0.5630455089603856,"confidence_rate":0.9942148310207573},{"cnt":[[247,1430],[1782,1430],[1782,1478],[247,1478]],"region":{"top_left_x":246,"top_left_y":1430,"width":1536,"height":48},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ed5ef9b38124ff6be8a216736e3e03f","type":"text","conversion_output":true,"text":"treatment with linagliptin in comparison with placebo (as add-on therapy on top of standard","text_display":" treatment with linagliptin in comparison with placebo (as add-on therapy on top of standard","confidence":1,"confidence_rate":1},{"cnt":[[247,1476],[1780,1476],[1780,1524],[247,1524]],"region":{"top_left_x":246,"top_left_y":1475,"width":1534,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bcbcedec418645a3942de6fd6ed099eb","type":"text","conversion_output":true,"text":"of care) with respect to time to first occurrence of any of the adjudicated components of the","text_display":" of care) with respect to time to first occurrence of any of the adjudicated components of the","confidence":0.975121021270752,"confidence_rate":0.9997429545591189},{"cnt":[[247,1524],[1702,1524],[1702,1574],[247,1574]],"region":{"top_left_x":246,"top_left_y":1523,"width":1456,"height":51},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d28496b112144644a2cfdb6e07950bf9","type":"text","conversion_output":true,"text":"primary composite endpoint (i.e. CV death fincluding fatal stroke, fatal MI and sudden","text_display":" primary composite endpoint (i.e. CV death fincluding fatal stroke, fatal MI and sudden","confidence":0.9570519924163818,"confidence_rate":0.9995177255574246},{"cnt":[[247,1572],[1812,1572],[1812,1620],[247,1620]],"region":{"top_left_x":246,"top_left_y":1571,"width":1566,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d49f272f5e264b15a24c315e1e83da29","type":"text","conversion_output":true,"text":"death], non-fatal stroke or non-fatal MI (excluding silent MI) and hospitalisation for unstable","text_display":" death], non-fatal stroke or non-fatal MI (excluding silent MI) and hospitalisation for unstable","confidence":0.855539083480835,"confidence_rate":0.9984409815165168},{"cnt":[[247,1622],[921,1622],[921,1670],[247,1670]],"region":{"top_left_x":246,"top_left_y":1621,"width":675,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"025f8bc56683401fa8932ccf29aca7a3","type":"text","conversion_output":true,"text":"angina pectoris) in patients with T2DM.","text_display":" angina pectoris) in patients with T2DM.","confidence":1,"confidence_rate":1},{"cnt":[[247,1732],[1793,1732],[1793,1780],[247,1780]],"region":{"top_left_x":246,"top_left_y":1731,"width":1548,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13860a826255423196650c138b5e2e3d","type":"text","conversion_output":true,"text":"If non-inferiority has been demonstrated, then the primary composite endpoint will be tested","text_display":"\n\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested","confidence":1,"confidence_rate":1},{"cnt":[[247,1782],[1766,1782],[1766,1830],[247,1830]],"region":{"top_left_x":246,"top_left_y":1781,"width":1520,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7382ac8fc9c496bb55f35dcd574f4df","type":"text","conversion_output":true,"text":"for superiority and the other objective, to assess the impact of treatment with respect to the","text_display":" for superiority and the other objective, to assess the impact of treatment with respect to the","confidence":1,"confidence_rate":1},{"cnt":[[247,1830],[1757,1830],[1757,1875],[247,1875]],"region":{"top_left_x":246,"top_left_y":1829,"width":1511,"height":47},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9db972a0e440434882822b67d4b37f39","type":"text","conversion_output":true,"text":"first occurrence of any of the adjudicated components of the composite renal endpoint","text_display":" first occurrence of any of the adjudicated components of the composite renal endpoint","confidence":0.92626953125,"confidence_rate":0.9991493618176884},{"cnt":[[247,1878],[1693,1878],[1693,1926],[247,1926]],"region":{"top_left_x":246,"top_left_y":1877,"width":1447,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2481d9a4c25f4898bbf55270f61d33c6","type":"text","conversion_output":true,"text":"(i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate","text_display":" (i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate","confidence":1,"confidence_rate":1},{"cnt":[[247,1923],[1588,1923],[1588,1976],[247,1976]],"region":{"top_left_x":246,"top_left_y":1923,"width":1342,"height":53},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"62b0172023484745a58de0ded140936e","type":"text","conversion_output":true,"text":"\\(( eGFR ) \\geq 50 4 0 \\%\\) from baseline), will be investigated with a test on superiority.","text_display":" \\(( eGFR ) \\geq 50 4 0 \\%\\) from baseline), will be investigated with a test on superiority.","confidence":0.6781490503413453,"confidence_rate":0.9955457179527653},{"cnt":[[247,1981],[1652,1981],[1652,2031],[247,2031]],"region":{"top_left_x":246,"top_left_y":1980,"width":1406,"height":51},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57eeae495530474f8a6bcd767254e079","type":"text","conversion_output":true,"text":"The CV and renal superiority tests will be performed separately, with an upfront","text_display":" The CV and renal superiority tests will be performed separately, with an upfront","confidence":0.7272875308990479,"confidence_rate":0.9962607335177917},{"cnt":[[247,2029],[1030,2029],[1030,2076],[247,2076]],"region":{"top_left_x":246,"top_left_y":2028,"width":785,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"951c74bdabfc44288f53e042aeef379e","type":"text","conversion_output":true,"text":"imbalance regarding the assigned alpha-levels.","text_display":" imbalance regarding the assigned alpha-levels.","confidence":1,"confidence_rate":1},{"cnt":[[247,2140],[1706,2140],[1706,2191],[247,2191]],"region":{"top_left_x":246,"top_left_y":2140,"width":1461,"height":51},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08fbbe323e8e45f1a9102a627d83bda6","type":"text","conversion_output":true,"text":"If linagliptin is superior with regard to the primary endpoint and/or the composite renal","text_display":"\n\nIf linagliptin is superior with regard to the primary endpoint and/or the composite renal","confidence":0.99853515625,"confidence_rate":0.9999844052526365},{"cnt":[[247,2188],[1688,2188],[1688,2236],[247,2236]],"region":{"top_left_x":246,"top_left_y":2188,"width":1443,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc7fa8ae8dd04c94b1883dac25d8d74a","type":"text","conversion_output":true,"text":"endpoint, a further test will evaluate the superiority of linagliptin with regard to the 3-","text_display":" endpoint, a further test will evaluate the superiority of linagliptin with regard to the 3","confidence":0.739872932434082,"confidence_rate":0.9968666191035958},{"cnt":[[247,2236],[1768,2236],[1768,2287],[247,2287]],"region":{"top_left_x":246,"top_left_y":2236,"width":1523,"height":51},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"860b022e36ab4e5dbdefd49d6d852a4a","type":"text","conversion_output":true,"text":"component Major Adverse Cardiovascular Events (MACE) endpoint (CV death [including","text_display":"component Major Adverse Cardiovascular Events (MACE) endpoint (CV death [including","confidence":0.998535871389322,"confidence_rate":0.999983158745329},{"cnt":[[247,2284],[1816,2284],[1816,2332],[247,2332]],"region":{"top_left_x":246,"top_left_y":2284,"width":1571,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d27207b6371e4a49bf189cd3af3b1b1d","type":"text","conversion_output":true,"text":"fatal stroke, fatal MI and sudden death], non-fatal stroke, non-fatal MI [excluding silent MI]).","text_display":" fatal stroke, fatal MI and sudden death], non-fatal stroke, non-fatal MI [excluding silent MI]).","confidence":1,"confidence_rate":1},{"cnt":[[247,2341],[1770,2341],[1770,2389],[247,2389]],"region":{"top_left_x":246,"top_left_y":2341,"width":1525,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69d703a3f59f474992977a26fe19b98c","type":"text","conversion_output":true,"text":"For a description of the endpoints chosen and statistical analyses to assess these objectives,","text_display":"\nFor a description of the endpoints chosen and statistical analyses to assess these objectives,","confidence":1,"confidence_rate":1},{"cnt":[[247,2389],[902,2389],[902,2437],[247,2437]],"region":{"top_left_x":246,"top_left_y":2389,"width":657,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0f8ea71afa242f48dbe09c1064b21f6","type":"text","conversion_output":true,"text":"please refer to Section 5 and Section 7.","text_display":" please refer to Section 5 and Section 7.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2622],[793,2622]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":38},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"21ce6c4e47bc4985acd621a98c9073c9","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999418018997234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7b99401c00614b19b035927baf76bf42","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.9912109375,"confidence_rate":0.9999258185992773},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c4522bd8eaef4f63a28c79f8d3bc5b0d","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-024","page":24,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eba8c0c7795a43bfae0f29c3d58b4161","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20ea9ad85fb94053bb8d66b8f1015079","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,164],[601,164],[601,203],[244,203]],"region":{"top_left_x":244,"top_left_y":164,"width":357,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a1e0092185284c1196e1de7fef3932fb","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,208],[637,208],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":207,"width":394,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92987d9b325f48b080355c3fb3e4354a","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1110,210],[1110,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":243,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d7dcd57841b43a989f3c737ed29f23f","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3365cbfc05df4e0c989b25d248e371bc","type":"page_info","conversion_output":false,"text":"Page 24 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[240,334],[1021,334],[1021,388],[240,388]],"region":{"top_left_x":239,"top_left_y":333,"width":783,"height":56},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7704ce3bab7d4d2c97f877e65857ce4b","type":"section_header","conversion_output":false,"children_ids":["5d8f6850794b43efba455c2ee78b7faf"],"text":"","text_display":""},{"cnt":[[247,338],[1017,338],[1017,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":771,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d8f6850794b43efba455c2ee78b7faf","type":"text","conversion_output":true,"parent_id":"7704ce3bab7d4d2c97f877e65857ce4b","text":"2.3 BENEFIT - RISK ASSESSMENT","text_display":"\n\n\\subsection*{2.3 BENEFIT - RISK ASSESSMENT}","confidence":0.9921875,"confidence_rate":0.9997693449149451},{"cnt":[[244,427],[1738,427],[1738,477],[244,477]],"region":{"top_left_x":244,"top_left_y":427,"width":1495,"height":51},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d37527d37af946de9df3ffabe3632222","type":"text","conversion_output":true,"text":"Potential general benefits for study participants in this trial irrespective of investigational","text_display":"\n\nPotential general benefits for study participants in this trial irrespective of investigational","confidence":1,"confidence_rate":1},{"cnt":[[247,477],[1777,477],[1777,525],[247,525]],"region":{"top_left_x":246,"top_left_y":477,"width":1532,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"885eab297b06416f885281baa2f6649d","type":"text","conversion_output":true,"text":"drug received are 1) improvements in glycaemic control, 2) improvements of other CV risk","text_display":" drug received are 1) improvements in glycaemic control, 2) improvements of other CV risk","confidence":0.9985356330871582,"confidence_rate":0.9999842427032235},{"cnt":[[247,525],[1658,525],[1658,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1413,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"977a61984fe34626aa332ac8d0e1cf60","type":"text","conversion_output":true,"text":"factors and 3) general medical benefit from careful and close monitoring by medical","text_display":" factors and 3) general medical benefit from careful and close monitoring by medical","confidence":1,"confidence_rate":1},{"cnt":[[244,571],[1318,571],[1318,624],[244,624]],"region":{"top_left_x":244,"top_left_y":571,"width":1075,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"122632e58be542a09389e177145f0584","type":"text","conversion_output":true,"text":"personnel and home blood glucose monitoring during the study.","text_display":" personnel and home blood glucose monitoring during the study.","confidence":1,"confidence_rate":1},{"cnt":[[244,662],[1734,662],[1734,710],[244,710]],"region":{"top_left_x":244,"top_left_y":662,"width":1490,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f2af13423b44c20b0906e2ebff5a774","type":"text","conversion_output":true,"text":"General risks associated with participating are related to trial specific procedures such as","text_display":"\n\nGeneral risks associated with participating are related to trial specific procedures such as","confidence":1,"confidence_rate":1},{"cnt":[[244,708],[1741,708],[1741,761],[244,761]],"region":{"top_left_x":244,"top_left_y":708,"width":1497,"height":53},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b4651c848724630967842efb0e794bb","type":"text","conversion_output":true,"text":"blood sampling that can be associated with bruising and pain. The amount of blood taken","text_display":" blood sampling that can be associated with bruising and pain. The amount of blood taken","confidence":1,"confidence_rate":1},{"cnt":[[247,758],[1775,758],[1775,806],[247,806]],"region":{"top_left_x":246,"top_left_y":758,"width":1529,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6403c4a7169441fbe18d6a6ab88c29e","type":"text","conversion_output":true,"text":"during the whole course of the trial is not believed to be associated with any discomfort for","text_display":" during the whole course of the trial is not believed to be associated with any discomfort for","confidence":1,"confidence_rate":1},{"cnt":[[244,806],[455,806],[455,857],[244,857]],"region":{"top_left_x":244,"top_left_y":806,"width":211,"height":51},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"379027b6f2a2451588a72db37d4630db","type":"text","conversion_output":true,"text":"the patients.","text_display":" the patients.","confidence":1,"confidence_rate":1},{"cnt":[[240,891],[811,891],[811,948],[240,948]],"region":{"top_left_x":239,"top_left_y":890,"width":572,"height":59},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fc16990785644309a9b8294d9a1558f","type":"section_header","conversion_output":false,"children_ids":["58fc721e1a9443f5a20363b1f4c17a2a"],"text":"","text_display":""},{"cnt":[[247,895],[806,895],[806,943],[247,943]],"region":{"top_left_x":246,"top_left_y":895,"width":561,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58fc721e1a9443f5a20363b1f4c17a2a","type":"text","conversion_output":true,"parent_id":"6fc16990785644309a9b8294d9a1558f","text":"Investigational drug specific risk","text_display":"\n\n\\section*{Investigational drug specific risk}","confidence":0.99951171875,"confidence_rate":0.9999874769887185},{"cnt":[[242,982],[1793,982],[1793,1035],[242,1035]],"region":{"top_left_x":242,"top_left_y":982,"width":1552,"height":53},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b8521a1390245c9a6577bd18fd248bd","type":"text","conversion_output":true,"text":"Linagliptin from its clinical phase III testing has shown a safety profile similar to placebo. It","text_display":"\n\nLinagliptin from its clinical phase III testing has shown a safety profile similar to placebo. It","confidence":1,"confidence_rate":1},{"cnt":[[247,1033],[1798,1033],[1798,1083],[247,1083]],"region":{"top_left_x":246,"top_left_y":1032,"width":1552,"height":51},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c980fa3773d24ee4b48377ec9e210089","type":"text","conversion_output":true,"text":"carries a low risk for inducing hypoglycaemia and is generally weight neutral. Safety will be","text_display":" carries a low risk for inducing hypoglycaemia and is generally weight neutral. Safety will be","confidence":1,"confidence_rate":1},{"cnt":[[244,1081],[1770,1081],[1770,1131],[244,1131]],"region":{"top_left_x":244,"top_left_y":1080,"width":1527,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa97ed30e1784ebaa7541234edf972d7","type":"text","conversion_output":true,"text":"ensured by monitoring the patients for AEs both clinically and by laboratory testing. If any","text_display":" ensured by monitoring the patients for AEs both clinically and by laboratory testing. If any","confidence":1,"confidence_rate":1},{"cnt":[[247,1128],[1757,1128],[1757,1179],[247,1179]],"region":{"top_left_x":246,"top_left_y":1128,"width":1511,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d032d37ac484d868540c7f9ba1fc2de","type":"text","conversion_output":true,"text":"investigator should have a clinical concern, the safety of the patients will be of paramount","text_display":" investigator should have a clinical concern, the safety of the patients will be of paramount","confidence":1,"confidence_rate":1},{"cnt":[[247,1176],[1725,1176],[1725,1227],[247,1227]],"region":{"top_left_x":246,"top_left_y":1176,"width":1479,"height":51},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"525ceb4dad7442ec897c9158dafbe503","type":"text","conversion_output":true,"text":"importance. Given the large safety margin derived from the toxicology studies, the wide","text_display":" importance. Given the large safety margin derived from the toxicology studies, the wide","confidence":1,"confidence_rate":1},{"cnt":[[244,1224],[1812,1224],[1812,1272],[244,1272]],"region":{"top_left_x":244,"top_left_y":1224,"width":1568,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42863a891aed4d90adc17f40d93e625d","type":"text","conversion_output":true,"text":"therapeutic window of linagliptin (120-fold recommended clinical dose), the high tolerability","text_display":" therapeutic window of linagliptin (120-fold recommended clinical dose), the high tolerability","confidence":0.95654296875,"confidence_rate":0.9995467398124814},{"cnt":[[247,1270],[1761,1270],[1761,1323],[247,1323]],"region":{"top_left_x":246,"top_left_y":1270,"width":1516,"height":53},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5fcd9ac7abd4a93879a67a35884d143","type":"text","conversion_output":true,"text":"observed in previous trials in subjects with T2DM, and the monitoring throughout the trial","text_display":" observed in previous trials in subjects with T2DM, and the monitoring throughout the trial","confidence":1,"confidence_rate":1},{"cnt":[[244,1320],[1716,1320],[1716,1373],[244,1373]],"region":{"top_left_x":244,"top_left_y":1320,"width":1472,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e3c472bd77f4997b7fe46e8cc8d881c","type":"text","conversion_output":true,"text":"the sponsor is of the opinion that the risks for the participating patients are minimal and","text_display":" the sponsor is of the opinion that the risks for the participating patients are minimal and","confidence":1,"confidence_rate":1},{"cnt":[[242,1366],[400,1366],[400,1419],[242,1419]],"region":{"top_left_x":242,"top_left_y":1366,"width":158,"height":53},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b19e72e44c5c40f2ac8f1667ef4a4ee0","type":"text","conversion_output":true,"text":"justified.","text_display":" justified.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2622],[793,2622]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":38},"line":28,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6a8d451d5c424caca6b36f1ec925c8ec","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999418018997234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":29,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bead7881c2c84e3a88492fb8b65515bf","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":30,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0f82934d643b4467b67a7d67a3d0006d","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-025","page":25,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d31a7fa5cbe842d395820001ee144f7f","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"717dfd8976474cc5bb0242669c81ea93","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[601,164],[601,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2468ac6078c445e81b9c2cd1ad793bb","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"642f53d5f02f4e4b958859ec8f07f3b4","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,247],[868,247]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":37},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1be31758e1a64044a48b9be7cc8edc91","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fc8370357204304ac322a2b5fd988c1","type":"page_info","conversion_output":false,"text":"Page 25 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[240,338],[1652,338],[1652,395],[240,395]],"region":{"top_left_x":239,"top_left_y":338,"width":1413,"height":58},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e986028edb2b4e93aeeea60fc2c9c4ae","type":"section_header","conversion_output":false,"children_ids":["46704881c0514eceb86644d6a41ab331"],"text":"","text_display":""},{"cnt":[[247,343],[1647,343],[1647,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":1402,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"46704881c0514eceb86644d6a41ab331","type":"text","conversion_output":true,"parent_id":"e986028edb2b4e93aeeea60fc2c9c4ae","text":"3. DESCRIPTION OF DESIGN AND TRIAL POPULATION","text_display":"\n\n\\section*{3. DESCRIPTION OF DESIGN AND TRIAL POPULATION}","confidence":1,"confidence_rate":1},{"cnt":[[242,434],[1158,434],[1158,482],[242,482]],"region":{"top_left_x":242,"top_left_y":434,"width":917,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d022dd91a67e444a9cca89a506a841d4","type":"section_header","conversion_output":false,"children_ids":["6862d5fbc152455f81ae457837b69b6e"],"text":"","text_display":""},{"cnt":[[247,439],[1154,439],[1154,480],[247,480]],"region":{"top_left_x":246,"top_left_y":438,"width":908,"height":42},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6862d5fbc152455f81ae457837b69b6e","type":"text","conversion_output":true,"parent_id":"d022dd91a67e444a9cca89a506a841d4","text":"3.1 OVERALL TRIAL DESIGN AND PLAN","text_display":"\n\n\\subsection*{3.1 OVERALL TRIAL DESIGN AND PLAN}","confidence":1,"confidence_rate":1},{"cnt":[[247,525],[1693,525],[1693,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1447,"height":49},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2baae999655b44b88e3470671f60332f","type":"text","conversion_output":true,"text":"This randomized, double-blind, and placebo controlled study compares treatment with","text_display":"\n\nThis randomized, double-blind, and placebo controlled study compares treatment with","confidence":1,"confidence_rate":1},{"cnt":[[247,576],[1789,576],[1789,624],[247,624]],"region":{"top_left_x":246,"top_left_y":575,"width":1543,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8b8ff5e8e761463ebfc3e406da9f8b69","type":"text","conversion_output":true,"text":"linagliptin ( 5 mg once daily) with placebo treatment (matching tablets once daily) as add-on","text_display":" linagliptin ( 5 mg once daily) with placebo treatment (matching tablets once daily) as add-on","confidence":0.89892578125,"confidence_rate":0.9989660222545661},{"cnt":[[247,624],[1766,624],[1766,672],[247,672]],"region":{"top_left_x":246,"top_left_y":623,"width":1520,"height":49},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"24116b5a92c24bdebfdfdceeda76271d","type":"text","conversion_output":true,"text":"therapy to standard of care background antidiabetic treatment as specified in Section 3.3.2.","text_display":" therapy to standard of care background antidiabetic treatment as specified in Section 3.3.2.","confidence":1,"confidence_rate":1},{"cnt":[[247,713],[1800,713],[1800,761],[247,761]],"region":{"top_left_x":246,"top_left_y":712,"width":1555,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3121b5503a1740aea9432466a2b0bbff","type":"text","conversion_output":true,"text":"The trial is event driven and will run until 625611 patients with a by adjudication confirmed","text_display":"\n\nThe trial is event driven and will run until 625611 patients with a by adjudication confirmed","confidence":0.8173828125,"confidence_rate":0.99800547947602},{"cnt":[[247,758],[1800,758],[1800,809],[247,809]],"region":{"top_left_x":246,"top_left_y":758,"width":1555,"height":51},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"450aabf1a4b940c7a2960c66ae505d10","type":"text","conversion_output":true,"text":"primary endpoint event are observed (Section 7.6), with an estimated 83007000 randomized","text_display":" primary endpoint event are observed (Section 7.6), with an estimated 83007000 randomized","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[247,809],[1782,809],[1782,857],[247,857]],"region":{"top_left_x":246,"top_left_y":808,"width":1536,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4fd0b1eaeb3b4559b66faef5e08f264b","type":"text","conversion_output":true,"text":"patients to be observed for an estimated study duration of 4854 months, beginning with the","text_display":" patients to be observed for an estimated study duration of 4854 months, beginning with the","confidence":0.9829568862915039,"confidence_rate":0.9998246070248435},{"cnt":[[247,854],[1761,854],[1761,902],[247,902]],"region":{"top_left_x":246,"top_left_y":854,"width":1516,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9576e9f26237452c93cef8488aa39249","type":"text","conversion_output":true,"text":"randomization of the first patient. The anticipated recruitment period is 36 months. In case","text_display":" randomization of the first patient. The anticipated recruitment period is 36 months. In case","confidence":1,"confidence_rate":1},{"cnt":[[247,905],[1752,905],[1752,953],[247,953]],"region":{"top_left_x":246,"top_left_y":904,"width":1507,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dcdb0477281a4cdb935a354934c41d45","type":"text","conversion_output":true,"text":"the number of primary endpoint events is not or may not be reached within this period the","text_display":" the number of primary endpoint events is not or may not be reached within this period the","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[247,950],[1738,950],[1738,998],[247,998]],"region":{"top_left_x":246,"top_left_y":950,"width":1493,"height":49},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"17104886be134290aa0f2f4261c2d0f8","type":"text","conversion_output":true,"text":"trial duration and/or the number of patients-will be increased until the defined number of","text_display":" trial duration and/or the number of patients-will be increased until the defined number of","confidence":1,"confidence_rate":1},{"cnt":[[247,1001],[1049,1001],[1049,1049],[247,1049]],"region":{"top_left_x":246,"top_left_y":1000,"width":803,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"74378bda46a94b10938cb3603b694bce","type":"text","conversion_output":true,"text":"adjudicated primary endpoint events is reached.","text_display":" adjudicated primary endpoint events is reached.","confidence":1,"confidence_rate":1},{"cnt":[[238,1122],[1734,1122],[1734,1610],[238,1610]],"region":{"top_left_x":237,"top_left_y":1121,"width":1497,"height":490},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dc2e1b95082e4ab6ae1adcfc2063b043","type":"diagram","conversion_output":true,"selected_labels":["c41203efd32d49128bfb92210468ffb8"],"text":"","text_display":"\n\n\\begin{figure}\n\\includegraphics[alt={},max width=\\textwidth]{https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-025.jpg?height=490&width=1497&top_left_y=1121&top_left_x=237}\n\\captionsetup{labelformat=empty}\n\\caption{Figure 3.1: 1 Treatment periods and treatment groups in the trial design}\n\\end{figure}"},{"cnt":[[247,1649],[1469,1649],[1469,1697],[247,1697]],"region":{"top_left_x":246,"top_left_y":1649,"width":1223,"height":49},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c41203efd32d49128bfb92210468ffb8","type":"figure_label","conversion_output":false,"text":"Figure 3.1: 1 Treatment periods and treatment groups in the trial design","text_display":"","confidence":0.9931640625,"confidence_rate":0.9999142610564071},{"cnt":[[247,1741],[1684,1741],[1684,1786],[247,1786]],"region":{"top_left_x":246,"top_left_y":1740,"width":1438,"height":47},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f1f0b80c2b54441c828927a429f306c4","type":"text","conversion_output":true,"text":"For all patients, site visits are scheduled at regular time intervals (see flow chart). The","text_display":"\n\nFor all patients, site visits are scheduled at regular time intervals (see flow chart). The","confidence":1,"confidence_rate":1},{"cnt":[[247,1786],[1807,1786],[1807,1834],[247,1834]],"region":{"top_left_x":246,"top_left_y":1786,"width":1561,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f405602317da4b78859c40a8ec7a9779","type":"text","conversion_output":true,"text":"estimated treatment duration for the first randomized patient is \\(4 8 5 4\\) months. The number of","text_display":" estimated treatment duration for the first randomized patient is \\(4 8 5 4\\) months. The number of","confidence":0.4617336907472236,"confidence_rate":0.9926673306342846},{"cnt":[[247,1837],[1757,1837],[1757,1885],[247,1885]],"region":{"top_left_x":246,"top_left_y":1836,"width":1511,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c5e717be88744901a778dd09e49c2542","type":"text","conversion_output":true,"text":"confirmed adjudicated primary endpoint events will be continuously monitored during the","text_display":" confirmed adjudicated primary endpoint events will be continuously monitored during the","confidence":1,"confidence_rate":1},{"cnt":[[247,1885],[1812,1885],[1812,1933],[247,1933]],"region":{"top_left_x":246,"top_left_y":1884,"width":1566,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4b73f84a85934dbaa57e0f099ba08c9c","type":"text","conversion_output":true,"text":"trial. Based on the available number of events the projected number of expected future events","text_display":" trial. Based on the available number of events the projected number of expected future events","confidence":1,"confidence_rate":1},{"cnt":[[247,1933],[1821,1933],[1821,1981],[247,1981]],"region":{"top_left_x":246,"top_left_y":1932,"width":1575,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cd682f3ea31d4471923b7010b1ebc71c","type":"text","conversion_output":true,"text":"will be calculated. As soon as the projection reliably suggests that the total number of patients","text_display":" will be calculated. As soon as the projection reliably suggests that the total number of patients","confidence":1,"confidence_rate":1},{"cnt":[[247,1981],[1793,1981],[1793,2031],[247,2031]],"region":{"top_left_x":246,"top_left_y":1980,"width":1548,"height":51},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4380947adbc34d54b996fd7d061ff741","type":"text","conversion_output":true,"text":"with a by adjudication confirmed primary endpoint event will reach \\(625 6 1 1\\) within the next","text_display":" with a by adjudication confirmed primary endpoint event will reach \\(625 6 1 1\\) within the next","confidence":0.6934936121106148,"confidence_rate":0.996346557616666},{"cnt":[[247,2031],[1805,2031],[1805,2079],[247,2079]],"region":{"top_left_x":246,"top_left_y":2030,"width":1559,"height":49},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"99ece687ba9a4a918ce6ee479d42f99c","type":"text","conversion_output":true,"text":"24 weeks, the trial team will perform respective actions to stop the trial. From this time point","text_display":" 24 weeks, the trial team will perform respective actions to stop the trial. From this time point","confidence":1,"confidence_rate":1},{"cnt":[[247,2079],[1652,2079],[1652,2127],[247,2127]],"region":{"top_left_x":246,"top_left_y":2078,"width":1406,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"11f041aa7b7c47dd9b213b1488dffa2f","type":"text","conversion_output":true,"text":"on, all patients are expected to perform their last visit (EOT visit) within the regular","text_display":" on, all patients are expected to perform their last visit (EOT visit) within the regular","confidence":1,"confidence_rate":1},{"cnt":[[247,2129],[1716,2129],[1716,2177],[247,2177]],"region":{"top_left_x":246,"top_left_y":2129,"width":1470,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"24aa7ee4ce8b482a9c4619d335310e0a","type":"text","conversion_output":true,"text":"proposed time schedule, which means within the next 24 weeks communicated via an","text_display":" proposed time schedule, which means within the next 24 weeks communicated via an","confidence":1,"confidence_rate":1},{"cnt":[[247,2179],[578,2179],[578,2227],[247,2227]],"region":{"top_left_x":246,"top_left_y":2179,"width":332,"height":49},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"18dc63092da74a87a2b85576d57a842f","type":"text","conversion_output":true,"text":"investigator letter.","text_display":" investigator letter.","confidence":1,"confidence_rate":1},{"cnt":[[247,2243],[1766,2243],[1766,2291],[247,2291]],"region":{"top_left_x":246,"top_left_y":2243,"width":1520,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"497b17d8088c472eab928eb68b159243","type":"text","conversion_output":true,"text":"The End of Treatment visit (EOT) activities will be performed when a patient discontinues","text_display":"\nThe End of Treatment visit (EOT) activities will be performed when a patient discontinues","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[247,2294],[1780,2294],[1780,2341],[247,2341]],"region":{"top_left_x":246,"top_left_y":2293,"width":1534,"height":49},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"61ae0aad215d46c2b1bb68ccadd6f527","type":"text","conversion_output":true,"text":"study medication treatment permanently. The EOT activities are not required for temporary","text_display":" study medication treatment permanently. The EOT activities are not required for temporary","confidence":1,"confidence_rate":1},{"cnt":[[247,2341],[1674,2341],[1674,2389],[247,2389]],"region":{"top_left_x":246,"top_left_y":2341,"width":1429,"height":49},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b697f66b937c4ad08a70a9817fb22315","type":"text","conversion_output":true,"text":"interruptions of study drug. All patients will have a follow up visit one week \\(3 0\\) days","text_display":" interruptions of study drug. All patients will have a follow up visit one week \\(3 0\\) days","confidence":0.52988869138062,"confidence_rate":0.9934740847092189},{"cnt":[[247,2389],[1752,2389],[1752,2437],[247,2437]],"region":{"top_left_x":246,"top_left_y":2389,"width":1507,"height":49},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"aa229e4ed4764f61bbe5bf8a7cc11f55","type":"text","conversion_output":true,"text":"following discontinuation of study drug, irrespective whether they complete the treatment","text_display":" following discontinuation of study drug, irrespective whether they complete the treatment","confidence":1,"confidence_rate":1},{"cnt":[[247,2435],[1729,2435],[1729,2488],[247,2488]],"region":{"top_left_x":246,"top_left_y":2435,"width":1484,"height":53},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5c9a15623f7b4edc8b345a3a3802b8ef","type":"text","conversion_output":true,"text":"period or pre-maturely discontinue study treatment. Patients who discontinue study drug","text_display":" period or pre-maturely discontinue study treatment. Patients who discontinue study drug","confidence":1,"confidence_rate":1},{"cnt":[[247,2485],[1789,2485],[1789,2533],[247,2533]],"region":{"top_left_x":246,"top_left_y":2485,"width":1543,"height":49},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a1cfaddf890f40919b073cf4b60b9e1b","type":"text","conversion_output":true,"text":"prematurely should continue study visits until study end. Study assessments may be omitted","text_display":" prematurely should continue study visits until study end. Study assessments may be omitted","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":39,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ee05c4b6aa514d49be5134d756f8661e","type":"section_header","conversion_output":false,"children_ids":["19ff28a66eeb4fe7abb8e95768d33be1"],"text":"","text_display":""},{"cnt":[[795,2586],[1300,2586],[1300,2620],[795,2620]],"region":{"top_left_x":794,"top_left_y":2585,"width":506,"height":36},"line":40,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"19ff28a66eeb4fe7abb8e95768d33be1","type":"text","conversion_output":true,"parent_id":"ee05c4b6aa514d49be5134d756f8661e","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":41,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f7daf9de1d1140fa95a69470003e0395","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2668],[1770,2668],[1770,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1475,"height":35},"line":42,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"189f363b372443869b9dfbb3a7952905","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-026","page":26,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc1aa01c5eba4123a4401f02d01df736","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85569a3f850442b885770eedd4efe77f","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0dbef07035564bbea7eef4f7a67db857","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89616fc4938845f3885abcba8e961927","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011059},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e884eb71d2024c52a0bb7ce41e932a6d","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"647a4d5caaa344b2a66dbcdf9837c719","type":"page_info","conversion_output":false,"text":"Page 26 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1574,338],[1574,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":1328,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67b7f0c31f734e418dcfec1dc3008ee7","type":"text","conversion_output":true,"text":"if a patient is willing to return to the pre-defined study visits, with exception of","text_display":"\nif a patient is willing to return to the pre-defined study visits, with exception of","confidence":1,"confidence_rate":1},{"cnt":[[489,388],[1674,388],[1674,436],[489,436]],"region":{"top_left_x":488,"top_left_y":388,"width":1187,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69485c8be4c7447d9e0eabad7ab574c7","type":"text","conversion_output":true,"text":"collection of adverse events, outcome events, concomitant therapy and","text_display":" collection of adverse events, outcome events, concomitant therapy and","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1302,434],[1302,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1057,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af7dc38b14ca47538bb9a7c6367b919b","type":"text","conversion_output":true,"text":"laboratory testing of creatinine for the calculation of the eGFR.","text_display":" laboratory testing of creatinine for the calculation of the eGFR.","confidence":0.99755859375,"confidence_rate":0.9999650807333806},{"cnt":[[247,525],[1702,525],[1702,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1456,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20a8fc90953c42f9890398c0236b98c2","type":"text","conversion_output":true,"text":"If a patient who prematurely discontinued study drug is not willing to return to the pre-","text_display":"\n\nIf a patient who prematurely discontinued study drug is not willing to return to the pre","confidence":1,"confidence_rate":1},{"cnt":[[247,571],[1761,571],[1761,619],[247,619]],"region":{"top_left_x":246,"top_left_y":571,"width":1516,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d03e57869d345d7ae83bc19dde9dbc9","type":"text","conversion_output":true,"text":"defined study visits, at minimum a yearly telephone call (preferably every 6 months) and a","text_display":"defined study visits, at minimum a yearly telephone call (preferably every 6 months) and a","confidence":1,"confidence_rate":1},{"cnt":[[247,621],[1768,621],[1768,669],[247,669]],"region":{"top_left_x":246,"top_left_y":621,"width":1523,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f8f48a34ae545e5b16eb37fb2d28ca5","type":"text","conversion_output":true,"text":"telephone call at study end will be required, to document the occurrence of outcome events","text_display":" telephone call at study end will be required, to document the occurrence of outcome events","confidence":1,"confidence_rate":1},{"cnt":[[247,667],[1716,667],[1716,715],[247,715]],"region":{"top_left_x":246,"top_left_y":667,"width":1470,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63d3c6da2239408b878e251014d86490","type":"text","conversion_output":true,"text":"and vital status. If possible, other AE's and concomitant therapy changes since last visit","text_display":" and vital status. If possible, other AE's and concomitant therapy changes since last visit","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[244,717],[1812,717],[1812,765],[244,765]],"region":{"top_left_x":244,"top_left_y":717,"width":1568,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c02651fd314947179da7226e6669da5c","type":"text","conversion_output":true,"text":"might be recorded. Every attempt will be made by the investigator to ensure patients continue","text_display":" might be recorded. Every attempt will be made by the investigator to ensure patients continue","confidence":1,"confidence_rate":1},{"cnt":[[247,763],[1770,763],[1770,811],[247,811]],"region":{"top_left_x":246,"top_left_y":762,"width":1525,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cc7f4297f79f4b49947e5b0a6e8e298e","type":"text","conversion_output":true,"text":"participating in the study during study drug interruptions and after discontinuation of study","text_display":" participating in the study during study drug interruptions and after discontinuation of study","confidence":1,"confidence_rate":1},{"cnt":[[247,813],[1798,813],[1798,861],[247,861]],"region":{"top_left_x":246,"top_left_y":813,"width":1552,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f87732099b441d28af75c311a5928e2","type":"text","conversion_output":true,"text":"drug. The ITT analysis requires that all study patients be followed until study end even if the","text_display":" drug. The ITT analysis requires that all study patients be followed until study end even if the","confidence":1,"confidence_rate":1},{"cnt":[[247,861],[1179,861],[1179,907],[247,907]],"region":{"top_left_x":246,"top_left_y":861,"width":933,"height":46},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e18e57d179ab45f4920d009ce3f768ce","type":"text","conversion_output":true,"text":"study drug was temporarily interrupted or discontinued.","text_display":" study drug was temporarily interrupted or discontinued.","confidence":1,"confidence_rate":1},{"cnt":[[247,950],[1670,950],[1670,998],[247,998]],"region":{"top_left_x":246,"top_left_y":950,"width":1424,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dec3528b52054c279937caf73b414e2e","type":"text","conversion_output":true,"text":"Patients will have a follow up visit ene week \\(3 0\\) days following regular or premature","text_display":"\n\nPatients will have a follow up visit ene week \\(3 0\\) days following regular or premature","confidence":0.728304386138916,"confidence_rate":0.9966683391259528},{"cnt":[[247,996],[1818,996],[1818,1044],[247,1044]],"region":{"top_left_x":246,"top_left_y":995,"width":1573,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92efc5f35a9a4bbcbb348462319c2eb1","type":"text","conversion_output":true,"text":"completion of the treatment period. The follow-up visit may be performed as a phone visit for","text_display":" completion of the treatment period. The follow-up visit may be performed as a phone visit for","confidence":1,"confidence_rate":1},{"cnt":[[247,1046],[1661,1046],[1661,1094],[247,1094]],"region":{"top_left_x":246,"top_left_y":1046,"width":1415,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69f3918843b44104b83026f2d5c75dbf","type":"text","conversion_output":true,"text":"patients who did not prematurely discontinue study medication and who do not have","text_display":" patients who did not prematurely discontinue study medication and who do not have","confidence":1,"confidence_rate":1},{"cnt":[[247,1092],[1816,1092],[1816,1140],[247,1140]],"region":{"top_left_x":246,"top_left_y":1091,"width":1571,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43e9f0142eea4e929f3c9f5f69049f61","type":"text","conversion_output":true,"text":"abnormalities at the EOT visit (only AEs/outcome events and changes in concomitant therapy","text_display":" abnormalities at the EOT visit (only AEs/outcome events and changes in concomitant therapy","confidence":1,"confidence_rate":1},{"cnt":[[247,1142],[514,1142],[514,1190],[247,1190]],"region":{"top_left_x":246,"top_left_y":1142,"width":268,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"acebc340f6704f688dcdc3dd73db1c94","type":"text","conversion_output":true,"text":"to be obtained).","text_display":" to be obtained).","confidence":1,"confidence_rate":1},{"cnt":[[247,1231],[1816,1231],[1816,1282],[247,1282]],"region":{"top_left_x":246,"top_left_y":1231,"width":1571,"height":51},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b61332a62e754fc59b6336fe863487b8","type":"text","conversion_output":true,"text":"In case early study termination is to be performed (e.g. based on recommendation by the Data","text_display":"\n\nIn case early study termination is to be performed (e.g. based on recommendation by the Data","confidence":1,"confidence_rate":1},{"cnt":[[247,1279],[1807,1279],[1807,1327],[247,1327]],"region":{"top_left_x":246,"top_left_y":1279,"width":1561,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8873e10856ba42a0a3889478f0acf164","type":"text","conversion_output":true,"text":"Monitoring Committee [DMC]), a reasonable timeframe to stop the trial (perform last patient","text_display":" Monitoring Committee [DMC]), a reasonable timeframe to stop the trial (perform last patient","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[247,1330],[1277,1330],[1277,1373],[247,1373]],"region":{"top_left_x":246,"top_left_y":1329,"width":1031,"height":44},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29336c91fd4e491a96fd814a2e393ad5","type":"text","conversion_output":true,"text":"visits) will be defined and communicated to the investigators.","text_display":" visits) will be defined and communicated to the investigators.","confidence":1,"confidence_rate":1},{"cnt":[[242,1412],[1053,1412],[1053,1460],[242,1460]],"region":{"top_left_x":242,"top_left_y":1411,"width":812,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a338078892f46fab0366e78f2a87f88","type":"section_header","conversion_output":false,"children_ids":["07eadbffadb24f9fa284598b98bc0e5b"],"text":"","text_display":""},{"cnt":[[247,1416],[1051,1416],[1051,1455],[247,1455]],"region":{"top_left_x":246,"top_left_y":1416,"width":805,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07eadbffadb24f9fa284598b98bc0e5b","type":"text","conversion_output":true,"parent_id":"1a338078892f46fab0366e78f2a87f88","text":"3.1.1 Administrative structure of the trial","text_display":"\n\n\\subsection*{3.1.1 Administrative structure of the trial}","confidence":1,"confidence_rate":1},{"cnt":[[247,1503],[1154,1503],[1154,1551],[247,1551]],"region":{"top_left_x":246,"top_left_y":1503,"width":908,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1afc89aa15d34a2a9095ae18653560ea","type":"text","conversion_output":true,"text":"The study is sponsored by Boehringer Ingelheim (BI).","text_display":"\n\nThe study is sponsored by Boehringer Ingelheim (BI).","confidence":1,"confidence_rate":1},{"cnt":[[247,1599],[1661,1599],[1661,1647],[247,1647]],"region":{"top_left_x":246,"top_left_y":1599,"width":1415,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e4058055f484b22803d634c09ef1d2b","type":"text","conversion_output":true,"text":"Co-ordinating Investigators who will (co) chair the Steering Committee (SC) will be","text_display":"\n\nCo-ordinating Investigators who will (co) chair the Steering Committee (SC) will be","confidence":0.9956102357245982,"confidence_rate":0.9999500077544184},{"cnt":[[247,1649],[436,1649],[436,1688],[247,1688]],"region":{"top_left_x":246,"top_left_y":1649,"width":191,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8010d3721bf4d699ec041066440207b","type":"text","conversion_output":true,"text":"nominated.","text_display":" nominated.","confidence":1,"confidence_rate":1},{"cnt":[[247,1743],[1802,1743],[1802,1793],[247,1793]],"region":{"top_left_x":246,"top_left_y":1742,"width":1557,"height":52},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b9db5aabb4c7430bbf4d5012f366c609","type":"text","conversion_output":true,"text":"Documents on principal investigators and other important participants at each site, especially","text_display":"\n\nDocuments on principal investigators and other important participants at each site, especially","confidence":1,"confidence_rate":1},{"cnt":[[247,1791],[1501,1791],[1501,1839],[247,1839]],"region":{"top_left_x":246,"top_left_y":1790,"width":1255,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d81702010b74d998ffb63d0bbef28f7","type":"text","conversion_output":true,"text":"their curricula vitae, will be filed in the Clinical Trial Master File (CTMF).","text_display":" their curricula vitae, will be filed in the Clinical Trial Master File (CTMF).","confidence":1,"confidence_rate":1},{"cnt":[[247,1878],[1770,1878],[1770,1926],[247,1926]],"region":{"top_left_x":246,"top_left_y":1877,"width":1525,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd1d94c1401b4eb48a93d3f67a9de366","type":"text","conversion_output":true,"text":"CRO's will be assigned for central laboratory, interactive response technology (IRT), ECG","text_display":"\n\nCRO's will be assigned for central laboratory, interactive response technology (IRT), ECG","confidence":1,"confidence_rate":1},{"cnt":[[247,1928],[797,1928],[797,1976],[247,1976]],"region":{"top_left_x":246,"top_left_y":1928,"width":552,"height":48},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"551efddf553d479ca9729e09e2cbf549","type":"text","conversion_output":true,"text":"analyses and conduct of the trial.","text_display":" analyses and conduct of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[247,2024],[1786,2024],[1786,2072],[247,2072]],"region":{"top_left_x":246,"top_left_y":2023,"width":1541,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42a170a4f80347edb64d22e762c24a70","type":"text","conversion_output":true,"text":"The following committees will participate in the conduct of the trial, their specific functions","text_display":"\n\nThe following committees will participate in the conduct of the trial, their specific functions","confidence":0.99560546875,"confidence_rate":0.9999559588139921},{"cnt":[[247,2074],[637,2074],[637,2113],[247,2113]],"region":{"top_left_x":246,"top_left_y":2074,"width":392,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0476abf0e0a4bec9d55ee03ccc38147","type":"text","conversion_output":true,"text":"are summarised below:","text_display":" are summarised below:","confidence":1,"confidence_rate":1},{"cnt":[[242,2166],[592,2166],[592,2218],[242,2218]],"region":{"top_left_x":242,"top_left_y":2165,"width":350,"height":54},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"530c5e59f23e4fb4aa48dec4393b6584","type":"section_header","conversion_output":false,"children_ids":["087b73a0084d46879c063a3046ab98c2"],"text":"","text_display":""},{"cnt":[[247,2170],[587,2170],[587,2214],[247,2214]],"region":{"top_left_x":246,"top_left_y":2170,"width":342,"height":44},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"087b73a0084d46879c063a3046ab98c2","type":"text","conversion_output":true,"parent_id":"530c5e59f23e4fb4aa48dec4393b6584","text":"Steering Committee","text_display":"\n\n\\section*{Steering Committee}","confidence":1,"confidence_rate":1},{"cnt":[[247,2216],[1782,2216],[1782,2262],[247,2262]],"region":{"top_left_x":246,"top_left_y":2215,"width":1536,"height":47},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aba1784d8dcc4717881340cf9fd8f3c3","type":"text","conversion_output":true,"text":"A SC will have a scientific and clinical advisory function in the study. The SC is comprised","text_display":"\n\nA SC will have a scientific and clinical advisory function in the study. The SC is comprised","confidence":1,"confidence_rate":1},{"cnt":[[247,2262],[1818,2262],[1818,2310],[247,2310]],"region":{"top_left_x":246,"top_left_y":2261,"width":1573,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b12283512d904e25a7ddcf1847e016d6","type":"text","conversion_output":true,"text":"of university- and sponsor-based scientists with clinical and methodological expertise. Details","text_display":" of university- and sponsor-based scientists with clinical and methodological expertise. Details","confidence":0.99853515625,"confidence_rate":0.9999853409306202},{"cnt":[[247,2312],[1684,2312],[1684,2360],[247,2360]],"region":{"top_left_x":246,"top_left_y":2311,"width":1438,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84e36d1491694adbb19de42d68891821","type":"text","conversion_output":true,"text":"on the composition of the committee, its procedures and interactions are provided in a","text_display":" on the composition of the committee, its procedures and interactions are provided in a","confidence":1,"confidence_rate":1},{"cnt":[[247,2357],[592,2357],[592,2405],[247,2405]],"region":{"top_left_x":246,"top_left_y":2357,"width":346,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d7ddb81f81d43dbb7c3b945fc45d881","type":"text","conversion_output":true,"text":"separate SC Charter.","text_display":" separate SC Charter.","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":43,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c1da894624f742d7866ade31159dfcb6","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99462890625,"confidence_rate":0.9998717803653022},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0239918301f14f74bdd57b2b4e295a1e","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c71c08abcb394833b8303e8052455da8","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-027","page":27,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90ed70885bdb4604919371562b8d386d","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1bb0faf1f77448bb5ba01b10fea13a1","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ae6bec1e8574b9796e573e7413701b4","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19e1245522114dad82c16f946e4b41a0","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8fbf337cf454ccfb3cae19a86dd1f52","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bba9ade986d342caa3106ad536402b47","type":"page_info","conversion_output":false,"text":"Page 27 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,384],[733,384],[733,436],[242,436]],"region":{"top_left_x":242,"top_left_y":383,"width":492,"height":54},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"43f54f92d8e74e3bbc7f8434d0ed52b6","type":"section_header","conversion_output":false,"children_ids":["5e09733008664d818054b496160267bc"],"text":"","text_display":""},{"cnt":[[247,388],[729,388],[729,432],[247,432]],"region":{"top_left_x":246,"top_left_y":388,"width":483,"height":44},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5e09733008664d818054b496160267bc","type":"text","conversion_output":true,"parent_id":"43f54f92d8e74e3bbc7f8434d0ed52b6","text":"Data Monitoring Committee","text_display":"\n\n\\section*{Data Monitoring Committee}","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1780,434],[1780,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1534,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec998c7b96cb47979df06efde7b16915","type":"text","conversion_output":true,"text":"An independent DMC will review safety and efficacy data and will make recommendations","text_display":"\n\nAn independent DMC will review safety and efficacy data and will make recommendations","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1684,484],[1684,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1438,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6129eb8ab291443c9a789c19da0d5f38","type":"text","conversion_output":true,"text":"whether to continue or terminate the study. The DMC analyses and operations will be","text_display":" whether to continue or terminate the study. The DMC analyses and operations will be","confidence":1,"confidence_rate":1},{"cnt":[[247,532],[1610,532],[1610,578],[247,578]],"region":{"top_left_x":246,"top_left_y":532,"width":1365,"height":46},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6eedd196854b4d758480de9b38967e5b","type":"text","conversion_output":true,"text":"formally separated from the sponsor, the investigators, and the SC. Details on the","text_display":" formally separated from the sponsor, the investigators, and the SC. Details on the","confidence":1,"confidence_rate":1},{"cnt":[[247,580],[1720,580],[1720,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1475,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"afcf7df1b6c84724914fb4f5c5414f29","type":"text","conversion_output":true,"text":"composition of the committee, its procedures and interactions are provided in a separate","text_display":" composition of the committee, its procedures and interactions are provided in a separate","confidence":0.97216796875,"confidence_rate":0.999696533344622},{"cnt":[[247,626],[491,626],[491,669],[247,669]],"region":{"top_left_x":246,"top_left_y":625,"width":246,"height":45},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e19e34c93144f99a565e2cfbb080a68","type":"text","conversion_output":true,"text":"DMC Charter.","text_display":" DMC Charter.","confidence":1,"confidence_rate":1},{"cnt":[[242,713],[692,713],[692,763],[242,763]],"region":{"top_left_x":242,"top_left_y":712,"width":451,"height":51},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"31ff2a8f5f53450ea2fe1c2a1dfc4ada","type":"section_header","conversion_output":false,"children_ids":["ed2ad10acf7747e4a7a8d61fd4f321a4"],"text":"","text_display":""},{"cnt":[[247,717],[688,717],[688,761],[247,761]],"region":{"top_left_x":246,"top_left_y":717,"width":442,"height":44},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ed2ad10acf7747e4a7a8d61fd4f321a4","type":"text","conversion_output":true,"parent_id":"31ff2a8f5f53450ea2fe1c2a1dfc4ada","text":"Clinical Event Committee","text_display":"\n\n\\section*{Clinical Event Committee}","confidence":1,"confidence_rate":1},{"cnt":[[247,763],[1494,763],[1494,811],[247,811]],"region":{"top_left_x":246,"top_left_y":762,"width":1248,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57ad171d9e2c45a7a13350141a9729ee","type":"text","conversion_output":true,"text":"The study is set up with prospective centralized blinded adjudication of all","text_display":"\n\nThe study is set up with prospective centralized blinded adjudication of all","confidence":1,"confidence_rate":1},{"cnt":[[247,813],[1752,813],[1752,861],[247,861]],"region":{"top_left_x":246,"top_left_y":813,"width":1507,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d0e66ff65244c349db180a739b69e2f","type":"text","conversion_output":true,"text":"cardio/cerebrovascular trigger events. The prospectively defined adjudication process will","text_display":" cardio/cerebrovascular trigger events. The prospectively defined adjudication process will","confidence":1,"confidence_rate":1},{"cnt":[[247,861],[1748,861],[1748,907],[247,907]],"region":{"top_left_x":246,"top_left_y":861,"width":1502,"height":46},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47c5ed7adaf0431da0e0780e39553b9d","type":"text","conversion_output":true,"text":"assess cardiac and neurological vascular events through an independent, blinded, external","text_display":" assess cardiac and neurological vascular events through an independent, blinded, external","confidence":1,"confidence_rate":1},{"cnt":[[247,909],[1629,909],[1629,957],[247,957]],"region":{"top_left_x":246,"top_left_y":909,"width":1383,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"025dfdfb5b164c8fba0a266748bb9413","type":"text","conversion_output":true,"text":"Clinical Event Committee (CEC). Details on the composition of the committee, its","text_display":" Clinical Event Committee (CEC). Details on the composition of the committee, its","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[244,955],[1377,955],[1377,1007],[244,1007]],"region":{"top_left_x":244,"top_left_y":954,"width":1134,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4077291ebda43febf21307dee34c1a1","type":"text","conversion_output":true,"text":"procedures and interactions are provided in a separate CEC charter.","text_display":" procedures and interactions are provided in a separate CEC charter.","confidence":0.98974609375,"confidence_rate":0.9998568596940597},{"cnt":[[247,1046],[1633,1046],[1633,1094],[247,1094]],"region":{"top_left_x":246,"top_left_y":1046,"width":1388,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78e5bc8b94684cb29e9a663d9702f64e","type":"text","conversion_output":true,"text":"Additionally, separate independent, blinded, external committees will be set up for","text_display":"\n\nAdditionally, separate independent, blinded, external committees will be set up for","confidence":1,"confidence_rate":1},{"cnt":[[244,1092],[1793,1092],[1793,1142],[244,1142]],"region":{"top_left_x":244,"top_left_y":1091,"width":1550,"height":52},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c877a5acf25a4ba2ac74ed00c824c4e5","type":"text","conversion_output":true,"text":"adjudication of renal events and pancreatic events. The adjudication process for renal events","text_display":" adjudication of renal events and pancreatic events. The adjudication process for renal events","confidence":1,"confidence_rate":1},{"cnt":[[244,1142],[1396,1142],[1396,1190],[244,1190]],"region":{"top_left_x":244,"top_left_y":1142,"width":1152,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c89dad034144f51b576f1aead004f08","type":"text","conversion_output":true,"text":"and pancreatic events will be clarified in a separate the CEC charter.","text_display":" and pancreatic events will be clarified in a separate the CEC charter.","confidence":1,"confidence_rate":1},{"cnt":[[240,1229],[1661,1229],[1661,1330],[240,1330]],"region":{"top_left_x":239,"top_left_y":1228,"width":1422,"height":102},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"39511a0ea28b45e8906a104acf7b2f0d","type":"section_header","conversion_output":false,"children_ids":["91c50f1611db43c98d7b856c3cf508cd","738698797f844d9481a571ad8bac59af"],"text":"","text_display":""},{"cnt":[[247,1234],[1656,1234],[1656,1277],[247,1277]],"region":{"top_left_x":246,"top_left_y":1233,"width":1411,"height":44},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"91c50f1611db43c98d7b856c3cf508cd","type":"text","conversion_output":true,"parent_id":"39511a0ea28b45e8906a104acf7b2f0d","text":"3.2 DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF","text_display":"\n\n\\subsection*{3.2 DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF","confidence":1,"confidence_rate":1},{"cnt":[[402,1279],[834,1279],[834,1327],[402,1327]],"region":{"top_left_x":402,"top_left_y":1279,"width":432,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"738698797f844d9481a571ad8bac59af","type":"text","conversion_output":true,"parent_id":"39511a0ea28b45e8906a104acf7b2f0d","text":"CONTROL GROUP(S)","text_display":" CONTROL GROUP(S)}","confidence":1,"confidence_rate":1},{"cnt":[[244,1366],[1789,1366],[1789,1416],[244,1416]],"region":{"top_left_x":244,"top_left_y":1366,"width":1545,"height":51},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e221873f847d41959a996f804ada3882","type":"text","conversion_output":true,"text":"A wide variety of antidiabetic medications are available for the treatment of T2DM, but it is","text_display":"\n\nA wide variety of antidiabetic medications are available for the treatment of T2DM, but it is","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[247,1416],[1697,1416],[1697,1464],[247,1464]],"region":{"top_left_x":246,"top_left_y":1416,"width":1452,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83b5e0264cac4be489e5e80781070305","type":"text","conversion_output":true,"text":"unclear how these drugs compare with respect to long term CV risk and microvascular","text_display":" unclear how these drugs compare with respect to long term CV risk and microvascular","confidence":1,"confidence_rate":1},{"cnt":[[247,1464],[1695,1464],[1695,1512],[247,1512]],"region":{"top_left_x":246,"top_left_y":1464,"width":1450,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0de21dbccbf94832b246ed8e7edc7a1a","type":"text","conversion_output":true,"text":"outcomes [R11-4860]. The aim of this study is to have patients with T2DM on various","text_display":" outcomes [R11-4860]. The aim of this study is to have patients with T2DM on various","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[247,1512],[1583,1512],[1583,1560],[247,1560]],"region":{"top_left_x":246,"top_left_y":1512,"width":1338,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36b5ca87f6f04d8cae86589553dfc2f0","type":"text","conversion_output":true,"text":"antidiabetic background therapies represented to evaluate the long term CV and","text_display":" antidiabetic background therapies represented to evaluate the long term CV and","confidence":1,"confidence_rate":1},{"cnt":[[244,1560],[1300,1560],[1300,1610],[244,1610]],"region":{"top_left_x":244,"top_left_y":1560,"width":1056,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66762118200e45d49089e8b1b056f49b","type":"text","conversion_output":true,"text":"microvascular safety of linagliptin in a real life clinical setting.","text_display":" microvascular safety of linagliptin in a real life clinical setting.","confidence":1,"confidence_rate":1},{"cnt":[[247,1649],[1780,1649],[1780,1697],[247,1697]],"region":{"top_left_x":246,"top_left_y":1649,"width":1534,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f56168cdf2ea451ba3d3e2d24a0bc5a0","type":"text","conversion_output":true,"text":"The placebo-controlled design is considered ethically acceptable on the basis of appropriate","text_display":"\n\nThe placebo-controlled design is considered ethically acceptable on the basis of appropriate","confidence":1,"confidence_rate":1},{"cnt":[[247,1695],[1750,1695],[1750,1745],[247,1745]],"region":{"top_left_x":246,"top_left_y":1695,"width":1504,"height":51},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e961b22079934c05b99c8c0430acfe35","type":"text","conversion_output":true,"text":"criteria for patient discontinuation, ability to change background treatment to maintain, or","text_display":" criteria for patient discontinuation, ability to change background treatment to maintain, or","confidence":1,"confidence_rate":1},{"cnt":[[247,1745],[1661,1745],[1661,1793],[247,1793]],"region":{"top_left_x":246,"top_left_y":1745,"width":1415,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8580f93fffe242b4a43d8ebc07506069","type":"text","conversion_output":true,"text":"obtain, sufficient level of glycaemic control as defined in relevant local and regional","text_display":" obtain, sufficient level of glycaemic control as defined in relevant local and regional","confidence":1,"confidence_rate":1},{"cnt":[[247,1793],[943,1793],[943,1843],[247,1843]],"region":{"top_left_x":246,"top_left_y":1793,"width":698,"height":51},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0e6d717cf464f94a7715c17a8491386","type":"text","conversion_output":true,"text":"guidelines for optimized standard of care.","text_display":" guidelines for optimized standard of care.","confidence":1,"confidence_rate":1},{"cnt":[[247,1882],[1738,1882],[1738,1930],[247,1930]],"region":{"top_left_x":246,"top_left_y":1882,"width":1493,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"812d0dcbcb6f44ff8c7304421a3cd545","type":"text","conversion_output":true,"text":"The treatment period is planned until the necessary number of by adjudication confirmed","text_display":"\n\nThe treatment period is planned until the necessary number of by adjudication confirmed","confidence":1,"confidence_rate":1},{"cnt":[[244,1930],[1784,1930],[1784,1981],[244,1981]],"region":{"top_left_x":244,"top_left_y":1930,"width":1541,"height":51},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eaaacf6d18364400aa546797ae10771c","type":"text","conversion_output":true,"text":"primary endpoint events is observed, to demonstrate non-inferiority of linagliptin compared","text_display":" primary endpoint events is observed, to demonstrate non-inferiority of linagliptin compared","confidence":1,"confidence_rate":1},{"cnt":[[244,1978],[1017,1978],[1017,2026],[244,2026]],"region":{"top_left_x":244,"top_left_y":1978,"width":773,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4bac0e55cf5e4ab5b59167981c00673f","type":"text","conversion_output":true,"text":"to placebo when added on to standard of care.","text_display":" to placebo when added on to standard of care.","confidence":1,"confidence_rate":1},{"cnt":[[247,2067],[1775,2067],[1775,2118],[247,2118]],"region":{"top_left_x":246,"top_left_y":2067,"width":1529,"height":51},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73d70fe96a6d4038bc43af6922e853c3","type":"text","conversion_output":true,"text":"Treatment with linagliptin will be compared against placebo. The treatment goal for \\(HbA _{1 c }\\)","text_display":"\n\nTreatment with linagliptin will be compared against placebo. The treatment goal for \\(HbA _{1 c }\\)","confidence":0.87744140625,"confidence_rate":0.998767316046067},{"cnt":[[247,2115],[1816,2115],[1816,2163],[247,2163]],"region":{"top_left_x":246,"top_left_y":2115,"width":1571,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b823d3f0c07f4eafb65db7e992213405","type":"text","conversion_output":true,"text":"in this trial, according to most international guidelines, will be a target of \\(\\leq 7.0 \\%\\), using open-","text_display":" in this trial, according to most international guidelines, will be a target of \\(\\leq 7.0 \\%\\), using open","confidence":1,"confidence_rate":1},{"cnt":[[247,2166],[1629,2166],[1629,2214],[247,2214]],"region":{"top_left_x":246,"top_left_y":2165,"width":1383,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03a70e4a2e134c94bcbe3408ae987eae","type":"text","conversion_output":true,"text":"label titration and addition of non-study therapies in both arms to achieve this goal","text_display":"label titration and addition of non-study therapies in both arms to achieve this goal","confidence":1,"confidence_rate":1},{"cnt":[[244,2211],[1775,2211],[1775,2259],[244,2259]],"region":{"top_left_x":244,"top_left_y":2211,"width":1531,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80221535a0a74ea185889b554832ea2d","type":"text","conversion_output":true,"text":"throughout the trial. During the trial, additional therapy will be allowed, and encouraged, if","text_display":" throughout the trial. During the trial, additional therapy will be allowed, and encouraged, if","confidence":1,"confidence_rate":1},{"cnt":[[247,2262],[1677,2262],[1677,2310],[247,2310]],"region":{"top_left_x":246,"top_left_y":2261,"width":1431,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"701e174c61594ab7a6a396302fd80ef3","type":"text","conversion_output":true,"text":"\\(HbA _{1 c }>7.5 \\%\\) during the trial treatment phase in accordance with guidelines. This is","text_display":" \\(HbA _{1 c }>7.5 \\%\\) during the trial treatment phase in accordance with guidelines. This is","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[247,2307],[1748,2307],[1748,2355],[247,2355]],"region":{"top_left_x":246,"top_left_y":2307,"width":1502,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2073f6d1180340b2a221e416e5a4bdd5","type":"text","conversion_output":true,"text":"considered important to ensure that an optimal level of standard of care is reached in both","text_display":" considered important to ensure that an optimal level of standard of care is reached in both","confidence":1,"confidence_rate":1},{"cnt":[[247,2357],[1812,2357],[1812,2405],[247,2405]],"region":{"top_left_x":246,"top_left_y":2357,"width":1566,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5094d583195e416a94ad17e424142b94","type":"text","conversion_output":true,"text":"arms of the trial. However, the decision to titrate or initiate medication to optimize glycaemic","text_display":" arms of the trial. However, the decision to titrate or initiate medication to optimize glycaemic","confidence":1,"confidence_rate":1},{"cnt":[[247,2403],[1812,2403],[1812,2453],[247,2453]],"region":{"top_left_x":246,"top_left_y":2403,"width":1566,"height":51},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b5e159a40874316b395dfeb85490575","type":"text","conversion_output":true,"text":"control will remain with the investigator and the patients' health care providers in accordance","text_display":" control will remain with the investigator and the patients' health care providers in accordance","confidence":1,"confidence_rate":1},{"cnt":[[247,2453],[975,2453],[975,2501],[247,2501]],"region":{"top_left_x":246,"top_left_y":2453,"width":730,"height":49},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b749ce6cf584b8ba5bdbd6d841d67ed","type":"text","conversion_output":true,"text":"with appropriate local treatment guidelines.","text_display":" with appropriate local treatment guidelines.","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"580cf20d103a426b9c8905ef0dabcef5","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99462890625,"confidence_rate":0.9998717803653021},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9e16ebd2b2ab42c681f9b8291962a2af","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":50,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c09bb32baff449998413fdcf254a2453","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-028","page":28,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5e8b82921144a609809a89c98305417","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3282f1d8568346ceb94e3925e5417ccb","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa4458a0d57947469c14b3dd0dd8a605","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22ab2e1e0c6f4435a058e5faf81535d0","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c2c7d304c4c4136ad6c1091fc3497fa","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f0cf4c83e504a75ab155e51d67d1487","type":"page_info","conversion_output":false,"text":"Page 28 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1802,338],[1802,386],[244,386]],"region":{"top_left_x":244,"top_left_y":338,"width":1559,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6576308a095a47a3b55f661546b7e4f1","type":"text","conversion_output":true,"text":"The protocol also encourages the investigators and the patients' health care providers to treat","text_display":"\n\nThe protocol also encourages the investigators and the patients' health care providers to treat","confidence":1,"confidence_rate":1},{"cnt":[[244,388],[1761,388],[1761,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1518,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bedffc9bcbcc4e13806b6a8881b74251","type":"text","conversion_output":true,"text":"all other CV risk factors (e.g. lipid levels, blood pressure, albuminuria, unhealthy lifestyle,","text_display":" all other CV risk factors (e.g. lipid levels, blood pressure, albuminuria, unhealthy lifestyle,","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1780,434],[1780,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1534,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d5dcd04e60394aff993d6215d90d26ac","type":"text","conversion_output":true,"text":"smoking) according to an optimal level of local/regional standard of care. In a high CV risk","text_display":" smoking) according to an optimal level of local/regional standard of care. In a high CV risk","confidence":1,"confidence_rate":1},{"cnt":[[244,484],[1757,484],[1757,532],[244,532]],"region":{"top_left_x":244,"top_left_y":484,"width":1513,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f80ba30a02e647a69b084532d6d15225","type":"text","conversion_output":true,"text":"population with renal impairment (i.e., albuminuria or eGFR [modification of diet in renal","text_display":" population with renal impairment (i.e., albuminuria or eGFR [modification of diet in renal","confidence":0.9975595474243164,"confidence_rate":0.99997427995883},{"cnt":[[244,525],[1684,525],[1684,580],[244,580]],"region":{"top_left_x":244,"top_left_y":525,"width":1440,"height":56},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"257a67a002d54148844a69bddaa80536","type":"text","conversion_output":true,"text":"disease (MDRD) formula] \\(15-75 mL / min / 1.73 m^{2}\\) ), this usually implies liberal use (if","text_display":" disease (MDRD) formula] \\(15-75 mL / min / 1.73 m^{2}\\) ), this usually implies liberal use (if","confidence":0.9990236759185791,"confidence_rate":0.9999907849387211},{"cnt":[[244,578],[1786,578],[1786,628],[244,628]],"region":{"top_left_x":244,"top_left_y":577,"width":1543,"height":52},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"377489b50b924e98ba6ec592de5907ec","type":"text","conversion_output":true,"text":"tolerated or not contraindicated) of statins, beta-blockers, calcium channel blockers, platelet","text_display":" tolerated or not contraindicated) of statins, beta-blockers, calcium channel blockers, platelet","confidence":1,"confidence_rate":1},{"cnt":[[244,626],[1706,626],[1706,678],[244,678]],"region":{"top_left_x":244,"top_left_y":625,"width":1463,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2dc3b62ed602466394048fc3f0826ca8","type":"text","conversion_output":true,"text":"inhibitors etc. This should be conducted in the context of local or regional guidance for","text_display":" inhibitors etc. This should be conducted in the context of local or regional guidance for","confidence":1,"confidence_rate":1},{"cnt":[[244,672],[948,672],[948,724],[244,724]],"region":{"top_left_x":244,"top_left_y":671,"width":705,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8155fa2338a48ccba112eba3c943fcc","type":"text","conversion_output":true,"text":"primary or secondary CV risk prevention.","text_display":" primary or secondary CV risk prevention.","confidence":1,"confidence_rate":1},{"cnt":[[247,763],[1620,763],[1620,813],[247,813]],"region":{"top_left_x":246,"top_left_y":762,"width":1374,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3c2f6306316439c9d2aa36f3dac1a7d","type":"text","conversion_output":true,"text":"As in management of any patient with diabetic nephropathy and hypertension, the","text_display":"\n\nAs in management of any patient with diabetic nephropathy and hypertension, the","confidence":1,"confidence_rate":1},{"cnt":[[244,811],[1757,811],[1757,861],[244,861]],"region":{"top_left_x":244,"top_left_y":810,"width":1513,"height":52},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"723994edca644b3b9772014fa5ac9667","type":"text","conversion_output":true,"text":"investigator may consider referral to a physician experienced in the care of kidney disease","text_display":" investigator may consider referral to a physician experienced in the care of kidney disease","confidence":1,"confidence_rate":1},{"cnt":[[244,859],[1798,859],[1798,909],[244,909]],"region":{"top_left_x":244,"top_left_y":858,"width":1554,"height":52},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5190d7b2a52945a4a5939ca303842ce1","type":"text","conversion_output":true,"text":"and hypertension for uncertainty about treatment. In particular it is expected that the patients","text_display":" and hypertension for uncertainty about treatment. In particular it is expected that the patients","confidence":1,"confidence_rate":1},{"cnt":[[247,909],[1661,909],[1661,957],[247,957]],"region":{"top_left_x":246,"top_left_y":909,"width":1415,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29cc62700af141358ccd10984a9771d7","type":"text","conversion_output":true,"text":"at least are treated with either an angiotensin converting enzyme inhibitor (ACEi) or","text_display":" at least are treated with either an angiotensin converting enzyme inhibitor (ACEi) or","confidence":1,"confidence_rate":1},{"cnt":[[244,955],[1798,955],[1798,1007],[244,1007]],"region":{"top_left_x":244,"top_left_y":954,"width":1554,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6bd62a94ef494ac7b36d834b5d13173d","type":"text","conversion_output":true,"text":"angiotensin receptor blocker (ARB) therapy (if one class is not tolerated, the other should be","text_display":" angiotensin receptor blocker (ARB) therapy (if one class is not tolerated, the other should be","confidence":0.9863345623016357,"confidence_rate":0.9998610231000641},{"cnt":[[244,1001],[1722,1001],[1722,1053],[244,1053]],"region":{"top_left_x":244,"top_left_y":1000,"width":1479,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"df69b0a7756e4a9a911046b9f3143342","type":"text","conversion_output":true,"text":"substituted) and that the target blood pressure (BP) goal is \\(<130 / 80 mmHg\\). When ACE","text_display":" substituted) and that the target blood pressure (BP) goal is \\(<130 / 80 mmHg\\). When ACE","confidence":0.9970703125,"confidence_rate":0.9999687878548241},{"cnt":[[247,1051],[1674,1051],[1674,1101],[247,1101]],"region":{"top_left_x":246,"top_left_y":1050,"width":1429,"height":52},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51abd6cc50f54b9098e6f027866ac50c","type":"text","conversion_output":true,"text":"inhibitors, ARBs, or diuretics are used, additional monitoring apart from the 24 week","text_display":" inhibitors, ARBs, or diuretics are used, additional monitoring apart from the 24 week","confidence":1,"confidence_rate":1},{"cnt":[[244,1099],[1597,1099],[1597,1149],[244,1149]],"region":{"top_left_x":244,"top_left_y":1098,"width":1353,"height":52},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4385ba43a9b14379b9db1604d57f8093","type":"text","conversion_output":true,"text":"assessments in the protocol of serum creatinine, is at the investigators discretion.","text_display":" assessments in the protocol of serum creatinine, is at the investigators discretion.","confidence":1,"confidence_rate":1},{"cnt":[[244,1195],[1775,1195],[1775,1245],[244,1245]],"region":{"top_left_x":244,"top_left_y":1194,"width":1531,"height":51},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"466d353824154fe0b3a32e44047f8692","type":"text","conversion_output":true,"text":"The background medication will not be provided as part of the clinical trial supplies, unless","text_display":"\n\nThe background medication will not be provided as part of the clinical trial supplies, unless","confidence":1,"confidence_rate":1},{"cnt":[[244,1243],[1706,1243],[1706,1291],[244,1291]],"region":{"top_left_x":244,"top_left_y":1242,"width":1463,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b2ad7cb857e4b56899c4808667a86d7","type":"text","conversion_output":true,"text":"required by local laws and regulations. The investigator can adjust the antihypertensive","text_display":" required by local laws and regulations. The investigator can adjust the antihypertensive","confidence":1,"confidence_rate":1},{"cnt":[[244,1291],[1761,1291],[1761,1341],[244,1341]],"region":{"top_left_x":244,"top_left_y":1290,"width":1518,"height":51},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cd797c2570242f5955ad2c19e5218e4","type":"text","conversion_output":true,"text":"therapy, or other needed therapy, according to local and international recommendations, if","text_display":" therapy, or other needed therapy, according to local and international recommendations, if","confidence":1,"confidence_rate":1},{"cnt":[[244,1339],[1245,1339],[1245,1387],[244,1387]],"region":{"top_left_x":244,"top_left_y":1338,"width":1001,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9cf226d159d64435b2ca6838456be7c1","type":"text","conversion_output":true,"text":"better BP control is warranted during the course of the trial.","text_display":" better BP control is warranted during the course of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[240,1421],[1156,1421],[1156,1476],[240,1476]],"region":{"top_left_x":239,"top_left_y":1420,"width":917,"height":56},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8442819eb73343009a0a5705210a1884","type":"section_header","conversion_output":false,"children_ids":["25495a8ae9034b378956e41ad8be1fb3"],"text":"","text_display":""},{"cnt":[[247,1428],[1154,1428],[1154,1473],[247,1473]],"region":{"top_left_x":246,"top_left_y":1427,"width":908,"height":47},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25495a8ae9034b378956e41ad8be1fb3","type":"text","conversion_output":true,"parent_id":"8442819eb73343009a0a5705210a1884","text":"3.3 SELECTION OF TRIAL POPULATION","text_display":"\n\n\\subsection*{3.3 SELECTION OF TRIAL POPULATION}","confidence":1,"confidence_rate":1},{"cnt":[[244,1517],[1688,1517],[1688,1565],[244,1565]],"region":{"top_left_x":244,"top_left_y":1516,"width":1445,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a0c65e82f7c464793a0e7dcde2e30f1","type":"text","conversion_output":true,"text":"An appropriate number of patients will be screened (synonym enrolled) for the trial in","text_display":"\n\nAn appropriate number of patients will be screened (synonym enrolled) for the trial in","confidence":1,"confidence_rate":1},{"cnt":[[247,1565],[1793,1565],[1793,1615],[247,1615]],"region":{"top_left_x":246,"top_left_y":1564,"width":1548,"height":52},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f67b626b2974538aeaaf5aa9b52a923","type":"text","conversion_output":true,"text":"approximately 600 study centres in up to 35 countries to ensure that an estimated 83007000","text_display":" approximately 600 study centres in up to 35 countries to ensure that an estimated 83007000","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[244,1613],[1748,1613],[1748,1665],[244,1665]],"region":{"top_left_x":244,"top_left_y":1612,"width":1504,"height":54},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61363e091d2c42f7af83147dc0b91f98","type":"text","conversion_output":true,"text":"patients are randomized ( 41503500 to each treatment group) and evaluable. Investigators","text_display":" patients are randomized ( 41503500 to each treatment group) and evaluable. Investigators","confidence":0.9770617485046387,"confidence_rate":0.9997583060170484},{"cnt":[[247,1663],[1711,1663],[1711,1711],[247,1711]],"region":{"top_left_x":246,"top_left_y":1663,"width":1465,"height":48},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"33a7ef768d774d218577090cc5193d4b","type":"text","conversion_output":true,"text":"who fail to randomize at least one study subject in the first 12 weeks of the trial may be","text_display":" who fail to randomize at least one study subject in the first 12 weeks of the trial may be","confidence":1,"confidence_rate":1},{"cnt":[[247,1709],[1693,1709],[1693,1759],[247,1759]],"region":{"top_left_x":246,"top_left_y":1708,"width":1447,"height":51},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ce60e71ff8d4c13948a717ecded8ff6","type":"text","conversion_output":true,"text":"excluded from further participation. If enrolment is delayed, additional centres may be","text_display":" excluded from further participation. If enrolment is delayed, additional centres may be","confidence":1,"confidence_rate":1},{"cnt":[[247,1759],[400,1759],[400,1800],[247,1800]],"region":{"top_left_x":246,"top_left_y":1758,"width":154,"height":43},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12b2165db73e49bba2ea42688d370509","type":"text","conversion_output":true,"text":"initiated.","text_display":" initiated.","confidence":1,"confidence_rate":1},{"cnt":[[247,1846],[1743,1846],[1743,1896],[247,1896]],"region":{"top_left_x":246,"top_left_y":1845,"width":1497,"height":52},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ac6cbf89f4d4231a9d0bfb601674a8e","type":"text","conversion_output":true,"text":"Screening of patients for this trial is competitive, i.e. screening for the trial will stop at all","text_display":"\n\nScreening of patients for this trial is competitive, i.e. screening for the trial will stop at all","confidence":0.98193359375,"confidence_rate":0.9998230098744381},{"cnt":[[247,1896],[1674,1896],[1674,1944],[247,1944]],"region":{"top_left_x":246,"top_left_y":1896,"width":1429,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1505390ca6c3458782646e6141ca450a","type":"text","conversion_output":true,"text":"centres when a sufficient number of patients have been randomized to trial treatment.","text_display":" centres when a sufficient number of patients have been randomized to trial treatment.","confidence":1,"confidence_rate":1},{"cnt":[[244,1942],[1770,1942],[1770,1994],[244,1994]],"region":{"top_left_x":244,"top_left_y":1941,"width":1527,"height":54},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34435e7709e244eba8b3a17f81ccb646","type":"text","conversion_output":true,"text":"Investigators will be notified when screening is complete and will not be allowed to recruit","text_display":" Investigators will be notified when screening is complete and will not be allowed to recruit","confidence":1,"confidence_rate":1},{"cnt":[[247,1992],[1679,1992],[1679,2040],[247,2040]],"region":{"top_left_x":246,"top_left_y":1991,"width":1434,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61c699a300b24a48a1c715c70dea3ee1","type":"text","conversion_output":true,"text":"additional patients thereafter. Patients who have completed visit 1 procedures prior to","text_display":" additional patients thereafter. Patients who have completed visit 1 procedures prior to","confidence":1,"confidence_rate":1},{"cnt":[[244,2038],[1825,2038],[1825,2088],[244,2088]],"region":{"top_left_x":244,"top_left_y":2037,"width":1582,"height":51},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a412245e9aa4a69bf077c781b66e13c","type":"text","conversion_output":true,"text":"notification of the termination of recruitment will be allowed to be randomized in the study, if","text_display":" notification of the termination of recruitment will be allowed to be randomized in the study, if","confidence":1,"confidence_rate":1},{"cnt":[[244,2086],[1748,2086],[1748,2136],[244,2136]],"region":{"top_left_x":244,"top_left_y":2085,"width":1504,"height":51},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"536e89b7913c4d01a3c8079a9ea1754c","type":"text","conversion_output":true,"text":"they meet all eligibility criteria. Subject eligibility will be based upon a complete medical","text_display":" they meet all eligibility criteria. Subject eligibility will be based upon a complete medical","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[244,2134],[1706,2134],[1706,2184],[244,2184]],"region":{"top_left_x":244,"top_left_y":2133,"width":1463,"height":51},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a22565de39c49a6a2b7d6ae7d0c1647","type":"text","conversion_output":true,"text":"history including a physical examination and clinical laboratory tests. Judgement of the","text_display":" history including a physical examination and clinical laboratory tests. Judgement of the","confidence":1,"confidence_rate":1},{"cnt":[[247,2184],[1604,2184],[1604,2232],[247,2232]],"region":{"top_left_x":246,"top_left_y":2183,"width":1358,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f7c5e834ed44e579851ab8c10adf209","type":"text","conversion_output":true,"text":"clinical relevance of a concomitant disease is at the discretion of the investigator.","text_display":" clinical relevance of a concomitant disease is at the discretion of the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[247,2271],[1348,2271],[1348,2323],[247,2323]],"region":{"top_left_x":246,"top_left_y":2270,"width":1102,"height":54},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"321d5159e2c84a03a3e58bfa20804c9e","type":"text","conversion_output":true,"text":"Re-screening and/or re-testing (of assessments) is permitted once.","text_display":"\n\nRe-screening and/or re-testing (of assessments) is permitted once.","confidence":0.99853515625,"confidence_rate":0.9999793534852197},{"cnt":[[244,2362],[1716,2362],[1716,2410],[244,2410]],"region":{"top_left_x":244,"top_left_y":2362,"width":1472,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f82b24857bd46f098b9280506bce16c","type":"text","conversion_output":true,"text":"A log of all patients included into the study (i.e. having given informed consent) will be","text_display":"\nA log of all patients included into the study (i.e. having given informed consent) will be","confidence":0.8405637741088867,"confidence_rate":0.9981734338627146},{"cnt":[[244,2408],[1802,2408],[1802,2460],[244,2460]],"region":{"top_left_x":244,"top_left_y":2407,"width":1559,"height":54},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be6fb869d7df450d91cf8a746ea657bc","type":"text","conversion_output":true,"text":"maintained in the investigator site file (ISF) at the investigational site irrespective of whether","text_display":" maintained in the investigator site file (ISF) at the investigational site irrespective of whether","confidence":1,"confidence_rate":1},{"cnt":[[247,2458],[1172,2458],[1172,2506],[247,2506]],"region":{"top_left_x":246,"top_left_y":2457,"width":926,"height":49},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8609bb1fba2f40aa928df8aa93557677","type":"text","conversion_output":true,"text":"they have been treated with investigational drug or not.","text_display":" they have been treated with investigational drug or not.","confidence":1,"confidence_rate":1},{"cnt":[[793,2584],[1300,2584],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2583,"width":508,"height":38},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8e2d81bba1a3447280d10e526ee12556","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"718c2b7438844d31b0b7d7b5e8997b0a","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7c806a1ad63146b1a8b687130e8a39eb","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-029","page":29,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e58965832cc4fc69a9b3a06cc3ed942","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b54cd1635df4d26bc9de9e938586576","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af565fc2ec494893beb05a88b78d5e1b","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7360e59dec348eba8380dc517afa4dd","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf34ca1e931843d3825e762515ab4fc7","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a980a0ce5c94037a0ff694650200838","type":"page_info","conversion_output":false,"text":"Page 29 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[925,338],[925,391],[242,391]],"region":{"top_left_x":242,"top_left_y":338,"width":684,"height":53},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7898f6f3bf0d4764a3251552147b6ef8","type":"section_header","conversion_output":false,"children_ids":["323be57f32b74d6c8834d7ad26f6b6de"],"text":"","text_display":""},{"cnt":[[247,343],[921,343],[921,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":675,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"323be57f32b74d6c8834d7ad26f6b6de","type":"text","conversion_output":true,"parent_id":"7898f6f3bf0d4764a3251552147b6ef8","text":"3.3.1 Main diagnosis for study entry","text_display":"\n\n\\subsection*{3.3.1 Main diagnosis for study entry}","confidence":1,"confidence_rate":1},{"cnt":[[247,429],[1812,429],[1812,477],[247,477]],"region":{"top_left_x":246,"top_left_y":429,"width":1566,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"41ab59f268a246bf8a0e8e48324e1f22","type":"text","conversion_output":true,"text":"Patients with documented diagnosis of T2DM at high risk of CV events and meeting all other","text_display":"\n\nPatients with documented diagnosis of T2DM at high risk of CV events and meeting all other","confidence":1,"confidence_rate":1},{"cnt":[[247,480],[1021,480],[1021,525],[247,525]],"region":{"top_left_x":246,"top_left_y":479,"width":776,"height":47},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"05deac9702c649708989c6c749e247eb","type":"text","conversion_output":true,"text":"eligibility criteria can be enrolled in the study.","text_display":" eligibility criteria can be enrolled in the study.","confidence":1,"confidence_rate":1},{"cnt":[[242,567],[720,567],[720,612],[242,612]],"region":{"top_left_x":242,"top_left_y":566,"width":478,"height":47},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6279b613b7894b6eb06a84fda31dccda","type":"section_header","conversion_output":false,"children_ids":["39cb41e4120a4b43bcde169a1a3b6d1f"],"text":"","text_display":""},{"cnt":[[247,569],[715,569],[715,610],[247,610]],"region":{"top_left_x":246,"top_left_y":568,"width":470,"height":42},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"39cb41e4120a4b43bcde169a1a3b6d1f","type":"text","conversion_output":true,"parent_id":"6279b613b7894b6eb06a84fda31dccda","text":"3.3.2 Inclusion criteria","text_display":"\n\n\\subsection*{3.3.2 Inclusion criteria}","confidence":1,"confidence_rate":1},{"cnt":[[249,658],[1300,658],[1300,706],[249,706]],"region":{"top_left_x":248,"top_left_y":657,"width":1052,"height":49},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"78d4897e2a1c4a9696669dd601ef8760","type":"text","conversion_output":true,"text":"1) Documented diagnosis of T2DM before visit 1 (screening).","text_display":"\n1) Documented diagnosis of T2DM before visit 1 (screening).","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[247,713],[1640,713],[1640,761],[247,761]],"region":{"top_left_x":246,"top_left_y":712,"width":1395,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4ae5c1cfe2b841c0bc1985dde805edf1","type":"text","conversion_output":true,"text":"2) Male or female patients who are drug-naïve or pre-treated with any antidiabetic","text_display":"\n2) Male or female patients who are drug-naïve or pre-treated with any antidiabetic","confidence":1,"confidence_rate":1},{"cnt":[[306,761],[1805,761],[1805,809],[306,809]],"region":{"top_left_x":306,"top_left_y":760,"width":1499,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"aa527f060d5e43a48564f8f232e7cc52","type":"text","conversion_output":true,"text":"background therapy, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors","text_display":" background therapy, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors","confidence":1,"confidence_rate":1},{"cnt":[[306,809],[1071,809],[1071,857],[306,857]],"region":{"top_left_x":306,"top_left_y":808,"width":766,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"452e884fe5484aa0a72b7c8fc9ef5162","type":"text","conversion_output":true,"text":"or SGLT-2 inhibitors if \\(\\geq 7\\) consecutive days.","text_display":" or SGLT-2 inhibitors if \\(\\geq 7\\) consecutive days.","confidence":1,"confidence_rate":1},{"cnt":[[247,863],[1757,863],[1757,911],[247,911]],"region":{"top_left_x":246,"top_left_y":863,"width":1511,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3286d70f3f4b4ec4835e4d7b98eeb66b","type":"text","conversion_output":true,"text":"3) Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks","text_display":"\n3) Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks","confidence":1,"confidence_rate":1},{"cnt":[[306,914],[1741,914],[1741,962],[306,962]],"region":{"top_left_x":306,"top_left_y":913,"width":1435,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"30c1eab597404333855db735727bbe9c","type":"text","conversion_output":true,"text":"prior to randomization. If insulin is part of the background therapy, the average daily","text_display":" prior to randomization. If insulin is part of the background therapy, the average daily","confidence":1,"confidence_rate":1},{"cnt":[[306,959],[1802,959],[1802,1007],[306,1007]],"region":{"top_left_x":306,"top_left_y":959,"width":1497,"height":49},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d2b267443e6042db9fbefd98d36c5d4c","type":"text","conversion_output":true,"text":"insulin dose should not have been changed by more than \\(10 \\%\\) within the 8 weeks prior to","text_display":" insulin dose should not have been changed by more than \\(10 \\%\\) within the 8 weeks prior to","confidence":0.98779296875,"confidence_rate":0.9998733879232882},{"cnt":[[306,1010],[1483,1010],[1483,1058],[306,1058]],"region":{"top_left_x":306,"top_left_y":1009,"width":1177,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b974228907594b238f0c7fca2cacbc75","type":"text","conversion_output":true,"text":"randomization compared with the daily insulin dose at randomization.","text_display":" randomization compared with the daily insulin dose at randomization.","confidence":1,"confidence_rate":1},{"cnt":[[247,1065],[1195,1065],[1195,1112],[247,1112]],"region":{"top_left_x":246,"top_left_y":1064,"width":949,"height":49},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1d66dcfc6a6d4a159dbe51c6cca96a42","type":"text","conversion_output":true,"text":"4) HbA 1 c of \\(\\geq 6.5 \\%\\) and \\(\\leq 10.0 \\%\\) at visit 1 (screening).","text_display":"\n4) HbA 1 c of \\(\\geq 6.5 \\%\\) and \\(\\leq 10.0 \\%\\) at visit 1 (screening).","confidence":0.9561367034912109,"confidence_rate":0.9994021203896869},{"cnt":[[247,1119],[1642,1119],[1642,1167],[247,1167]],"region":{"top_left_x":246,"top_left_y":1119,"width":1397,"height":49},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dd7888f7f5b543f69e5f841636af9a52","type":"text","conversion_output":true,"text":"5) Age \\(\\geq 18\\) years at visit 1 (screening). For Japan only: Age \\(\\geq 20\\) years at Visit 1.","text_display":"\n5) Age \\(\\geq 18\\) years at visit 1 (screening). For Japan only: Age \\(\\geq 20\\) years at Visit 1.","confidence":1,"confidence_rate":1},{"cnt":[[247,1174],[1282,1174],[1282,1229],[247,1229]],"region":{"top_left_x":246,"top_left_y":1174,"width":1036,"height":55},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4e374ada377f4cdaa0a56a3c5dec44c5","type":"text","conversion_output":true,"text":"6) Body Mass Index (BMI) \\(\\leq 45 kg / m ^{2}\\) at visit 1 (screening).","text_display":"\n6) Body Mass Index (BMI) \\(\\leq 45 kg / m ^{2}\\) at visit 1 (screening).","confidence":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[247,1236],[1761,1236],[1761,1284],[247,1284]],"region":{"top_left_x":246,"top_left_y":1235,"width":1516,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"843d7bf99f004d2bba1185fcee308446","type":"text","conversion_output":true,"text":"7) Signed and dated written informed consent by date of visit 1 (screening) in accordance","text_display":"\n7) Signed and dated written informed consent by date of visit 1 (screening) in accordance","confidence":1,"confidence_rate":1},{"cnt":[[306,1284],[1441,1284],[1441,1332],[306,1332]],"region":{"top_left_x":306,"top_left_y":1283,"width":1136,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0b309c60656841519602ed133521816a","type":"text","conversion_output":true,"text":"with GCP and local legislation prior to any study related procedure.","text_display":" with GCP and local legislation prior to any study related procedure.","confidence":1,"confidence_rate":1},{"cnt":[[247,1339],[939,1339],[939,1387],[247,1387]],"region":{"top_left_x":246,"top_left_y":1338,"width":693,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2f65f383213940308f9ff3bf3a52f648","type":"text","conversion_output":true,"text":"8) High risk of CV events (I and/or II):","text_display":"\n8) High risk of CV events (I and/or II):","confidence":1,"confidence_rate":1},{"cnt":[[244,1444],[1841,1444],[1841,2538],[244,2538]],"region":{"top_left_x":244,"top_left_y":1443,"width":1598,"height":1095},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"454688e39b7941feb4e13a3ec7662910","type":"table","conversion_output":true,"children_ids":["af24f485b9c64d43a440a5e68496c4b2","23b69109fe5144f5b121f8be21a526cf","c2950ce6c7fe491babced8bb6268b0d3","7937cf93fb0345a18a5a4dcd3e45ce62","6a15d253a6e244b3be3b7e9bf2146047","98ba4982d98646ca9c2d23b8cb7c061a","25299979d15342ae86dfeb1b1c07a9c2","455f90207c1c49d6b6f689cda78ad255","a7d55f8b7e754a458d91d5b66c1abc94","5ad072216054418d94c5c52c356023c4","2ad7061118a8401fbe8a28748302853e","e00ac586aef043fc942ae91cab28a934"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline I. & & Albuminuria (UACR \\(\\geq 3 0 ~ m g / g\\) creatinine or \\(\\geq 3 0 \\mu g / m i n\\) [microgram albumin per minute] or \\(\\geq 30 mg / 24 h\\) [milligram albumin per 24 hours] in two out of three unrelated spot urine or timed samples in the last 24 months prior to randomization)* AND previous macrovascular disease, defined as either one or more: \\\\\n\\hline & a & Confirmed history of MI (> 2 months prior to Visit 1) \\\\\n\\hline & b & \\begin{tabular}{l}\nAdvanced coronary artery disease, defined by any one of the following: \\\\\n- \\(\\geq 50 \\%\\) narrowing of the luminal diameter in 2 or more major coronary arteries by coronary angiography, MRI angiography or CT angiography; \\\\\nDefinition of major coronary arteries: LAD (Left Anterior Descending). CX (Circumflex) or RCA (right coronary artery) \\\\\n- Left main stem coronary artery with \\(\\geq 50 \\%\\) narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography; \\\\\n- Prior percutaneous or surgical revascularization of \\(\\geq 2\\) major coronary arteries at least 2 months prior to Visit 1 (screening); \\\\\n- The combination of prior percutaneous or surgical revascularization of 1 major coronary artery at least 2 months prior to visit 1 (screening), and \\(\\geq 50 \\%\\) narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography of at least 1 additional major coronary artery.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline I. & & Albuminuria (UACR \\(\\geq 3 0 ~ m g / g\\) creatinine or \\(\\geq 3 0 \\mu g / m i n\\) [microgram albumin per minute] or \\(\\geq 30 mg / 24 h\\) [milligram albumin per 24 hours] in two out of three unrelated spot urine or timed samples in the last 24 months prior to randomization)* AND previous macrovascular disease, defined as either one or more: \\\\\n\\hline & a & Confirmed history of MI (> 2 months prior to Visit 1) \\\\\n\\hline & b & \\begin{tabular}{l}\nAdvanced coronary artery disease, defined by any one of the following: \\\\\n- \\(\\geq 50 \\%\\) narrowing of the luminal diameter in 2 or more major coronary arteries by coronary angiography, MRI angiography or CT angiography; \\\\\nDefinition of major coronary arteries: LAD (Left Anterior Descending). CX (Circumflex) or RCA (right coronary artery) \\\\\n- Left main stem coronary artery with \\(\\geq 50 \\%\\) narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography; \\\\\n- Prior percutaneous or surgical revascularization of \\(\\geq 2\\) major coronary arteries at least 2 months prior to Visit 1 (screening); \\\\\n- The combination of prior percutaneous or surgical revascularization of 1 major coronary artery at least 2 months prior to visit 1 (screening), and \\(\\geq 50 \\%\\) narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography of at least 1 additional major coronary artery.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.6086297878016335,"confidence_rate":0.9997887898203712},{"cnt":[[306,1443],[343,1443],[343,2537],[306,2537]],"region":{"top_left_x":306,"top_left_y":1443,"width":38,"height":1094},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af24f485b9c64d43a440a5e68496c4b2","type":"table_column","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"","text_display":""},{"cnt":[[345,1443],[384,1443],[384,2537],[345,2537]],"region":{"top_left_x":345,"top_left_y":1443,"width":40,"height":1094},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23b69109fe5144f5b121f8be21a526cf","type":"table_column","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"","text_display":""},{"cnt":[[398,1443],[1817,1443],[1817,2539],[398,2539]],"region":{"top_left_x":398,"top_left_y":1443,"width":1419,"height":1096},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2950ce6c7fe491babced8bb6268b0d3","type":"table_column","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"","text_display":""},{"cnt":[[244,1450],[1842,1450],[1842,1641],[244,1641]],"region":{"top_left_x":244,"top_left_y":1449,"width":1598,"height":193},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7937cf93fb0345a18a5a4dcd3e45ce62","type":"table_row","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"","text_display":""},{"cnt":[[244,1648],[1842,1648],[1842,1699],[244,1699]],"region":{"top_left_x":244,"top_left_y":1647,"width":1598,"height":52},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a15d253a6e244b3be3b7e9bf2146047","type":"table_row","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"","text_display":""},{"cnt":[[244,1696],[1842,1696],[1842,2504],[244,2504]],"region":{"top_left_x":244,"top_left_y":1696,"width":1598,"height":809},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98ba4982d98646ca9c2d23b8cb7c061a","type":"table_row","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"","text_display":""},{"cnt":[[299,1443],[341,1443],[341,1494],[299,1494]],"region":{"top_left_x":299,"top_left_y":1443,"width":42,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25299979d15342ae86dfeb1b1c07a9c2","type":"simple_cell","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"I.","text_display":"I.","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[403,1455],[1803,1455],[1803,1639],[403,1639]],"region":{"top_left_x":402,"top_left_y":1454,"width":1401,"height":185},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"455f90207c1c49d6b6f689cda78ad255","type":"complex_cell","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","children_ids":["9e04c41fa9f94f87b6b069e37f9bf31f","1d10f2fccb134d568053af138a51ef06","3d11ba2aef174a688b873146911f7b2e","5c1ee46ed1034d3c87a12bc521d6d11d"],"text":"Albuminuria (UACR \\(\\geq 3 0 ~ m g / g\\) creatinine or \\(\\geq 3 0 \\mu g / m i n\\) [microgram albumin per minute] or \\(\\geq 30 mg / 24 h\\) [milligram albumin per 24 hours] in two out of three unrelated spot urine or timed samples in the last 24 months prior to randomization)* AND previous macrovascular disease, defined as either one or more:","text_display":"Albuminuria (UACR \\(\\geq 3 0 ~ m g / g\\) creatinine or \\(\\geq 3 0 \\mu g / m i n\\) [microgram albumin per minute] or \\(\\geq 30 mg / 24 h\\) [milligram albumin per 24 hours] in two out of three unrelated spot urine or timed samples in the last 24 months prior to randomization)* AND previous macrovascular disease, defined as either one or more:","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.6086297878016335,"confidence_rate":0.998736102967308},{"cnt":[[405,1457],[1766,1457],[1766,1503],[405,1503]],"region":{"top_left_x":405,"top_left_y":1456,"width":1361,"height":47},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e04c41fa9f94f87b6b069e37f9bf31f","type":"text","conversion_output":false,"parent_id":"455f90207c1c49d6b6f689cda78ad255","text":"Albuminuria (UACR \\(\\geq 3 0 ~ m g / g\\) creatinine or \\(\\geq 3 0 \\mu g / m i n\\) [microgram albumin per","text_display":"Albuminuria (UACR \\(\\geq 3 0 ~ m g / g\\) creatinine or \\(\\geq 3 0 \\mu g / m i n\\) [microgram albumin per","confidence":0.6086297878016335,"confidence_rate":0.9954129131711537},{"cnt":[[407,1503],[1674,1503],[1674,1547],[407,1547]],"region":{"top_left_x":407,"top_left_y":1502,"width":1267,"height":45},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d10f2fccb134d568053af138a51ef06","type":"text","conversion_output":false,"parent_id":"455f90207c1c49d6b6f689cda78ad255","text":"minute] or \\(\\geq 30 mg / 24 h\\) [milligram albumin per 24 hours] in two out of three","text_display":" minute] or \\(\\geq 30 mg / 24 h\\) [milligram albumin per 24 hours] in two out of three","confidence":0.9648773588705808,"confidence_rate":0.9996028091792455},{"cnt":[[407,1547],[1796,1547],[1796,1593],[407,1593]],"region":{"top_left_x":407,"top_left_y":1546,"width":1389,"height":47},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d11ba2aef174a688b873146911f7b2e","type":"text","conversion_output":false,"parent_id":"455f90207c1c49d6b6f689cda78ad255","text":"unrelated spot urine or timed samples in the last 24 months prior to randomization)*","text_display":" unrelated spot urine or timed samples in the last 24 months prior to randomization)*","confidence":0.994140625,"confidence_rate":0.9999361258608116},{"cnt":[[405,1590],[1529,1590],[1529,1634],[405,1634]],"region":{"top_left_x":405,"top_left_y":1590,"width":1124,"height":45},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c1ee46ed1034d3c87a12bc521d6d11d","type":"text","conversion_output":false,"parent_id":"455f90207c1c49d6b6f689cda78ad255","text":"AND previous macrovascular disease, defined as either one or more:","text_display":" AND previous macrovascular disease, defined as either one or more:","confidence":1,"confidence_rate":1},{"cnt":[[338,1648],[380,1648],[380,1692],[338,1692]],"region":{"top_left_x":338,"top_left_y":1647,"width":42,"height":45},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7d55f8b7e754a458d91d5b66c1abc94","type":"simple_cell","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"a","text_display":"a","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[405,1650],[1234,1650],[1234,1696],[405,1696]],"region":{"top_left_x":405,"top_left_y":1650,"width":830,"height":47},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ad072216054418d94c5c52c356023c4","type":"simple_cell","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"Confirmed history of MI (> 2 months prior to Visit 1)","text_display":"Confirmed history of MI (> 2 months prior to Visit 1)","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[338,1701],[380,1701],[380,1738],[338,1738]],"region":{"top_left_x":338,"top_left_y":1700,"width":42,"height":38},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ad7061118a8401fbe8a28748302853e","type":"simple_cell","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","text":"b","text_display":"b","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[403,1696],[1812,1696],[1812,2500],[403,2500]],"region":{"top_left_x":402,"top_left_y":1696,"width":1411,"height":804},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e00ac586aef043fc942ae91cab28a934","type":"complex_cell","conversion_output":false,"parent_id":"454688e39b7941feb4e13a3ec7662910","children_ids":["26cb5aba566a459f85ad68c3480d4b29","20601ed3d8954d48bdc1303a235c7606","95278f2c15214893b9ba7fabb6a37d65","889510af3a814a8ea1fa9aa31381e4c3","5620c6820c0a458199db005efea49088","5b5b74fe159145a5b574e0211a9b9f1b","7c274058658f4f9cb2e352b2fa79900c","209a6f04571d4dafbd6a536f52fb4c5d","e11ea55d56e74c1eb7d7960548255850","e31fae0614624de6a3121aae43af31bd","756bd92a0f194933902ffc4c9d955d5e","2ff0dc45e7ad4a158cdaca0aa0cb11e3","8feed491b6634380a17af5ebfc71e7fa"],"text":"\\begin{tabular}{l}\nAdvanced coronary artery disease, defined by any one of the following: \\\\\n- \\(\\geq 50 \\%\\) narrowing of the luminal diameter in 2 or more major coronary arteries by coronary angiography, MRI angiography or CT angiography; \\\\\nDefinition of major coronary arteries: LAD (Left Anterior Descending). CX (Circumflex) or RCA (right coronary artery) \\\\\n- Left main stem coronary artery with \\(\\geq 50 \\%\\) narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography; \\\\\n- Prior percutaneous or surgical revascularization of \\(\\geq 2\\) major coronary arteries at least 2 months prior to Visit 1 (screening); \\\\\n- The combination of prior percutaneous or surgical revascularization of 1 major coronary artery at least 2 months prior to visit 1 (screening), and \\(\\geq 50 \\%\\) narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography of at least 1 additional major coronary artery.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAdvanced coronary artery disease, defined by any one of the following: \\\\\n- \\(\\geq 50 \\%\\) narrowing of the luminal diameter in 2 or more major coronary arteries by coronary angiography, MRI angiography or CT angiography; \\\\\nDefinition of major coronary arteries: LAD (Left Anterior Descending). CX (Circumflex) or RCA (right coronary artery) \\\\\n- Left main stem coronary artery with \\(\\geq 50 \\%\\) narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography; \\\\\n- Prior percutaneous or surgical revascularization of \\(\\geq 2\\) major coronary arteries at least 2 months prior to Visit 1 (screening); \\\\\n- The combination of prior percutaneous or surgical revascularization of 1 major coronary artery at least 2 months prior to visit 1 (screening), and \\(\\geq 50 \\%\\) narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography of at least 1 additional major coronary artery.\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.99853515625,"confidence_rate":0.9999973015019848},{"cnt":[[405,1701],[1510,1701],[1510,1747],[405,1747]],"region":{"top_left_x":405,"top_left_y":1700,"width":1106,"height":47},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"26cb5aba566a459f85ad68c3480d4b29","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"Advanced coronary artery disease, defined by any one of the following:","text_display":"Advanced coronary artery disease, defined by any one of the following:","confidence":1,"confidence_rate":1},{"cnt":[[477,1788],[1794,1788],[1794,1837],[477,1837]],"region":{"top_left_x":476,"top_left_y":1788,"width":1318,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20601ed3d8954d48bdc1303a235c7606","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"- \\(\\geq 50 \\%\\) narrowing of the luminal diameter in 2 or more major coronary arteries by","text_display":"\n- \\(\\geq 50 \\%\\) narrowing of the luminal diameter in 2 or more major coronary arteries by","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[539,1834],[1485,1834],[1485,1880],[539,1880]],"region":{"top_left_x":538,"top_left_y":1834,"width":948,"height":47},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95278f2c15214893b9ba7fabb6a37d65","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"coronary angiography, MRI angiography or CT angiography;","text_display":" coronary angiography, MRI angiography or CT angiography;","confidence":1,"confidence_rate":1},{"cnt":[[539,1917],[1711,1917],[1711,1966],[539,1966]],"region":{"top_left_x":538,"top_left_y":1917,"width":1173,"height":49},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"889510af3a814a8ea1fa9aa31381e4c3","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"Definition of major coronary arteries: LAD (Left Anterior Descending). CX","text_display":"\nDefinition of major coronary arteries: LAD (Left Anterior Descending). CX","confidence":0.99853515625,"confidence_rate":0.9999812063601604},{"cnt":[[541,1966],[1229,1966],[1229,2012],[541,2012]],"region":{"top_left_x":541,"top_left_y":1965,"width":689,"height":47},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5620c6820c0a458199db005efea49088","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"(Circumflex) or RCA (right coronary artery)","text_display":" (Circumflex) or RCA (right coronary artery)","confidence":1,"confidence_rate":1},{"cnt":[[479,2053],[1794,2053],[1794,2099],[479,2099]],"region":{"top_left_x":478,"top_left_y":2053,"width":1316,"height":47},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b5b74fe159145a5b574e0211a9b9f1b","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"- Left main stem coronary artery with \\(\\geq 50 \\%\\) narrowing of the luminal diameter by","text_display":"\n- Left main stem coronary artery with \\(\\geq 50 \\%\\) narrowing of the luminal diameter by","confidence":1,"confidence_rate":1},{"cnt":[[539,2097],[1485,2097],[1485,2145],[539,2145]],"region":{"top_left_x":538,"top_left_y":2096,"width":948,"height":50},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c274058658f4f9cb2e352b2fa79900c","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"coronary angiography, MRI angiography or CT angiography;","text_display":" coronary angiography, MRI angiography or CT angiography;","confidence":1,"confidence_rate":1},{"cnt":[[479,2184],[1784,2184],[1784,2233],[479,2233]],"region":{"top_left_x":478,"top_left_y":2184,"width":1307,"height":49},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"209a6f04571d4dafbd6a536f52fb4c5d","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"- Prior percutaneous or surgical revascularization of \\(\\geq 2\\) major coronary arteries at","text_display":"\n- Prior percutaneous or surgical revascularization of \\(\\geq 2\\) major coronary arteries at","confidence":1,"confidence_rate":1},{"cnt":[[539,2230],[1195,2230],[1195,2277],[539,2277]],"region":{"top_left_x":538,"top_left_y":2230,"width":657,"height":47},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e11ea55d56e74c1eb7d7960548255850","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"least 2 months prior to Visit 1 (screening);","text_display":" least 2 months prior to Visit 1 (screening);","confidence":1,"confidence_rate":1},{"cnt":[[477,2318],[1757,2318],[1757,2366],[477,2366]],"region":{"top_left_x":476,"top_left_y":2317,"width":1281,"height":50},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e31fae0614624de6a3121aae43af31bd","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"- The combination of prior percutaneous or surgical revascularization of 1 major","text_display":"\n- The combination of prior percutaneous or surgical revascularization of 1 major","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[539,2359],[1812,2359],[1812,2408],[539,2408]],"region":{"top_left_x":538,"top_left_y":2359,"width":1275,"height":49},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"756bd92a0f194933902ffc4c9d955d5e","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"coronary artery at least 2 months prior to visit 1 (screening), and \\(\\geq 50 \\%\\) narrowing","text_display":" coronary artery at least 2 months prior to visit 1 (screening), and \\(\\geq 50 \\%\\) narrowing","confidence":1,"confidence_rate":1},{"cnt":[[539,2405],[1692,2405],[1692,2451],[539,2451]],"region":{"top_left_x":538,"top_left_y":2405,"width":1155,"height":47},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ff0dc45e7ad4a158cdaca0aa0cb11e3","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"of the luminal diameter by coronary angiography, MRI angiography or CT","text_display":" of the luminal diameter by coronary angiography, MRI angiography or CT","confidence":1,"confidence_rate":1},{"cnt":[[539,2449],[1439,2449],[1439,2495],[539,2495]],"region":{"top_left_x":538,"top_left_y":2449,"width":902,"height":47},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8feed491b6634380a17af5ebfc71e7fa","type":"text","conversion_output":false,"parent_id":"e00ac586aef043fc942ae91cab28a934","text":"angiography of at least 1 additional major coronary artery.","text_display":" angiography of at least 1 additional major coronary artery.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":57,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"406904883ff94b68b2ecfef08527f589","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":58,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"56abbc57b5db46f28b6cc677e75b3d4b","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":59,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e07e28b1a75b484d9506e9f0d9e0f5e4","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-030","page":30,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3002b9ce3c4e4d6fac96f9a5c26f0ca9","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,117],[1816,160],[1503,162]],"region":{"top_left_x":1502,"top_left_y":116,"width":315,"height":47},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee060f5b6a4543bb9a3f482a8d1f1835","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45d0d3194b0c43129065b093fb560fa0","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85e3971fb87c4712b641e23d631fb65d","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,247],[868,247]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":37},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3794a36348f045bda35242da8b1faae4","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5dbd1501f7db4a06be69ca197cfa8011","type":"page_info","conversion_output":false,"text":"Page 30 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1841,334],[1841,2495],[244,2495]],"region":{"top_left_x":244,"top_left_y":333,"width":1598,"height":2162},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3358d94d0fbf4a3d8ef498fd84349fe3","type":"table","conversion_output":true,"children_ids":["ccbd1914258e48e99e747dd418081824","45aa007ae5e54242b355f70d4bc632bc","334ff9d2e3fc4ac78b7ca314cbc173f0","669235803e4444dd986538f685756ddd","9e729212f35e444e93145b97c367c3a4","7a3d047507714430b4cc0b2a61b967e4","d3e0fa6f9f3945e490c0c884c50fae38","6ec1feb627014794b2387de13e4945cd","e1fcb37181aa4a7a8a2ceafe841db149","5bb55f46a27e4ea197ed0d6763901a43","c6bcb0d0110a4328b018a5d06676c84a","532cdca11dcb4560b8a8655e79922033","502391616e49401e96f6ff6a50e471d7","61b82021d08c4a2793aa673488e64e2a","04a774ed74c0436aa22089406f0a6d46","7243976347694cd1b8b131335aed1dc5","48dbfc8339bb425fb151467a02679376","509907fb149e4d0ba0bebb81b8cf099b"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline & c & \\begin{tabular}{l}\nHigh-risk single-vessel coronary artery disease, defined as the presence of \\(\\geq 50 \\%\\) narrowing of the luminal diameter of one major coronary artery by coronary angiography, MRI angiography or CT angiography in patients not revascularised: \\\\\nAND at least one of the following: \\\\\n- A positive non invasive stress test, confirmed by either: \\\\\n- a positive ECG exercise tolerance test in patients without left bundle branch block, Wolff-Parkinson-White syndrome, left ventricular hypertrophy with repolarization abnormality, or paced ventricular rhythm, atrial fibrillation in case of abnormal ST-T segments; \\\\\n- a positive stress echocardiogram showing induced regional systolic wall motion abnormalities; \\\\\n- a positive nuclear myocardial perfusion imaging stress test showing stressinduced reversible perfusion abnormality; \\\\\n- a positive cardiac stress perfusion MRI showing a stress induced perfusion defect; \\\\\n- Patient discharged from hospital with a documented diagnosis of unstable angina pectoris between 2 and 12 months prior to visit 1 (screening).\n\\end{tabular} \\\\\n\\hline & d & History of ischemic or haemorrhagic stroke (>3 months prior to visit 1) \\\\\n\\hline & e & \\begin{tabular}{l}\nPresence of carotid artery disease (symptomatic or not) documented by either: \\\\\n- imaging techniques with at least one lesion estimated to be \\(\\geq 50 \\%\\) narrowing of the luminal diameter; \\\\\n- prior percutaneous or surgical carotid revascularization.\n\\end{tabular} \\\\\n\\hline & f & \\begin{tabular}{l}\nPresence of peripheral artery disease documented by either: \\\\\n- previous limb angioplasty, stenting or bypass surgery; \\\\\n- previous limb or foot amputation due to macrocirculatory insufficiency; \\\\\n- angiographic evidence of peripheral artery stenosis \\(\\geq 50 \\%\\) narrowing of the luminal diameter in at least one limb (definition of peripheral artery: common iliac artery, internal iliac artery, external iliac artery, femoral artery, popliteal artery).\n\\end{tabular} \\\\\n\\hline II. & & \\begin{tabular}{l}\nEvidence of impaired renal function with predefined UACR, with or without CV comorbidities, defined as follows (and/or criteria): \\\\\n- Impaired renal function (as defined by MDRD formula) with an eGFR:15-<45 \\(mL / min / 1.73 m^{2}\\) at visit 1 (screening) with any UACR. \\\\\n- Impaired renal function (as defined by MDRD formula) with an eGFR \\(\\geq 45-75 mL / \\min / 1.73 m^{2}\\) at visit 1 (screening) with an UACR \\(>200 mg / g\\) creatinine or \\(>200 \\mu g / min\\) (microgram albumin per minute) or \\(>200 mg / 24 h\\) [milligram albumin per 24 hours] demonstrated in two out of three unrelated spot urine or timed samples in the last 24 months prior to randomization*.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline & c & \\begin{tabular}{l}\nHigh-risk single-vessel coronary artery disease, defined as the presence of \\(\\geq 50 \\%\\) narrowing of the luminal diameter of one major coronary artery by coronary angiography, MRI angiography or CT angiography in patients not revascularised: \\\\\nAND at least one of the following: \\\\\n- A positive non invasive stress test, confirmed by either: \\\\\n- a positive ECG exercise tolerance test in patients without left bundle branch block, Wolff-Parkinson-White syndrome, left ventricular hypertrophy with repolarization abnormality, or paced ventricular rhythm, atrial fibrillation in case of abnormal ST-T segments; \\\\\n- a positive stress echocardiogram showing induced regional systolic wall motion abnormalities; \\\\\n- a positive nuclear myocardial perfusion imaging stress test showing stressinduced reversible perfusion abnormality; \\\\\n- a positive cardiac stress perfusion MRI showing a stress induced perfusion defect; \\\\\n- Patient discharged from hospital with a documented diagnosis of unstable angina pectoris between 2 and 12 months prior to visit 1 (screening).\n\\end{tabular} \\\\\n\\hline & d & History of ischemic or haemorrhagic stroke (>3 months prior to visit 1) \\\\\n\\hline & e & \\begin{tabular}{l}\nPresence of carotid artery disease (symptomatic or not) documented by either: \\\\\n- imaging techniques with at least one lesion estimated to be \\(\\geq 50 \\%\\) narrowing of the luminal diameter; \\\\\n- prior percutaneous or surgical carotid revascularization.\n\\end{tabular} \\\\\n\\hline & f & \\begin{tabular}{l}\nPresence of peripheral artery disease documented by either: \\\\\n- previous limb angioplasty, stenting or bypass surgery; \\\\\n- previous limb or foot amputation due to macrocirculatory insufficiency; \\\\\n- angiographic evidence of peripheral artery stenosis \\(\\geq 50 \\%\\) narrowing of the luminal diameter in at least one limb (definition of peripheral artery: common iliac artery, internal iliac artery, external iliac artery, femoral artery, popliteal artery).\n\\end{tabular} \\\\\n\\hline II. & & \\begin{tabular}{l}\nEvidence of impaired renal function with predefined UACR, with or without CV comorbidities, defined as follows (and/or criteria): \\\\\n- Impaired renal function (as defined by MDRD formula) with an eGFR:15-<45 \\(mL / min / 1.73 m^{2}\\) at visit 1 (screening) with any UACR. \\\\\n- Impaired renal function (as defined by MDRD formula) with an eGFR \\(\\geq 45-75 mL / \\min / 1.73 m^{2}\\) at visit 1 (screening) with an UACR \\(>200 mg / g\\) creatinine or \\(>200 \\mu g / min\\) (microgram albumin per minute) or \\(>200 mg / 24 h\\) [milligram albumin per 24 hours] demonstrated in two out of three unrelated spot urine or timed samples in the last 24 months prior to randomization*.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.5846753120422363,"confidence_rate":0.9998985537168625},{"cnt":[[338,333],[340,2082],[340,2085],[338,2492],[333,2495],[301,2495],[296,2492],[294,2488],[290,413],[290,333]],"region":{"top_left_x":290,"top_left_y":333,"width":50,"height":2162},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ccbd1914258e48e99e747dd418081824","type":"table_column","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"","text_display":""},{"cnt":[[348,333],[348,338],[345,340],[345,342],[348,345],[348,420],[350,423],[350,448],[348,450],[348,455],[350,457],[350,464],[348,467],[348,476],[350,478],[350,485],[348,487],[348,515],[350,517],[350,522],[348,524],[348,531],[350,533],[350,538],[348,540],[348,552],[350,554],[350,561],[348,563],[348,570],[350,572],[350,575],[348,577],[348,607],[350,609],[350,612],[348,614],[348,644],[350,646],[350,651],[348,653],[348,660],[350,662],[350,667],[348,669],[348,678],[350,681],[350,688],[348,690],[348,699],[350,701],[350,704],[348,706],[348,736],[350,738],[350,741],[348,743],[348,754],[350,757],[350,759],[348,761],[348,770],[350,773],[350,780],[348,782],[348,789],[350,791],[350,796],[348,798],[348,828],[350,830],[348,833],[348,846],[350,849],[348,851],[348,865],[350,867],[350,869],[348,872],[348,902],[350,904],[350,909],[348,911],[348,918],[350,920],[350,925],[348,927],[348,994],[350,996],[350,1001],[348,1003],[348,1031],[350,1033],[350,1035],[348,1038],[348,1049],[350,1051],[350,1054],[348,1056],[348,1123],[350,1125],[350,1127],[348,1130],[348,1160],[350,1162],[350,1164],[348,1167],[348,1178],[350,1180],[350,1183],[348,1185],[348,1252],[350,1254],[350,1261],[348,1263],[348,1314],[345,1316],[345,1325],[348,1328],[348,1330],[345,1332],[345,1337],[348,1339],[348,1346],[350,1348],[348,1351],[348,1473],[350,1475],[350,1477],[348,1480],[348,1510],[350,1512],[350,1514],[348,1516],[348,1528],[350,1530],[350,1533],[348,1535],[348,1602],[350,1604],[350,1609],[348,1611],[348,1620],[350,1622],[350,1627],[348,1629],[348,1657],[350,1659],[350,1662],[348,1664],[348,1675],[350,1678],[350,1680],[348,1682],[348,1694],[350,1696],[350,1698],[348,1701],[348,1712],[350,1715],[350,1717],[348,1719],[348,1731],[350,1733],[350,1735],[348,1738],[348,1747],[350,1749],[350,1758],[348,1761],[348,1765],[350,1767],[350,1774],[348,1777],[348,1786],[350,1788],[350,1793],[348,1795],[348,1804],[350,1807],[350,1809],[348,1811],[348,1823],[350,1825],[350,1830],[348,1832],[348,1839],[350,1841],[350,1848],[348,1850],[348,1860],[350,1862],[350,1866],[348,1869],[348,1878],[350,1880],[350,1885],[348,1887],[348,1896],[350,1899],[350,1901],[348,1903],[348,1915],[350,1917],[350,1924],[348,1926],[348,1933],[350,1936],[350,1940],[348,1942],[348,1970],[350,1972],[350,1975],[348,1977],[348,2007],[350,2009],[350,2018],[348,2021],[348,2060],[350,2062],[350,2074],[348,2076],[348,2083],[350,2085],[350,2127],[348,2129],[348,2136],[350,2138],[350,2143],[348,2145],[348,2147],[350,2150],[350,2161],[348,2163],[348,2191],[350,2193],[350,2196],[348,2198],[348,2210],[350,2212],[350,2214],[348,2216],[348,2228],[350,2230],[350,2233],[348,2235],[348,2244],[350,2246],[350,2256],[348,2258],[348,2262],[350,2265],[350,2269],[348,2272],[348,2299],[350,2302],[350,2311],[348,2313],[348,2318],[350,2320],[350,2325],[348,2327],[348,2338],[350,2341],[350,2348],[348,2350],[348,2355],[350,2357],[350,2364],[348,2366],[348,2375],[350,2378],[350,2380],[348,2382],[348,2391],[350,2394],[350,2401],[348,2403],[348,2414],[350,2417],[348,2419],[348,2431],[350,2433],[350,2444],[348,2447],[348,2449],[350,2451],[348,2454],[348,2477],[350,2479],[350,2493],[352,2495],[382,2495],[384,2493],[384,2442],[382,2440],[384,2437],[384,2428],[382,2426],[382,2410],[380,2408],[380,2401],[382,2398],[382,2396],[380,2394],[380,2385],[382,2382],[382,2375],[380,2373],[380,2253],[382,2251],[382,2246],[380,2244],[380,2198],[382,2196],[382,2193],[380,2191],[380,2180],[382,2177],[382,2173],[380,2170],[380,2143],[382,2140],[382,2134],[380,2131],[380,2088],[382,2085],[382,2076],[380,2074],[382,2071],[382,2060],[380,2058],[380,2053],[382,2051],[382,2044],[380,2041],[380,1811],[382,1809],[382,1807],[380,1804],[380,1738],[382,1735],[382,1731],[380,1728],[380,1719],[382,1717],[382,1710],[380,1708],[380,1685],[382,1682],[382,1675],[380,1673],[380,1668],[382,1666],[382,1664],[384,1662],[384,1627],[382,1625],[382,1599],[380,1597],[380,1553],[382,1551],[382,1546],[380,1544],[380,1461],[382,1459],[382,1452],[380,1450],[380,1445],[382,1443],[382,1434],[380,1431],[380,1424],[382,1422],[382,1415],[380,1413],[380,1408],[382,1406],[382,1390],[384,1388],[384,1371],[382,1369],[384,1367],[384,1358],[382,1355],[382,1351],[384,1348],[384,1291],[382,1289],[382,1286],[380,1284],[380,1277],[382,1275],[382,1270],[380,1268],[380,1033],[378,1031],[378,1021],[380,1019],[380,902],[378,899],[378,893],[380,890],[380,773],[378,770],[378,764],[380,761],[380,676],[378,674],[378,671],[380,669],[380,467],[382,464],[382,462],[380,460],[380,432],[382,430],[382,420],[380,418],[380,414],[382,411],[382,402],[380,400],[380,395],[382,393],[382,377],[384,374],[384,361],[382,358],[382,340],[380,338],[380,333]],"region":{"top_left_x":345,"top_left_y":333,"width":40,"height":2163},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45aa007ae5e54242b355f70d4bc632bc","type":"table_column","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"","text_display":""},{"cnt":[[398,333],[1824,333],[1824,2495],[398,2495]],"region":{"top_left_x":398,"top_left_y":333,"width":1426,"height":2163},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"334ff9d2e3fc4ac78b7ca314cbc173f0","type":"table_column","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"","text_display":""},{"cnt":[[244,338],[1842,338],[1842,1312],[244,1312]],"region":{"top_left_x":244,"top_left_y":337,"width":1598,"height":975},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"669235803e4444dd986538f685756ddd","type":"table_row","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"","text_display":""},{"cnt":[[244,1300],[1842,1300],[1842,1353],[244,1353]],"region":{"top_left_x":244,"top_left_y":1300,"width":1598,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e729212f35e444e93145b97c367c3a4","type":"table_row","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"","text_display":""},{"cnt":[[244,1348],[1842,1348],[1842,1618],[244,1618]],"region":{"top_left_x":244,"top_left_y":1348,"width":1598,"height":270},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a3d047507714430b4cc0b2a61b967e4","type":"table_row","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"","text_display":""},{"cnt":[[244,1622],[1842,1622],[1842,2069],[244,2069]],"region":{"top_left_x":244,"top_left_y":1622,"width":1598,"height":448},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3e0fa6f9f3945e490c0c884c50fae38","type":"table_row","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"","text_display":""},{"cnt":[[244,2060],[1842,2060],[1842,2495],[244,2495]],"region":{"top_left_x":244,"top_left_y":2059,"width":1598,"height":437},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ec1feb627014794b2387de13e4945cd","type":"table_row","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"","text_display":""},{"cnt":[[338,333],[378,333],[378,377],[338,377]],"region":{"top_left_x":338,"top_left_y":333,"width":40,"height":44},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1fcb37181aa4a7a8a2ceafe841db149","type":"simple_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"c","text_display":"c","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[403,340],[1819,340],[1819,1305],[403,1305]],"region":{"top_left_x":402,"top_left_y":339,"width":1417,"height":966},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bb55f46a27e4ea197ed0d6763901a43","type":"complex_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","children_ids":["e0252c04c5e3475185a3962f08cc3bd8","795aa38a40154758afed1a463bf5ee8e","70020ea1c4dc4e35b74b99aeda54e1bc","b1c32534d3c1448188ee95179ed5f31c","9e696e26737c4ab3842fb96ed157debe","34e5efb8100045c9a61be368d062fd8b","48b026af4c8e48ffa68b3abab345a5bc","e5b2774374c243ae92ef93d709b8830b","294a2984d17f48cda1dc1bf251e5d3aa","c45ad7d0e0884f7fbfcfe65b5122e224","e9611c5657d04e21bf09048afe118725","ff76aeb8875b405a9946250df266916f","dd979167225e4019846b2c01f69cddce","4d7624ec46e145399e49bbcb9042e8d3","70f9f24417264e0f84530b7e154a288f","f23a9673d21d4ad5b612d963ac686158","efbb234ed80c46e7bc45978ec87bae50"],"text":"\\begin{tabular}{l}\nHigh-risk single-vessel coronary artery disease, defined as the presence of \\(\\geq 50 \\%\\) narrowing of the luminal diameter of one major coronary artery by coronary angiography, MRI angiography or CT angiography in patients not revascularised: \\\\\nAND at least one of the following: \\\\\n- A positive non invasive stress test, confirmed by either: \\\\\n- a positive ECG exercise tolerance test in patients without left bundle branch block, Wolff-Parkinson-White syndrome, left ventricular hypertrophy with repolarization abnormality, or paced ventricular rhythm, atrial fibrillation in case of abnormal ST-T segments; \\\\\n- a positive stress echocardiogram showing induced regional systolic wall motion abnormalities; \\\\\n- a positive nuclear myocardial perfusion imaging stress test showing stressinduced reversible perfusion abnormality; \\\\\n- a positive cardiac stress perfusion MRI showing a stress induced perfusion defect; \\\\\n- Patient discharged from hospital with a documented diagnosis of unstable angina pectoris between 2 and 12 months prior to visit 1 (screening).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nHigh-risk single-vessel coronary artery disease, defined as the presence of \\(\\geq 50 \\%\\) narrowing of the luminal diameter of one major coronary artery by coronary angiography, MRI angiography or CT angiography in patients not revascularised: \\\\\nAND at least one of the following: \\\\\n- A positive non invasive stress test, confirmed by either: \\\\\n- a positive ECG exercise tolerance test in patients without left bundle branch block, Wolff-Parkinson-White syndrome, left ventricular hypertrophy with repolarization abnormality, or paced ventricular rhythm, atrial fibrillation in case of abnormal ST-T segments; \\\\\n- a positive stress echocardiogram showing induced regional systolic wall motion abnormalities; \\\\\n- a positive nuclear myocardial perfusion imaging stress test showing stressinduced reversible perfusion abnormality; \\\\\n- a positive cardiac stress perfusion MRI showing a stress induced perfusion defect; \\\\\n- Patient discharged from hospital with a documented diagnosis of unstable angina pectoris between 2 and 12 months prior to visit 1 (screening).\n\\end{tabular}","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999996877235154},{"cnt":[[405,342],[1658,342],[1658,391],[405,391]],"region":{"top_left_x":405,"top_left_y":342,"width":1253,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0252c04c5e3475185a3962f08cc3bd8","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"High-risk single-vessel coronary artery disease, defined as the presence of \\(\\geq 50 \\%\\)","text_display":"High-risk single-vessel coronary artery disease, defined as the presence of \\(\\geq 50 \\%\\)","confidence":1,"confidence_rate":1},{"cnt":[[407,388],[1789,388],[1789,432],[407,432]],"region":{"top_left_x":407,"top_left_y":388,"width":1382,"height":45},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"795aa38a40154758afed1a463bf5ee8e","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"narrowing of the luminal diameter of one major coronary artery by coronary angiography,","text_display":" narrowing of the luminal diameter of one major coronary artery by coronary angiography,","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[407,432],[1453,432],[1453,478],[407,478]],"region":{"top_left_x":407,"top_left_y":432,"width":1046,"height":47},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70020ea1c4dc4e35b74b99aeda54e1bc","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"MRI angiography or CT angiography in patients not revascularised:","text_display":" MRI angiography or CT angiography in patients not revascularised:","confidence":1,"confidence_rate":1},{"cnt":[[405,517],[946,517],[946,561],[405,561]],"region":{"top_left_x":405,"top_left_y":517,"width":542,"height":44},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1c32534d3c1448188ee95179ed5f31c","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"AND at least one of the following:","text_display":"\nAND at least one of the following:","confidence":1,"confidence_rate":1},{"cnt":[[470,563],[1388,563],[1388,612],[470,612]],"region":{"top_left_x":469,"top_left_y":563,"width":920,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e696e26737c4ab3842fb96ed157debe","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"- A positive non invasive stress test, confirmed by either:","text_display":"\n- A positive non invasive stress test, confirmed by either:","confidence":1,"confidence_rate":1},{"cnt":[[594,609],[1713,609],[1713,653],[594,653]],"region":{"top_left_x":593,"top_left_y":609,"width":1120,"height":45},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34e5efb8100045c9a61be368d062fd8b","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"- a positive ECG exercise tolerance test in patients without left bundle","text_display":"\n- a positive ECG exercise tolerance test in patients without left bundle","confidence":1,"confidence_rate":1},{"cnt":[[656,651],[1651,651],[1651,697],[656,697]],"region":{"top_left_x":656,"top_left_y":650,"width":995,"height":47},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48b026af4c8e48ffa68b3abab345a5bc","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"branch block, Wolff-Parkinson-White syndrome, left ventricular","text_display":" branch block, Wolff-Parkinson-White syndrome, left ventricular","confidence":1,"confidence_rate":1},{"cnt":[[656,697],[1798,697],[1798,741],[656,741]],"region":{"top_left_x":656,"top_left_y":696,"width":1143,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5b2774374c243ae92ef93d709b8830b","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"hypertrophy with repolarization abnormality, or paced ventricular rhythm,","text_display":" hypertrophy with repolarization abnormality, or paced ventricular rhythm,","confidence":1,"confidence_rate":1},{"cnt":[[658,741],[1480,741],[1480,787],[658,787]],"region":{"top_left_x":658,"top_left_y":740,"width":823,"height":47},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"294a2984d17f48cda1dc1bf251e5d3aa","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"atrial fibrillation in case of abnormal ST-T segments;","text_display":" atrial fibrillation in case of abnormal ST-T segments;","confidence":1,"confidence_rate":1},{"cnt":[[594,823],[1771,823],[1771,872],[594,872]],"region":{"top_left_x":593,"top_left_y":823,"width":1178,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c45ad7d0e0884f7fbfcfe65b5122e224","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"- a positive stress echocardiogram showing induced regional systolic wall","text_display":"\n- a positive stress echocardiogram showing induced regional systolic wall","confidence":1,"confidence_rate":1},{"cnt":[[656,869],[1002,869],[1002,913],[656,913]],"region":{"top_left_x":656,"top_left_y":869,"width":346,"height":45},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9611c5657d04e21bf09048afe118725","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"motion abnormalities;","text_display":" motion abnormalities;","confidence":1,"confidence_rate":1},{"cnt":[[594,955],[1807,955],[1807,1001],[594,1001]],"region":{"top_left_x":593,"top_left_y":954,"width":1215,"height":47},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff76aeb8875b405a9946250df266916f","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"- a positive nuclear myocardial perfusion imaging stress test showing stress-","text_display":"\n- a positive nuclear myocardial perfusion imaging stress test showing stress","confidence":1,"confidence_rate":1},{"cnt":[[658,998],[1305,998],[1305,1044],[658,1044]],"region":{"top_left_x":658,"top_left_y":998,"width":648,"height":47},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd979167225e4019846b2c01f69cddce","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"induced reversible perfusion abnormality;","text_display":"induced reversible perfusion abnormality;","confidence":1,"confidence_rate":1},{"cnt":[[596,1084],[1807,1084],[1807,1130],[596,1130]],"region":{"top_left_x":596,"top_left_y":1083,"width":1212,"height":47},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d7624ec46e145399e49bbcb9042e8d3","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"- a positive cardiac stress perfusion MRI showing a stress induced perfusion","text_display":"\n- a positive cardiac stress perfusion MRI showing a stress induced perfusion","confidence":1,"confidence_rate":1},{"cnt":[[658,1130],[767,1130],[767,1173],[658,1173]],"region":{"top_left_x":658,"top_left_y":1129,"width":109,"height":45},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70f9f24417264e0f84530b7e154a288f","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"defect;","text_display":" defect;","confidence":1,"confidence_rate":1},{"cnt":[[470,1217],[1780,1217],[1780,1261],[470,1261]],"region":{"top_left_x":469,"top_left_y":1217,"width":1311,"height":44},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f23a9673d21d4ad5b612d963ac686158","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"- Patient discharged from hospital with a documented diagnosis of unstable angina","text_display":"\n- Patient discharged from hospital with a documented diagnosis of unstable angina","confidence":1,"confidence_rate":1},{"cnt":[[530,1261],[1476,1261],[1476,1305],[530,1305]],"region":{"top_left_x":529,"top_left_y":1260,"width":947,"height":45},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"efbb234ed80c46e7bc45978ec87bae50","type":"text","conversion_output":false,"parent_id":"5bb55f46a27e4ea197ed0d6763901a43","text":"pectoris between 2 and 12 months prior to visit 1 (screening).","text_display":" pectoris between 2 and 12 months prior to visit 1 (screening).","confidence":1,"confidence_rate":1},{"cnt":[[355,1298],[382,1298],[382,1341],[355,1341]],"region":{"top_left_x":354,"top_left_y":1297,"width":29,"height":45},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6bcb0d0110a4328b018a5d06676c84a","type":"simple_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"d","text_display":"d","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[405,1305],[1503,1305],[1503,1351],[405,1351]],"region":{"top_left_x":405,"top_left_y":1304,"width":1099,"height":47},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"532cdca11dcb4560b8a8655e79922033","type":"simple_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"History of ischemic or haemorrhagic stroke (>3 months prior to visit 1)","text_display":"History of ischemic or haemorrhagic stroke (>3 months prior to visit 1)","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[355,1353],[378,1353],[378,1392],[355,1392]],"region":{"top_left_x":354,"top_left_y":1353,"width":24,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"502391616e49401e96f6ff6a50e471d7","type":"simple_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"e","text_display":"e","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[401,1351],[1669,1351],[1669,1615],[401,1615]],"region":{"top_left_x":400,"top_left_y":1350,"width":1270,"height":266},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61b82021d08c4a2793aa673488e64e2a","type":"complex_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","children_ids":["6c17cbd2283e405a8ddbc518c1eb8095","3ece4f7a65114f298cfc10ca2865aacf","516087b67b7845bd99d383fcd45fe26d","af9956a098f749adbf1a116d05f63184"],"text":"\\begin{tabular}{l}\nPresence of carotid artery disease (symptomatic or not) documented by either: \\\\\n- imaging techniques with at least one lesion estimated to be \\(\\geq 50 \\%\\) narrowing of the luminal diameter; \\\\\n- prior percutaneous or surgical carotid revascularization.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nPresence of carotid artery disease (symptomatic or not) documented by either: \\\\\n- imaging techniques with at least one lesion estimated to be \\(\\geq 50 \\%\\) narrowing of the luminal diameter; \\\\\n- prior percutaneous or surgical carotid revascularization.\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[405,1351],[1609,1351],[1609,1399],[405,1399]],"region":{"top_left_x":405,"top_left_y":1350,"width":1205,"height":50},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c17cbd2283e405a8ddbc518c1eb8095","type":"text","conversion_output":false,"parent_id":"61b82021d08c4a2793aa673488e64e2a","text":"Presence of carotid artery disease (symptomatic or not) documented by either:","text_display":"Presence of carotid artery disease (symptomatic or not) documented by either:","confidence":1,"confidence_rate":1},{"cnt":[[594,1434],[1665,1434],[1665,1482],[594,1482]],"region":{"top_left_x":593,"top_left_y":1433,"width":1072,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ece4f7a65114f298cfc10ca2865aacf","type":"text","conversion_output":false,"parent_id":"61b82021d08c4a2793aa673488e64e2a","text":"- imaging techniques with at least one lesion estimated to be \\(\\geq 50 \\%\\)","text_display":"\n- imaging techniques with at least one lesion estimated to be \\(\\geq 50 \\%\\)","confidence":1,"confidence_rate":1},{"cnt":[[656,1481],[1200,1478],[1200,1526],[656,1528]],"region":{"top_left_x":655,"top_left_y":1478,"width":545,"height":51},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"516087b67b7845bd99d383fcd45fe26d","type":"text","conversion_output":false,"parent_id":"61b82021d08c4a2793aa673488e64e2a","text":"narrowing of the luminal diameter;","text_display":" narrowing of the luminal diameter;","confidence":1,"confidence_rate":1},{"cnt":[[594,1567],[1517,1567],[1517,1613],[594,1613]],"region":{"top_left_x":593,"top_left_y":1567,"width":925,"height":47},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af9956a098f749adbf1a116d05f63184","type":"text","conversion_output":false,"parent_id":"61b82021d08c4a2793aa673488e64e2a","text":"- prior percutaneous or surgical carotid revascularization.","text_display":"\n- prior percutaneous or surgical carotid revascularization.","confidence":1,"confidence_rate":1},{"cnt":[[338,1627],[380,1627],[380,1668],[338,1668]],"region":{"top_left_x":338,"top_left_y":1627,"width":42,"height":42},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04a774ed74c0436aa22089406f0a6d46","type":"simple_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"f","text_display":"f","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[403,1625],[1824,1625],[1824,2067],[403,2067]],"region":{"top_left_x":402,"top_left_y":1624,"width":1422,"height":443},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7243976347694cd1b8b131335aed1dc5","type":"complex_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","children_ids":["f16d648dead24e4082b678b5af7e4c59","8594c1f7de6444f4bf853b8bb17f49e0","12714a11f6e04fb293df3cb241d57782","d29ffb8548ad40beb9e1a80745b09687","22828bb5231a43cba7225943711b9624","4b2b5a2d43114627b6cf405c0c4d7c7b","a79afa599c824a1a96005d8c41000a59"],"text":"\\begin{tabular}{l}\nPresence of peripheral artery disease documented by either: \\\\\n- previous limb angioplasty, stenting or bypass surgery; \\\\\n- previous limb or foot amputation due to macrocirculatory insufficiency; \\\\\n- angiographic evidence of peripheral artery stenosis \\(\\geq 50 \\%\\) narrowing of the luminal diameter in at least one limb (definition of peripheral artery: common iliac artery, internal iliac artery, external iliac artery, femoral artery, popliteal artery).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nPresence of peripheral artery disease documented by either: \\\\\n- previous limb angioplasty, stenting or bypass surgery; \\\\\n- previous limb or foot amputation due to macrocirculatory insufficiency; \\\\\n- angiographic evidence of peripheral artery stenosis \\(\\geq 50 \\%\\) narrowing of the luminal diameter in at least one limb (definition of peripheral artery: common iliac artery, internal iliac artery, external iliac artery, femoral artery, popliteal artery).\n\\end{tabular}","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[405,1627],[1324,1627],[1324,1673],[405,1673]],"region":{"top_left_x":405,"top_left_y":1627,"width":919,"height":47},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f16d648dead24e4082b678b5af7e4c59","type":"text","conversion_output":false,"parent_id":"7243976347694cd1b8b131335aed1dc5","text":"Presence of peripheral artery disease documented by either:","text_display":"Presence of peripheral artery disease documented by either:","confidence":1,"confidence_rate":1},{"cnt":[[594,1710],[1490,1710],[1490,1758],[594,1758]],"region":{"top_left_x":593,"top_left_y":1709,"width":897,"height":50},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8594c1f7de6444f4bf853b8bb17f49e0","type":"text","conversion_output":false,"parent_id":"7243976347694cd1b8b131335aed1dc5","text":"- previous limb angioplasty, stenting or bypass surgery;","text_display":"\n- previous limb angioplasty, stenting or bypass surgery;","confidence":1,"confidence_rate":1},{"cnt":[[596,1797],[1764,1797],[1764,1846],[596,1846]],"region":{"top_left_x":596,"top_left_y":1797,"width":1168,"height":49},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12714a11f6e04fb293df3cb241d57782","type":"text","conversion_output":false,"parent_id":"7243976347694cd1b8b131335aed1dc5","text":"- previous limb or foot amputation due to macrocirculatory insufficiency;","text_display":"\n- previous limb or foot amputation due to macrocirculatory insufficiency;","confidence":1,"confidence_rate":1},{"cnt":[[596,1885],[1821,1885],[1821,1931],[596,1931]],"region":{"top_left_x":596,"top_left_y":1884,"width":1226,"height":47},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d29ffb8548ad40beb9e1a80745b09687","type":"text","conversion_output":false,"parent_id":"7243976347694cd1b8b131335aed1dc5","text":"- angiographic evidence of peripheral artery stenosis \\(\\geq 50 \\%\\) narrowing of the","text_display":"\n- angiographic evidence of peripheral artery stenosis \\(\\geq 50 \\%\\) narrowing of the","confidence":1,"confidence_rate":1},{"cnt":[[656,1931],[1711,1931],[1711,1975],[656,1975]],"region":{"top_left_x":656,"top_left_y":1930,"width":1055,"height":45},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22828bb5231a43cba7225943711b9624","type":"text","conversion_output":false,"parent_id":"7243976347694cd1b8b131335aed1dc5","text":"luminal diameter in at least one limb (definition of peripheral artery:","text_display":" luminal diameter in at least one limb (definition of peripheral artery:","confidence":1,"confidence_rate":1},{"cnt":[[658,1975],[1738,1975],[1738,2021],[658,2021]],"region":{"top_left_x":658,"top_left_y":1974,"width":1081,"height":47},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b2b5a2d43114627b6cf405c0c4d7c7b","type":"text","conversion_output":false,"parent_id":"7243976347694cd1b8b131335aed1dc5","text":"common iliac artery, internal iliac artery, external iliac artery, femoral","text_display":" common iliac artery, internal iliac artery, external iliac artery, femoral","confidence":1,"confidence_rate":1},{"cnt":[[658,2018],[1027,2018],[1027,2067],[658,2067]],"region":{"top_left_x":658,"top_left_y":2018,"width":369,"height":49},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a79afa599c824a1a96005d8c41000a59","type":"text","conversion_output":false,"parent_id":"7243976347694cd1b8b131335aed1dc5","text":"artery, popliteal artery).","text_display":" artery, popliteal artery).","confidence":1,"confidence_rate":1},{"cnt":[[299,2064],[341,2064],[341,2101],[299,2101]],"region":{"top_left_x":299,"top_left_y":2064,"width":42,"height":38},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48dbfc8339bb425fb151467a02679376","type":"simple_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","text":"II.","text_display":"II.","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[403,2064],[1819,2064],[1819,2490],[403,2490]],"region":{"top_left_x":402,"top_left_y":2064,"width":1417,"height":427},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"509907fb149e4d0ba0bebb81b8cf099b","type":"complex_cell","conversion_output":false,"parent_id":"3358d94d0fbf4a3d8ef498fd84349fe3","children_ids":["0de8ee6da72243e38ef84468d66bc7c2","b7c57a5a9fe44d198578edb445baa586","57068149e5d446eb82ec7560d27e1e28","74583a16668542549cf774d02dcca545","97af90efa20b40c58c6645f426307223","8c0669cd1a5c4a85baac4c7b1137d7a1","2aa8310f051240b29d3ed79a14dd1f67","11c2f079cbf846e9b8a7b617b41c0964","5526fdb445d8467fb1420814d28960ae"],"text":"\\begin{tabular}{l}\nEvidence of impaired renal function with predefined UACR, with or without CV comorbidities, defined as follows (and/or criteria): \\\\\n- Impaired renal function (as defined by MDRD formula) with an eGFR:15-<45 \\(mL / min / 1.73 m^{2}\\) at visit 1 (screening) with any UACR. \\\\\n- Impaired renal function (as defined by MDRD formula) with an eGFR \\(\\geq 45-75 mL / \\min / 1.73 m^{2}\\) at visit 1 (screening) with an UACR \\(>200 mg / g\\) creatinine or \\(>200 \\mu g / min\\) (microgram albumin per minute) or \\(>200 mg / 24 h\\) [milligram albumin per 24 hours] demonstrated in two out of three unrelated spot urine or timed samples in the last 24 months prior to randomization*.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nEvidence of impaired renal function with predefined UACR, with or without CV comorbidities, defined as follows (and/or criteria): \\\\\n- Impaired renal function (as defined by MDRD formula) with an eGFR:15-<45 \\(mL / min / 1.73 m^{2}\\) at visit 1 (screening) with any UACR. \\\\\n- Impaired renal function (as defined by MDRD formula) with an eGFR \\(\\geq 45-75 mL / \\min / 1.73 m^{2}\\) at visit 1 (screening) with an UACR \\(>200 mg / g\\) creatinine or \\(>200 \\mu g / min\\) (microgram albumin per minute) or \\(>200 mg / 24 h\\) [milligram albumin per 24 hours] demonstrated in two out of three unrelated spot urine or timed samples in the last 24 months prior to randomization*.\n\\end{tabular}","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.5846753120422363,"confidence_rate":0.9989863121139758},{"cnt":[[405,2067],[1787,2067],[1787,2113],[405,2113]],"region":{"top_left_x":405,"top_left_y":2066,"width":1382,"height":47},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0de8ee6da72243e38ef84468d66bc7c2","type":"text","conversion_output":false,"parent_id":"509907fb149e4d0ba0bebb81b8cf099b","text":"Evidence of impaired renal function with predefined UACR, with or without CV co-","text_display":"Evidence of impaired renal function with predefined UACR, with or without CV co","confidence":1,"confidence_rate":1},{"cnt":[[407,2111],[1195,2111],[1195,2159],[407,2159]],"region":{"top_left_x":407,"top_left_y":2110,"width":788,"height":49},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7c57a5a9fe44d198578edb445baa586","type":"text","conversion_output":false,"parent_id":"509907fb149e4d0ba0bebb81b8cf099b","text":"morbidities, defined as follows (and/or criteria):","text_display":"morbidities, defined as follows (and/or criteria):","confidence":1,"confidence_rate":1},{"cnt":[[532,2166],[1812,2166],[1812,2210],[532,2210]],"region":{"top_left_x":531,"top_left_y":2165,"width":1282,"height":45},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57068149e5d446eb82ec7560d27e1e28","type":"text","conversion_output":false,"parent_id":"509907fb149e4d0ba0bebb81b8cf099b","text":"- Impaired renal function (as defined by MDRD formula) with an eGFR:15-<45","text_display":"\n- Impaired renal function (as defined by MDRD formula) with an eGFR:15-<45","confidence":0.9243531227111816,"confidence_rate":0.999004785264982},{"cnt":[[594,2203],[1444,2203],[1444,2256],[594,2256]],"region":{"top_left_x":593,"top_left_y":2202,"width":851,"height":54},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74583a16668542549cf774d02dcca545","type":"text","conversion_output":false,"parent_id":"509907fb149e4d0ba0bebb81b8cf099b","text":"\\(mL / min / 1.73 m^{2}\\) at visit 1 (screening) with any UACR.","text_display":" \\(mL / min / 1.73 m^{2}\\) at visit 1 (screening) with any UACR.","confidence":0.99755859375,"confidence_rate":0.9999669682301315},{"cnt":[[532,2262],[1812,2262],[1812,2311],[532,2311]],"region":{"top_left_x":531,"top_left_y":2262,"width":1282,"height":49},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97af90efa20b40c58c6645f426307223","type":"text","conversion_output":false,"parent_id":"509907fb149e4d0ba0bebb81b8cf099b","text":"- Impaired renal function (as defined by MDRD formula) with an eGFR \\(\\geq 45-75\\)","text_display":"\n- Impaired renal function (as defined by MDRD formula) with an eGFR \\(\\geq 45-75","confidence":0.795879602432251,"confidence_rate":0.9970772621312689},{"cnt":[[594,2304],[1807,2304],[1807,2355],[594,2355]],"region":{"top_left_x":593,"top_left_y":2303,"width":1215,"height":52},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c0669cd1a5c4a85baac4c7b1137d7a1","type":"text","conversion_output":false,"parent_id":"509907fb149e4d0ba0bebb81b8cf099b","text":"\\(mL / \\min / 1.73 m^{2}\\) at visit 1 (screening) with an UACR \\(>200 mg / g\\) creatinine or","text_display":" mL / \\min / 1.73 m^{2}\\) at visit 1 (screening) with an UACR \\(>200 mg / g\\) creatinine or","confidence":0.5846753120422363,"confidence_rate":0.9948527292937286},{"cnt":[[589,2350],[1771,2350],[1771,2398],[589,2398]],"region":{"top_left_x":589,"top_left_y":2349,"width":1182,"height":50},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2aa8310f051240b29d3ed79a14dd1f67","type":"text","conversion_output":false,"parent_id":"509907fb149e4d0ba0bebb81b8cf099b","text":"\\(>200 \\mu g / min\\) (microgram albumin per minute) or \\(>200 mg / 24 h\\) [milligram","text_display":" \\(>200 \\mu g / min\\) (microgram albumin per minute) or \\(>200 mg / 24 h\\) [milligram","confidence":0.9990234375,"confidence_rate":0.9999885054819704},{"cnt":[[592,2396],[1805,2396],[1805,2444],[592,2444]],"region":{"top_left_x":591,"top_left_y":2396,"width":1215,"height":49},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11c2f079cbf846e9b8a7b617b41c0964","type":"text","conversion_output":false,"parent_id":"509907fb149e4d0ba0bebb81b8cf099b","text":"albumin per 24 hours] demonstrated in two out of three unrelated spot urine or","text_display":" albumin per 24 hours] demonstrated in two out of three unrelated spot urine or","confidence":1,"confidence_rate":1},{"cnt":[[589,2440],[1531,2440],[1531,2486],[589,2486]],"region":{"top_left_x":589,"top_left_y":2439,"width":943,"height":47},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5526fdb445d8467fb1420814d28960ae","type":"text","conversion_output":false,"parent_id":"509907fb149e4d0ba0bebb81b8cf099b","text":"timed samples in the last 24 months prior to randomization*.","text_display":" timed samples in the last 24 months prior to randomization*.","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":63,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"171531aa2045406dae6d62d97aba9c60","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99462890625,"confidence_rate":0.9998717803653022},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":64,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9ed0a69605204084bef8b44fd3fc668e","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":65,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"147ed227c2834b26bf7c15d3130dd526","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-031","page":31,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bdfbaa7a783549ac9a9cde45ff298d06","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"692052bb28ca4790b9e2d68452be80df","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66bf1e5bd4524da5bb09a9b8be3efe6a","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c52279a97884448fb60d181efc82743c","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fa00491c52645bda9aa094a4ac61d00","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2044614f135e43e890b2cce4cd6c3e25","type":"page_info","conversion_output":false,"text":"Page 31 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1818,338],[1818,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":1573,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e744ce802c524106adcd9b273ce2ae33","type":"text","conversion_output":true,"text":"*If the UACR result at Visit 2 is required to fulfil inclusion criterion 8, randomization may be","text_display":"\n*If the UACR result at Visit 2 is required to fulfil inclusion criterion 8, randomization may be","confidence":1,"confidence_rate":1},{"cnt":[[247,388],[1067,388],[1067,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":821,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dbf01ffbaf70412cbbad8d614a35e2c1","type":"text","conversion_output":true,"text":"postponed until the laboratory results are known.","text_display":" postponed until the laboratory results are known.","confidence":1,"confidence_rate":1},{"cnt":[[244,498],[1789,498],[1789,546],[244,546]],"region":{"top_left_x":244,"top_left_y":497,"width":1545,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c48694bbdd454e7d94487d0dc288903d","type":"text","conversion_output":true,"text":"Note: To ensure appropriate representation of patients from the different CV risk categories,","text_display":"\n\nNote: To ensure appropriate representation of patients from the different CV risk categories,","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[247,548],[1734,548],[1734,594],[247,594]],"region":{"top_left_x":246,"top_left_y":548,"width":1488,"height":46},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89a5a2041e0f4440829a7493bd9fc85c","type":"text","conversion_output":true,"text":"the trial team will monitor the proportion of patients being recruited into these categories","text_display":" the trial team will monitor the proportion of patients being recruited into these categories","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[247,594],[1665,594],[1665,642],[247,642]],"region":{"top_left_x":246,"top_left_y":593,"width":1420,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8c7cd0f2acd474daf3cc6ff20c4aa56","type":"text","conversion_output":true,"text":"(trial level, and by region and/or country if appropriate). In consultation with the SC,","text_display":" (trial level, and by region and/or country if appropriate). In consultation with the SC,","confidence":1,"confidence_rate":1},{"cnt":[[247,644],[1766,644],[1766,690],[247,690]],"region":{"top_left_x":246,"top_left_y":644,"width":1520,"height":46},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bae1f584a9284c9087581585049bbcea","type":"text","conversion_output":true,"text":"limitation of recruitment of a particular category may be arranged (trial level, or per region","text_display":" limitation of recruitment of a particular category may be arranged (trial level, or per region","confidence":1,"confidence_rate":1},{"cnt":[[247,690],[1812,690],[1812,738],[247,738]],"region":{"top_left_x":246,"top_left_y":689,"width":1566,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c87fd4bf89247709ecf4a5dc8628ea0","type":"text","conversion_output":true,"text":"and/or country level). This process will be implemented to ensure a proper distribution of CV","text_display":" and/or country level). This process will be implemented to ensure a proper distribution of CV","confidence":0.9800166911445558,"confidence_rate":0.9997940449291846},{"cnt":[[247,740],[692,740],[692,788],[247,788]],"region":{"top_left_x":246,"top_left_y":740,"width":447,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"713cd965ae58421fbbc5f9d6c0e687bd","type":"text","conversion_output":true,"text":"risk categories worldwide.","text_display":" risk categories worldwide.","confidence":1,"confidence_rate":1},{"cnt":[[242,850],[733,850],[733,898],[242,898]],"region":{"top_left_x":242,"top_left_y":849,"width":492,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f18fabba83d42f482be024438c99a47","type":"section_header","conversion_output":false,"children_ids":["4b716a18846b4e00845c1cb0dab7b73c"],"text":"","text_display":""},{"cnt":[[247,854],[726,854],[726,893],[247,893]],"region":{"top_left_x":246,"top_left_y":854,"width":481,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b716a18846b4e00845c1cb0dab7b73c","type":"text","conversion_output":true,"parent_id":"9f18fabba83d42f482be024438c99a47","text":"3.3.3 Exclusion criteria","text_display":"\n\n\\subsection*{3.3.3 Exclusion criteria}","confidence":0.99658203125,"confidence_rate":0.9998819440950243},{"cnt":[[249,941],[733,941],[733,989],[249,989]],"region":{"top_left_x":248,"top_left_y":941,"width":486,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f9fd374c17d4be78cdd44156062cc49","type":"text","conversion_output":true,"text":"1) Type 1 diabetes mellitus.","text_display":"\n1) Type 1 diabetes mellitus.","confidence":1,"confidence_rate":1},{"cnt":[[247,996],[1818,996],[1818,1044],[247,1044]],"region":{"top_left_x":246,"top_left_y":995,"width":1573,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4e9da82d31c4e85a69748231f5025dc","type":"text","conversion_output":true,"text":"2) Treatment ( \\(\\geq 7\\) consecutive days) with GLP-1 receptor agonists, other DPP-4 inhibitors or","text_display":"\n2) Treatment ( \\(\\geq 7\\) consecutive days) with GLP-1 receptor agonists, other DPP-4 inhibitors or","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[306,1046],[1711,1046],[1711,1092],[306,1092]],"region":{"top_left_x":306,"top_left_y":1046,"width":1405,"height":46},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b71267ccea541e79ad5b20023aa0f03","type":"text","conversion_output":true,"text":"SGLT-2 inhibitors prior to informed consent. Note: This also includes clinical trials","text_display":" SGLT-2 inhibitors prior to informed consent. Note: This also includes clinical trials","confidence":1,"confidence_rate":1},{"cnt":[[306,1092],[1391,1092],[1391,1140],[306,1140]],"region":{"top_left_x":306,"top_left_y":1091,"width":1086,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bb3155eb690439a90d57eb60e65a606","type":"text","conversion_output":true,"text":"where these antidiabetic drugs have been provided to the patient.","text_display":" where these antidiabetic drugs have been provided to the patient.","confidence":1,"confidence_rate":1},{"cnt":[[247,1147],[1786,1147],[1786,1197],[247,1197]],"region":{"top_left_x":246,"top_left_y":1146,"width":1541,"height":52},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8e3e2802a48439aa0aa45d47ceea661","type":"text","conversion_output":true,"text":"3) Active liver disease or impaired hepatic function, defined by serum levels of either ALT","text_display":"\n3) Active liver disease or impaired hepatic function, defined by serum levels of either ALT","confidence":1,"confidence_rate":1},{"cnt":[[306,1197],[1816,1197],[1816,1245],[306,1245]],"region":{"top_left_x":306,"top_left_y":1197,"width":1511,"height":48},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42dc15c9d0d74c12b32eeb545e96b361","type":"text","conversion_output":true,"text":"(SGPT), AST (SGOT), or alkaline phosphatase (AP) \\(\\geq 3\\) x upper limit of normal (ULN) as","text_display":" (SGPT), AST (SGOT), or alkaline phosphatase (AP) \\(\\geq 3\\) x upper limit of normal (ULN) as","confidence":0.5075564424041659,"confidence_rate":0.9926559334914195},{"cnt":[[306,1247],[674,1247],[674,1286],[306,1286]],"region":{"top_left_x":306,"top_left_y":1247,"width":368,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9490538c206d47648f0811201df0dea3","type":"text","conversion_output":true,"text":"determined at Visit 1.","text_display":" determined at Visit 1.","confidence":1,"confidence_rate":1},{"cnt":[[244,1293],[1711,1293],[1711,1350],[244,1350]],"region":{"top_left_x":244,"top_left_y":1292,"width":1467,"height":59},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f325dacc213495da5b3f3f56978d8c9","type":"text","conversion_output":true,"text":"4) \\(eGFR <15 ml / min / 1 . 7 3 m ^{2}\\) (severe renal impairment or ESRD, MDRD formula), as","text_display":"\n4) \\(eGFR <15 ml / min / 1 . 7 3 m ^{2}\\) (severe renal impairment or ESRD, MDRD formula), as","confidence":0.48387662212533655,"confidence_rate":0.9931102693211247},{"cnt":[[306,1348],[1649,1348],[1649,1396],[306,1396]],"region":{"top_left_x":306,"top_left_y":1347,"width":1344,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0242cf8acea34de5bd5eb4404af0c652","type":"text","conversion_output":true,"text":"determined during screening at Visit 1 and/or the need for maintenance dialysis.","text_display":" determined during screening at Visit 1 and/or the need for maintenance dialysis.","confidence":1,"confidence_rate":1},{"cnt":[[247,1407],[1812,1407],[1812,1455],[247,1455]],"region":{"top_left_x":246,"top_left_y":1407,"width":1566,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9fa127d2271a4a128e2d367d3cf1dbc1","type":"text","conversion_output":true,"text":"5) Any previous (or planned within next 12 months) bariatric surgery (open or laparoscopic)","text_display":"\n5) Any previous (or planned within next 12 months) bariatric surgery (open or laparoscopic)","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[306,1457],[834,1457],[834,1501],[306,1501]],"region":{"top_left_x":306,"top_left_y":1457,"width":528,"height":44},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7bf0ea96c39f49878604900091beb1e8","type":"text","conversion_output":true,"text":"or intervention (gastric sleeve).","text_display":" or intervention (gastric sleeve).","confidence":1,"confidence_rate":1},{"cnt":[[247,1512],[1793,1512],[1793,1560],[247,1560]],"region":{"top_left_x":246,"top_left_y":1512,"width":1548,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e845b94685e4f16b67cfdd57eea81f6","type":"text","conversion_output":true,"text":"6) Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or","text_display":"\n6) Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or","confidence":0.6497769355773926,"confidence_rate":0.9953749635092911},{"cnt":[[306,1558],[1021,1558],[1021,1606],[306,1606]],"region":{"top_left_x":306,"top_left_y":1557,"width":716,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9eb7fac608ee41a080205fb01199c8e6","type":"text","conversion_output":true,"text":"\\(CABG \\leq 2\\) months prior informed consent","text_display":" \\(CABG \\leq 2\\) months prior informed consent","confidence":0.99169921875,"confidence_rate":0.999806171703899},{"cnt":[[247,1613],[1684,1613],[1684,1665],[247,1665]],"region":{"top_left_x":246,"top_left_y":1612,"width":1438,"height":54},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ed8dd7844ca4148a4d9f03c8119da7c","type":"text","conversion_output":true,"text":"7) Known hypersensitivity or allergy to the investigational products or its excipients.","text_display":"\n7) Known hypersensitivity or allergy to the investigational products or its excipients.","confidence":0.9990236759185791,"confidence_rate":0.9999893826542317},{"cnt":[[247,1670],[1807,1670],[1807,1720],[247,1720]],"region":{"top_left_x":246,"top_left_y":1669,"width":1561,"height":52},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48f3b5054bce498a98b167274b611d8f","type":"text","conversion_output":true,"text":"8) Any previous or current alcohol or drug abuse that would interfere with trial participation","text_display":"\n8) Any previous or current alcohol or drug abuse that would interfere with trial participation","confidence":1,"confidence_rate":1},{"cnt":[[306,1718],[870,1718],[870,1766],[306,1766]],"region":{"top_left_x":306,"top_left_y":1717,"width":565,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68e1ca8163314590af7934fb4f41bdc8","type":"text","conversion_output":true,"text":"in the opinion of the investigator.","text_display":" in the opinion of the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[244,1775],[1734,1775],[1734,1823],[244,1823]],"region":{"top_left_x":244,"top_left_y":1774,"width":1490,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97c8b625514c42a3ab6d37dd13fa0b5b","type":"text","conversion_output":true,"text":"9) Participation in another trial with an investigational drug ongoing or within 2 months","text_display":"\n9) Participation in another trial with an investigational drug ongoing or within 2 months","confidence":1,"confidence_rate":1},{"cnt":[[306,1823],[779,1823],[779,1871],[306,1871]],"region":{"top_left_x":306,"top_left_y":1822,"width":473,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a29c25d6f2540799440f66e9bd9605a","type":"text","conversion_output":true,"text":"prior to visit 1 (screening)*.","text_display":" prior to visit 1 (screening)*.","confidence":1,"confidence_rate":1},{"cnt":[[249,1882],[1713,1882],[1713,1930],[249,1930]],"region":{"top_left_x":248,"top_left_y":1882,"width":1466,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e3fba76e5454482ab369aef56024e7a","type":"text","conversion_output":true,"text":"10) Pre-menopausal women (last menstruation \\(\\leq 1\\) year prior to informed consent) who:","text_display":"\n10) Pre-menopausal women (last menstruation \\(\\leq 1\\) year prior to informed consent) who:","confidence":0.9970722198486328,"confidence_rate":0.9999677799203567},{"cnt":[[306,1942],[738,1942],[738,1985],[306,1985]],"region":{"top_left_x":306,"top_left_y":1941,"width":432,"height":45},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37bf31e4f3df426f851faa18434ef49b","type":"text","conversion_output":true,"text":"- are nursing or pregnant,","text_display":" - are nursing or pregnant,","confidence":1,"confidence_rate":1},{"cnt":[[306,1994],[1748,1994],[1748,2042],[306,2042]],"region":{"top_left_x":306,"top_left_y":1994,"width":1442,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bba4baf67ca541be8712af14ef96e6e8","type":"text","conversion_output":true,"text":"- or are of child-bearing potential and are not practicing an acceptable method of birth","text_display":" - or are of child-bearing potential and are not practicing an acceptable method of birth","confidence":1,"confidence_rate":1},{"cnt":[[306,2042],[1741,2042],[1741,2090],[306,2090]],"region":{"top_left_x":306,"top_left_y":2042,"width":1435,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ecf46d9c77645d0b03b3fea9efaaa1a","type":"text","conversion_output":true,"text":"control (acceptable methods of birth control include tubal ligation, transdermal patch,","text_display":" control (acceptable methods of birth control include tubal ligation, transdermal patch,","confidence":1,"confidence_rate":1},{"cnt":[[306,2092],[1802,2092],[1802,2140],[306,2140]],"region":{"top_left_x":306,"top_left_y":2092,"width":1497,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67a8b67c89944e8fa0d7e844ba0de91f","type":"text","conversion_output":true,"text":"intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives,","text_display":" intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives,","confidence":1,"confidence_rate":1},{"cnt":[[306,2138],[1606,2138],[1606,2186],[306,2186]],"region":{"top_left_x":306,"top_left_y":2138,"width":1300,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73b2b9697aa346728edadcc63d502278","type":"text","conversion_output":true,"text":"sexual abstinence (if allowed by local authorities), double barrier method and","text_display":" sexual abstinence (if allowed by local authorities), double barrier method and","confidence":1,"confidence_rate":1},{"cnt":[[306,2186],[1807,2186],[1807,2236],[306,2236]],"region":{"top_left_x":306,"top_left_y":2186,"width":1501,"height":51},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19e6e054a7c243c0baf4e2243317b16d","type":"text","conversion_output":true,"text":"vasectomised partner) or do not plan to continue using acceptable method of birth control","text_display":" vasectomised partner) or do not plan to continue using acceptable method of birth control","confidence":1,"confidence_rate":1},{"cnt":[[306,2234],[1729,2234],[1729,2282],[306,2282]],"region":{"top_left_x":306,"top_left_y":2234,"width":1424,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc065f6d0f4e4985a0ceeda8e296d951","type":"text","conversion_output":true,"text":"throughout the study and do not agree to submit to periodic pregnancy testing during","text_display":" throughout the study and do not agree to submit to periodic pregnancy testing during","confidence":1,"confidence_rate":1},{"cnt":[[306,2280],[715,2280],[715,2332],[306,2332]],"region":{"top_left_x":306,"top_left_y":2279,"width":410,"height":54},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f17fd50605840d0a99a7f7b6d298e28","type":"text","conversion_output":true,"text":"participation in the trial.","text_display":" participation in the trial.","confidence":1,"confidence_rate":1},{"cnt":[[247,2371],[1812,2371],[1812,2419],[247,2419]],"region":{"top_left_x":246,"top_left_y":2371,"width":1566,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d54ce8579f94f159335846497816fc4","type":"text","conversion_output":true,"text":"11) Patients considered unreliable by the investigator concerning the requirements for follow-","text_display":"\n11) Patients considered unreliable by the investigator concerning the requirements for follow","confidence":0.99365234375,"confidence_rate":0.9999356799647565},{"cnt":[[306,2421],[1674,2421],[1674,2469],[306,2469]],"region":{"top_left_x":306,"top_left_y":2421,"width":1369,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bbfcc65b9c084a8eb14efdbfef3c04dc","type":"text","conversion_output":true,"text":"up during the study and/or compliance with study drug administration, have a life","text_display":"up during the study and/or compliance with study drug administration, have a life","confidence":1,"confidence_rate":1},{"cnt":[[306,2467],[1812,2467],[1812,2515],[306,2515]],"region":{"top_left_x":306,"top_left_y":2467,"width":1506,"height":49},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4abd17330fdb4a148e5e12db677ffe17","type":"text","conversion_output":true,"text":"expectancy less than 5 years for non-CV causes, or have cancer other than non-melanoma","text_display":" expectancy less than 5 years for non-CV causes, or have cancer other than non-melanoma","confidence":0.9877986907958984,"confidence_rate":0.9998694089931719},{"cnt":[[790,2586],[1300,2586],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2585,"width":510,"height":36},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0d61a4578949402a90eaeddde0b9446d","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.9951171875,"confidence_rate":0.9998834645913324},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ea437cd66cc0448da3d7d537225243d4","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e493410849b0437a858278fca1a3094d","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-032","page":32,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9436f2c7996345519f552e574eaa0e8d","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73b002a00e9a4cc188f2099328b8af62","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d606bcb444c5449f85934c6f5cbc1c09","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d1651a45f0d4162814813215cd7d100","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2ca3c34a2bf41fc9e7e3e723db8b94b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d89c334e405d42769978e893b8b98f22","type":"page_info","conversion_output":false,"text":"Page 32 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[306,338],[1757,338],[1757,388],[306,388]],"region":{"top_left_x":306,"top_left_y":338,"width":1451,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6904d0fd5f94cf284d50cabdf8eaf9d","type":"text","conversion_output":true,"text":"skin cancer within last 3 years, or has any other condition than mentioned which in the","text_display":"\nskin cancer within last 3 years, or has any other condition than mentioned which in the","confidence":1,"confidence_rate":1},{"cnt":[[306,388],[1560,388],[1560,436],[306,436]],"region":{"top_left_x":306,"top_left_y":388,"width":1255,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c923a3cc25874d439be22b702b9f6060","type":"text","conversion_output":true,"text":"opinion of the investigator, would not allow safe participation in the study.","text_display":" opinion of the investigator, would not allow safe participation in the study.","confidence":1,"confidence_rate":1},{"cnt":[[247,443],[1706,443],[1706,491],[247,491]],"region":{"top_left_x":246,"top_left_y":443,"width":1461,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b70f6f7ccc584c2d8a9f8c588d48125b","type":"text","conversion_output":true,"text":"12) Acute coronary syndrome (ACS), diagnosed \\(\\leq 2\\) months prior to visit 1 (screening).","text_display":"\n12) Acute coronary syndrome (ACS), diagnosed \\(\\leq 2\\) months prior to visit 1 (screening).","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[247,498],[1199,498],[1199,551],[247,551]],"region":{"top_left_x":246,"top_left_y":497,"width":954,"height":54},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b2c27641516a4625a60638afb25f9377","type":"text","conversion_output":true,"text":"13) Stroke or TIA \\(\\leq 3\\) months prior to visit 1 (screening).","text_display":"\n13) Stroke or TIA \\(\\leq 3\\) months prior to visit 1 (screening).","confidence":0.99462890625,"confidence_rate":0.99992080357837},{"cnt":[[242,644],[242,585],[1286,587],[1286,646]],"region":{"top_left_x":242,"top_left_y":584,"width":1045,"height":63},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15094c40a9f845bfa8ea72d83ad35a45","type":"section_header","conversion_output":false,"children_ids":["9527eedb05394974a7ab7403ee66cddd"],"text":"","text_display":""},{"cnt":[[247,589],[1282,589],[1282,642],[247,642]],"region":{"top_left_x":246,"top_left_y":589,"width":1036,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9527eedb05394974a7ab7403ee66cddd","type":"text","conversion_output":true,"parent_id":"15094c40a9f845bfa8ea72d83ad35a45","text":"3.3.4 Removal of patients from therapy or assessments","text_display":"\n\n\\subsection*{3.3.4 Removal of patients from therapy or assessments}","confidence":1,"confidence_rate":1},{"cnt":[[242,676],[927,676],[927,733],[242,733]],"region":{"top_left_x":242,"top_left_y":676,"width":686,"height":58},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71bfadf5311e4f0d81f65a3b13c6efa3","type":"section_header","conversion_output":false,"children_ids":["e4d4aa2c5e3b452b961845762b339ded"],"text":"","text_display":""},{"cnt":[[247,681],[925,681],[925,729],[247,729]],"region":{"top_left_x":246,"top_left_y":680,"width":680,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e4d4aa2c5e3b452b961845762b339ded","type":"text","conversion_output":true,"parent_id":"71bfadf5311e4f0d81f65a3b13c6efa3","text":"3.3.4.1 Removal of individual patients","text_display":"\n\n\\subsection*{3.3.4.1 Removal of individual patients}","confidence":0.9985356330871582,"confidence_rate":0.9999659205773228},{"cnt":[[247,770],[1807,770],[1807,818],[247,818]],"region":{"top_left_x":246,"top_left_y":769,"width":1561,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5a7ac0d5e524ea295c6f354dc2e1979","type":"text","conversion_output":true,"text":"This is a long-term safety outcome study and every effort should be made by the site staff","text_display":"\n\nThis is a long-term safety outcome study and every effort should be made by the site staff","confidence":1,"confidence_rate":1},{"cnt":[[247,818],[1679,818],[1679,868],[247,868]],"region":{"top_left_x":246,"top_left_y":817,"width":1434,"height":52},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c448c6edf4745ae8d1029d59ec5c501","type":"text","conversion_output":true,"text":"to encourage patients to remain in the study and on study drug if medically safe.","text_display":" to encourage patients to remain in the study and on study drug if medically safe.","confidence":1,"confidence_rate":1},{"cnt":[[244,868],[1745,868],[1745,916],[244,916]],"region":{"top_left_x":244,"top_left_y":868,"width":1502,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01dd4146aca6417ea1b48b814d79affa","type":"text","conversion_output":true,"text":"Patients who discontinue study drug prematurely should be observed until study end as if","text_display":"\nPatients who discontinue study drug prematurely should be observed until study end as if","confidence":1,"confidence_rate":1},{"cnt":[[244,916],[1807,916],[1807,964],[244,964]],"region":{"top_left_x":244,"top_left_y":916,"width":1563,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"05c83f889c164d279f286306dd1dd92e","type":"text","conversion_output":true,"text":"they were still receiving blinded study treatment. Patients who prematurely discontinue study","text_display":" they were still receiving blinded study treatment. Patients who prematurely discontinue study","confidence":1,"confidence_rate":1},{"cnt":[[244,964],[1784,964],[1784,1012],[244,1012]],"region":{"top_left_x":244,"top_left_y":964,"width":1541,"height":48},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"991a3d4153a84cb1ab88604557cb3e66","type":"text","conversion_output":true,"text":"drug should remain in the study. Study assessments may be omitted if a patient is willing to","text_display":" drug should remain in the study. Study assessments may be omitted if a patient is willing to","confidence":1,"confidence_rate":1},{"cnt":[[244,1012],[1802,1012],[1802,1062],[244,1062]],"region":{"top_left_x":244,"top_left_y":1011,"width":1559,"height":52},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6a7233110dd4bf8baaad3bc440d0fe2","type":"text","conversion_output":true,"text":"return to the pre-defined study visits, with exception of , collection of","text_display":" return to the pre-defined study visits, with exception of , collection of","confidence":1,"confidence_rate":1},{"cnt":[[244,1060],[1793,1060],[1793,1110],[244,1110]],"region":{"top_left_x":244,"top_left_y":1059,"width":1550,"height":52},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e1db50a2f864d068c74fb8f6971d896","type":"text","conversion_output":true,"text":"adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for","text_display":" adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for","confidence":1,"confidence_rate":1},{"cnt":[[247,1110],[722,1110],[722,1154],[247,1154]],"region":{"top_left_x":246,"top_left_y":1110,"width":476,"height":44},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8637d80b2b91408e863e3acdd392efec","type":"text","conversion_output":true,"text":"the calculation of the eGFR.","text_display":" the calculation of the eGFR.","confidence":0.9853515625,"confidence_rate":0.9995529246574973},{"cnt":[[247,1179],[1702,1179],[1702,1227],[247,1227]],"region":{"top_left_x":246,"top_left_y":1178,"width":1456,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d819682a111493b9995013ecedd6581","type":"text","conversion_output":true,"text":"If a patient who prematurely discontinued study drug is not willing to return at the pre-","text_display":"\n\nIf a patient who prematurely discontinued study drug is not willing to return at the pre","confidence":1,"confidence_rate":1},{"cnt":[[244,1229],[1684,1229],[1684,1277],[244,1277]],"region":{"top_left_x":244,"top_left_y":1228,"width":1440,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d89760decc443c881e8b9b232a78b52","type":"text","conversion_output":true,"text":"defined regular visit schedule, at minimum a yearly telephone call (preferably every 6","text_display":"defined regular visit schedule, at minimum a yearly telephone call (preferably every 6","confidence":1,"confidence_rate":1},{"cnt":[[244,1275],[1686,1275],[1686,1323],[244,1323]],"region":{"top_left_x":244,"top_left_y":1274,"width":1442,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b02e5a3f1568452d8f77008a381beb88","type":"text","conversion_output":true,"text":"months) and a telephone call at study end will be asked for required, to document the","text_display":" months) and a telephone call at study end will be asked for required, to document the","confidence":1,"confidence_rate":1},{"cnt":[[244,1325],[1775,1325],[1775,1373],[244,1373]],"region":{"top_left_x":244,"top_left_y":1324,"width":1531,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9deb99c38934a609b720e86da4b937a","type":"text","conversion_output":true,"text":"occurrence of outcome events and vital status. If possible, also other AE's and concomitant","text_display":" occurrence of outcome events and vital status. If possible, also other AE's and concomitant","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[244,1373],[1807,1373],[1807,1423],[244,1423]],"region":{"top_left_x":244,"top_left_y":1372,"width":1563,"height":52},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9411a45fba7470690a0f54e66e33928","type":"text","conversion_output":true,"text":"therapy changes since last visit might should be recorded. Every attempt will be made by the","text_display":" therapy changes since last visit might should be recorded. Every attempt will be made by the","confidence":1,"confidence_rate":1},{"cnt":[[244,1421],[1638,1421],[1638,1471],[244,1471]],"region":{"top_left_x":244,"top_left_y":1420,"width":1394,"height":52},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d0111b4670240bdbf26b0d57c00d8a0","type":"text","conversion_output":true,"text":"investigator to ensure patients continue participating in the study during study drug","text_display":" investigator to ensure patients continue participating in the study during study drug","confidence":1,"confidence_rate":1},{"cnt":[[247,1471],[1131,1471],[1131,1519],[247,1519]],"region":{"top_left_x":246,"top_left_y":1471,"width":885,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d62b69614ff4369bf9b5af837911820","type":"text","conversion_output":true,"text":"interruptions and after discontinuation of study drug.","text_display":" interruptions and after discontinuation of study drug.","confidence":1,"confidence_rate":1},{"cnt":[[244,1540],[1693,1540],[1693,1588],[244,1588]],"region":{"top_left_x":244,"top_left_y":1539,"width":1449,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e10b290d8630436ca46a4d972b3a7155","type":"text","conversion_output":true,"text":"Patients who prematurely discontinue study medication during the treatment phase are","text_display":"\n\nPatients who prematurely discontinue study medication during the treatment phase are","confidence":1,"confidence_rate":1},{"cnt":[[244,1585],[1679,1585],[1679,1636],[244,1636]],"region":{"top_left_x":244,"top_left_y":1585,"width":1436,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12e19a944c784f89916280d8449398ca","type":"text","conversion_output":true,"text":"allowed to restart the study medication at any time if appropriate in the opinion of the","text_display":" allowed to restart the study medication at any time if appropriate in the opinion of the","confidence":1,"confidence_rate":1},{"cnt":[[247,1636],[1750,1636],[1750,1684],[247,1684]],"region":{"top_left_x":246,"top_left_y":1635,"width":1504,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"072d28a4cdbc40ec8780bf423c29aacc","type":"text","conversion_output":true,"text":"investigator and if not contraindicated. In this study, patients are allowed to have multiple","text_display":" investigator and if not contraindicated. In this study, patients are allowed to have multiple","confidence":1,"confidence_rate":1},{"cnt":[[247,1684],[1812,1684],[1812,1732],[247,1732]],"region":{"top_left_x":246,"top_left_y":1683,"width":1566,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5274d248441f439382c1c21d74d4c4e1","type":"text","conversion_output":true,"text":"study drug interruptions. There is no limit on either the number of study drug interruptions or","text_display":" study drug interruptions. There is no limit on either the number of study drug interruptions or","confidence":1,"confidence_rate":1},{"cnt":[[247,1732],[1661,1732],[1661,1780],[247,1780]],"region":{"top_left_x":246,"top_left_y":1731,"width":1415,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ab222633e7c4935af67a99677e2beb6","type":"text","conversion_output":true,"text":"the maximum length of any study drug interruption. Investigators should routinely","text_display":" the maximum length of any study drug interruption. Investigators should routinely","confidence":1,"confidence_rate":1},{"cnt":[[247,1780],[1720,1780],[1720,1830],[247,1830]],"region":{"top_left_x":246,"top_left_y":1779,"width":1475,"height":51},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b9f8929de6b64b408ab084bf5077f210","type":"text","conversion_output":true,"text":"consider re-starting study drug at every visit following study drug discontinuation.","text_display":" consider re-starting study drug at every visit following study drug discontinuation.","confidence":1,"confidence_rate":1},{"cnt":[[247,1869],[1720,1869],[1720,1917],[247,1917]],"region":{"top_left_x":246,"top_left_y":1868,"width":1475,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec736108d87543999847dfd629012e6e","type":"text","conversion_output":true,"text":"A patient should be instructed to stop the study drug only after discussion between","text_display":"\n\nA patient should be instructed to stop the study drug only after discussion between","confidence":1,"confidence_rate":1},{"cnt":[[247,1914],[1812,1914],[1812,1967],[247,1967]],"region":{"top_left_x":246,"top_left_y":1914,"width":1566,"height":53},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ea545b0f2734773a70cee20eba50be0","type":"text","conversion_output":true,"text":"sponsor representative and investigator, if eligibility criteria are being violated, or if the","text_display":" sponsor representative and investigator, if eligibility criteria are being violated, or if the","confidence":1,"confidence_rate":1},{"cnt":[[247,1965],[1729,1965],[1729,2015],[247,2015]],"region":{"top_left_x":246,"top_left_y":1964,"width":1484,"height":51},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"254c67a9dfe24040a1e12832e6c3a189","type":"text","conversion_output":true,"text":"patient fails to comply with the protocol (e.g. non-attendance at study assessments).","text_display":" patient fails to comply with the protocol (e.g. non-attendance at study assessments).","confidence":1,"confidence_rate":1},{"cnt":[[242,2051],[1775,2051],[1775,2154],[242,2154]],"region":{"top_left_x":242,"top_left_y":2051,"width":1533,"height":104},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71259502831c469893e69e65da3f5a0f","type":"section_header","conversion_output":false,"children_ids":["84e6a07b109a45eabbb2482a9ce56801","4c6e87d5fb1641d5974c19cfca794b46"],"text":"","text_display":""},{"cnt":[[247,2056],[1770,2056],[1770,2104],[247,2104]],"region":{"top_left_x":246,"top_left_y":2055,"width":1525,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84e6a07b109a45eabbb2482a9ce56801","type":"text","conversion_output":true,"parent_id":"71259502831c469893e69e65da3f5a0f","text":"Early discontinuation of study medication is not a criterion for withdrawal of consent","text_display":"\n\n\\section*{Early discontinuation of study medication is not a criterion for withdrawal of consent","confidence":0.9970729344058782,"confidence_rate":0.9999677877954348},{"cnt":[[247,2104],[777,2104],[777,2150],[247,2150]],"region":{"top_left_x":246,"top_left_y":2103,"width":531,"height":47},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c6e87d5fb1641d5974c19cfca794b46","type":"text","conversion_output":true,"parent_id":"71259502831c469893e69e65da3f5a0f","text":"for participating in the study.","text_display":" for participating in the study.}","confidence":1,"confidence_rate":1},{"cnt":[[244,2193],[1805,2193],[1805,2241],[244,2241]],"region":{"top_left_x":244,"top_left_y":2193,"width":1561,"height":48},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d30c0eb84284ffaba00188da05d6623","type":"text","conversion_output":true,"text":"If a patient becomes pregnant during the trial, the study treatment will be stopped, the patient","text_display":"\n\nIf a patient becomes pregnant during the trial, the study treatment will be stopped, the patient","confidence":1,"confidence_rate":1},{"cnt":[[247,2239],[1720,2239],[1720,2287],[247,2287]],"region":{"top_left_x":246,"top_left_y":2238,"width":1475,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a41e7fcfb3534dd493300304938c2409","type":"text","conversion_output":true,"text":"will be followed up during the study and until birth or termination of the pregnancy (see","text_display":" will be followed up during the study and until birth or termination of the pregnancy (see","confidence":1,"confidence_rate":1},{"cnt":[[247,2289],[811,2289],[811,2335],[247,2335]],"region":{"top_left_x":246,"top_left_y":2288,"width":565,"height":47},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65ba1ed14fdf4e90a85b1e8f0c1c7a90","type":"text","conversion_output":true,"text":"further details in Section 5.2.2.2).","text_display":" further details in Section 5.2.2.2).","confidence":1,"confidence_rate":1},{"cnt":[[247,2378],[1355,2378],[1355,2426],[247,2426]],"region":{"top_left_x":246,"top_left_y":2378,"width":1109,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d1dbd7ab25d46aa83fa090c5b52e096","type":"text","conversion_output":true,"text":"If pancreatitis is suspected, the study treatment should be stopped.","text_display":"\n\nIf pancreatitis is suspected, the study treatment should be stopped.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b2eeb0f029584d1e958047c0f387fa68","type":"section_header","conversion_output":false,"children_ids":["7f3b75734c41409e8145769bb4a0cd96"],"text":"","text_display":""},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7f3b75734c41409e8145769bb4a0cd96","type":"text","conversion_output":true,"parent_id":"b2eeb0f029584d1e958047c0f387fa68","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"73926ec3d57446d6b7225371e4aae2f9","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c672a5eef33d4afe8a66dc1c0309557e","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-033","page":33,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f9e4935b0fd4da9a4dedfbd9046c261","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ece75835d44479296d6f8a94f747d3a","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"345527144f2a47298158d6975f81151e","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa31e8b1bb8c40c991b257668e26f4d1","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f8f6543c6d244429fcb077b126f350b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4da25aa433074875a176b473933d0616","type":"page_info","conversion_output":false,"text":"Page 33 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,340],[1780,340],[1780,391],[247,391]],"region":{"top_left_x":246,"top_left_y":340,"width":1534,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7be6ed1541d479fb47b5a408832f02e","type":"text","conversion_output":true,"text":"A patient has the right to withdraw informed consent for participation at any time for","text_display":"\n\nA patient has the right to withdraw informed consent for participation at any time for","confidence":1,"confidence_rate":1},{"cnt":[[247,388],[1768,388],[1768,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1523,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36f25c3427974c0bbe8296d101554326","type":"text","conversion_output":true,"text":"any reason. However, withdrawal of consent from study participation should be very","text_display":" any reason. However, withdrawal of consent from study participation should be very","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1812,434],[1812,487],[247,487]],"region":{"top_left_x":246,"top_left_y":434,"width":1566,"height":53},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8d1b49e861a4eac95e00c84d76b179c","type":"text","conversion_output":true,"text":"rare and unusual. Because of this, the investigator should be involved in the discussions","text_display":" rare and unusual. Because of this, the investigator should be involved in the discussions","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1706,484],[1706,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1461,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"999e90fdddc149dbb226a5c1bc616d94","type":"text","conversion_output":true,"text":"with the patient regarding a withdrawal of consent. Additionally, the investigator","text_display":" with the patient regarding a withdrawal of consent. Additionally, the investigator","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[247,532],[1695,532],[1695,580],[247,580]],"region":{"top_left_x":246,"top_left_y":532,"width":1450,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5320d006f8d546aaa1dffd838597ffbd","type":"text","conversion_output":true,"text":"should discuss the withdrawal of consent with the sponsor representative prior to","text_display":" should discuss the withdrawal of consent with the sponsor representative prior to","confidence":1,"confidence_rate":1},{"cnt":[[247,580],[765,580],[765,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":520,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9cfac041a33b4b6dbbd7f1060cacd85a","type":"text","conversion_output":true,"text":"stopping study participation.","text_display":" stopping study participation.","confidence":1,"confidence_rate":1},{"cnt":[[247,669],[1780,669],[1780,720],[247,720]],"region":{"top_left_x":246,"top_left_y":669,"width":1534,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb602ec9e9f4472283eb34038402924e","type":"text","conversion_output":true,"text":"Patients that are not actively taking study drug may be less motivated to adhere to the","text_display":"\n\nPatients that are not actively taking study drug may be less motivated to adhere to the","confidence":1,"confidence_rate":1},{"cnt":[[247,717],[1729,717],[1729,765],[247,765]],"region":{"top_left_x":246,"top_left_y":717,"width":1484,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3bdda91aeb84ab9aee74ff62ea00cf7","type":"text","conversion_output":true,"text":"study visit schedule. Investigators and site staff should work to detect early signs of","text_display":" study visit schedule. Investigators and site staff should work to detect early signs of","confidence":1,"confidence_rate":1},{"cnt":[[247,763],[1761,763],[1761,816],[247,816]],"region":{"top_left_x":246,"top_left_y":762,"width":1516,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7297af7c1b84dc18b78df3dbbb75ec3","type":"text","conversion_output":true,"text":"losing interest and readily present such patients (not actively taking study drug) with","text_display":" losing interest and readily present such patients (not actively taking study drug) with","confidence":1,"confidence_rate":1},{"cnt":[[247,813],[1302,813],[1302,861],[247,861]],"region":{"top_left_x":246,"top_left_y":813,"width":1057,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ceca0a29c10040879b75e56c1b5f6b29","type":"text","conversion_output":true,"text":"the following options to encourage continued participation:","text_display":" the following options to encourage continued participation:","confidence":1,"confidence_rate":1},{"cnt":[[247,900],[1793,900],[1793,953],[247,953]],"region":{"top_left_x":246,"top_left_y":900,"width":1548,"height":53},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f30b3b68f48f44e1a3e437175cd74f19","type":"text","conversion_output":true,"text":"Option 1 Continue to attend regularly scheduled study visits at the site until the study ends","text_display":"\n\nOption 1 Continue to attend regularly scheduled study visits at the site until the study ends","confidence":1,"confidence_rate":1},{"cnt":[[247,989],[1272,989],[1272,1039],[247,1039]],"region":{"top_left_x":246,"top_left_y":989,"width":1027,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42c935c69aad4eaabdb8e5cdcc9ed270","type":"text","conversion_output":true,"text":"Option 2 Conduct all remaining study visits over the phone","text_display":"\nOption 2 Conduct all remaining study visits over the phone","confidence":1,"confidence_rate":1},{"cnt":[[247,1078],[1757,1078],[1757,1131],[247,1131]],"region":{"top_left_x":246,"top_left_y":1078,"width":1511,"height":53},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5cd59b289464a1080743913fb263c58","type":"text","conversion_output":true,"text":"Option 3 Discontinue participation in remaining study activities but permit collection of","text_display":"\nOption 3 Discontinue participation in remaining study activities but permit collection of","confidence":1,"confidence_rate":1},{"cnt":[[434,1128],[1766,1128],[1766,1179],[434,1179]],"region":{"top_left_x":434,"top_left_y":1128,"width":1332,"height":51},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9ee88c033534178b73756405d3558be","type":"text","conversion_output":true,"text":"vital status and CV outcome events at minimum at the end of the study through","text_display":" vital status and CV outcome events at minimum at the end of the study through","confidence":1,"confidence_rate":1},{"cnt":[[434,1176],[1757,1176],[1757,1227],[434,1227]],"region":{"top_left_x":434,"top_left_y":1176,"width":1323,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be8a3b7087af4d4fb06faa3f9adec8f8","type":"text","conversion_output":true,"text":"the patient or alternative person designated by the patient (e.g., family, spouse,","text_display":" the patient or alternative person designated by the patient (e.g., family, spouse,","confidence":1,"confidence_rate":1},{"cnt":[[434,1224],[1579,1224],[1579,1272],[434,1272]],"region":{"top_left_x":434,"top_left_y":1224,"width":1145,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"852b3cf504e043abbdb2c7e3bb7063f0","type":"text","conversion_output":true,"text":"partner, legal representative, or physician) even if only by telephone","text_display":" partner, legal representative, or physician) even if only by telephone","confidence":0.99951171875,"confidence_rate":0.9999934880145616},{"cnt":[[247,1311],[1757,1311],[1757,1364],[247,1364]],"region":{"top_left_x":246,"top_left_y":1311,"width":1511,"height":53},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6cecc81f08c4453488cf1b1310b3f8fd","type":"text","conversion_output":true,"text":"Option 4 Discontinue participation in remaining study activities but permit collection of","text_display":"\n\nOption 4 Discontinue participation in remaining study activities but permit collection of","confidence":1,"confidence_rate":1},{"cnt":[[434,1361],[1716,1361],[1716,1412],[434,1412]],"region":{"top_left_x":434,"top_left_y":1361,"width":1282,"height":51},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8a65a1747b948cf93b102fbf2584a21","type":"text","conversion_output":true,"text":"vital status at minimum at the end of the trial through the patient, alternative","text_display":" vital status at minimum at the end of the trial through the patient, alternative","confidence":1,"confidence_rate":1},{"cnt":[[434,1409],[1640,1409],[1640,1460],[434,1460]],"region":{"top_left_x":434,"top_left_y":1409,"width":1207,"height":51},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a3bbcababdb4d2bb6c442838d5ff19d","type":"text","conversion_output":true,"text":"person designated by the patient, or through review of patient's medical","text_display":" person designated by the patient, or through review of patient's medical","confidence":1,"confidence_rate":1},{"cnt":[[434,1457],[1775,1457],[1775,1508],[434,1508]],"region":{"top_left_x":434,"top_left_y":1457,"width":1341,"height":51},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84198b80b94f4919be3e225b8058d0e9","type":"text","conversion_output":true,"text":"information from alternative sources (e.g., doctor's notes, hospital records, etc.)","text_display":" information from alternative sources (e.g., doctor's notes, hospital records, etc.)","confidence":1,"confidence_rate":1},{"cnt":[[247,1547],[1784,1547],[1784,1597],[247,1597]],"region":{"top_left_x":246,"top_left_y":1546,"width":1539,"height":51},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18a4b03dbbc345ea8bce3420f44df694","type":"text","conversion_output":true,"text":"Patients will be asked to choose the most rigorous form of follow-up that they are willing to","text_display":"\n\nPatients will be asked to choose the most rigorous form of follow-up that they are willing to","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[247,1594],[473,1594],[473,1647],[247,1647]],"region":{"top_left_x":246,"top_left_y":1594,"width":227,"height":54},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"444487e98a68446a80309ad395b32e46","type":"text","conversion_output":true,"text":"comply with.","text_display":" comply with.","confidence":1,"confidence_rate":1},{"cnt":[[247,1686],[1674,1686],[1674,1734],[247,1734]],"region":{"top_left_x":246,"top_left_y":1685,"width":1429,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"266693a6e32943a188502dc5f17f77d2","type":"text","conversion_output":true,"text":"Patients who refuse all four of the above are considered to have fully withdrawn","text_display":"\n\nPatients who refuse all four of the above are considered to have fully withdrawn","confidence":1,"confidence_rate":1},{"cnt":[[247,1732],[1766,1732],[1766,1784],[247,1784]],"region":{"top_left_x":246,"top_left_y":1731,"width":1520,"height":54},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd1d55c44ebd46eaa41fa4b323cb91f7","type":"text","conversion_output":true,"text":"informed consent to participate in the study. A patient should be withdrawn from the","text_display":" informed consent to participate in the study. A patient should be withdrawn from the","confidence":1,"confidence_rate":1},{"cnt":[[247,1782],[1706,1782],[1706,1830],[247,1830]],"region":{"top_left_x":246,"top_left_y":1781,"width":1461,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af39b9b4ad0c4b359ac85a879e9acaf3","type":"text","conversion_output":true,"text":"study and all follow up assessments only if the patient refused all four options and","text_display":" study and all follow up assessments only if the patient refused all four options and","confidence":1,"confidence_rate":1},{"cnt":[[247,1830],[1766,1830],[1766,1878],[247,1878]],"region":{"top_left_x":246,"top_left_y":1829,"width":1520,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e06dc60013054bf2adb5c23d75597f33","type":"text","conversion_output":true,"text":"withdraws informed consent, without the need to justify the decision. Where allowed,","text_display":" withdraws informed consent, without the need to justify the decision. Where allowed,","confidence":1,"confidence_rate":1},{"cnt":[[247,1878],[1071,1878],[1071,1926],[247,1926]],"region":{"top_left_x":246,"top_left_y":1877,"width":826,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2b957c65aff46958c70b6abd15be877","type":"text","conversion_output":true,"text":"patients should be followed-up for vital status.","text_display":" patients should be followed-up for vital status.","confidence":0.99951171875,"confidence_rate":0.9999907849387211},{"cnt":[[247,1965],[1812,1965],[1812,2015],[247,2015]],"region":{"top_left_x":246,"top_left_y":1964,"width":1566,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb36d0d7d31c4f708fd46c8b696367a6","type":"text","conversion_output":true,"text":"If the patient withdraws informed consent for participation in the study, the study will end for","text_display":"\n\nIf the patient withdraws informed consent for participation in the study, the study will end for","confidence":1,"confidence_rate":1},{"cnt":[[244,2015],[1812,2015],[1812,2063],[244,2063]],"region":{"top_left_x":244,"top_left_y":2014,"width":1568,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b84ed0020b4e4966a51dae01d87d8343","type":"text","conversion_output":true,"text":"that patient. The patient should stop taking study medication and should be asked to complete","text_display":" that patient. The patient should stop taking study medication and should be asked to complete","confidence":1,"confidence_rate":1},{"cnt":[[247,2061],[1665,2061],[1665,2111],[247,2111]],"region":{"top_left_x":246,"top_left_y":2060,"width":1420,"height":51},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2223f104edd345b99247b55ea5fed508","type":"text","conversion_output":true,"text":"the EOT and follow-up procedures as described in the Flow Chart. Completing these","text_display":" the EOT and follow-up procedures as described in the Flow Chart. Completing these","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[247,2111],[1798,2111],[1798,2159],[247,2159]],"region":{"top_left_x":246,"top_left_y":2110,"width":1552,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c83fe15bb3a401486af3f6cf9050797","type":"text","conversion_output":true,"text":"procedures is strongly recommended for the patient's safety. A patient could be instructed to","text_display":" procedures is strongly recommended for the patient's safety. A patient could be instructed to","confidence":0.99658203125,"confidence_rate":0.9999650636373343},{"cnt":[[247,2159],[1615,2159],[1615,2204],[247,2204]],"region":{"top_left_x":246,"top_left_y":2158,"width":1370,"height":47},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c605e9294fc47059412d81710bec449","type":"text","conversion_output":true,"text":"stop the study treatment only after discussion between sponsor representative and","text_display":"\nstop the study treatment only after discussion between sponsor representative and","confidence":0.8933797164404496,"confidence_rate":0.9986898871562118},{"cnt":[[247,2207],[1789,2207],[1789,2255],[247,2255]],"region":{"top_left_x":246,"top_left_y":2206,"width":1543,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c63b55ee2fb4fba9dfc12b7969b3d8d","type":"text","conversion_output":true,"text":"investigator, if eligibility criteria are being violated, or if the patient fails to comply with the","text_display":" investigator, if eligibility criteria are being violated, or if the patient fails to comply with the","confidence":0.99365234375,"confidence_rate":0.9999393552838918},{"cnt":[[247,2252],[1677,2252],[1677,2305],[247,2305]],"region":{"top_left_x":246,"top_left_y":2252,"width":1431,"height":53},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d0c0d7b5bdb4f639cefa8d4f9e17a1b","type":"text","conversion_output":true,"text":"protocol (e.g. non-attendance at study assessments). Patients that withdraw informed","text_display":" protocol (e.g. non-attendance at study assessments). Patients that withdraw informed","confidence":0.9946351032704115,"confidence_rate":0.999939559810098},{"cnt":[[247,2303],[1574,2303],[1574,2351],[247,2351]],"region":{"top_left_x":246,"top_left_y":2302,"width":1328,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd6c203d688c44f59f455a6329f1e433","type":"text","conversion_output":true,"text":"consent or discontinue from the study after randomization will not be replaced.","text_display":" consent or discontinue from the study after randomization will not be replaced.","confidence":0.8144609928131104,"confidence_rate":0.9975597828602947},{"cnt":[[247,2389],[1706,2389],[1706,2442],[247,2442]],"region":{"top_left_x":246,"top_left_y":2389,"width":1461,"height":53},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"064c878167e34e10bb8aa5471c6b9a9c","type":"text","conversion_output":true,"text":"If a patient is lost, every effort should be made by the Investigator and site staff to","text_display":"\n\nIf a patient is lost, every effort should be made by the Investigator and site staff to","confidence":1,"confidence_rate":1},{"cnt":[[247,2440],[1610,2440],[1610,2490],[247,2490]],"region":{"top_left_x":246,"top_left_y":2439,"width":1365,"height":51},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f6a53565f9b4ab2b806de8b36e4133c","type":"text","conversion_output":true,"text":"contact and locate the patient before the patient is declared lost to follow-up.","text_display":" contact and locate the patient before the patient is declared lost to follow-up.","confidence":1,"confidence_rate":1},{"cnt":[[247,2490],[1793,2490],[1793,2538],[247,2538]],"region":{"top_left_x":246,"top_left_y":2489,"width":1548,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe3ab16db75e4b929ac357718361d370","type":"text","conversion_output":true,"text":"Investigators and site staff should use every possible allowable means to locate patients","text_display":" Investigators and site staff should use every possible allowable means to locate patients","confidence":0.9912109375,"confidence_rate":0.9999060904297419},{"cnt":[[793,2584],[1300,2584],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2583,"width":508,"height":38},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9fb9f319f5ef4db89ff8d6819a080dfd","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c9d759f358844a3a9b8769641f1e6e1e","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fecb1a8f8f224ef5be488dcaff9a765d","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-034","page":34,"lines":[{"cnt":[[244,119],[612,119],[612,167],[244,167]],"region":{"top_left_x":244,"top_left_y":118,"width":369,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04358caa66974e2ea22c0be264f01413","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c87eec9eea34e258d881c24ee8c0703","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,164],[601,164],[601,208],[242,208]],"region":{"top_left_x":242,"top_left_y":164,"width":359,"height":44},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a1c4fcf087184c7c9a108c29fa4c03ad","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,206],[637,206],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":205,"width":396,"height":44},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31ae5c959953457c9b417862611a87e2","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,206],[1110,206],[1110,249],[868,249]],"region":{"top_left_x":868,"top_left_y":205,"width":243,"height":44},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5dabc7eed9774298ae22ab077f16b605","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,206],[1818,206],[1818,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":205,"width":248,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"09ff3549a22342d6bd8c874faa669daa","type":"page_info","conversion_output":false,"text":"Page 34 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1759,338],[1759,391],[242,391]],"region":{"top_left_x":242,"top_left_y":338,"width":1517,"height":53},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5ab5d64d34848d891593b553d5a1010","type":"text","conversion_output":true,"text":"who have missed visits. The sponsor might involve third party vendor in compliance","text_display":"\nwho have missed visits. The sponsor might involve third party vendor in compliance","confidence":1,"confidence_rate":1},{"cnt":[[242,386],[628,386],[628,441],[242,441]],"region":{"top_left_x":242,"top_left_y":386,"width":387,"height":55},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3df227095f8241f7b734889247814abd","type":"text","conversion_output":true,"text":"with local legislation.","text_display":" with local legislation.","confidence":1,"confidence_rate":1},{"cnt":[[242,471],[1117,471],[1117,528],[242,528]],"region":{"top_left_x":242,"top_left_y":470,"width":876,"height":58},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43e6bedc75554f67956a33e014626f04","type":"text","conversion_output":true,"text":"3.3.4.2 Discontinuation of the trial by the sponsor","text_display":"\n3.3.4.2 Discontinuation of the trial by the sponsor","confidence":1,"confidence_rate":1},{"cnt":[[242,562],[1789,562],[1789,614],[242,614]],"region":{"top_left_x":242,"top_left_y":561,"width":1547,"height":54},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"521c77ae5a214ac59f4a14379bb738bd","type":"text","conversion_output":true,"text":"BI reserves the right to discontinue the trial overall or at a particular trial site at any time for","text_display":"\n\nBI reserves the right to discontinue the trial overall or at a particular trial site at any time for","confidence":1,"confidence_rate":1},{"cnt":[[242,612],[624,612],[624,665],[242,665]],"region":{"top_left_x":242,"top_left_y":612,"width":382,"height":53},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed04b122370d4314af2dcd9a5e8fca2f","type":"text","conversion_output":true,"text":"the following reasons:","text_display":" the following reasons:","confidence":1,"confidence_rate":1},{"cnt":[[244,701],[1574,701],[1574,754],[244,754]],"region":{"top_left_x":244,"top_left_y":701,"width":1330,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0cd5963a1047423b84cbdb13722b6b0f","type":"text","conversion_output":true,"text":"1) Failure to meet expected enrolment goals overall or at a particular trial site,","text_display":"\n1) Failure to meet expected enrolment goals overall or at a particular trial site,","confidence":1,"confidence_rate":1},{"cnt":[[242,749],[1802,749],[1802,802],[242,802]],"region":{"top_left_x":242,"top_left_y":749,"width":1561,"height":53},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0d164d284cc460ab6910d790fa7239d","type":"text","conversion_output":true,"text":"2) Emergence of any efficacy/safety information that could significantly affect continuation","text_display":"\n2) Emergence of any efficacy/safety information that could significantly affect continuation","confidence":1,"confidence_rate":1},{"cnt":[[306,799],[491,797],[492,843],[306,845]],"region":{"top_left_x":305,"top_left_y":796,"width":187,"height":50},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0156c825b4144258dcb5e84238f596c","type":"text","conversion_output":true,"text":"of the trial","text_display":" of the trial","confidence":1,"confidence_rate":1},{"cnt":[[242,843],[1821,843],[1821,898],[242,898]],"region":{"top_left_x":242,"top_left_y":842,"width":1579,"height":56},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8419a9c0e22b491bb5f898d04070f19b","type":"text","conversion_output":true,"text":"3) Violation of good clinical practice (GCP), the clinical trial protocol (CTP), or the contract","text_display":"\n3) Violation of good clinical practice (GCP), the clinical trial protocol (CTP), or the contract","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[302,891],[1574,891],[1574,946],[302,946]],"region":{"top_left_x":301,"top_left_y":890,"width":1273,"height":56},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f789e4b66e44f758c5eb6b4e1182d7a","type":"text","conversion_output":true,"text":"by a trial site or investigator, disturbing the appropriate conduct of the trial.","text_display":" by a trial site or investigator, disturbing the appropriate conduct of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[242,959],[1814,959],[1814,1012],[242,1012]],"region":{"top_left_x":242,"top_left_y":959,"width":1572,"height":53},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c3a07b807b94e998f3b6fee6dbe06a8","type":"text","conversion_output":true,"text":"The investigator / the trial site will be reimbursed for reasonable expenses incurred in case of","text_display":"\nThe investigator / the trial site will be reimbursed for reasonable expenses incurred in case of","confidence":0.83984375,"confidence_rate":0.9982733792943799},{"cnt":[[242,1010],[1122,1010],[1122,1062],[242,1062]],"region":{"top_left_x":242,"top_left_y":1009,"width":880,"height":54},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c952176df8f64dd6925bd785e7392ff3","type":"text","conversion_output":true,"text":"trial termination (except in case of the third reason).","text_display":" trial termination (except in case of the third reason).","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":19,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5f55600c1eac48ceaf45be7dc2df50f5","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[288,2618],[1802,2618],[1802,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2617,"width":1516,"height":45},"line":20,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2bb7137416524e3aa8fbd96cd1552ec2","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[295,2664],[1770,2664],[1770,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1477,"height":40},"line":21,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"41fac8acd305428382c1d4455c683758","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-035","page":35,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9812f382d53a431ab6a4cc3b6e27f0f2","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e886039d92a543c5959a1184086a7585","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed1648b0ee02433b8aa505537fc1a462","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"104fa76416ac495793fc838ccc4d30b3","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b3a9b48fa3244f0a4eead670f9a3fc4","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc3e83378ca94f24a194b8a4d84866a3","type":"page_info","conversion_output":false,"text":"Page 35 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[754,338],[754,391],[242,391]],"region":{"top_left_x":242,"top_left_y":338,"width":512,"height":53},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bc20b096b4df4f15966239475c914751","type":"section_header","conversion_output":false,"children_ids":["ff8f5048c25c4906ae5c5f27eb7c4372"],"text":"","text_display":""},{"cnt":[[247,343],[752,343],[752,388],[247,388]],"region":{"top_left_x":246,"top_left_y":342,"width":506,"height":47},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ff8f5048c25c4906ae5c5f27eb7c4372","type":"text","conversion_output":true,"parent_id":"bc20b096b4df4f15966239475c914751","text":"4. TREATMENTS","text_display":"\n\n\\section*{4. TREATMENTS}","confidence":1,"confidence_rate":1},{"cnt":[[242,434],[1181,434],[1181,482],[242,482]],"region":{"top_left_x":242,"top_left_y":434,"width":940,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"69f94cecc7814778aa7dec35c26608c5","type":"section_header","conversion_output":false,"children_ids":["5dcad25637304d34a6621c5c5b446f36"],"text":"","text_display":""},{"cnt":[[247,439],[1176,439],[1176,477],[247,477]],"region":{"top_left_x":246,"top_left_y":438,"width":931,"height":40},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5dcad25637304d34a6621c5c5b446f36","type":"text","conversion_output":true,"parent_id":"69f94cecc7814778aa7dec35c26608c5","text":"4.1 TREATMENTS TO BE ADMINISTERED","text_display":"\n\n\\subsection*{4.1 TREATMENTS TO BE ADMINISTERED}","confidence":1,"confidence_rate":1},{"cnt":[[247,525],[1780,525],[1780,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1534,"height":49},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c248367f88f845efa1a29f0c646eae96","type":"text","conversion_output":true,"text":"The study medication will be provided by Boehringer Ingelheim Pharma GmbH \\& Co. KG.","text_display":"\n\nThe study medication will be provided by Boehringer Ingelheim Pharma GmbH \\& Co. KG.","confidence":1,"confidence_rate":1},{"cnt":[[242,614],[1569,614],[1569,669],[242,669]],"region":{"top_left_x":242,"top_left_y":614,"width":1328,"height":56},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9559ba4b694e47ffb10bd38adbefe1da","type":"section_header","conversion_output":false,"children_ids":["201cf94603134fb284723ef8052282bd"],"text":"","text_display":""},{"cnt":[[247,617],[1565,617],[1565,665],[247,665]],"region":{"top_left_x":246,"top_left_y":616,"width":1319,"height":49},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"201cf94603134fb284723ef8052282bd","type":"text","conversion_output":true,"parent_id":"9559ba4b694e47ffb10bd38adbefe1da","text":"4.1.1 Identity of BI investigational product and comparator product(s)","text_display":"\n\n\\subsection*{4.1.1 Identity of BI investigational product and comparator product(s)}","confidence":1,"confidence_rate":1},{"cnt":[[247,706],[1076,706],[1076,752],[247,752]],"region":{"top_left_x":246,"top_left_y":705,"width":830,"height":47},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"50cfdb9cd7e4478e8d472cec778daf7a","type":"text","conversion_output":true,"text":"The characteristics of the test products are below.","text_display":"\n\nThe characteristics of the test products are below.","confidence":1,"confidence_rate":1},{"cnt":[[242,800],[1563,800],[1563,1327],[242,1327]],"region":{"top_left_x":242,"top_left_y":799,"width":1321,"height":529},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"10e905df3ae94353acbed74556214cb9","type":"table","conversion_output":true,"children_ids":["b12acabf3ced46769a721ea6ea1a7d60","5ea1b8eba52f4c5da41daf7d21e75112","26312a5fa41d4067b91f431db4719995","cfb063ac5afa404caf59193be792a9bd","792bd6c7a1be466bac6e4ad1ab111ead","84590ac780bf4532a4f00353d37d5d10","1fd7fb7fdb984d4a98adbb3d7440463a","645bc3ea26e045edae2952a78f931137","c61a3cfaf25d4dc78e6085e400c09c4c","6cc8285bfab944d69211fb29b6f2a10d","6ee37bc285fd47cea2d35416292c8e88","f3ceb87b9b27497bb5340d15c9db26d1","5d7b452bf17a4b849de54647e06167d2","2b3ce1f6c084438b882a361f3f7c3dde","0e78c840315a4a1d865645d63636ea8f","93a153fa9ef845438a1dbe36d66b4a61","ab98affe0915443aae2b8eabadfa6c8b","9b6c693399674d1494d08d7e97347499","23368b1db66547168111d6a7551e7a08","8b97d185f5484d998ea0a8292f3c9664","82761409f0b04f8b9359c92b676037f4","f554057f18aa4dacaffec54f173ae060","a5dbeaa0870d4bf9a854bb84fdd43720","0a1d93c3a0324182a78601dcf3b88dce","3e53cfc778d54d11bec51df5585e283e","27ea3f90a7ca432d802ada672d427a6e","bf1aa9f4524847c7a4d7e68684bae286","400fc520126c4a17b59362850b1bcaa6","840f102a72834b4b86f7ae501996c70f","8d1c317469334fdea9ad08b177235158","064031f64c3e484dbedb170692584bbc","3d05b3a7faea42ad89a7f2d6efb7ec68"],"text":"\\begin{tabular}{|l|l|}\n\\hline Substance: & Linagliptin (BI linagliptin) \\\\\n\\hline Pharmaceutical form: & film-coated tablet \\\\\n\\hline Source: & Boehringer Ingelheim Pharma GmbH \\& Co. KG \\\\\n\\hline Unit Strength: & 5 mg \\\\\n\\hline Route of administration: & p.o., once daily \\\\\n\\hline Substance: & Placebo matching linagliptin 5 mg \\\\\n\\hline Pharmaceutical form: & film-coated tablet \\\\\n\\hline Source: & Boehringer Ingelheim Pharma GmbH \\& Co. KG \\\\\n\\hline Unit Strength: & - \\\\\n\\hline Route of administration: & p.o., once daily \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Substance: & Linagliptin (BI linagliptin) \\\\\n\\hline Pharmaceutical form: & film-coated tablet \\\\\n\\hline Source: & Boehringer Ingelheim Pharma GmbH \\& Co. KG \\\\\n\\hline Unit Strength: & 5 mg \\\\\n\\hline Route of administration: & p.o., once daily \\\\\n\\hline Substance: & Placebo matching linagliptin 5 mg \\\\\n\\hline Pharmaceutical form: & film-coated tablet \\\\\n\\hline Source: & Boehringer Ingelheim Pharma GmbH \\& Co. KG \\\\\n\\hline Unit Strength: & - \\\\\n\\hline Route of administration: & p.o., once daily \\\\\n\\hline\n\\end{tabular}","confidence":0.958554744720459,"confidence_rate":0.9998682401215602},{"cnt":[[242,799],[663,799],[663,1324],[242,1324]],"region":{"top_left_x":242,"top_left_y":799,"width":421,"height":526},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b12acabf3ced46769a721ea6ea1a7d60","type":"table_column","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[732,799],[1559,799],[1559,1327],[732,1327]],"region":{"top_left_x":732,"top_left_y":799,"width":828,"height":528},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5ea1b8eba52f4c5da41daf7d21e75112","type":"table_column","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,799],[1562,799],[1562,851],[242,851]],"region":{"top_left_x":242,"top_left_y":799,"width":1320,"height":53},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"26312a5fa41d4067b91f431db4719995","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,848],[1562,848],[1562,895],[242,895]],"region":{"top_left_x":242,"top_left_y":848,"width":1320,"height":47},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cfb063ac5afa404caf59193be792a9bd","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,895],[1559,895],[1559,947],[242,947]],"region":{"top_left_x":242,"top_left_y":894,"width":1318,"height":53},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"792bd6c7a1be466bac6e4ad1ab111ead","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,944],[1562,944],[1562,996],[242,996]],"region":{"top_left_x":242,"top_left_y":944,"width":1320,"height":53},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"84590ac780bf4532a4f00353d37d5d10","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,990],[1559,990],[1559,1046],[242,1046]],"region":{"top_left_x":242,"top_left_y":990,"width":1318,"height":56},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1fd7fb7fdb984d4a98adbb3d7440463a","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,1077],[1559,1077],[1559,1133],[242,1133]],"region":{"top_left_x":242,"top_left_y":1077,"width":1318,"height":56},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"645bc3ea26e045edae2952a78f931137","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,1127],[1562,1127],[1562,1176],[242,1176]],"region":{"top_left_x":242,"top_left_y":1126,"width":1320,"height":51},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c61a3cfaf25d4dc78e6085e400c09c4c","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,1176],[1562,1176],[1562,1228],[242,1228]],"region":{"top_left_x":242,"top_left_y":1176,"width":1320,"height":53},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6cc8285bfab944d69211fb29b6f2a10d","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,1277],[242,1223],[1562,1225],[1562,1280]],"region":{"top_left_x":241,"top_left_y":1222,"width":1322,"height":58},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6ee37bc285fd47cea2d35416292c8e88","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[242,1275],[1562,1275],[1562,1324],[242,1324]],"region":{"top_left_x":242,"top_left_y":1274,"width":1320,"height":51},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f3ceb87b9b27497bb5340d15c9db26d1","type":"table_row","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"","text_display":""},{"cnt":[[248,802],[431,802],[431,843],[248,843]],"region":{"top_left_x":247,"top_left_y":801,"width":184,"height":42},"line":28,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"5d7b452bf17a4b849de54647e06167d2","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Substance:","text_display":"Substance:","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[738,802],[1191,802],[1191,848],[738,848]],"region":{"top_left_x":738,"top_left_y":801,"width":453,"height":48},"line":29,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2b3ce1f6c084438b882a361f3f7c3dde","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Linagliptin (BI linagliptin)","text_display":"Linagliptin (BI linagliptin)","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9921875,"confidence_rate":0.9997623561974893},{"cnt":[[248,851],[610,851],[610,889],[248,889]],"region":{"top_left_x":247,"top_left_y":851,"width":364,"height":38},"line":30,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"0e78c840315a4a1d865645d63636ea8f","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Pharmaceutical form:","text_display":"Pharmaceutical form:","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[741,851],[1048,851],[1048,889],[741,889]],"region":{"top_left_x":740,"top_left_y":851,"width":309,"height":38},"line":31,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"93a153fa9ef845438a1dbe36d66b4a61","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"film-coated tablet","text_display":"film-coated tablet","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,898],[381,898],[381,938],[248,938]],"region":{"top_left_x":247,"top_left_y":897,"width":135,"height":42},"line":32,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ab98affe0915443aae2b8eabadfa6c8b","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Source:","text_display":"Source:","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[741,898],[1556,898],[1556,944],[741,944]],"region":{"top_left_x":740,"top_left_y":897,"width":817,"height":48},"line":33,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"9b6c693399674d1494d08d7e97347499","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Boehringer Ingelheim Pharma GmbH \\& Co. KG","text_display":"Boehringer Ingelheim Pharma GmbH \\& Co. KG","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.965364933013916,"confidence_rate":0.9992340091686008},{"cnt":[[248,950],[486,950],[486,993],[248,993]],"region":{"top_left_x":247,"top_left_y":949,"width":239,"height":45},"line":34,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"23368b1db66547168111d6a7551e7a08","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Unit Strength:","text_display":"Unit Strength:","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[741,950],[831,950],[831,996],[741,996]],"region":{"top_left_x":740,"top_left_y":949,"width":91,"height":48},"line":35,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"8b97d185f5484d998ea0a8292f3c9664","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"5 mg","text_display":"5 mg","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,996],[657,996],[657,1034],[248,1034]],"region":{"top_left_x":247,"top_left_y":996,"width":410,"height":38},"line":36,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"82761409f0b04f8b9359c92b676037f4","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Route of administration:","text_display":"Route of administration:","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9931640625,"confidence_rate":0.9997634966075137},{"cnt":[[741,996],[999,996],[999,1040],[741,1040]],"region":{"top_left_x":740,"top_left_y":996,"width":260,"height":44},"line":37,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"f554057f18aa4dacaffec54f173ae060","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"p.o., once daily","text_display":"p.o., once daily","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1083],[431,1083],[431,1121],[248,1121]],"region":{"top_left_x":247,"top_left_y":1083,"width":184,"height":39},"line":38,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"a5dbeaa0870d4bf9a854bb84fdd43720","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Substance:","text_display":"Substance:","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[741,1083],[1318,1083],[1318,1127],[741,1127]],"region":{"top_left_x":740,"top_left_y":1083,"width":579,"height":44},"line":39,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"0a1d93c3a0324182a78601dcf3b88dce","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Placebo matching linagliptin 5 mg","text_display":"Placebo matching linagliptin 5 mg","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1130],[610,1130],[610,1167],[248,1167]],"region":{"top_left_x":247,"top_left_y":1129,"width":364,"height":39},"line":40,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"3e53cfc778d54d11bec51df5585e283e","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Pharmaceutical form:","text_display":"Pharmaceutical form:","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[741,1130],[1048,1130],[1048,1167],[741,1167]],"region":{"top_left_x":740,"top_left_y":1129,"width":309,"height":39},"line":41,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"27ea3f90a7ca432d802ada672d427a6e","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"film-coated tablet","text_display":"film-coated tablet","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1182],[378,1182],[378,1217],[248,1217]],"region":{"top_left_x":247,"top_left_y":1181,"width":132,"height":36},"line":42,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"bf1aa9f4524847c7a4d7e68684bae286","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Source:","text_display":"Source:","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[741,1182],[1556,1182],[1556,1225],[741,1225]],"region":{"top_left_x":740,"top_left_y":1181,"width":817,"height":45},"line":43,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"400fc520126c4a17b59362850b1bcaa6","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Boehringer Ingelheim Pharma GmbH \\& Co. KG","text_display":"Boehringer Ingelheim Pharma GmbH \\& Co. KG","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.958554744720459,"confidence_rate":0.9990802362175804},{"cnt":[[248,1228],[486,1228],[486,1272],[248,1272]],"region":{"top_left_x":247,"top_left_y":1228,"width":239,"height":44},"line":44,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"840f102a72834b4b86f7ae501996c70f","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Unit Strength:","text_display":"Unit Strength:","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[735,1240],[764,1240],[764,1263],[735,1263]],"region":{"top_left_x":735,"top_left_y":1239,"width":30,"height":25},"line":45,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"8d1c317469334fdea9ad08b177235158","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"-","text_display":"-","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[248,1275],[657,1275],[657,1312],[248,1312]],"region":{"top_left_x":247,"top_left_y":1274,"width":410,"height":39},"line":46,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"064031f64c3e484dbedb170692584bbc","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"Route of administration:","text_display":"Route of administration:","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.986328125,"confidence_rate":0.9995254162448528},{"cnt":[[741,1278],[999,1278],[999,1318],[741,1318]],"region":{"top_left_x":740,"top_left_y":1277,"width":260,"height":42},"line":47,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"3d05b3a7faea42ad89a7f2d6efb7ec68","type":"simple_cell","conversion_output":false,"parent_id":"10e905df3ae94353acbed74556214cb9","text":"p.o., once daily","text_display":"p.o., once daily","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,1361],[1288,1361],[1288,1416],[242,1416]],"region":{"top_left_x":242,"top_left_y":1361,"width":1047,"height":56},"line":48,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"924792aec0d740a69e4d718e1d30dc89","type":"section_header","conversion_output":false,"children_ids":["412a16065e0344d093e6c8fb0e05e1ce"],"text":"","text_display":""},{"cnt":[[247,1366],[1286,1366],[1286,1414],[247,1414]],"region":{"top_left_x":246,"top_left_y":1366,"width":1041,"height":49},"line":49,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"412a16065e0344d093e6c8fb0e05e1ce","type":"text","conversion_output":true,"parent_id":"924792aec0d740a69e4d718e1d30dc89","text":"4.1.2 Method of assigning patients to treatment groups","text_display":"\n\n\\subsection*{4.1.2 Method of assigning patients to treatment groups}","confidence":1,"confidence_rate":1},{"cnt":[[247,1453],[1665,1453],[1665,1501],[247,1501]],"region":{"top_left_x":246,"top_left_y":1452,"width":1420,"height":49},"line":50,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"56d8888728774133867b72deab00cd96","type":"text","conversion_output":true,"text":"When a patient is qualified for entry into the randomized treatment period, treatment","text_display":"\n\nWhen a patient is qualified for entry into the randomized treatment period, treatment","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[247,1503],[1725,1503],[1725,1551],[247,1551]],"region":{"top_left_x":246,"top_left_y":1503,"width":1479,"height":49},"line":51,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e2b4127b81584cf491006c50be7a5d96","type":"text","conversion_output":true,"text":"assignment will be by means of a third-party phone/web-based randomization on visit 2 .","text_display":" assignment will be by means of a third-party phone/web-based randomization on visit 2 .","confidence":0.99609375,"confidence_rate":0.9999588019084422},{"cnt":[[247,1592],[1706,1592],[1706,1638],[247,1638]],"region":{"top_left_x":246,"top_left_y":1592,"width":1461,"height":46},"line":52,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d14f39b29e124e37bfcb22a91899782c","type":"text","conversion_output":true,"text":"Patient assignment to the treatment groups will be determined by a computer generated","text_display":"\n\nPatient assignment to the treatment groups will be determined by a computer generated","confidence":1,"confidence_rate":1},{"cnt":[[247,1640],[1818,1640],[1818,1688],[247,1688]],"region":{"top_left_x":246,"top_left_y":1640,"width":1573,"height":49},"line":53,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"212baadf76b44d9b844be03fc2dac9d2","type":"text","conversion_output":true,"text":"random sequence using IRT. Details are described in the manual for IRT procedures, which is","text_display":" random sequence using IRT. Details are described in the manual for IRT procedures, which is","confidence":1,"confidence_rate":1},{"cnt":[[247,1686],[1752,1686],[1752,1734],[247,1734]],"region":{"top_left_x":246,"top_left_y":1685,"width":1507,"height":49},"line":54,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"850688bbe75e4bd38cd0ef732b8b3783","type":"text","conversion_output":true,"text":"available in the ISF. Details of the process of treatment allocation can be found in Section","text_display":" available in the ISF. Details of the process of treatment allocation can be found in Section","confidence":1,"confidence_rate":1},{"cnt":[[240,1736],[315,1736],[315,1782],[240,1782]],"region":{"top_left_x":239,"top_left_y":1736,"width":77,"height":46},"line":55,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"59fb1ee11e9c466a9ac5884c9cdf9958","type":"text","conversion_output":true,"text":"7.5.","text_display":" 7.5.","confidence":1,"confidence_rate":1},{"cnt":[[247,1832],[1674,1832],[1674,1880],[247,1880]],"region":{"top_left_x":246,"top_left_y":1832,"width":1429,"height":49},"line":56,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1f90c68f3f57461397612a4181e89b61","type":"text","conversion_output":true,"text":"The assigned medication number(s) will be entered in the electronic case record form","text_display":"\n\nThe assigned medication number(s) will be entered in the electronic case record form","confidence":1,"confidence_rate":1},{"cnt":[[247,1878],[1574,1878],[1574,1930],[247,1930]],"region":{"top_left_x":246,"top_left_y":1877,"width":1328,"height":54},"line":57,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0c0d3d454dac4d2b922be62b853a6c88","type":"text","conversion_output":true,"text":"(eCRF), and the corresponding medication kit(s) should be given to the patient.","text_display":" (eCRF), and the corresponding medication kit(s) should be given to the patient.","confidence":0.998046875,"confidence_rate":0.9999767260466069},{"cnt":[[242,1969],[921,1969],[921,2015],[242,2015]],"region":{"top_left_x":242,"top_left_y":1969,"width":679,"height":46},"line":58,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0f8528706f0841a5baf9db6636f97ff1","type":"section_header","conversion_output":false,"children_ids":["6d1c6000b8c34927a3769cb75f56ddda"],"text":"","text_display":""},{"cnt":[[247,1974],[918,1974],[918,2013],[247,2013]],"region":{"top_left_x":246,"top_left_y":1973,"width":673,"height":40},"line":59,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6d1c6000b8c34927a3769cb75f56ddda","type":"text","conversion_output":true,"parent_id":"0f8528706f0841a5baf9db6636f97ff1","text":"4.1.3 Selection of doses in the trial","text_display":"\n\n\\subsection*{4.1.3 Selection of doses in the trial}","confidence":1,"confidence_rate":1},{"cnt":[[247,2061],[1748,2061],[1748,2108],[247,2108]],"region":{"top_left_x":246,"top_left_y":2060,"width":1502,"height":49},"line":60,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"675099c8e6e04570861e23e1d87d89cf","type":"text","conversion_output":true,"text":"The dose of 5 mg linagliptin was selected based on the results from previous dose finding","text_display":"\n\nThe dose of 5 mg linagliptin was selected based on the results from previous dose finding","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[247,2108],[1181,2108],[1181,2159],[247,2159]],"region":{"top_left_x":246,"top_left_y":2108,"width":936,"height":51},"line":61,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bc36cbe571f94d74866ac430ce261dfb","type":"text","conversion_output":true,"text":"studies and represents the approved dose for linagliptin.","text_display":" studies and represents the approved dose for linagliptin.","confidence":1,"confidence_rate":1},{"cnt":[[242,2195],[1510,2195],[1510,2250],[242,2250]],"region":{"top_left_x":242,"top_left_y":2195,"width":1268,"height":56},"line":62,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9758afb5fd5647e0b22918169f279273","type":"section_header","conversion_output":false,"children_ids":["ebb66ccf47544eb0ae5af6f5d28b0428"],"text":"","text_display":""},{"cnt":[[247,2198],[1505,2198],[1505,2246],[247,2246]],"region":{"top_left_x":246,"top_left_y":2197,"width":1260,"height":49},"line":63,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ebb66ccf47544eb0ae5af6f5d28b0428","type":"text","conversion_output":true,"parent_id":"9758afb5fd5647e0b22918169f279273","text":"4.1.4 Drug assignment and administration of doses for each patient","text_display":"\n\n\\subsection*{4.1.4 Drug assignment and administration of doses for each patient}","confidence":1,"confidence_rate":1},{"cnt":[[247,2287],[1738,2287],[1738,2335],[247,2335]],"region":{"top_left_x":246,"top_left_y":2286,"width":1493,"height":49},"line":64,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4f33762f13f84b66adb34c78fd119159","type":"text","conversion_output":true,"text":"Patients will continue with their standard background antidiabetic therapy throughout the","text_display":"\n\nPatients will continue with their standard background antidiabetic therapy throughout the","confidence":1,"confidence_rate":1},{"cnt":[[247,2335],[1775,2335],[1775,2383],[247,2383]],"region":{"top_left_x":246,"top_left_y":2334,"width":1529,"height":49},"line":65,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9bc773e331a140bba1fbc959090ce438","type":"text","conversion_output":true,"text":"entire study with an unchanged dose unless medical emergencies or other plausible reasons","text_display":" entire study with an unchanged dose unless medical emergencies or other plausible reasons","confidence":1,"confidence_rate":1},{"cnt":[[247,2383],[1677,2383],[1677,2433],[247,2433]],"region":{"top_left_x":246,"top_left_y":2382,"width":1431,"height":51},"line":66,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6265268323f44791a45ca93ddab8f563","type":"text","conversion_output":true,"text":"(e.g. renal impairment, lactacidosis, heart failure, dose intolerance, hypoglycaemia or","text_display":" (e.g. renal impairment, lactacidosis, heart failure, dose intolerance, hypoglycaemia or","confidence":1,"confidence_rate":1},{"cnt":[[247,2431],[1693,2431],[1693,2479],[247,2479]],"region":{"top_left_x":246,"top_left_y":2430,"width":1447,"height":49},"line":67,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7aef06369bc74703bb813d56d88ba8fd","type":"text","conversion_output":true,"text":"hyperglycaemia) necessitates changes (at the discretion of the investigator). In case of","text_display":" hyperglycaemia) necessitates changes (at the discretion of the investigator). In case of","confidence":1,"confidence_rate":1},{"cnt":[[247,2481],[1775,2481],[1775,2527],[247,2527]],"region":{"top_left_x":246,"top_left_y":2480,"width":1529,"height":47},"line":68,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"84308f00b0a84e29ad075fa9e81035a3","type":"text","conversion_output":true,"text":"contrast exposure for investigation of coronary artery pathology or other vessel assessment,","text_display":" contrast exposure for investigation of coronary artery pathology or other vessel assessment,","confidence":1,"confidence_rate":1},{"cnt":[[247,2527],[1622,2527],[1622,2574],[247,2574]],"region":{"top_left_x":246,"top_left_y":2526,"width":1376,"height":49},"line":69,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b30dd4b96a274558a12444d334e3aaae","type":"text","conversion_output":true,"text":"metformin is allowed to be temporally held according to regional/local guidelines.","text_display":" metformin is allowed to be temporally held according to regional/local guidelines.","confidence":0.99072265625,"confidence_rate":0.9998928718727244},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":70,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d753248550cb40bba1ee7fe5edf1468e","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":71,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0c192ea96a9a4d73b926eb6008d775e8","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":72,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b5021dd141eb400090b09373e0dfb71e","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-036","page":36,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1aedab9cb3448cfa410103ffef903cf","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"220e16bcc22646d4a79827bac03be9bc","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d82e00910d2d42009648f4434fb187c7","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3183d6d3496a4eddabfebff253a2a490","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13681ebe0e614ad89dcef0687759a477","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae00ff1ddbd8428b8e469485f52bdc5b","type":"page_info","conversion_output":false,"text":"Page 36 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1786,338],[1786,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":1541,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1aa4db562dba4605b8e2ca6817bb09dd","type":"text","conversion_output":true,"text":"Therefore, during the treatment phase it is investigator judgement to change the background","text_display":"\n\nTherefore, during the treatment phase it is investigator judgement to change the background","confidence":1,"confidence_rate":1},{"cnt":[[244,388],[1793,388],[1793,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1550,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba9d189e70f4466fa463a90fc40174c6","type":"text","conversion_output":true,"text":"medication dose, as the background medication of the trial is standard of care treatment with","text_display":" medication dose, as the background medication of the trial is standard of care treatment with","confidence":1,"confidence_rate":1},{"cnt":[[244,434],[1812,434],[1812,484],[244,484]],"region":{"top_left_x":244,"top_left_y":434,"width":1568,"height":51},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25fae7cc1c074d2391e215c6e633feca","type":"text","conversion_output":true,"text":"hypoglycaemic targets as defined by guidelines. Medication for optimising glycaemic control","text_display":" hypoglycaemic targets as defined by guidelines. Medication for optimising glycaemic control","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1512,484],[1512,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1267,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7396349aac864ee19a2b4cba564d960f","type":"text","conversion_output":true,"text":"could also be initiated provided protocol criteria are met (see section 4.2.1).","text_display":" could also be initiated provided protocol criteria are met (see section 4.2.1).","confidence":1,"confidence_rate":1},{"cnt":[[247,571],[1807,571],[1807,619],[247,619]],"region":{"top_left_x":246,"top_left_y":571,"width":1561,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9eeeaaf8b4f14db293f2b97c78d807a4","type":"text","conversion_output":true,"text":"Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, caution is advised","text_display":"\n\nSulphonylureas and insulin are known to cause hypoglycaemia. Therefore, caution is advised","confidence":1,"confidence_rate":1},{"cnt":[[247,621],[1818,621],[1818,669],[247,669]],"region":{"top_left_x":246,"top_left_y":621,"width":1573,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a25ac9f12c84d1688fb89d3cd387ee4","type":"text","conversion_output":true,"text":"when linagliptin is used in combination with a sulphonylurea and/or insulin. A dose reduction","text_display":" when linagliptin is used in combination with a sulphonylurea and/or insulin. A dose reduction","confidence":1,"confidence_rate":1},{"cnt":[[247,667],[1099,667],[1099,715],[247,715]],"region":{"top_left_x":246,"top_left_y":667,"width":853,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a6d96d8f70a40acb949cb0808af124c","type":"text","conversion_output":true,"text":"of the sulphonylurea or insulin may be considered.","text_display":" of the sulphonylurea or insulin may be considered.","confidence":1,"confidence_rate":1},{"cnt":[[244,763],[1816,763],[1816,811],[244,811]],"region":{"top_left_x":244,"top_left_y":762,"width":1573,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b2b7316cc064b179d69a44e323a2981","type":"text","conversion_output":true,"text":"Medication will be dispensed in a double-blind-manner as either 5 mg linagliptin or matching","text_display":"\n\nMedication will be dispensed in a double-blind-manner as either 5 mg linagliptin or matching","confidence":1,"confidence_rate":1},{"cnt":[[244,813],[1743,813],[1743,861],[244,861]],"region":{"top_left_x":244,"top_left_y":813,"width":1499,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"306e009d65ce47c4a4d77b82c5aea7c9","type":"text","conversion_output":true,"text":"placebo. IRT will allocate medication kit numbers at all study visits from visit 2 till study","text_display":" placebo. IRT will allocate medication kit numbers at all study visits from visit 2 till study","confidence":1,"confidence_rate":1},{"cnt":[[247,859],[1800,859],[1800,907],[247,907]],"region":{"top_left_x":246,"top_left_y":858,"width":1555,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6f37ac0676b4dad81e975237a56645a","type":"text","conversion_output":true,"text":"end. At visit 2 patients will receive one treatment box sufficient for 12 weeks treatment (plus","text_display":" end. At visit 2 patients will receive one treatment box sufficient for 12 weeks treatment (plus","confidence":1,"confidence_rate":1},{"cnt":[[247,909],[1759,909],[1759,957],[247,957]],"region":{"top_left_x":246,"top_left_y":909,"width":1513,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e25818c77a3f461a9da6d6c22e7fc69c","type":"text","conversion_output":true,"text":"one week reserve). As of visit 3 (till study end) patients will receive two medication boxes","text_display":" one week reserve). As of visit 3 (till study end) patients will receive two medication boxes","confidence":1,"confidence_rate":1},{"cnt":[[247,955],[1695,955],[1695,1007],[247,1007]],"region":{"top_left_x":246,"top_left_y":954,"width":1450,"height":54},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bfe323306efa472a9e99c044162dbf8e","type":"text","conversion_output":true,"text":"sufficient for 24 weeks treatment (plus two weeks reserve). The protocol allows a time","text_display":" sufficient for 24 weeks treatment (plus two weeks reserve). The protocol allows a time","confidence":1,"confidence_rate":1},{"cnt":[[247,1005],[1711,1005],[1711,1053],[247,1053]],"region":{"top_left_x":246,"top_left_y":1005,"width":1465,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a99d7d22e6c945bfa28d1bf443360a2f","type":"text","conversion_output":true,"text":"window of +/- 7 days for visit 3 and +/- 14 days for all scheduled visits in the treatment","text_display":" window of +/- 7 days for visit 3 and +/- 14 days for all scheduled visits in the treatment","confidence":0.9960973262786865,"confidence_rate":0.9999624015816049},{"cnt":[[244,1051],[1764,1051],[1764,1101],[244,1101]],"region":{"top_left_x":244,"top_left_y":1050,"width":1520,"height":52},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee45768ed7fa43e38e0afb56e566d4da","type":"text","conversion_output":true,"text":"period after visit 3 . To ensure sufficient medication, visits after visit 3 should be scheduled","text_display":" period after visit 3 . To ensure sufficient medication, visits after visit 3 should be scheduled","confidence":0.907804012298584,"confidence_rate":0.9990964199776377},{"cnt":[[244,1099],[1569,1097],[1569,1147],[244,1149]],"region":{"top_left_x":244,"top_left_y":1096,"width":1326,"height":54},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b27a4dc5c15b40e4a7730538612c8d5f","type":"text","conversion_output":true,"text":"within 182 days and visit 3 should take place no later than 91 days after visit 2 .","text_display":" within 182 days and visit 3 should take place no later than 91 days after visit 2 .","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[247,1190],[1688,1190],[1688,1238],[247,1238]],"region":{"top_left_x":246,"top_left_y":1190,"width":1443,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a64675ef931a4fe29c274a35aa70a452","type":"text","conversion_output":true,"text":"The patients will be instructed to bring their home blood glucose monitoring (HBGM)","text_display":"\n\nThe patients will be instructed to bring their home blood glucose monitoring (HBGM)","confidence":1,"confidence_rate":1},{"cnt":[[247,1238],[1181,1238],[1181,1286],[247,1286]],"region":{"top_left_x":246,"top_left_y":1238,"width":936,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b6c92a687e64e3e91a9e9c5a4eec2e8","type":"text","conversion_output":true,"text":"devices to each visit for measurement of fasted glucose.","text_display":" devices to each visit for measurement of fasted glucose.","confidence":1,"confidence_rate":1},{"cnt":[[247,1327],[1750,1327],[1750,1375],[247,1375]],"region":{"top_left_x":246,"top_left_y":1327,"width":1504,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0c1c2a6d9224da0bddd6dccec7a9343","type":"text","conversion_output":true,"text":"Administration of the study medication is once daily. Patients should be instructed to take","text_display":"\n\nAdministration of the study medication is once daily. Patients should be instructed to take","confidence":1,"confidence_rate":1},{"cnt":[[244,1375],[1802,1375],[1802,1419],[244,1419]],"region":{"top_left_x":244,"top_left_y":1375,"width":1559,"height":44},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1177fa5c7c88455e90b0d9f810563174","type":"text","conversion_output":true,"text":"their trial medication with water. To ensure a dose interval of about 24 hours, the medication","text_display":" their trial medication with water. To ensure a dose interval of about 24 hours, the medication","confidence":1,"confidence_rate":1},{"cnt":[[247,1421],[1766,1421],[1766,1469],[247,1469]],"region":{"top_left_x":246,"top_left_y":1420,"width":1520,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f161c9091d8405092ac19c0c8590909","type":"text","conversion_output":true,"text":"should be taken at the same time every day. If a dose is missed by more than 12 hours, that","text_display":" should be taken at the same time every day. If a dose is missed by more than 12 hours, that","confidence":1,"confidence_rate":1},{"cnt":[[247,1471],[1734,1471],[1734,1519],[247,1519]],"region":{"top_left_x":246,"top_left_y":1471,"width":1488,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"39073248554e448294a680adfacb5409","type":"text","conversion_output":true,"text":"dose should be skipped and the next dose should be taken as scheduled. No double doses","text_display":" dose should be skipped and the next dose should be taken as scheduled. No double doses","confidence":1,"confidence_rate":1},{"cnt":[[247,1519],[1409,1519],[1409,1565],[247,1565]],"region":{"top_left_x":246,"top_left_y":1519,"width":1164,"height":46},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8db562371b7244bd8b5881c7d5e487db","type":"text","conversion_output":true,"text":"should be taken. Study medication can be taken with or without food.","text_display":" should be taken. Study medication can be taken with or without food.","confidence":1,"confidence_rate":1},{"cnt":[[247,1608],[1780,1608],[1780,1656],[247,1656]],"region":{"top_left_x":246,"top_left_y":1608,"width":1534,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"254cabe586c34210aa13862d32ec73f6","type":"text","conversion_output":true,"text":"In some situations, it might be necessary to interrupt study medication temporarily. Patients","text_display":"\n\nIn some situations, it might be necessary to interrupt study medication temporarily. Patients","confidence":1,"confidence_rate":1},{"cnt":[[247,1658],[1818,1658],[1818,1706],[247,1706]],"region":{"top_left_x":246,"top_left_y":1658,"width":1573,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd7b7e0277eb498fa367d2df3260ecec","type":"text","conversion_output":true,"text":"are encouraged to re-start study treatment after an interruption if appropriate in the opinion of","text_display":" are encouraged to re-start study treatment after an interruption if appropriate in the opinion of","confidence":1,"confidence_rate":1},{"cnt":[[244,1704],[957,1704],[957,1752],[244,1752]],"region":{"top_left_x":244,"top_left_y":1704,"width":714,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc1a03ae8284474fab26dbb482c03aca","type":"text","conversion_output":true,"text":"the investigator and if not contraindicated.","text_display":" the investigator and if not contraindicated.","confidence":1,"confidence_rate":1},{"cnt":[[247,1793],[1807,1793],[1807,1841],[247,1841]],"region":{"top_left_x":246,"top_left_y":1793,"width":1561,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0bead540cef24cf699a7107c7876b192","type":"text","conversion_output":true,"text":"Patients should be instructed to be fasted and not to take their trial medication in the morning","text_display":"\n\nPatients should be instructed to be fasted and not to take their trial medication in the morning","confidence":1,"confidence_rate":1},{"cnt":[[247,1841],[1789,1841],[1789,1889],[247,1889]],"region":{"top_left_x":246,"top_left_y":1841,"width":1543,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a7ab2f56b92417c9ee5cf1e80d80c7d","type":"text","conversion_output":true,"text":"of visit days as they will be dosed whilst in the clinic. Patients who fail to do so should have","text_display":" of visit days as they will be dosed whilst in the clinic. Patients who fail to do so should have","confidence":1,"confidence_rate":1},{"cnt":[[244,1889],[1784,1889],[1784,1939],[244,1939]],"region":{"top_left_x":244,"top_left_y":1889,"width":1541,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0707ef4edd240fdb713bc7922324cb7","type":"text","conversion_output":true,"text":"the visit rescheduled as soon as possible, reminding the patient about the expectations at the","text_display":" the visit rescheduled as soon as possible, reminding the patient about the expectations at the","confidence":1,"confidence_rate":1},{"cnt":[[247,1937],[1816,1937],[1816,1985],[247,1985]],"region":{"top_left_x":246,"top_left_y":1937,"width":1571,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0bde5dc0d6294d48b1029efbf6bc0d3f","type":"text","conversion_output":true,"text":"study visit. Background and/or optimizing hypoglycaemic control medication will be taken as","text_display":" study visit. Background and/or optimizing hypoglycaemic control medication will be taken as","confidence":1,"confidence_rate":1},{"cnt":[[247,1987],[770,1987],[770,2035],[247,2035]],"region":{"top_left_x":246,"top_left_y":1987,"width":524,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d79997f3416b4d3db62cac58c3edc9a6","type":"text","conversion_output":true,"text":"prescribed including visit days.","text_display":" prescribed including visit days.","confidence":1,"confidence_rate":1},{"cnt":[[242,2072],[1124,2072],[1124,2127],[242,2127]],"region":{"top_left_x":242,"top_left_y":2071,"width":882,"height":56},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18d68f952fb84e93978ef9b166db1855","type":"section_header","conversion_output":false,"children_ids":["f0a47866abb04649a791a885006d8697"],"text":"","text_display":""},{"cnt":[[247,2074],[1119,2074],[1119,2122],[247,2122]],"region":{"top_left_x":246,"top_left_y":2074,"width":874,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0a47866abb04649a791a885006d8697","type":"text","conversion_output":true,"parent_id":"18d68f952fb84e93978ef9b166db1855","text":"4.1.5 Blinding and procedures for unblinding","text_display":"\n\n\\subsection*{4.1.5 Blinding and procedures for unblinding}","confidence":1,"confidence_rate":1},{"cnt":[[242,2161],[560,2161],[560,2218],[242,2218]],"region":{"top_left_x":242,"top_left_y":2161,"width":318,"height":58},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f3fff5372164af3ab975ff9814cb577","type":"section_header","conversion_output":false,"children_ids":["f7f4a76a45e24b85be84ff482ba37436"],"text":"","text_display":""},{"cnt":[[247,2166],[555,2166],[555,2214],[247,2214]],"region":{"top_left_x":246,"top_left_y":2165,"width":310,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7f4a76a45e24b85be84ff482ba37436","type":"text","conversion_output":true,"parent_id":"1f3fff5372164af3ab975ff9814cb577","text":"4.1.5.1 Blinding","text_display":"\n\n\\subsection*{4.1.5.1 Blinding}","confidence":1,"confidence_rate":1},{"cnt":[[247,2255],[1775,2255],[1775,2300],[247,2300]],"region":{"top_left_x":246,"top_left_y":2254,"width":1529,"height":47},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e65a168d45b47998b37997f5f7a0be9","type":"text","conversion_output":true,"text":"Patients, investigators and everyone involved in analyzing or with an interest in this double","text_display":"\n\nPatients, investigators and everyone involved in analyzing or with an interest in this double","confidence":1,"confidence_rate":1},{"cnt":[[247,2303],[1757,2303],[1757,2351],[247,2351]],"region":{"top_left_x":246,"top_left_y":2302,"width":1511,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e8af2c5d8320447cb9c65d3b22781c40","type":"text","conversion_output":true,"text":"blind study will remain blinded with regard to the randomized treatment assignments until","text_display":" blind study will remain blinded with regard to the randomized treatment assignments until","confidence":1,"confidence_rate":1},{"cnt":[[247,2348],[573,2348],[573,2392],[247,2392]],"region":{"top_left_x":246,"top_left_y":2348,"width":328,"height":44},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"962858558c0245a99479580108d5c20e","type":"text","conversion_output":true,"text":"after database lock.","text_display":" after database lock.","confidence":1,"confidence_rate":1},{"cnt":[[247,2447],[1738,2447],[1738,2495],[247,2495]],"region":{"top_left_x":246,"top_left_y":2446,"width":1493,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c58c245621541608bf4a7315fe7191e","type":"text","conversion_output":true,"text":"The randomization code will be kept secret by Clinical Trial Support up to database lock.","text_display":"\n\nThe randomization code will be kept secret by Clinical Trial Support up to database lock.","confidence":1,"confidence_rate":1},{"cnt":[[247,2495],[1780,2495],[1780,2543],[247,2543]],"region":{"top_left_x":246,"top_left_y":2494,"width":1534,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3957829baceb429ea10da3ceb144438f","type":"text","conversion_output":true,"text":"Refer to Section 4.1.5.2 for rules of breaking the code for an individual or for all patients in","text_display":" Refer to Section 4.1.5.2 for rules of breaking the code for an individual or for all patients in","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"dce04b6a89094073bdbf2ea8934a17bf","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99560546875,"confidence_rate":0.9998951432220243},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4d9ddf6dce474d90a52df14ee0b2f237","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"72b2d62840cf4cd28fdbb82c153e80d0","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-037","page":37,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7f4d9546f6a418b89aecd5080c2a715","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a56445d227264f8bbbbec937265de8fa","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"821f16c301914c798ea7122747c1d5dd","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b7db88599fb4fb68b164504e3046e79","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76066c36754f45078a73c3423279ef11","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe22d283d7fb40e7aa3d6bcfb8f2e6ae","type":"page_info","conversion_output":false,"text":"Page 37 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,343],[614,343],[614,386],[247,386]],"region":{"top_left_x":246,"top_left_y":342,"width":369,"height":45},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73502aeb1a214400a5023b5bf078a609","type":"text","conversion_output":true,"text":"emergency situations.","text_display":"\nemergency situations.","confidence":0.9990234375,"confidence_rate":0.9999624222580676},{"cnt":[[247,434],[1743,434],[1743,484],[247,484]],"region":{"top_left_x":246,"top_left_y":434,"width":1497,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"094ea94fdbf94c21a3970ed37885da9d","type":"text","conversion_output":true,"text":"Due to the requirements to report Suspected Unexpected Serious Adverse Reactions","text_display":"\n\nDue to the requirements to report Suspected Unexpected Serious Adverse Reactions","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1690,484],[1690,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1445,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9fd7c3920c744249b25b88225fe202ad","type":"text","conversion_output":true,"text":"(SUSARs), it may be necessary for a representative from Boehringer Ingelheim's","text_display":" (SUSARs), it may be necessary for a representative from Boehringer Ingelheim's","confidence":1,"confidence_rate":1},{"cnt":[[247,532],[1711,532],[1711,580],[247,580]],"region":{"top_left_x":246,"top_left_y":532,"width":1465,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2baac11eb8243bb93814277d215a7f4","type":"text","conversion_output":true,"text":"Pharmacovigilance group to access the randomization code for individual patients","text_display":" Pharmacovigilance group to access the randomization code for individual patients","confidence":1,"confidence_rate":1},{"cnt":[[247,580],[1592,580],[1592,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1347,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73a2e2b47a704e1692fee8025f1d78cd","type":"text","conversion_output":true,"text":"during trial conduct. The access to the code will only be given to authorized","text_display":" during trial conduct. The access to the code will only be given to authorized","confidence":1,"confidence_rate":1},{"cnt":[[247,626],[1355,626],[1355,674],[247,674]],"region":{"top_left_x":246,"top_left_y":625,"width":1109,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"397bb17e9f044b70809752e776828ffb","type":"text","conversion_output":true,"text":"Pharmacovigilance representatives and not be shared further.","text_display":" Pharmacovigilance representatives and not be shared further.","confidence":1,"confidence_rate":1},{"cnt":[[247,722],[1770,722],[1770,770],[247,770]],"region":{"top_left_x":246,"top_left_y":721,"width":1525,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d0384abd092404bade6cada8486570f","type":"text","conversion_output":true,"text":"For Japan only: in this blinded trial, an emergency code break will be available to the","text_display":"\n\nFor Japan only: in this blinded trial, an emergency code break will be available to the","confidence":1,"confidence_rate":1},{"cnt":[[247,772],[1752,772],[1752,820],[247,820]],"region":{"top_left_x":246,"top_left_y":772,"width":1507,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3939d6098f274aeda9e06fba458725ed","type":"text","conversion_output":true,"text":"Investigator via the IRT system. This code break may only be accessed in emergency","text_display":" Investigator via the IRT system. This code break may only be accessed in emergency","confidence":1,"confidence_rate":1},{"cnt":[[247,818],[1812,818],[1812,866],[247,866]],"region":{"top_left_x":246,"top_left_y":817,"width":1566,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bfd0e0794a2440da870d1dbff76abcd","type":"text","conversion_output":true,"text":"situations when the identity of the trial drug must be known to the Investigator in order","text_display":" situations when the identity of the trial drug must be known to the Investigator in order","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[247,868],[1727,868],[1727,916],[247,916]],"region":{"top_left_x":246,"top_left_y":868,"width":1481,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abe310f142944bddb28b5e078bb7e883","type":"text","conversion_output":true,"text":"to provide appropriate medical treatment or if required to assure the safety of trial","text_display":" to provide appropriate medical treatment or if required to assure the safety of trial","confidence":1,"confidence_rate":1},{"cnt":[[247,916],[1633,916],[1633,962],[247,962]],"region":{"top_left_x":246,"top_left_y":916,"width":1388,"height":46},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ffb58b35e2d4e2db94c3f0c5d264909","type":"text","conversion_output":true,"text":"participants. Each site receives a manual from the IRT provider that contains","text_display":" participants. Each site receives a manual from the IRT provider that contains","confidence":1,"confidence_rate":1},{"cnt":[[247,964],[1706,964],[1706,1012],[247,1012]],"region":{"top_left_x":246,"top_left_y":964,"width":1461,"height":48},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d07e9850f0ca4e8fbd161c5605de21d4","type":"text","conversion_output":true,"text":"instructions on how to unblind the treatment of a patient via the IRT (via 24-hour","text_display":" instructions on how to unblind the treatment of a patient via the IRT (via 24-hour","confidence":0.99755859375,"confidence_rate":0.9999719039424972},{"cnt":[[247,1010],[1748,1010],[1748,1062],[247,1062]],"region":{"top_left_x":246,"top_left_y":1009,"width":1502,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d54c45b903b04912acd057517f1a3ff7","type":"text","conversion_output":true,"text":"Emergency helpline). If the code break for a patient is accessed, the sponsor must be","text_display":" Emergency helpline). If the code break for a patient is accessed, the sponsor must be","confidence":1,"confidence_rate":1},{"cnt":[[247,1060],[1798,1060],[1798,1108],[247,1108]],"region":{"top_left_x":246,"top_left_y":1059,"width":1552,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc2b6d1954294f3687813e4e685d63f0","type":"text","conversion_output":true,"text":"informed immediately. The reason for accessing the code break, together with the date,","text_display":" informed immediately. The reason for accessing the code break, together with the date,","confidence":1,"confidence_rate":1},{"cnt":[[247,1106],[1780,1106],[1780,1156],[247,1156]],"region":{"top_left_x":246,"top_left_y":1105,"width":1534,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a1441245f1842f19ac9465adcbcd6e6","type":"text","conversion_output":true,"text":"must be documented on the appropriate CRF page. In case third party needs to break","text_display":" must be documented on the appropriate CRF page. In case third party needs to break","confidence":1,"confidence_rate":1},{"cnt":[[247,1154],[1798,1154],[1798,1202],[247,1202]],"region":{"top_left_x":246,"top_left_y":1153,"width":1552,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b24000f069c4f18b94e6e6ac0357cee","type":"text","conversion_output":true,"text":"the code, however, when the Investigator cannot be reached, the code can be opened by","text_display":" the code, however, when the Investigator cannot be reached, the code can be opened by","confidence":1,"confidence_rate":1},{"cnt":[[247,1202],[843,1202],[843,1250],[247,1250]],"region":{"top_left_x":246,"top_left_y":1201,"width":597,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d93a10725655413295c481e1fc0eeb75","type":"text","conversion_output":true,"text":"calling emergency code manager.","text_display":" calling emergency code manager.","confidence":0.99951171875,"confidence_rate":0.9999864334115239},{"cnt":[[247,1298],[1652,1298],[1652,1345],[247,1345]],"region":{"top_left_x":246,"top_left_y":1297,"width":1406,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36b24d6603274129bc8578d720d93e7a","type":"text","conversion_output":true,"text":"The DMC will have access to unblinded data, refer to Section 3.1 and Section 7.3.4.","text_display":"\n\nThe DMC will have access to unblinded data, refer to Section 3.1 and Section 7.3.4.","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[242,1391],[1044,1391],[1044,1446],[242,1446]],"region":{"top_left_x":242,"top_left_y":1391,"width":802,"height":56},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27de252354204dfb8e51478ee1d01027","type":"section_header","conversion_output":false,"children_ids":["b1faa4a786664238ba68747ae2bdeb01"],"text":"","text_display":""},{"cnt":[[247,1446],[247,1393],[1040,1396],[1039,1448]],"region":{"top_left_x":246,"top_left_y":1393,"width":794,"height":56},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1faa4a786664238ba68747ae2bdeb01","type":"text","conversion_output":true,"parent_id":"27de252354204dfb8e51478ee1d01027","text":"4.1.5.2 Procedures for emergency unblinding","text_display":"\n\n\\subsection*{4.1.5.2 Procedures for emergency unblinding}","confidence":1,"confidence_rate":1},{"cnt":[[247,1485],[1729,1485],[1729,1533],[247,1533]],"region":{"top_left_x":246,"top_left_y":1484,"width":1484,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31d3b9b5b95f40cb81e9b36426334d2d","type":"text","conversion_output":true,"text":"In the event of a medical emergency that requires identification of an individual patient's","text_display":"\n\nIn the event of a medical emergency that requires identification of an individual patient's","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[247,1531],[1759,1531],[1759,1579],[247,1579]],"region":{"top_left_x":246,"top_left_y":1530,"width":1513,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be9ece3c09184570ab4e6118dd0f3a15","type":"text","conversion_output":true,"text":"treatment, investigators will be able to access this information via IRT. The monitor or the","text_display":" treatment, investigators will be able to access this information via IRT. The monitor or the","confidence":1,"confidence_rate":1},{"cnt":[[247,1581],[1750,1581],[1750,1629],[247,1629]],"region":{"top_left_x":246,"top_left_y":1580,"width":1504,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce8bda5c1c5c4fcfb29460fc4a35eaf4","type":"text","conversion_output":true,"text":"onsite monitor/CRA should be contacted immediately (preferably before unblinding takes","text_display":" onsite monitor/CRA should be contacted immediately (preferably before unblinding takes","confidence":1,"confidence_rate":1},{"cnt":[[247,1629],[1729,1629],[1729,1677],[247,1677]],"region":{"top_left_x":246,"top_left_y":1628,"width":1484,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5199c9a3bf94d818d569581319408a5","type":"text","conversion_output":true,"text":"place) and the reason for unblinding the patient's treatment should be documented in the","text_display":" place) and the reason for unblinding the patient's treatment should be documented in the","confidence":1,"confidence_rate":1},{"cnt":[[247,1677],[1652,1677],[1652,1725],[247,1725]],"region":{"top_left_x":246,"top_left_y":1676,"width":1406,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ea811c09c3743e7a3e40eecf244e559","type":"text","conversion_output":true,"text":"medical records. The patient could continue with study medication after unblinding.","text_display":" medical records. The patient could continue with study medication after unblinding.","confidence":1,"confidence_rate":1},{"cnt":[[242,1764],[1039,1764],[1039,1821],[242,1821]],"region":{"top_left_x":242,"top_left_y":1763,"width":798,"height":58},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a398397239b543b88181c448172255d8","type":"section_header","conversion_output":false,"children_ids":["775379ea849f4b8aafa41a8ba5983e91"],"text":"","text_display":""},{"cnt":[[247,1768],[1035,1768],[1035,1816],[247,1816]],"region":{"top_left_x":246,"top_left_y":1768,"width":789,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"775379ea849f4b8aafa41a8ba5983e91","type":"text","conversion_output":true,"parent_id":"a398397239b543b88181c448172255d8","text":"4.1.6 Packaging, labelling, and re-supply","text_display":"\n\n\\subsection*{4.1.6 Packaging, labelling, and re-supply}","confidence":1,"confidence_rate":1},{"cnt":[[247,1855],[1684,1855],[1684,1903],[247,1903]],"region":{"top_left_x":246,"top_left_y":1854,"width":1438,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"169950f6735241b787ba1327d8227e1d","type":"text","conversion_output":true,"text":"Drug supplies will be provided by the Department of Pharmaceutical Development of","text_display":"\n\nDrug supplies will be provided by the Department of Pharmaceutical Development of","confidence":1,"confidence_rate":1},{"cnt":[[247,1903],[1734,1903],[1734,1951],[247,1951]],"region":{"top_left_x":246,"top_left_y":1902,"width":1488,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bdc5d36e37d74cae8ab6d3ff96e05ba4","type":"text","conversion_output":true,"text":"Boehringer Ingelheim Pharma GmbH \\& Co. KG, Germany. All study medication will be","text_display":" Boehringer Ingelheim Pharma GmbH \\& Co. KG, Germany. All study medication will be","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[247,1951],[1798,1951],[1798,1994],[247,1994]],"region":{"top_left_x":246,"top_left_y":1950,"width":1552,"height":45},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3ea0db02ed84b7082dbb4d94c98f77c","type":"text","conversion_output":true,"text":"contained in medication boxes identified with the trial number and medication number. Each","text_display":" contained in medication boxes identified with the trial number and medication number. Each","confidence":1,"confidence_rate":1},{"cnt":[[247,1997],[1768,1997],[1768,2049],[247,2049]],"region":{"top_left_x":246,"top_left_y":1996,"width":1523,"height":54},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a591863887a4a29940cc5bbd25401cd","type":"text","conversion_output":true,"text":"medication box will contain sufficient BI linagliptin tablets or matching placebo tablets for","text_display":" medication box will contain sufficient BI linagliptin tablets or matching placebo tablets for","confidence":1,"confidence_rate":1},{"cnt":[[247,2047],[991,2047],[991,2095],[247,2095]],"region":{"top_left_x":246,"top_left_y":2046,"width":746,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9faade74d8249ef9bfb0b51e738b7dd","type":"text","conversion_output":true,"text":"12 weeks treatment (plus one week reserve).","text_display":" 12 weeks treatment (plus one week reserve).","confidence":1,"confidence_rate":1},{"cnt":[[247,2138],[1579,2138],[1579,2186],[247,2186]],"region":{"top_left_x":246,"top_left_y":2138,"width":1333,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"05a33513a3a8413ea85f21a520a59479","type":"text","conversion_output":true,"text":"Trial drug will be supplied on a per visit basis. Supply will be managed by IRT.","text_display":"\n\nTrial drug will be supplied on a per visit basis. Supply will be managed by IRT.","confidence":1,"confidence_rate":1},{"cnt":[[247,2225],[1099,2225],[1099,2273],[247,2273]],"region":{"top_left_x":246,"top_left_y":2224,"width":853,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2415aaa231614c5c8a26685780421a31","type":"text","conversion_output":true,"text":"Examples of the labels will be available in the ISF.","text_display":"\nExamples of the labels will be available in the ISF.","confidence":1,"confidence_rate":1},{"cnt":[[242,2312],[742,2312],[742,2369],[242,2369]],"region":{"top_left_x":242,"top_left_y":2311,"width":501,"height":58},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc76d0dfc7bc45c29229f4aed030f240","type":"section_header","conversion_output":false,"children_ids":["fbbc7fb2933849a89a8ec7dd2e77a205"],"text":"","text_display":""},{"cnt":[[247,2316],[738,2316],[738,2364],[247,2364]],"region":{"top_left_x":246,"top_left_y":2316,"width":492,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fbbc7fb2933849a89a8ec7dd2e77a205","type":"text","conversion_output":true,"parent_id":"bc76d0dfc7bc45c29229f4aed030f240","text":"4.1.7 Storage conditions","text_display":"\n\n\\subsection*{4.1.7 Storage conditions}","confidence":0.9990234375,"confidence_rate":0.9999663095451973},{"cnt":[[247,2408],[1761,2408],[1761,2456],[247,2456]],"region":{"top_left_x":246,"top_left_y":2407,"width":1516,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d11528e5d1134b1ca8dd8ced49ca77cc","type":"text","conversion_output":true,"text":"The study medication must be kept in its original packaging under the recommended","text_display":"\n\nThe study medication must be kept in its original packaging under the recommended","confidence":1,"confidence_rate":1},{"cnt":[[247,2453],[1816,2453],[1816,2501],[247,2501]],"region":{"top_left_x":246,"top_left_y":2453,"width":1571,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e3307a27979462cada0c463c65f3bce","type":"text","conversion_output":true,"text":"storage conditions indicated on the label. All trial medication should be stored according to","text_display":" storage conditions indicated on the label. All trial medication should be stored according to","confidence":1,"confidence_rate":1},{"cnt":[[247,2499],[1816,2499],[1816,2549],[247,2549]],"region":{"top_left_x":246,"top_left_y":2499,"width":1571,"height":51},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff6f877003654e84ac7d1a67d26a1c65","type":"text","conversion_output":true,"text":"the storage conditions as specified on the label and in the original package. Patients should be","text_display":" the storage conditions as specified on the label and in the original package. Patients should be","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"55f8519ed8684e008ca365388b78a300","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"71d62a3cdf1f49edbe2eba3feef9b6c2","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"718c7972eb974c38b80bd1e2bfdb2b75","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-038","page":38,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f09f5d56f51d46aa8f9895e2b8028346","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"320d9064574441c483a670b52b9a4c01","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54d09f6b67f64dedb0f31fe200a70e2f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e60ca26f42ef4239a0f33eb9a8dcfda7","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad16b6314ca6438ab9a4429352cd1a65","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0cf1070fd2bf49e0a9faca0a23360c62","type":"page_info","conversion_output":false,"text":"Page 38 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1777,338],[1777,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":1532,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6447dc1132a4c6e97c3bb51b47a1725","type":"text","conversion_output":true,"text":"instructed not to remove the trial medication from the blisters until immediately prior to the","text_display":"\ninstructed not to remove the trial medication from the blisters until immediately prior to the","confidence":1,"confidence_rate":1},{"cnt":[[247,388],[1761,388],[1761,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1516,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3058adf18054517b82731c03a0fd218","type":"text","conversion_output":true,"text":"time of intake to protect tablets from humidity and light. Patients will be reminded to keep","text_display":" time of intake to protect tablets from humidity and light. Patients will be reminded to keep","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1124,434],[1124,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":878,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0246559cb35d44f58029f75cdae199ae","type":"text","conversion_output":true,"text":"the study drug out of the sight and reach of children.","text_display":" the study drug out of the sight and reach of children.","confidence":1,"confidence_rate":1},{"cnt":[[244,532],[1775,532],[1775,578],[244,578]],"region":{"top_left_x":244,"top_left_y":532,"width":1531,"height":46},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73f77475ab3146d393a83071cdb81a10","type":"text","conversion_output":true,"text":"A temperature log must be maintained at sites. If storage conditions are found to be outside","text_display":"\n\nA temperature log must be maintained at sites. If storage conditions are found to be outside","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[247,580],[1784,580],[1784,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1539,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16a31699df85499f8143121a648c533c","type":"text","conversion_output":true,"text":"the specific range, the monitor or designee, IRT and the BI clinical trial supply unit (CTSU)","text_display":" the specific range, the monitor or designee, IRT and the BI clinical trial supply unit (CTSU)","confidence":1,"confidence_rate":1},{"cnt":[[244,626],[1748,626],[1748,674],[244,674]],"region":{"top_left_x":244,"top_left_y":625,"width":1504,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e21ebb157e0740f2914825bd50418eeb","type":"text","conversion_output":true,"text":"must be contacted immediately in order to clarify whether the trial medication can still be","text_display":" must be contacted immediately in order to clarify whether the trial medication can still be","confidence":1,"confidence_rate":1},{"cnt":[[247,672],[338,672],[338,715],[247,715]],"region":{"top_left_x":246,"top_left_y":671,"width":93,"height":45},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2db7d806abc4cf4877788366ec50d24","type":"text","conversion_output":true,"text":"used.","text_display":" used.","confidence":1,"confidence_rate":1},{"cnt":[[242,818],[242,761],[770,763],[770,820]],"region":{"top_left_x":241,"top_left_y":760,"width":530,"height":60},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3fee6424a7a048f2a4445e38e661f6b1","type":"section_header","conversion_output":false,"children_ids":["963d87950c884aa8b528d0231dc5d87f"],"text":"","text_display":""},{"cnt":[[247,763],[765,763],[765,816],[247,816]],"region":{"top_left_x":246,"top_left_y":762,"width":520,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"963d87950c884aa8b528d0231dc5d87f","type":"text","conversion_output":true,"parent_id":"3fee6424a7a048f2a4445e38e661f6b1","text":"4.1.8 Drug accountability","text_display":"\n\n\\subsection*{4.1.8 Drug accountability}","confidence":1,"confidence_rate":1},{"cnt":[[247,854],[1706,854],[1706,902],[247,902]],"region":{"top_left_x":246,"top_left_y":854,"width":1461,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42b24ff05e2243e8a39031f53a2528b2","type":"text","conversion_output":true,"text":"Drug supplies, which will be provided by the sponsor, must be kept in a secure, limited","text_display":"\n\nDrug supplies, which will be provided by the sponsor, must be kept in a secure, limited","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[247,905],[1446,905],[1446,953],[247,953]],"region":{"top_left_x":246,"top_left_y":904,"width":1201,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8bb357ab630f446991f20e0a715b7f40","type":"text","conversion_output":true,"text":"access storage area under the storage conditions defined by the sponsor.","text_display":" access storage area under the storage conditions defined by the sponsor.","confidence":0.99951171875,"confidence_rate":0.9999936571565041},{"cnt":[[247,971],[1738,971],[1738,1019],[247,1019]],"region":{"top_left_x":246,"top_left_y":970,"width":1493,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34631140e2f94ad396bd2adefd759829","type":"text","conversion_output":true,"text":"The investigator, pharmacist and/or investigational drug storage manager will receive the","text_display":"\n\nThe investigator, pharmacist and/or investigational drug storage manager will receive the","confidence":1,"confidence_rate":1},{"cnt":[[247,1019],[1679,1019],[1679,1067],[247,1067]],"region":{"top_left_x":246,"top_left_y":1018,"width":1434,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e7a7876ba23413fb2835c5d4ed13717","type":"text","conversion_output":true,"text":"investigational drugs when all country specific required approvals are in place and all","text_display":" investigational drugs when all country specific required approvals are in place and all","confidence":1,"confidence_rate":1},{"cnt":[[244,1067],[1307,1067],[1307,1117],[244,1117]],"region":{"top_left_x":244,"top_left_y":1066,"width":1063,"height":52},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0eb5e8db66b446a39cf6a7ef39487729","type":"text","conversion_output":true,"text":"required country specific essential documents are in house e.g.:","text_display":" required country specific essential documents are in house e.g.:","confidence":1,"confidence_rate":1},{"cnt":[[306,1128],[1674,1128],[1674,1176],[306,1176]],"region":{"top_left_x":306,"top_left_y":1128,"width":1369,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf69a3e1904b4bdcb32813d60a604dc6","type":"text","conversion_output":true,"text":"- approval of the study protocol by the independent review board (IRB) / ethics","text_display":"\n- approval of the study protocol by the independent review board (IRB) / ethics","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[370,1179],[564,1179],[564,1222],[370,1222]],"region":{"top_left_x":370,"top_left_y":1178,"width":195,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42f3a3e72a1d4618857e17e16260d728","type":"text","conversion_output":true,"text":"committee,","text_display":" committee,","confidence":1,"confidence_rate":1},{"cnt":[[311,1238],[1638,1238],[1638,1286],[311,1286]],"region":{"top_left_x":310,"top_left_y":1238,"width":1328,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1763d82e85774e61b023c2b25db1f635","type":"text","conversion_output":true,"text":"- availability of a signed and dated clinical trial contract between the sponsor","text_display":"\n- availability of a signed and dated clinical trial contract between the sponsor","confidence":1,"confidence_rate":1},{"cnt":[[370,1284],[1108,1284],[1108,1332],[370,1332]],"region":{"top_left_x":370,"top_left_y":1283,"width":738,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e35768e4cc654d40ada5816e8e684821","type":"text","conversion_output":true,"text":"representative and the Head of Trial Centre,","text_display":" representative and the Head of Trial Centre,","confidence":1,"confidence_rate":1},{"cnt":[[306,1348],[1610,1348],[1610,1396],[306,1396]],"region":{"top_left_x":306,"top_left_y":1347,"width":1305,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9375a3ac8e19473b8af723248e59bbde","type":"text","conversion_output":true,"text":"- approval/notification of the regulatory authority, e.g. competent authority,","text_display":"\n- approval/notification of the regulatory authority, e.g. competent authority,","confidence":1,"confidence_rate":1},{"cnt":[[306,1407],[1437,1407],[1437,1455],[306,1455]],"region":{"top_left_x":306,"top_left_y":1407,"width":1131,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fc9f363f7cc49e583e3674190fed47d","type":"text","conversion_output":true,"text":"- availability of the curriculum vitae of the principal investigator,","text_display":"\n- availability of the curriculum vitae of the principal investigator,","confidence":1,"confidence_rate":1},{"cnt":[[306,1469],[1725,1469],[1725,1519],[306,1519]],"region":{"top_left_x":306,"top_left_y":1468,"width":1419,"height":52},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e76e9feabb84f4495e04a8a59c1fb86","type":"text","conversion_output":true,"text":"- availability of a signed and dated clinical trial protocol or immediately imminent","text_display":"\n- availability of a signed and dated clinical trial protocol or immediately imminent","confidence":1,"confidence_rate":1},{"cnt":[[370,1517],[975,1517],[975,1565],[370,1565]],"region":{"top_left_x":370,"top_left_y":1516,"width":606,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"226d5896030c441b9e21f11bfb3dffaf","type":"text","conversion_output":true,"text":"signing of the clinical trial protocol,","text_display":" signing of the clinical trial protocol,","confidence":1,"confidence_rate":1},{"cnt":[[306,1576],[1624,1576],[1624,1629],[306,1629]],"region":{"top_left_x":306,"top_left_y":1576,"width":1319,"height":53},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6b98ea006e44af29a82dff98dc199fe","type":"text","conversion_output":true,"text":"- if applicable: availability of the proof of a medical licence for the principal","text_display":"\n- if applicable: availability of the proof of a medical licence for the principal","confidence":1,"confidence_rate":1},{"cnt":[[370,1626],[583,1626],[583,1674],[370,1674]],"region":{"top_left_x":370,"top_left_y":1626,"width":213,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1ef41fe8d4443d383921f6513ee2a1d","type":"text","conversion_output":true,"text":"investigator,","text_display":" investigator,","confidence":1,"confidence_rate":1},{"cnt":[[306,1686],[989,1686],[989,1738],[306,1738]],"region":{"top_left_x":306,"top_left_y":1685,"width":684,"height":54},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4542403bd90445fcb3d4fd028a2a3024","type":"text","conversion_output":true,"text":"- For USA: availability of Form 1572.","text_display":"\n- For USA: availability of Form 1572.","confidence":1,"confidence_rate":1},{"cnt":[[244,1777],[1720,1777],[1720,1825],[244,1825]],"region":{"top_left_x":244,"top_left_y":1777,"width":1477,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b2255fac752948339774b13e085cc2e0","type":"text","conversion_output":true,"text":"The investigator, pharmacist and/or investigational drug storage manager must maintain","text_display":"\n\nThe investigator, pharmacist and/or investigational drug storage manager must maintain","confidence":1,"confidence_rate":1},{"cnt":[[244,1823],[1734,1823],[1734,1871],[244,1871]],"region":{"top_left_x":244,"top_left_y":1822,"width":1490,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b20cd6642604426ac26405b1273e66f","type":"text","conversion_output":true,"text":"records of the product's delivery to the trial site, the inventory at the site, the use by each","text_display":" records of the product's delivery to the trial site, the inventory at the site, the use by each","confidence":1,"confidence_rate":1},{"cnt":[[244,1873],[1652,1873],[1652,1921],[244,1921]],"region":{"top_left_x":244,"top_left_y":1873,"width":1408,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"304f1ead6f91479f93d0cacdfb6de70b","type":"text","conversion_output":true,"text":"patient, and the return to the sponsor or alternative disposition of unused product(s).","text_display":" patient, and the return to the sponsor or alternative disposition of unused product(s).","confidence":1,"confidence_rate":1},{"cnt":[[247,1962],[1816,1962],[1816,2013],[247,2013]],"region":{"top_left_x":246,"top_left_y":1962,"width":1571,"height":51},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aaa382ba496a405f8ab2c97dd8bde778","type":"text","conversion_output":true,"text":"These records will include dates, quantities, batch/serial numbers, expiry ('use by') dates, and","text_display":"\n\nThese records will include dates, quantities, batch/serial numbers, expiry ('use by') dates, and","confidence":1,"confidence_rate":1},{"cnt":[[247,2010],[1738,2010],[1738,2058],[247,2058]],"region":{"top_left_x":246,"top_left_y":2010,"width":1493,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84ec56ac256b4afd8188c82db76fc672","type":"text","conversion_output":true,"text":"the unique code numbers assigned to the investigational product(s) and trial patients. The","text_display":" the unique code numbers assigned to the investigational product(s) and trial patients. The","confidence":1,"confidence_rate":1},{"cnt":[[247,2058],[1761,2058],[1761,2106],[247,2106]],"region":{"top_left_x":246,"top_left_y":2058,"width":1516,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67721a51672a4910a043e83ce205465e","type":"text","conversion_output":true,"text":"investigator, pharmacist and/or investigational drug storage manager will maintain records","text_display":" investigator, pharmacist and/or investigational drug storage manager will maintain records","confidence":1,"confidence_rate":1},{"cnt":[[244,2106],[1741,2106],[1741,2154],[244,2154]],"region":{"top_left_x":244,"top_left_y":2106,"width":1497,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45d5a79582ee4e4f89200071d6380043","type":"text","conversion_output":true,"text":"that document adequately that the patients were provided the doses specified by the CTP,","text_display":" that document adequately that the patients were provided the doses specified by the CTP,","confidence":1,"confidence_rate":1},{"cnt":[[244,2152],[1704,2152],[1704,2204],[244,2204]],"region":{"top_left_x":244,"top_left_y":2151,"width":1461,"height":54},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c4cee6c82e4b4aedbd4af6b9ec619142","type":"text","conversion_output":true,"text":"plus kits assigned by IRT and reconcile all investigational product(s) received from the","text_display":" plus kits assigned by IRT and reconcile all investigational product(s) received from the","confidence":1,"confidence_rate":1},{"cnt":[[247,2202],[1592,2202],[1592,2250],[247,2250]],"region":{"top_left_x":246,"top_left_y":2202,"width":1347,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"88fb57890ae444649d3384de4bc3b2b6","type":"text","conversion_output":true,"text":"sponsor. At the time of return to the sponsor, the investigator, pharmacist and/or","text_display":" sponsor. At the time of return to the sponsor, the investigator, pharmacist and/or","confidence":1,"confidence_rate":1},{"cnt":[[247,2250],[1693,2250],[1693,2298],[247,2298]],"region":{"top_left_x":246,"top_left_y":2250,"width":1447,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72a23805bb044879ae01d37e63bbf333","type":"text","conversion_output":true,"text":"investigational drug storage manager must verify that all unused or partially used drug","text_display":" investigational drug storage manager must verify that all unused or partially used drug","confidence":1,"confidence_rate":1},{"cnt":[[247,2298],[1793,2298],[1793,2346],[247,2346]],"region":{"top_left_x":246,"top_left_y":2298,"width":1548,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76970d9627f84c86bd19d2bb683c34e6","type":"text","conversion_output":true,"text":"supplies have been returned by the clinical trial patient and that no remaining supplies are in","text_display":" supplies have been returned by the clinical trial patient and that no remaining supplies are in","confidence":1,"confidence_rate":1},{"cnt":[[244,2346],[738,2346],[738,2396],[244,2396]],"region":{"top_left_x":244,"top_left_y":2346,"width":494,"height":51},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43ecd7cff0a14ab8b3088186b8f1dbb3","type":"text","conversion_output":true,"text":"the investigator's possession.","text_display":" the investigator's possession.","confidence":0.9990234375,"confidence_rate":0.9999720849711223},{"cnt":[[247,2435],[1044,2435],[1044,2488],[247,2488]],"region":{"top_left_x":246,"top_left_y":2435,"width":798,"height":53},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f3c6856e8ac4f12807348aa259023e9","type":"text","conversion_output":true,"text":"The following text is only applicable for Japan:","text_display":"\n\nThe following text is only applicable for Japan:","confidence":1,"confidence_rate":1},{"cnt":[[247,2524],[1674,2524],[1674,2574],[247,2574]],"region":{"top_left_x":246,"top_left_y":2524,"width":1429,"height":51},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7db97c811d98433b860f3a7718d7c800","type":"text","conversion_output":true,"text":"The investigator / pharmacist / investigational drug storage manager will receive the","text_display":"\nThe investigator / pharmacist / investigational drug storage manager will receive the","confidence":0.99755859375,"confidence_rate":0.9999728404650293},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"dac70b22667e41169b18e7c66cb9fa3e","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\nProprietary confidential information.","confidence":0.99609375,"confidence_rate":0.9999068162627995},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"51496745e7bd40b597c4f0c3ba73c398","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"dd8212d6b56847029971ebd788ef1569","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-039","page":39,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c41d1294fd51437590cf95415002ac62","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97947846d4e746dfa6821e8bf97335d7","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"108f1ca9abe94ed894996fa7772a612e","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc2391a85ad84f5c8fb33f5fa8d97f46","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0fdadcd48ec4c59a0b50979856eb94b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"427aedfc2fbc46488be1401e4478b90e","type":"page_info","conversion_output":false,"text":"Page 39 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1748,338],[1748,388],[244,388]],"region":{"top_left_x":244,"top_left_y":338,"width":1504,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90b197e44f114fb2b40eae0576a6bd95","type":"text","conversion_output":true,"text":"investigational drugs delivered by the sponsor representative after IRB / ethics committee","text_display":"\ninvestigational drugs delivered by the sponsor representative after IRB / ethics committee","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[244,388],[1668,388],[1668,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1424,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3546cb4978c84142b4def0e329f97fd8","type":"text","conversion_output":true,"text":"approval of the study and completion of a clinical trial contract between the sponsor","text_display":" approval of the study and completion of a clinical trial contract between the sponsor","confidence":1,"confidence_rate":1},{"cnt":[[244,434],[994,434],[994,482],[244,482]],"region":{"top_left_x":244,"top_left_y":434,"width":750,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"886edb7df9304362883c0274d7d92fca","type":"text","conversion_output":true,"text":"representative and the Head of Trial Centre.","text_display":" representative and the Head of Trial Centre.","confidence":1,"confidence_rate":1},{"cnt":[[247,532],[1706,532],[1706,578],[247,578]],"region":{"top_left_x":246,"top_left_y":532,"width":1461,"height":46},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20a060407e8a4e1aaa012b134629afa6","type":"text","conversion_output":true,"text":"The investigator / pharmacist / investigational drug storage manager should return the","text_display":"\n\nThe investigator / pharmacist / investigational drug storage manager should return the","confidence":0.99462890625,"confidence_rate":0.9999408196640538},{"cnt":[[247,580],[1777,580],[1777,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1532,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43df11be80d34f1698cd0250f590f500","type":"text","conversion_output":true,"text":"unused and collected investigational drugs (including the empty boxes) to the sponsor after","text_display":" unused and collected investigational drugs (including the empty boxes) to the sponsor after","confidence":1,"confidence_rate":1},{"cnt":[[247,626],[587,626],[587,678],[247,678]],"region":{"top_left_x":246,"top_left_y":625,"width":342,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2beae29f11b4326b9a708b8599a275d","type":"text","conversion_output":true,"text":"unblinding the trial.","text_display":" unblinding the trial.","confidence":1,"confidence_rate":1},{"cnt":[[244,724],[1757,724],[1757,774],[244,774]],"region":{"top_left_x":244,"top_left_y":724,"width":1513,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab8b1d4059a34640ae2580a443602ab1","type":"text","conversion_output":true,"text":"In case investigational drugs are returned before unblinding of the trial, the investigator /","text_display":"\n\nIn case investigational drugs are returned before unblinding of the trial, the investigator /","confidence":1,"confidence_rate":1},{"cnt":[[242,772],[1757,772],[1757,825],[242,825]],"region":{"top_left_x":242,"top_left_y":772,"width":1515,"height":53},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3021b89f664b4b8ab4870886e43945b3","type":"text","conversion_output":true,"text":"pharmacist / investigational drug storage manager should seal the opened box (excluding","text_display":" pharmacist / investigational drug storage manager should seal the opened box (excluding","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[244,818],[1770,818],[1770,870],[244,870]],"region":{"top_left_x":244,"top_left_y":817,"width":1527,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"975e0aed80f4458d94ee429b36c5b64e","type":"text","conversion_output":true,"text":"empty boxes) for the patient, and before returning the unused and collected investigational","text_display":" empty boxes) for the patient, and before returning the unused and collected investigational","confidence":1,"confidence_rate":1},{"cnt":[[244,868],[1782,868],[1782,918],[244,918]],"region":{"top_left_x":244,"top_left_y":868,"width":1538,"height":51},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80e8166354ef469f83a424aba435b7dd","type":"text","conversion_output":true,"text":"drugs (including the empty boxes) to the sponsor. When returning the investigational drugs,","text_display":" drugs (including the empty boxes) to the sponsor. When returning the investigational drugs,","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[244,916],[1789,916],[1789,966],[244,966]],"region":{"top_left_x":244,"top_left_y":916,"width":1545,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c670c7ecd4f34b4dbd4dd87bb59d4ec3","type":"text","conversion_output":true,"text":"the investigator / pharmacist / investigational drug storage manager should exercise utmost","text_display":" the investigator / pharmacist / investigational drug storage manager should exercise utmost","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[244,964],[1711,964],[1711,1012],[244,1012]],"region":{"top_left_x":244,"top_left_y":964,"width":1467,"height":48},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"924f71a6bd2d489cb6a7a4fbaa786aa5","type":"text","conversion_output":true,"text":"caution to assure that the sponsor representative and other relevant trial staff members","text_display":" caution to assure that the sponsor representative and other relevant trial staff members","confidence":1,"confidence_rate":1},{"cnt":[[242,1012],[1734,1012],[1734,1062],[242,1062]],"region":{"top_left_x":242,"top_left_y":1011,"width":1492,"height":52},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01874b1c67014874b12c80d0f44975d0","type":"text","conversion_output":true,"text":"remain blinded to the patient's name on the package (box or label) of the investigational","text_display":" remain blinded to the patient's name on the package (box or label) of the investigational","confidence":1,"confidence_rate":1},{"cnt":[[247,1060],[354,1060],[354,1108],[247,1108]],"region":{"top_left_x":246,"top_left_y":1059,"width":109,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5466471afbe345f28affc33a1324ac89","type":"text","conversion_output":true,"text":"drugs.","text_display":" drugs.","confidence":1,"confidence_rate":1},{"cnt":[[247,1106],[1805,1106],[1805,1156],[247,1156]],"region":{"top_left_x":246,"top_left_y":1105,"width":1559,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb54477df0d24de59fca8b26a4b07da5","type":"text","conversion_output":true,"text":"Upon completion of the trial, the investigator / pharmacist / investigational storage manager","text_display":"\nUpon completion of the trial, the investigator / pharmacist / investigational storage manager","confidence":0.99658203125,"confidence_rate":0.9999650636373343},{"cnt":[[244,1156],[1711,1156],[1711,1204],[244,1204]],"region":{"top_left_x":244,"top_left_y":1155,"width":1467,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d5735cd89a37493baefb92398fee00d2","type":"text","conversion_output":true,"text":"submits to the sponsor representative a copy of the investigational drug dispensing and","text_display":" submits to the sponsor representative a copy of the investigational drug dispensing and","confidence":1,"confidence_rate":1},{"cnt":[[244,1202],[1745,1202],[1745,1254],[244,1254]],"region":{"top_left_x":244,"top_left_y":1201,"width":1502,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8426dca021434f91addff81e3ed3f10e","type":"text","conversion_output":true,"text":"return log. When submitting the copy, the investigator / pharmacist / investigational drug","text_display":" return log. When submitting the copy, the investigator / pharmacist / investigational drug","confidence":0.9931697845458984,"confidence_rate":0.9999278589376935},{"cnt":[[244,1252],[1802,1252],[1802,1300],[244,1300]],"region":{"top_left_x":244,"top_left_y":1251,"width":1559,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"835866af180347baa01264ee75684e0b","type":"text","conversion_output":true,"text":"storage manager should exercise caution to assure that the sponsor representative and other","text_display":" storage manager should exercise caution to assure that the sponsor representative and other","confidence":1,"confidence_rate":1},{"cnt":[[244,1298],[1307,1298],[1307,1348],[244,1348]],"region":{"top_left_x":244,"top_left_y":1297,"width":1063,"height":51},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5351e8d541f04d9fbd732ede5f05401a","type":"text","conversion_output":true,"text":"relevant trial staff members remain blind to the patient's name.","text_display":" relevant trial staff members remain blind to the patient's name.","confidence":0.99609375,"confidence_rate":0.9999432784301618},{"cnt":[[240,1393],[1583,1393],[1583,1492],[240,1492]],"region":{"top_left_x":239,"top_left_y":1393,"width":1345,"height":99},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca417ba94f3548eca5d2deb052167791","type":"section_header","conversion_output":false,"children_ids":["ed439a79eb60499dbc04e7d207f89116","a9c634fc3dde41238556b26aceadb23c"],"text":"","text_display":""},{"cnt":[[247,1398],[1579,1398],[1579,1446],[247,1446]],"region":{"top_left_x":246,"top_left_y":1398,"width":1333,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed439a79eb60499dbc04e7d207f89116","type":"text","conversion_output":true,"parent_id":"ca417ba94f3548eca5d2deb052167791","text":"4.2 CONCOMITANT THERAPY, RESTRICTIONS, AND RESCUE","text_display":"\n\n\\subsection*{4.2 CONCOMITANT THERAPY, RESTRICTIONS, AND RESCUE","confidence":0.99267578125,"confidence_rate":0.9998638764410034},{"cnt":[[402,1448],[678,1448],[678,1487],[402,1487]],"region":{"top_left_x":402,"top_left_y":1448,"width":277,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9c634fc3dde41238556b26aceadb23c","type":"text","conversion_output":true,"parent_id":"ca417ba94f3548eca5d2deb052167791","text":"TREATMENT","text_display":" TREATMENT}","confidence":1,"confidence_rate":1},{"cnt":[[240,1531],[1672,1531],[1672,1592],[240,1592]],"region":{"top_left_x":239,"top_left_y":1530,"width":1434,"height":63},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a23ea9ecec74a379c3626697285fd1d","type":"section_header","conversion_output":false,"children_ids":["fa7f600f32a642e389f50f2539ec3695"],"text":"","text_display":""},{"cnt":[[242,1535],[1665,1535],[1665,1585],[242,1585]],"region":{"top_left_x":242,"top_left_y":1535,"width":1424,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa7f600f32a642e389f50f2539ec3695","type":"text","conversion_output":true,"parent_id":"4a23ea9ecec74a379c3626697285fd1d","text":"4.2.1 Glycaemic control, emergency procedures, and additional treatment(s)","text_display":"\n\n\\subsection*{4.2.1 Glycaemic control, emergency procedures, and additional treatment(s)}","confidence":0.9990234375,"confidence_rate":0.9999876324859995},{"cnt":[[244,1622],[1706,1622],[1706,1674],[244,1674]],"region":{"top_left_x":244,"top_left_y":1621,"width":1463,"height":54},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87a32019cbee4664bb6c32d1ec2a2b79","type":"text","conversion_output":true,"text":"The use of medication for optimization of glycaemic control as standard of care will be","text_display":"\n\nThe use of medication for optimization of glycaemic control as standard of care will be","confidence":1,"confidence_rate":1},{"cnt":[[247,1672],[1661,1672],[1661,1720],[247,1720]],"region":{"top_left_x":246,"top_left_y":1672,"width":1415,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d659ae93b4649f1ab69880529741fd3","type":"text","conversion_output":true,"text":"permitted in this trial. This medication can include all types of approved antidiabetic","text_display":" permitted in this trial. This medication can include all types of approved antidiabetic","confidence":1,"confidence_rate":1},{"cnt":[[244,1720],[1807,1720],[1807,1770],[244,1770]],"region":{"top_left_x":244,"top_left_y":1720,"width":1563,"height":51},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"649349d3b3744977a80933f7e5a880ea","type":"text","conversion_output":true,"text":"medication except for DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors. The","text_display":" medication except for DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors. The","confidence":1,"confidence_rate":1},{"cnt":[[247,1768],[1665,1768],[1665,1816],[247,1816]],"region":{"top_left_x":246,"top_left_y":1768,"width":1420,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e080143c4144bb9a6ef7e80bfe33c96","type":"text","conversion_output":true,"text":"dose of glycaemic optimization medication will be according to local labelling at the","text_display":" dose of glycaemic optimization medication will be according to local labelling at the","confidence":1,"confidence_rate":1},{"cnt":[[247,1816],[1556,1816],[1556,1866],[247,1866]],"region":{"top_left_x":246,"top_left_y":1816,"width":1310,"height":51},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f223049fc7b43e5a8d920ce09bf100a","type":"text","conversion_output":true,"text":"investigator's discretion and in accordance with local/international guidelines.","text_display":" investigator's discretion and in accordance with local/international guidelines.","confidence":0.9990234375,"confidence_rate":0.9999885054819704},{"cnt":[[244,1905],[1807,1905],[1807,1953],[244,1953]],"region":{"top_left_x":244,"top_left_y":1905,"width":1563,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ec629dbebfc4a5eb152ac986b38ee73","type":"text","conversion_output":true,"text":"The use of medication for optimizing glycaemic control in case of hyperglycaemia is advised","text_display":"\n\nThe use of medication for optimizing glycaemic control in case of hyperglycaemia is advised","confidence":1,"confidence_rate":1},{"cnt":[[244,1951],[818,1951],[818,2003],[244,2003]],"region":{"top_left_x":244,"top_left_y":1950,"width":574,"height":54},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be28b26c953c4743916d0bc00dcd4644","type":"text","conversion_output":true,"text":"when during the treatment period:","text_display":" when during the treatment period:","confidence":1,"confidence_rate":1},{"cnt":[[306,2047],[1748,2047],[1748,2095],[306,2095]],"region":{"top_left_x":306,"top_left_y":2046,"width":1442,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"626fcc1115a445dca755dfb7b47afcd0","type":"text","conversion_output":true,"text":"- the patient has a glucose level \\(>180 mg / dl (>10.0 mmol / L )\\) after an overnight fast;","text_display":"\n- the patient has a glucose level \\(>180 mg / dl (>10.0 mmol / L )\\) after an overnight fast;","confidence":0.99755859375,"confidence_rate":0.9999757983983905},{"cnt":[[306,2138],[1190,2138],[1190,2188],[306,2188]],"region":{"top_left_x":306,"top_left_y":2138,"width":885,"height":51},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89a86e4d1bf74cb5b04b9dad694e15e6","type":"text","conversion_output":true,"text":"- the patient has an \\(HbA _{1 c }>7.5 \\%(58 mmol / mol )\\).","text_display":"\n- the patient has an \\(HbA _{1 c }>7.5 \\%(58 mmol / mol )\\).","confidence":1,"confidence_rate":1},{"cnt":[[244,2230],[1734,2230],[1734,2278],[244,2278]],"region":{"top_left_x":244,"top_left_y":2229,"width":1490,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b14c929784744113b1be321ffc098bbe","type":"text","conversion_output":true,"text":"The above results for FPG should be confirmed, meaning that there is a minimum of two","text_display":"\n\nThe above results for FPG should be confirmed, meaning that there is a minimum of two","confidence":1,"confidence_rate":1},{"cnt":[[247,2275],[866,2275],[866,2325],[247,2325]],"region":{"top_left_x":246,"top_left_y":2275,"width":620,"height":51},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"daaec22786ea46a4b47ab4a26645150c","type":"text","conversion_output":true,"text":"measurements on two different days.","text_display":" measurements on two different days.","confidence":1,"confidence_rate":1},{"cnt":[[244,2367],[1770,2367],[1770,2415],[244,2415]],"region":{"top_left_x":244,"top_left_y":2366,"width":1527,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8510ef4c13b548b5a7aa12f992f5e14e","type":"text","conversion_output":true,"text":"The use of medication optimizing glycaemic control has to be taken in accordance with the","text_display":"\n\nThe use of medication optimizing glycaemic control has to be taken in accordance with the","confidence":1,"confidence_rate":1},{"cnt":[[244,2412],[1752,2412],[1752,2463],[244,2463]],"region":{"top_left_x":244,"top_left_y":2412,"width":1509,"height":51},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b04d2f84ca54fa9af4571e597f9480f","type":"text","conversion_output":true,"text":"prescribing information and will be recorded in the eCRF. Patients who have to be treated","text_display":" prescribing information and will be recorded in the eCRF. Patients who have to be treated","confidence":1,"confidence_rate":1},{"cnt":[[244,2463],[1782,2463],[1782,2511],[244,2511]],"region":{"top_left_x":244,"top_left_y":2462,"width":1538,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2024adb7a0ed4228b1a69049d466c53c","type":"text","conversion_output":true,"text":"with other medication than specified in the protocol should discontinue study treatment, but","text_display":" with other medication than specified in the protocol should discontinue study treatment, but","confidence":1,"confidence_rate":1},{"cnt":[[244,2508],[633,2508],[633,2552],[244,2552]],"region":{"top_left_x":244,"top_left_y":2508,"width":389,"height":44},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5593b1660ad94eedbfe2a9c193cb9b81","type":"text","conversion_output":true,"text":"will remain in the trial.","text_display":" will remain in the trial.","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":42},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5c112b7b8bb34b29a17af12ef79d6652","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99072265625,"confidence_rate":0.9997781044716556},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"343b998cf4584851b68737a443c8b0a5","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fbaba1c1bbb74720822c7f91264667e1","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-040","page":40,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22ebe4b9e8ef48b7b0ef45fe0d7caa1f","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d03181c5faff4b4390f31b4f6386cb70","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b8d1cea592c4dfbb3a5d24815fa19d6","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5af64d24dac6409fa704561dd462d0e6","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7060d50a8f674139b4335b4b56dcfb17","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f7abf415d914dc0b81f8cade6e99a70","type":"page_info","conversion_output":false,"text":"Page 40 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1812,338],[1812,388],[244,388]],"region":{"top_left_x":244,"top_left_y":338,"width":1568,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a73f9179d3134f83afeb6b01a3a16c07","type":"text","conversion_output":true,"text":"Any additional treatment, that does not qualify as a medication optimizing glycaemic control,","text_display":"\n\nAny additional treatment, that does not qualify as a medication optimizing glycaemic control,","confidence":1,"confidence_rate":1},{"cnt":[[244,388],[1738,388],[1738,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1495,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"93cff8175e4c423890eac3559918766f","type":"text","conversion_output":true,"text":"and is considered necessary for the patient's welfare may be given at the discretion of the","text_display":" and is considered necessary for the patient's welfare may be given at the discretion of the","confidence":0.99853515625,"confidence_rate":0.9999847301407262},{"cnt":[[247,434],[1537,434],[1537,484],[247,484]],"region":{"top_left_x":246,"top_left_y":434,"width":1292,"height":51},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d73f8ed2faed4643ac269f4c48cd2267","type":"text","conversion_output":true,"text":"investigator. Exceptions to this are the restrictions described in Section 4.2.2.","text_display":" investigator. Exceptions to this are the restrictions described in Section 4.2.2.","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[247,530],[1814,530],[1814,578],[247,578]],"region":{"top_left_x":246,"top_left_y":529,"width":1568,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d357557d2a4d4930b30f3e38dba603ed","type":"text","conversion_output":true,"text":"Handling of hypoglycaemic episodes can be done according to the guidelines and standard of","text_display":"\n\nHandling of hypoglycaemic episodes can be done according to the guidelines and standard of","confidence":1,"confidence_rate":1},{"cnt":[[247,580],[1629,580],[1629,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1383,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5351231d4ad546bbb613677e8e2be7cc","type":"text","conversion_output":true,"text":"care used by the treating physicians. These episodes need to be documented on the","text_display":" care used by the treating physicians. These episodes need to be documented on the","confidence":1,"confidence_rate":1},{"cnt":[[247,626],[772,626],[772,678],[247,678]],"region":{"top_left_x":246,"top_left_y":625,"width":527,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"377e174c5b814b92b05860bfd15c5aa0","type":"text","conversion_output":true,"text":"appropriate pages of the eCRF.","text_display":" appropriate pages of the eCRF.","confidence":0.9951171875,"confidence_rate":0.9998601591393097},{"cnt":[[244,715],[1661,715],[1661,765],[244,765]],"region":{"top_left_x":244,"top_left_y":715,"width":1417,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5747d353d02a464a8a0bebd0276a47b5","type":"text","conversion_output":true,"text":"All concomitant (additional) medications and other therapies will be recorded on the","text_display":"\n\nAll concomitant (additional) medications and other therapies will be recorded on the","confidence":1,"confidence_rate":1},{"cnt":[[244,763],[772,763],[772,813],[244,813]],"region":{"top_left_x":244,"top_left_y":762,"width":529,"height":52},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"357dc6034bf24c76ac0cf800773a7017","type":"text","conversion_output":true,"text":"appropriate pages of the eCRF.","text_display":" appropriate pages of the eCRF.","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[247,854],[1236,854],[1236,902],[247,902]],"region":{"top_left_x":246,"top_left_y":854,"width":990,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56c15f74252e4f63b822289e2f49c8ff","type":"text","conversion_output":true,"text":"There are no special emergency procedures to be followed.","text_display":"\n\nThere are no special emergency procedures to be followed.","confidence":1,"confidence_rate":1},{"cnt":[[242,941],[628,941],[628,989],[242,989]],"region":{"top_left_x":242,"top_left_y":941,"width":387,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d5ce873027dc4e50afbc3b23006122e9","type":"section_header","conversion_output":false,"children_ids":["ed5472a06e8946048027888adc5d7e6d"],"text":"","text_display":""},{"cnt":[[247,946],[624,946],[624,985],[247,985]],"region":{"top_left_x":246,"top_left_y":945,"width":378,"height":40},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed5472a06e8946048027888adc5d7e6d","type":"text","conversion_output":true,"parent_id":"d5ce873027dc4e50afbc3b23006122e9","text":"4.2.2 Restrictions","text_display":"\n\n\\subsection*{4.2.2 Restrictions}","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[242,1028],[1172,1028],[1172,1085],[242,1085]],"region":{"top_left_x":242,"top_left_y":1027,"width":930,"height":59},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6baf6034a413439b98d7f16fbf9d8d00","type":"section_header","conversion_output":false,"children_ids":["133bf7b037214b82bac2d3ce9ef7982b"],"text":"","text_display":""},{"cnt":[[247,1033],[1165,1033],[1165,1083],[247,1083]],"region":{"top_left_x":246,"top_left_y":1032,"width":920,"height":51},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"133bf7b037214b82bac2d3ce9ef7982b","type":"text","conversion_output":true,"parent_id":"6baf6034a413439b98d7f16fbf9d8d00","text":"4.2.2.1 Restrictions regarding concomitant treatment","text_display":"\n\n\\subsection*{4.2.2.1 Restrictions regarding concomitant treatment}","confidence":1,"confidence_rate":1},{"cnt":[[247,1119],[1729,1119],[1729,1172],[247,1172]],"region":{"top_left_x":246,"top_left_y":1119,"width":1484,"height":53},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6b069c41f7b41cd9c43202ec7d7dac2","type":"text","conversion_output":true,"text":"The use of other DDP DPP4 inhibitors and/or injectable GLP-1 receptor agonists and/or","text_display":"\n\nThe use of other DDP DPP4 inhibitors and/or injectable GLP-1 receptor agonists and/or","confidence":0.98046875,"confidence_rate":0.9997808628435241},{"cnt":[[247,1170],[1805,1170],[1805,1218],[247,1218]],"region":{"top_left_x":246,"top_left_y":1169,"width":1559,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2c4b259174d4e74b108da623cfd4f7e","type":"text","conversion_output":true,"text":"SGLT-2 inhibitors (next to background therapy and any additional anti-diabetic therapy) will","text_display":" SGLT-2 inhibitors (next to background therapy and any additional anti-diabetic therapy) will","confidence":1,"confidence_rate":1},{"cnt":[[247,1218],[989,1218],[989,1268],[247,1268]],"region":{"top_left_x":246,"top_left_y":1217,"width":744,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d2478063f714ae78d7db99969332402","type":"text","conversion_output":true,"text":"be prohibited during the course of the study.","text_display":" be prohibited during the course of the study.","confidence":1,"confidence_rate":1},{"cnt":[[247,1307],[1665,1307],[1665,1357],[247,1357]],"region":{"top_left_x":246,"top_left_y":1306,"width":1420,"height":51},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b17b68250824637a215f853612526ce","type":"text","conversion_output":true,"text":"If any restricted treatments or any other concomitant drugs interfering with the study","text_display":"\n\nIf any restricted treatments or any other concomitant drugs interfering with the study","confidence":1,"confidence_rate":1},{"cnt":[[244,1357],[1818,1357],[1818,1405],[244,1405]],"region":{"top_left_x":244,"top_left_y":1356,"width":1575,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f871fd6aa7334215831ae5cfe281b47b","type":"text","conversion_output":true,"text":"medication are given during the conduct of the trial, the study medication can be discontinued","text_display":" medication are given during the conduct of the trial, the study medication can be discontinued","confidence":1,"confidence_rate":1},{"cnt":[[247,1403],[893,1403],[893,1453],[247,1453]],"region":{"top_left_x":246,"top_left_y":1402,"width":648,"height":51},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c47bf2644fb1478692e9bdabdd19b66c","type":"text","conversion_output":true,"text":"temporarily, or if needed permanently.","text_display":" temporarily, or if needed permanently.","confidence":1,"confidence_rate":1},{"cnt":[[242,1489],[982,1489],[982,1540],[242,1540]],"region":{"top_left_x":242,"top_left_y":1489,"width":741,"height":51},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f72857121db48deb32384609e45f85f","type":"section_header","conversion_output":false,"children_ids":["cc0d1d5ec17b4abcb1c41d585cd6eb2a"],"text":"","text_display":""},{"cnt":[[247,1494],[978,1494],[978,1537],[247,1537]],"region":{"top_left_x":246,"top_left_y":1493,"width":732,"height":45},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cc0d1d5ec17b4abcb1c41d585cd6eb2a","type":"text","conversion_output":true,"parent_id":"3f72857121db48deb32384609e45f85f","text":"4.3 TREATMENT COMPLIANCE","text_display":"\n\n\\subsection*{4.3 TREATMENT COMPLIANCE}","confidence":1,"confidence_rate":1},{"cnt":[[247,1581],[1780,1581],[1780,1631],[247,1631]],"region":{"top_left_x":246,"top_left_y":1580,"width":1534,"height":52},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9cc4e3a92acc4181a5de326adca2f237","type":"text","conversion_output":true,"text":"Patients will be asked to bring all trial medication (boxes, including blisters with or without","text_display":"\n\nPatients will be asked to bring all trial medication (boxes, including blisters with or without","confidence":1,"confidence_rate":1},{"cnt":[[247,1631],[1679,1631],[1679,1679],[247,1679]],"region":{"top_left_x":246,"top_left_y":1631,"width":1434,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fcd38cab47f145e1890e385e4c057944","type":"text","conversion_output":true,"text":"any remaining tablets) with them to each trial visit. The tablets will be counted by the","text_display":" any remaining tablets) with them to each trial visit. The tablets will be counted by the","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[247,1677],[1761,1677],[1761,1727],[247,1727]],"region":{"top_left_x":246,"top_left_y":1676,"width":1516,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b619bfb5431542acaea52e95bacf6ec1","type":"text","conversion_output":true,"text":"investigator or his/her designate and compliance will be calculated. The compliance check","text_display":" investigator or his/her designate and compliance will be calculated. The compliance check","confidence":1,"confidence_rate":1},{"cnt":[[247,1727],[1807,1727],[1807,1775],[247,1775]],"region":{"top_left_x":246,"top_left_y":1726,"width":1561,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3b2500d14ed4e0d8aca6f23ad755498","type":"text","conversion_output":true,"text":"will be based on the number of eapsules tablets missing (i.e. actually taken) in relation to the","text_display":" will be based on the number of eapsules tablets missing (i.e. actually taken) in relation to the","confidence":0.99853515625,"confidence_rate":0.9999854860688677},{"cnt":[[244,1773],[1190,1773],[1190,1821],[244,1821]],"region":{"top_left_x":244,"top_left_y":1772,"width":947,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c2c59b2922c466e809ad655921e0184","type":"text","conversion_output":true,"text":"number of eapsules tablets that should have been taken.","text_display":" number of eapsules tablets that should have been taken.","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[247,1864],[1752,1864],[1752,1912],[247,1912]],"region":{"top_left_x":246,"top_left_y":1864,"width":1507,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed110014d04d4084b42bd7f2cc2d9cb1","type":"text","conversion_output":true,"text":"Compliance should be between \\(80 \\%\\) and \\(120 \\%\\). Compliance should be emphasised with a","text_display":"\n\nCompliance should be between \\(80 \\%\\) and \\(120 \\%\\). Compliance should be emphasised with a","confidence":1,"confidence_rate":1},{"cnt":[[247,1912],[1802,1912],[1802,1962],[247,1962]],"region":{"top_left_x":246,"top_left_y":1912,"width":1557,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2878acd45ca445d0afb7a87c5f4580d9","type":"text","conversion_output":true,"text":"goal of at least \\(80 \\%\\) compliance rate. However, randomized patients will not be discontinued","text_display":" goal of at least \\(80 \\%\\) compliance rate. However, randomized patients will not be discontinued","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[247,1960],[1542,1960],[1542,2008],[247,2008]],"region":{"top_left_x":246,"top_left_y":1959,"width":1296,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfc628ba63674c9ea733347b4399f2b2","type":"text","conversion_output":true,"text":"for lack of compliance without prior discussion with the monitor or designee.","text_display":" for lack of compliance without prior discussion with the monitor or designee.","confidence":1,"confidence_rate":1},{"cnt":[[244,2049],[1775,2049],[1775,2099],[244,2099]],"region":{"top_left_x":244,"top_left_y":2049,"width":1531,"height":51},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"225dde38ebb9490ead0d9dabb21625b9","type":"text","conversion_output":true,"text":"Patients who are not compliant with their medication should again be carefully interviewed","text_display":"\n\nPatients who are not compliant with their medication should again be carefully interviewed","confidence":1,"confidence_rate":1},{"cnt":[[244,2097],[1396,2097],[1396,2145],[244,2145]],"region":{"top_left_x":244,"top_left_y":2097,"width":1152,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c62a74c5da404c8397219cd4e2b567d6","type":"text","conversion_output":true,"text":"and again re-informed about the purpose and the conduct of the trial.","text_display":" and again re-informed about the purpose and the conduct of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":38,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a30ff0dda0c0478da999c125c44cafd3","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99462890625,"confidence_rate":0.9998717803653021},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":39,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d9e589dea36c48bd8cb279e540ef79b2","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":40,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8d257aa3a71449a09eb67e7c67bed320","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-041","page":41,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c13c57b26bd846c7989ec29d0cb89187","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d2ed86219524b4981554758fd20d0f7","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4642ec3eb2f4c32b86c2a4409d33fe4","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e43ed90c9d0046998ed4e8ba6c0519a3","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"325c2c91e8c34b88b416e379f60b01c4","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7b84582634f4d7ead64a48886c5e963","type":"page_info","conversion_output":false,"text":"Page 41 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1318,338],[1318,395],[242,395]],"region":{"top_left_x":242,"top_left_y":338,"width":1077,"height":58},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e28eb5f663b645f2b06e0d0c4d6f1ec4","type":"section_header","conversion_output":false,"children_ids":["e8dc2def8358435ab3cb08d5a1303d2e"],"text":"","text_display":""},{"cnt":[[247,343],[1314,343],[1314,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":1068,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e8dc2def8358435ab3cb08d5a1303d2e","type":"text","conversion_output":true,"parent_id":"e28eb5f663b645f2b06e0d0c4d6f1ec4","text":"5. VARIABLES AND THEIR ASSESSMENT","text_display":"\n\n\\section*{5. VARIABLES AND THEIR ASSESSMENT}","confidence":1,"confidence_rate":1},{"cnt":[[242,434],[628,434],[628,482],[242,482]],"region":{"top_left_x":242,"top_left_y":434,"width":387,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"02bb0d6a0e724024856bf278c3b77714","type":"section_header","conversion_output":false,"children_ids":["d0711a6f276f4a4caaf33d964be0d4b5"],"text":"","text_display":""},{"cnt":[[247,439],[624,439],[624,477],[247,477]],"region":{"top_left_x":246,"top_left_y":438,"width":378,"height":40},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d0711a6f276f4a4caaf33d964be0d4b5","type":"text","conversion_output":true,"parent_id":"02bb0d6a0e724024856bf278c3b77714","text":"5.1 EFFICACY","text_display":"\n\n\\subsection*{5.1 EFFICACY}","confidence":0.6071252822875977,"confidence_rate":0.9692925949627224},{"cnt":[[242,523],[818,523],[818,580],[242,580]],"region":{"top_left_x":242,"top_left_y":523,"width":576,"height":58},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ee475278ae0d46c893625dc3994d0d38","type":"section_header","conversion_output":false,"children_ids":["95c81b848ea5417b9f83f72bff69e4ed"],"text":"","text_display":""},{"cnt":[[247,525],[813,525],[813,578],[247,578]],"region":{"top_left_x":246,"top_left_y":525,"width":568,"height":53},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"95c81b848ea5417b9f83f72bff69e4ed","type":"text","conversion_output":true,"parent_id":"ee475278ae0d46c893625dc3994d0d38","text":"5.1.1 Endpoint(s) of efficacy","text_display":"\n\n\\subsection*{5.1.1 Endpoint(s) of efficacy}","confidence":1,"confidence_rate":1},{"cnt":[[247,617],[1757,617],[1757,665],[247,665]],"region":{"top_left_x":246,"top_left_y":616,"width":1511,"height":49},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a61bdbe2fd514aa7a13b8dd688a714ec","type":"text","conversion_output":true,"text":"The primary endpoint in this trial is time to the first occurrence of any of the following by","text_display":"\n\nThe primary endpoint in this trial is time to the first occurrence of any of the following by","confidence":0.998046875,"confidence_rate":0.9999800508639275},{"cnt":[[244,662],[1670,662],[1670,715],[244,715]],"region":{"top_left_x":244,"top_left_y":662,"width":1426,"height":54},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9b9a27dc219d4debb7eaa41e8c36c607","type":"text","conversion_output":true,"text":"adjudicationed confirmed components of the primary composite endpoint (4 3-point","text_display":" adjudicationed confirmed components of the primary composite endpoint (4 3-point","confidence":0.8475442062280081,"confidence_rate":0.9980558654549204},{"cnt":[[247,713],[1652,713],[1652,761],[247,761]],"region":{"top_left_x":246,"top_left_y":712,"width":1406,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0ea8fcd3d5d94974a5aa17fde34c8576","type":"text","conversion_output":true,"text":"MACE): CV death (including fatal stroke, fatal MI and sudden death), non-fatal MI","text_display":" MACE): CV death (including fatal stroke, fatal MI and sudden death), non-fatal MI","confidence":0.9990234375,"confidence_rate":0.9999886391383975},{"cnt":[[247,758],[1734,758],[1734,811],[247,811]],"region":{"top_left_x":246,"top_left_y":758,"width":1488,"height":53},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ea18acc4536649138dbda90538c89395","type":"text","conversion_output":true,"text":"(excluding silent MI) or non-fatal stroke and hospitalisation for unstable angina pectoris.","text_display":" (excluding silent MI) or non-fatal stroke and hospitalisation for unstable angina pectoris.","confidence":0.9907269477844238,"confidence_rate":0.9999029597647325},{"cnt":[[247,854],[1766,854],[1766,907],[247,907]],"region":{"top_left_x":246,"top_left_y":854,"width":1520,"height":53},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"097e3a19bc7549e49992cb83fd3c388c","type":"text","conversion_output":true,"text":"The key secondary endpoints are is time to the first occurrence of any of the following by","text_display":"\n\nThe key secondary endpoints are is time to the first occurrence of any of the following by","confidence":0.9892578125,"confidence_rate":0.999886319079526},{"cnt":[[247,905],[907,905],[907,953],[247,953]],"region":{"top_left_x":246,"top_left_y":904,"width":661,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"abf247f347064d71b5e712b619b12e27","type":"text","conversion_output":true,"text":"adjudication confirmed components:","text_display":" adjudication confirmed components:","confidence":1,"confidence_rate":1},{"cnt":[[306,1001],[1807,1001],[1807,1053],[306,1053]],"region":{"top_left_x":306,"top_left_y":1000,"width":1501,"height":54},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5fd08e11bc194086ad91019c8e394bb9","type":"text","conversion_output":true,"text":"- CV death (including fatal stroke, fatal MI and sudden death), non fatal MI (excluding","text_display":"\n- CV death (including fatal stroke, fatal MI and sudden death), non fatal MI (excluding","confidence":0.9244203567504883,"confidence_rate":0.9991461432298293},{"cnt":[[370,1051],[1117,1051],[1117,1099],[370,1099]],"region":{"top_left_x":370,"top_left_y":1050,"width":748,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b17ae30b40b04f32a2fe38289755480d","type":"text","conversion_output":true,"text":"silent MI), non-fatal stroke ( 3 point MACE)","text_display":" silent MI), non-fatal stroke ( 3 point MACE)","confidence":0.5763245270993571,"confidence_rate":0.9894581823875312},{"cnt":[[306,1101],[1738,1101],[1738,1149],[306,1149]],"region":{"top_left_x":306,"top_left_y":1101,"width":1433,"height":49},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"587d5f681d154ae991a9368098319486","type":"text","conversion_output":true,"text":"- Composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50","text_display":"\n- Composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50","confidence":1,"confidence_rate":1},{"cnt":[[370,1147],[761,1147],[761,1199],[370,1199]],"region":{"top_left_x":370,"top_left_y":1146,"width":391,"height":54},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0c70fd8b6601406191da32f11b2f3067","type":"text","conversion_output":true,"text":"40\\% or more in eGFR)","text_display":" 40\\% or more in eGFR)","confidence":0.9428987503051758,"confidence_rate":0.9976509085684448},{"cnt":[[244,1256],[1725,1256],[1725,1307],[244,1307]],"region":{"top_left_x":244,"top_left_y":1256,"width":1481,"height":51},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"381446d86e3b4935bbc89fe53991bfca","type":"text","conversion_output":true,"text":"At the final analysis the The primary endpoint (4 3-point MACE) will be tested for non-","text_display":"\n\nAt the final analysis the The primary endpoint (4 3-point MACE) will be tested for non","confidence":0.822544782422483,"confidence_rate":0.9978788576878366},{"cnt":[[247,1307],[1793,1307],[1793,1355],[247,1355]],"region":{"top_left_x":246,"top_left_y":1306,"width":1548,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ea704a6aa5b64888a974fa3fcdad853b","type":"text","conversion_output":true,"text":"inferiority. Thereafter, if non-inferiority has been demonstrated, the \\(4\\)-point MACE and","text_display":"inferiority. Thereafter, if non-inferiority has been demonstrated, the \\(4\\)-point MACE and","confidence":0.9970715045928955,"confidence_rate":0.9999703762787923},{"cnt":[[247,1352],[1622,1352],[1622,1403],[247,1403]],"region":{"top_left_x":246,"top_left_y":1352,"width":1376,"height":51},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"49ccb25c54b644c998f5378917b87143","type":"text","conversion_output":true,"text":"the combined composite renal endpoint will be tested separately (=in parallel) for","text_display":" the combined composite renal endpoint will be tested separately (=in parallel) for","confidence":0.9517526626586914,"confidence_rate":0.9994317697100108},{"cnt":[[247,1403],[1702,1403],[1702,1451],[247,1451]],"region":{"top_left_x":246,"top_left_y":1402,"width":1456,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e5ee1e7da48f4cb3be67e6e6b7c27ecb","type":"text","conversion_output":true,"text":"superiority. In case the 4 point MACE and/or composite renal endpoint is significantly","text_display":" superiority. In case the 4 point MACE and/or composite renal endpoint is significantly","confidence":0.99072265625,"confidence_rate":0.9999008491037157},{"cnt":[[247,1448],[1300,1448],[1300,1501],[247,1501]],"region":{"top_left_x":246,"top_left_y":1448,"width":1054,"height":53},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d87863c7cb944e10aa4ff8bbc1dcb9b8","type":"text","conversion_output":true,"text":"superior, the 3 point MACE will then be tested for superiority.","text_display":" superior, the 3 point MACE will then be tested for superiority.","confidence":0.643852949142456,"confidence_rate":0.9938179916940459},{"cnt":[[247,1517],[1812,1517],[1812,1567],[247,1567]],"region":{"top_left_x":246,"top_left_y":1516,"width":1566,"height":52},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"773770e82e6c4b0e8370cddab60a5b5e","type":"text","conversion_output":true,"text":"Even after occurrence of a non-fatal endpoint, the patient should be followed-up until the end","text_display":"\nEven after occurrence of a non-fatal endpoint, the patient should be followed-up until the end","confidence":1,"confidence_rate":1},{"cnt":[[247,1567],[1245,1567],[1245,1615],[247,1615]],"region":{"top_left_x":246,"top_left_y":1567,"width":999,"height":49},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ecc4dcbfc9ee41908b75d93df66e71ec","type":"text","conversion_output":true,"text":"of the study in order to document other endpoints/variables.","text_display":" of the study in order to document other endpoints/variables.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":30,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6eaf5275615547a589ecf3c96e8372f8","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":31,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d2ec4a2d424645728d3123503d660d95","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":32,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b1c36b480b7c41a69bc1463ea97ea4df","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-042","page":42,"lines":[{"cnt":[[242,119],[612,119],[612,167],[242,167]],"region":{"top_left_x":242,"top_left_y":118,"width":371,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d52bdf2d6bc475ba922c47641056846","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9b259232f8c49d58f9c0549895fbfed","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,164],[601,164],[601,208],[242,208]],"region":{"top_left_x":242,"top_left_y":164,"width":359,"height":44},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b99212120df34fb7af590012e3709bb3","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,206],[642,206],[642,251],[242,251]],"region":{"top_left_x":242,"top_left_y":205,"width":400,"height":47},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29fd8edeb8d34ce494c44c78e5d3287b","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,206],[1112,206],[1112,249],[868,249]],"region":{"top_left_x":868,"top_left_y":205,"width":245,"height":44},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e159076fcfab47b491745c876fe2287c","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,206],[1818,206],[1818,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":205,"width":248,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dcebef9a3ec74687a2a2baa997d323a6","type":"page_info","conversion_output":false,"text":"Page 42 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,2298],[1684,2298],[1684,2351],[244,2351]],"region":{"top_left_x":244,"top_left_y":2298,"width":1440,"height":53},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1fa0680e360541d8a5e01eb48fe16c2c","type":"text","conversion_output":true,"text":"* Silent MI is an investigator reported endpoint, and is a trigger term for central","text_display":"\n* Silent MI is an investigator reported endpoint, and is a trigger term for central","confidence":1,"confidence_rate":1},{"cnt":[[242,2346],[1713,2346],[1713,2401],[242,2401]],"region":{"top_left_x":242,"top_left_y":2346,"width":1472,"height":55},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ec8f7125160d40c3bf4c3e3bb45dfba6","type":"text","conversion_output":true,"text":"adjudication for cardiovascular events. Any investigator reported silent MI that is","text_display":" adjudication for cardiovascular events. Any investigator reported silent MI that is","confidence":1,"confidence_rate":1},{"cnt":[[242,2394],[1636,2394],[1636,2451],[242,2451]],"region":{"top_left_x":242,"top_left_y":2394,"width":1394,"height":58},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1d308928b4ab44b2a3721d32ae12bdd1","type":"text","conversion_output":true,"text":"adjudicated and confirmed as being an MI by the CEC will be counted as MI.","text_display":" adjudicated and confirmed as being an MI by the CEC will be counted as MI.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fd939866f3ab469bb66fd14ae71deba8","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99560546875,"confidence_rate":0.9998951432220243},{"cnt":[[288,2618],[1802,2618],[1802,2664],[288,2664]],"region":{"top_left_x":287,"top_left_y":2617,"width":1516,"height":47},"line":11,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f627b7c8cf034cd2b74f11738b694b65","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[292,2664],[1770,2664],[1770,2707],[292,2707]],"region":{"top_left_x":292,"top_left_y":2663,"width":1479,"height":44},"line":12,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4f9c8f0b8fc14f7bb15ccf95bc0cfa4e","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-043","page":43,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"815ccb85c2cf49bb83f1bde48d5001e3","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3eed022733d488aa64bc5d81e78e495","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d61ff5b5218447583366e1beacab00f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2bcfa57d9544e449a6fa8900c120287","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b9772a19c6464391bc267b54cd8f6397","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"953b6b0fe0b44f118f034071d934bc73","type":"page_info","conversion_output":false,"text":"Page 43 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1752,338],[1752,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":1507,"height":49},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"aafab046a7334493a3365fd0bdf29dc3","type":"text","conversion_output":true,"text":"Albuminuria progression is defined according to change from normoalbuminuria to either","text_display":"\n\nAlbuminuria progression is defined according to change from normoalbuminuria to either","confidence":1,"confidence_rate":1},{"cnt":[[244,388],[1802,388],[1802,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1559,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"16296c32198d4bc5816d99a8b3fc0a32","type":"text","conversion_output":true,"text":"microalbuminuria (UACR \\(>30 mg / g\\) and \\(\\leq \\leq 300 mg / g\\) ) or clinical proteinuria (UACR > 300","text_display":" microalbuminuria (UACR \\(>30 mg / g\\) and \\(\\leq \\leq 300 mg / g\\) ) or clinical proteinuria (UACR > 300","confidence":0.9162833243608475,"confidence_rate":0.9991596834939998},{"cnt":[[247,434],[1800,434],[1800,484],[247,484]],"region":{"top_left_x":246,"top_left_y":434,"width":1555,"height":51},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8db2740dc0264a9aa5cd570bdfc217e9","type":"text","conversion_output":true,"text":"\\(mg / g\\) ) or from microalbuminuria (UACR \\(>30 mg / g\\) and \\(\\leq \\leq 300 mg / g\\) ) to clinical proteinuria","text_display":" \\(mg / g\\) ) or from microalbuminuria (UACR \\(>30 mg / g\\) and \\(\\leq \\leq 300 mg / g\\) ) to clinical proteinuria","confidence":0.978515625,"confidence_rate":0.9998078191420752},{"cnt":[[247,484],[605,484],[605,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":360,"height":49},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"aaebe0dda2f04acf89affae921bf4074","type":"text","conversion_output":true,"text":"(UACR \\(>300 mg / g\\) ).","text_display":" (UACR \\(>300 mg / g\\) ).","confidence":0.99658203125,"confidence_rate":0.9998895601844238},{"cnt":[[240,1403],[811,1403],[811,1464],[240,1464]],"region":{"top_left_x":239,"top_left_y":1402,"width":572,"height":63},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"11c8f834a53d40ac9cdd2f834697e401","type":"section_header","conversion_output":false,"children_ids":["b52fb12f1d544af29d2a61080486d684"],"text":"","text_display":""},{"cnt":[[242,1407],[806,1407],[806,1460],[242,1460]],"region":{"top_left_x":242,"top_left_y":1407,"width":565,"height":53},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b52fb12f1d544af29d2a61080486d684","type":"text","conversion_output":true,"parent_id":"11c8f834a53d40ac9cdd2f834697e401","text":"5.1.2 Assessment of efficacy","text_display":"\n\n\\subsection*{5.1.2 Assessment of efficacy}","confidence":1,"confidence_rate":1},{"cnt":[[244,1499],[368,1499],[368,1542],[244,1542]],"region":{"top_left_x":244,"top_left_y":1498,"width":124,"height":44},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3ef8fc83256e4460af9b48868131e8b3","type":"text","conversion_output":true,"text":"\\(H b A_{1 c}\\) :","text_display":"\n\\(H b A_{1 c}\\) :","confidence":1,"confidence_rate":1},{"cnt":[[247,1544],[1812,1544],[1812,1594],[247,1594]],"region":{"top_left_x":246,"top_left_y":1544,"width":1566,"height":51},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8243bec8a1fc472bb2c60290f61a9868","type":"text","conversion_output":true,"text":"Blood samples for the determination of \\(HbA _{1 c }\\) will be taken according to the Flow Chart. The","text_display":"\nBlood samples for the determination of \\(HbA _{1 c }\\) will be taken according to the Flow Chart. The","confidence":1,"confidence_rate":1},{"cnt":[[244,1594],[1734,1594],[1734,1642],[244,1642]],"region":{"top_left_x":244,"top_left_y":1594,"width":1490,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"94cc104347b54aa68d0eeeb790f0fc9b","type":"text","conversion_output":true,"text":"blood sample can be taken at any time during the visit. The samples will be analysed at a","text_display":" blood sample can be taken at any time during the visit. The samples will be analysed at a","confidence":1,"confidence_rate":1},{"cnt":[[247,1640],[1688,1640],[1688,1688],[247,1688]],"region":{"top_left_x":246,"top_left_y":1640,"width":1443,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"406d7aa6eab44ad5be1e2281d08c93ec","type":"text","conversion_output":true,"text":"central laboratory or its affiliates having a National Glycohemoglobin Standardization","text_display":" central laboratory or its affiliates having a National Glycohemoglobin Standardization","confidence":1,"confidence_rate":1},{"cnt":[[247,1690],[1752,1690],[1752,1738],[247,1738]],"region":{"top_left_x":246,"top_left_y":1690,"width":1507,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2f6a828162324fd9866e775ef0206ed1","type":"text","conversion_output":true,"text":"Program (NGSP) Level I certificate. Further details about sample handling, shipment, and","text_display":" Program (NGSP) Level I certificate. Further details about sample handling, shipment, and","confidence":1,"confidence_rate":1},{"cnt":[[247,1738],[1181,1738],[1181,1786],[247,1786]],"region":{"top_left_x":246,"top_left_y":1738,"width":936,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fa86f21c13cd40988d69552a4a3e2db9","type":"text","conversion_output":true,"text":"assay procedures can be found in the ISF (Lab manual).","text_display":" assay procedures can be found in the ISF (Lab manual).","confidence":1,"confidence_rate":1},{"cnt":[[244,1828],[345,1828],[345,1866],[244,1866]],"region":{"top_left_x":244,"top_left_y":1827,"width":101,"height":40},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dd9030a196c94327a9e83ae06f9645b4","type":"text","conversion_output":true,"text":"FPG :","text_display":"\n\nFPG :","confidence":0.2700219443063645,"confidence_rate":0.9107216211618985},{"cnt":[[247,1873],[1697,1873],[1697,1921],[247,1921]],"region":{"top_left_x":246,"top_left_y":1873,"width":1452,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5ea22bc1a8ea40f8997f74636b811056","type":"text","conversion_output":true,"text":"Blood samples for the determination of FPG will be taken according to the Flow Chart","text_display":"\nBlood samples for the determination of FPG will be taken according to the Flow Chart","confidence":1,"confidence_rate":1},{"cnt":[[247,1923],[1793,1923],[1793,1971],[247,1971]],"region":{"top_left_x":246,"top_left_y":1923,"width":1548,"height":49},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1223f3eb267e4677b7c3e7f1fc1490ef","type":"text","conversion_output":true,"text":"after an overnight fast (at least 10 hours no food and only water). At all respective visits, the","text_display":" after an overnight fast (at least 10 hours no food and only water). At all respective visits, the","confidence":1,"confidence_rate":1},{"cnt":[[247,1969],[1775,1969],[1775,2017],[247,2017]],"region":{"top_left_x":246,"top_left_y":1969,"width":1529,"height":49},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"03af12299bef44e68802a5cb87437eb2","type":"text","conversion_output":true,"text":"samples should be taken before breakfast and before trial drug administration. The samples","text_display":" samples should be taken before breakfast and before trial drug administration. The samples","confidence":1,"confidence_rate":1},{"cnt":[[247,2019],[943,2019],[943,2061],[247,2061]],"region":{"top_left_x":246,"top_left_y":2019,"width":698,"height":42},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f1bb1656d35d43f885df970d8e3db54b","type":"text","conversion_output":true,"text":"will be measured with the HBGM device.","text_display":" will be measured with the HBGM device.","confidence":1,"confidence_rate":1},{"cnt":[[242,2111],[578,2111],[578,2159],[242,2159]],"region":{"top_left_x":242,"top_left_y":2110,"width":336,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"30c5523cd3564908aa7d1445b5f71ef6","type":"section_header","conversion_output":false,"children_ids":["abd63eb56a3b4880b8bfec7f60379245"],"text":"","text_display":""},{"cnt":[[247,2115],[573,2115],[573,2154],[247,2154]],"region":{"top_left_x":246,"top_left_y":2115,"width":328,"height":40},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"abd63eb56a3b4880b8bfec7f60379245","type":"text","conversion_output":true,"parent_id":"30c5523cd3564908aa7d1445b5f71ef6","text":"5.2 SAFETY","text_display":"\n\n\\subsection*{5.2 SAFETY}","confidence":0.99853515625,"confidence_rate":0.9999022769297106},{"cnt":[[242,2200],[784,2200],[784,2259],[242,2259]],"region":{"top_left_x":242,"top_left_y":2199,"width":542,"height":61},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"946b54355a824b1582783de974a59ba0","type":"section_header","conversion_output":false,"children_ids":["e7b2fa5765544202bd181e57ba1f129f"],"text":"","text_display":""},{"cnt":[[247,2204],[779,2204],[779,2255],[247,2255]],"region":{"top_left_x":246,"top_left_y":2204,"width":533,"height":51},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e7b2fa5765544202bd181e57ba1f129f","type":"text","conversion_output":true,"parent_id":"946b54355a824b1582783de974a59ba0","text":"5.2.1 Endpoint(s) of safety","text_display":"\n\n\\subsection*{5.2.1 Endpoint(s) of safety}","confidence":1,"confidence_rate":1},{"cnt":[[247,2294],[1807,2294],[1807,2341],[247,2341]],"region":{"top_left_x":246,"top_left_y":2293,"width":1561,"height":49},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"51e9ea1ef05b4d08a43a0922d59102c0","type":"text","conversion_output":true,"text":"Incidence and intensity of adverse events, physical examination, vital signs, ECG and change","text_display":"\n\nIncidence and intensity of adverse events, physical examination, vital signs, ECG and change","confidence":1,"confidence_rate":1},{"cnt":[[247,2341],[1183,2341],[1183,2392],[247,2392]],"region":{"top_left_x":246,"top_left_y":2341,"width":938,"height":51},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ece96a6cb42d4d6687227d220e9a4030","type":"text","conversion_output":true,"text":"from baseline in laboratory parameters will be assessed.","text_display":" from baseline in laboratory parameters will be assessed.","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":30,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a4f17a1b9587441bb504f40e2f95582c","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99462890625,"confidence_rate":0.9998717803653022},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":31,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"728fec85679144afb1f9d0b4c9e23b01","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":32,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2c9823139dac42b08a168d5cfdc02276","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-044","page":44,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4205bda76754df2a789847e11ffb532","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,158],[1503,158]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":40},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9a59758e57d4d778418371e83fabfb6","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,167],[596,167],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":166,"width":351,"height":38},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1aee06a677c149069e90a0df3375cc82","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8ade46117d84e0a938b1e93081d7eaa","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14895e8496094f8aa06794959b7ad43a","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfc94a5814bd4bae8a92a8f86a329629","type":"page_info","conversion_output":false,"text":"Page 44 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,334],[1377,334],[1377,391],[242,391]],"region":{"top_left_x":242,"top_left_y":333,"width":1136,"height":58},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aed41be342fc48e6b5490d7cca287854","type":"section_header","conversion_output":false,"children_ids":["a7e88406fcba418694d2f6b400370b35"],"text":"","text_display":""},{"cnt":[[247,338],[1373,338],[1373,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":1127,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7e88406fcba418694d2f6b400370b35","type":"text","conversion_output":true,"parent_id":"aed41be342fc48e6b5490d7cca287854","text":"5.2.1.1 Reporting waiver for cardiovascular-outcome events","text_display":"\n\n\\subsection*{5.2.1.1 Reporting waiver for cardiovascular-outcome events}","confidence":1,"confidence_rate":1},{"cnt":[[247,429],[1757,429],[1757,477],[247,477]],"region":{"top_left_x":246,"top_left_y":429,"width":1511,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d15490c7d732422ca581e8b82fad1c09","type":"text","conversion_output":true,"text":"In accordance with ICH-guideline E2A and in order to maintain the integrity of this study,","text_display":"\n\nIn accordance with ICH-guideline E2A and in order to maintain the integrity of this study,","confidence":1,"confidence_rate":1},{"cnt":[[247,480],[1793,480],[1793,525],[247,525]],"region":{"top_left_x":246,"top_left_y":479,"width":1548,"height":47},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b4909b040e4b4f46831cb88240ba6828","type":"text","conversion_output":true,"text":"CV outcome events that occur after randomization and represent an SAE are exempted from","text_display":" CV outcome events that occur after randomization and represent an SAE are exempted from","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[247,525],[1725,525],[1725,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1479,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50bbb3331a5f4af0bd0eb6249c84f7a7","type":"text","conversion_output":true,"text":"expedited reporting to health authorities. The medication code will not be broken for the","text_display":" expedited reporting to health authorities. The medication code will not be broken for the","confidence":1,"confidence_rate":1},{"cnt":[[247,573],[1186,573],[1186,624],[247,624]],"region":{"top_left_x":246,"top_left_y":573,"width":940,"height":51},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60c44352d08f405cb656f05283d70288","type":"text","conversion_output":true,"text":"purpose of expedited reporting to regulatory authorities.","text_display":" purpose of expedited reporting to regulatory authorities.","confidence":1,"confidence_rate":1},{"cnt":[[247,642],[1782,642],[1782,690],[247,690]],"region":{"top_left_x":246,"top_left_y":641,"width":1536,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b8b4fbe770a4b33bfec2605ed38e6a5","type":"text","conversion_output":true,"text":"CV outcome events are defined as the following components of the primary, key secondary","text_display":"\n\nCV outcome events are defined as the following components of the primary, key secondary","confidence":1,"confidence_rate":1},{"cnt":[[247,690],[660,690],[660,738],[247,738]],"region":{"top_left_x":246,"top_left_y":689,"width":415,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a505e4b84b44b3f85aaf3364a361b33","type":"text","conversion_output":true,"text":"and other CV endpoints:","text_display":" and other CV endpoints:","confidence":1,"confidence_rate":1},{"cnt":[[247,786],[436,786],[436,827],[247,827]],"region":{"top_left_x":246,"top_left_y":785,"width":191,"height":42},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ec32e4524d448c5a410df0fefd70cf5","type":"text","conversion_output":true,"text":"- CV death","text_display":"\n- CV death","confidence":1,"confidence_rate":1},{"cnt":[[247,834],[487,834],[487,875],[247,875]],"region":{"top_left_x":246,"top_left_y":833,"width":241,"height":42},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2ba9f9d014d41f4a3ad93e7ec2efed7","type":"text","conversion_output":true,"text":"- non fatal MI","text_display":"\n- non fatal MI","confidence":1,"confidence_rate":1},{"cnt":[[247,882],[429,882],[429,921],[247,921]],"region":{"top_left_x":246,"top_left_y":881,"width":184,"height":40},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91fcc7f16ecf4580a28c3e9dacd7e952","type":"text","conversion_output":true,"text":"- silent MI","text_display":"\n- silent MI","confidence":1,"confidence_rate":1},{"cnt":[[247,927],[1256,927],[1256,975],[247,975]],"region":{"top_left_x":246,"top_left_y":927,"width":1011,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77ba7600e51e4b8eb7a200149d36c189","type":"text","conversion_output":true,"text":"- non fatal stroke (ischemic/hemorrhagic/etiology unknown)","text_display":"\n- non fatal stroke (ischemic/hemorrhagic/etiology unknown)","confidence":1,"confidence_rate":1},{"cnt":[[247,978],[994,978],[994,1026],[247,1026]],"region":{"top_left_x":246,"top_left_y":977,"width":748,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6c384c987ef4f8697f4aeb84599b728","type":"text","conversion_output":true,"text":"- hospitalisation for unstable angina pectoris","text_display":"\n- hospitalisation for unstable angina pectoris","confidence":1,"confidence_rate":1},{"cnt":[[247,1023],[1218,1023],[1218,1071],[247,1071]],"region":{"top_left_x":246,"top_left_y":1023,"width":972,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2218190c94b64c4c87f92caa2ef24776","type":"text","conversion_output":true,"text":"- hospitalisation due to congestive for heart failure (CHF)","text_display":"\n- hospitalisation due to congestive for heart failure (CHF)","confidence":1,"confidence_rate":1},{"cnt":[[247,1074],[797,1074],[797,1122],[247,1122]],"region":{"top_left_x":246,"top_left_y":1073,"width":552,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7dfe1bf80b746e8a0f75abd8694efbb","type":"text","conversion_output":true,"text":"- transient ischemic attack (TIA)","text_display":"\n- transient ischemic attack (TIA)","confidence":1,"confidence_rate":1},{"cnt":[[247,1122],[1208,1122],[1208,1172],[247,1172]],"region":{"top_left_x":246,"top_left_y":1121,"width":963,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"327f094a582d46d4ab9af1efacdf89e4","type":"text","conversion_output":true,"text":"- coronary revascularisation procedures (PCI and CABG)","text_display":"\n- coronary revascularisation procedures (PCI and CABG)","confidence":1,"confidence_rate":1},{"cnt":[[247,1170],[934,1170],[934,1218],[247,1218]],"region":{"top_left_x":246,"top_left_y":1169,"width":689,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"434f5442ef4446cdae908b52c6cc4127","type":"text","conversion_output":true,"text":"- peripheral revascularization procedures","text_display":"\n- peripheral revascularization procedures","confidence":1,"confidence_rate":1},{"cnt":[[247,1266],[1275,1266],[1275,1314],[247,1314]],"region":{"top_left_x":246,"top_left_y":1265,"width":1029,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad31f523c7e14b26aeb05af64a7fb2d4","type":"text","conversion_output":true,"text":"For definitions of the CV outcome events see Appendix 10.2.","text_display":"\n\nFor definitions of the CV outcome events see Appendix 10.2.","confidence":1,"confidence_rate":1},{"cnt":[[242,1366],[930,1366],[930,1419],[242,1419]],"region":{"top_left_x":242,"top_left_y":1366,"width":688,"height":53},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"189912631a2a49e1ae3b049f4ccc5f31","type":"section_header","conversion_output":false,"children_ids":["d2a1201572fb484f98389be36e0fe738"],"text":"","text_display":""},{"cnt":[[247,1371],[925,1371],[925,1414],[247,1414]],"region":{"top_left_x":246,"top_left_y":1370,"width":680,"height":45},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2a1201572fb484f98389be36e0fe738","type":"text","conversion_output":true,"parent_id":"189912631a2a49e1ae3b049f4ccc5f31","text":"5.2.2 Assessment of adverse events","text_display":"\n\n\\subsection*{5.2.2 Assessment of adverse events}","confidence":0.99951171875,"confidence_rate":0.9999874769887185},{"cnt":[[242,1457],[900,1457],[900,1510],[242,1510]],"region":{"top_left_x":242,"top_left_y":1457,"width":659,"height":53},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"410881a773744bd38f36a9597a0a5c3c","type":"section_header","conversion_output":false,"children_ids":["5c1e8649a1024c5f8d417685549c7163"],"text":"","text_display":""},{"cnt":[[247,1457],[898,1457],[898,1505],[247,1505]],"region":{"top_left_x":246,"top_left_y":1457,"width":652,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c1e8649a1024c5f8d417685549c7163","type":"text","conversion_output":true,"parent_id":"410881a773744bd38f36a9597a0a5c3c","text":"5.2.2.1 Definitions of adverse events","text_display":"\n\n\\subsection*{5.2.2.1 Definitions of adverse events}","confidence":1,"confidence_rate":1},{"cnt":[[242,1547],[496,1547],[496,1601],[242,1601]],"region":{"top_left_x":242,"top_left_y":1546,"width":254,"height":56},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4e79bd7355fb4f9ea931daf89d028103","type":"section_header","conversion_output":false,"children_ids":["eaa87571baa545c198a0561f32cde13c"],"text":"","text_display":""},{"cnt":[[247,1549],[496,1549],[496,1597],[247,1597]],"region":{"top_left_x":246,"top_left_y":1548,"width":250,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"eaa87571baa545c198a0561f32cde13c","type":"text","conversion_output":true,"parent_id":"4e79bd7355fb4f9ea931daf89d028103","text":"Adverse event","text_display":"\n\n\\section*{Adverse event}","confidence":1,"confidence_rate":1},{"cnt":[[247,1617],[1656,1617],[1656,1665],[247,1665]],"region":{"top_left_x":246,"top_left_y":1617,"width":1411,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"163f16243856476e867229169e460e90","type":"text","conversion_output":true,"text":"An adverse event (AE) is defined as any untoward medical occurrence, including an","text_display":"\n\nAn adverse event (AE) is defined as any untoward medical occurrence, including an","confidence":1,"confidence_rate":1},{"cnt":[[247,1668],[1816,1668],[1816,1716],[247,1716]],"region":{"top_left_x":246,"top_left_y":1667,"width":1571,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3da76c0990c844a48f97bcb617003695","type":"text","conversion_output":true,"text":"exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a","text_display":" exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a","confidence":0.998046875,"confidence_rate":0.9999808331754918},{"cnt":[[247,1713],[1748,1713],[1748,1764],[247,1764]],"region":{"top_left_x":246,"top_left_y":1713,"width":1502,"height":51},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dcad99edaf31456e9745c4e5f96ed4a5","type":"text","conversion_output":true,"text":"pharmaceutical product. The event does not necessarily have to have a causal relationship","text_display":" pharmaceutical product. The event does not necessarily have to have a causal relationship","confidence":0.9970715045928955,"confidence_rate":0.999968800573522},{"cnt":[[247,1764],[1704,1764],[1704,1812],[247,1812]],"region":{"top_left_x":246,"top_left_y":1763,"width":1459,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3228a0abf0ad4680961f994f28241310","type":"text","conversion_output":true,"text":"with this treatment. An AE can therefore be any unfavourable and unintended sign","text_display":" with this treatment. An AE can therefore be any unfavourable and unintended sign","confidence":1,"confidence_rate":1},{"cnt":[[247,1812],[1800,1812],[1800,1862],[247,1862]],"region":{"top_left_x":246,"top_left_y":1811,"width":1555,"height":51},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3b4354d5ca84c7aa68ed70dc70304db","type":"text","conversion_output":true,"text":"(including an abnormal laboratory finding), symptom, or disease temporally associated","text_display":" (including an abnormal laboratory finding), symptom, or disease temporally associated","confidence":1,"confidence_rate":1},{"cnt":[[247,1859],[1798,1859],[1798,1907],[247,1907]],"region":{"top_left_x":246,"top_left_y":1859,"width":1552,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"090787d9efb34520b2c6be6d1f01d6bb","type":"text","conversion_output":true,"text":"with the use of a medicinal product, whether or not considered related to the medicinal","text_display":" with the use of a medicinal product, whether or not considered related to the medicinal","confidence":1,"confidence_rate":1},{"cnt":[[247,1910],[404,1910],[404,1958],[247,1958]],"region":{"top_left_x":246,"top_left_y":1909,"width":159,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e4dcfdd146e4d4d8a14b0d7d8ef7236","type":"text","conversion_output":true,"text":"product.","text_display":" product.","confidence":1,"confidence_rate":1},{"cnt":[[242,1969],[560,1969],[560,2026],[242,2026]],"region":{"top_left_x":242,"top_left_y":1969,"width":318,"height":58},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74b3f1cdecc54dd78455e95a0bdbdf35","type":"section_header","conversion_output":false,"children_ids":["0ef02b7d609341f8825095f83f117d4c"],"text":"","text_display":""},{"cnt":[[247,1974],[555,1974],[555,2022],[247,2022]],"region":{"top_left_x":246,"top_left_y":1973,"width":310,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ef02b7d609341f8825095f83f117d4c","type":"text","conversion_output":true,"parent_id":"74b3f1cdecc54dd78455e95a0bdbdf35","text":"Adverse reaction","text_display":"\n\n\\section*{Adverse reaction}","confidence":1,"confidence_rate":1},{"cnt":[[247,2024],[1748,2024],[1748,2072],[247,2072]],"region":{"top_left_x":246,"top_left_y":2023,"width":1502,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41ea0e997b7d4bd98523cff721a4298e","type":"text","conversion_output":true,"text":"An adverse reaction is defined as a response to a medicinal product which is noxious","text_display":"\n\nAn adverse reaction is defined as a response to a medicinal product which is noxious","confidence":0.9912109375,"confidence_rate":0.9999008148728378},{"cnt":[[247,2072],[1750,2072],[1750,2122],[247,2122]],"region":{"top_left_x":246,"top_left_y":2071,"width":1504,"height":52},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c575a48002b49b5a50b0f29006e50b3","type":"text","conversion_output":true,"text":"and unintended. Response in this context means that a causal relationship between a","text_display":" and unintended. Response in this context means that a causal relationship between a","confidence":0.97607421875,"confidence_rate":0.9997248486376835},{"cnt":[[247,2120],[1729,2120],[1729,2168],[247,2168]],"region":{"top_left_x":246,"top_left_y":2119,"width":1484,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e900feb18ea0487bab6dffc1f80cffc6","type":"text","conversion_output":true,"text":"medicinal product and an adverse event is at least a reasonable possibility. Adverse","text_display":" medicinal product and an adverse event is at least a reasonable possibility. Adverse","confidence":0.99169921875,"confidence_rate":0.999906347929685},{"cnt":[[247,2168],[1629,2168],[1629,2216],[247,2216]],"region":{"top_left_x":246,"top_left_y":2167,"width":1383,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d8f0e43ee614c8180412edc9050e5c2","type":"text","conversion_output":true,"text":"reactions may arise from use of the product within or outside the terms of the","text_display":" reactions may arise from use of the product within or outside the terms of the","confidence":0.9985356330871582,"confidence_rate":0.9999823442504918},{"cnt":[[247,2216],[1775,2216],[1775,2264],[247,2264]],"region":{"top_left_x":246,"top_left_y":2215,"width":1529,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d342ce89edd74e938075983c9f6a1008","type":"text","conversion_output":true,"text":"marketing authorisation or from occupational exposure. Conditions of use outside the","text_display":" marketing authorisation or from occupational exposure. Conditions of use outside the","confidence":1,"confidence_rate":1},{"cnt":[[247,2262],[1780,2262],[1780,2310],[247,2310]],"region":{"top_left_x":246,"top_left_y":2261,"width":1534,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"615d172b4bc9475f858a65b408d5a25a","type":"text","conversion_output":true,"text":"marketing authorization include off label use, overdose, misuse, abuse and medication","text_display":" marketing authorization include off label use, overdose, misuse, abuse and medication","confidence":1,"confidence_rate":1},{"cnt":[[247,2316],[372,2316],[372,2355],[247,2355]],"region":{"top_left_x":246,"top_left_y":2316,"width":127,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01cacdf034774baf9a6cc01ab3a68b21","type":"text","conversion_output":true,"text":"errors.","text_display":" errors.","confidence":1,"confidence_rate":1},{"cnt":[[242,2403],[624,2403],[624,2456],[242,2456]],"region":{"top_left_x":242,"top_left_y":2403,"width":382,"height":53},"line":47,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"575e0ebaec804c02bfd8ec5b94ee68bf","type":"section_header","conversion_output":false,"children_ids":["111948d2ff63499fbbaac46b24733d75"],"text":"","text_display":""},{"cnt":[[247,2408],[619,2408],[619,2451],[247,2451]],"region":{"top_left_x":246,"top_left_y":2407,"width":374,"height":45},"line":48,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"111948d2ff63499fbbaac46b24733d75","type":"text","conversion_output":true,"parent_id":"575e0ebaec804c02bfd8ec5b94ee68bf","text":"Serious adverse event","text_display":"\n\n\\section*{Serious adverse event}","confidence":1,"confidence_rate":1},{"cnt":[[244,2474],[1805,2474],[1805,2524],[244,2524]],"region":{"top_left_x":244,"top_left_y":2473,"width":1561,"height":52},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36fee8b5d23a4fc788c243d3f7c6fd18","type":"text","conversion_output":true,"text":"A serious adverse event (SAE) is defined as any AE that results in death, is immediately life-","text_display":"\n\nA serious adverse event (SAE) is defined as any AE that results in death, is immediately life","confidence":1,"confidence_rate":1},{"cnt":[[244,2522],[1741,2522],[1741,2572],[244,2572]],"region":{"top_left_x":244,"top_left_y":2521,"width":1497,"height":52},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3023c8d0192443d889a0169bd444c0ca","type":"text","conversion_output":true,"text":"threatening, results in persistent or significant disability / incapacity, requires or prolongs","text_display":"threatening, results in persistent or significant disability / incapacity, requires or prolongs","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":51,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9ab33dc32a0745a298422d090a3e793e","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99560546875,"confidence_rate":0.9998951432220243},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":52,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cc826fbc91ec488ca83df4b49c0e0835","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":53,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3d9e2c93651b4dde83c4a72a3bfd6640","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-045","page":45,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e838c0f3b23402bb7ad240603914b3a","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d2b23465afb4288a47e6f65b66509d6","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfea719f82cd4a76b8513eb5b39c3a01","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a227276eeecc458b9b181d574a72e494","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8924b6508324daf8dd1c45e03d501e4","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"461934b10e564b9c9cbdbe8b847fd8f9","type":"page_info","conversion_output":false,"text":"Page 45 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1775,338],[1775,386],[244,386]],"region":{"top_left_x":244,"top_left_y":338,"width":1531,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fcf46b622754ed8a8f8cfeb3567194b","type":"text","conversion_output":true,"text":"patient hospitalisation, is a congenital anomaly / birth defect, or is to be deemed serious for","text_display":"\npatient hospitalisation, is a congenital anomaly / birth defect, or is to be deemed serious for","confidence":1,"confidence_rate":1},{"cnt":[[244,388],[1743,388],[1743,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1499,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02892bc026ba42edb7dbd96887e9f6ec","type":"text","conversion_output":true,"text":"any other reason if it is an important medical event when based upon appropriate medical","text_display":" any other reason if it is an important medical event when based upon appropriate medical","confidence":1,"confidence_rate":1},{"cnt":[[242,434],[1816,434],[1816,484],[242,484]],"region":{"top_left_x":242,"top_left_y":434,"width":1575,"height":51},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e5cb939e77343f28bfa2045f4838433","type":"text","conversion_output":true,"text":"judgement that may jeopardise the patient and may require medical or surgical intervention to","text_display":" judgement that may jeopardise the patient and may require medical or surgical intervention to","confidence":1,"confidence_rate":1},{"cnt":[[242,484],[1336,484],[1336,532],[242,532]],"region":{"top_left_x":242,"top_left_y":484,"width":1095,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa6e29f56f14490f9ea89d0f1720f271","type":"text","conversion_output":true,"text":"prevent one of the other outcomes listed in the above definitions.","text_display":" prevent one of the other outcomes listed in the above definitions.","confidence":1,"confidence_rate":1},{"cnt":[[247,553],[1665,553],[1665,601],[247,601]],"region":{"top_left_x":246,"top_left_y":552,"width":1420,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a0735c681ed40ddb0e34370368bee8a","type":"text","conversion_output":true,"text":"Medical and scientific judgement should be exercised in deciding whether other","text_display":"\n\nMedical and scientific judgement should be exercised in deciding whether other","confidence":1,"confidence_rate":1},{"cnt":[[247,599],[1812,599],[1812,649],[247,649]],"region":{"top_left_x":246,"top_left_y":598,"width":1566,"height":51},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7885e8eeea8b4f5d8b08de156e25d2ff","type":"text","conversion_output":true,"text":"situations should be considered serious reactions, such as important medical events that","text_display":" situations should be considered serious reactions, such as important medical events that","confidence":1,"confidence_rate":1},{"cnt":[[247,649],[1816,649],[1816,697],[247,697]],"region":{"top_left_x":246,"top_left_y":648,"width":1571,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"33641e85ad414cdd9c2ebc7daa4d3806","type":"text","conversion_output":true,"text":"might not be immediately life threatening or result in death or hospitalization but might","text_display":" might not be immediately life threatening or result in death or hospitalization but might","confidence":1,"confidence_rate":1},{"cnt":[[244,697],[1658,697],[1658,745],[244,745]],"region":{"top_left_x":244,"top_left_y":696,"width":1415,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a3646e7fab04cdd80eae9a702df7878","type":"text","conversion_output":true,"text":"jeopardize the patient or might require intervention to prevent one of the other","text_display":" jeopardize the patient or might require intervention to prevent one of the other","confidence":1,"confidence_rate":1},{"cnt":[[247,745],[1816,745],[1816,793],[247,793]],"region":{"top_left_x":246,"top_left_y":744,"width":1571,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d83f1d6a7d2e479ebb4013de89361d7a","type":"text","conversion_output":true,"text":"outcomes listed above. Examples of such events are intensive treatment in an emergency","text_display":" outcomes listed above. Examples of such events are intensive treatment in an emergency","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[247,793],[1816,793],[1816,843],[247,843]],"region":{"top_left_x":246,"top_left_y":792,"width":1571,"height":51},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3727f8dd4ddc49f9a23e62ad221abe46","type":"text","conversion_output":true,"text":"room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not","text_display":" room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not","confidence":1,"confidence_rate":1},{"cnt":[[247,841],[1665,841],[1665,889],[247,889]],"region":{"top_left_x":246,"top_left_y":840,"width":1420,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c18825f5049495ebb3dcfd3466f8d52","type":"text","conversion_output":true,"text":"result in hospitalization or development of dependency or abuse. Any suspected","text_display":" result in hospitalization or development of dependency or abuse. Any suspected","confidence":1,"confidence_rate":1},{"cnt":[[247,889],[1789,886],[1789,937],[247,939]],"region":{"top_left_x":246,"top_left_y":886,"width":1543,"height":54},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ca3be0e147845e0b0bb7a1b869cae2a","type":"text","conversion_output":true,"text":"transmission via a medicinal product of an infectious agent is also considered a serious","text_display":" transmission via a medicinal product of an infectious agent is also considered a serious","confidence":0.9058976173400879,"confidence_rate":0.9989378871891686},{"cnt":[[247,937],[555,937],[555,980],[247,980]],"region":{"top_left_x":246,"top_left_y":936,"width":310,"height":44},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cdcede45d8834249b6d7cac4a52bd7de","type":"text","conversion_output":true,"text":"adverse reaction.","text_display":" adverse reaction.","confidence":1,"confidence_rate":1},{"cnt":[[244,1033],[1702,1033],[1702,1081],[244,1081]],"region":{"top_left_x":244,"top_left_y":1032,"width":1458,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8211a34c91547669c5d551570727588","type":"text","conversion_output":true,"text":"For Japan: An AE which possibly leads to disability will be reported as an SAE. Every","text_display":"\n\nFor Japan: An AE which possibly leads to disability will be reported as an SAE. Every","confidence":1,"confidence_rate":1},{"cnt":[[242,1078],[1713,1078],[1713,1128],[242,1128]],"region":{"top_left_x":242,"top_left_y":1078,"width":1472,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"095021ec5af2439594cd8a70f74750ce","type":"text","conversion_output":true,"text":"new occurrence of cancer will be reported as a SAE regardless of the duration between","text_display":" new occurrence of cancer will be reported as a SAE regardless of the duration between","confidence":1,"confidence_rate":1},{"cnt":[[242,1128],[1272,1128],[1272,1176],[242,1176]],"region":{"top_left_x":242,"top_left_y":1128,"width":1031,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78f8efd9fe214c7ab4ca8e20aa59d7be","type":"text","conversion_output":true,"text":"discontinuation of the drug and the occurrence of the cancer.","text_display":" discontinuation of the drug and the occurrence of the cancer.","confidence":0.8746335209580138,"confidence_rate":0.997972507939103},{"cnt":[[244,1197],[685,1197],[685,1245],[244,1245]],"region":{"top_left_x":244,"top_left_y":1197,"width":442,"height":48},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"990fcfde4e044762a64e6163b43aca47","type":"text","conversion_output":true,"text":"Intensity of adverse event","text_display":"\n\nIntensity of adverse event","confidence":1,"confidence_rate":1},{"cnt":[[244,1266],[1341,1266],[1341,1314],[244,1314]],"region":{"top_left_x":244,"top_left_y":1265,"width":1097,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ebb05b7b932452385c1afcfb458cdad","type":"text","conversion_output":true,"text":"The intensity of the AE should be judged based on the following:","text_display":"\nThe intensity of the AE should be judged based on the following:","confidence":0.97900390625,"confidence_rate":0.9996925161753262},{"cnt":[[244,1334],[1542,1334],[1542,1382],[244,1382]],"region":{"top_left_x":244,"top_left_y":1334,"width":1298,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"859053b669e946a6a364dabad66619c5","type":"text","conversion_output":true,"text":"Mild: Awareness of sign(s) or symptom(s) that is/are easily tolerated","text_display":"\nMild: Awareness of sign(s) or symptom(s) that is/are easily tolerated","confidence":1,"confidence_rate":1},{"cnt":[[244,1380],[1494,1380],[1494,1430],[244,1430]],"region":{"top_left_x":244,"top_left_y":1379,"width":1250,"height":52},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b892313f6d04b13bd01af77106df059","type":"text","conversion_output":true,"text":"Moderate: Enough discomfort to cause interference with usual activity","text_display":"\nModerate: Enough discomfort to cause interference with usual activity","confidence":1,"confidence_rate":1},{"cnt":[[244,1430],[1697,1430],[1697,1478],[244,1478]],"region":{"top_left_x":244,"top_left_y":1430,"width":1454,"height":48},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2f3119778064f999c435a4623e546e4","type":"text","conversion_output":true,"text":"Severe: Incapacitating or causing inability to work or to perform usual activities","text_display":"\nSevere: Incapacitating or causing inability to work or to perform usual activities","confidence":0.99853515625,"confidence_rate":0.9999831505134198},{"cnt":[[242,1512],[861,1512],[861,1569],[242,1569]],"region":{"top_left_x":242,"top_left_y":1512,"width":620,"height":58},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4eb757f54b2449be831e8cd9acebcb1e","type":"section_header","conversion_output":false,"children_ids":["1d3846df3ef6480a8d5f4886c0ab84ab"],"text":"","text_display":""},{"cnt":[[247,1517],[857,1517],[857,1565],[247,1565]],"region":{"top_left_x":246,"top_left_y":1516,"width":611,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d3846df3ef6480a8d5f4886c0ab84ab","type":"text","conversion_output":true,"parent_id":"4eb757f54b2449be831e8cd9acebcb1e","text":"Causal relationship of adverse event","text_display":"\n\n\\section*{Causal relationship of adverse event}","confidence":1,"confidence_rate":1},{"cnt":[[244,1585],[1716,1585],[1716,1636],[244,1636]],"region":{"top_left_x":244,"top_left_y":1585,"width":1472,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca81bd1443f247958253a73a8725d938","type":"text","conversion_output":true,"text":"Medical judgment should be used to determine the relationship, considering all relevant","text_display":"\n\nMedical judgment should be used to determine the relationship, considering all relevant","confidence":1,"confidence_rate":1},{"cnt":[[247,1636],[1741,1636],[1741,1684],[247,1684]],"region":{"top_left_x":246,"top_left_y":1635,"width":1495,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bd026c4b01334063b474fa78cbd430f8","type":"text","conversion_output":true,"text":"factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge,","text_display":" factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge,","confidence":1,"confidence_rate":1},{"cnt":[[247,1684],[1725,1684],[1725,1729],[247,1729]],"region":{"top_left_x":246,"top_left_y":1683,"width":1479,"height":47},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a5e969e3b3f4e5ba2b635c35cf80ba7","type":"text","conversion_output":true,"text":"confounding factors such as concomitant medication, concomitant diseases and relevant","text_display":" confounding factors such as concomitant medication, concomitant diseases and relevant","confidence":1,"confidence_rate":1},{"cnt":[[244,1732],[1770,1732],[1770,1780],[244,1780]],"region":{"top_left_x":244,"top_left_y":1731,"width":1527,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c594e796a5e64fa9b176ca8b09307f48","type":"text","conversion_output":true,"text":"history. Assessment of causal relationship should be recorded in the case report forms. For","text_display":" history. Assessment of causal relationship should be recorded in the case report forms. For","confidence":1,"confidence_rate":1},{"cnt":[[242,1780],[1777,1780],[1777,1830],[242,1830]],"region":{"top_left_x":242,"top_left_y":1779,"width":1536,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f23b3dc9977142789d2d5a3e7c1a09fd","type":"text","conversion_output":true,"text":"Japan: The reason for the decision on causal relationship needs to be provided in the CRF.","text_display":" Japan: The reason for the decision on causal relationship needs to be provided in the CRF.","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[247,1846],[1656,1846],[1656,1894],[247,1894]],"region":{"top_left_x":246,"top_left_y":1845,"width":1411,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ae7c8f59c3d48d1af3adddcc466f6a1","type":"text","conversion_output":true,"text":"Yes: There is a reasonable causal relationship between the investigational product","text_display":"\n\nYes: There is a reasonable causal relationship between the investigational product","confidence":1,"confidence_rate":1},{"cnt":[[368,1896],[797,1896],[797,1939],[368,1939]],"region":{"top_left_x":367,"top_left_y":1896,"width":431,"height":44},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c718e250cf2e479caffed1a24146ba5f","type":"text","conversion_output":true,"text":"administered and the AE.","text_display":" administered and the AE.","confidence":0.99560546875,"confidence_rate":0.9998481420286601},{"cnt":[[244,1942],[1679,1942],[1679,1994],[244,1994]],"region":{"top_left_x":244,"top_left_y":1941,"width":1436,"height":54},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce32682cb4814dc3962af89c17f85dfc","type":"text","conversion_output":true,"text":"No: There is no reasonable causal relationship between the investigational product","text_display":"\nNo: There is no reasonable causal relationship between the investigational product","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[368,1992],[811,1992],[811,2035],[368,2035]],"region":{"top_left_x":367,"top_left_y":1991,"width":444,"height":45},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"965c900098564208a18fca1b94d0af09","type":"text","conversion_output":true,"text":"administered and the AE.","text_display":" administered and the AE.","confidence":0.99951171875,"confidence_rate":0.999983158745329},{"cnt":[[247,2061],[1821,2061],[1821,2108],[247,2108]],"region":{"top_left_x":246,"top_left_y":2060,"width":1575,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d51bdb63ac2240a18469154086324fba","type":"text","conversion_output":true,"text":"If an SAE is reported from a still blinded trial, the causal relationship must be provided by the","text_display":"\n\nIf an SAE is reported from a still blinded trial, the causal relationship must be provided by the","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[247,2108],[1780,2108],[1780,2159],[247,2159]],"region":{"top_left_x":246,"top_left_y":2108,"width":1534,"height":51},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6211d235872b42219bb60fcb91af820d","type":"text","conversion_output":true,"text":"investigator for all potential trial drugs, i.e. the BI trial drug and for all other trial drugs (i.e.","text_display":" investigator for all potential trial drugs, i.e. the BI trial drug and for all other trial drugs (i.e.","confidence":0.99560546875,"confidence_rate":0.9999588399537807},{"cnt":[[247,2156],[1304,2156],[1304,2204],[247,2204]],"region":{"top_left_x":246,"top_left_y":2156,"width":1059,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"772c395895514e72a796c29ef554f4f5","type":"text","conversion_output":true,"text":"any active comparator or placebo according to the trial design).","text_display":" any active comparator or placebo according to the trial design).","confidence":0.9990234375,"confidence_rate":0.9999858401053562},{"cnt":[[247,2243],[1339,2243],[1339,2294],[247,2294]],"region":{"top_left_x":246,"top_left_y":2243,"width":1093,"height":51},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2401a46642644d25851ed7de61066b6f","type":"text","conversion_output":true,"text":"Worsening of underlying disease or other pre-existing conditions","text_display":"\n\nWorsening of underlying disease or other pre-existing conditions","confidence":1,"confidence_rate":1},{"cnt":[[247,2314],[1821,2314],[1821,2364],[247,2364]],"region":{"top_left_x":246,"top_left_y":2314,"width":1575,"height":51},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce39889271ac49a28b86038e445b97fc","type":"text","conversion_output":true,"text":"Worsening of the underlying disease or of other pre-existing conditions will be recorded as an","text_display":"\nWorsening of the underlying disease or of other pre-existing conditions will be recorded as an","confidence":0.998046875,"confidence_rate":0.9999802523683627},{"cnt":[[247,2362],[610,2362],[610,2410],[247,2410]],"region":{"top_left_x":246,"top_left_y":2362,"width":364,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7138174752db4ca792ecb8848f5bb02a","type":"text","conversion_output":true,"text":"(S)AE in the (e)CRF.","text_display":" (S)AE in the (e)CRF.","confidence":1,"confidence_rate":1},{"cnt":[[247,2453],[1556,2453],[1556,2501],[247,2501]],"region":{"top_left_x":246,"top_left_y":2453,"width":1310,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"975da4aeca174c5cb1bfb5ac2886c825","type":"text","conversion_output":true,"text":"Changes in vital signs, ECG, physical examination, and laboratory test results","text_display":"\n\nChanges in vital signs, ECG, physical examination, and laboratory test results","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cd4dae9ab2d34c9cb31db5cb1dd6b1a8","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"393e13a83c50438dba8b5e0bd0987aa6","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d1f434633bfb447898d33a05b6dde284","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-046","page":46,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7eaadd5fcf644330913031a06fb15696","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b658c8068c24c7c97313dd9ed892e65","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bab5d24cedcb443390756114edbe8929","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"131dc2eba43e405e99e6bc3d1815806c","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"047effd6aac348ef9a05854848b4fbde","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"682eda576a7b472c83116da4941d4441","type":"page_info","conversion_output":false,"text":"Page 46 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1686,338],[1686,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":1440,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3fae5255eea4e85835464749c2d6d36","type":"text","conversion_output":true,"text":"Changes in vital signs, ECG*, physical examination and laboratory test results will be","text_display":"\n\nChanges in vital signs, ECG*, physical examination and laboratory test results will be","confidence":0.53125,"confidence_rate":0.9930733035705308},{"cnt":[[247,388],[1802,388],[1802,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1557,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"728d021cc2ee47a6bc2e03b8f51dfa11","type":"text","conversion_output":true,"text":"recorded as an (S)AE in the (e)CRF, if they are judged clinically relevant by the investigator.","text_display":" recorded as an (S)AE in the (e)CRF, if they are judged clinically relevant by the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[247,477],[1784,477],[1784,523],[247,523]],"region":{"top_left_x":246,"top_left_y":477,"width":1539,"height":47},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a839eb5a7e9457aa1e2c85c58ab2836","type":"text","conversion_output":true,"text":"*Changes in the ECG indicating (silent) MI should be reported as a cardiovascular outcome","text_display":"\n*Changes in the ECG indicating (silent) MI should be reported as a cardiovascular outcome","confidence":1,"confidence_rate":1},{"cnt":[[247,530],[350,530],[350,569],[247,569]],"region":{"top_left_x":246,"top_left_y":529,"width":104,"height":40},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f4a08f63c254456b2cd5629049a077e","type":"text","conversion_output":true,"text":"event.","text_display":" event.","confidence":1,"confidence_rate":1},{"cnt":[[242,612],[637,612],[637,665],[242,665]],"region":{"top_left_x":242,"top_left_y":612,"width":396,"height":53},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5205a40f69c94fc4a34aeb450d286694","type":"section_header","conversion_output":false,"children_ids":["94792e6a07a44d1fbba5227398c63ed0"],"text":"","text_display":""},{"cnt":[[247,617],[633,617],[633,662],[247,662]],"region":{"top_left_x":246,"top_left_y":616,"width":387,"height":47},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94792e6a07a44d1fbba5227398c63ed0","type":"text","conversion_output":true,"parent_id":"5205a40f69c94fc4a34aeb450d286694","text":"Hypoglycaemic events","text_display":"\n\n\\section*{Hypoglycaemic events}","confidence":1,"confidence_rate":1},{"cnt":[[247,704],[1606,704],[1606,752],[247,752]],"region":{"top_left_x":246,"top_left_y":703,"width":1360,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dadf7b0d3ff94c458773626a0ddc137a","type":"text","conversion_output":true,"text":"Hypoglycaemic events should be documented according to the following criteria:","text_display":"\n\nHypoglycaemic events should be documented according to the following criteria:","confidence":1,"confidence_rate":1},{"cnt":[[311,797],[1706,797],[1706,845],[311,845]],"region":{"top_left_x":310,"top_left_y":797,"width":1397,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de2a9b61a1c24d85b64a4b25302e5295","type":"text","conversion_output":true,"text":"- Asymptomatic hypoglycaemia: Event not accompanied by typical symptoms of","text_display":"\n- Asymptomatic hypoglycaemia: Event not accompanied by typical symptoms of","confidence":1,"confidence_rate":1},{"cnt":[[370,845],[1812,845],[1812,893],[370,893]],"region":{"top_left_x":370,"top_left_y":845,"width":1442,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c840f21203b54411a90b0aa8115bf9ed","type":"text","conversion_output":true,"text":"hypoglycaemia but with a measured plasma glucose concentration \\(\\geq 54 mg / dl\\) and \\(\\leq 70\\)","text_display":" hypoglycaemia but with a measured plasma glucose concentration \\(\\geq 54 mg / dl\\) and \\(\\leq 70","confidence":1,"confidence_rate":1},{"cnt":[[370,891],[1017,891],[1017,939],[370,939]],"region":{"top_left_x":370,"top_left_y":890,"width":647,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f685033601747fa8d65936022f16b3d","type":"text","conversion_output":true,"text":"\\(mg / dl (\\geq 3.0 mmol / l\\) and \\(\\leq 3.9 mmol / l )\\) :","text_display":" mg / dl (\\geq 3.0 mmol / l\\) and \\(\\leq 3.9 mmol / l )\\) :","confidence":0.9637824848992567,"confidence_rate":0.9993749471574246},{"cnt":[[311,943],[1706,943],[1706,991],[311,991]],"region":{"top_left_x":310,"top_left_y":943,"width":1397,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fa4acbe11d046f78862717918545fe4","type":"text","conversion_output":true,"text":"- Asymptomatic hypoglycaemia: Event not accompanied by typical symptoms of","text_display":"\n- Asymptomatic hypoglycaemia: Event not accompanied by typical symptoms of","confidence":1,"confidence_rate":1},{"cnt":[[370,991],[1775,991],[1775,1039],[370,1039]],"region":{"top_left_x":370,"top_left_y":991,"width":1405,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8831d4d362d449e9665169b9b13e444","type":"text","conversion_output":true,"text":"hypoglycaemia but with a measured plasma glucose concentration \\(<54 mg / dl\\) ( \\(<3.0\\)","text_display":" hypoglycaemia but with a measured plasma glucose concentration \\(<54 mg / dl\\) ( \\(<3.0\\)","confidence":0.8935546875,"confidence_rate":0.9987639761522993},{"cnt":[[370,1037],[514,1037],[514,1085],[370,1085]],"region":{"top_left_x":370,"top_left_y":1037,"width":144,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c35f655eb5243a189b352e5bf423157","type":"text","conversion_output":true,"text":"mmol/l)","text_display":" mmol/l)","confidence":1,"confidence_rate":1},{"cnt":[[311,1090],[1793,1090],[1793,1140],[311,1140]],"region":{"top_left_x":310,"top_left_y":1089,"width":1484,"height":51},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1bfd895123f44745b19f148d5a3670e0","type":"text","conversion_output":true,"text":"- Documented symptomatic hypoglycaemia with glucose concentration \\(\\geq 54 mg / dl\\) and","text_display":"\n- Documented symptomatic hypoglycaemia with glucose concentration \\(\\geq 54 mg / dl\\) and","confidence":1,"confidence_rate":1},{"cnt":[[370,1138],[1786,1138],[1786,1186],[370,1186]],"region":{"top_left_x":370,"top_left_y":1137,"width":1417,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"614fbe7e817f4a8dabaa250d953f2f9c","type":"text","conversion_output":true,"text":"\\(\\leq 70 mg / dl (\\geq 3.0 mmol / 1\\) and \\(\\leq 3.9 mmol / l )\\) : Event accompanied by typical symptoms","text_display":" \\(\\leq 70 mg / dl (\\geq 3.0 mmol / 1\\) and \\(\\leq 3.9 mmol / l )\\) : Event accompanied by typical symptoms","confidence":0.967489229062128,"confidence_rate":0.9996593262188613},{"cnt":[[370,1183],[678,1183],[678,1234],[370,1234]],"region":{"top_left_x":370,"top_left_y":1183,"width":309,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79d6c2ce84764405a4fe70d27dcc3512","type":"text","conversion_output":true,"text":"of hypoglycaemia","text_display":" of hypoglycaemia","confidence":1,"confidence_rate":1},{"cnt":[[306,1238],[1734,1238],[1734,1286],[306,1286]],"region":{"top_left_x":306,"top_left_y":1238,"width":1428,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2aa673ca9ea9483c9d1618ba06e17a0e","type":"text","conversion_output":true,"text":"- Documented symptomatic hypoglycaemia with glucose concentration \\(<54 mg / dl\\)","text_display":"\n- Documented symptomatic hypoglycaemia with glucose concentration \\(<54 mg / dl\\)","confidence":1,"confidence_rate":1},{"cnt":[[370,1284],[1743,1284],[1743,1332],[370,1332]],"region":{"top_left_x":370,"top_left_y":1283,"width":1373,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b962c7e6d68b463d9238f2404a4e4616","type":"text","conversion_output":true,"text":"( \\(<3.0 mmol / l\\) ): Event accompanied by typical symptoms of hypoglycaemia but no","text_display":" ( \\(<3.0 mmol / l\\) ): Event accompanied by typical symptoms of hypoglycaemia but no","confidence":0.98974609375,"confidence_rate":0.9998867444390888},{"cnt":[[370,1330],[838,1330],[838,1375],[370,1375]],"region":{"top_left_x":370,"top_left_y":1329,"width":469,"height":47},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8af47fe1ddd145998234bba42eaa49ab","type":"text","conversion_output":true,"text":"need for external assistance","text_display":" need for external assistance","confidence":1,"confidence_rate":1},{"cnt":[[306,1384],[1802,1384],[1802,1432],[306,1432]],"region":{"top_left_x":306,"top_left_y":1384,"width":1497,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9633fc21b2554c3787debefec88bbe83","type":"text","conversion_output":true,"text":"- Severe hypoglycaemic episode: Event with any degree of documented hypoglycemia,","text_display":"\n- Severe hypoglycaemic episode: Event with any degree of documented hypoglycemia,","confidence":1,"confidence_rate":1},{"cnt":[[370,1430],[1679,1430],[1679,1483],[370,1483]],"region":{"top_left_x":370,"top_left_y":1430,"width":1310,"height":53},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95e91875db7c498ca3ccc5696bd043b5","type":"text","conversion_output":true,"text":"requiring the assistance of another person to actively administer carbohydrate,","text_display":" requiring the assistance of another person to actively administer carbohydrate,","confidence":1,"confidence_rate":1},{"cnt":[[370,1480],[1017,1480],[1017,1528],[370,1528]],"region":{"top_left_x":370,"top_left_y":1480,"width":647,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd90d90a23dc4b83bf5ed85e762dd755","type":"text","conversion_output":true,"text":"glucagon or other resuscitative actions","text_display":" glucagon or other resuscitative actions","confidence":1,"confidence_rate":1},{"cnt":[[244,1576],[1738,1576],[1738,1624],[244,1624]],"region":{"top_left_x":244,"top_left_y":1576,"width":1495,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e8a1e21809f42dcbd8323e70319dda4","type":"text","conversion_output":true,"text":"All symptomatic hypoglycaemic events, all asymptomatic events with glucose levels less","text_display":"\n\nAll symptomatic hypoglycaemic events, all asymptomatic events with glucose levels less","confidence":1,"confidence_rate":1},{"cnt":[[247,1622],[1775,1622],[1775,1672],[247,1672]],"region":{"top_left_x":246,"top_left_y":1621,"width":1529,"height":52},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fda0336a67c44edfaa2985010c7357aa","type":"text","conversion_output":true,"text":"than \\(3.0 mmol / l\\) and all asymptomatic hypoglycaemic events that are considered as adverse","text_display":" than \\(3.0 mmol / l\\) and all asymptomatic hypoglycaemic events that are considered as adverse","confidence":0.84130859375,"confidence_rate":0.9982906037775899},{"cnt":[[247,1672],[1345,1672],[1345,1720],[247,1720]],"region":{"top_left_x":246,"top_left_y":1672,"width":1100,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ebd99a8aed54f6f9fef35f151f3de8d","type":"text","conversion_output":true,"text":"event by the investigator have to be recorded as an adverse event.","text_display":" event by the investigator have to be recorded as an adverse event.","confidence":1,"confidence_rate":1},{"cnt":[[242,1759],[834,1759],[834,1812],[242,1812]],"region":{"top_left_x":242,"top_left_y":1758,"width":592,"height":54},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08026f00b7834b55b72478e53c136de7","type":"section_header","conversion_output":false,"children_ids":["e8e4944016c94d4f82cff027e0f1f6dd"],"text":"","text_display":""},{"cnt":[[247,1764],[829,1764],[829,1807],[247,1807]],"region":{"top_left_x":246,"top_left_y":1763,"width":584,"height":44},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e8e4944016c94d4f82cff027e0f1f6dd","type":"text","conversion_output":true,"parent_id":"08026f00b7834b55b72478e53c136de7","text":"Adverse Events of Special Interest","text_display":"\n\n\\section*{Adverse Events of Special Interest}","confidence":0.83740234375,"confidence_rate":0.9954603195757541},{"cnt":[[247,1850],[1798,1850],[1798,1898],[247,1898]],"region":{"top_left_x":246,"top_left_y":1850,"width":1552,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aca40ca77512486face06a2606cdfc4b","type":"text","conversion_output":true,"text":"The term AESI relates to any specific AE that has been identified at the project level as","text_display":"\n\nThe term AESI relates to any specific AE that has been identified at the project level as","confidence":1,"confidence_rate":1},{"cnt":[[247,1901],[1738,1901],[1738,1949],[247,1949]],"region":{"top_left_x":246,"top_left_y":1900,"width":1493,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7bd352bf7bb44de1b28f9f869f640bf0","type":"text","conversion_output":true,"text":"being of particular concern for prospective safety monitoring and safety assessment","text_display":" being of particular concern for prospective safety monitoring and safety assessment","confidence":1,"confidence_rate":1},{"cnt":[[247,1946],[1775,1946],[1775,1997],[247,1997]],"region":{"top_left_x":246,"top_left_y":1946,"width":1529,"height":51},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"feb96e33bcdd4f089d56c8b2c4210865","type":"text","conversion_output":true,"text":"within this trial, e.g. the potential for AEs based on knowledge from other compounds","text_display":" within this trial, e.g. the potential for AEs based on knowledge from other compounds","confidence":1,"confidence_rate":1},{"cnt":[[247,1994],[1695,1994],[1695,2042],[247,2042]],"region":{"top_left_x":246,"top_left_y":1994,"width":1450,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e82ed2d757ee46e4bea10a39e69e349e","type":"text","conversion_output":true,"text":"in the same class. AESI's need to be reported to the sponsor's Pharmacovigilance","text_display":" in the same class. AESI's need to be reported to the sponsor's Pharmacovigilance","confidence":1,"confidence_rate":1},{"cnt":[[247,2042],[1318,2042],[1318,2090],[247,2090]],"region":{"top_left_x":246,"top_left_y":2042,"width":1073,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8a590b442de428fa5381de7a116f71d","type":"text","conversion_output":true,"text":"Department within the same timeframe that applies to SAE.","text_display":" Department within the same timeframe that applies to SAE.","confidence":1,"confidence_rate":1},{"cnt":[[247,2138],[1601,2138],[1601,2186],[247,2186]],"region":{"top_left_x":246,"top_left_y":2138,"width":1356,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"535ad14dee4d4371955805226fea7ee1","type":"text","conversion_output":true,"text":"The following events are considered as adverse events of special interest (AESI):","text_display":"\n\nThe following events are considered as adverse events of special interest (AESI):","confidence":1,"confidence_rate":1},{"cnt":[[306,2230],[1652,2230],[1652,2278],[306,2278]],"region":{"top_left_x":306,"top_left_y":2229,"width":1346,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14c843c25a884ffa84532f04023456f5","type":"text","conversion_output":true,"text":"- Hypersensitivity reactions such as angioedema, angioedema-like events, and","text_display":"\n- Hypersensitivity reactions such as angioedema, angioedema-like events, and","confidence":1,"confidence_rate":1},{"cnt":[[370,2280],[573,2280],[573,2328],[370,2328]],"region":{"top_left_x":370,"top_left_y":2279,"width":204,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6511ce15256548e5853e113758652a13","type":"text","conversion_output":true,"text":"anaphylaxis","text_display":" anaphylaxis","confidence":1,"confidence_rate":1},{"cnt":[[306,2330],[1583,2330],[1583,2378],[306,2378]],"region":{"top_left_x":306,"top_left_y":2330,"width":1278,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f9adeb4dbd842518a7f6dbd37a1d0a2","type":"text","conversion_output":true,"text":"- Skin lesions such as exfoliative rash, skin necrosis, or bullous dermatitis","text_display":"\n- Skin lesions such as exfoliative rash, skin necrosis, or bullous dermatitis","confidence":1,"confidence_rate":1},{"cnt":[[306,2380],[1734,2380],[1734,2428],[306,2428]],"region":{"top_left_x":306,"top_left_y":2380,"width":1428,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13128ce0f0534c13a10c1b5a006ca2da","type":"text","conversion_output":true,"text":"- Hepatic events such as \\(\\geq 3\\) fold ULN of AST and/or ALT in combination with an","text_display":"\n- Hepatic events such as \\(\\geq 3\\) fold ULN of AST and/or ALT in combination with an","confidence":0.99853515625,"confidence_rate":0.9999827540583306},{"cnt":[[370,2426],[1750,2426],[1750,2476],[370,2476]],"region":{"top_left_x":370,"top_left_y":2426,"width":1380,"height":51},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af2f28aeb1c84adabe8d531f78f6e241","type":"text","conversion_output":true,"text":"elevation of total bilirubin >2 fold ULN measured in the same blood draw sample,","text_display":" elevation of total bilirubin >2 fold ULN measured in the same blood draw sample,","confidence":0.9296875,"confidence_rate":0.9991426410270215},{"cnt":[[370,2476],[1446,2476],[1446,2524],[370,2524]],"region":{"top_left_x":370,"top_left_y":2476,"width":1077,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a582b6afdd4449dd91734d23f23f9947","type":"text","conversion_output":true,"text":"hepatitis, hepatic injury, jaundice and potential Hy's Law cases.","text_display":" hepatitis, hepatic injury, jaundice and potential Hy's Law cases.","confidence":0.966796875,"confidence_rate":0.9995177325787521},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"42cb2fe0f2ea4cb2abe9323e1860e85f","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99755859375,"confidence_rate":0.9999418018997234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d4f3087d68964583b7422664a9fa4612","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6ac09eedb5a640df8a1c2a87e92fbcba","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-047","page":47,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c85880b197e44c4da1579f11094eb9af","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e0fa0b4c7cf45be92610e122fb13aaa","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d142f30a74844ec183165f9727d1489a","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e8092731dfa941b3b4e8c71f41ad58ef","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"937e1aa3edd54bc3812b03c6a1b8739f","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42962cd3bd9b4293893956f52942b51e","type":"page_info","conversion_output":false,"text":"Page 47 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[306,343],[1172,343],[1172,386],[306,386]],"region":{"top_left_x":306,"top_left_y":342,"width":866,"height":45},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c446ad43b44e434586ec9618fbf8dcf6","type":"text","conversion_output":true,"text":"- Renal adverse events such as acute renal failure","text_display":"\n- Renal adverse events such as acute renal failure","confidence":1,"confidence_rate":1},{"cnt":[[306,393],[884,393],[884,441],[306,441]],"region":{"top_left_x":306,"top_left_y":392,"width":579,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"027c2bd028804782a02d70329f6bd693","type":"text","conversion_output":true,"text":"- Pancreatitis (refer to the ISF)","text_display":"\n- Pancreatitis (refer to the ISF)","confidence":1,"confidence_rate":1},{"cnt":[[306,443],[834,443],[834,496],[306,496]],"region":{"top_left_x":306,"top_left_y":443,"width":528,"height":53},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1c8a215d3fd48a482aa6836ddb2f7c2","type":"text","conversion_output":true,"text":"- Thyroid neoplasm (benign)","text_display":"\n- Thyroid neoplasm (benign)","confidence":1,"confidence_rate":1},{"cnt":[[306,496],[633,496],[633,544],[306,544]],"region":{"top_left_x":306,"top_left_y":495,"width":327,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"306aa3959dca470dbb11226487567f62","type":"text","conversion_output":true,"text":"- Thyroid cancer","text_display":"\n- Thyroid cancer","confidence":1,"confidence_rate":1},{"cnt":[[306,544],[672,544],[672,592],[306,592]],"region":{"top_left_x":306,"top_left_y":543,"width":366,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19d7cc30998146418b9f74d9e8b48c24","type":"text","conversion_output":true,"text":"- Pancreatic cancer","text_display":"\n- Pancreatic cancer","confidence":1,"confidence_rate":1},{"cnt":[[244,635],[1693,635],[1693,683],[244,683]],"region":{"top_left_x":244,"top_left_y":635,"width":1449,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37d95bc7a6054969b9121f5c11204481","type":"text","conversion_output":true,"text":"A list of terms that must be documented as AESI for each topic is provided in the ISF.","text_display":"\n\nA list of terms that must be documented as AESI for each topic is provided in the ISF.","confidence":1,"confidence_rate":1},{"cnt":[[242,681],[1711,681],[1711,733],[242,733]],"region":{"top_left_x":242,"top_left_y":680,"width":1469,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"898f334f8d0644d4ac16c45cafa99f17","type":"text","conversion_output":true,"text":"The renal events and pancreatic events will be adjudicated by independent adjudication","text_display":" The renal events and pancreatic events will be adjudicated by independent adjudication","confidence":0.94970703125,"confidence_rate":0.9994331087643926},{"cnt":[[244,731],[459,731],[459,774],[244,774]],"region":{"top_left_x":244,"top_left_y":731,"width":216,"height":44},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b13f815b4454a4b94a166755a34fa63","type":"text","conversion_output":true,"text":"committees.","text_display":" committees.","confidence":0.9936552047729492,"confidence_rate":0.999602266055431},{"cnt":[[242,777],[1798,777],[1798,829],[242,829]],"region":{"top_left_x":242,"top_left_y":776,"width":1556,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00d184a887774b7195c6d35d55de2c32","type":"text","conversion_output":true,"text":"AESI's, even though they might be non-serious are to be documented in the eCRF within 24","text_display":"\nAESI's, even though they might be non-serious are to be documented in the eCRF within 24","confidence":0.9990236759185791,"confidence_rate":0.9999893826542317},{"cnt":[[242,827],[1789,827],[1789,879],[242,879]],"region":{"top_left_x":242,"top_left_y":826,"width":1547,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7ad4aa43f634ef8a3c193030cfd69e8","type":"text","conversion_output":true,"text":"hours of receipt and must be reported to the sponsor/CRO in an expedited manner similar to","text_display":" hours of receipt and must be reported to the sponsor/CRO in an expedited manner similar to","confidence":0.9737221819814295,"confidence_rate":0.9997197313864626},{"cnt":[[242,873],[1300,873],[1300,925],[242,925]],"region":{"top_left_x":242,"top_left_y":872,"width":1058,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65dda37ac44543adb96853e7cfd0d90e","type":"text","conversion_output":true,"text":"Serious Adverse Events. For details please see Section 5.2.2.2.","text_display":" Serious Adverse Events. For details please see Section 5.2.2.2.","confidence":0.97900390625,"confidence_rate":0.9996879950598632},{"cnt":[[244,964],[1629,964],[1629,1017],[244,1017]],"region":{"top_left_x":244,"top_left_y":964,"width":1385,"height":53},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"293a202d307f4dddb78bc758a1e42ea5","type":"text","conversion_output":true,"text":"Protocol-specified AESIs (as identified by the investigator based on the above","text_display":"\n\nProtocol-specified AESIs (as identified by the investigator based on the above","confidence":1,"confidence_rate":1},{"cnt":[[244,1012],[1732,1012],[1732,1062],[244,1062]],"region":{"top_left_x":244,"top_left_y":1011,"width":1488,"height":52},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"decaf8b04e8e4412a4269f54cc0e0417","type":"text","conversion_output":true,"text":"definitions for adverse events of special interest) can be classified as serious or non-","text_display":" definitions for adverse events of special interest) can be classified as serious or non","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[247,1060],[1766,1060],[1766,1110],[247,1110]],"region":{"top_left_x":246,"top_left_y":1059,"width":1520,"height":52},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e26da6c7857d44d3aba4896c30489cd4","type":"text","conversion_output":true,"text":"serious but all these AESIs once identified by the investigator must be reported on an","text_display":"serious but all these AESIs once identified by the investigator must be reported on an","confidence":1,"confidence_rate":1},{"cnt":[[247,1108],[1782,1108],[1782,1158],[247,1158]],"region":{"top_left_x":246,"top_left_y":1107,"width":1536,"height":52},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d835d9cd1174a2eba59d382b6aac399","type":"text","conversion_output":true,"text":"SAE form in an expedited manner similar to SAEs, even if they do not meet any of the","text_display":" SAE form in an expedited manner similar to SAEs, even if they do not meet any of the","confidence":1,"confidence_rate":1},{"cnt":[[247,1156],[697,1156],[697,1202],[247,1202]],"region":{"top_left_x":246,"top_left_y":1155,"width":451,"height":47},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95cbabbfffef4e189cc199c780f56cd1","type":"text","conversion_output":true,"text":"SAE seriousness criteria.","text_display":" SAE seriousness criteria.","confidence":1,"confidence_rate":1},{"cnt":[[247,1247],[1729,1247],[1729,1300],[247,1300]],"region":{"top_left_x":246,"top_left_y":1247,"width":1484,"height":53},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2a7582ce774489c8e0ad1654ca161cf","type":"text","conversion_output":true,"text":"Beyond of this, and for the purposes of ongoing pharmacovigilance activities by the","text_display":"\n\nBeyond of this, and for the purposes of ongoing pharmacovigilance activities by the","confidence":0.98779296875,"confidence_rate":0.9998604398645167},{"cnt":[[247,1293],[1713,1293],[1713,1345],[247,1345]],"region":{"top_left_x":246,"top_left_y":1292,"width":1468,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aac1f6b7203649eba20573a76194d3fc","type":"text","conversion_output":true,"text":"sponsor, adverse events based on additional searches for coded preferred terms of","text_display":" sponsor, adverse events based on additional searches for coded preferred terms of","confidence":1,"confidence_rate":1},{"cnt":[[247,1343],[1670,1343],[1670,1391],[247,1391]],"region":{"top_left_x":246,"top_left_y":1343,"width":1424,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7ba0d7980d34cc7b6c88464a8f747b1","type":"text","conversion_output":true,"text":"adverse events captured in the trial database (such as Special MedDRA Queries","text_display":" adverse events captured in the trial database (such as Special MedDRA Queries","confidence":1,"confidence_rate":1},{"cnt":[[247,1389],[1658,1389],[1658,1439],[247,1439]],"region":{"top_left_x":246,"top_left_y":1388,"width":1413,"height":52},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"345262344bca441385b2a4ffb5e669b8","type":"text","conversion_output":true,"text":"(SMQs), and user defined searches (BicMQs)) will be queried to verify with the","text_display":" (SMQs), and user defined searches (BicMQs)) will be queried to verify with the","confidence":1,"confidence_rate":1},{"cnt":[[247,1439],[1775,1439],[1775,1487],[247,1487]],"region":{"top_left_x":246,"top_left_y":1439,"width":1529,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf0ba32087b04583961db51eb50d7191","type":"text","conversion_output":true,"text":"investigator if the adverse event reported represent a suspected or diagnosed protocol","text_display":" investigator if the adverse event reported represent a suspected or diagnosed protocol","confidence":0.966796875,"confidence_rate":0.9996290044131322},{"cnt":[[247,1485],[1780,1485],[1780,1537],[247,1537]],"region":{"top_left_x":246,"top_left_y":1484,"width":1534,"height":54},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac768d9216e740a28cb4f9fd217574d6","type":"text","conversion_output":true,"text":"specified AESI. AESIs once identified by the investigator must be reported on an SAE","text_display":" specified AESI. AESIs once identified by the investigator must be reported on an SAE","confidence":0.99853515625,"confidence_rate":0.9999835291504493},{"cnt":[[247,1535],[1780,1535],[1780,1583],[247,1583]],"region":{"top_left_x":246,"top_left_y":1535,"width":1534,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7649d3308b4c41398ededdb24ff187f4","type":"text","conversion_output":true,"text":"form in an expedited manner similar to SAEs, even if they do not meet any of the SAE","text_display":" form in an expedited manner similar to SAEs, even if they do not meet any of the SAE","confidence":1,"confidence_rate":1},{"cnt":[[247,1581],[605,1581],[605,1629],[247,1629]],"region":{"top_left_x":246,"top_left_y":1580,"width":360,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d2a0fd1b1254140962ef2a0aff3ce0b","type":"text","conversion_output":true,"text":"seriousness criteria.","text_display":" seriousness criteria.","confidence":1,"confidence_rate":1},{"cnt":[[247,1677],[1688,1677],[1688,1727],[247,1727]],"region":{"top_left_x":246,"top_left_y":1676,"width":1443,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fce9c7cd6e43409d8036f4f76c8bcd53","type":"text","conversion_output":true,"text":"These additional searches (summarized under the so called 'overview of protocol","text_display":"\n\nThese additional searches (summarized under the so called 'overview of protocol","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[247,1727],[1610,1727],[1610,1775],[247,1775]],"region":{"top_left_x":246,"top_left_y":1726,"width":1365,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3ed14818d1c45fbabac61598f8cde8a","type":"text","conversion_output":true,"text":"defined AESIs and safety topics of interest ') may change according to active","text_display":" defined AESIs and safety topics of interest ') may change according to active","confidence":0.5596246719360352,"confidence_rate":0.9929458645227267},{"cnt":[[247,1773],[1704,1773],[1704,1825],[247,1825]],"region":{"top_left_x":246,"top_left_y":1772,"width":1459,"height":54},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fa28155832c49cd8e500b69c1f63207","type":"text","conversion_output":true,"text":"pharmacovigilance of linagliptin. The most up to date list of these searches will be","text_display":" pharmacovigilance of linagliptin. The most up to date list of these searches will be","confidence":0.9990236759185791,"confidence_rate":0.999989024768136},{"cnt":[[247,1821],[1567,1821],[1567,1871],[247,1871]],"region":{"top_left_x":246,"top_left_y":1820,"width":1322,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e1991e00b574aa0a82092400095518a","type":"text","conversion_output":true,"text":"included in the ISF and changes will be communicated to all investigators.","text_display":" included in the ISF and changes will be communicated to all investigators.","confidence":1,"confidence_rate":1},{"cnt":[[242,1914],[514,1914],[514,1969],[242,1969]],"region":{"top_left_x":242,"top_left_y":1914,"width":272,"height":56},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11dc65ed08b342f1acda08b38ff871fa","type":"section_header","conversion_output":false,"children_ids":["fb969b2d0b444d1598b758947d71bd26"],"text":"","text_display":""},{"cnt":[[247,1919],[509,1919],[509,1967],[247,1967]],"region":{"top_left_x":246,"top_left_y":1918,"width":264,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb969b2d0b444d1598b758947d71bd26","type":"text","conversion_output":true,"parent_id":"11dc65ed08b342f1acda08b38ff871fa","text":"Hepatic events:","text_display":"\n\n\\section*{Hepatic events:}","confidence":1,"confidence_rate":1},{"cnt":[[244,2006],[1802,2006],[1802,2054],[244,2054]],"region":{"top_left_x":244,"top_left_y":2005,"width":1559,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"208ba40fd64347aca5d985c9eaaafd90","type":"text","conversion_output":true,"text":"Patients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation","text_display":"\n\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation","confidence":1,"confidence_rate":1},{"cnt":[[244,2051],[1761,2051],[1761,2104],[244,2104]],"region":{"top_left_x":244,"top_left_y":2051,"width":1518,"height":53},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7543d5bddb3245f4a0743ef5857178d0","type":"text","conversion_output":true,"text":"of total bilirubin \\(\\geq 2\\) fold ULN measured in the same blood sample need to be followed up","text_display":" of total bilirubin \\(\\geq 2\\) fold ULN measured in the same blood sample need to be followed up","confidence":1,"confidence_rate":1},{"cnt":[[244,2102],[1215,2102],[1215,2152],[244,2152]],"region":{"top_left_x":244,"top_left_y":2101,"width":972,"height":51},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d5a85f972804c9ebc3faab7f8607bc9","type":"text","conversion_output":true,"text":"locally according to the \"DILI checklist\" provided in ISF.","text_display":" locally according to the \"DILI checklist\" provided in ISF.","confidence":1,"confidence_rate":1},{"cnt":[[242,2193],[477,2193],[477,2243],[242,2243]],"region":{"top_left_x":242,"top_left_y":2193,"width":236,"height":51},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d80f68af9b0c4b3c9e50719914647f5a","type":"section_header","conversion_output":false,"children_ids":["b0f0f0b5b5f04cf8b4d554b30f27e37f"],"text":"","text_display":""},{"cnt":[[247,2198],[477,2198],[477,2239],[247,2239]],"region":{"top_left_x":246,"top_left_y":2197,"width":232,"height":42},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0f0f0b5b5f04cf8b4d554b30f27e37f","type":"text","conversion_output":true,"parent_id":"d80f68af9b0c4b3c9e50719914647f5a","text":"Renal events:","text_display":"\n\n\\section*{Renal events:}","confidence":1,"confidence_rate":1},{"cnt":[[244,2287],[1720,2287],[1720,2337],[244,2337]],"region":{"top_left_x":244,"top_left_y":2286,"width":1477,"height":51},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c24430bde695452ab1a38bcb79176ea5","type":"text","conversion_output":true,"text":"Estimated creatinine clearance eGFR will be calculated using the MDRD formula. This","text_display":"\n\nEstimated creatinine clearance eGFR will be calculated using the MDRD formula. This","confidence":0.9902603521477431,"confidence_rate":0.9998887858613442},{"cnt":[[247,2335],[1761,2335],[1761,2383],[247,2383]],"region":{"top_left_x":246,"top_left_y":2334,"width":1516,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f5cc95198b6453981cb063868bf2d61","type":"text","conversion_output":true,"text":"formula considers the race as an adjustment factor, therefore, the race must be known (and","text_display":" formula considers the race as an adjustment factor, therefore, the race must be known (and","confidence":1,"confidence_rate":1},{"cnt":[[244,2385],[943,2385],[943,2433],[244,2433]],"region":{"top_left_x":244,"top_left_y":2384,"width":700,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f569c08913ef46d69fde85147bf83620","type":"text","conversion_output":true,"text":"will be collected) for accurate estimation.","text_display":" will be collected) for accurate estimation.","confidence":0.998046875,"confidence_rate":0.9999592709370382},{"cnt":[[244,2472],[1793,2472],[1793,2522],[244,2522]],"region":{"top_left_x":244,"top_left_y":2471,"width":1550,"height":51},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81326433329e44adbc34c7a1fc089bba","type":"text","conversion_output":true,"text":"In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2 ) and again in case of an eGFR","text_display":"\n\nIn case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2 ) and again in case of an eGFR","confidence":0.5390625,"confidence_rate":0.9939006201790674},{"cnt":[[244,2517],[1807,2517],[1807,2570],[244,2570]],"region":{"top_left_x":244,"top_left_y":2517,"width":1563,"height":53},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7c6b8b02ac645e983877c5390589538","type":"text","conversion_output":true,"text":"decrease of \\(\\geq 50 \\%\\) since baseline (visit 2 ) an additional visit \\(4-8\\) weeks after detection should","text_display":" decrease of \\(\\geq 50 \\%\\) since baseline (visit 2 ) an additional visit \\(4-8\\) weeks after detection should","confidence":0.6339399242187937,"confidence_rate":0.9958270696340441},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"957ee00b930d451aa95cb554d656aea6","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9951171875,"confidence_rate":0.9998834645913324},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"593fb16a7c4d4ba5b1cd02588a60770d","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4bcf3ecd4dfb4d359dacdc4d1ba62112","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-048","page":48,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aeafcc2560df4346a219eafeae812904","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5473b7558c54146bfeb64b0b759d1ae","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0aaa98c0fa1e400991793dbcf1415be2","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab8e0c516a2b4f64bdbc613488effa54","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"005716634b3441749e0cdb16747f961d","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8755dc9d6d854464a1844bfe8446f5ac","type":"page_info","conversion_output":false,"text":"Page 48 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1734,338],[1734,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":1488,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d9578ad492d48d2af08a2d018b0289c","type":"text","conversion_output":true,"text":"be scheduled (unless detected at the EOT visit at study end) to collect a blood sample for","text_display":"\nbe scheduled (unless detected at the EOT visit at study end) to collect a blood sample for","confidence":1,"confidence_rate":1},{"cnt":[[244,388],[1784,388],[1784,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1541,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"482ae2eea8e54d3288cb9c9befba46a5","type":"text","conversion_output":true,"text":"repeat analysis of creatinine for calculation of the eGFR. An additional sample of creatinine","text_display":" repeat analysis of creatinine for calculation of the eGFR. An additional sample of creatinine","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1802,434],[1802,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1557,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9250328d6bac4da9bca0fd1faa2df391","type":"text","conversion_output":true,"text":"should also be taken between the visits interval if a signal of increasing creatinine is reported","text_display":" should also be taken between the visits interval if a signal of increasing creatinine is reported","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1382,484],[1382,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1137,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7119c99fcdba49dd96c73d97cc0b7b3b","type":"text","conversion_output":true,"text":"to the study site by others (e.g., treating physicians from local labs).","text_display":" to the study site by others (e.g., treating physicians from local labs).","confidence":1,"confidence_rate":1},{"cnt":[[242,658],[466,658],[466,706],[242,706]],"region":{"top_left_x":242,"top_left_y":657,"width":225,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba661bc0315e459d891a7eca5f795c6e","type":"section_header","conversion_output":false,"children_ids":["0a613de1df654c10b37fd4bf22cf7993"],"text":"","text_display":""},{"cnt":[[247,662],[464,662],[464,701],[247,701]],"region":{"top_left_x":246,"top_left_y":662,"width":218,"height":40},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a613de1df654c10b37fd4bf22cf7993","type":"text","conversion_output":true,"parent_id":"ba661bc0315e459d891a7eca5f795c6e","text":"Skin lesions:","text_display":"\n\n\\section*{Skin lesions:}","confidence":0.99951171875,"confidence_rate":0.9999728670071003},{"cnt":[[247,754],[1757,754],[1757,800],[247,800]],"region":{"top_left_x":246,"top_left_y":753,"width":1511,"height":47},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d28056cbf474b84a1c76183e68b1b53","type":"text","conversion_output":true,"text":"If skin lesions occur (such as exfoliative rash, skin necrosis, or bullous dermatitis): further","text_display":"\n\nIf skin lesions occur (such as exfoliative rash, skin necrosis, or bullous dermatitis): further","confidence":1,"confidence_rate":1},{"cnt":[[247,800],[1766,800],[1766,848],[247,848]],"region":{"top_left_x":246,"top_left_y":799,"width":1520,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fb2186e3f544ed8af22393703361df7","type":"text","conversion_output":true,"text":"follow-up investigations should be done according to medical judgement depending on the","text_display":" follow-up investigations should be done according to medical judgement depending on the","confidence":1,"confidence_rate":1},{"cnt":[[247,848],[1441,848],[1441,898],[247,898]],"region":{"top_left_x":246,"top_left_y":847,"width":1196,"height":51},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29b37a9db0154af193c8e8681f0ade85","type":"text","conversion_output":true,"text":"clinical course until the patient is recovered and/or a diagnosis is made.","text_display":" clinical course until the patient is recovered and/or a diagnosis is made.","confidence":1,"confidence_rate":1},{"cnt":[[242,932],[1256,932],[1256,989],[242,989]],"region":{"top_left_x":242,"top_left_y":932,"width":1015,"height":58},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b04e40c5305148d09ac4d9cf20ccd399","type":"section_header","conversion_output":false,"children_ids":["103c666085624307a3491ff1f1011f2f"],"text":"","text_display":""},{"cnt":[[247,937],[1252,937],[1252,985],[247,985]],"region":{"top_left_x":246,"top_left_y":936,"width":1006,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"103c666085624307a3491ff1f1011f2f","type":"text","conversion_output":true,"parent_id":"b04e40c5305148d09ac4d9cf20ccd399","text":"5.2.2.2 Adverse event and serious adverse event reporting","text_display":"\n\n\\subsection*{5.2.2.2 Adverse event and serious adverse event reporting}","confidence":1,"confidence_rate":1},{"cnt":[[242,1023],[1748,1023],[1748,1122],[242,1122]],"region":{"top_left_x":242,"top_left_y":1023,"width":1506,"height":99},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"93842c9b2fff4ded8d470c5eb5a9fe75","type":"section_header","conversion_output":false,"children_ids":["6f167dcf67024629940ec27940134e41","30f8f521c6b44adb8bcb02503ac81e8e"],"text":"","text_display":""},{"cnt":[[247,1028],[1741,1028],[1741,1076],[247,1076]],"region":{"top_left_x":246,"top_left_y":1027,"width":1495,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f167dcf67024629940ec27940134e41","type":"text","conversion_output":true,"parent_id":"93842c9b2fff4ded8d470c5eb5a9fe75","text":"The Investigator shall maintain and keep detailed records of all AEs in their patient","text_display":"\n\n\\section*{The Investigator shall maintain and keep detailed records of all AEs in their patient","confidence":1,"confidence_rate":1},{"cnt":[[247,1074],[336,1074],[336,1117],[247,1117]],"region":{"top_left_x":246,"top_left_y":1073,"width":90,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30f8f521c6b44adb8bcb02503ac81e8e","type":"text","conversion_output":true,"parent_id":"93842c9b2fff4ded8d470c5eb5a9fe75","text":"files.","text_display":" files.}","confidence":1,"confidence_rate":1},{"cnt":[[247,1170],[1775,1170],[1775,1218],[247,1218]],"region":{"top_left_x":246,"top_left_y":1169,"width":1529,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"edfef2ef5565440da3fe5a679582bf39","type":"text","conversion_output":true,"text":"All adverse events, serious and non-serious, occurring during the course of the clinical trial","text_display":"\n\nAll adverse events, serious and non-serious, occurring during the course of the clinical trial","confidence":1,"confidence_rate":1},{"cnt":[[247,1218],[1770,1218],[1770,1268],[247,1268]],"region":{"top_left_x":246,"top_left_y":1217,"width":1525,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35ce8a8d439248bca1707184f31806ef","type":"text","conversion_output":true,"text":"(i.e., from signing the informed consent onwards through the last per protocol visit) will be","text_display":" (i.e., from signing the informed consent onwards through the last per protocol visit) will be","confidence":1,"confidence_rate":1},{"cnt":[[247,1266],[1624,1266],[1624,1314],[247,1314]],"region":{"top_left_x":246,"top_left_y":1265,"width":1379,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34e4249d23dc4c47905b966160613092","type":"text","conversion_output":true,"text":"collected, documented and reported to the sponsor/CRO by the investigator on the","text_display":" collected, documented and reported to the sponsor/CRO by the investigator on the","confidence":1,"confidence_rate":1},{"cnt":[[247,1316],[1679,1316],[1679,1364],[247,1364]],"region":{"top_left_x":246,"top_left_y":1315,"width":1434,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27ff3009ccf74a938a5a61f47016899f","type":"text","conversion_output":true,"text":"appropriate \\(\\operatorname{CRF}(s) /\\) eCRFs \\(/\\) SAE reporting forms. The investigator does not need to","text_display":" appropriate \\(\\operatorname{CRF}(s) /\\) eCRFs \\(/\\) SAE reporting forms. The investigator does not need to","confidence":0.1367577133520645,"confidence_rate":0.9794888537499293},{"cnt":[[247,1361],[1798,1361],[1798,1409],[247,1409]],"region":{"top_left_x":246,"top_left_y":1361,"width":1552,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0e7060aba664a75a7cfa1c735ab9efd","type":"text","conversion_output":true,"text":"actively monitor patients for adverse events once the clinical trial has ended. However, if the","text_display":" actively monitor patients for adverse events once the clinical trial has ended. However, if the","confidence":1,"confidence_rate":1},{"cnt":[[247,1412],[1729,1412],[1729,1460],[247,1460]],"region":{"top_left_x":246,"top_left_y":1411,"width":1484,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"358547aa1a9d45aaa604b8809916a536","type":"text","conversion_output":true,"text":"investigator becomes aware of an SAE(s) that occurred after the last per protocol visit, it","text_display":" investigator becomes aware of an SAE(s) that occurred after the last per protocol visit, it","confidence":0.9833984375,"confidence_rate":0.9998256306949188},{"cnt":[[247,1457],[1610,1457],[1610,1505],[247,1505]],"region":{"top_left_x":246,"top_left_y":1457,"width":1365,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8b624f5dd9d40ccaa81cb3009dc0d4c","type":"text","conversion_output":true,"text":"should be reported by the investigator to the sponsor if considered relevant by the","text_display":" should be reported by the investigator to the sponsor if considered relevant by the","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[247,1508],[1738,1508],[1738,1556],[247,1556]],"region":{"top_left_x":246,"top_left_y":1507,"width":1493,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a0821fbdad445e8a5ced27d50eb6f91","type":"text","conversion_output":true,"text":"investigator. Reporting will be done according to the specific definitions and instructions","text_display":" investigator. Reporting will be done according to the specific definitions and instructions","confidence":1,"confidence_rate":1},{"cnt":[[247,1553],[1556,1553],[1556,1601],[247,1601]],"region":{"top_left_x":246,"top_left_y":1553,"width":1310,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce94f28906724ccd86c77f53066bea7d","type":"text","conversion_output":true,"text":"detailed in the 'Adverse Event Reporting' section of the Investigator Site File.","text_display":" detailed in the 'Adverse Event Reporting' section of the Investigator Site File.","confidence":1,"confidence_rate":1},{"cnt":[[247,1649],[1702,1649],[1702,1697],[247,1697]],"region":{"top_left_x":246,"top_left_y":1649,"width":1456,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce75aca3ed3746fb8339aa6a006bf078","type":"text","conversion_output":true,"text":"For each adverse event, the investigator will provide the onset date, end date, intensity,","text_display":"\n\nFor each adverse event, the investigator will provide the onset date, end date, intensity,","confidence":1,"confidence_rate":1},{"cnt":[[247,1695],[1802,1695],[1802,1745],[247,1745]],"region":{"top_left_x":246,"top_left_y":1695,"width":1557,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b48d9840cba46149b0e631b803ed562","type":"text","conversion_output":true,"text":"treatment required, outcome, seriousness, and action taken with the investigational drug. The","text_display":" treatment required, outcome, seriousness, and action taken with the investigational drug. The","confidence":1,"confidence_rate":1},{"cnt":[[247,1745],[1821,1745],[1821,1793],[247,1793]],"region":{"top_left_x":246,"top_left_y":1745,"width":1575,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50dc631ae5be49b8a48f3e04b3035864","type":"text","conversion_output":true,"text":"investigator will determine the relationship of the investigational drug to all AEs as defined in","text_display":" investigator will determine the relationship of the investigational drug to all AEs as defined in","confidence":1,"confidence_rate":1},{"cnt":[[244,1791],[514,1791],[514,1839],[244,1839]],"region":{"top_left_x":244,"top_left_y":1790,"width":270,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2d690ae89064fb2869c2629e93a6637","type":"text","conversion_output":true,"text":"Section 5.2.2.1.","text_display":" Section 5.2.2.1.","confidence":1,"confidence_rate":1},{"cnt":[[244,1859],[1642,1859],[1642,1912],[244,1912]],"region":{"top_left_x":244,"top_left_y":1859,"width":1399,"height":54},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64df208421ef497fb1a35a8a80b67bd8","type":"text","conversion_output":true,"text":"The investigator must report the following events, immediately (within 24 hours of","text_display":"\n\nThe investigator must report the following events, immediately (within 24 hours of","confidence":1,"confidence_rate":1},{"cnt":[[247,1910],[1782,1910],[1782,1960],[247,1960]],"region":{"top_left_x":246,"top_left_y":1909,"width":1536,"height":51},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b39467b78f440a5b0431893465f984f","type":"text","conversion_output":true,"text":"awareness) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported","text_display":" awareness) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported","confidence":1,"confidence_rate":1},{"cnt":[[247,1960],[487,1960],[487,1999],[247,1999]],"region":{"top_left_x":246,"top_left_y":1959,"width":241,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ecb1f0e26194aa981e591610d451823","type":"text","conversion_output":true,"text":"SAE or AESI.","text_display":" SAE or AESI.","confidence":1,"confidence_rate":1},{"cnt":[[247,2054],[1757,2054],[1757,2104],[247,2104]],"region":{"top_left_x":246,"top_left_y":2053,"width":1511,"height":51},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e66fa0d1d434e99834d17902aad4aa0","type":"text","conversion_output":true,"text":"The investigator must document immediately (within 24 hours of awareness) CV outcome","text_display":"\n\nThe investigator must document immediately (within 24 hours of awareness) CV outcome","confidence":1,"confidence_rate":1},{"cnt":[[247,2102],[1780,2102],[1780,2150],[247,2150]],"region":{"top_left_x":246,"top_left_y":2101,"width":1534,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"372a5ffa6bcd4cf18a7e5b8159bc082e","type":"text","conversion_output":true,"text":"events if they occur after randomization on the appropriate eCRF page. CV outcome events","text_display":" events if they occur after randomization on the appropriate eCRF page. CV outcome events","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[247,2147],[1355,2147],[1355,2198],[247,2198]],"region":{"top_left_x":246,"top_left_y":2147,"width":1109,"height":51},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4fbcca21107a4c6595d037d26d894a57","type":"text","conversion_output":true,"text":"which occur prior randomization have to be reported as an (S)AE.","text_display":" which occur prior randomization have to be reported as an (S)AE.","confidence":1,"confidence_rate":1},{"cnt":[[247,2243],[1780,2243],[1780,2294],[247,2294]],"region":{"top_left_x":246,"top_left_y":2243,"width":1534,"height":51},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66fbc42079114dbea8e0be2b79717223","type":"text","conversion_output":true,"text":"Clinically relevant abnormalities found at physical examination, vital signs or ECG that are","text_display":"\n\nClinically relevant abnormalities found at physical examination, vital signs or ECG that are","confidence":1,"confidence_rate":1},{"cnt":[[244,2294],[1786,2294],[1786,2341],[244,2341]],"region":{"top_left_x":244,"top_left_y":2293,"width":1543,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2742440e6fc14dd49c17225f09920b63","type":"text","conversion_output":true,"text":"not pre-existing prior to signing of informed consent (study inclusion) should be reported as","text_display":" not pre-existing prior to signing of informed consent (study inclusion) should be reported as","confidence":1,"confidence_rate":1},{"cnt":[[247,2341],[1798,2341],[1798,2392],[247,2392]],"region":{"top_left_x":246,"top_left_y":2341,"width":1552,"height":51},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64f90cea81f940ddb4c2d5c3a931d4c5","type":"text","conversion_output":true,"text":"adverse events. If such abnormalities already pre-exist prior to signed informed consent they","text_display":" adverse events. If such abnormalities already pre-exist prior to signed informed consent they","confidence":1,"confidence_rate":1},{"cnt":[[247,2389],[989,2389],[989,2433],[247,2433]],"region":{"top_left_x":246,"top_left_y":2389,"width":744,"height":44},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9ea0f27de024303b04c398006f9dcc5","type":"text","conversion_output":true,"text":"should be considered as baseline conditions.","text_display":" should be considered as baseline conditions.","confidence":1,"confidence_rate":1},{"cnt":[[242,2472],[861,2472],[861,2529],[242,2529]],"region":{"top_left_x":242,"top_left_y":2471,"width":620,"height":58},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0823ae30a0664762a6f2c1c2936401f1","type":"section_header","conversion_output":false,"children_ids":["738c02a3f62d4fecbea52a16df6a688f"],"text":"","text_display":""},{"cnt":[[247,2481],[854,2481],[854,2524],[247,2524]],"region":{"top_left_x":246,"top_left_y":2480,"width":609,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"738c02a3f62d4fecbea52a16df6a688f","type":"text","conversion_output":true,"parent_id":"0823ae30a0664762a6f2c1c2936401f1","text":"AEs considered \"Always Serious\"","text_display":"\n\n\\section*{AEs considered \"Always Serious\"}","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1e5ec076536b4076b8426dd6821a80e9","type":"section_header","conversion_output":false,"children_ids":["2819e68e081c4de483cf794a7c709a0d"],"text":"","text_display":""},{"cnt":[[795,2586],[1300,2586],[1300,2620],[795,2620]],"region":{"top_left_x":794,"top_left_y":2585,"width":506,"height":36},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2819e68e081c4de483cf794a7c709a0d","type":"text","conversion_output":true,"parent_id":"1e5ec076536b4076b8426dd6821a80e9","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":1,"confidence_rate":1},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8f0b411453dc43be9df1e741ddee8725","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7b1d6733b2644249b7b6e649756717d7","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-049","page":49,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"991b058a358145dea1c378aa057307f1","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64f02c058b7b490bb1f74fca9ca59723","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"677395644c494589ab8e1ea32055d0cb","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d9653bb8ac84b0585cab059a1d80b46","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c197447ad094ceebd3f4ac9f1248858","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd74e44a9f9e44daac5431177537f839","type":"page_info","conversion_output":false,"text":"Page 49 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,340],[1743,340],[1743,391],[247,391]],"region":{"top_left_x":246,"top_left_y":340,"width":1497,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72fdfd104bab4d08a8ac584237a2b24c","type":"text","conversion_output":true,"text":"Cancers of new histology and exacerbations of existing cancer must be reported as a","text_display":"\n\nCancers of new histology and exacerbations of existing cancer must be reported as a","confidence":1,"confidence_rate":1},{"cnt":[[247,388],[1748,388],[1748,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1502,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc9acf9d2daa4a3e9caa3d80844ad5ad","type":"text","conversion_output":true,"text":"serious event regardless of the duration between discontinuation of the drug and the","text_display":" serious event regardless of the duration between discontinuation of the drug and the","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1802,434],[1802,487],[247,487]],"region":{"top_left_x":246,"top_left_y":434,"width":1557,"height":53},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a50856e057f4264a2fa95edc65396d2","type":"text","conversion_output":true,"text":"occurrence of the cancer. In accordance with the European Medicines Agency initiative","text_display":" occurrence of the cancer. In accordance with the European Medicines Agency initiative","confidence":0.998535871389322,"confidence_rate":0.9999837201159151},{"cnt":[[247,484],[1748,484],[1748,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1502,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e772e7f7fe3a4b5ba93493304d99db63","type":"text","conversion_output":true,"text":"on Important Medical Events, Boehringer Ingelheim has set up a list of further AEs,","text_display":" on Important Medical Events, Boehringer Ingelheim has set up a list of further AEs,","confidence":1,"confidence_rate":1},{"cnt":[[247,532],[1780,532],[1780,580],[247,580]],"region":{"top_left_x":246,"top_left_y":532,"width":1534,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f15dd8c7bef4aac866c4be7b1188ef8","type":"text","conversion_output":true,"text":"which by their nature, can always be considered to be \"serious\" even though they may","text_display":" which by their nature, can always be considered to be \"serious\" even though they may","confidence":1,"confidence_rate":1},{"cnt":[[247,580],[1158,580],[1158,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":913,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"947a98ede6d342e79d4144029637474f","type":"text","conversion_output":true,"text":"not have met the criteria of an SAE as given above.","text_display":" not have met the criteria of an SAE as given above.","confidence":0.9990234375,"confidence_rate":0.9999825530156321},{"cnt":[[247,626],[1798,626],[1798,678],[247,678]],"region":{"top_left_x":246,"top_left_y":625,"width":1552,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b30536abfea48a0a3dfd543a5e6c2d1","type":"text","conversion_output":true,"text":"The latest list of \"Always Serious AEs\" can be found in the ISF. A copy of the latest list","text_display":"\nThe latest list of \"Always Serious AEs\" can be found in the ISF. A copy of the latest list","confidence":1,"confidence_rate":1},{"cnt":[[247,676],[1734,676],[1734,724],[247,724]],"region":{"top_left_x":246,"top_left_y":676,"width":1488,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3b5a64deb9543919e1eedfaeabd844f","type":"text","conversion_output":true,"text":"of \"Always Serious AEs\" will be provided to you upon request. These events should","text_display":" of \"Always Serious AEs\" will be provided to you upon request. These events should","confidence":1,"confidence_rate":1},{"cnt":[[247,722],[1099,722],[1099,772],[247,772]],"region":{"top_left_x":246,"top_left_y":721,"width":853,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa11f5149c5f412f8a8bf48109321795","type":"text","conversion_output":true,"text":"always be reported as SAEs as described above.","text_display":" always be reported as SAEs as described above.","confidence":1,"confidence_rate":1},{"cnt":[[247,809],[1738,809],[1738,861],[247,861]],"region":{"top_left_x":246,"top_left_y":808,"width":1493,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"290d90849a17483092f36438243a8ec3","type":"text","conversion_output":true,"text":"BI has set up a list of AEs which are defined to be always serious. In order to support the","text_display":"\n\nBI has set up a list of AEs which are defined to be always serious. In order to support the","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[247,859],[1793,859],[1793,907],[247,907]],"region":{"top_left_x":246,"top_left_y":858,"width":1548,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef28537c094a4ee08873bdcfc7acd76c","type":"text","conversion_output":true,"text":"investigator with the identification of these \"always serious adverse events\", if a non-serious","text_display":" investigator with the identification of these \"always serious adverse events\", if a non-serious","confidence":1,"confidence_rate":1},{"cnt":[[247,905],[1793,905],[1793,955],[247,955]],"region":{"top_left_x":246,"top_left_y":904,"width":1548,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e5c3c815acb41bbafce75413aa0dc1e","type":"text","conversion_output":true,"text":"AE is identified to be serious per BI definition, a query will be raised. The investigator must","text_display":" AE is identified to be serious per BI definition, a query will be raised. The investigator must","confidence":0.8908348083496094,"confidence_rate":0.9988673451835253},{"cnt":[[244,955],[1812,955],[1812,1003],[244,1003]],"region":{"top_left_x":244,"top_left_y":954,"width":1568,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85430cc6bbbe479f82ab0b55b76bf931","type":"text","conversion_output":true,"text":"verify the description and seriousness of the event. If the event description is correct, the item","text_display":" verify the description and seriousness of the event. If the event description is correct, the item","confidence":1,"confidence_rate":1},{"cnt":[[247,1001],[1816,1001],[1816,1053],[247,1053]],"region":{"top_left_x":246,"top_left_y":1000,"width":1571,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e61c19cc2e38442383543846ef24668b","type":"text","conversion_output":true,"text":"\"serious\" needs to be ticked and an SAE has to be reported in expedited fashion following the","text_display":" \"serious\" needs to be ticked and an SAE has to be reported in expedited fashion following the","confidence":1,"confidence_rate":1},{"cnt":[[247,1051],[678,1051],[678,1099],[247,1099]],"region":{"top_left_x":246,"top_left_y":1050,"width":433,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db62e249694a424fa08d6142cf72b016","type":"text","conversion_output":true,"text":"same procedure as above.","text_display":" same procedure as above.","confidence":1,"confidence_rate":1},{"cnt":[[244,1188],[1775,1188],[1775,1236],[244,1236]],"region":{"top_left_x":244,"top_left_y":1187,"width":1531,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"276eca5c0eb04c638aadb66913473846","type":"text","conversion_output":true,"text":"For Japan: This information must be also reported immediately to the head of the trial site.","text_display":"\n\nFor Japan: This information must be also reported immediately to the head of the trial site.","confidence":1,"confidence_rate":1},{"cnt":[[247,1284],[1734,1284],[1734,1332],[247,1332]],"region":{"top_left_x":246,"top_left_y":1283,"width":1488,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3897543a8e5425bbdb358f6741c89a3","type":"text","conversion_output":true,"text":"With receipt of any further information to these events, a follow-up SAE report has to be","text_display":"\n\nWith receipt of any further information to these events, a follow-up SAE report has to be","confidence":1,"confidence_rate":1},{"cnt":[[244,1330],[1780,1330],[1780,1382],[244,1382]],"region":{"top_left_x":244,"top_left_y":1329,"width":1536,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aaaac44e551a4fc2af2367102869380c","type":"text","conversion_output":true,"text":"provided. SAEs, AESIs and non-serious AEs must include a causal relationship assessment","text_display":" provided. SAEs, AESIs and non-serious AEs must include a causal relationship assessment","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[247,1380],[1798,1380],[1798,1428],[247,1428]],"region":{"top_left_x":246,"top_left_y":1379,"width":1552,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec883d8279ba4587bacce1f561ec608e","type":"text","conversion_output":true,"text":"made by the investigator. The SAE form is to be forwarded to the defined unique entry point","text_display":" made by the investigator. The SAE form is to be forwarded to the defined unique entry point","confidence":1,"confidence_rate":1},{"cnt":[[247,1428],[1697,1428],[1697,1476],[247,1476]],"region":{"top_left_x":246,"top_left_y":1427,"width":1452,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f99dd427580f4680870d83338f3cdec1","type":"text","conversion_output":true,"text":"(contact details will be provided in the Investigator Site File). This immediate report is","text_display":" (contact details will be provided in the Investigator Site File). This immediate report is","confidence":1,"confidence_rate":1},{"cnt":[[247,1476],[1802,1476],[1802,1524],[247,1524]],"region":{"top_left_x":246,"top_left_y":1475,"width":1557,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2646ef2253e43e985124ce28c6e3fe0","type":"text","conversion_output":true,"text":"required irrespective of whether the investigational product has been administered or not and","text_display":" required irrespective of whether the investigational product has been administered or not and","confidence":1,"confidence_rate":1},{"cnt":[[247,1524],[1725,1524],[1725,1574],[247,1574]],"region":{"top_left_x":246,"top_left_y":1523,"width":1479,"height":51},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f5c17409c6a4269a83d8c65386d34be","type":"text","conversion_output":true,"text":"irrespective of causal relationship. It also applies if new information to existing SAEs or","text_display":" irrespective of causal relationship. It also applies if new information to existing SAEs or","confidence":1,"confidence_rate":1},{"cnt":[[247,1572],[1154,1572],[1154,1620],[247,1620]],"region":{"top_left_x":246,"top_left_y":1571,"width":908,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7cddfdc151040a5a904d35dae88f23f","type":"text","conversion_output":true,"text":"Adverse Events of Special Interest becomes available.","text_display":" Adverse Events of Special Interest becomes available.","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[242,1665],[432,1665],[432,1720],[242,1720]],"region":{"top_left_x":242,"top_left_y":1665,"width":190,"height":56},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9bbbd619976d4c86b6ed2cfa7cc566f3","type":"section_header","conversion_output":false,"children_ids":["4f2fb08e165d4422aa0d33732020eab3"],"text":"","text_display":""},{"cnt":[[247,1668],[429,1668],[429,1716],[247,1716]],"region":{"top_left_x":246,"top_left_y":1667,"width":184,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f2fb08e165d4422aa0d33732020eab3","type":"text","conversion_output":true,"parent_id":"9bbbd619976d4c86b6ed2cfa7cc566f3","text":"Pregnancy","text_display":"\n\n\\section*{Pregnancy}","confidence":1,"confidence_rate":1},{"cnt":[[247,1736],[1679,1736],[1679,1784],[247,1784]],"region":{"top_left_x":246,"top_left_y":1736,"width":1434,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e22bfbc1550949a2bbc4a7428ad82f0d","type":"text","conversion_output":true,"text":"In rare cases, pregnancy might occur in clinical trials. Once a female subject has been","text_display":"\n\nIn rare cases, pregnancy might occur in clinical trials. Once a female subject has been","confidence":1,"confidence_rate":1},{"cnt":[[247,1784],[1725,1784],[1725,1832],[247,1832]],"region":{"top_left_x":246,"top_left_y":1784,"width":1479,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"683f47987d0d4f7f8e8111b4527766b4","type":"text","conversion_output":true,"text":"enrolled into the clinical trial, after having taken study medication, the investigator must","text_display":" enrolled into the clinical trial, after having taken study medication, the investigator must","confidence":1,"confidence_rate":1},{"cnt":[[244,1832],[1800,1832],[1800,1880],[244,1880]],"region":{"top_left_x":244,"top_left_y":1832,"width":1557,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54a91ebb38cf413ca672a270ffe90cef","type":"text","conversion_output":true,"text":"report immediately any drug exposure during pregnancy to the sponsor/CRO. Drug exposure","text_display":" report immediately any drug exposure during pregnancy to the sponsor/CRO. Drug exposure","confidence":1,"confidence_rate":1},{"cnt":[[247,1878],[1702,1878],[1702,1928],[247,1928]],"region":{"top_left_x":246,"top_left_y":1877,"width":1456,"height":52},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bdc4a449e15b400db73b1eb0a32cc784","type":"text","conversion_output":true,"text":"during pregnancy has to be reported immediately (within 24 hours of awareness) to the","text_display":" during pregnancy has to be reported immediately (within 24 hours of awareness) to the","confidence":1,"confidence_rate":1},{"cnt":[[247,1928],[1812,1928],[1812,1976],[247,1976]],"region":{"top_left_x":246,"top_left_y":1928,"width":1566,"height":48},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41117041c2f244508acb74502188f867","type":"text","conversion_output":true,"text":"defined unique entry point for SAE forms (contact details will be provided in the Investigator","text_display":" defined unique entry point for SAE forms (contact details will be provided in the Investigator","confidence":1,"confidence_rate":1},{"cnt":[[247,1974],[1816,1974],[1816,2022],[247,2022]],"region":{"top_left_x":246,"top_left_y":1973,"width":1571,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"33114566d919411590c9b316e529b9cf","type":"text","conversion_output":true,"text":"Site File). The outcome of the pregnancy associated with the drug exposure during pregnancy","text_display":" Site File). The outcome of the pregnancy associated with the drug exposure during pregnancy","confidence":1,"confidence_rate":1},{"cnt":[[247,2024],[1766,2024],[1766,2072],[247,2072]],"region":{"top_left_x":246,"top_left_y":2023,"width":1520,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a895d542a40d4ed6bd0670e9f0b33934","type":"text","conversion_output":true,"text":"must be followed up. In the absence of an (S)AE, only the Pregnancy Monitoring Form for","text_display":" must be followed up. In the absence of an (S)AE, only the Pregnancy Monitoring Form for","confidence":1,"confidence_rate":1},{"cnt":[[247,2070],[1798,2070],[1798,2118],[247,2118]],"region":{"top_left_x":246,"top_left_y":2069,"width":1552,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"944f1fe5cf484dbba748e4da708de3ee","type":"text","conversion_output":true,"text":"Clinical Trials and not the SAE form is to be completed. The ISF will contain the Pregnancy","text_display":" Clinical Trials and not the SAE form is to be completed. The ISF will contain the Pregnancy","confidence":1,"confidence_rate":1},{"cnt":[[247,2120],[1190,2120],[1190,2168],[247,2168]],"region":{"top_left_x":246,"top_left_y":2119,"width":945,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1301db0e86eb440ebb38d36136500df2","type":"text","conversion_output":true,"text":"Monitoring Form for Clinical Trials (Part A and Part B).","text_display":" Monitoring Form for Clinical Trials (Part A and Part B).","confidence":1,"confidence_rate":1},{"cnt":[[242,2207],[838,2207],[838,2259],[242,2259]],"region":{"top_left_x":242,"top_left_y":2206,"width":597,"height":54},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e259db24ed204ef097211ff0df5f5f17","type":"section_header","conversion_output":false,"children_ids":["2690132afc474c61bdad8dad825bcd99"],"text":"","text_display":""},{"cnt":[[247,2209],[834,2209],[834,2255],[247,2255]],"region":{"top_left_x":246,"top_left_y":2208,"width":588,"height":47},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2690132afc474c61bdad8dad825bcd99","type":"text","conversion_output":true,"parent_id":"e259db24ed204ef097211ff0df5f5f17","text":"5.2.2.3 Oncological adverse events","text_display":"\n\n\\subsection*{5.2.2.3 Oncological adverse events}","confidence":1,"confidence_rate":1},{"cnt":[[247,2298],[1802,2298],[1802,2346],[247,2346]],"region":{"top_left_x":246,"top_left_y":2298,"width":1557,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d93c74ba624452a809aff10a950f5d7","type":"text","conversion_output":true,"text":"Epidemiological evidence suggests that people with diabetes are at a significantly higher risk","text_display":"\n\nEpidemiological evidence suggests that people with diabetes are at a significantly higher risk","confidence":1,"confidence_rate":1},{"cnt":[[247,2346],[1807,2346],[1807,2394],[247,2394]],"region":{"top_left_x":246,"top_left_y":2346,"width":1561,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73a9f83f23a44f3fad474ab8a1de4cdf","type":"text","conversion_output":true,"text":"of several forms of cancer compared with subjects without diabetes [R10-6495]. Currently, it","text_display":" of several forms of cancer compared with subjects without diabetes [R10-6495]. Currently, it","confidence":0.9980475902557373,"confidence_rate":0.9999798525928524},{"cnt":[[247,2394],[1784,2394],[1784,2442],[247,2442]],"region":{"top_left_x":246,"top_left_y":2394,"width":1539,"height":48},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e933d4f8c055417b9770db84f0035c0f","type":"text","conversion_output":true,"text":"is unclear whether the association between cancer and diabetes is indirect and largely due to","text_display":" is unclear whether the association between cancer and diabetes is indirect and largely due to","confidence":1,"confidence_rate":1},{"cnt":[[247,2442],[1750,2442],[1750,2490],[247,2490]],"region":{"top_left_x":246,"top_left_y":2441,"width":1504,"height":49},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08aba4e76fa042e5a114488edb87a499","type":"text","conversion_output":true,"text":"shared risk factors (such as the modifiable risk factors: e.g. obesity, diet, physical activity,","text_display":" shared risk factors (such as the modifiable risk factors: e.g. obesity, diet, physical activity,","confidence":1,"confidence_rate":1},{"cnt":[[247,2490],[1656,2490],[1656,2538],[247,2538]],"region":{"top_left_x":246,"top_left_y":2489,"width":1411,"height":49},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e62fd8902d65401489779d306cd913ba","type":"text","conversion_output":true,"text":"tobacco smoking, alcohol, or non-modifiable risk factors: e.g. age, gender, race, and","text_display":" tobacco smoking, alcohol, or non-modifiable risk factors: e.g. age, gender, race, and","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"359740a1e5cc4ce0a27de42ffcca1058","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"20fab77765f44759866bd9eb33382963","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":50,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a06e279a9019479aa24168373427e7b9","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-050","page":50,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18508ae1c3974f78ad23d02b6d7ec63d","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95722cfc77084171ba1c5b7e3d8b78ae","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9072f3defb0b430a9132c092f7ca6419","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3a2f202afef473fa10a5890f18d4148","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e97a6677edb345c3add82c054bcfce1c","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11783b676feb4222bf7e66e4cc451044","type":"page_info","conversion_output":false,"text":"Page 50 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1793,338],[1793,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":1548,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06d4625682dd4505aecc06147206df96","type":"text","conversion_output":true,"text":"ethnicity), whether it is direct influence (e.g. due to hyperglycaemia), whether it is related to","text_display":"\nethnicity), whether it is direct influence (e.g. due to hyperglycaemia), whether it is related to","confidence":1,"confidence_rate":1},{"cnt":[[244,388],[1775,388],[1775,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1531,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4fb253ac491848958261648025a7a1ae","type":"text","conversion_output":true,"text":"medical therapies used in the treatment of T2DM, or whether T2DM represents a condition","text_display":" medical therapies used in the treatment of T2DM, or whether T2DM represents a condition","confidence":0.9863345623016357,"confidence_rate":0.999850449561457},{"cnt":[[247,434],[1592,434],[1592,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1347,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a08503cf49684523b6f0bac3fe9fefdf","type":"text","conversion_output":true,"text":"with underlying biologic factors that alter cancer risk (e.g. insulin resistance and","text_display":" with underlying biologic factors that alter cancer risk (e.g. insulin resistance and","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1519,484],[1519,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1274,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41b8703c4a994d9e9f5aaa7f194957c3","type":"text","conversion_output":true,"text":"hyperinsulinemia) [R10-6496, R10-6498, R10-6536, R10-6497, R10-6494].","text_display":" hyperinsulinemia) [R10-6496, R10-6498, R10-6536, R10-6497, R10-6494].","confidence":0.8665958746661728,"confidence_rate":0.998066971655647},{"cnt":[[247,532],[1780,532],[1780,578],[247,578]],"region":{"top_left_x":246,"top_left_y":532,"width":1534,"height":46},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3d5f11ca4af4699916f4c82c5e2aea3","type":"text","conversion_output":true,"text":"In order to assess patients with oncological adverse events (benign and malignant) in detail,","text_display":"\nIn order to assess patients with oncological adverse events (benign and malignant) in detail,","confidence":1,"confidence_rate":1},{"cnt":[[247,580],[1725,580],[1725,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1479,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"973792c5126145199bc6b2e6ecec3663","type":"text","conversion_output":true,"text":"and in addition to the AESIs thyroid neoplasm (benign), thyroid cancer, and pancreatitic","text_display":" and in addition to the AESIs thyroid neoplasm (benign), thyroid cancer, and pancreatitic","confidence":1,"confidence_rate":1},{"cnt":[[247,626],[1780,626],[1780,674],[247,674]],"region":{"top_left_x":246,"top_left_y":625,"width":1534,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7796be4c3cd45658da41802a4d2f1f7","type":"text","conversion_output":true,"text":"cancer, detailed information will be requested and should be provided by the site. The main","text_display":" cancer, detailed information will be requested and should be provided by the site. The main","confidence":1,"confidence_rate":1},{"cnt":[[247,672],[1798,672],[1798,724],[247,724]],"region":{"top_left_x":246,"top_left_y":671,"width":1552,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8745e6a8d8f41e8866d4d7c1c71ff67","type":"text","conversion_output":true,"text":"focus on oncological adverse events is on the following organ systems, based on [R10-6638]","text_display":" focus on oncological adverse events is on the following organ systems, based on [R10-6638]","confidence":1,"confidence_rate":1},{"cnt":[[247,722],[1766,722],[1766,770],[247,770]],"region":{"top_left_x":246,"top_left_y":721,"width":1520,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd368bfe8f094ff5a106e6c9ffaba591","type":"text","conversion_output":true,"text":"where an increased risk for cancer in the population of patients with T2DM was described:","text_display":" where an increased risk for cancer in the population of patients with T2DM was described:","confidence":1,"confidence_rate":1},{"cnt":[[306,777],[468,777],[468,816],[306,816]],"region":{"top_left_x":306,"top_left_y":776,"width":163,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64d7082d0b224baeac3a244a4b622d1c","type":"text","conversion_output":true,"text":"- Liver","text_display":"\n- Liver","confidence":1,"confidence_rate":1},{"cnt":[[306,825],[608,825],[608,866],[306,866]],"region":{"top_left_x":306,"top_left_y":824,"width":302,"height":42},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed91fd8dda0346fb96a091630204def9","type":"text","conversion_output":true,"text":"- Endometrium","text_display":"\n- Endometrium","confidence":1,"confidence_rate":1},{"cnt":[[306,873],[678,873],[678,916],[306,916]],"region":{"top_left_x":306,"top_left_y":872,"width":373,"height":45},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb61e7c4b6384494b15b7562be51a079","type":"text","conversion_output":true,"text":"- Colon and rectum","text_display":"\n- Colon and rectum","confidence":1,"confidence_rate":1},{"cnt":[[306,927],[487,927],[487,966],[306,966]],"region":{"top_left_x":306,"top_left_y":927,"width":181,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0316e6bf997c4e869a35d0b4b6a73e0c","type":"text","conversion_output":true,"text":"- Breast","text_display":"\n- Breast","confidence":1,"confidence_rate":1},{"cnt":[[306,978],[514,978],[514,1017],[306,1017]],"region":{"top_left_x":306,"top_left_y":977,"width":208,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ef824bf9d9d460c8816d7f51cd0b658","type":"text","conversion_output":true,"text":"- Bladder","text_display":"\n- Bladder","confidence":1,"confidence_rate":1},{"cnt":[[306,1028],[514,1028],[514,1071],[306,1071]],"region":{"top_left_x":306,"top_left_y":1027,"width":208,"height":45},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8be0fcee07b4ef1ac273460533ce8c5","type":"text","conversion_output":true,"text":"- Prostate","text_display":"\n- Prostate","confidence":1,"confidence_rate":1},{"cnt":[[247,1124],[1757,1124],[1757,1172],[247,1172]],"region":{"top_left_x":246,"top_left_y":1123,"width":1511,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9fa52f9372e942dfbdfe5be76a702750","type":"text","conversion_output":true,"text":"Request for detailed information (e.g. medical history, diagnostic result, laboratory results","text_display":"\n\nRequest for detailed information (e.g. medical history, diagnostic result, laboratory results","confidence":1,"confidence_rate":1},{"cnt":[[244,1172],[1793,1172],[1793,1220],[244,1220]],"region":{"top_left_x":244,"top_left_y":1171,"width":1550,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe6108b91518499aa45244830d6fe338","type":"text","conversion_output":true,"text":"staging), will be mainly focused on the above listed organ systems, however is not restricted","text_display":" staging), will be mainly focused on the above listed organ systems, however is not restricted","confidence":1,"confidence_rate":1},{"cnt":[[247,1220],[1519,1220],[1519,1268],[247,1268]],"region":{"top_left_x":246,"top_left_y":1219,"width":1274,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3140b9ee091e4fccb56b9fbbd0d18766","type":"text","conversion_output":true,"text":"to them. For details refer to the oncology committee assessment charter.","text_display":" to them. For details refer to the oncology committee assessment charter.","confidence":1,"confidence_rate":1},{"cnt":[[242,1307],[1190,1307],[1190,1364],[242,1364]],"region":{"top_left_x":242,"top_left_y":1306,"width":949,"height":58},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45abc017af984959aaafa056fe4d0383","type":"section_header","conversion_output":false,"children_ids":["697da7c6877d42f5a2786991a9a0187f"],"text":"","text_display":""},{"cnt":[[247,1311],[1186,1311],[1186,1359],[247,1359]],"region":{"top_left_x":246,"top_left_y":1311,"width":940,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"697da7c6877d42f5a2786991a9a0187f","type":"text","conversion_output":true,"parent_id":"45abc017af984959aaafa056fe4d0383","text":"5.2.3 Assessment of safety laboratory parameters","text_display":"\n\n\\subsection*{5.2.3 Assessment of safety laboratory parameters}","confidence":1,"confidence_rate":1},{"cnt":[[247,1398],[1738,1398],[1738,1448],[247,1448]],"region":{"top_left_x":246,"top_left_y":1398,"width":1493,"height":51},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b52cedcf895c41db8b464dde5652a197","type":"text","conversion_output":true,"text":"The parameters that will be determined are listed below. Analysis will be performed by a","text_display":"\n\nThe parameters that will be determined are listed below. Analysis will be performed by a","confidence":1,"confidence_rate":1},{"cnt":[[247,1448],[557,1448],[557,1496],[247,1496]],"region":{"top_left_x":246,"top_left_y":1448,"width":312,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ada9a58a00f41bf92ed5b5cc4cc8417","type":"text","conversion_output":true,"text":"central laboratory:","text_display":" central laboratory:","confidence":1,"confidence_rate":1},{"cnt":[[247,1544],[573,1544],[573,1592],[247,1592]],"region":{"top_left_x":246,"top_left_y":1544,"width":328,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0494cc47de24c0ead406f3d5491e2d9","type":"text","conversion_output":true,"text":"Visit 1 (screening):","text_display":"\n\nVisit 1 (screening):","confidence":1,"confidence_rate":1},{"cnt":[[306,1594],[1325,1594],[1325,1642],[306,1642]],"region":{"top_left_x":306,"top_left_y":1594,"width":1019,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b531ba4f5daf4a348f773722f41b20d5","type":"text","conversion_output":true,"text":"- Clinical chemistry: ALT, AST, AP, lipase and creatinine","text_display":"\n- Clinical chemistry: ALT, AST, AP, lipase and creatinine","confidence":1,"confidence_rate":1},{"cnt":[[306,1645],[1021,1645],[1021,1693],[306,1693]],"region":{"top_left_x":306,"top_left_y":1644,"width":716,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a88b23ab0914c18b6d2f6359a8e66f2","type":"text","conversion_output":true,"text":"- Urine analysis: albumin and creatinine","text_display":"\n- Urine analysis: albumin and creatinine","confidence":1,"confidence_rate":1},{"cnt":[[247,1741],[551,1741],[551,1789],[247,1789]],"region":{"top_left_x":246,"top_left_y":1740,"width":305,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"500362aad0e740ea9d7acd52be658659","type":"text","conversion_output":true,"text":"Visit 2 (baseline):","text_display":"\n\nVisit 2 (baseline):","confidence":1,"confidence_rate":1},{"cnt":[[306,1791],[1775,1791],[1775,1839],[306,1839]],"region":{"top_left_x":306,"top_left_y":1790,"width":1469,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72d404961b5c42b6acb8e8318d13340d","type":"text","conversion_output":true,"text":"- Haematology: haematocrit, haemoglobin, erythrocyte count, platelet count and total","text_display":"\n- Haematology: haematocrit, haemoglobin, erythrocyte count, platelet count and total","confidence":1,"confidence_rate":1},{"cnt":[[370,1841],[1451,1841],[1451,1889],[370,1889]],"region":{"top_left_x":370,"top_left_y":1841,"width":1081,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a1e90d23b3448c18f42c4e167e94159","type":"text","conversion_output":true,"text":"and automates differential leukocyte counts (in absolute counts).","text_display":" and automates differential leukocyte counts (in absolute counts).","confidence":1,"confidence_rate":1},{"cnt":[[306,1891],[1793,1891],[1793,1939],[306,1939]],"region":{"top_left_x":306,"top_left_y":1891,"width":1488,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"595d63717e3548cea44aabfdbe4aa6b2","type":"text","conversion_output":true,"text":"- Clinical chemistry: ALT, AST, \\(\\gamma\\)-GT, AP, lipase, lactate dehydrogenase (LDH), total","text_display":"\n- Clinical chemistry: ALT, AST, \\(\\gamma\\)-GT, AP, lipase, lactate dehydrogenase (LDH), total","confidence":0.99853515625,"confidence_rate":0.9999842375685026},{"cnt":[[370,1937],[1629,1937],[1629,1985],[370,1985]],"region":{"top_left_x":370,"top_left_y":1937,"width":1259,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db895c8072d94b5bae2cd045cf497aa5","type":"text","conversion_output":true,"text":"bilirubin, albumin, potassium, Sodium, creatinine, urea, calcium, inorganic","text_display":" bilirubin, albumin, potassium, Sodium, creatinine, urea, calcium, inorganic","confidence":1,"confidence_rate":1},{"cnt":[[370,1985],[1620,1985],[1620,2035],[370,2035]],"region":{"top_left_x":370,"top_left_y":1985,"width":1250,"height":51},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"902fdc7c08b14dfc8788ca5e8a56df58","type":"text","conversion_output":true,"text":"phosphorous, urid acid, cholesterol (total), high density lipoprotein (HDL)","text_display":" phosphorous, urid acid, cholesterol (total), high density lipoprotein (HDL)","confidence":1,"confidence_rate":1},{"cnt":[[370,2033],[1579,2033],[1579,2081],[370,2081]],"region":{"top_left_x":370,"top_left_y":2033,"width":1209,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"312bc3cc029f46bb9fe3f4351bd685c5","type":"text","conversion_output":true,"text":"cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.","text_display":" cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.","confidence":1,"confidence_rate":1},{"cnt":[[306,2083],[1496,2083],[1496,2131],[306,2131]],"region":{"top_left_x":306,"top_left_y":2083,"width":1191,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e773b1f8fdca496fa2a2fea1a438ce17","type":"text","conversion_output":true,"text":"- Urine analysis: albumin, creatinine, protein, ketone and leucocytes.","text_display":"\n- Urine analysis: albumin, creatinine, protein, ketone and leucocytes.","confidence":1,"confidence_rate":1},{"cnt":[[247,2225],[578,2225],[578,2273],[247,2273]],"region":{"top_left_x":246,"top_left_y":2224,"width":332,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6999b04acd1540c5aa330f5884191a09","type":"text","conversion_output":true,"text":"Visit 3 - EOT - FU","text_display":"\n\nVisit 3 - EOT - FU","confidence":0.8469896866813542,"confidence_rate":0.9936331715908865},{"cnt":[[306,2321],[1049,2321],[1049,2369],[306,2369]],"region":{"top_left_x":306,"top_left_y":2320,"width":743,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6810eda4580a42ca9e8c8a83323071d7","type":"text","conversion_output":true,"text":"- Clinical chemistry: creatinine and lipase","text_display":"\n- Clinical chemistry: creatinine and lipase","confidence":1,"confidence_rate":1},{"cnt":[[306,2371],[1652,2371],[1652,2419],[306,2419]],"region":{"top_left_x":306,"top_left_y":2371,"width":1346,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d71559b8071435396f074aa27221d26","type":"text","conversion_output":true,"text":"- Urine analysis: albumin and creatinine (visit 4, visit 6 and thereafter yearly).","text_display":"\n- Urine analysis: albumin and creatinine (visit 4, visit 6 and thereafter yearly).","confidence":0.56591796875,"confidence_rate":0.9936943408307318},{"cnt":[[306,2421],[1665,2421],[1665,2472],[306,2472]],"region":{"top_left_x":306,"top_left_y":2421,"width":1360,"height":51},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6bf8e1f67d4043499ae7b6b1d80f7e52","type":"text","conversion_output":true,"text":"- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and","text_display":"\n- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and","confidence":1,"confidence_rate":1},{"cnt":[[370,2472],[1208,2472],[1208,2520],[370,2520]],"region":{"top_left_x":370,"top_left_y":2471,"width":839,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa6bd87532a04b1ab4c1641854ad76aa","type":"text","conversion_output":true,"text":"triglycerides (visit 4, visit 6 and thereafter yearly)","text_display":" triglycerides (visit 4, visit 6 and thereafter yearly)","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":40},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"60cb43f7eb00431ca7612e7396322be2","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99169921875,"confidence_rate":0.9998015572024007},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"76bc761869e1454bae54d34e1dd944b0","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"611e61010009474e8d50ebd72fe98075","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-051","page":51,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0beb3851ae04e8d9e7a7b8f3675f820","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c206c72cc9f4cb5a1a477727d27fce8","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d8ed6632fc843c799d25c1e42d52bcb","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af9538e7d08648c1a4d3d6af3348b3cc","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c523261b8464060ac9ce5da3213c2a8","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f995b0b6f4ef4186a3e4d32e4ffee616","type":"page_info","conversion_output":false,"text":"Page 51 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1576,338],[1576,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":1331,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d54f06dc05d46a5ad4ef663dcf6986a","type":"text","conversion_output":true,"text":"\\(HbA _{1 c }\\) will be determined at all scheduled visits, with exception of the FU visit.","text_display":"\n\\(HbA _{1 c }\\) will be determined at all scheduled visits, with exception of the FU visit.","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1800,434],[1800,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1555,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68887eca6de94f0cbf88127aeaf298a1","type":"text","conversion_output":true,"text":"Exact date and time of blood and urine sampling should be recorded in the central laboratory","text_display":"\n\nExact date and time of blood and urine sampling should be recorded in the central laboratory","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[532,484],[532,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":287,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04b79ab8ca9a439a8d2fb124f7e2f0b7","type":"text","conversion_output":true,"text":"requisition form.","text_display":" requisition form.","confidence":1,"confidence_rate":1},{"cnt":[[247,571],[1777,571],[1777,619],[247,619]],"region":{"top_left_x":246,"top_left_y":571,"width":1532,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8be12bed236b440aa4db7733abccb0f4","type":"text","conversion_output":true,"text":"UACR will be calculated at the central lab, and should be measured on a first morning void","text_display":"\n\nUACR will be calculated at the central lab, and should be measured on a first morning void","confidence":1,"confidence_rate":1},{"cnt":[[247,621],[1656,621],[1656,669],[247,669]],"region":{"top_left_x":246,"top_left_y":621,"width":1411,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bd97eaa56e2843cda86fc3ccdd0fd085","type":"text","conversion_output":true,"text":"specimen wherever possible. UACR will be performed according to the Flow Chart.","text_display":" specimen wherever possible. UACR will be performed according to the Flow Chart.","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[247,708],[1802,708],[1802,758],[247,758]],"region":{"top_left_x":246,"top_left_y":708,"width":1557,"height":51},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bebf870b54994d5e86f358b34dbd1b30","type":"text","conversion_output":true,"text":"Pregnancy testing (beta Human Chorionic Gonadotropin [ \\(\\beta HCG\\) method]) will be performed","text_display":"\n\nPregnancy testing (beta Human Chorionic Gonadotropin [ \\(\\beta HCG\\) method]) will be performed","confidence":0.9570046936583552,"confidence_rate":0.9995470409366666},{"cnt":[[247,758],[1469,758],[1469,806],[247,806]],"region":{"top_left_x":246,"top_left_y":758,"width":1223,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10eebaadb50d476884e1d89b5ae25d81","type":"text","conversion_output":true,"text":"in female patients of child-bearing potential according to the Flow Chart.","text_display":" in female patients of child-bearing potential according to the Flow Chart.","confidence":1,"confidence_rate":1},{"cnt":[[244,848],[1770,848],[1770,898],[244,898]],"region":{"top_left_x":244,"top_left_y":847,"width":1527,"height":51},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02b4c94391db435e9580cad4418d974b","type":"text","conversion_output":true,"text":"A negative pregnancy test result is required at visit 2 for all female patients of childbearing","text_display":"\n\nA negative pregnancy test result is required at visit 2 for all female patients of childbearing","confidence":1,"confidence_rate":1},{"cnt":[[244,895],[1780,895],[1780,943],[244,943]],"region":{"top_left_x":244,"top_left_y":895,"width":1536,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f7b1704a4f844d19c38c05eb9ff1f13","type":"text","conversion_output":true,"text":"potential to remain eligible for entry into the treatment phase of the trial and reconfirmed at","text_display":" potential to remain eligible for entry into the treatment phase of the trial and reconfirmed at","confidence":1,"confidence_rate":1},{"cnt":[[247,946],[459,946],[459,985],[247,985]],"region":{"top_left_x":246,"top_left_y":945,"width":214,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6e80139acd94765b113708228249141","type":"text","conversion_output":true,"text":"future visits.","text_display":" future visits.","confidence":1,"confidence_rate":1},{"cnt":[[242,1028],[660,1028],[660,1081],[242,1081]],"region":{"top_left_x":242,"top_left_y":1027,"width":419,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0442f1f83666402297f601be68e65e5d","type":"section_header","conversion_output":false,"children_ids":["fd5053c1b6ba484a940c2b2ed3e70cbc"],"text":"","text_display":""},{"cnt":[[247,1033],[656,1033],[656,1076],[247,1076]],"region":{"top_left_x":246,"top_left_y":1032,"width":410,"height":44},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd5053c1b6ba484a940c2b2ed3e70cbc","type":"text","conversion_output":true,"parent_id":"0442f1f83666402297f601be68e65e5d","text":"5.2.3.1 Renal function","text_display":"\n\n\\subsection*{5.2.3.1 Renal function}","confidence":1,"confidence_rate":1},{"cnt":[[247,1122],[1697,1122],[1697,1172],[247,1172]],"region":{"top_left_x":246,"top_left_y":1121,"width":1452,"height":51},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fadede3c4d74cffbcc2dfc346b8e83c","type":"text","conversion_output":true,"text":"Renal function will be assessed by the central lab based on the plasma creatinine value","text_display":"\n\nRenal function will be assessed by the central lab based on the plasma creatinine value","confidence":1,"confidence_rate":1},{"cnt":[[247,1170],[1768,1170],[1768,1218],[247,1218]],"region":{"top_left_x":246,"top_left_y":1169,"width":1523,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b870db8405c48b5933ea64a3d6c0bf9","type":"text","conversion_output":true,"text":"measured according to the Flow Chart. The eGFR will be calculated from serum creatinine","text_display":" measured according to the Flow Chart. The eGFR will be calculated from serum creatinine","confidence":1,"confidence_rate":1},{"cnt":[[247,1220],[866,1220],[866,1268],[247,1268]],"region":{"top_left_x":246,"top_left_y":1219,"width":620,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83f3922a362841f2a155b6cb52c5a99b","type":"text","conversion_output":true,"text":"using the following MDRD formula:","text_display":" using the following MDRD formula:","confidence":1,"confidence_rate":1},{"cnt":[[247,1298],[1807,1298],[1807,1359],[247,1359]],"region":{"top_left_x":246,"top_left_y":1297,"width":1561,"height":63},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58f8b4bf5cc641ad9e4bd8f3f57f47c6","type":"text","conversion_output":true,"text":"eGFR \\(=175 \\times(\\text { creatinine }(\\mu mol / L ) / 88.4)^{-1.154} \\times\\) age \\(^{-0.203} \\times(0.742\\) if female \\() \\times(1.212\\) if black \\()\\)","text_display":"\neGFR \\(=175 \\times(\\text { creatinine }(\\mu mol / L ) / 88.4)^{-1.154} \\times\\) age \\(^{-0.203} \\times(0.742\\) if female \\() \\times(1.212\\) if black \\()\\)","confidence":0.979116906524204,"confidence_rate":0.9998351367995715},{"cnt":[[247,1398],[1213,1398],[1213,1446],[247,1446]],"region":{"top_left_x":246,"top_left_y":1398,"width":968,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22fc7f9718784d168786782962398309","type":"text","conversion_output":true,"text":"Renal impairment will be classified in the following way:","text_display":"\nRenal impairment will be classified in the following way:","confidence":1,"confidence_rate":1},{"cnt":[[306,1453],[1158,1453],[1158,1505],[306,1505]],"region":{"top_left_x":306,"top_left_y":1452,"width":853,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eea8be7d325848418f34491e9ff00da5","type":"text","conversion_output":true,"text":"No renal impairment: \\(eGFR \\geq 90 mL / min / 1.73 m^{2}\\);","text_display":"\nNo renal impairment: \\(eGFR \\geq 90 mL / min / 1.73 m^{2}\\);","confidence":0.6803362369537354,"confidence_rate":0.9945127085304017},{"cnt":[[306,1503],[1793,1503],[1793,1560],[306,1560]],"region":{"top_left_x":306,"top_left_y":1503,"width":1488,"height":58},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99901cd83b704e62be351f62855ed05b","type":"text","conversion_output":true,"text":"No renal impairment with evidence of kidney damage ( \\(e G F R \\geq 9 0 ~ m L / m i n / 1 . 7 3 m ^{ 2 }\\) and","text_display":"\nNo renal impairment with evidence of kidney damage ( \\(e G F R \\geq 9 0 ~ m L / m i n / 1 . 7 3 m ^{ 2 }\\) and","confidence":0.38781358735494664,"confidence_rate":0.9915026997751288},{"cnt":[[306,1558],[802,1558],[802,1606],[306,1606]],"region":{"top_left_x":306,"top_left_y":1557,"width":496,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e285183cd39644cda6f712a2584f1729","type":"text","conversion_output":true,"text":"UACR \\(\\geq 30 mg / g\\) creatinine);","text_display":"\nUACR \\(\\geq 30 mg / g\\) creatinine);","confidence":0.99951171875,"confidence_rate":0.9999874769887185},{"cnt":[[306,1599],[1208,1599],[1208,1656],[306,1656]],"region":{"top_left_x":306,"top_left_y":1599,"width":903,"height":58},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8de898909e9844db80a79a32f3e11d99","type":"text","conversion_output":true,"text":"Mild renal impairment: eGFR \\(60-89 mL / min / 1.73 m^{2}\\);","text_display":"\nMild renal impairment: eGFR \\(60-89 mL / min / 1.73 m^{2}\\);","confidence":1,"confidence_rate":1},{"cnt":[[306,1647],[1286,1647],[1286,1702],[306,1702]],"region":{"top_left_x":306,"top_left_y":1647,"width":981,"height":55},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e6af4b1be7274f499bb1762f88b02a56","type":"text","conversion_output":true,"text":"Moderate renal impairment: eGFR \\(30-59 mL / min / 1.73 m^{2}\\);","text_display":"\nModerate renal impairment: eGFR \\(30-59 mL / min / 1.73 m^{2}\\);","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[306,1695],[1240,1695],[1240,1750],[306,1750]],"region":{"top_left_x":306,"top_left_y":1695,"width":935,"height":55},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa74e30fea0e4cf4b96d7944f8744d09","type":"text","conversion_output":true,"text":"Severe renal impairment: eGFR \\(15-29 mL / min / 1.73 m^{2}\\);","text_display":"\nSevere renal impairment: eGFR \\(15-29 mL / min / 1.73 m^{2}\\);","confidence":0.9990234375,"confidence_rate":0.9999867968486782},{"cnt":[[306,1741],[916,1741],[916,1793],[306,1793]],"region":{"top_left_x":306,"top_left_y":1740,"width":611,"height":54},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3bd0345fba24ab99eb7b17cbbfb2d66","type":"text","conversion_output":true,"text":"ESRD: \\(eGFR <15 mL / min / 1.73 m^{2}\\).","text_display":"\nESRD: \\(eGFR <15 mL / min / 1.73 m^{2}\\).","confidence":0.6111798284109682,"confidence_rate":0.9910878769640343},{"cnt":[[242,1841],[1343,1841],[1343,1898],[242,1898]],"region":{"top_left_x":242,"top_left_y":1841,"width":1102,"height":58},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be4e2e220a364ad8a58f8b20b274e98b","type":"section_header","conversion_output":false,"children_ids":["ba4824b5ce5a4bb38b28f108ac380f72"],"text":"","text_display":""},{"cnt":[[247,1846],[1341,1846],[1341,1894],[247,1894]],"region":{"top_left_x":246,"top_left_y":1845,"width":1095,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba4824b5ce5a4bb38b28f108ac380f72","type":"text","conversion_output":true,"parent_id":"be4e2e220a364ad8a58f8b20b274e98b","text":"Prevalent kidney disease will be defined in the following way:","text_display":"\n\n\\section*{Prevalent kidney disease will be defined in the following way:}","confidence":0.9990236759185791,"confidence_rate":0.9999854209869283},{"cnt":[[306,1896],[1492,1896],[1492,1949],[306,1949]],"region":{"top_left_x":306,"top_left_y":1896,"width":1186,"height":53},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7cb23176fdde4b899b9b22cea3635991","type":"section_header","conversion_output":false,"children_ids":["a66eecc2a04a4771b2fd2bf55b772786"],"text":"","text_display":""},{"cnt":[[311,1896],[1487,1896],[1487,1944],[311,1944]],"region":{"top_left_x":310,"top_left_y":1896,"width":1178,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a66eecc2a04a4771b2fd2bf55b772786","type":"text","conversion_output":true,"parent_id":"7cb23176fdde4b899b9b22cea3635991","text":"- eGFR \\(<60 mL / min / 1.73 m 2\\) and/or UACR \\(>300 mg / g\\) creatinine","text_display":"\n\n\\section*{- eGFR \\(<60 mL / min / 1.73 m 2\\) and/or UACR \\(>300 mg / g\\) creatinine}","confidence":0.9385116103768183,"confidence_rate":0.9992168493926876},{"cnt":[[242,2010],[752,2010],[752,2067],[242,2067]],"region":{"top_left_x":242,"top_left_y":2010,"width":510,"height":58},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f294a02c26c54a7bab9e49a37c6d0281","type":"section_header","conversion_output":false,"children_ids":["8a04f6ebf2fa4c2ea286ec87b2b0b9e6"],"text":"","text_display":""},{"cnt":[[247,2015],[747,2015],[747,2063],[247,2063]],"region":{"top_left_x":246,"top_left_y":2014,"width":501,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a04f6ebf2fa4c2ea286ec87b2b0b9e6","type":"text","conversion_output":true,"parent_id":"f294a02c26c54a7bab9e49a37c6d0281","text":"5.2.4 Electrocardiogram","text_display":"\n\n\\subsection*{5.2.4 Electrocardiogram}","confidence":0.99951171875,"confidence_rate":0.9999825572771935},{"cnt":[[247,2102],[1750,2102],[1750,2150],[247,2150]],"region":{"top_left_x":246,"top_left_y":2101,"width":1504,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49c643e7508941798383ea9a50a1890f","type":"text","conversion_output":true,"text":"12-lead ECGs (I, II, III, aVR, aVL, aVF, V1 - V6) will be recorded according to the Flow","text_display":"\n\n12-lead ECGs (I, II, III, aVR, aVL, aVF, V1 - V6) will be recorded according to the Flow","confidence":0.943359375,"confidence_rate":0.9993732290687446},{"cnt":[[247,2152],[354,2152],[354,2195],[247,2195]],"region":{"top_left_x":246,"top_left_y":2151,"width":109,"height":45},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25c53d6bedf74ee28c5cde80ae1ee258","type":"text","conversion_output":true,"text":"Chart.","text_display":" Chart.","confidence":1,"confidence_rate":1},{"cnt":[[247,2239],[1786,2239],[1786,2289],[247,2289]],"region":{"top_left_x":246,"top_left_y":2238,"width":1541,"height":51},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abb3eaf8166e4bc2840c1890aaefb968","type":"text","conversion_output":true,"text":"The ECGs will be centrally analysed. Additional ECGs may be collected by the investigator","text_display":"\n\nThe ECGs will be centrally analysed. Additional ECGs may be collected by the investigator","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[247,2289],[1784,2289],[1784,2337],[247,2337]],"region":{"top_left_x":246,"top_left_y":2288,"width":1539,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79b749871384488cb84cb6b38bc121e1","type":"text","conversion_output":true,"text":"for safety reasons. Clinically relevant abnormal findings will be reported as AEs, if they are","text_display":" for safety reasons. Clinically relevant abnormal findings will be reported as AEs, if they are","confidence":1,"confidence_rate":1},{"cnt":[[247,2335],[985,2335],[985,2383],[247,2383]],"region":{"top_left_x":246,"top_left_y":2334,"width":739,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4574b524ded14a26a0ba12dd5e9e76eb","type":"text","conversion_output":true,"text":"newly discovered after inclusion in the trial.","text_display":" newly discovered after inclusion in the trial.","confidence":1,"confidence_rate":1},{"cnt":[[247,2426],[1674,2426],[1674,2474],[247,2474]],"region":{"top_left_x":246,"top_left_y":2426,"width":1429,"height":48},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1236ece5a6b3424c9f4d8fccc0d83bb0","type":"text","conversion_output":true,"text":"The recordings will be checked for pathological results by the investigator. Any ECG","text_display":"\n\nThe recordings will be checked for pathological results by the investigator. Any ECG","confidence":1,"confidence_rate":1},{"cnt":[[247,2474],[1323,2474],[1323,2524],[247,2524]],"region":{"top_left_x":246,"top_left_y":2473,"width":1077,"height":52},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1c96e53f6604901b4dcfca090a7eaaf","type":"text","conversion_output":true,"text":"abnormalities will be carefully monitored and medically treated.","text_display":" abnormalities will be carefully monitored and medically treated.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"953fec2123254a8298f3d65a271c9196","type":"section_header","conversion_output":false,"children_ids":["e7aa9b7f5ffe4ad8b6b95d59e0685a77"],"text":"","text_display":""},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e7aa9b7f5ffe4ad8b6b95d59e0685a77","type":"text","conversion_output":true,"parent_id":"953fec2123254a8298f3d65a271c9196","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5d4f8547f18c41c48d1a0ae15ca27645","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4c42f0d73d574cff94b9ca05589a5fea","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-052","page":52,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77283f93fafa402b9eaf2865c5b9b53f","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f48746de40f455cbbf9f07578df6aaa","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e2a1ce0f9d24cffbee0278aea721f54","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ed3f13918a14b3bafe107b43e447e2c","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65d25ccd43b447679ad07fd68216445b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7bca24a07194a72a05ecc91cba420a1","type":"page_info","conversion_output":false,"text":"Page 52 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1062,338],[1062,393],[242,393]],"region":{"top_left_x":242,"top_left_y":338,"width":821,"height":55},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad5577f85de44cd49237d3dbb249a7d1","type":"section_header","conversion_output":false,"children_ids":["3f721053bf184c58843cede07285b2a0"],"text":"","text_display":""},{"cnt":[[247,343],[1058,343],[1058,388],[247,388]],"region":{"top_left_x":246,"top_left_y":342,"width":812,"height":47},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f721053bf184c58843cede07285b2a0","type":"text","conversion_output":true,"parent_id":"ad5577f85de44cd49237d3dbb249a7d1","text":"5.2.5 Assessment of other safety parameters","text_display":"\n\n\\subsection*{5.2.5 Assessment of other safety parameters}","confidence":1,"confidence_rate":1},{"cnt":[[244,425],[624,425],[624,482],[244,482]],"region":{"top_left_x":244,"top_left_y":424,"width":380,"height":59},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"367341d9cd644be1a90239bd43a4b51a","type":"section_header","conversion_output":false,"children_ids":["86652a32de86468ba8c277eaad92a67b"],"text":"","text_display":""},{"cnt":[[251,429],[619,429],[619,477],[251,477]],"region":{"top_left_x":251,"top_left_y":429,"width":369,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"86652a32de86468ba8c277eaad92a67b","type":"text","conversion_output":true,"parent_id":"367341d9cd644be1a90239bd43a4b51a","text":"Vital signs and height","text_display":"\n\n\\section*{Vital signs and height}","confidence":1,"confidence_rate":1},{"cnt":[[247,519],[1674,519],[1674,569],[247,569]],"region":{"top_left_x":246,"top_left_y":518,"width":1429,"height":51},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69345f7ad6734bb1a4af41b3c6f4505c","type":"text","conversion_output":true,"text":"Systolic and diastolic blood pressure (DBP) as well as pulse rate (electronically or by","text_display":"\n\nSystolic and diastolic blood pressure (DBP) as well as pulse rate (electronically or by","confidence":1,"confidence_rate":1},{"cnt":[[247,567],[1786,567],[1786,614],[247,614]],"region":{"top_left_x":246,"top_left_y":566,"width":1541,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd0836a808cf49afb61f25c43b8c67c3","type":"text","conversion_output":true,"text":"palpation, count for 1 minute) will be measured after 5 minutes of rest in the seated position","text_display":" palpation, count for 1 minute) will be measured after 5 minutes of rest in the seated position","confidence":1,"confidence_rate":1},{"cnt":[[247,614],[1709,614],[1709,665],[247,665]],"region":{"top_left_x":246,"top_left_y":614,"width":1463,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee09ac253513493f836ac68c29b2e9c1","type":"text","conversion_output":true,"text":"according to the Flow Chart. All recordings should be made using a similar type of and","text_display":" according to the Flow Chart. All recordings should be made using a similar type of and","confidence":1,"confidence_rate":1},{"cnt":[[247,662],[1720,662],[1720,710],[247,710]],"region":{"top_left_x":246,"top_left_y":662,"width":1475,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56513ec9bb70490da65b743e05caef79","type":"text","conversion_output":true,"text":"validated certified blood pressure recording instrument on the same arm. See for further","text_display":" validated certified blood pressure recording instrument on the same arm. See for further","confidence":1,"confidence_rate":1},{"cnt":[[247,708],[1802,708],[1802,758],[247,758]],"region":{"top_left_x":246,"top_left_y":708,"width":1557,"height":51},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1260bcb02eba4280bb0a8807920e75b5","type":"text","conversion_output":true,"text":"details Section 10.3. Height (metres, m ) will be measured according to the Flow Chart. Body","text_display":" details Section 10.3. Height (metres, m ) will be measured according to the Flow Chart. Body","confidence":0.9512417090591043,"confidence_rate":0.9995148062331053},{"cnt":[[244,752],[1672,752],[1672,806],[244,806]],"region":{"top_left_x":244,"top_left_y":751,"width":1429,"height":56},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1b02a3ef3944580b0bd1bba75466478","type":"text","conversion_output":true,"text":"mass index, BMI ( \\(kg / m ^{2}\\) ) will be calculated for determination of eligibility at Visit 1.","text_display":" mass index, BMI ( \\(kg / m ^{2}\\) ) will be calculated for determination of eligibility at Visit 1.","confidence":0.8516347408294678,"confidence_rate":0.9985277128428139},{"cnt":[[242,850],[802,850],[802,907],[242,907]],"region":{"top_left_x":242,"top_left_y":849,"width":560,"height":58},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af4848e531dc4d059ca85f77851332bf","type":"section_header","conversion_output":false,"children_ids":["2a0e93ffc54f448a88098955f0d4ff75"],"text":"","text_display":""},{"cnt":[[247,854],[797,854],[797,902],[247,902]],"region":{"top_left_x":246,"top_left_y":854,"width":552,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a0e93ffc54f448a88098955f0d4ff75","type":"text","conversion_output":true,"parent_id":"af4848e531dc4d059ca85f77851332bf","text":"Weight and Waist circumference","text_display":"\n\n\\section*{Weight and Waist circumference}","confidence":1,"confidence_rate":1},{"cnt":[[247,941],[1738,941],[1738,994],[247,994]],"region":{"top_left_x":246,"top_left_y":941,"width":1493,"height":53},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fabbf1582c2f4ff1a11831d1816768a4","type":"text","conversion_output":true,"text":"Weight measurements should always be done on a similar approved type of scale for one","text_display":"\n\nWeight measurements should always be done on a similar approved type of scale for one","confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[244,991],[1665,991],[1665,1044],[244,1044]],"region":{"top_left_x":244,"top_left_y":991,"width":1422,"height":53},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d18f94c931614aeda049570fb75c955c","type":"text","conversion_output":true,"text":"patient. In order to get comparable body weight values, it should be performed in the","text_display":" patient. In order to get comparable body weight values, it should be performed in the","confidence":1,"confidence_rate":1},{"cnt":[[247,1037],[505,1037],[505,1090],[247,1090]],"region":{"top_left_x":246,"top_left_y":1037,"width":259,"height":53},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed6faac3971a481ab133699d426e85da","type":"text","conversion_output":true,"text":"following way:","text_display":" following way:","confidence":1,"confidence_rate":1},{"cnt":[[370,1128],[1081,1128],[1081,1181],[370,1181]],"region":{"top_left_x":370,"top_left_y":1128,"width":711,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b7ce3c7b94445748ee65fa36bc97e94","type":"text","conversion_output":true,"text":"- fasting (except for the screening visit),","text_display":"\n- fasting (except for the screening visit),","confidence":1,"confidence_rate":1},{"cnt":[[370,1183],[1357,1183],[1357,1234],[370,1234]],"region":{"top_left_x":370,"top_left_y":1183,"width":987,"height":51},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0c99e1d133b40f799ef4116c2297281","type":"text","conversion_output":true,"text":"- after the urine sampling (weight after bladder voiding),","text_display":"\n- after the urine sampling (weight after bladder voiding),","confidence":1,"confidence_rate":1},{"cnt":[[370,1234],[1147,1234],[1147,1282],[370,1282]],"region":{"top_left_x":370,"top_left_y":1233,"width":777,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"454e220897924771a722cffb43e7bb2d","type":"text","conversion_output":true,"text":"- shoes and coat/jackets should be taken off","text_display":"\n- shoes and coat/jackets should be taken off","confidence":1,"confidence_rate":1},{"cnt":[[370,1284],[1519,1284],[1519,1336],[370,1336]],"region":{"top_left_x":370,"top_left_y":1283,"width":1150,"height":54},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"233c1be91dc9485182a00a08676824f1","type":"text","conversion_output":true,"text":"- pockets should be emptied of heavy objects (i.e. keys, coins etc).","text_display":"\n- pockets should be emptied of heavy objects (i.e. keys, coins etc).","confidence":0.99609375,"confidence_rate":0.999946386378068},{"cnt":[[244,1352],[1743,1352],[1743,1403],[244,1403]],"region":{"top_left_x":244,"top_left_y":1352,"width":1499,"height":51},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d9a1da8947443d19342e6289f79f89c","type":"text","conversion_output":true,"text":"Waist circumference measurements should be made around a patient's bare midriff, 1 cm","text_display":"\n\nWaist circumference measurements should be made around a patient's bare midriff, 1 cm","confidence":1,"confidence_rate":1},{"cnt":[[247,1400],[1757,1400],[1757,1451],[247,1451]],"region":{"top_left_x":246,"top_left_y":1400,"width":1511,"height":51},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9edc39f1b7ab4a118c7bff3823126e16","type":"text","conversion_output":true,"text":"above the iliac crests, after the patient exhales while standing without shoes and with both","text_display":" above the iliac crests, after the patient exhales while standing without shoes and with both","confidence":1,"confidence_rate":1},{"cnt":[[244,1448],[1802,1448],[1802,1501],[244,1501]],"region":{"top_left_x":244,"top_left_y":1448,"width":1559,"height":53},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3285ac9f4dd54c9fabad2793d0f2ccea","type":"text","conversion_output":true,"text":"feet touching and arms hanging freely. The measuring tape should be made of a material that","text_display":" feet touching and arms hanging freely. The measuring tape should be made of a material that","confidence":1,"confidence_rate":1},{"cnt":[[244,1494],[1812,1494],[1812,1547],[244,1547]],"region":{"top_left_x":244,"top_left_y":1493,"width":1568,"height":54},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7642a9108eb14e2983893821f19e8170","type":"text","conversion_output":true,"text":"is not easily stretched, such as fibreglass. The tape should be placed perpendicular to the long","text_display":" is not easily stretched, such as fibreglass. The tape should be placed perpendicular to the long","confidence":1,"confidence_rate":1},{"cnt":[[247,1544],[1716,1544],[1716,1592],[247,1592]],"region":{"top_left_x":246,"top_left_y":1544,"width":1470,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7c7b4e603c749a39db40e7fe4d1fb1f","type":"text","conversion_output":true,"text":"axis of the body and parallel with the floor and with sufficient tension to conform to the","text_display":" axis of the body and parallel with the floor and with sufficient tension to conform to the","confidence":1,"confidence_rate":1},{"cnt":[[247,1592],[820,1592],[820,1642],[247,1642]],"region":{"top_left_x":246,"top_left_y":1592,"width":575,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16e8a1fa5d9b46c6a3dc3a757d5f81e6","type":"text","conversion_output":true,"text":"measurement surface [R07-4080].","text_display":" measurement surface [R07-4080].","confidence":0.9951171875,"confidence_rate":0.9998640433435904},{"cnt":[[242,1677],[614,1677],[614,1734],[242,1734]],"region":{"top_left_x":242,"top_left_y":1676,"width":373,"height":58},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a574f0d6065b4842a1fe383e709bf048","type":"section_header","conversion_output":false,"children_ids":["c13e25b99c3a49b28d8b8485c98e86b6"],"text":"","text_display":""},{"cnt":[[247,1681],[612,1681],[612,1729],[247,1729]],"region":{"top_left_x":246,"top_left_y":1681,"width":367,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c13e25b99c3a49b28d8b8485c98e86b6","type":"text","conversion_output":true,"parent_id":"a574f0d6065b4842a1fe383e709bf048","text":"Physical examination","text_display":"\n\n\\section*{Physical examination}","confidence":1,"confidence_rate":1},{"cnt":[[247,1773],[1702,1773],[1702,1821],[247,1821]],"region":{"top_left_x":246,"top_left_y":1772,"width":1456,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"994d607225e6419991ff2204606d0a4a","type":"text","conversion_output":true,"text":"A head-to toe physical examination (e.g. evaluation of the body and its functions using","text_display":"\n\nA head-to toe physical examination (e.g. evaluation of the body and its functions using","confidence":1,"confidence_rate":1},{"cnt":[[247,1818],[1738,1818],[1738,1871],[247,1871]],"region":{"top_left_x":246,"top_left_y":1818,"width":1493,"height":53},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"387aba1c825d4c44823ccfd56795465b","type":"text","conversion_output":true,"text":"inspection, palpation, percussion, and auscultation) will be performed by the investigator","text_display":" inspection, palpation, percussion, and auscultation) will be performed by the investigator","confidence":1,"confidence_rate":1},{"cnt":[[244,1866],[1738,1866],[1738,1917],[244,1917]],"region":{"top_left_x":244,"top_left_y":1866,"width":1495,"height":51},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db624ea3e88f4de5961351664a3b7f94","type":"text","conversion_output":true,"text":"according to Flow Chart. Documentation of, and findings from the physical examination,","text_display":" according to Flow Chart. Documentation of, and findings from the physical examination,","confidence":1,"confidence_rate":1},{"cnt":[[244,1914],[1215,1914],[1215,1965],[244,1965]],"region":{"top_left_x":244,"top_left_y":1914,"width":972,"height":51},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65f3d3a1033645949fb6c771e0cd5ec6","type":"text","conversion_output":true,"text":"must be part of the source documents available at the site.","text_display":" must be part of the source documents available at the site.","confidence":1,"confidence_rate":1},{"cnt":[[242,2001],[816,2001],[816,2058],[242,2058]],"region":{"top_left_x":242,"top_left_y":2001,"width":574,"height":58},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b56048903ca3476b98fce83a1fb1a77e","type":"section_header","conversion_output":false,"children_ids":["4bee47c57d0e4a1fb74cbd34563aeb7d"],"text":"","text_display":""},{"cnt":[[247,2006],[811,2006],[811,2054],[247,2054]],"region":{"top_left_x":246,"top_left_y":2005,"width":565,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4bee47c57d0e4a1fb74cbd34563aeb7d","type":"text","conversion_output":true,"parent_id":"b56048903ca3476b98fce83a1fb1a77e","text":"Home Blood Glucose Monitoring","text_display":"\n\n\\section*{Home Blood Glucose Monitoring}","confidence":1,"confidence_rate":1},{"cnt":[[247,2092],[1725,2092],[1725,2145],[247,2145]],"region":{"top_left_x":246,"top_left_y":2092,"width":1479,"height":54},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6301f145313d45fc81ee9da405e21d04","type":"text","conversion_output":true,"text":"All patients will be provided with HBGM equipment and supplies for use at home at the","text_display":"\n\nAll patients will be provided with HBGM equipment and supplies for use at home at the","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[244,2143],[1818,2143],[1818,2191],[244,2191]],"region":{"top_left_x":244,"top_left_y":2142,"width":1575,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03ddae341e7d464ea6f6d491fa0b5077","type":"text","conversion_output":true,"text":"randomization visit. Weekly finger stick glucose measurements are recommended. During the","text_display":" randomization visit. Weekly finger stick glucose measurements are recommended. During the","confidence":1,"confidence_rate":1},{"cnt":[[247,2188],[1807,2188],[1807,2241],[247,2241]],"region":{"top_left_x":246,"top_left_y":2188,"width":1561,"height":53},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4ada5d0edf24f49b2133ae4fc58f08b","type":"text","conversion_output":true,"text":"whole trial participation, additional measurements should be done if necessary and in case of","text_display":" whole trial participation, additional measurements should be done if necessary and in case of","confidence":1,"confidence_rate":1},{"cnt":[[244,2239],[1796,2239],[1796,2287],[244,2287]],"region":{"top_left_x":244,"top_left_y":2238,"width":1552,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8348566c4c7744a69ad4e44826ff9004","type":"text","conversion_output":true,"text":"hypo- or hyperglycaemia related symptoms. Patients will be instructed to bring their HBGM","text_display":" hypo- or hyperglycaemia related symptoms. Patients will be instructed to bring their HBGM","confidence":1,"confidence_rate":1},{"cnt":[[244,2284],[1323,2284],[1323,2337],[244,2337]],"region":{"top_left_x":244,"top_left_y":2284,"width":1079,"height":53},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5487c53f28074ba0a47302829a21a350","type":"text","conversion_output":true,"text":"device to visits for an additional measurement of fasted glucose.","text_display":" device to visits for an additional measurement of fasted glucose.","confidence":0.99951171875,"confidence_rate":0.9999930228743673},{"cnt":[[247,2376],[1738,2376],[1738,2426],[247,2426]],"region":{"top_left_x":246,"top_left_y":2375,"width":1493,"height":52},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4163004b3ace4c7fb291fab24ebf163d","type":"text","conversion_output":true,"text":"More frequent testing can be done if deemed necessary by the investigator or required by","text_display":"\n\nMore frequent testing can be done if deemed necessary by the investigator or required by","confidence":1,"confidence_rate":1},{"cnt":[[247,2421],[1780,2421],[1780,2474],[247,2474]],"region":{"top_left_x":246,"top_left_y":2421,"width":1534,"height":53},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15fbfcacab35411ea2a1345d32e1bac5","type":"text","conversion_output":true,"text":"local authorities. The respective procedure for illiterate patients (if included) is described in","text_display":" local authorities. The respective procedure for illiterate patients (if included) is described in","confidence":1,"confidence_rate":1},{"cnt":[[244,2472],[605,2472],[605,2524],[244,2524]],"region":{"top_left_x":244,"top_left_y":2471,"width":362,"height":54},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"167e54c7991f4e7bb02e6b7e202a0b28","type":"text","conversion_output":true,"text":"the Appendix 10.1.1.","text_display":" the Appendix 10.1.1.","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bbe4594d6bd24d19b67202406c4d3438","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99169921875,"confidence_rate":0.9998015572024007},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e3c0f491739c4e3caa61c92d7e4a7b4e","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":50,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"048178916d5d4e28b35af02b8b8187be","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-053","page":53,"lines":[{"cnt":[[244,119],[610,119],[610,167],[244,167]],"region":{"top_left_x":244,"top_left_y":118,"width":366,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca010102125345eeb37aeb443e046187","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e991ea953ac64c2b9e405f17e0a2ff3f","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c83fcc73b21b4ad9950bcb7d79dd37c2","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b04f3b46da4740409fe6264138f67d6e","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96d68273b7134a9b8938cff6063c0ab5","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ae53199c7134c20a903ce59f1c885f2","type":"page_info","conversion_output":false,"text":"Page 53 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1766,338],[1766,388],[244,388]],"region":{"top_left_x":244,"top_left_y":338,"width":1522,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34a222df28f04c85b5e3591c95e40658","type":"text","conversion_output":true,"text":"Instruction on the proper use of the HBGM will be provided by the study staff. The patient","text_display":"\n\nInstruction on the proper use of the HBGM will be provided by the study staff. The patient","confidence":1,"confidence_rate":1},{"cnt":[[244,386],[1789,386],[1789,436],[244,436]],"region":{"top_left_x":244,"top_left_y":386,"width":1545,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51f8fd80638d4863b529a38ae20fcc28","type":"text","conversion_output":true,"text":"will be asked to record the results of the HBGM test on a HBGM diary that will be included","text_display":" will be asked to record the results of the HBGM test on a HBGM diary that will be included","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1661,434],[1661,484],[247,484]],"region":{"top_left_x":246,"top_left_y":434,"width":1415,"height":51},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1044e0c5d0754e8893e6f583d5b96e58","type":"text","conversion_output":true,"text":"in the patient's source document file. Only in the case of linked adverse events or of","text_display":" in the patient's source document file. Only in the case of linked adverse events or of","confidence":0.970703125,"confidence_rate":0.999673299543683},{"cnt":[[244,482],[1800,482],[1800,532],[244,532]],"region":{"top_left_x":244,"top_left_y":482,"width":1557,"height":51},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9cca6d7af7824626aed4542de4bb1cde","type":"text","conversion_output":true,"text":"asymptomatic hypoglycaemia with a measured plasma glucose concentration \\(\\geq 3.0\\) and \\(\\leq 3.9\\)","text_display":" asymptomatic hypoglycaemia with a measured plasma glucose concentration \\(\\geq 3.0\\) and \\(\\leq 3.9","confidence":1,"confidence_rate":1},{"cnt":[[244,530],[1702,530],[1702,580],[244,580]],"region":{"top_left_x":244,"top_left_y":529,"width":1458,"height":52},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c67352838d7f4e408bfd51710b353dba","type":"text","conversion_output":true,"text":"\\(mmol / l (\\geq 54\\) and \\(\\leq 70 mg / dL )\\), the single HBGM values will be recorded in the eCRF.","text_display":" mmol / l (\\geq 54\\) and \\(\\leq 70 mg / dL )\\), the single HBGM values will be recorded in the eCRF.","confidence":0.9299880156759173,"confidence_rate":0.999259625444353},{"cnt":[[244,617],[1702,617],[1702,669],[244,669]],"region":{"top_left_x":244,"top_left_y":616,"width":1458,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be9fedc7f43b406592056543a9063220","type":"text","conversion_output":true,"text":"If the results of a HBGM test reveal blood plasma glucose value of \\(>180 mg / dl (>10.0\\)","text_display":"\n\nIf the results of a HBGM test reveal blood plasma glucose value of \\(>180 mg / dl (>10.0","confidence":0.9042544364929199,"confidence_rate":0.9989066361811556},{"cnt":[[244,667],[1743,667],[1743,717],[244,717]],"region":{"top_left_x":244,"top_left_y":667,"width":1499,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bd07fad0865b4a29a8fbd754a13de474","type":"text","conversion_output":true,"text":"\\(mmol / L\\) ) after an overnight fast or \\(>400 mg / dl (22.2 mmol / L )\\) randomly determined and","text_display":" mmol / L\\) ) after an overnight fast or \\(>400 mg / dl (22.2 mmol / L )\\) randomly determined and","confidence":0.8434641727944836,"confidence_rate":0.9983952714808837},{"cnt":[[244,715],[1766,715],[1766,765],[244,765]],"region":{"top_left_x":244,"top_left_y":715,"width":1522,"height":51},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6021fd09bcf64669b49bccae2b7ca10e","type":"text","conversion_output":true,"text":"confirmed by a second HBGM (not on the same day) the patient should contact the site for","text_display":" confirmed by a second HBGM (not on the same day) the patient should contact the site for","confidence":1,"confidence_rate":1},{"cnt":[[247,763],[496,763],[496,806],[247,806]],"region":{"top_left_x":246,"top_left_y":762,"width":250,"height":45},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17980a6e749e4c248bc91fcbcb775080","type":"text","conversion_output":true,"text":"further advice.","text_display":" further advice.","confidence":1,"confidence_rate":1},{"cnt":[[247,854],[1770,854],[1770,902],[247,902]],"region":{"top_left_x":246,"top_left_y":854,"width":1525,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d23b719a889048cdb9f5e350c21c160b","type":"text","conversion_output":true,"text":"During the trial, the patient should also contact the site for advice if the results of a HBGM","text_display":"\n\nDuring the trial, the patient should also contact the site for advice if the results of a HBGM","confidence":0.998046875,"confidence_rate":0.9999802523683627},{"cnt":[[244,900],[1812,900],[1812,953],[244,953]],"region":{"top_left_x":244,"top_left_y":900,"width":1568,"height":53},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f9cbbc8a8c34ca3b1ac33db20767406","type":"text","conversion_output":true,"text":"test reveal blood plasma glucose value of \\(<70 mg / dL (3.9 mmol / L )\\) after an overnight fast. If","text_display":" test reveal blood plasma glucose value of \\(<70 mg / dL (3.9 mmol / L )\\) after an overnight fast. If","confidence":0.7373046875,"confidence_rate":0.9972333428482361},{"cnt":[[247,950],[1693,950],[1693,998],[247,998]],"region":{"top_left_x":246,"top_left_y":950,"width":1447,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d22cf3e34e142d396b93e50aa358e8d","type":"text","conversion_output":true,"text":"the blood glucose level is \\(<54 mg / dL (3.0 mmol / L )\\), the patient should be instructed to","text_display":" the blood glucose level is \\(<54 mg / dL (3.0 mmol / L )\\), the patient should be instructed to","confidence":0.68603515625,"confidence_rate":0.9964176092290429},{"cnt":[[247,996],[736,996],[736,1044],[247,1044]],"region":{"top_left_x":246,"top_left_y":995,"width":490,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"193c2117e4f241499cf134a43063e8f7","type":"text","conversion_output":true,"text":"eat/drink some carbohydrate.","text_display":" eat/drink some carbohydrate.","confidence":1,"confidence_rate":1},{"cnt":[[247,1087],[1764,1087],[1764,1135],[247,1135]],"region":{"top_left_x":246,"top_left_y":1087,"width":1518,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9928b0356f144118be7bccaed160838","type":"text","conversion_output":true,"text":"The HBGM diary should be brought to each visit for review by investigator/trial staff. The","text_display":"\n\nThe HBGM diary should be brought to each visit for review by investigator/trial staff. The","confidence":1,"confidence_rate":1},{"cnt":[[247,1135],[1818,1135],[1818,1183],[247,1183]],"region":{"top_left_x":246,"top_left_y":1135,"width":1573,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b906090a79104e49a555947af61ae326","type":"text","conversion_output":true,"text":"HBGM diary should be collected at the visit (if completed) and a new HBGM diary should be","text_display":" HBGM diary should be collected at the visit (if completed) and a new HBGM diary should be","confidence":1,"confidence_rate":1},{"cnt":[[247,1183],[583,1183],[583,1231],[247,1231]],"region":{"top_left_x":246,"top_left_y":1183,"width":337,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"265b6f813c5747cebc16bcd4f2c78d69","type":"text","conversion_output":true,"text":"given to the patient.","text_display":" given to the patient.","confidence":1,"confidence_rate":1},{"cnt":[[242,1270],[569,1270],[569,1318],[242,1318]],"region":{"top_left_x":242,"top_left_y":1270,"width":327,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be740ea1caa940499edf889cf928e739","type":"section_header","conversion_output":false,"children_ids":["8d3bd0ae335a41ddb80a1d1fca5b0cc6"],"text":"","text_display":""},{"cnt":[[247,1275],[562,1275],[562,1314],[247,1314]],"region":{"top_left_x":246,"top_left_y":1274,"width":316,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d3bd0ae335a41ddb80a1d1fca5b0cc6","type":"text","conversion_output":true,"parent_id":"be740ea1caa940499edf889cf928e739","text":"5.3 OTHER","text_display":"\n\n\\subsection*{5.3 OTHER}","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":25,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f2a603591e8648409b1dba0e65b00a61","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":26,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"39e0eda29def4e3e9edf902e9a922b8d","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":27,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fbdc34c50f6e49efa9519623fcefa22e","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-054","page":54,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ff5a211df9846fdb6259bb2fdcef4b9","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b90ca69bd70431192b1ec371e647953","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0b2ed2e177e4eb793a15b7ead276400","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ae1f0c66170417ba5a88f610a18ef05","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04a4bec8d6bb4cb18e27484e957299c2","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83f5c55c5a8f4759a8aafbb1109bd17a","type":"page_info","conversion_output":false,"text":"Page 54 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[975,338],[975,386],[242,386]],"region":{"top_left_x":242,"top_left_y":338,"width":734,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2947e9fc07e4062a626da1cb30e0798","type":"section_header","conversion_output":false,"children_ids":["3c178f46db904fa691409837b4a83110"],"text":"","text_display":""},{"cnt":[[247,343],[971,343],[971,381],[247,381]],"region":{"top_left_x":246,"top_left_y":342,"width":725,"height":40},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c178f46db904fa691409837b4a83110","type":"text","conversion_output":true,"parent_id":"e2947e9fc07e4062a626da1cb30e0798","text":"5.3.2 Post stroke functional assessment","text_display":"\n\n\\subsection*{5.3.2 Post stroke functional assessment}","confidence":1,"confidence_rate":1},{"cnt":[[247,429],[1775,429],[1775,477],[247,477]],"region":{"top_left_x":246,"top_left_y":429,"width":1529,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c3d975d3966496da9c3ee36719c037b","type":"text","conversion_output":true,"text":"To assess clinical disability after stroke the reported value from the modified Rankin Scale,","text_display":"\n\nTo assess clinical disability after stroke the reported value from the modified Rankin Scale,","confidence":1,"confidence_rate":1},{"cnt":[[247,477],[1697,477],[1697,525],[247,525]],"region":{"top_left_x":246,"top_left_y":477,"width":1452,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7cd2823034d44d3a3ad8ec9a80c9310","type":"text","conversion_output":true,"text":"an ordinary scale that is being widely used in clinical practice to rank disability will be","text_display":" an ordinary scale that is being widely used in clinical practice to rank disability will be","confidence":1,"confidence_rate":1},{"cnt":[[247,525],[1775,525],[1775,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1529,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db79d0aabaf84fbf842ee770af0f98e5","type":"text","conversion_output":true,"text":"collected. It is reported as a single digit from \\(0-6\\) (covering the spectrum \"no symptoms\" to","text_display":" collected. It is reported as a single digit from \\(0-6\\) (covering the spectrum \"no symptoms\" to","confidence":0.7428011894226074,"confidence_rate":0.9970311473028528},{"cnt":[[247,573],[1727,573],[1727,624],[247,624]],"region":{"top_left_x":246,"top_left_y":573,"width":1481,"height":51},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c77f9a18734344b1a2e5e0bf90a41f0a","type":"text","conversion_output":true,"text":"\"dead\") approximately one week after stroke onset and 3 months after stroke onset. This","text_display":" \"dead\") approximately one week after stroke onset and 3 months after stroke onset. This","confidence":1,"confidence_rate":1},{"cnt":[[247,621],[845,621],[845,669],[247,669]],"region":{"top_left_x":246,"top_left_y":621,"width":600,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c32d96167dc94dbe945b8f242b4da677","type":"text","conversion_output":true,"text":"might require an additional contact.","text_display":" might require an additional contact.","confidence":1,"confidence_rate":1},{"cnt":[[242,706],[886,706],[886,761],[242,761]],"region":{"top_left_x":242,"top_left_y":705,"width":645,"height":56},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb4c70374f4e4b97b6416568f9bbcd3f","type":"section_header","conversion_output":false,"children_ids":["318f75a1467c4b32ab713dc5a6ff04f7"],"text":"","text_display":""},{"cnt":[[247,708],[882,708],[882,756],[247,756]],"region":{"top_left_x":246,"top_left_y":708,"width":636,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"318f75a1467c4b32ab713dc5a6ff04f7","type":"text","conversion_output":true,"parent_id":"fb4c70374f4e4b97b6416568f9bbcd3f","text":"5.3.3 Pharmacogenomic evaluation","text_display":"\n\n\\subsection*{5.3.3 Pharmacogenomic evaluation}","confidence":1,"confidence_rate":1},{"cnt":[[247,800],[1768,800],[1768,848],[247,848]],"region":{"top_left_x":246,"top_left_y":799,"width":1523,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"952ac3f8a43d4bb5bcf648a042cc991d","type":"text","conversion_output":true,"text":"For DNA Banking an additional blood sample will be requested. The DNA sample derived","text_display":"\n\nFor DNA Banking an additional blood sample will be requested. The DNA sample derived","confidence":1,"confidence_rate":1},{"cnt":[[247,848],[1738,848],[1738,898],[247,898]],"region":{"top_left_x":246,"top_left_y":847,"width":1493,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa180d686f634a638f5b24a1cb61cfde","type":"text","conversion_output":true,"text":"from the original blood sample will be stored by Boehringer Ingelheim for up to 15 years","text_display":" from the original blood sample will be stored by Boehringer Ingelheim for up to 15 years","confidence":1,"confidence_rate":1},{"cnt":[[247,895],[1665,895],[1665,943],[247,943]],"region":{"top_left_x":246,"top_left_y":895,"width":1420,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3345273893804c7b9440bbc971fcbcdc","type":"text","conversion_output":true,"text":"after the end of the clinical trial. The stored DNA may be analysed at a later time for","text_display":" after the end of the clinical trial. The stored DNA may be analysed at a later time for","confidence":1,"confidence_rate":1},{"cnt":[[247,943],[1802,943],[1802,994],[247,994]],"region":{"top_left_x":246,"top_left_y":943,"width":1557,"height":51},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2ccdfeeda3b4f0c8206c77f8db88ba5","type":"text","conversion_output":true,"text":"pharmacogenomic analyses, e.g. to identify whether there are other genetic factors that could","text_display":" pharmacogenomic analyses, e.g. to identify whether there are other genetic factors that could","confidence":1,"confidence_rate":1},{"cnt":[[247,991],[1750,991],[1750,1039],[247,1039]],"region":{"top_left_x":246,"top_left_y":991,"width":1504,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fd3c151def9474ca6c7750d63aa140c","type":"text","conversion_output":true,"text":"contribute to a better therapeutic outcome or a higher risk of developing treatment-related","text_display":" contribute to a better therapeutic outcome or a higher risk of developing treatment-related","confidence":1,"confidence_rate":1},{"cnt":[[247,1037],[635,1037],[635,1090],[247,1090]],"region":{"top_left_x":246,"top_left_y":1037,"width":390,"height":53},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7afd6277f484f1b84d36e5fc63b3e48","type":"text","conversion_output":true,"text":"adverse drug reactions.","text_display":" adverse drug reactions.","confidence":1,"confidence_rate":1},{"cnt":[[242,1124],[1412,1124],[1412,1181],[242,1181]],"region":{"top_left_x":242,"top_left_y":1123,"width":1170,"height":59},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5035d641cc964850a85571361b8d8f02","type":"section_header","conversion_output":false,"children_ids":["d0244a4edb7d44b9b3de2c175d82932c"],"text":"","text_display":""},{"cnt":[[247,1128],[1409,1128],[1409,1176],[247,1176]],"region":{"top_left_x":246,"top_left_y":1128,"width":1164,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0244a4edb7d44b9b3de2c175d82932c","type":"text","conversion_output":true,"parent_id":"5035d641cc964850a85571361b8d8f02","text":"5.3.3.1 Methods and timing of Pharmacogenetics sample collection","text_display":"\n\n\\subsection*{5.3.3.1 Methods and timing of Pharmacogenetics sample collection}","confidence":0.9936552047729492,"confidence_rate":0.9999077577475188},{"cnt":[[247,1218],[1766,1218],[1766,1268],[247,1268]],"region":{"top_left_x":246,"top_left_y":1217,"width":1520,"height":51},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff3c44fd401d4844bec279eedd4e454d","type":"text","conversion_output":true,"text":"One (1) blood sample for DNA banking will be taken at visit 2 or later. A maximum of 8.5","text_display":"\n\nOne (1) blood sample for DNA banking will be taken at visit 2 or later. A maximum of 8.5","confidence":1,"confidence_rate":1},{"cnt":[[247,1266],[1775,1266],[1775,1318],[247,1318]],"region":{"top_left_x":246,"top_left_y":1265,"width":1529,"height":54},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e2edeb30db4453e868ac3734343a69a","type":"text","conversion_output":true,"text":"mL blood will be collected per PAXgene Blood DNA sampling tube for those patients who","text_display":" mL blood will be collected per PAXgene Blood DNA sampling tube for those patients who","confidence":0.95166015625,"confidence_rate":0.9994615875324331},{"cnt":[[247,1316],[1814,1316],[1814,1364],[247,1364]],"region":{"top_left_x":246,"top_left_y":1315,"width":1568,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"414257790ec54c7fa864b380c5a4d45c","type":"text","conversion_output":true,"text":"signed a separate informed consent concerning the sample banking part. The PAXgene Blood","text_display":" signed a separate informed consent concerning the sample banking part. The PAXgene Blood","confidence":1,"confidence_rate":1},{"cnt":[[247,1361],[1812,1361],[1812,1412],[247,1412]],"region":{"top_left_x":246,"top_left_y":1361,"width":1566,"height":51},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b813265134f847ac891bd61c10ad87d5","type":"text","conversion_output":true,"text":"DNA tubes can be stored and shipped at room temperature within 14 days. If a longer storage","text_display":" DNA tubes can be stored and shipped at room temperature within 14 days. If a longer storage","confidence":1,"confidence_rate":1},{"cnt":[[247,1412],[1793,1412],[1793,1460],[247,1460]],"region":{"top_left_x":246,"top_left_y":1411,"width":1548,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"001d4355ad6448318f9ba09391f03f16","type":"text","conversion_output":true,"text":"and shipment period for PAXgene Blood DNA tubes is necessary, the blood samples should","text_display":" and shipment period for PAXgene Blood DNA tubes is necessary, the blood samples should","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[247,1457],[1711,1457],[1711,1508],[247,1508]],"region":{"top_left_x":246,"top_left_y":1457,"width":1465,"height":51},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"32b1a986f0064163b0ef22a0997157f7","type":"text","conversion_output":true,"text":"be stored at a temperature of - 20 degrees Celsius or below. Once frozen, thawing of the","text_display":" be stored at a temperature of - 20 degrees Celsius or below. Once frozen, thawing of the","confidence":0.6071186065673828,"confidence_rate":0.9948152467536131},{"cnt":[[247,1505],[1775,1505],[1775,1556],[247,1556]],"region":{"top_left_x":246,"top_left_y":1505,"width":1529,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7da90089e2843b79a73486fe9bcc1ed","type":"text","conversion_output":true,"text":"samples should be avoided. Detailed instructions for pharmacogenomic sampling, handling","text_display":" samples should be avoided. Detailed instructions for pharmacogenomic sampling, handling","confidence":1,"confidence_rate":1},{"cnt":[[247,1553],[1284,1553],[1284,1604],[247,1604]],"region":{"top_left_x":246,"top_left_y":1553,"width":1038,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4392a22f9652467f988b37b30b5756bb","type":"text","conversion_output":true,"text":"and shipment of samples are provided in the ISF/Lab Manual.","text_display":" and shipment of samples are provided in the ISF/Lab Manual.","confidence":1,"confidence_rate":1},{"cnt":[[247,1645],[1668,1645],[1668,1693],[247,1693]],"region":{"top_left_x":246,"top_left_y":1644,"width":1422,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b189cae525514be486fd4796ba275804","type":"text","conversion_output":true,"text":"Participation in the pharmacogenetic sampling is voluntary and not a prerequisite for","text_display":"\n\nParticipation in the pharmacogenetic sampling is voluntary and not a prerequisite for","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[247,1690],[678,1690],[678,1741],[247,1741]],"region":{"top_left_x":246,"top_left_y":1690,"width":433,"height":51},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3642e367da374627a43cdfe06c405ef5","type":"text","conversion_output":true,"text":"participation in the study.","text_display":" participation in the study.","confidence":1,"confidence_rate":1},{"cnt":[[242,1777],[1254,1777],[1254,1830],[242,1830]],"region":{"top_left_x":242,"top_left_y":1777,"width":1013,"height":53},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4922f4fce63047dd8d75c58058acd316","type":"section_header","conversion_output":false,"children_ids":["f40b736509c04fc2bf3b5df36e6273f2"],"text":"","text_display":""},{"cnt":[[247,1782],[1250,1782],[1250,1825],[247,1825]],"region":{"top_left_x":246,"top_left_y":1781,"width":1004,"height":45},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f40b736509c04fc2bf3b5df36e6273f2","type":"text","conversion_output":true,"parent_id":"4922f4fce63047dd8d75c58058acd316","text":"5.4 APPROPRIATENESS OF MEASUREMENTS","text_display":"\n\n\\subsection*{5.4 APPROPRIATENESS OF MEASUREMENTS}","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[247,1869],[1665,1869],[1665,1921],[247,1921]],"region":{"top_left_x":246,"top_left_y":1868,"width":1420,"height":54},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64ef7a8b33d741a2860aecde5ea2f10c","type":"text","conversion_output":true,"text":"All measurements performed during this trial are standard measurements and will be","text_display":"\n\nAll measurements performed during this trial are standard measurements and will be","confidence":1,"confidence_rate":1},{"cnt":[[244,1919],[1588,1919],[1588,1969],[244,1969]],"region":{"top_left_x":244,"top_left_y":1918,"width":1344,"height":52},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b55702ba57bb44d38dcad19ca0a3fb9b","type":"text","conversion_output":true,"text":"performed in order to monitor efficacy and safety aspects in an appropriate way.","text_display":" performed in order to monitor efficacy and safety aspects in an appropriate way.","confidence":1,"confidence_rate":1},{"cnt":[[247,2006],[1720,2006],[1720,2058],[247,2058]],"region":{"top_left_x":246,"top_left_y":2005,"width":1475,"height":54},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b96f92c5f26a4320832621c0107bc4e1","type":"text","conversion_output":true,"text":"The scheduled measurements are appropriate to see drug induced changes in vital signs,","text_display":"\n\nThe scheduled measurements are appropriate to see drug induced changes in vital signs,","confidence":1,"confidence_rate":1},{"cnt":[[247,2056],[1706,2056],[1706,2104],[247,2104]],"region":{"top_left_x":246,"top_left_y":2055,"width":1461,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"124a7b8986ed40579e20dcdbe4accffe","type":"text","conversion_output":true,"text":"laboratory values, and ECG. The endpoints are standard and accepted for evaluation of","text_display":" laboratory values, and ECG. The endpoints are standard and accepted for evaluation of","confidence":1,"confidence_rate":1},{"cnt":[[247,2104],[1816,2104],[1816,2154],[247,2154]],"region":{"top_left_x":246,"top_left_y":2103,"width":1571,"height":52},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69716141e6584e50bd96ec7eae8f06fd","type":"text","conversion_output":true,"text":"efficacy and safety of an oral antidiabetic drug, and they are widely used in this kind of study.","text_display":" efficacy and safety of an oral antidiabetic drug, and they are widely used in this kind of study.","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[247,2193],[1579,2193],[1579,2243],[247,2243]],"region":{"top_left_x":246,"top_left_y":2193,"width":1333,"height":51},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e3f3354ca1b452d982d0a01b4f71a71","type":"text","conversion_output":true,"text":"Therefore, the appropriateness of all measurements applied in this trial is given.","text_display":"\n\nTherefore, the appropriateness of all measurements applied in this trial is given.","confidence":1,"confidence_rate":1},{"cnt":[[240,2280],[1391,2280],[1391,2378],[240,2378]],"region":{"top_left_x":239,"top_left_y":2279,"width":1153,"height":100},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8d52a97cefe46eaba099e48e7b385ab","type":"section_header","conversion_output":false,"children_ids":["4fad5700bbff49ce9c9d4f78e68fdb98","18e4dd41b8894ebcb43860efad03c88d"],"text":"","text_display":""},{"cnt":[[247,2284],[1387,2284],[1387,2328],[247,2328]],"region":{"top_left_x":246,"top_left_y":2284,"width":1141,"height":44},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4fad5700bbff49ce9c9d4f78e68fdb98","type":"text","conversion_output":true,"parent_id":"f8d52a97cefe46eaba099e48e7b385ab","text":"5.5 DRUG CONCENTRATION MEASUREMENTS AND","text_display":"\n\n\\subsection*{5.5 DRUG CONCENTRATION MEASUREMENTS AND","confidence":1,"confidence_rate":1},{"cnt":[[404,2335],[866,2335],[866,2373],[404,2373]],"region":{"top_left_x":404,"top_left_y":2334,"width":462,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18e4dd41b8894ebcb43860efad03c88d","type":"text","conversion_output":true,"parent_id":"f8d52a97cefe46eaba099e48e7b385ab","text":"PHARMACOKINETICS","text_display":" PHARMACOKINETICS}","confidence":1,"confidence_rate":1},{"cnt":[[247,2421],[1304,2421],[1304,2469],[247,2469]],"region":{"top_left_x":246,"top_left_y":2421,"width":1059,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b403683156d0477da1abc2cab583f84d","type":"text","conversion_output":true,"text":"The plasma concentration of linagliptin will not be determined.","text_display":"\n\nThe plasma concentration of linagliptin will not be determined.","confidence":0.9990234375,"confidence_rate":0.9999856318731074},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6f43e6c99c194099ab22e9ca43538990","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999418018997234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4ff0616d00cc4f07a0b4ace52b8923fa","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3387e776f08f4e49bb5141d84d5394d0","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-055","page":55,"lines":[{"cnt":[[244,119],[612,119],[612,167],[244,167]],"region":{"top_left_x":244,"top_left_y":118,"width":369,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52db8923a59f4d5383656527eed12eea","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b803bcc54ecf4fc48991e191468a2202","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,164],[601,164],[601,203],[242,203]],"region":{"top_left_x":242,"top_left_y":164,"width":359,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0616d0d0f8147f8a40f1e648478640f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,206],[637,206],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":205,"width":396,"height":44},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"977c963c979b48b4b4cdcb966db36c16","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,208],[1108,208],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":207,"width":240,"height":42},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bd3345aeb444484ab06c9b2ec1dd7915","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,206],[1816,206],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":205,"width":246,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5bc43dcc7ea4d319a17a85ec8154bfe","type":"page_info","conversion_output":false,"text":"Page 55 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[238,331],[733,331],[733,395],[238,395]],"region":{"top_left_x":237,"top_left_y":331,"width":497,"height":65},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e22153af3b704b4db69fa4591cd1e310","type":"section_header","conversion_output":false,"children_ids":["04b29923ed464bfbb13013218598fc35"],"text":"","text_display":""},{"cnt":[[242,338],[729,338],[729,391],[242,391]],"region":{"top_left_x":242,"top_left_y":338,"width":487,"height":53},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"04b29923ed464bfbb13013218598fc35","type":"text","conversion_output":true,"parent_id":"e22153af3b704b4db69fa4591cd1e310","text":"5.6 BIOMARKER(S)","text_display":"\n\n\\subsection*{5.6 BIOMARKER(S)}","confidence":1,"confidence_rate":1},{"cnt":[[242,425],[1227,425],[1227,480],[242,480]],"region":{"top_left_x":242,"top_left_y":424,"width":985,"height":56},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"634e6a009e3d4a35ada7e3e24b625840","type":"text","conversion_output":true,"text":"No additional biomarkers will be determined in this study.","text_display":"\n\nNo additional biomarkers will be determined in this study.","confidence":1,"confidence_rate":1},{"cnt":[[238,512],[898,512],[898,569],[238,569]],"region":{"top_left_x":237,"top_left_y":511,"width":661,"height":58},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01aa69540512434daa5efabf8340f9f1","type":"section_header","conversion_output":false,"children_ids":["4aedeb3de5b6430e87741462f3c17b10"],"text":"","text_display":""},{"cnt":[[242,516],[891,516],[891,564],[242,564]],"region":{"top_left_x":242,"top_left_y":516,"width":649,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4aedeb3de5b6430e87741462f3c17b10","type":"text","conversion_output":true,"parent_id":"01aa69540512434daa5efabf8340f9f1","text":"5.7 PHARMACODYNAMICS","text_display":"\n\n\\subsection*{5.7 PHARMACODYNAMICS}","confidence":1,"confidence_rate":1},{"cnt":[[242,605],[1537,605],[1537,660],[242,660]],"region":{"top_left_x":242,"top_left_y":605,"width":1296,"height":56},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06945ac606c245aab68e5ec115f67621","type":"text","conversion_output":true,"text":"No additional pharmacodynamic parameters will be determined in this study.","text_display":"\n\nNo additional pharmacodynamic parameters will be determined in this study.","confidence":1,"confidence_rate":1},{"cnt":[[238,690],[1670,690],[1670,752],[238,752]],"region":{"top_left_x":237,"top_left_y":689,"width":1433,"height":63},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13a764517ded4c45afcc6fe664da4d6b","type":"section_header","conversion_output":false,"children_ids":["8ed0baaf00ee4a76b343394838e01a47"],"text":"","text_display":""},{"cnt":[[242,694],[1665,694],[1665,747],[242,747]],"region":{"top_left_x":242,"top_left_y":694,"width":1424,"height":53},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ed0baaf00ee4a76b343394838e01a47","type":"text","conversion_output":true,"parent_id":"13a764517ded4c45afcc6fe664da4d6b","text":"5.8 PHARMACOKINETIC - PHARMACODYNAMIC RELATIONSHIP","text_display":"\n\n\\subsection*{5.8 PHARMACOKINETIC - PHARMACODYNAMIC RELATIONSHIP}","confidence":0.99853515625,"confidence_rate":0.9999733473064166},{"cnt":[[242,786],[1816,786],[1816,836],[242,836]],"region":{"top_left_x":242,"top_left_y":785,"width":1575,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a58b0d7206e246f8ad3f708f118481f1","type":"text","conversion_output":true,"text":"The relationship between linagliptin trough plasma concentrations and biomarkers will not be","text_display":"\n\nThe relationship between linagliptin trough plasma concentrations and biomarkers will not be","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[242,834],[464,834],[464,884],[242,884]],"region":{"top_left_x":242,"top_left_y":833,"width":222,"height":52},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"228847e10c744b3488942086ed977fe8","type":"text","conversion_output":true,"text":"investigated.","text_display":" investigated.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":17,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d49f4ed3a5984955807fb544b5c8e722","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[288,2618],[1800,2618],[1800,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2617,"width":1514,"height":45},"line":18,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"afb98d7114d44caeb14131fb065c93a8","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99267578125,"confidence_rate":0.9999382273489243},{"cnt":[[295,2664],[1770,2664],[1770,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1477,"height":40},"line":19,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a64ad15e950349ea970dc40ec3e7fa55","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-056","page":56,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8a69b33f28a4552b2faa684d9a723b2","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cddbb0ce66394064a87ddc7b05c81d13","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"794f2cc78d55483a8056acb0145ee848","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84ddcd6039db4e48a533914adcd638c7","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ad2ad8105d1428394b69b2924d4be6d","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b57d9b0da884c95933a0e7a8359acab","type":"page_info","conversion_output":false,"text":"Page 56 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1026,338],[1026,395],[242,395]],"region":{"top_left_x":242,"top_left_y":338,"width":784,"height":58},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a2115410459c4046bf43ee16720285b5","type":"section_header","conversion_output":false,"children_ids":["aefbe95c848544e0965e897f40a282cd"],"text":"","text_display":""},{"cnt":[[247,343],[1019,343],[1019,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":773,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"aefbe95c848544e0965e897f40a282cd","type":"text","conversion_output":true,"parent_id":"a2115410459c4046bf43ee16720285b5","text":"6. INVESTIGATIONAL PLAN","text_display":"\n\n\\section*{6. INVESTIGATIONAL PLAN}","confidence":1,"confidence_rate":1},{"cnt":[[242,434],[770,434],[770,482],[242,482]],"region":{"top_left_x":242,"top_left_y":434,"width":528,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b7bb9313ad2a4599b933195b4e4ea0a9","type":"section_header","conversion_output":false,"children_ids":["82dbf84531474499a282c8731f02cbd5"],"text":"","text_display":""},{"cnt":[[247,439],[765,439],[765,480],[247,480]],"region":{"top_left_x":246,"top_left_y":438,"width":520,"height":42},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"82dbf84531474499a282c8731f02cbd5","type":"text","conversion_output":true,"parent_id":"b7bb9313ad2a4599b933195b4e4ea0a9","text":"6.1 VISIT SCHEDULE","text_display":"\n\n\\subsection*{6.1 VISIT SCHEDULE}","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[247,525],[1732,525],[1732,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1486,"height":49},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"363cc697bf1d4dad957d30acc41a36db","type":"text","conversion_output":true,"text":"All trial visits should take place preferably between 7:00 AM and 11:00 AM. If a patient","text_display":"\n\nAll trial visits should take place preferably between 7:00 AM and 11:00 AM. If a patient","confidence":0.9921875,"confidence_rate":0.9999156683146001},{"cnt":[[247,576],[1711,576],[1711,624],[247,624]],"region":{"top_left_x":246,"top_left_y":575,"width":1465,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"21499d1661cb457ea6f8503a8310b0f1","type":"text","conversion_output":true,"text":"mistakenly takes trial medication in the morning of a visit before attending the clinic or","text_display":" mistakenly takes trial medication in the morning of a visit before attending the clinic or","confidence":1,"confidence_rate":1},{"cnt":[[247,621],[1775,621],[1775,672],[247,672]],"region":{"top_left_x":246,"top_left_y":621,"width":1529,"height":51},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2cdba56f1ab7487096a2008620747933","type":"text","conversion_output":true,"text":"comes in non-fasted where a fasting condition is required (all visits except visit 1), the visit","text_display":" comes in non-fasted where a fasting condition is required (all visits except visit 1), the visit","confidence":0.994140625,"confidence_rate":0.9999418174502049},{"cnt":[[247,672],[1748,672],[1748,720],[247,720]],"region":{"top_left_x":246,"top_left_y":671,"width":1502,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8b05412d666a49a085cfaba90c43aa9d","type":"text","conversion_output":true,"text":"should be rescheduled for another day as soon as possible reminding the patient about the","text_display":" should be rescheduled for another day as soon as possible reminding the patient about the","confidence":1,"confidence_rate":1},{"cnt":[[244,717],[1775,717],[1775,770],[244,770]],"region":{"top_left_x":244,"top_left_y":717,"width":1531,"height":53},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cc56ca0694814294add2ea6ce5a01894","type":"text","conversion_output":true,"text":"expected conditions. The rescheduled visit must take place in a short enough time-frame so","text_display":" expected conditions. The rescheduled visit must take place in a short enough time-frame so","confidence":1,"confidence_rate":1},{"cnt":[[247,768],[1176,768],[1176,816],[247,816]],"region":{"top_left_x":246,"top_left_y":767,"width":931,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c55f6dedd8d54977a8c8f3fdf123a5f5","type":"text","conversion_output":true,"text":"that the patient has sufficient trial medication available.","text_display":" that the patient has sufficient trial medication available.","confidence":1,"confidence_rate":1},{"cnt":[[247,854],[1816,854],[1816,905],[247,905]],"region":{"top_left_x":246,"top_left_y":854,"width":1571,"height":51},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"982be6174c354d768802c174c72463f6","type":"text","conversion_output":true,"text":"All patients are to adhere to the visit schedule as specified in the Flow Chart. Some flexibility","text_display":"\n\nAll patients are to adhere to the visit schedule as specified in the Flow Chart. Some flexibility","confidence":0.9877986907958984,"confidence_rate":0.99987965080872},{"cnt":[[244,905],[1770,905],[1770,953],[244,953]],"region":{"top_left_x":244,"top_left_y":904,"width":1527,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c551bb58d8894c83aca2c38d799d0bc8","type":"text","conversion_output":true,"text":"is allowed in scheduling the visits according to visit time windows as specified in the Flow","text_display":" is allowed in scheduling the visits according to visit time windows as specified in the Flow","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[244,950],[1748,950],[1748,1001],[244,1001]],"region":{"top_left_x":244,"top_left_y":950,"width":1504,"height":51},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a9cbd4f2d01744eb830a7f815aacf0a1","type":"text","conversion_output":true,"text":"Chart. If any visit has to be rescheduled, subsequent visits should follow the original visit","text_display":" Chart. If any visit has to be rescheduled, subsequent visits should follow the original visit","confidence":1,"confidence_rate":1},{"cnt":[[247,1001],[1149,1001],[1149,1049],[247,1049]],"region":{"top_left_x":246,"top_left_y":1000,"width":904,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6e1806446e614d27b913748401cca96e","type":"text","conversion_output":true,"text":"date schedule (calculated from randomization visit 2).","text_display":" date schedule (calculated from randomization visit 2).","confidence":0.998046875,"confidence_rate":0.9999668643653395},{"cnt":[[242,1083],[1556,1083],[1556,1135],[242,1135]],"region":{"top_left_x":242,"top_left_y":1082,"width":1314,"height":54},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3f7db8b659de4cbab672d5afe736268f","type":"section_header","conversion_output":false,"children_ids":["35798f3311dc4b948865e884719e40e8"],"text":"","text_display":""},{"cnt":[[247,1087],[1551,1087],[1551,1131],[247,1131]],"region":{"top_left_x":246,"top_left_y":1087,"width":1306,"height":44},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"35798f3311dc4b948865e884719e40e8","type":"text","conversion_output":true,"parent_id":"3f7db8b659de4cbab672d5afe736268f","text":"6.2 DETAILS OF TRIAL PROCEDURES AT SELECTED VISITS","text_display":"\n\n\\subsection*{6.2 DETAILS OF TRIAL PROCEDURES AT SELECTED VISITS}","confidence":1,"confidence_rate":1},{"cnt":[[247,1179],[1716,1179],[1716,1227],[247,1227]],"region":{"top_left_x":246,"top_left_y":1178,"width":1470,"height":49},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8f505e5f72664863924035503b3751d5","type":"text","conversion_output":true,"text":"The Flow Chart summarizes the investigational procedures to be done at each visit. The","text_display":"\n\nThe Flow Chart summarizes the investigational procedures to be done at each visit. The","confidence":1,"confidence_rate":1},{"cnt":[[244,1227],[911,1227],[911,1277],[244,1277]],"region":{"top_left_x":244,"top_left_y":1226,"width":668,"height":51},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fb0b219a2edf4eec8cdb8b37f50bbf59","type":"text","conversion_output":true,"text":"procedures are further described below.","text_display":" procedures are further described below.","confidence":1,"confidence_rate":1},{"cnt":[[242,1311],[720,1311],[720,1373],[242,1373]],"region":{"top_left_x":242,"top_left_y":1311,"width":478,"height":62},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3d552430422b4a0999787f994ae06d63","type":"section_header","conversion_output":false,"children_ids":["ae4e984d4ad2475e93919faac96c7665"],"text":"","text_display":""},{"cnt":[[247,1316],[715,1316],[715,1368],[247,1368]],"region":{"top_left_x":246,"top_left_y":1315,"width":470,"height":54},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ae4e984d4ad2475e93919faac96c7665","type":"text","conversion_output":true,"parent_id":"3d552430422b4a0999787f994ae06d63","text":"6.2.1 Screening period","text_display":"\n\n\\subsection*{6.2.1 Screening period}","confidence":1,"confidence_rate":1},{"cnt":[[247,1407],[1802,1407],[1802,1455],[247,1455]],"region":{"top_left_x":246,"top_left_y":1407,"width":1557,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b7780ce849d140ac8bbaa526b0de2283","type":"text","conversion_output":true,"text":"After the informed consent process is complete and written informed consent is obtained, the","text_display":"\n\nAfter the informed consent process is complete and written informed consent is obtained, the","confidence":1,"confidence_rate":1},{"cnt":[[247,1453],[1816,1453],[1816,1503],[247,1503]],"region":{"top_left_x":246,"top_left_y":1452,"width":1571,"height":52},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dbb1864ecb594269b854ccb2e74643bc","type":"text","conversion_output":true,"text":"patients will be assessed for study eligibility (visit 1) including central laboratory assessments","text_display":" patients will be assessed for study eligibility (visit 1) including central laboratory assessments","confidence":0.8831472396850586,"confidence_rate":0.9987942872339161},{"cnt":[[247,1503],[733,1503],[733,1551],[247,1551]],"region":{"top_left_x":246,"top_left_y":1503,"width":488,"height":49},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7a76e39687564f40a7596b417debde22","type":"text","conversion_output":true,"text":"as specified in Section 5.2.3.","text_display":" as specified in Section 5.2.3.","confidence":1,"confidence_rate":1},{"cnt":[[247,1572],[1250,1572],[1250,1620],[247,1620]],"region":{"top_left_x":246,"top_left_y":1571,"width":1004,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8da58af404824eb293302582d3fe9b66","type":"text","conversion_output":true,"text":"Screening will occur at visit 1 and will be registered in IRT.","text_display":"\n\nScreening will occur at visit 1 and will be registered in IRT.","confidence":1,"confidence_rate":1},{"cnt":[[247,1640],[1789,1640],[1789,1688],[247,1688]],"region":{"top_left_x":246,"top_left_y":1640,"width":1543,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"59a8774c63fd4841a1ba18e524659070","type":"text","conversion_output":true,"text":"Those patients who qualify at screening (as determined at visit 1) and meet all inclusion and","text_display":"\nThose patients who qualify at screening (as determined at visit 1) and meet all inclusion and","confidence":0.9926791191101074,"confidence_rate":0.9999250251571927},{"cnt":[[247,1686],[1784,1686],[1784,1738],[247,1738]],"region":{"top_left_x":246,"top_left_y":1685,"width":1539,"height":54},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"87785cf1f5ad41bab2016c9e440775df","type":"text","conversion_output":true,"text":"exclusion criteria prior to randomization (see Sections 3.3.2.and 3.3.3.), will be randomized","text_display":" exclusion criteria prior to randomization (see Sections 3.3.2.and 3.3.3.), will be randomized","confidence":0.9960973262786865,"confidence_rate":0.9999600996835463},{"cnt":[[247,1736],[1759,1736],[1759,1784],[247,1784]],"region":{"top_left_x":246,"top_left_y":1736,"width":1513,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ef14f606025643fdb42edd7f141830b0","type":"text","conversion_output":true,"text":"at visit 2. Randomization may be done as soon as the visit 1 (safety) laboratory results and","text_display":" at visit 2. Randomization may be done as soon as the visit 1 (safety) laboratory results and","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[247,1782],[1697,1782],[1697,1830],[247,1830]],"region":{"top_left_x":246,"top_left_y":1781,"width":1452,"height":49},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d1bf1795ea3c4d3cae75fc8202214829","type":"text","conversion_output":true,"text":"eGFR are known and all other eligibility criteria are met. No additional medication for","text_display":" eGFR are known and all other eligibility criteria are met. No additional medication for","confidence":1,"confidence_rate":1},{"cnt":[[247,1832],[1563,1832],[1563,1880],[247,1880]],"region":{"top_left_x":246,"top_left_y":1832,"width":1317,"height":49},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c3ef2ccc0a684a17895ae8bbeae9297c","type":"text","conversion_output":true,"text":"optimization of glycaemic control may be initiated during the screening phase.","text_display":" optimization of glycaemic control may be initiated during the screening phase.","confidence":1,"confidence_rate":1},{"cnt":[[242,1914],[733,1914],[733,1976],[242,1976]],"region":{"top_left_x":242,"top_left_y":1914,"width":492,"height":62},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2070dba8e0a14bb1a7ae3e8c137e59eb","type":"section_header","conversion_output":false,"children_ids":["fd2bad3e415648fb80f5868c149afa22"],"text":"","text_display":""},{"cnt":[[247,1921],[726,1921],[726,1971],[247,1971]],"region":{"top_left_x":246,"top_left_y":1921,"width":481,"height":51},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fd2bad3e415648fb80f5868c149afa22","type":"text","conversion_output":true,"parent_id":"2070dba8e0a14bb1a7ae3e8c137e59eb","text":"6.2.2 Treatment period","text_display":"\n\n\\subsection*{6.2.2 Treatment period}","confidence":1,"confidence_rate":1},{"cnt":[[247,2010],[1026,2010],[1026,2058],[247,2058]],"region":{"top_left_x":246,"top_left_y":2010,"width":780,"height":49},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f40f70bd2b3d442babf30266ae0e4875","type":"text","conversion_output":true,"text":"Randomization will occur at visit 2 using IRT.","text_display":"\n\nRandomization will occur at visit 2 using IRT.","confidence":1,"confidence_rate":1},{"cnt":[[247,2097],[1757,2097],[1757,2150],[247,2150]],"region":{"top_left_x":246,"top_left_y":2097,"width":1511,"height":53},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5fda6534c3b94764a3e9b6b34cdf48f3","type":"text","conversion_output":true,"text":"Patients will return to the clinic for regularly scheduled study visits after randomization as","text_display":"\nPatients will return to the clinic for regularly scheduled study visits after randomization as","confidence":1,"confidence_rate":1},{"cnt":[[247,2147],[1738,2147],[1738,2198],[247,2198]],"region":{"top_left_x":246,"top_left_y":2147,"width":1493,"height":51},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4ed0da8e8ce343f4a2efee4487ddda7a","type":"text","conversion_output":true,"text":"specified in the Flow Chart. These visits will assess the occurrence of safety and efficacy","text_display":" specified in the Flow Chart. These visits will assess the occurrence of safety and efficacy","confidence":0.7925815582275391,"confidence_rate":0.9975814724250981},{"cnt":[[247,2195],[1649,2195],[1649,2246],[247,2246]],"region":{"top_left_x":246,"top_left_y":2195,"width":1404,"height":51},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3bcac2a31f0147b4a62002c90d42979b","type":"text","conversion_output":true,"text":"endpoints, study medication compliance and accountability, concomitant therapy or","text_display":" endpoints, study medication compliance and accountability, concomitant therapy or","confidence":1,"confidence_rate":1},{"cnt":[[247,2243],[464,2243],[464,2287],[247,2287]],"region":{"top_left_x":246,"top_left_y":2243,"width":218,"height":44},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f8ac9dba019b49ef933afb4c305386ee","type":"text","conversion_output":true,"text":"intervention.","text_display":" intervention.","confidence":1,"confidence_rate":1},{"cnt":[[247,2332],[1816,2332],[1816,2383],[247,2383]],"region":{"top_left_x":246,"top_left_y":2332,"width":1571,"height":51},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"71c1c9152f284b318e60d68345cdcc92","type":"text","conversion_output":true,"text":"Patient visits should be routinely scheduled in the morning, at approximately the same time at","text_display":"\n\nPatient visits should be routinely scheduled in the morning, at approximately the same time at","confidence":1,"confidence_rate":1},{"cnt":[[247,2380],[1800,2380],[1800,2428],[247,2428]],"region":{"top_left_x":246,"top_left_y":2380,"width":1555,"height":49},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"efff90bdcdcc4fd6a08e39b29e703364","type":"text","conversion_output":true,"text":"each visit. The actual date/time of trial drug administration at the study visit will be recorded","text_display":" each visit. The actual date/time of trial drug administration at the study visit will be recorded","confidence":1,"confidence_rate":1},{"cnt":[[247,2426],[464,2426],[464,2469],[247,2469]],"region":{"top_left_x":246,"top_left_y":2426,"width":218,"height":44},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"057652fff88846c2af045a6d24988345","type":"text","conversion_output":true,"text":"in the eCRF.","text_display":" in the eCRF.","confidence":0.998046875,"confidence_rate":0.9998850045633173},{"cnt":[[793,2621],[793,2584],[1300,2586],[1300,2623]],"region":{"top_left_x":792,"top_left_y":2583,"width":508,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b9e2e68f289b48f986b64c1162c5accb","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bbea1db5a0824e12b34dc54b6ad6a7e6","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b419b5405af84e1faa190319c42d28d1","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-057","page":57,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00c9dd17cd7345caa6cd5fe6da950ecd","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9706217510f40a680d67f8fb512bae6","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"067a8ec95e9e41918ea560e0aa4f2f12","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[635,210],[635,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":390,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b24a826c4ed549a5b4e3e3d9e9db91dd","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4048c00828fa4c9081d51961ba2c1d8c","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06512254b0134539ac06a2219fb6f210","type":"page_info","conversion_output":false,"text":"Page 57 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1807,338],[1807,386],[247,386]],"region":{"top_left_x":246,"top_left_y":338,"width":1561,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc629b39b4d94dabb74d5b595507d70d","type":"text","conversion_output":true,"text":"At each visit all trial medication will be returned, compliance will be calculated and new trial","text_display":"\n\nAt each visit all trial medication will be returned, compliance will be calculated and new trial","confidence":1,"confidence_rate":1},{"cnt":[[247,388],[1332,388],[1332,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1086,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"62bfe527c2d64fb59787bb20b078af59","type":"text","conversion_output":true,"text":"medication kit(s) will be assigned via IRT and will be dispensed.","text_display":" medication kit(s) will be assigned via IRT and will be dispensed.","confidence":1,"confidence_rate":1},{"cnt":[[247,480],[1816,480],[1816,525],[247,525]],"region":{"top_left_x":246,"top_left_y":479,"width":1571,"height":47},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed7b749b58704419895436173afda19a","type":"text","conversion_output":true,"text":"This is a long-term safety outcome study and every effort should be made by the site staff","text_display":"\n\nThis is a long-term safety outcome study and every effort should be made by the site staff","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[247,525],[1741,525],[1741,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1495,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"936de94a7af54510a19175c110c87605","type":"text","conversion_output":true,"text":"to encourage patients to remain in the study and on study drug if medically safe. All","text_display":" to encourage patients to remain in the study and on study drug if medically safe. All","confidence":1,"confidence_rate":1},{"cnt":[[247,571],[1786,571],[1786,619],[247,619]],"region":{"top_left_x":246,"top_left_y":571,"width":1541,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8890eeca96684574a407ae4bec619026","type":"text","conversion_output":true,"text":"patients, including those who discontinue treatment must be followed up until the end of the","text_display":" patients, including those who discontinue treatment must be followed up until the end of the","confidence":1,"confidence_rate":1},{"cnt":[[247,621],[1761,621],[1761,669],[247,669]],"region":{"top_left_x":246,"top_left_y":621,"width":1516,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"804d8cafce704e2a9dc24c2f1c3685f4","type":"text","conversion_output":true,"text":"study. Patients who prematurely discontinue treatment will continue to be contacted by the","text_display":" study. Patients who prematurely discontinue treatment will continue to be contacted by the","confidence":1,"confidence_rate":1},{"cnt":[[247,669],[1725,669],[1725,715],[247,715]],"region":{"top_left_x":246,"top_left_y":669,"width":1479,"height":47},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca20fc95de9949b187c127670a04b0cd","type":"text","conversion_output":true,"text":"investigator at regular intervals (according to the original visit schedule or an alternative","text_display":" investigator at regular intervals (according to the original visit schedule or an alternative","confidence":1,"confidence_rate":1},{"cnt":[[247,717],[1720,717],[1720,765],[247,765]],"region":{"top_left_x":246,"top_left_y":717,"width":1475,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4606467a1979499c8c0a0110dff4a0a7","type":"text","conversion_output":true,"text":"reduced schedule negotiated with the patient) either by clinic visits or by phone (refer to","text_display":" reduced schedule negotiated with the patient) either by clinic visits or by phone (refer to","confidence":1,"confidence_rate":1},{"cnt":[[247,763],[487,763],[487,811],[247,811]],"region":{"top_left_x":246,"top_left_y":762,"width":241,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8b5fd82047c41448853220db93dc781","type":"text","conversion_output":true,"text":"section 6.2.3).","text_display":" section 6.2.3).","confidence":1,"confidence_rate":1},{"cnt":[[247,854],[1713,854],[1713,902],[247,902]],"region":{"top_left_x":246,"top_left_y":854,"width":1468,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ed6e34bb62a43a59ed400b7d75b8151","type":"text","conversion_output":true,"text":"Patients who prematurely discontinued study medication during the treatment phase are","text_display":"\n\nPatients who prematurely discontinued study medication during the treatment phase are","confidence":1,"confidence_rate":1},{"cnt":[[247,905],[1679,905],[1679,953],[247,953]],"region":{"top_left_x":246,"top_left_y":904,"width":1434,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ed6680a35a94d2db58dce4c8919877b","type":"text","conversion_output":true,"text":"allowed to restart the study medication at any time if appropriate in the opinion of the","text_display":" allowed to restart the study medication at any time if appropriate in the opinion of the","confidence":1,"confidence_rate":1},{"cnt":[[247,950],[1802,950],[1802,998],[247,998]],"region":{"top_left_x":246,"top_left_y":950,"width":1557,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecb954e28d774234b7d711accaef80f6","type":"text","conversion_output":true,"text":"investigator and if not contraindicated. Investigators should routinely consider re-starting","text_display":" investigator and if not contraindicated. Investigators should routinely consider re-starting","confidence":1,"confidence_rate":1},{"cnt":[[247,1001],[1355,1001],[1355,1046],[247,1046]],"region":{"top_left_x":246,"top_left_y":1000,"width":1109,"height":47},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a1753320d004a3e8d58808d51d76602","type":"text","conversion_output":true,"text":"study drug at every visit following study drug discontinuation.","text_display":" study drug at every visit following study drug discontinuation.","confidence":1,"confidence_rate":1},{"cnt":[[247,1090],[1768,1090],[1768,1135],[247,1135]],"region":{"top_left_x":246,"top_left_y":1089,"width":1523,"height":47},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9a1fe36cc304b8cb50b6ee585d0b725","type":"text","conversion_output":true,"text":"Early discontinuation of study medication is not a criterion for withdrawal of consent","text_display":"\n\nEarly discontinuation of study medication is not a criterion for withdrawal of consent","confidence":0.9956104733286111,"confidence_rate":0.9999516584330064},{"cnt":[[247,1138],[774,1138],[774,1186],[247,1186]],"region":{"top_left_x":246,"top_left_y":1137,"width":529,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8412c836fdeb44f79428684ec3584129","type":"text","conversion_output":true,"text":"for participating in the study.","text_display":" for participating in the study.","confidence":1,"confidence_rate":1},{"cnt":[[242,1220],[1103,1220],[1103,1277],[242,1277]],"region":{"top_left_x":242,"top_left_y":1219,"width":862,"height":58},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25b112efd06b405580a7719f28864266","type":"section_header","conversion_output":false,"children_ids":["2376234331a945128704819358d9d2ed"],"text":"","text_display":""},{"cnt":[[247,1224],[1099,1224],[1099,1272],[247,1272]],"region":{"top_left_x":246,"top_left_y":1224,"width":853,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2376234331a945128704819358d9d2ed","type":"text","conversion_output":true,"parent_id":"25b112efd06b405580a7719f28864266","text":"6.2.3 End of treatment and follow-up period","text_display":"\n\n\\subsection*{6.2.3 End of treatment and follow-up period}","confidence":1,"confidence_rate":1},{"cnt":[[247,1316],[1802,1316],[1802,1364],[247,1364]],"region":{"top_left_x":246,"top_left_y":1315,"width":1557,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9377162e640a4f95a96d44ae19c5290a","type":"text","conversion_output":true,"text":"Patients who discontinue study drug should continue study visits until study end. Study","text_display":"\n\nPatients who discontinue study drug should continue study visits until study end. Study","confidence":1,"confidence_rate":1},{"cnt":[[247,1364],[1727,1364],[1727,1412],[247,1412]],"region":{"top_left_x":246,"top_left_y":1363,"width":1481,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65470b37df3e498c8cf6dc3925910371","type":"text","conversion_output":true,"text":"assessments may be omitted if a patient is willing to return to the pre-defined study","text_display":" assessments may be omitted if a patient is willing to return to the pre-defined study","confidence":1,"confidence_rate":1},{"cnt":[[247,1412],[619,1412],[619,1460],[247,1460]],"region":{"top_left_x":246,"top_left_y":1411,"width":374,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"433ad433dc184d658653ee0efe2cb22a","type":"text","conversion_output":true,"text":"visits, with exception","text_display":" visits, with exception","confidence":1,"confidence_rate":1},{"cnt":[[1074,1412],[1757,1412],[1757,1460],[1074,1460]],"region":{"top_left_x":1073,"top_left_y":1411,"width":684,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d6e61aab4f94c48a89e77e8be0ebb99","type":"text","conversion_output":true,"text":", collection of adverse events, outcome","text_display":" , collection of adverse events, outcome","confidence":1,"confidence_rate":1},{"cnt":[[247,1457],[1775,1457],[1775,1505],[247,1505]],"region":{"top_left_x":246,"top_left_y":1457,"width":1529,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c276e64a9be943d6821cdc50b94d3b9f","type":"text","conversion_output":true,"text":"events, concomitant therapy and laboratory testing of creatinine for the calculation of","text_display":" events, concomitant therapy and laboratory testing of creatinine for the calculation of","confidence":1,"confidence_rate":1},{"cnt":[[247,1508],[436,1508],[436,1547],[247,1547]],"region":{"top_left_x":246,"top_left_y":1507,"width":191,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fd1b574d6fd44eb8d0df212ff6bde6f","type":"text","conversion_output":true,"text":"the eGFR.","text_display":" the eGFR.","confidence":1,"confidence_rate":1},{"cnt":[[247,1597],[1818,1597],[1818,1642],[247,1642]],"region":{"top_left_x":246,"top_left_y":1596,"width":1573,"height":47},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"731626e60e79491e833fd37b77f5f566","type":"text","conversion_output":true,"text":"If a patient who discontinued study drug is not willing to return to the pre-defined study","text_display":"\n\nIf a patient who discontinued study drug is not willing to return to the pre-defined study","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[247,1645],[1786,1645],[1786,1693],[247,1693]],"region":{"top_left_x":246,"top_left_y":1644,"width":1541,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0ac47ba4366411f8852ecd770302f03","type":"text","conversion_output":true,"text":"visits, at minimum a yearly telephone call (preferably every 6 months) and a telephone","text_display":" visits, at minimum a yearly telephone call (preferably every 6 months) and a telephone","confidence":0.95166015625,"confidence_rate":0.9994730400979965},{"cnt":[[247,1695],[1757,1695],[1757,1738],[247,1738]],"region":{"top_left_x":246,"top_left_y":1695,"width":1511,"height":44},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7665fb902f814a9e9968c1eb68e99ca0","type":"text","conversion_output":true,"text":"call at study end will be required, to document the occurrence of outcome events and","text_display":" call at study end will be required, to document the occurrence of outcome events and","confidence":0.9985356330871582,"confidence_rate":0.9999835345159404},{"cnt":[[247,1741],[1729,1741],[1729,1789],[247,1789]],"region":{"top_left_x":246,"top_left_y":1740,"width":1484,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f3a6942423347e79d77570d7d00afa9","type":"text","conversion_output":true,"text":"vital status. If possible, other AE's and concomitant therapy changes since last visit","text_display":" vital status. If possible, other AE's and concomitant therapy changes since last visit","confidence":1,"confidence_rate":1},{"cnt":[[247,1786],[1770,1786],[1770,1834],[247,1834]],"region":{"top_left_x":246,"top_left_y":1786,"width":1525,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"46286e3737894adfb90e68ac5b5c33f8","type":"text","conversion_output":true,"text":"should be recorded. Every attempt will be made by the investigator to ensure patients","text_display":" should be recorded. Every attempt will be made by the investigator to ensure patients","confidence":1,"confidence_rate":1},{"cnt":[[247,1837],[1620,1837],[1620,1885],[247,1885]],"region":{"top_left_x":246,"top_left_y":1836,"width":1374,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d0c6e7f37614f268e65443bf7934c18","type":"text","conversion_output":true,"text":"continue participating in the study during study drug interruptions and after","text_display":" continue participating in the study during study drug interruptions and after","confidence":1,"confidence_rate":1},{"cnt":[[246,1885],[788,1883],[788,1930],[247,1933]],"region":{"top_left_x":246,"top_left_y":1882,"width":543,"height":51},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81ca08285de549b7af97c1da8adf149d","type":"text","conversion_output":true,"text":"discontinuation of study drug.","text_display":" discontinuation of study drug.","confidence":1,"confidence_rate":1},{"cnt":[[247,1974],[1777,1974],[1777,2022],[247,2022]],"region":{"top_left_x":246,"top_left_y":1973,"width":1532,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"577231b02c9a40389c23db1e4f35370c","type":"text","conversion_output":true,"text":"Patients that are not actively taking study drug may be less motivated to adhere to the","text_display":"\n\nPatients that are not actively taking study drug may be less motivated to adhere to the","confidence":1,"confidence_rate":1},{"cnt":[[247,2024],[1729,2024],[1729,2067],[247,2067]],"region":{"top_left_x":246,"top_left_y":2023,"width":1484,"height":45},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d03ca1791061482e803d6bd3a275aa8b","type":"text","conversion_output":true,"text":"study visit schedule. Investigators and site staff should work to detect early signs of","text_display":" study visit schedule. Investigators and site staff should work to detect early signs of","confidence":1,"confidence_rate":1},{"cnt":[[247,2070],[1759,2070],[1759,2118],[247,2118]],"region":{"top_left_x":246,"top_left_y":2069,"width":1513,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2defbce230f452898c54e4f0134473f","type":"text","conversion_output":true,"text":"losing interest and readily present such patients (not actively taking study drug) with","text_display":" losing interest and readily present such patients (not actively taking study drug) with","confidence":1,"confidence_rate":1},{"cnt":[[247,2120],[1732,2120],[1732,2163],[247,2163]],"region":{"top_left_x":246,"top_left_y":2119,"width":1486,"height":45},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b39d5ad3197421a9806f8a1630089fd","type":"text","conversion_output":true,"text":"options to encourage continued participation. Refer to section 3.3.4.1 for options to","text_display":" options to encourage continued participation. Refer to section 3.3.4.1 for options to","confidence":1,"confidence_rate":1},{"cnt":[[247,2166],[1757,2166],[1757,2214],[247,2214]],"region":{"top_left_x":246,"top_left_y":2165,"width":1511,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2c2a382a24a4699ac0936ac0f4b359e","type":"text","conversion_output":true,"text":"encourage continued participation and for details regarding patients who are lost-to-","text_display":" encourage continued participation and for details regarding patients who are lost-to-","confidence":1,"confidence_rate":1},{"cnt":[[247,2216],[1183,2216],[1183,2259],[247,2259]],"region":{"top_left_x":246,"top_left_y":2215,"width":938,"height":45},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b742b051b2714f449619d2ffce341541","type":"text","conversion_output":true,"text":"follow-up or who have withdrawn informed consent.","text_display":"follow-up or who have withdrawn informed consent.","confidence":0.99951171875,"confidence_rate":0.9999909555872323},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":43,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b095f98952cb4735b7aee84221e2c498","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"68b419d83b184250b2435b6af42ae844","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2668],[1766,2668],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1470,"height":35},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5a04aa19bb274e989242b976bca3ffb8","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-058","page":58,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f53d5e9d65904533bcce68d8b49492f8","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70b0d30f66674028b102cb69586bb705","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0c09cff2e0c4afd968291e93896f076","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71f30f50c14947f7b1f3a62086f41518","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60d340bd2b5d4602a2b0ff41096c96f0","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2aa8a52aeab64068b0e29066ba9bace5","type":"page_info","conversion_output":false,"text":"Page 58 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1812,338],[1812,388],[242,388]],"region":{"top_left_x":242,"top_left_y":338,"width":1570,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01099166f73b41f29951aea9cf86d8f9","type":"text","conversion_output":true,"text":"Patients whe discontinue study drug prematurely should continue study visits until study end.","text_display":"\n\nPatients whe discontinue study drug prematurely should continue study visits until study end.","confidence":0.69921875,"confidence_rate":0.9963557214720041},{"cnt":[[242,386],[1748,386],[1748,436],[242,436]],"region":{"top_left_x":242,"top_left_y":386,"width":1506,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"782b890055dc4dc9ac4e0dce0a114f5f","type":"text","conversion_output":true,"text":"Study assessments may be omitted if a patient is willing to return to the pre-defined study","text_display":" Study assessments may be omitted if a patient is willing to return to the pre-defined study","confidence":1,"confidence_rate":1},{"cnt":[[242,434],[1702,434],[1702,482],[242,482]],"region":{"top_left_x":242,"top_left_y":434,"width":1460,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e90e20af3804a9b88ac02baf83d0a08","type":"text","conversion_output":true,"text":"visits, with exception of ,collection of adverse events, outcome","text_display":" visits, with exception of ,collection of adverse events, outcome","confidence":0.99853515625,"confidence_rate":0.9999787550418731},{"cnt":[[242,482],[1738,482],[1738,532],[242,532]],"region":{"top_left_x":242,"top_left_y":482,"width":1497,"height":51},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4937e6a354b4bb1b7e96b515816d2d6","type":"text","conversion_output":true,"text":"events, concomitant therapy and laboratory testing of creatinine for the calculation of the","text_display":" events, concomitant therapy and laboratory testing of creatinine for the calculation of the","confidence":0.9859140591288451,"confidence_rate":0.9998522391541136},{"cnt":[[244,532],[363,532],[363,573],[244,573]],"region":{"top_left_x":244,"top_left_y":532,"width":120,"height":42},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87f1449a593a4715a3e78efb3f623ac8","type":"text","conversion_output":true,"text":"eGFR.","text_display":" eGFR.","confidence":1,"confidence_rate":1},{"cnt":[[242,617],[1704,617],[1704,669],[242,669]],"region":{"top_left_x":242,"top_left_y":616,"width":1463,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1f2499efeec4bf48275f8b02562429e","type":"text","conversion_output":true,"text":"If a patient who prematurely discontinued study drug is not willing to return to the pre-","text_display":"\n\nIf a patient who prematurely discontinued study drug is not willing to return to the pre","confidence":0.9677734375,"confidence_rate":0.9996515791034137},{"cnt":[[242,667],[1766,667],[1766,720],[242,720]],"region":{"top_left_x":242,"top_left_y":667,"width":1524,"height":53},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42e97c82f5434211aabd42756c3e7d26","type":"text","conversion_output":true,"text":"defined study visits, at minimum a yearly telephone call (preferably every 6 months) and a","text_display":"defined study visits, at minimum a yearly telephone call (preferably every 6 months) and a","confidence":0.9985356330871582,"confidence_rate":0.9999850466409257},{"cnt":[[242,717],[1770,717],[1770,765],[242,765]],"region":{"top_left_x":242,"top_left_y":717,"width":1529,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b8fd991ccf94e42aa8673752063dee1","type":"text","conversion_output":true,"text":"telephone call at study end will be required, to document the occurrence of outcome events","text_display":" telephone call at study end will be required, to document the occurrence of outcome events","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[242,763],[1716,763],[1716,816],[242,816]],"region":{"top_left_x":242,"top_left_y":762,"width":1474,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab04360ce4344315a3e7bacea7b17ad7","type":"text","conversion_output":true,"text":"and vital status. If possible, other AE 's and concomitant therapy changes since last visit","text_display":" and vital status. If possible, other AE 's and concomitant therapy changes since last visit","confidence":0.9695178299352847,"confidence_rate":0.9996965517986222},{"cnt":[[242,811],[1814,811],[1814,861],[242,861]],"region":{"top_left_x":242,"top_left_y":810,"width":1572,"height":52},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d2958cc193a41eeac470523c82f52e6","type":"text","conversion_output":true,"text":"might be recorded. Every attempt will be made by the investigator to ensure patients continue","text_display":" might be recorded. Every attempt will be made by the investigator to ensure patients continue","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[242,859],[1770,859],[1770,911],[242,911]],"region":{"top_left_x":242,"top_left_y":858,"width":1529,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97252974436241418bc3aaf0ac1efe63","type":"text","conversion_output":true,"text":"participating in the study during study drug interruptions and after discontinuation of study","text_display":" participating in the study during study drug interruptions and after discontinuation of study","confidence":1,"confidence_rate":1},{"cnt":[[242,909],[340,909],[340,957],[242,957]],"region":{"top_left_x":242,"top_left_y":909,"width":99,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d267e154eb2e4808a8b14dbfb8f68245","type":"text","conversion_output":true,"text":"drug.","text_display":" drug.","confidence":0.9965834617614746,"confidence_rate":0.9996578197637258},{"cnt":[[242,996],[1732,996],[1732,1049],[242,1049]],"region":{"top_left_x":242,"top_left_y":995,"width":1490,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55acd143aff0456f8994a30920e88d37","type":"text","conversion_output":true,"text":"All patients will have a follow up visit ene week \\(3 0\\) days following regular or premature","text_display":"\n\nAll patients will have a follow up visit ene week \\(3 0\\) days following regular or premature","confidence":0.7862892150878906,"confidence_rate":0.9975743547635219},{"cnt":[[242,1044],[1821,1044],[1821,1094],[242,1094]],"region":{"top_left_x":242,"top_left_y":1043,"width":1579,"height":52},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea7c9dff943a4a789ba1d499459352c6","type":"text","conversion_output":true,"text":"completion of the treatment period. The follow-up visit may be performed as a phone visit for","text_display":" completion of the treatment period. The follow-up visit may be performed as a phone visit for","confidence":1,"confidence_rate":1},{"cnt":[[242,1092],[1658,1092],[1658,1144],[242,1144]],"region":{"top_left_x":242,"top_left_y":1091,"width":1417,"height":54},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae9a8091fab241e8908130de837eebd4","type":"text","conversion_output":true,"text":"patients who did not prematurely discontinue study medication and who do not have","text_display":" patients who did not prematurely discontinue study medication and who do not have","confidence":1,"confidence_rate":1},{"cnt":[[242,1142],[1638,1142],[1638,1190],[242,1190]],"region":{"top_left_x":242,"top_left_y":1142,"width":1396,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e034ec6672894ca7b0a09e6578398dc4","type":"text","conversion_output":true,"text":"abnormalities at the EOT visit (only adverse events/outcome events and changes in","text_display":" abnormalities at the EOT visit (only adverse events/outcome events and changes in","confidence":1,"confidence_rate":1},{"cnt":[[242,1188],[863,1188],[863,1240],[242,1240]],"region":{"top_left_x":242,"top_left_y":1187,"width":622,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9257730a82e499aa3dbaef61a1ca02a","type":"text","conversion_output":true,"text":"concomitant therapy to be obtained).","text_display":" concomitant therapy to be obtained).","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":24,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"72155a61a50245dfbf61f1db8383c81a","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":25,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"95ab5a64005f4ac0adfa330bad8bff54","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":26,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"318cb5ab3e2e4718961af23604cdea90","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-059","page":59,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"930e5eb28f0545879be29391a1d3137b","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"007ca9674a4842db987c63f0b374dd66","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9f45e2ae95b4343a0dbc5249e3546b6","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01ef5affa4894ae3a82bc605bd5c7e6e","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7586a6dcd5f44f188e2b7c859bbb3e8","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73bbab74d2eb454ea2043f5cc331b769","type":"page_info","conversion_output":false,"text":"Page 59 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1638,338],[1638,448],[242,448]],"region":{"top_left_x":242,"top_left_y":338,"width":1396,"height":110},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8113faa8b0914b94ad57001336671c11","type":"section_header","conversion_output":false,"children_ids":["905637e797fe4935bcfb2ccf832a274b","788beb13841b4b259c9d003075d250f4"],"text":"","text_display":""},{"cnt":[[247,343],[1633,343],[1633,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":1388,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"905637e797fe4935bcfb2ccf832a274b","type":"text","conversion_output":true,"parent_id":"8113faa8b0914b94ad57001336671c11","text":"7. STATISTICAL METHODS AND DETERMINATION OF","text_display":"\n\n\\section*{7. STATISTICAL METHODS AND DETERMINATION OF","confidence":1,"confidence_rate":1},{"cnt":[[404,397],[733,397],[733,443],[404,443]],"region":{"top_left_x":404,"top_left_y":397,"width":330,"height":47},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"788beb13841b4b259c9d003075d250f4","type":"text","conversion_output":true,"parent_id":"8113faa8b0914b94ad57001336671c11","text":"SAMPLE SIZE","text_display":" SAMPLE SIZE}","confidence":1,"confidence_rate":1},{"cnt":[[242,489],[1055,489],[1055,541],[242,541]],"region":{"top_left_x":242,"top_left_y":488,"width":814,"height":54},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7020f3dc8fd646f381a74e3a0d2653b6","type":"section_header","conversion_output":false,"children_ids":["6bc81d610fe64cefa02d39f8da0a8e22"],"text":"","text_display":""},{"cnt":[[247,493],[1053,493],[1053,537],[247,537]],"region":{"top_left_x":246,"top_left_y":493,"width":808,"height":44},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6bc81d610fe64cefa02d39f8da0a8e22","type":"text","conversion_output":true,"parent_id":"7020f3dc8fd646f381a74e3a0d2653b6","text":"7.1 STATISTICAL DESIGN - MODEL","text_display":"\n\n\\subsection*{7.1 STATISTICAL DESIGN - MODEL}","confidence":1,"confidence_rate":1},{"cnt":[[242,580],[377,580],[377,635],[242,635]],"region":{"top_left_x":242,"top_left_y":580,"width":135,"height":56},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"617725df4aab4fea9d5f870cda05e992","type":"section_header","conversion_output":false,"children_ids":["1e680223c0e446e2b694f072301ae561"],"text":"","text_display":""},{"cnt":[[247,585],[372,585],[372,630],[247,630]],"region":{"top_left_x":246,"top_left_y":584,"width":127,"height":47},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1e680223c0e446e2b694f072301ae561","type":"text","conversion_output":true,"parent_id":"617725df4aab4fea9d5f870cda05e992","text":"Design","text_display":"\n\n\\section*{Design}","confidence":0.99755859375,"confidence_rate":0.9997778072937495},{"cnt":[[247,672],[1702,672],[1702,720],[247,720]],"region":{"top_left_x":246,"top_left_y":671,"width":1456,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3c1a26b57df64b0d9308d92a639db99c","type":"text","conversion_output":true,"text":"This is a multicentre, multinational, randomized, double blind, parallel group, placebo-","text_display":"\n\nThis is a multicentre, multinational, randomized, double blind, parallel group, placebo","confidence":1,"confidence_rate":1},{"cnt":[[247,720],[1748,720],[1748,770],[247,770]],"region":{"top_left_x":246,"top_left_y":719,"width":1502,"height":51},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8ac3494577c145d5a3408da25cbc21d6","type":"text","conversion_output":true,"text":"controlled safety study of linagliptin versus placebo. The trial is event driven and will run","text_display":"controlled safety study of linagliptin versus placebo. The trial is event driven and will run","confidence":1,"confidence_rate":1},{"cnt":[[247,768],[1812,768],[1812,816],[247,816]],"region":{"top_left_x":246,"top_left_y":767,"width":1566,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"879a72884e734295acd7ae05ac804d96","type":"text","conversion_output":true,"text":"with an estimated number of 83007000 randomized patients for an estimated period of 4854","text_display":" with an estimated number of 83007000 randomized patients for an estimated period of 4854","confidence":0.7812611013650894,"confidence_rate":0.9974049953001234},{"cnt":[[247,816],[1793,816],[1793,863],[247,863]],"region":{"top_left_x":246,"top_left_y":815,"width":1548,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9dfea2a8b67942b08140ebb7d29a1ae2","type":"text","conversion_output":true,"text":"months beginning with the randomization of the first patient. In case the number of events is","text_display":" months beginning with the randomization of the first patient. In case the number of events is","confidence":1,"confidence_rate":1},{"cnt":[[247,863],[1780,863],[1780,911],[247,911]],"region":{"top_left_x":246,"top_left_y":863,"width":1534,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8d866386c3ef4d249b04a35ef0296371","type":"text","conversion_output":true,"text":"not or may not be reached within this period the trial duration and/or the number of patients","text_display":" not or may not be reached within this period the trial duration and/or the number of patients","confidence":1,"confidence_rate":1},{"cnt":[[247,909],[1757,909],[1757,962],[247,962]],"region":{"top_left_x":246,"top_left_y":909,"width":1511,"height":53},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"77201d856f0a4fb2980d55562d248b2c","type":"text","conversion_output":true,"text":"will be prolonged or increased respectively, to ensure that the required number of \\(625 6 1 1\\)","text_display":" will be prolonged or increased respectively, to ensure that the required number of \\(625 6 1 1\\)","confidence":0.8403043746948242,"confidence_rate":0.9981892341063554},{"cnt":[[247,959],[1272,959],[1272,1007],[247,1007]],"region":{"top_left_x":246,"top_left_y":959,"width":1027,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"267ea3e797424be48250996ec1ceec7e","type":"text","conversion_output":true,"text":"patients with adjudicated primary endpoint events is reached.","text_display":" patients with adjudicated primary endpoint events is reached.","confidence":1,"confidence_rate":1},{"cnt":[[242,1046],[436,1046],[436,1099],[242,1099]],"region":{"top_left_x":242,"top_left_y":1046,"width":195,"height":53},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6b0ec0b1307e4d49b811e8a3e0912e10","type":"section_header","conversion_output":false,"children_ids":["d511896df24a4873b6e167da2331e733"],"text":"","text_display":""},{"cnt":[[247,1051],[432,1051],[432,1099],[247,1099]],"region":{"top_left_x":246,"top_left_y":1050,"width":186,"height":49},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d511896df24a4873b6e167da2331e733","type":"text","conversion_output":true,"parent_id":"6b0ec0b1307e4d49b811e8a3e0912e10","text":"Objectives","text_display":"\n\n\\section*{Objectives}","confidence":1,"confidence_rate":1},{"cnt":[[247,1138],[1081,1138],[1081,1190],[247,1190]],"region":{"top_left_x":246,"top_left_y":1137,"width":835,"height":54},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b722e10ab9394150bbbe2814e11c1d0c","type":"text","conversion_output":true,"text":"The study objectives are described in Section 2.2.","text_display":"\n\nThe study objectives are described in Section 2.2.","confidence":1,"confidence_rate":1},{"cnt":[[247,1229],[1775,1229],[1775,1277],[247,1277]],"region":{"top_left_x":246,"top_left_y":1228,"width":1529,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9479616fe5954c8aa4f317e77bb87953","type":"text","conversion_output":true,"text":"For the primary objective the upper bound of the two-sided ( \\(1-2^{*}\\) alpha) confidence interval","text_display":"\nFor the primary objective the upper bound of the two-sided ( \\(1-2^{*}\\) alpha) confidence interval","confidence":0.773945489898324,"confidence_rate":0.997607969826394},{"cnt":[[247,1275],[1780,1275],[1780,1325],[247,1325]],"region":{"top_left_x":246,"top_left_y":1274,"width":1534,"height":51},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"06f6f299c1934f60a08790504482a37f","type":"text","conversion_output":true,"text":"which equals the upper bound of the one-sided (1-alpha) confidence interval will be used to","text_display":" which equals the upper bound of the one-sided (1-alpha) confidence interval will be used to","confidence":0.97802734375,"confidence_rate":0.9997685929194416},{"cnt":[[247,1325],[1802,1325],[1802,1373],[247,1373]],"region":{"top_left_x":246,"top_left_y":1324,"width":1557,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cf5077e041964663b453a0a30f9ccb58","type":"text","conversion_output":true,"text":"investigate non-inferiority (NI) of linagliptin versus placebo regarding the hazard ratio of the","text_display":" investigate non-inferiority (NI) of linagliptin versus placebo regarding the hazard ratio of the","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[247,1373],[1793,1373],[1793,1421],[247,1421]],"region":{"top_left_x":246,"top_left_y":1372,"width":1548,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c18a45934eb240d299fdbabfc65037d0","type":"text","conversion_output":true,"text":"primary endpoint. The non-inferiority margin is chosen as 1.3 (FDA Guidance for Industry -","text_display":" primary endpoint. The non-inferiority margin is chosen as 1.3 (FDA Guidance for Industry ","confidence":0.9975595474243164,"confidence_rate":0.9999750672972136},{"cnt":[[247,1421],[1780,1421],[1780,1469],[247,1469]],"region":{"top_left_x":246,"top_left_y":1420,"width":1534,"height":49},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9170da828c9f4281ad868d875763a8cd","type":"text","conversion_output":true,"text":"Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat","text_display":"Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat","confidence":0.99853515625,"confidence_rate":0.9999844052526365},{"cnt":[[247,1467],[1574,1467],[1574,1519],[247,1519]],"region":{"top_left_x":246,"top_left_y":1466,"width":1328,"height":54},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"23671a56b7df48cea136f9de2afd0d00","type":"text","conversion_output":true,"text":"Type 2 Diabetes, (R09-2151). The overall one-sided significance level is \\(2.5 \\%\\).","text_display":" Type 2 Diabetes, (R09-2151). The overall one-sided significance level is \\(2.5 \\%\\).","confidence":0.8710373030044138,"confidence_rate":0.998467059763272},{"cnt":[[242,1553],[551,1553],[551,1610],[242,1610]],"region":{"top_left_x":242,"top_left_y":1553,"width":309,"height":58},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"73ea078a7707445385b9d5ce9617f31c","type":"section_header","conversion_output":false,"children_ids":["18328d74b7b14ae185fa2efa7ba5203d"],"text":"","text_display":""},{"cnt":[[247,1558],[546,1558],[546,1606],[247,1606]],"region":{"top_left_x":246,"top_left_y":1557,"width":300,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"18328d74b7b14ae185fa2efa7ba5203d","type":"text","conversion_output":true,"parent_id":"73ea078a7707445385b9d5ce9617f31c","text":"Primary endpoint","text_display":"\n\n\\section*{Primary endpoint}","confidence":1,"confidence_rate":1},{"cnt":[[247,1647],[1711,1647],[1711,1697],[247,1697]],"region":{"top_left_x":246,"top_left_y":1647,"width":1465,"height":51},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7a0b2b8a7a2d426bb0a530b8047e9d78","type":"text","conversion_output":true,"text":"The primary endpoint is time to the first occurrence of any of the following adjudicated","text_display":"\n\nThe primary endpoint is time to the first occurrence of any of the following adjudicated","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[247,1695],[1780,1695],[1780,1743],[247,1743]],"region":{"top_left_x":246,"top_left_y":1695,"width":1534,"height":48},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0956713e86794df695a98dce8cb282f3","type":"text","conversion_output":true,"text":"components of the composite endpoint ( \\(4 3\\)-point MACE): CV death (including fatal stroke,","text_display":" components of the composite endpoint ( \\(4 3\\)-point MACE): CV death (including fatal stroke,","confidence":0.8301526444388034,"confidence_rate":0.9981402745749428},{"cnt":[[247,1741],[1654,1741],[1654,1793],[247,1793]],"region":{"top_left_x":246,"top_left_y":1740,"width":1408,"height":54},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a8a7af23422c47d7a71a46f2c90c19bf","type":"text","conversion_output":true,"text":"fatal MI, and sudden death), non-fatal MI (excluding silent MI),or non-fatal stroke-","text_display":" fatal MI, and sudden death), non-fatal MI (excluding silent MI),or non-fatal stroke","confidence":0.48079514503479004,"confidence_rate":0.9918055122504815},{"cnt":[[247,1791],[975,1791],[975,1839],[247,1839]],"region":{"top_left_x":246,"top_left_y":1790,"width":730,"height":49},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2fa4d87f9f364b76bdc4607e03ca0e50","type":"text","conversion_output":true,"text":"hospitalisation for unstable angina pectoris.","text_display":"hospitalisation for unstable angina pectoris.","confidence":0.9990234375,"confidence_rate":0.9999804593979635},{"cnt":[[247,1878],[1663,1878],[1663,1930],[247,1930]],"region":{"top_left_x":246,"top_left_y":1877,"width":1418,"height":54},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"67318484f6a04b4fb40b32f36b61ada7","type":"text","conversion_output":true,"text":"Patients without occurrence of a specific endpoint (composite endpoint or individual","text_display":"\n\nPatients without occurrence of a specific endpoint (composite endpoint or individual","confidence":0.9990234375,"confidence_rate":0.9999890220866866},{"cnt":[[247,1928],[1656,1928],[1656,1976],[247,1976]],"region":{"top_left_x":246,"top_left_y":1928,"width":1411,"height":48},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a4d520fac4ad4487a61541bb88a66395","type":"text","conversion_output":true,"text":"components) will be considered censored at their last documented study visit. If any","text_display":" components) will be considered censored at their last documented study visit. If any","confidence":1,"confidence_rate":1},{"cnt":[[247,1976],[1816,1976],[1816,2026],[247,2026]],"region":{"top_left_x":246,"top_left_y":1975,"width":1571,"height":52},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6c6e17ef7d4f4527b00eed7cebbf1264","type":"text","conversion_output":true,"text":"measurement of laboratory data or ECG is available after the last visit of a patient, the date of","text_display":" measurement of laboratory data or ECG is available after the last visit of a patient, the date of","confidence":1,"confidence_rate":1},{"cnt":[[247,2024],[1610,2024],[1610,2072],[247,2072]],"region":{"top_left_x":246,"top_left_y":2023,"width":1365,"height":49},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"763e427052204a1494545ceb56af14b0","type":"text","conversion_output":true,"text":"the respective measurement will be used for censoring of the CV endpoint. If any","text_display":" the respective measurement will be used for censoring of the CV endpoint. If any","confidence":1,"confidence_rate":1},{"cnt":[[247,2072],[1766,2072],[1766,2122],[247,2122]],"region":{"top_left_x":246,"top_left_y":2071,"width":1520,"height":52},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a5765c69a7504af1a18685a6019c9660","type":"text","conversion_output":true,"text":"measurement of eGFR is available after the last visit of a patient, the date of the respective","text_display":" measurement of eGFR is available after the last visit of a patient, the date of the respective","confidence":0.9833984375,"confidence_rate":0.9998309141665112},{"cnt":[[247,2120],[1807,2120],[1807,2168],[247,2168]],"region":{"top_left_x":246,"top_left_y":2119,"width":1561,"height":49},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6e189e916553416a863583908bb86139","type":"text","conversion_output":true,"text":"measurement will be used for censoring of the renal endpoint. For all endpoints including the","text_display":" measurement will be used for censoring of the renal endpoint. For all endpoints including the","confidence":1,"confidence_rate":1},{"cnt":[[247,2166],[1782,2166],[1782,2218],[247,2218]],"region":{"top_left_x":246,"top_left_y":2165,"width":1536,"height":54},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fa32d44c2bd340c5b0438ee355204bf0","type":"text","conversion_output":true,"text":"component CV (renal) death, adjudicated CV (renal) death will be counted even if occurred","text_display":" component CV (renal) death, adjudicated CV (renal) death will be counted even if occurred","confidence":1,"confidence_rate":1},{"cnt":[[247,2216],[423,2216],[423,2259],[247,2259]],"region":{"top_left_x":246,"top_left_y":2215,"width":177,"height":45},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f6a210d9aed946b694109758edcb8d63","type":"text","conversion_output":true,"text":"thereafter.","text_display":" thereafter.","confidence":1,"confidence_rate":1},{"cnt":[[242,2353],[1204,2353],[1204,2401],[242,2401]],"region":{"top_left_x":242,"top_left_y":2352,"width":962,"height":49},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5b0b003ab55f47cf8778ba6c503e890a","type":"section_header","conversion_output":false,"children_ids":["80abdc659c4248d08b021acd42eae8fa"],"text":"","text_display":""},{"cnt":[[247,2353],[1199,2353],[1199,2396],[247,2396]],"region":{"top_left_x":246,"top_left_y":2352,"width":954,"height":45},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"80abdc659c4248d08b021acd42eae8fa","type":"text","conversion_output":true,"parent_id":"5b0b003ab55f47cf8778ba6c503e890a","text":"7.2 NULL AND ALTERNATIVE HYPOTHESES","text_display":"\n\n\\subsection*{7.2 NULL AND ALTERNATIVE HYPOTHESES}","confidence":1,"confidence_rate":1},{"cnt":[[247,2447],[1805,2447],[1805,2492],[247,2492]],"region":{"top_left_x":246,"top_left_y":2446,"width":1559,"height":47},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7e7d54cfa21a42298a2efd48cb92159c","type":"text","conversion_output":true,"text":"An interim analysis will be performed at the one-sided alpha-level of \\(1.0 \\%\\), the final analysis","text_display":"\n\nAn interim analysis will be performed at the one-sided alpha-level of \\(1.0 \\%\\), the final analysis","confidence":0.7702974462881684,"confidence_rate":0.9974694350115052},{"cnt":[[247,2490],[1812,2490],[1812,2538],[247,2538]],"region":{"top_left_x":246,"top_left_y":2489,"width":1566,"height":49},"line":47,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"240f090058484c78bddfb642b6408d26","type":"text","conversion_output":true,"text":"at the one-sided alpha-level of \\(2.12 \\%\\). At the interim analysis MACE endpoints will be tested","text_display":" at the one-sided alpha-level of \\(2.12 \\%\\). At the interim analysis MACE endpoints will be tested","confidence":0.9722065925598145,"confidence_rate":0.9997209601931071},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"23a7d72e700e41339f58d0acd9efd32f","type":"section_header","conversion_output":false,"children_ids":["97c76c3e719842cf924d39594500f63c"],"text":"","text_display":""},{"cnt":[[795,2586],[1300,2586],[1300,2620],[795,2620]],"region":{"top_left_x":794,"top_left_y":2585,"width":506,"height":36},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"97c76c3e719842cf924d39594500f63c","type":"text","conversion_output":true,"parent_id":"23a7d72e700e41339f58d0acd9efd32f","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":1,"confidence_rate":1},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":50,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3dc5c94da6d14ef19190b47425881230","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":51,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"312de0e580374338bd9f6393c059cc3d","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-060","page":60,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6285dc3b5b2e4f7582348f3d0dd794bd","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ed90df494be4a079ea6d69deca31469","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a6cd074e8ee4c7fbd7c0743f557060d","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"474d2cdf69a741aea7988ed430d6a8db","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f33b429171604191a5dff19bd77ad426","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44e24e81d67049cab6c02f70077d8f6b","type":"page_info","conversion_output":false,"text":"Page 60 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1789,338],[1789,386],[244,386]],"region":{"top_left_x":244,"top_left_y":338,"width":1545,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed575ba627ac4b5588a678b5aa4fc96a","type":"text","conversion_output":true,"text":"in a pre-specified order, at the final analysis also the composite renal endpoint will be tested","text_display":"\nin a pre-specified order, at the final analysis also the composite renal endpoint will be tested","confidence":1,"confidence_rate":1},{"cnt":[[244,388],[1757,388],[1757,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1513,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee57cac4b3d449d4855d94814f6732e5","type":"text","conversion_output":true,"text":"for superiority. The experimentwise (multiple) level alpha is controlled with the following","text_display":" for superiority. The experimentwise (multiple) level alpha is controlled with the following","confidence":1,"confidence_rate":1},{"cnt":[[244,434],[1638,434],[1638,482],[244,482]],"region":{"top_left_x":244,"top_left_y":434,"width":1394,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ae1129121594752af0f2c3ebd6273f4","type":"text","conversion_output":true,"text":"three step gatekeeping hierarchy within the interim and final analysis, respectively.","text_display":" three step gatekeeping hierarchy within the interim and final analysis, respectively.","confidence":1,"confidence_rate":1},{"cnt":[[247,525],[1793,525],[1793,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1548,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20239a98b8dd445aaefe5390c3c6ef24","type":"text","conversion_output":true,"text":"No confirmatory interim analysis for efficacy endpoints will be performed. For the final","text_display":"\n\nNo confirmatory interim analysis for efficacy endpoints will be performed. For the final","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[247,571],[1748,571],[1748,619],[247,619]],"region":{"top_left_x":246,"top_left_y":571,"width":1502,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f7c4e7f22354eb4b7ef5cb2b78e765a","type":"text","conversion_output":true,"text":"analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the","text_display":" analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the","confidence":1,"confidence_rate":1},{"cnt":[[247,617],[1789,617],[1789,669],[247,669]],"region":{"top_left_x":246,"top_left_y":616,"width":1543,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"875288a314ad41eea4ff998939c9ab3a","type":"text","conversion_output":true,"text":"one-sided alpha-level of \\(2.12 \\% 2 . 5 \\%\\). In case of significance, the null hypothesis is rejected","text_display":" one-sided alpha-level of \\(2.12 \\% 2 . 5 \\%\\). In case of significance, the null hypothesis is rejected","confidence":0.42064014420247986,"confidence_rate":0.991707863554052},{"cnt":[[247,667],[1800,667],[1800,717],[247,717]],"region":{"top_left_x":246,"top_left_y":667,"width":1555,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a56cfd2ae90840baab20118f6dea9eba","type":"text","conversion_output":true,"text":"in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be","text_display":" in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be","confidence":1,"confidence_rate":1},{"cnt":[[244,717],[1693,717],[1693,765],[244,765]],"region":{"top_left_x":244,"top_left_y":717,"width":1449,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fb1049405d74241b3c711cac955f330","type":"text","conversion_output":true,"text":"tested: a) test of the primary endpoint for superiority and b) test of the composite renal","text_display":" tested: a) test of the primary endpoint for superiority and b) test of the composite renal","confidence":0.9775879383087158,"confidence_rate":0.9997614281606321},{"cnt":[[247,763],[1748,763],[1748,811],[247,811]],"region":{"top_left_x":246,"top_left_y":762,"width":1502,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61e9cb034d2e4625bdadd22735b4e15a","type":"text","conversion_output":true,"text":"endpoint for superiority. To adjust for multiplicity the truncated Hochberg a sequentially","text_display":" endpoint for superiority. To adjust for multiplicity the truncated Hochberg a sequentially","confidence":0.9058074951171875,"confidence_rate":0.9989591896685526},{"cnt":[[247,813],[1766,813],[1766,861],[247,861]],"region":{"top_left_x":246,"top_left_y":813,"width":1520,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c162185b906846478382726499359af2","type":"text","conversion_output":true,"text":"rejective multiple test procedure will be applied ( \\(R 1 6 - 4 4 7 3\\) ) with a selected gamma of 0.5","text_display":" rejective multiple test procedure will be applied ( \\(R 1 6 - 4 4 7 3\\) ) with a selected gamma of 0.5","confidence":0.9402983708469783,"confidence_rate":0.9993907001709599},{"cnt":[[247,859],[1782,859],[1782,911],[247,911]],"region":{"top_left_x":246,"top_left_y":858,"width":1536,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b844baa652334219af787a455638de88","type":"text","conversion_output":true,"text":"(R12-4087). Both one-sided hypotheses \\(H _{0(\\text { Sup1 })}\\) and \\(H _{0(\\text { Sup2 })}\\) will be tested separately, at the","text_display":" (R12-4087). Both one-sided hypotheses \\(H _{0(\\text { Sup1 })}\\) and \\(H _{0(\\text { Sup2 })}\\) will be tested separately, at the","confidence":0.91705017244606,"confidence_rate":0.9993539916298776},{"cnt":[[247,909],[1725,909],[1725,957],[247,957]],"region":{"top_left_x":246,"top_left_y":909,"width":1479,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5084f849bd547a6a5a2fee7060821ab","type":"text","conversion_output":true,"text":"initial alpha-levels of 0.2*alpha for 3-point MACE and 0.8*alpha for the composite","text_display":" initial alpha-levels of 0.2*alpha for 3-point MACE and 0.8*alpha for the composite","confidence":0.9453904628753662,"confidence_rate":0.9993547226649405},{"cnt":[[247,955],[1770,955],[1770,1007],[247,1007]],"region":{"top_left_x":246,"top_left_y":954,"width":1525,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1dca749ac4ce48e68069546967a1fd77","type":"text","conversion_output":true,"text":"renal endpoint, respectively. If both null hypotheses cannot be rejected at these initial","text_display":" renal endpoint, respectively. If both null hypotheses cannot be rejected at these initial","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[247,1005],[1734,1005],[1734,1053],[247,1053]],"region":{"top_left_x":246,"top_left_y":1005,"width":1488,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70dc956837774d538971533249a6ace1","type":"text","conversion_output":true,"text":"alpha-levels, the procedure stops and for none of these endpoints superiority can be","text_display":" alpha-levels, the procedure stops and for none of these endpoints superiority can be","confidence":1,"confidence_rate":1},{"cnt":[[247,1053],[1802,1053],[1802,1101],[247,1101]],"region":{"top_left_x":246,"top_left_y":1053,"width":1557,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cafe718267d48c6a801fac3c5296b5e","type":"text","conversion_output":true,"text":"declared. After having shown superiority for one of these endpoints, the used alpha can","text_display":" declared. After having shown superiority for one of these endpoints, the used alpha can","confidence":1,"confidence_rate":1},{"cnt":[[247,1101],[1764,1101],[1764,1149],[247,1149]],"region":{"top_left_x":246,"top_left_y":1101,"width":1518,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"950545a2468840a8ac2be8e56c3bbcb2","type":"text","conversion_output":true,"text":"be shuffled to the other test: If \\(H _{0(\\text { Sup2 })}\\) is rejected at the alpha-level of \\(0 . 8\\) *alpha, then","text_display":" be shuffled to the other test: If \\(H _{0(\\text { Sup2 })}\\) is rejected at the alpha-level of \\(0 . 8\\) *alpha, then","confidence":0.12419500036392846,"confidence_rate":0.983047773452948},{"cnt":[[247,1147],[1786,1147],[1786,1197],[247,1197]],"region":{"top_left_x":246,"top_left_y":1146,"width":1541,"height":52},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1669d24d6a7c425fa8da6c533d1b791a","type":"text","conversion_output":true,"text":"\\(H _{0 \\text { (Sup1) }}\\) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided). If \\(H _{0 \\text { (Sup1) }}\\) is rejected at","text_display":" \\(H _{0 \\text { (Sup1) }}\\) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided). If \\(H _{0 \\text { (Sup1) }}\\) is rejected at","confidence":0.3325867854920135,"confidence_rate":0.9918183219444093},{"cnt":[[247,1197],[1752,1197],[1752,1245],[247,1245]],"region":{"top_left_x":246,"top_left_y":1197,"width":1507,"height":48},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec1aa43affb94033977090b2eab3a998","type":"text","conversion_output":true,"text":"the alpha-level of \\(0 . 2 { }^{*}\\) alpha, then \\(H _{ 0 ( S u p 2 ) }\\) can be tested at the full alpha-level of 2.5\\%","text_display":" the alpha-level of \\(0 . 2 { }^{*}\\) alpha, then \\(H _{ 0 ( S u p 2 ) }\\) can be tested at the full alpha-level of 2.5\\%","confidence":0.11801027293478658,"confidence_rate":0.9829139127566474},{"cnt":[[247,1243],[1647,1243],[1647,1291],[247,1291]],"region":{"top_left_x":246,"top_left_y":1242,"width":1402,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f598c803c4240c293ace6cca06e96a7","type":"text","conversion_output":true,"text":"(one-sided). If both tests are significant at the one-sided alpha-level of \\(1.59 \\%\\) each,","text_display":" (one-sided). If both tests are significant at the one-sided alpha-level of \\(1.59 \\%\\) each,","confidence":0.8536569429708152,"confidence_rate":0.998318161919721},{"cnt":[[247,1293],[1684,1293],[1684,1341],[247,1341]],"region":{"top_left_x":246,"top_left_y":1292,"width":1438,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cef2fadbe6d24549ae935e1c53126ea2","type":"text","conversion_output":true,"text":"superiority of both endpoints (4 point MACE and composite renal endpoint) has been","text_display":" superiority of both endpoints (4 point MACE and composite renal endpoint) has been","confidence":0.7121918932534754,"confidence_rate":0.9961063598258426},{"cnt":[[247,1339],[1816,1339],[1816,1387],[247,1387]],"region":{"top_left_x":246,"top_left_y":1338,"width":1571,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b409c6f248ba431c8ac98cf104435d89","type":"text","conversion_output":true,"text":"demonstrated. If not, superiority can only be claimed for the endpoint significant at the alpha-","text_display":" demonstrated. If not, superiority can only be claimed for the endpoint significant at the alpha","confidence":1,"confidence_rate":1},{"cnt":[[247,1384],[1766,1384],[1766,1437],[247,1437]],"region":{"top_left_x":246,"top_left_y":1384,"width":1520,"height":53},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c9c90ce2c5143dd8b4c85ea176aad81","type":"text","conversion_output":true,"text":"level of \\(1.06 \\%\\). If superiority of both, the 4 point MACE and the composite renal endpoint","text_display":"level of \\(1.06 \\%\\). If superiority of both, the 4 point MACE and the composite renal endpoint","confidence":0.9719046304719541,"confidence_rate":0.999717885384647},{"cnt":[[244,1435],[1789,1435],[1789,1483],[244,1483]],"region":{"top_left_x":244,"top_left_y":1434,"width":1545,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a89e40b3817841379546b2706a239727","type":"text","conversion_output":true,"text":"has been demonstrated at the one-sided alpha-level of \\(1.59 \\%\\) each, then superiority of the 3 -","text_display":" has been demonstrated at the one-sided alpha-level of \\(1.59 \\%\\) each, then superiority of the 3 ","confidence":0.6968942974208403,"confidence_rate":0.996533699103892},{"cnt":[[244,1483],[1738,1483],[1738,1533],[244,1533]],"region":{"top_left_x":244,"top_left_y":1482,"width":1495,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"286938c25eb34ef1a89c261ede4fbdc4","type":"text","conversion_output":true,"text":"point MACE can be tested at the alpha level of \\(2.12 \\%\\). If superiority of only one of these","text_display":"point MACE can be tested at the alpha level of \\(2.12 \\%\\). If superiority of only one of these","confidence":0.9052320845222539,"confidence_rate":0.9989845575316664},{"cnt":[[247,1531],[1761,1531],[1761,1579],[247,1579]],"region":{"top_left_x":246,"top_left_y":1530,"width":1516,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0066a403e040409c9674cfd2fcfd4899","type":"text","conversion_output":true,"text":"endpoints (4-point MACE or composite renal endpoint) has been demonstrated at the one-","text_display":" endpoints (4-point MACE or composite renal endpoint) has been demonstrated at the one","confidence":0.9455480575561523,"confidence_rate":0.9993849083177978},{"cnt":[[247,1581],[1793,1581],[1793,1629],[247,1629]],"region":{"top_left_x":246,"top_left_y":1580,"width":1548,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48564e79e75f4c33a36df5897e93bb1d","type":"text","conversion_output":true,"text":"sided alpha-level of \\(1.06 \\%\\), then superiority of the 3 -point MACE can be tested at the alpha-","text_display":"sided alpha-level of \\(1.06 \\%\\), then superiority of the 3 -point MACE can be tested at the alpha","confidence":0.7659467733465135,"confidence_rate":0.9974637683681876},{"cnt":[[247,1626],[509,1626],[509,1670],[247,1670]],"region":{"top_left_x":246,"top_left_y":1626,"width":264,"height":44},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"947a4e5bdc374d85a8ea2633ac496006","type":"text","conversion_output":true,"text":"level of \\(0.53 \\%\\).","text_display":"level of \\(0.53 \\%\\).","confidence":0.90478515625,"confidence_rate":0.9958396051934694},{"cnt":[[247,1718],[1729,1718],[1729,1766],[247,1766]],"region":{"top_left_x":246,"top_left_y":1717,"width":1484,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d91245567e448b3bb84cb70e96616e5","type":"text","conversion_output":true,"text":"At the interim analysis superiority of the composite renal endpoint will not be tested and","text_display":"\n\nAt the interim analysis superiority of the composite renal endpoint will not be tested and","confidence":1,"confidence_rate":1},{"cnt":[[247,1764],[1802,1764],[1802,1812],[247,1812]],"region":{"top_left_x":246,"top_left_y":1763,"width":1557,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61709cc9189e4c7e8cd2fb51ed141f30","type":"text","conversion_output":true,"text":"therefore all tests on MACE can be performed in the pre-specified order at the alpha-level of","text_display":" therefore all tests on MACE can be performed in the pre-specified order at the alpha-level of","confidence":0.9970703125,"confidence_rate":0.999970061800863},{"cnt":[[247,1814],[350,1814],[350,1853],[247,1853]],"region":{"top_left_x":246,"top_left_y":1813,"width":104,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"085196064f384ea18fcb7ea0fbe0006e","type":"text","conversion_output":true,"text":"1.0\\%.","text_display":" 1.0\\%.","confidence":0.9565844535827637,"confidence_rate":0.9955712161541844},{"cnt":[[247,1903],[1713,1903],[1713,1951],[247,1951]],"region":{"top_left_x":246,"top_left_y":1902,"width":1468,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ec087f686dd4727b573211f8cd75632","type":"text","conversion_output":true,"text":"If a step is not significant, all subsequent steps may not be interpreted in a confirmatory","text_display":"\n\nIf a step is not significant, all subsequent steps may not be interpreted in a confirmatory","confidence":0.9838943481445312,"confidence_rate":0.9998308814118876},{"cnt":[[247,1951],[939,1951],[939,1999],[247,1999]],"region":{"top_left_x":246,"top_left_y":1950,"width":693,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"53277dd5fad9414d8daf76b33511f5af","type":"text","conversion_output":true,"text":"sense. The sequence of tests is as follows:","text_display":" sense. The sequence of tests is as follows:","confidence":0.903901792713441,"confidence_rate":0.9978973270356982},{"cnt":[[249,2033],[381,2033],[381,2086],[249,2086]],"region":{"top_left_x":248,"top_left_y":2033,"width":134,"height":53},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"469b0b5d2f2647109abc00a20f1f2be2","type":"text","conversion_output":true,"text":"\\(1^{\\text {st }}\\) step:","text_display":"\n\\(1^{\\text {st }}\\) step:","confidence":0.9921875,"confidence_rate":0.9996863221087591},{"cnt":[[247,2129],[1656,2129],[1656,2177],[247,2177]],"region":{"top_left_x":246,"top_left_y":2129,"width":1411,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b463a253f4424aaab2d65243b99ffef5","type":"text","conversion_output":true,"text":"The primary endpoint ( \\(4\\) 3-point MACE) is time to the first occurrence of any of the","text_display":"\nThe primary endpoint ( \\(4\\) 3-point MACE) is time to the first occurrence of any of the","confidence":0.9059127883731987,"confidence_rate":0.9989604119291517},{"cnt":[[247,2177],[1722,2177],[1722,2225],[247,2225]],"region":{"top_left_x":246,"top_left_y":2177,"width":1477,"height":48},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5becaad5bae34bd2a5307ccc3e3265ad","type":"text","conversion_output":true,"text":"following adjudicated components of the composite endpoint: CV death (including fatal","text_display":" following adjudicated components of the composite endpoint: CV death (including fatal","confidence":0.99365234375,"confidence_rate":0.9999292481887752},{"cnt":[[247,2225],[1725,2225],[1725,2273],[247,2273]],"region":{"top_left_x":246,"top_left_y":2224,"width":1479,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0161f7def12943cd952f4de78c85cebf","type":"text","conversion_output":true,"text":"stroke, fatal MI, and sudden death), non-fatal MI, or non-fatal stroke, hospitalisation for","text_display":" stroke, fatal MI, and sudden death), non-fatal MI, or non-fatal stroke, hospitalisation for","confidence":0.8324779570102692,"confidence_rate":0.9980919420827908},{"cnt":[[247,2275],[665,2275],[665,2323],[247,2323]],"region":{"top_left_x":246,"top_left_y":2275,"width":419,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"309e1fdb7cf94a7686c5da82a339154d","type":"text","conversion_output":true,"text":"unstable angina pectoris.","text_display":" unstable angina pectoris.","confidence":1,"confidence_rate":1},{"cnt":[[247,2362],[758,2362],[758,2415],[247,2415]],"region":{"top_left_x":246,"top_left_y":2362,"width":513,"height":53},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c061f4c86e344b4394f99c839ee06097","type":"text","conversion_output":true,"text":"\\(H _{0( NI )}: HR _{\\text {linagliptin vs. placebo }} \\geq 1.3\\)","text_display":"\n\\(H _{0( NI )}: HR _{\\text {linagliptin vs. placebo }} \\geq 1.3\\)","confidence":0.998535871389322,"confidence_rate":0.9999771064887115},{"cnt":[[247,2453],[1775,2453],[1775,2501],[247,2501]],"region":{"top_left_x":246,"top_left_y":2453,"width":1529,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70197f9d36674f26bd2eff589cc0ed74","type":"text","conversion_output":true,"text":"(Interpretation of \\(H _{0( NI )}\\) : Regarding the time to first occurrence of the primary endpoint, the","text_display":"\n(Interpretation of \\(H _{0( NI )}\\) : Regarding the time to first occurrence of the primary endpoint, the","confidence":0.9936649716709098,"confidence_rate":0.9999452154682033},{"cnt":[[247,2499],[1821,2499],[1821,2547],[247,2547]],"region":{"top_left_x":246,"top_left_y":2499,"width":1575,"height":49},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78dacaabe279436abf2978c378580dcf","type":"text","conversion_output":true,"text":"risk (expressed as hazard ratio (HR)) for linagliptin relative to placebo is at least \\(30 \\%\\) higher.)","text_display":" risk (expressed as hazard ratio (HR)) for linagliptin relative to placebo is at least \\(30 \\%\\) higher.)","confidence":0.9795200824737549,"confidence_rate":0.9998048064204162},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9dbc8ba2c51945f7bd6d48a3820542b6","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e7ace19975034eec96ac438902d6af31","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c0910d8ee90a434aa574b0d7b7ca8b52","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-061","page":61,"lines":[{"cnt":[[244,119],[610,119],[610,167],[244,167]],"region":{"top_left_x":244,"top_left_y":118,"width":366,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b56e88b18338497a886ab5533b240691","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74ded53a27ac4e749563da399cd89004","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79564e413514407b9325cc4ae810c9c7","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7ae19edc2b94c9aacc469142590b1c0","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b37357faea140b196bd893882908f4b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40574dce10e04e6781dfdb44102a43ae","type":"page_info","conversion_output":false,"text":"Page 61 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[240,347],[302,347],[302,384],[240,384]],"region":{"top_left_x":239,"top_left_y":347,"width":63,"height":37},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3a91a79033f403296978c885cb86672","type":"text","conversion_output":true,"text":"vs.","text_display":"\nvs.","confidence":1,"confidence_rate":1},{"cnt":[[244,429],[765,429],[765,477],[244,477]],"region":{"top_left_x":244,"top_left_y":429,"width":522,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c2f065f98b04c13a4ebf6c70aefcb2e","type":"text","conversion_output":true,"text":"\\(H _{1( NI )}: HR _{\\text {linagliptin vs. placebo }}<1.3\\)","text_display":"\n\\(H _{1( NI )}: HR _{\\text {linagliptin vs. placebo }}<1.3\\)","confidence":0.9873256683349609,"confidence_rate":0.9998007177314345},{"cnt":[[247,516],[1805,516],[1805,569],[247,569]],"region":{"top_left_x":246,"top_left_y":516,"width":1559,"height":53},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3c6f1c9596d4d3e89a79b6fd846bbc3","type":"text","conversion_output":true,"text":"\\(\\left( H _{1( NI )}\\right)\\) : Regarding the time to first occurrence of the primary endpoint, the risk for linagliptin","text_display":"\n\\(\\left( H _{1( NI )}\\right)\\) : Regarding the time to first occurrence of the primary endpoint, the risk for linagliptin","confidence":0.379523432260612,"confidence_rate":0.9916827217330486},{"cnt":[[244,567],[1766,567],[1766,614],[244,614]],"region":{"top_left_x":244,"top_left_y":566,"width":1522,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c41a1e2b7eb245668eb3fdd7843d99cb","type":"text","conversion_output":true,"text":"relative to placebo is less than \\(30 \\%\\) higher, i.e. linagliptin can be regarded as non-inferior.)","text_display":" relative to placebo is less than \\(30 \\%\\) higher, i.e. linagliptin can be regarded as non-inferior.)","confidence":0.9829915780574083,"confidence_rate":0.9998334631264426},{"cnt":[[244,649],[391,649],[391,706],[244,706]],"region":{"top_left_x":244,"top_left_y":648,"width":147,"height":58},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03b38b9cd4e74c0f931871cfbb94c5cc","type":"text","conversion_output":true,"text":"\\(2^{\\text {nd }}\\) step:","text_display":"\n\\(2^{\\text {nd }}\\) step:","confidence":1,"confidence_rate":1},{"cnt":[[247,740],[1761,740],[1761,793],[247,793]],"region":{"top_left_x":246,"top_left_y":740,"width":1516,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fea4b225a72144dd87e61cfe80330ed9","type":"text","conversion_output":true,"text":"If the null hypothesis of non-inferiority ( \\(1^{\\text {st }}\\) step) can be rejected, then in a second step two","text_display":"\nIf the null hypothesis of non-inferiority ( \\(1^{\\text {st }}\\) step) can be rejected, then in a second step two","confidence":0.9941477742982556,"confidence_rate":0.9999494028569814},{"cnt":[[247,795],[1451,795],[1451,843],[247,843]],"region":{"top_left_x":246,"top_left_y":794,"width":1205,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90a29510ce0c404d9ece90fe2f44c0dd","type":"text","conversion_output":true,"text":"confirmatory tests on superiority will be performed at the final analysis:","text_display":" confirmatory tests on superiority will be performed at the final analysis:","confidence":0.986328125,"confidence_rate":0.9998257595390485},{"cnt":[[306,845],[1489,845],[1489,893],[306,893]],"region":{"top_left_x":306,"top_left_y":845,"width":1184,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73fbb432d068468ebfe47bc0244e9078","type":"text","conversion_output":true,"text":"- time to first occurrence of the primary endpoint (4 3-point MACE)","text_display":"\n- time to first occurrence of the primary endpoint (4 3-point MACE)","confidence":0.9805799299465434,"confidence_rate":0.9997276604648963},{"cnt":[[306,895],[1304,895],[1304,943],[306,943]],"region":{"top_left_x":306,"top_left_y":895,"width":999,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d5e8279764a4205ab4b3e206fcd51eb","type":"text","conversion_output":true,"text":"- time to first occurrence of the composite renal endpoint","text_display":"\n- time to first occurrence of the composite renal endpoint","confidence":1,"confidence_rate":1},{"cnt":[[244,941],[1770,941],[1770,994],[244,994]],"region":{"top_left_x":244,"top_left_y":941,"width":1527,"height":53},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"844c3d1426524fb682312ec598554390","type":"text","conversion_output":true,"text":"At the interim analysis superiority of the composite renal endpoint (i.e. \\(H _{0( Sup 2)}\\) ) will not be","text_display":"\n\nAt the interim analysis superiority of the composite renal endpoint (i.e. \\(H _{0( Sup 2)}\\) ) will not be","confidence":0.7691850250774793,"confidence_rate":0.9977595756113189},{"cnt":[[247,991],[361,991],[361,1035],[247,1035]],"region":{"top_left_x":246,"top_left_y":991,"width":115,"height":44},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"752a4cffb7c042778d21a7c911e54dd9","type":"text","conversion_output":true,"text":"tested.","text_display":" tested.","confidence":1,"confidence_rate":1},{"cnt":[[247,1081],[756,1081],[756,1131],[247,1131]],"region":{"top_left_x":246,"top_left_y":1080,"width":511,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c73136ff9f5473a9a76ae79020bad3a","type":"text","conversion_output":true,"text":"\\(H _{0(\\text { Supl })}: HR _{\\text {linagliptin vs. placebo }} \\geq 1\\)","text_display":"\n\\(H _{0(\\text { Supl })}: HR _{\\text {linagliptin vs. placebo }} \\geq 1\\)","confidence":0.28583234635880217,"confidence_rate":0.9812038943885475},{"cnt":[[247,1170],[1652,1170],[1652,1220],[247,1220]],"region":{"top_left_x":246,"top_left_y":1169,"width":1406,"height":51},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a27e96aaf88b440f96764fbdcbf99112","type":"text","conversion_output":true,"text":"( \\(H _{0(\\text { Sup } 1)}\\) : Regarding the time to first occurrence of the primary endpoint, the risk for","text_display":"\n( \\(H _{0(\\text { Sup } 1)}\\) : Regarding the time to first occurrence of the primary endpoint, the risk for","confidence":0.28552850633390015,"confidence_rate":0.988871197287864},{"cnt":[[247,1220],[921,1220],[921,1268],[247,1268]],"region":{"top_left_x":246,"top_left_y":1219,"width":675,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc2c49e4fcdd44069a39338ff72a25c3","type":"text","conversion_output":true,"text":"linagliptin relative to placebo is higher.)","text_display":" linagliptin relative to placebo is higher.)","confidence":1,"confidence_rate":1},{"cnt":[[240,1316],[302,1316],[302,1352],[240,1352]],"region":{"top_left_x":239,"top_left_y":1315,"width":63,"height":38},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6afdf096779a41e0a0f893f21362f45c","type":"text","conversion_output":true,"text":"vs.","text_display":"\nvs.","confidence":1,"confidence_rate":1},{"cnt":[[247,1398],[752,1398],[752,1446],[247,1446]],"region":{"top_left_x":246,"top_left_y":1398,"width":506,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecce2ba547f74311b5368207e980ee73","type":"text","conversion_output":true,"text":"\\(H _{1(\\text { Supl })}: HR _{\\text {linagliptin vs. placebo }}<1\\)","text_display":"\n\\(H _{1(\\text { Supl })}: HR _{\\text {linagliptin vs. placebo }}<1\\)","confidence":0.5958301964363695,"confidence_rate":0.9921852473552345},{"cnt":[[247,1487],[1647,1487],[1647,1537],[247,1537]],"region":{"top_left_x":246,"top_left_y":1487,"width":1402,"height":51},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"409bb3e00d594f9e9e0902646782c3f2","type":"text","conversion_output":true,"text":"( \\(H _{1 \\text { (Sup1) }}\\) : Regarding the time to first occurrence of the primary endpoint, the risk for","text_display":"\n( \\(H _{1 \\text { (Sup1) }}\\) : Regarding the time to first occurrence of the primary endpoint, the risk for","confidence":0.6318035390270038,"confidence_rate":0.9959085999169106},{"cnt":[[247,1535],[907,1535],[907,1583],[247,1583]],"region":{"top_left_x":246,"top_left_y":1535,"width":661,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9a27e0db0ae4b54a1a2ce8eccd79cce","type":"text","conversion_output":true,"text":"linagliptin relative to placebo is lower.)","text_display":" linagliptin relative to placebo is lower.)","confidence":1,"confidence_rate":1},{"cnt":[[247,1626],[756,1626],[756,1674],[247,1674]],"region":{"top_left_x":246,"top_left_y":1626,"width":511,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91bb7fb9ab8143f9a219c175e5d8580a","type":"text","conversion_output":true,"text":"\\(H _{0(Sup2)}: HR _{\\text {linagliptin vs. placebo }} \\geq 1\\)","text_display":"\n\\(H _{0(Sup2)}: HR _{\\text {linagliptin vs. placebo }} \\geq 1\\)","confidence":0.4360354243846657,"confidence_rate":0.9871144915577688},{"cnt":[[247,1713],[1784,1713],[1784,1764],[247,1764]],"region":{"top_left_x":246,"top_left_y":1713,"width":1539,"height":51},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da26e56f3a7a4c6996806f396f013f75","type":"text","conversion_output":true,"text":"( \\(H _{0(\\text { Sup } 2)}\\) : Regarding the time to first occurrence of the composite renal endpoint, the risk for","text_display":"\n( \\(H _{0(\\text { Sup } 2)}\\) : Regarding the time to first occurrence of the composite renal endpoint, the risk for","confidence":0.7069578501630147,"confidence_rate":0.9971143030446646},{"cnt":[[247,1764],[921,1764],[921,1812],[247,1812]],"region":{"top_left_x":246,"top_left_y":1763,"width":675,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0959c3e6417b4dfe89af28c60487a002","type":"text","conversion_output":true,"text":"linagliptin relative to placebo is higher.)","text_display":" linagliptin relative to placebo is higher.)","confidence":1,"confidence_rate":1},{"cnt":[[240,1857],[302,1857],[302,1896],[240,1896]],"region":{"top_left_x":239,"top_left_y":1857,"width":63,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2d2eba1cfe34d099e274dab23f3e100","type":"text","conversion_output":true,"text":"vs.","text_display":"\nvs.","confidence":1,"confidence_rate":1},{"cnt":[[247,1942],[752,1942],[752,1994],[247,1994]],"region":{"top_left_x":246,"top_left_y":1941,"width":506,"height":54},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"267347d5daf94fac876a910335a08c43","type":"text","conversion_output":true,"text":"\\(H _{1(\\text { Sup2 })}: HR _{\\text {linagliptin vs. placebo }}<1\\)","text_display":"\n\\(H _{1(\\text { Sup2 })}: HR _{\\text {linagliptin vs. placebo }}<1\\)","confidence":0.8453459501751134,"confidence_rate":0.9974576414192264},{"cnt":[[247,2031],[1780,2031],[1780,2081],[247,2081]],"region":{"top_left_x":246,"top_left_y":2030,"width":1534,"height":52},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9c74826827b426bb1ccd597c6e2e004","type":"text","conversion_output":true,"text":"( \\(H _{1 \\text { (Sup2) }}\\) : Regarding the time to first occurrence of the composite renal endpoint, the risk for","text_display":"\n( \\(H _{1 \\text { (Sup2) }}\\) : Regarding the time to first occurrence of the composite renal endpoint, the risk for","confidence":0.41956977313384414,"confidence_rate":0.992788417141268},{"cnt":[[247,2079],[909,2079],[909,2127],[247,2127]],"region":{"top_left_x":246,"top_left_y":2078,"width":664,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6e777ce10484930bd1dde9d4d2c2789","type":"text","conversion_output":true,"text":"linagliptin relative to placebo is lower.)","text_display":" linagliptin relative to placebo is lower.)","confidence":1,"confidence_rate":1},{"cnt":[[247,2170],[1665,2170],[1665,2218],[247,2218]],"region":{"top_left_x":246,"top_left_y":2170,"width":1420,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55a8df9958fc45acbc5de51cc7f7c513","type":"text","conversion_output":true,"text":"To adjust for multiplicity at the final analysis the trucated Hochberg a sequentially","text_display":"\n\nTo adjust for multiplicity at the final analysis the trucated Hochberg a sequentially","confidence":0.8122945898606028,"confidence_rate":0.9976927523612812},{"cnt":[[247,2216],[1067,2216],[1067,2268],[247,2268]],"region":{"top_left_x":246,"top_left_y":2215,"width":821,"height":54},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb647035e2bd488582978b4199d5a9ed","type":"text","conversion_output":true,"text":"rejective multiple test procedure will be applied.","text_display":" rejective multiple test procedure will be applied.","confidence":1,"confidence_rate":1},{"cnt":[[247,2298],[386,2298],[386,2355],[247,2355]],"region":{"top_left_x":246,"top_left_y":2298,"width":141,"height":58},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74c30c65a361417784964e0d7a96a48b","type":"text","conversion_output":true,"text":"\\(3^{\\text {rd }}\\)-step:","text_display":"\n\\(3^{\\text {rd }}\\)-step:","confidence":0.43767719250172377,"confidence_rate":0.968719913790993},{"cnt":[[244,2396],[1777,2396],[1777,2442],[244,2442]],"region":{"top_left_x":244,"top_left_y":2396,"width":1534,"height":46},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"efe42a416eaf4150a25a203f3bbb8a50","type":"text","conversion_output":true,"text":"If superiority of the primary endpoint (4 point MACE) and/or the composite renal endpoint","text_display":"\nIf superiority of the primary endpoint (4 point MACE) and/or the composite renal endpoint","confidence":0.9014163056712109,"confidence_rate":0.9988964808190519},{"cnt":[[247,2444],[1812,2444],[1812,2492],[247,2492]],"region":{"top_left_x":246,"top_left_y":2444,"width":1566,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ca22907f737479db42f6494c6c186df","type":"text","conversion_output":true,"text":"has been demonstrated, then as a further confirmatory test superiority is tested with respect to","text_display":" has been demonstrated, then as a further confirmatory test superiority is tested with respect to","confidence":0.8141519114356015,"confidence_rate":0.9979663448724934},{"cnt":[[247,2492],[1019,2492],[1019,2543],[247,2543]],"region":{"top_left_x":246,"top_left_y":2492,"width":773,"height":51},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d514907f2c154e3e9d0f2d8a68ae7e70","type":"text","conversion_output":true,"text":"time to first occurrence of the 3 -point MACE.","text_display":" time to first occurrence of the 3 -point MACE.","confidence":0.9635967230424285,"confidence_rate":0.9993135244545989},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":38,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"aa63ab44acea42dfab2babc7e694c2da","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99560546875,"confidence_rate":0.9998951432220243},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":39,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"77c8bbfa26fc4b26bbbf840d8a80f844","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":40,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6ec133babae04fe08eccd254b3d74a55","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-062","page":62,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b1b92df369241e38d33e684b42b31e6","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad9614d4e633445abbb822cf872daa8d","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,167],[599,167],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":166,"width":353,"height":38},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1670ca8b0241416d9adf32f2f7de9b69","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a60985c2ab747068ea23c6b1ce7633d","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4f6ac64ca564a9a9f4902ec66058c97","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38b49c59de1a45d489dc6f3492a5969f","type":"page_info","conversion_output":false,"text":"Page 62 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[240,334],[1802,334],[1802,848],[240,848]],"region":{"top_left_x":239,"top_left_y":333,"width":1564,"height":515},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d24d21c9ba4a4338bb2de97ebaf737ff","type":"diagram","conversion_output":false,"children_ids":["043f0c3a40784ac6927df54f48f0c54f","49699559329e4ba38ec582671295c0b0","c6b9dd3aa0414b389d30b11074e00f94","8936fc3d627c43b39ab890f88f7ed020","2f15137eaf2145fabfc51809d7de633d","ca04ad77eb434c6bb11de3112de52d35","7e6d2899fb604b24ab3fdfe89d32236e"],"text":"","text_display":"","subtype":"pseudocode"},{"cnt":[[247,343],[761,343],[761,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":515,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"043f0c3a40784ac6927df54f48f0c54f","type":"pseudocode","conversion_output":true,"parent_id":"d24d21c9ba4a4338bb2de97ebaf737ff","text":"\\(H _{0( Sup 3)}: HR _{\\text {linagliptin vs. placebe }} \\geq 1\\)","text_display":"\n```\n\\(H _{0( Sup 3)}: HR _{\\text {linagliptin vs. placebe }} \\geq 1\\)","confidence":0.49889375758570076,"confidence_rate":0.9891937782125123},{"cnt":[[247,429],[1798,429],[1798,477],[247,477]],"region":{"top_left_x":246,"top_left_y":429,"width":1552,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"49699559329e4ba38ec582671295c0b0","type":"pseudocode","conversion_output":true,"parent_id":"d24d21c9ba4a4338bb2de97ebaf737ff","text":"\\(\\left( H _{0( Sup 3)}\\right):\\) Regarding the time to first occurrence of the 3 -point MACE, the risk for linagliptin","text_display":"\n\\(\\left( H _{0( Sup 3)}\\right):\\) Regarding the time to first occurrence of the 3 -point MACE, the risk for linagliptin","confidence":0.04397598996304016,"confidence_rate":0.9736515338326743},{"cnt":[[247,480],[742,480],[742,525],[247,525]],"region":{"top_left_x":246,"top_left_y":479,"width":497,"height":47},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c6b9dd3aa0414b389d30b11074e00f94","type":"pseudocode","conversion_output":true,"parent_id":"d24d21c9ba4a4338bb2de97ebaf737ff","text":"relative to placebo is higher.)","text_display":"\nrelative to placebo is higher.)","confidence":0.99951171875,"confidence_rate":0.9999864334115239},{"cnt":[[247,576],[306,576],[306,608],[247,608]],"region":{"top_left_x":246,"top_left_y":575,"width":61,"height":33},"line":11,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8936fc3d627c43b39ab890f88f7ed020","type":"pseudocode","conversion_output":true,"parent_id":"d24d21c9ba4a4338bb2de97ebaf737ff","text":"VS.","text_display":"\nVS.","confidence":0.9360694885253906,"confidence_rate":0.9917758095534019},{"cnt":[[247,658],[758,658],[758,706],[247,706]],"region":{"top_left_x":246,"top_left_y":657,"width":513,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2f15137eaf2145fabfc51809d7de633d","type":"pseudocode","conversion_output":true,"parent_id":"d24d21c9ba4a4338bb2de97ebaf737ff","text":"\\(H _{1( Sup 3)} \\div HR _{\\text {linagliptin vs. placeba }} \\leftarrow 1\\)","text_display":"\n\\(H _{1( Sup 3)} \\div HR _{\\text {linagliptin vs. placeba }} \\leftarrow 1\\)","confidence":0.5535530775999243,"confidence_rate":0.9908019749534237},{"cnt":[[247,745],[1793,745],[1793,795],[247,795]],"region":{"top_left_x":246,"top_left_y":744,"width":1548,"height":51},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ca04ad77eb434c6bb11de3112de52d35","type":"pseudocode","conversion_output":true,"parent_id":"d24d21c9ba4a4338bb2de97ebaf737ff","text":"( \\(H _{1(\\text { Sup } 3)}\\) : Regarding the time to first occurrence of the 3 point MACE, the risk for linagliptin","text_display":"\n( \\(H _{1(\\text { Sup } 3)}\\) : Regarding the time to first occurrence of the 3 point MACE, the risk for linagliptin","confidence":0.2795134724873987,"confidence_rate":0.9896900620162131},{"cnt":[[247,795],[729,795],[729,843],[247,843]],"region":{"top_left_x":246,"top_left_y":794,"width":483,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7e6d2899fb604b24ab3fdfe89d32236e","type":"pseudocode","conversion_output":true,"parent_id":"d24d21c9ba4a4338bb2de97ebaf737ff","text":"relative to placebo is lower.)","text_display":"\nrelative to placebo is lower.)\n```\n","confidence":1,"confidence_rate":1},{"cnt":[[242,882],[848,882],[848,930],[242,930]],"region":{"top_left_x":242,"top_left_y":881,"width":606,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7feb6dea826345b8bb216b637dea9883","type":"section_header","conversion_output":false,"children_ids":["47b2d87547204b9298c02dc7127edf63"],"text":"","text_display":""},{"cnt":[[247,886],[843,886],[843,925],[247,925]],"region":{"top_left_x":246,"top_left_y":886,"width":597,"height":40},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"47b2d87547204b9298c02dc7127edf63","type":"text","conversion_output":true,"parent_id":"7feb6dea826345b8bb216b637dea9883","text":"7.3 PLANNED ANALYSES","text_display":"\n\n\\subsection*{7.3 PLANNED ANALYSES}","confidence":1,"confidence_rate":1},{"cnt":[[244,973],[1711,973],[1711,1021],[244,1021]],"region":{"top_left_x":244,"top_left_y":973,"width":1467,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6466c4c7452e46d486d6688952735dad","type":"text","conversion_output":true,"text":"The primary analyses (including all confirmatory tests described in Section 7.2) will be","text_display":"\n\nThe primary analyses (including all confirmatory tests described in Section 7.2) will be","confidence":1,"confidence_rate":1},{"cnt":[[244,1019],[1766,1019],[1766,1069],[244,1069]],"region":{"top_left_x":244,"top_left_y":1018,"width":1522,"height":52},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"53090c64439e4f248a1d0fb8011806bf","type":"text","conversion_output":true,"text":"performed on the full analysis set (FAS) Treated Set (TS). The FAS TS will consist of all","text_display":" performed on the full analysis set (FAS) Treated Set (TS). The FAS TS will consist of all","confidence":1,"confidence_rate":1},{"cnt":[[244,1069],[1501,1069],[1501,1117],[244,1117]],"region":{"top_left_x":244,"top_left_y":1069,"width":1257,"height":49},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a5dcba47dfad46e2bf4a4abec537a3ae","type":"text","conversion_output":true,"text":"randomized patients who were treated with at least one dose of study drug.","text_display":" randomized patients who were treated with at least one dose of study drug.","confidence":0.99462890625,"confidence_rate":0.9999318305523438},{"cnt":[[247,1158],[1786,1158],[1786,1208],[247,1208]],"region":{"top_left_x":246,"top_left_y":1158,"width":1541,"height":51},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ea146fa8436f48a4984fb7e75c1429b3","type":"text","conversion_output":true,"text":"For the primary and key secondary endpoints a 'classical intention to treat (ITT) analysis on","text_display":"\n\nFor the primary and key secondary endpoints a 'classical intention to treat (ITT) analysis on","confidence":1,"confidence_rate":1},{"cnt":[[247,1206],[980,1206],[980,1250],[247,1250]],"region":{"top_left_x":246,"top_left_y":1206,"width":734,"height":44},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c75d3ff6b6754329b8b309fd7225eda0","type":"text","conversion_output":true,"text":"the FAS TS' will be done. That means that:","text_display":" the FAS TS' will be done. That means that:","confidence":1,"confidence_rate":1},{"cnt":[[306,1293],[1035,1293],[1035,1345],[306,1345]],"region":{"top_left_x":306,"top_left_y":1292,"width":729,"height":54},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"85b11f4138634d51bbbd5c027cde8d37","type":"text","conversion_output":true,"text":"- the analysis set consists of the FAS TS,","text_display":"\n- the analysis set consists of the FAS TS,","confidence":1,"confidence_rate":1},{"cnt":[[306,1343],[1697,1343],[1697,1391],[306,1391]],"region":{"top_left_x":306,"top_left_y":1343,"width":1392,"height":49},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"215ffe8cb516499892a36be3f6ba1556","type":"text","conversion_output":true,"text":"- the allocated study treatment at randomization will be used for the analysis ('as","text_display":"\n- the allocated study treatment at randomization will be used for the analysis ('as","confidence":1,"confidence_rate":1},{"cnt":[[368,1393],[610,1393],[610,1439],[368,1439]],"region":{"top_left_x":367,"top_left_y":1393,"width":243,"height":47},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"26ce5cfd25c7464d96fef2b0b0ce7229","type":"text","conversion_output":true,"text":"randomized'),","text_display":" randomized'),","confidence":1,"confidence_rate":1},{"cnt":[[306,1439],[1457,1439],[1457,1487],[306,1487]],"region":{"top_left_x":306,"top_left_y":1439,"width":1152,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e93c294763e54886b833d674c4c9d7ef","type":"text","conversion_output":true,"text":"- all events which occur until study end will be taken into account.","text_display":"\n- all events which occur until study end will be taken into account.","confidence":1,"confidence_rate":1},{"cnt":[[247,1508],[1757,1508],[1757,1556],[247,1556]],"region":{"top_left_x":246,"top_left_y":1507,"width":1511,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7edd56953d5c443892cd4fce9d24d208","type":"text","conversion_output":true,"text":"A per protocol set (PPS) of patients following the trial protocol in essential criteria will be","text_display":"\n\nA per protocol set (PPS) of patients following the trial protocol in essential criteria will be","confidence":1,"confidence_rate":1},{"cnt":[[247,1558],[1821,1558],[1821,1606],[247,1606]],"region":{"top_left_x":246,"top_left_y":1557,"width":1575,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"688035cbf4de4ba2b0fe7a97e1df37c3","type":"text","conversion_output":true,"text":"created for sensitivity analyses. Patients included in the FAS TS who have important protocol","text_display":" created for sensitivity analyses. Patients included in the FAS TS who have important protocol","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[247,1604],[1702,1604],[1702,1652],[247,1652]],"region":{"top_left_x":246,"top_left_y":1603,"width":1456,"height":49},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"77224806ebbb44c1b04b9b2cdeed1331","type":"text","conversion_output":true,"text":"violations will be excluded from the PPS. A protocol violation (PV) will be considered","text_display":" violations will be excluded from the PPS. A protocol violation (PV) will be considered","confidence":1,"confidence_rate":1},{"cnt":[[247,1652],[1816,1652],[1816,1702],[247,1702]],"region":{"top_left_x":246,"top_left_y":1651,"width":1571,"height":51},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a858e140b6564d439558bfe7b66ba587","type":"text","conversion_output":true,"text":"important if it can be expected to have a distorting influence on the assessment of the primary","text_display":" important if it can be expected to have a distorting influence on the assessment of the primary","confidence":0.9985356330871582,"confidence_rate":0.9999853457059158},{"cnt":[[247,1700],[409,1700],[409,1748],[247,1748]],"region":{"top_left_x":246,"top_left_y":1699,"width":163,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"910b339322654e279905cc232964755a","type":"text","conversion_output":true,"text":"endpoint.","text_display":" endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[247,1791],[884,1791],[884,1839],[247,1839]],"region":{"top_left_x":246,"top_left_y":1790,"width":639,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b0ab51f9d93e4b3390e9c1777e67545f","type":"text","conversion_output":true,"text":"Important protocol violations include:","text_display":"\n\nImportant protocol violations include:","confidence":1,"confidence_rate":1},{"cnt":[[306,1878],[1240,1878],[1240,1926],[306,1926]],"region":{"top_left_x":306,"top_left_y":1877,"width":935,"height":49},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"58a0ca263bce4afc852c31ec1b468ddf","type":"text","conversion_output":true,"text":"- Randomized study drug: incorrect study drug taken.","text_display":"\n- Randomized study drug: incorrect study drug taken.","confidence":1,"confidence_rate":1},{"cnt":[[306,1928],[1816,1928],[1816,1976],[306,1976]],"region":{"top_left_x":306,"top_left_y":1928,"width":1511,"height":48},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f9d925d44cd349b3ae4c2e56833e4b1e","type":"text","conversion_output":true,"text":"- Severe violation of treatment compliance (defined as compliance with study treatment","text_display":"\n- Severe violation of treatment compliance (defined as compliance with study treatment","confidence":1,"confidence_rate":1},{"cnt":[[368,1974],[1789,1974],[1789,2022],[368,2022]],"region":{"top_left_x":367,"top_left_y":1973,"width":1422,"height":49},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2b6778b1a70b498bbc50ba620672f7df","type":"text","conversion_output":true,"text":"\\(<80 \\%\\) for more than \\(50 \\%\\) of the time between randomization and first endpoint (CV","text_display":" \\(<80 \\%\\) for more than \\(50 \\%\\) of the time between randomization and first endpoint (CV","confidence":0.8706920146942139,"confidence_rate":0.9983912145045106},{"cnt":[[370,2022],[1741,2022],[1741,2072],[370,2072]],"region":{"top_left_x":370,"top_left_y":2021,"width":1371,"height":51},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dadb2a3bb3144ba89931dc1b917d93cf","type":"text","conversion_output":true,"text":"death, non-fatal MI, non-fatal stroke, hospitalisation for unstable angina pectoris).","text_display":" death, non-fatal MI, non-fatal stroke, hospitalisation for unstable angina pectoris).","confidence":0.9699321873486042,"confidence_rate":0.9996608450829426},{"cnt":[[306,2070],[1725,2070],[1725,2120],[306,2120]],"region":{"top_left_x":306,"top_left_y":2069,"width":1419,"height":51},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0787b5b61d6f492b8fcd181ae3e8ff55","type":"text","conversion_output":true,"text":"- Non-adherence to other specifications of the protocol that could bias the primary","text_display":"\n- Non-adherence to other specifications of the protocol that could bias the primary","confidence":1,"confidence_rate":1},{"cnt":[[368,2120],[1777,2120],[1777,2168],[368,2168]],"region":{"top_left_x":367,"top_left_y":2119,"width":1411,"height":49},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a31456e56cf5427f8faec5f94df52d94","type":"text","conversion_output":true,"text":"composite endpoint (e.g. limited life expectancy ( \\(<5\\) years) at randomization due to","text_display":" composite endpoint (e.g. limited life expectancy ( \\(<5\\) years) at randomization due to","confidence":0.92626953125,"confidence_rate":0.9991678462557781},{"cnt":[[370,2166],[838,2166],[838,2214],[370,2214]],"region":{"top_left_x":370,"top_left_y":2165,"width":469,"height":49},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f3a2c205282d496bbf5ad1c01da83244","type":"text","conversion_output":true,"text":"various medical conditions)","text_display":" various medical conditions)","confidence":1,"confidence_rate":1},{"cnt":[[247,2234],[1738,2234],[1738,2287],[247,2287]],"region":{"top_left_x":246,"top_left_y":2234,"width":1493,"height":53},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9129450d09b24ff2b2d9af2d2f1590b8","type":"text","conversion_output":true,"text":"Additionally a '30-day treatment' 'on-treatment' set (OS) of patients will be created for","text_display":"\n\nAdditionally a '30-day treatment' 'on-treatment' set (OS) of patients will be created for","confidence":0.9975605006329715,"confidence_rate":0.9999740165099835},{"cnt":[[247,2284],[1757,2284],[1757,2332],[247,2332]],"region":{"top_left_x":246,"top_left_y":2284,"width":1511,"height":49},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a52757b414e7403bb150715b8e8fc932","type":"text","conversion_output":true,"text":"sensitivity analysis. The ' 30 dathere \\({ }^{\\prime}\\) OS set will include all patients with minimum","text_display":" sensitivity analysis. The ' 30 dathere \\({ }^{\\prime}\\) OS set will include all patients with minimum","confidence":0.002031622930740918,"confidence_rate":0.9421366010459106},{"cnt":[[247,2330],[756,2330],[756,2378],[247,2378]],"region":{"top_left_x":246,"top_left_y":2330,"width":511,"height":49},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"74dd1c091a04476ebafbde33b629325d","type":"text","conversion_output":true,"text":"treatment duration of 30-days.","text_display":" treatment duration of 30-days.","confidence":1,"confidence_rate":1},{"cnt":[[247,2421],[1784,2421],[1784,2469],[247,2469]],"region":{"top_left_x":246,"top_left_y":2421,"width":1539,"height":49},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"137f360d3a244e65978571bd44a89036","type":"text","conversion_output":true,"text":"All patients treated with at least one dose of study drug (the Treated Set) will be included in","text_display":"\n\nAll patients treated with at least one dose of study drug (the Treated Set) will be included in","confidence":1,"confidence_rate":1},{"cnt":[[244,2469],[1812,2469],[1812,2517],[244,2517]],"region":{"top_left_x":244,"top_left_y":2469,"width":1568,"height":49},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bd7bfee3219e4382b655ca88bb74f64f","type":"text","conversion_output":true,"text":"the safety evaluation.-In case only randomized patients take study drug, this set is identical to","text_display":" the safety evaluation.-In case only randomized patients take study drug, this set is identical to","confidence":0.5319344997406006,"confidence_rate":0.993830532177829},{"cnt":[[244,2517],[1309,2517],[1309,2565],[244,2565]],"region":{"top_left_x":244,"top_left_y":2517,"width":1065,"height":49},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a99171c7499943919f6f3c18c2046259","type":"text","conversion_output":true,"text":"the FAS; the safety analyses will be displayed 'as randomized'.","text_display":" the FAS; the safety analyses will be displayed 'as randomized'.","confidence":0.998046875,"confidence_rate":0.9999712499010008},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7644df6f18314156a615158f6a951c1b","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99560546875,"confidence_rate":0.9998951432220243},{"cnt":[[292,2622],[1800,2622],[1800,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1509,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"64ac88cf3bc343c88910a98416803b6a","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.98046875,"confidence_rate":0.9998342615903483},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c5083c6d2fbd4f03ad095a20eb31f282","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-063","page":63,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"514471ea080047d1be41615a5b36b66a","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e4c406d3544949a4b260e250106b9efa","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a4e4ac31c6c49bc9ff7e40027977c59","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"464db066716c4e0fb15a4c52d13569b9","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27c7b701a4f14d07bf1fe6a293d597dd","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07c04ea7b4e5461e8f213a6bcf164d5f","type":"page_info","conversion_output":false,"text":"Page 63 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1821,338],[1821,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":1575,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"add2f1e0083d43f7a1a6a6e62fd04e72","type":"text","conversion_output":true,"text":"Data recorded on entry into the study and at randomization will be summarized and compared","text_display":"\n\nData recorded on entry into the study and at randomization will be summarized and compared","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[247,388],[875,388],[875,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":629,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5912eaf6b88442b38f5271f2fe3c9cc1","type":"text","conversion_output":true,"text":"using univariate descriptive statistics.","text_display":" using univariate descriptive statistics.","confidence":1,"confidence_rate":1},{"cnt":[[247,477],[1793,477],[1793,525],[247,525]],"region":{"top_left_x":246,"top_left_y":477,"width":1548,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a620a002b90425eaab86c3b8fd7294d","type":"text","conversion_output":true,"text":"Additional analyses will be explored in specifie subgroups, e.g. depending on characteristics","text_display":"\n\nAdditional analyses will be explored in specifie subgroups, e.g. depending on characteristics","confidence":0.8853650093078613,"confidence_rate":0.9987583706531349},{"cnt":[[247,525],[1629,525],[1629,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1383,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8cd918fcbd4d4ce19ce6aa98b06ce8cd","type":"text","conversion_output":true,"text":"at baseline with respect to the primary and key secondary endpoints. Examples of","text_display":" at baseline with respect to the primary and key secondary endpoints. Examples of","confidence":1,"confidence_rate":1},{"cnt":[[247,573],[948,573],[948,619],[247,619]],"region":{"top_left_x":246,"top_left_y":573,"width":703,"height":47},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe492a1348614bf3835ddb57a00a8ae2","type":"text","conversion_output":true,"text":"Gcovariates that will be explored include:","text_display":" Gcovariates that will be explored include:","confidence":0.9013671875,"confidence_rate":0.997793022557558},{"cnt":[[370,667],[1158,667],[1158,715],[370,715]],"region":{"top_left_x":370,"top_left_y":667,"width":789,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"769010e9f4194a63ac352c174b8b12a0","type":"text","conversion_output":true,"text":"- Region (North America, Europe, Asia etc.)","text_display":"\n- Region (North America, Europe, Asia etc.)","confidence":1,"confidence_rate":1},{"cnt":[[370,717],[806,717],[806,765],[370,765]],"region":{"top_left_x":370,"top_left_y":717,"width":437,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea906275a789401c9be61d717741bf7d","type":"text","conversion_output":true,"text":"- Age (<65, \\(\\geq 65\\) years)","text_display":"\n- Age (<65, \\(\\geq 65\\) years)","confidence":1,"confidence_rate":1},{"cnt":[[370,763],[1805,763],[1805,816],[370,816]],"region":{"top_left_x":370,"top_left_y":762,"width":1435,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7cdbeec8ded44b1280e4eb0ac8bcb05d","type":"text","conversion_output":true,"text":"- Systolic and diastolic blood pressure ( \\(< 1 4 0 1 6 0\\) and \\(< 9 0 1 0 0 mmHg , \\geq 1 4 0 1 6 0\\) or","text_display":"\n- Systolic and diastolic blood pressure ( \\(< 1 4 0 1 6 0\\) and \\(< 9 0 1 0 0 mmHg , \\geq 1 4 0 1 6 0\\) or","confidence":0.6764265532711238,"confidence_rate":0.9960188498949484},{"cnt":[[432,813],[717,813],[717,863],[432,863]],"region":{"top_left_x":431,"top_left_y":813,"width":287,"height":51},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ad6fe036812444fada625a707bcf3db","type":"text","conversion_output":true,"text":"\\(\\geq 9 0 100 mmHg\\) )","text_display":" \\(\\geq 9 0 100 mmHg\\) )","confidence":0.552221820450427,"confidence_rate":0.9733698485187914},{"cnt":[[370,868],[816,868],[816,916],[370,916]],"region":{"top_left_x":370,"top_left_y":868,"width":446,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb2e7b297b36472fb8fd2db10ac54ee4","type":"text","conversion_output":true,"text":"- Gender (male, female)","text_display":"\n- Gender (male, female)","confidence":1,"confidence_rate":1},{"cnt":[[370,918],[1816,918],[1816,966],[370,966]],"region":{"top_left_x":370,"top_left_y":918,"width":1447,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14a971b6a0f94e3f8820b6bf785e5c9f","type":"text","conversion_output":true,"text":"- Prior anti-diabetic treatment (none, monotherapy, combination therapy insulin, no","text_display":"\n- Prior anti-diabetic treatment (none, monotherapy, combination therapy insulin, no","confidence":0.5780962659046054,"confidence_rate":0.993791908574944},{"cnt":[[434,964],[573,964],[573,1012],[434,1012]],"region":{"top_left_x":434,"top_left_y":964,"width":140,"height":48},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e3e207096cf42a5a5ad7671db8a16bb","type":"text","conversion_output":true,"text":"insulin)","text_display":" insulin)","confidence":1,"confidence_rate":1},{"cnt":[[370,1010],[1108,1010],[1108,1062],[370,1062]],"region":{"top_left_x":370,"top_left_y":1009,"width":738,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa5638b3211043298f6300f8e2a221f6","type":"text","conversion_output":true,"text":"- eGFR \\(<60 mL / min / 1.73 m^{2}\\) at baseline","text_display":"\n- eGFR \\(<60 mL / min / 1.73 m^{2}\\) at baseline","confidence":0.9375302791595459,"confidence_rate":0.998907271634297},{"cnt":[[370,1060],[1775,1060],[1775,1117],[370,1117]],"region":{"top_left_x":370,"top_left_y":1059,"width":1405,"height":59},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6eb21031f69a4122be4b981ac67701af","type":"text","conversion_output":true,"text":"- Prevalent kidney disease defined as eGFR \\(<60 mL / min / 1.73 m^{2}\\) at baseline","text_display":"\n- Prevalent kidney disease defined as eGFR \\(<60 mL / min / 1.73 m^{2}\\) at baseline","confidence":0.98681640625,"confidence_rate":0.9998603121914003},{"cnt":[[434,1115],[1272,1115],[1272,1163],[434,1163]],"region":{"top_left_x":434,"top_left_y":1114,"width":839,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5181f57663854cd5989c44b345519861","type":"text","conversion_output":true,"text":"and/or UACR \\(> 3 0 0 m g / g\\) creatinine at baseline","text_display":" and/or UACR \\(> 3 0 0 m g / g\\) creatinine at baseline","confidence":0.5914772118140892,"confidence_rate":0.991699212863963},{"cnt":[[247,1256],[1446,1256],[1446,1307],[247,1307]],"region":{"top_left_x":246,"top_left_y":1256,"width":1201,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e52114e0550f46f88ecc667cd9a5fd93","type":"text","conversion_output":true,"text":"Further details will be given in the trial statistical analysis plan (TSAP).","text_display":"\n\nFurther details will be given in the trial statistical analysis plan (TSAP).","confidence":1,"confidence_rate":1},{"cnt":[[242,1345],[724,1345],[724,1400],[242,1400]],"region":{"top_left_x":242,"top_left_y":1345,"width":483,"height":56},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07ba928bc0e34cf8b89c56dff1f92074","type":"section_header","conversion_output":false,"children_ids":["d33a0553ce3246b6bea56e043291e8dc"],"text":"","text_display":""},{"cnt":[[247,1348],[720,1348],[720,1396],[247,1396]],"region":{"top_left_x":246,"top_left_y":1347,"width":474,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d33a0553ce3246b6bea56e043291e8dc","type":"text","conversion_output":true,"parent_id":"07ba928bc0e34cf8b89c56dff1f92074","text":"7.3.1 Primary analyses","text_display":"\n\n\\subsection*{7.3.1 Primary analyses}","confidence":1,"confidence_rate":1},{"cnt":[[247,1439],[1711,1439],[1711,1487],[247,1487]],"region":{"top_left_x":246,"top_left_y":1439,"width":1465,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c59af8b69441477297cab3ed3c36f7b2","type":"text","conversion_output":true,"text":"A classical ITT-approach on the FAS TS will be performed as described above. For the","text_display":"\n\nA classical ITT-approach on the FAS TS will be performed as described above. For the","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[247,1485],[1784,1485],[1784,1533],[247,1533]],"region":{"top_left_x":246,"top_left_y":1484,"width":1539,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f5137aa8567492f83649f6a847ba35c","type":"text","conversion_output":true,"text":"primary analysis a Cox proportional hazards regression model of time to the first event with","text_display":" primary analysis a Cox proportional hazards regression model of time to the first event with","confidence":1,"confidence_rate":1},{"cnt":[[247,1535],[1713,1535],[1713,1583],[247,1583]],"region":{"top_left_x":246,"top_left_y":1535,"width":1468,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6af8965262a48809e5a63a1b6096f4d","type":"text","conversion_output":true,"text":"randomized treatment and geographical region as factors will be applied. Kaplan-Meier","text_display":" randomized treatment and geographical region as factors will be applied. Kaplan-Meier","confidence":1,"confidence_rate":1},{"cnt":[[247,1581],[1805,1581],[1805,1629],[247,1629]],"region":{"top_left_x":246,"top_left_y":1580,"width":1559,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"808a18d5a3314baab5a8304002838454","type":"text","conversion_output":true,"text":"estimates by treatment group will be displayed. The confirmatory test approach is outlined in","text_display":" estimates by treatment group will be displayed. The confirmatory test approach is outlined in","confidence":1,"confidence_rate":1},{"cnt":[[247,1631],[450,1631],[450,1674],[247,1674]],"region":{"top_left_x":246,"top_left_y":1631,"width":205,"height":44},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95c31cc600194db8a311e10c6d3cd0b8","type":"text","conversion_output":true,"text":"Section 7.2.","text_display":" Section 7.2.","confidence":1,"confidence_rate":1},{"cnt":[[244,1718],[1741,1718],[1741,1766],[244,1766]],"region":{"top_left_x":244,"top_left_y":1717,"width":1497,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8f7b5218aad484793e351cec57ab03e","type":"text","conversion_output":true,"text":"No centre effect will be included into the Cox models, as the centre size is expected to be","text_display":"\n\nNo centre effect will be included into the Cox models, as the centre size is expected to be","confidence":1,"confidence_rate":1},{"cnt":[[247,1768],[1711,1768],[1711,1812],[247,1812]],"region":{"top_left_x":246,"top_left_y":1768,"width":1465,"height":44},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e370335349743e9b9681780708f05b1","type":"text","conversion_output":true,"text":"small. Furthermore, due to the low event rate there would not be a sufficient number of","text_display":" small. Furthermore, due to the low event rate there would not be a sufficient number of","confidence":0.9931640625,"confidence_rate":0.999925443979972},{"cnt":[[247,1814],[1720,1814],[1720,1862],[247,1862]],"region":{"top_left_x":246,"top_left_y":1813,"width":1475,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0313e9eb66f4526bab8332bbd6264fa","type":"text","conversion_output":true,"text":"events per centre for the analysis of a centre effect and a centre by treatment interaction.","text_display":" events per centre for the analysis of a centre effect and a centre by treatment interaction.","confidence":0.5695459842681885,"confidence_rate":0.9942135511595093},{"cnt":[[247,1905],[1770,1905],[1770,1953],[247,1953]],"region":{"top_left_x":246,"top_left_y":1905,"width":1525,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f5f8cab962845b1ba0f053acdefd351","type":"text","conversion_output":true,"text":"For the primary and key secondary endpoints, sensitivity analyses will be done on the PPS,","text_display":"\n\nFor the primary and key secondary endpoints, sensitivity analyses will be done on the PPS,","confidence":1,"confidence_rate":1},{"cnt":[[247,1951],[1782,1951],[1782,1999],[247,1999]],"region":{"top_left_x":246,"top_left_y":1950,"width":1536,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"007976293da745d08a809f7a78d0020d","type":"text","conversion_output":true,"text":"for the ' \\(3 0\\) days treatment' set \\(O S\\) and as an 'on-treatment' a 'TS+30' analysis as described","text_display":" for the ' \\(3 0\\) days treatment' set \\(O S\\) and as an 'on-treatment' a 'TS+30' analysis as described","confidence":0.6163747001599412,"confidence_rate":0.9955703882307776},{"cnt":[[247,2001],[1780,2001],[1780,2049],[247,2049]],"region":{"top_left_x":246,"top_left_y":2001,"width":1534,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9afaf06d6b8420b83a2bd7ad785275f","type":"text","conversion_output":true,"text":"below. These sensitivity analyses will be performed based on the corresponding patient sets","text_display":" below. These sensitivity analyses will be performed based on the corresponding patient sets","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[247,2047],[1798,2047],[1798,2095],[247,2095]],"region":{"top_left_x":246,"top_left_y":2046,"width":1552,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"250cfa7b7b8b4be1924611a864104a07","type":"text","conversion_output":true,"text":"for the time patients are on-treatment +30 days after permanent treatment discontinuation or","text_display":" for the time patients are on-treatment +30 days after permanent treatment discontinuation or","confidence":0.99365234375,"confidence_rate":0.99993632314463},{"cnt":[[247,2097],[1816,2097],[1816,2143],[247,2143]],"region":{"top_left_x":246,"top_left_y":2097,"width":1571,"height":46},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16971186b30b47c8a5bd20a2b9d487ad","type":"text","conversion_output":true,"text":"end of observation, whichever comes first. The 'on-treatment analysis' ' TS+30' analysis will","text_display":" end of observation, whichever comes first. The 'on-treatment analysis' ' TS+30' analysis will","confidence":0.4955854309431626,"confidence_rate":0.9928621724252066},{"cnt":[[247,2143],[1798,2143],[1798,2191],[247,2191]],"region":{"top_left_x":246,"top_left_y":2142,"width":1552,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c5b757c67894cd4bcd99345a2c595f8","type":"text","conversion_output":true,"text":"be performed on the FAS TS (consisting of all randomized patients who were treated with at","text_display":" be performed on the FAS TS (consisting of all randomized patients who were treated with at","confidence":0.6575603485107422,"confidence_rate":0.995596893440366},{"cnt":[[247,2193],[1770,2193],[1770,2241],[247,2241]],"region":{"top_left_x":246,"top_left_y":2193,"width":1525,"height":48},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"342acfb6f8ed4a7d90ff57842e629da7","type":"text","conversion_output":true,"text":"least one dose of study drug) with censoring at the time patients are on treatment +30 days","text_display":" least one dose of study drug) with censoring at the time patients are on treatment +30 days","confidence":0.9990236759185791,"confidence_rate":0.999990133371946},{"cnt":[[247,2239],[1716,2239],[1716,2287],[247,2287]],"region":{"top_left_x":246,"top_left_y":2238,"width":1470,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7664c79d9b3404b8e1e20c9075eb9e7","type":"text","conversion_output":true,"text":"after permanent treatment discontinuation or end of observation, whichever comes first.","text_display":" after permanent treatment discontinuation or end of observation, whichever comes first.","confidence":0.99755859375,"confidence_rate":0.999973430881859},{"cnt":[[247,2335],[1807,2335],[1807,2383],[247,2383]],"region":{"top_left_x":246,"top_left_y":2334,"width":1561,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb59e1d93b744720a80425ef307f061a","type":"text","conversion_output":true,"text":"For these sensitivity analyses, the randomized study treatment ('as randomized') will be used","text_display":"\n\nFor these sensitivity analyses, the randomized study treatment ('as randomized') will be used","confidence":0.99755859375,"confidence_rate":0.9999750575422747},{"cnt":[[247,2385],[678,2385],[678,2433],[247,2433]],"region":{"top_left_x":246,"top_left_y":2384,"width":433,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76a66d9440a442d0934e2d3560fb654d","type":"text","conversion_output":true,"text":"for treatment assignment.","text_display":" for treatment assignment.","confidence":1,"confidence_rate":1},{"cnt":[[247,2472],[1784,2472],[1784,2520],[247,2520]],"region":{"top_left_x":246,"top_left_y":2471,"width":1539,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85e3ec6beb0e48e597ea32b1a06bb906","type":"text","conversion_output":true,"text":"To check the proportional hazards assumption, Schoenfeld residuals will be plotted for each","text_display":"\n\nTo check the proportional hazards assumption, Schoenfeld residuals will be plotted for each","confidence":1,"confidence_rate":1},{"cnt":[[247,2522],[1697,2522],[1697,2570],[247,2570]],"region":{"top_left_x":246,"top_left_y":2521,"width":1452,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f44d5116ff7f45e386059938496ea20a","type":"text","conversion_output":true,"text":"covariate versus time; in addition, \\(\\ln (-\\ln ( S ( t )))\\) will be plotted vs. time and checked for","text_display":" covariate versus time; in addition, \\(\\ln (-\\ln ( S ( t )))\\) will be plotted vs. time and checked for","confidence":0.96044921875,"confidence_rate":0.9996332112128208},{"cnt":[[790,2584],[1300,2584],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":40},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1fe99356ca9a4e4f8baba64499e581ee","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9912109375,"confidence_rate":0.9997898336565273},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cc45e5cdd1a94c90be9bbbc34d4e95c0","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2668],[1768,2668],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1473,"height":35},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"97f92bc4066c42b087b935f50e79e95c","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-064","page":64,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eaf34722fbe54ef9b6ed455bf97fe3c0","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d65b4c9ce994a9caf6d84c829559892","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f436c0b914f243a99514456954471afe","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"737fd324abf24f92b8b88c026194494b","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf72753131da4f8288f4553fa9420d3d","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54a74975bdc74e6985f99f6bcf702457","type":"page_info","conversion_output":false,"text":"Page 64 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1622,338],[1622,388],[244,388]],"region":{"top_left_x":244,"top_left_y":338,"width":1378,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bbf7ebb7847f4587b9b677c1396515f5","type":"text","conversion_output":true,"text":"parallelism. As a further assessment the interaction of covariates with time will be","text_display":"\nparallelism. As a further assessment the interaction of covariates with time will be","confidence":1,"confidence_rate":1},{"cnt":[[247,388],[1768,388],[1768,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1523,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"660bf5b9cbf74c458a8e61824a4699f4","type":"text","conversion_output":true,"text":"investigated. In case the proportionality assumption does not hold, a stratified log-rank test","text_display":" investigated. In case the proportionality assumption does not hold, a stratified log-rank test","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[560,434],[560,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":314,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f019aee4e0d4f88b6bfd3efd8f2d630","type":"text","conversion_output":true,"text":"will be performed.","text_display":" will be performed.","confidence":0.99755859375,"confidence_rate":0.9998937277628692},{"cnt":[[242,521],[761,521],[761,578],[242,578]],"region":{"top_left_x":242,"top_left_y":520,"width":519,"height":58},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9c99232b8e464193873979882b8325bf","type":"section_header","conversion_output":false,"children_ids":["9dce895f09a9436282a604834ea98b99"],"text":"","text_display":""},{"cnt":[[247,525],[756,525],[756,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":511,"height":49},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9dce895f09a9436282a604834ea98b99","type":"text","conversion_output":true,"parent_id":"9c99232b8e464193873979882b8325bf","text":"7.3.2 Secondary analyses","text_display":"\n\n\\subsection*{7.3.2 Secondary analyses}","confidence":1,"confidence_rate":1},{"cnt":[[247,612],[1775,612],[1775,662],[247,662]],"region":{"top_left_x":246,"top_left_y":612,"width":1529,"height":51},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3af17820c2fe48de925668351308fcb9","type":"text","conversion_output":true,"text":"In addition to the primary analysis (time to first event), crude rates will be displayed for the","text_display":"\n\nIn addition to the primary analysis (time to first event), crude rates will be displayed for the","confidence":1,"confidence_rate":1},{"cnt":[[247,662],[1697,662],[1697,710],[247,710]],"region":{"top_left_x":246,"top_left_y":662,"width":1452,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1bc3c9972ca4a4494b699e30c12f839","type":"text","conversion_output":true,"text":"primary and key secondary endpoints. The interpretation of crude rates has to take into","text_display":" primary and key secondary endpoints. The interpretation of crude rates has to take into","confidence":1,"confidence_rate":1},{"cnt":[[247,708],[1686,708],[1686,756],[247,756]],"region":{"top_left_x":246,"top_left_y":708,"width":1440,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4d9083d48b44c7aba8c7c205aa9df19","type":"text","conversion_output":true,"text":"account that the likelihood to observe an event increases with a longer survival and/or","text_display":" account that the likelihood to observe an event increases with a longer survival and/or","confidence":1,"confidence_rate":1},{"cnt":[[247,758],[1752,758],[1752,806],[247,806]],"region":{"top_left_x":246,"top_left_y":758,"width":1507,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44a0206938e843849002440a8ea39620","type":"text","conversion_output":true,"text":"observation period; therefore a difference between the treatment groups with regard to the","text_display":" observation period; therefore a difference between the treatment groups with regard to the","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[247,806],[962,806],[962,857],[247,857]],"region":{"top_left_x":246,"top_left_y":806,"width":716,"height":51},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd8227011b894d108ad071d5d8a8d5b0","type":"text","conversion_output":true,"text":"actual observation period will be explored.","text_display":" actual observation period will be explored.","confidence":1,"confidence_rate":1},{"cnt":[[247,891],[1761,891],[1761,943],[247,943]],"region":{"top_left_x":246,"top_left_y":890,"width":1516,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"352355bb26f341f4976f90604a70bf4f","type":"text","conversion_output":true,"text":"The key secondary endpoints are is time to the first occurrence of any of the following by","text_display":"\n\nThe key secondary endpoints are is time to the first occurrence of any of the following by","confidence":0.7893693447113037,"confidence_rate":0.9975134025058864},{"cnt":[[247,946],[907,946],[907,994],[247,994]],"region":{"top_left_x":246,"top_left_y":945,"width":661,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb299c2dd2d2440c96b681e4ed616bec","type":"text","conversion_output":true,"text":"adjudication confirmed components:","text_display":" adjudication confirmed components:","confidence":1,"confidence_rate":1},{"cnt":[[306,1035],[1807,1035],[1807,1085],[306,1085]],"region":{"top_left_x":306,"top_left_y":1034,"width":1501,"height":52},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4d8104e9b554f76883628c5ed645812","type":"text","conversion_output":true,"text":"- CV death (including fatal stroke, fatal MI and sudden death), non-fatal MI (excluding","text_display":"\n- CV death (including fatal stroke, fatal MI and sudden death), non-fatal MI (excluding","confidence":0.99462890625,"confidence_rate":0.9999414629097472},{"cnt":[[370,1083],[1117,1083],[1117,1135],[370,1135]],"region":{"top_left_x":370,"top_left_y":1082,"width":748,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91cf10c71a8f4f1890170995fb39df84","type":"text","conversion_output":true,"text":"silent MI), non-fatal stroke ( 3 -point MACE)","text_display":" silent MI), non-fatal stroke ( 3 -point MACE)","confidence":0.9912149906158447,"confidence_rate":0.9998335265926296},{"cnt":[[306,1135],[1738,1135],[1738,1183],[306,1183]],"region":{"top_left_x":306,"top_left_y":1135,"width":1433,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"711eb2e0e28d479cb70543f23087c880","type":"text","conversion_output":true,"text":"- Composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50","text_display":"\n- Composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[370,1181],[761,1181],[761,1231],[370,1231]],"region":{"top_left_x":370,"top_left_y":1181,"width":391,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e6214df73b5c4164a13aab26fbdf80ff","type":"text","conversion_output":true,"text":"40\\% or more in eGFR)","text_display":" 40\\% or more in eGFR)","confidence":0.9873268473918415,"confidence_rate":0.9994899644325906},{"cnt":[[247,1279],[1757,1279],[1757,1327],[247,1327]],"region":{"top_left_x":246,"top_left_y":1279,"width":1511,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"633f681ee1c24b9dbfc33cc1471e8cf9","type":"text","conversion_output":true,"text":"After non-inferiority has been established for the primary endpoint ( 4 3-point MACE), the","text_display":"\n\nAfter non-inferiority has been established for the primary endpoint ( 4 3-point MACE), the","confidence":0.8347111174950328,"confidence_rate":0.998158131172396},{"cnt":[[247,1325],[1711,1325],[1711,1377],[247,1377]],"region":{"top_left_x":246,"top_left_y":1324,"width":1465,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"508c0b06118d491d8cfb28ef2e4d4037","type":"text","conversion_output":true,"text":"same endpoint and the composite renal endpoint (at the final analysis) will be tested for","text_display":" same endpoint and the composite renal endpoint (at the final analysis) will be tested for","confidence":1,"confidence_rate":1},{"cnt":[[247,1375],[1816,1375],[1816,1423],[247,1423]],"region":{"top_left_x":246,"top_left_y":1375,"width":1571,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ad0aaa5d87a46139e44d4f2ac0fe3ee","type":"text","conversion_output":true,"text":"superiority. In case of significant superiority of the 4 point MACE and/or the composite renal","text_display":" superiority. In case of significant superiority of the 4 point MACE and/or the composite renal","confidence":0.8721547513268888,"confidence_rate":0.9986598360414759},{"cnt":[[247,1421],[1309,1421],[1309,1473],[247,1473]],"region":{"top_left_x":246,"top_left_y":1420,"width":1063,"height":54},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"399e8db893d84053b8f433aec90583d6","type":"text","conversion_output":true,"text":"endpoint, the 3 -point MACE will then be tested for superiority.","text_display":" endpoint, the 3 -point MACE will then be tested for superiority.","confidence":0.9975595474243164,"confidence_rate":0.99996606397398},{"cnt":[[247,1512],[1665,1512],[1665,1560],[247,1560]],"region":{"top_left_x":246,"top_left_y":1512,"width":1420,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b1ad4e358244fcf8004882b17a5f869","type":"text","conversion_output":true,"text":"For the primary, and-key secondary endpoints and, their individual components; and","text_display":"\n\nFor the primary, and-key secondary endpoints and, their individual components; and","confidence":0.9951193332672119,"confidence_rate":0.9999437646147967},{"cnt":[[649,1558],[1782,1558],[1782,1610],[649,1610]],"region":{"top_left_x":648,"top_left_y":1557,"width":1134,"height":54},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c2a60cf954c46a78f5733da56114fca","type":"text","conversion_output":true,"text":"the time-to-event analyses will be based on the randomization date;","text_display":" the time-to-event analyses will be based on the randomization date;","confidence":1,"confidence_rate":1},{"cnt":[[247,1608],[1784,1608],[1784,1656],[247,1656]],"region":{"top_left_x":246,"top_left_y":1608,"width":1539,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9d2a8b2d2e24d35b0d1f724d76b9a06","type":"text","conversion_output":true,"text":"for the other endpoints time-to-AE analyses the date of first study drug intake will be used.","text_display":" for the other endpoints time-to-AE analyses the date of first study drug intake will be used.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":30,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b5261a9a72954c27a341a471c842c7b3","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":31,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"01c3437e3fac44768aaa259b285a6bc5","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":32,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f06cdbb4504c4955abefe7acb4d0e18d","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-065","page":65,"lines":[{"cnt":[[244,119],[610,119],[610,167],[244,167]],"region":{"top_left_x":244,"top_left_y":118,"width":366,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b616e21c40d74c209e1245e6cf7fbb67","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6cafedf366d446e093c6b06e5f623e08","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19d21b8dc35a4836bbaa6898db15479f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,206],[637,206],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":205,"width":394,"height":44},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"867a25dfeb3948b6a4ded6d05cca3a95","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,208],[1108,208],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":207,"width":240,"height":42},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf6e994fe070439892504b5f5987701a","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,206],[1816,206],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":205,"width":246,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ef0c6d28f8d43e2b78f14741978b3a2","type":"page_info","conversion_output":false,"text":"Page 65 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,2444],[532,2444],[532,2492],[244,2492]],"region":{"top_left_x":244,"top_left_y":2444,"width":289,"height":49},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3a203808e2b64788b875ac5e6663e336","type":"text","conversion_output":true,"text":"Other endpoints:","text_display":"\n\nOther endpoints:","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":8,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d0398fc4fb2440d09025c46f092c1982","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[288,2618],[1800,2618],[1800,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2617,"width":1514,"height":45},"line":9,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"33922ee6355e4f89afc5c99dfe5554ee","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99267578125,"confidence_rate":0.9999382273489243},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1b812d0757274fbfbea77cf72d440530","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-066","page":66,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba8214fe1a2746b7a4e70bf5c1715a70","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f620334dd52b440493d4c40a77c213a8","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"363fa672f8f843c4adea4326c5c491c1","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"86404f7eab27430c880f0a9937f53513","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b6de65c5c05409a98ca4978c9f87fa3","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ce0c9839128474e85445556ca253be2","type":"page_info","conversion_output":false,"text":"Page 66 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,964],[1654,964],[1654,1012],[247,1012]],"region":{"top_left_x":246,"top_left_y":964,"width":1408,"height":48},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b03744b44bb430daa5d1c7aa6f6a8e9","type":"text","conversion_output":true,"text":"The key secondary endpoints and the individual components of the primary and key","text_display":"\n\nThe key secondary endpoints and the individual components of the primary and key","confidence":1,"confidence_rate":1},{"cnt":[[244,1010],[1798,1010],[1798,1058],[244,1058]],"region":{"top_left_x":244,"top_left_y":1009,"width":1554,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41d52a8a8aa544789fef85da3f8d2725","type":"text","conversion_output":true,"text":"secondary endpoints will be analysed as time to first occurrence. In addition, crude rates will","text_display":" secondary endpoints will be analysed as time to first occurrence. In addition, crude rates will","confidence":1,"confidence_rate":1},{"cnt":[[244,1055],[1807,1055],[1807,1108],[244,1108]],"region":{"top_left_x":244,"top_left_y":1055,"width":1563,"height":53},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25f9484f94324c48be0a18f7da6f9ec7","type":"text","conversion_output":true,"text":"be displayed. Chi-Square tests will be applied for efficacy data; these tests will be interpreted","text_display":" be displayed. Chi-Square tests will be applied for efficacy data; these tests will be interpreted","confidence":1,"confidence_rate":1},{"cnt":[[247,1106],[1716,1106],[1716,1154],[247,1154]],"region":{"top_left_x":246,"top_left_y":1105,"width":1470,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9faf8245faa4a5db4fc4e24ece88f47","type":"text","conversion_output":true,"text":"in an exploratory sense, two-sided p-values without alpha-adjustment will be presented.","text_display":" in an exploratory sense, two-sided p-values without alpha-adjustment will be presented.","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[247,1154],[1784,1154],[1784,1202],[247,1202]],"region":{"top_left_x":246,"top_left_y":1153,"width":1539,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7350f0a8242419585f513d839f97561","type":"text","conversion_output":true,"text":"Wilson confidence intervals will be reported for the proportion of patients with primary and","text_display":" Wilson confidence intervals will be reported for the proportion of patients with primary and","confidence":1,"confidence_rate":1},{"cnt":[[247,1202],[1579,1202],[1579,1250],[247,1250]],"region":{"top_left_x":246,"top_left_y":1201,"width":1333,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3222ced02125456580834577271abdf6","type":"text","conversion_output":true,"text":"key secondary endpoints; in addition logistic regression models will be applied.","text_display":" key secondary endpoints; in addition logistic regression models will be applied.","confidence":1,"confidence_rate":1},{"cnt":[[242,1288],[683,1288],[683,1345],[242,1345]],"region":{"top_left_x":242,"top_left_y":1288,"width":442,"height":58},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eeeac2dc374443718b9203206631ac33","type":"section_header","conversion_output":false,"children_ids":["01100c9d3d484c0d8e5867049b66c98b"],"text":"","text_display":""},{"cnt":[[247,1293],[678,1293],[678,1341],[247,1341]],"region":{"top_left_x":246,"top_left_y":1292,"width":433,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01100c9d3d484c0d8e5867049b66c98b","type":"text","conversion_output":true,"parent_id":"eeeac2dc374443718b9203206631ac33","text":"7.3.3 Safety analyses","text_display":"\n\n\\subsection*{7.3.3 Safety analyses}","confidence":1,"confidence_rate":1},{"cnt":[[247,1380],[1638,1380],[1638,1428],[247,1428]],"region":{"top_left_x":246,"top_left_y":1379,"width":1392,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9779183cfd6a4aa19a8c6b12b45f42b9","type":"text","conversion_output":true,"text":"All safety data will be displayed and analysed (Treated Set, 'as randomized') using","text_display":"\n\nAll safety data will be displayed and analysed (Treated Set, 'as randomized') using","confidence":1,"confidence_rate":1},{"cnt":[[247,1430],[1622,1430],[1622,1478],[247,1478]],"region":{"top_left_x":246,"top_left_y":1430,"width":1376,"height":48},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19c5373324274b2e8df1e9f83d284fee","type":"text","conversion_output":true,"text":"descriptive statistical methods. No formal inferential analysis is planned for safety","text_display":" descriptive statistical methods. No formal inferential analysis is planned for safety","confidence":1,"confidence_rate":1},{"cnt":[[247,1476],[1761,1476],[1761,1524],[247,1524]],"region":{"top_left_x":246,"top_left_y":1475,"width":1516,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6bdec7d9f06e4aa4b54bed0612869159","type":"text","conversion_output":true,"text":"comparisons. AEs will be coded using the medical dictionary for drug regulatory activities","text_display":" comparisons. AEs will be coded using the medical dictionary for drug regulatory activities","confidence":1,"confidence_rate":1},{"cnt":[[247,1524],[1629,1524],[1629,1574],[247,1574]],"region":{"top_left_x":246,"top_left_y":1523,"width":1383,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3cfa89b09f64800927ed51703f8df01","type":"text","conversion_output":true,"text":"(MedDRA) coding dictionary. All events with an onset after the first dose of study","text_display":" (MedDRA) coding dictionary. All events with an onset after the first dose of study","confidence":1,"confidence_rate":1},{"cnt":[[247,1572],[1684,1572],[1684,1620],[247,1620]],"region":{"top_left_x":246,"top_left_y":1571,"width":1438,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd4822396b964013abb85b6374162f49","type":"text","conversion_output":true,"text":"medication up to a period of seven days after the last dose of study medication will be","text_display":" medication up to a period of seven days after the last dose of study medication will be","confidence":1,"confidence_rate":1},{"cnt":[[247,1622],[1725,1622],[1725,1670],[247,1670]],"region":{"top_left_x":246,"top_left_y":1621,"width":1479,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd5bfcb34d6244fab7eaec104a5a7a30","type":"text","conversion_output":true,"text":"assigned to the treatment phase for evaluation; in addition, all AEs after the first dose of","text_display":" assigned to the treatment phase for evaluation; in addition, all AEs after the first dose of","confidence":1,"confidence_rate":1},{"cnt":[[247,1668],[1793,1668],[1793,1716],[247,1716]],"region":{"top_left_x":246,"top_left_y":1667,"width":1548,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d47ec75f57c4ff2987c7695793f4d62","type":"text","conversion_output":true,"text":"study medication will be displayed by randomized treatment group. Laboratory values taken","text_display":" study medication will be displayed by randomized treatment group. Laboratory values taken","confidence":1,"confidence_rate":1},{"cnt":[[247,1718],[1780,1718],[1780,1766],[247,1766]],"region":{"top_left_x":246,"top_left_y":1717,"width":1534,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a734e61af9345fdb4e53bca1252c089","type":"text","conversion_output":true,"text":"after the first dose of randomized treatment up to a period of seven days after the last intake","text_display":" after the first dose of randomized treatment up to a period of seven days after the last intake","confidence":1,"confidence_rate":1},{"cnt":[[247,1764],[1802,1764],[1802,1812],[247,1812]],"region":{"top_left_x":246,"top_left_y":1763,"width":1557,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7956f2c8acc8491abbeee593ff28b1dc","type":"text","conversion_output":true,"text":"of treatment will be assigned to the treatment phase for evaluation. Laboratory values will be","text_display":" of treatment will be assigned to the treatment phase for evaluation. Laboratory values will be","confidence":1,"confidence_rate":1},{"cnt":[[247,1814],[1775,1814],[1775,1862],[247,1862]],"region":{"top_left_x":246,"top_left_y":1813,"width":1529,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a418e6fbea942c69595082d848df811","type":"text","conversion_output":true,"text":"compared to their reference ranges and frequency tables will be provided for the number of","text_display":" compared to their reference ranges and frequency tables will be provided for the number of","confidence":1,"confidence_rate":1},{"cnt":[[244,1859],[1802,1859],[1802,1907],[244,1907]],"region":{"top_left_x":244,"top_left_y":1859,"width":1559,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01d66e87d0314956908157664962f3fb","type":"text","conversion_output":true,"text":"patients within and outside the reference range. Changes from baseline in blood pressure and","text_display":" patients within and outside the reference range. Changes from baseline in blood pressure and","confidence":1,"confidence_rate":1},{"cnt":[[244,1907],[1784,1907],[1784,1958],[244,1958]],"region":{"top_left_x":244,"top_left_y":1907,"width":1541,"height":51},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bffc6e4089a740a585c613201bbfdb21","type":"text","conversion_output":true,"text":"pulse rate will be summarised by treatment group. For hypoglycaemic events the incidences","text_display":" pulse rate will be summarised by treatment group. For hypoglycaemic events the incidences","confidence":1,"confidence_rate":1},{"cnt":[[247,1955],[1286,1955],[1286,2003],[247,2003]],"region":{"top_left_x":246,"top_left_y":1955,"width":1041,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06e36f7730c54d2c8862010beb677167","type":"text","conversion_output":true,"text":"and the treatment-time adjusted frequencies will be displayed.","text_display":" and the treatment-time adjusted frequencies will be displayed.","confidence":1,"confidence_rate":1},{"cnt":[[242,2042],[708,2042],[708,2099],[242,2099]],"region":{"top_left_x":242,"top_left_y":2042,"width":467,"height":58},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1cdd20238a2f45349b86645d340eaf4c","type":"section_header","conversion_output":false,"children_ids":["d3a89705fba641d6b29f296152f7dd27"],"text":"","text_display":""},{"cnt":[[247,2047],[706,2047],[706,2095],[247,2095]],"region":{"top_left_x":246,"top_left_y":2046,"width":460,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3a89705fba641d6b29f296152f7dd27","type":"text","conversion_output":true,"parent_id":"1cdd20238a2f45349b86645d340eaf4c","text":"7.3.4 Interim analyses","text_display":"\n\n\\subsection*{7.3.4 Interim analyses}","confidence":1,"confidence_rate":1},{"cnt":[[244,2134],[1812,2134],[1812,2182],[244,2182]],"region":{"top_left_x":244,"top_left_y":2133,"width":1568,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4e53eda29fd48f1af7b94387d5cefc8","type":"text","conversion_output":true,"text":"An independent Data Monitoring Committee (DMC) will review safety and efficacy data and","text_display":"\n\nAn independent Data Monitoring Committee (DMC) will review safety and efficacy data and","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[247,2184],[1784,2184],[1784,2232],[247,2232]],"region":{"top_left_x":246,"top_left_y":2183,"width":1539,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abfc69894dc64ae8987d4bb52b16474e","type":"text","conversion_output":true,"text":"make recommendations whether to continue or terminate the study. As described in Section","text_display":" make recommendations whether to continue or terminate the study. As described in Section","confidence":1,"confidence_rate":1},{"cnt":[[247,2230],[1720,2230],[1720,2278],[247,2278]],"region":{"top_left_x":246,"top_left_y":2229,"width":1475,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49b3dfdd3c694e8ba01025aacf9c3578","type":"text","conversion_output":true,"text":"3.1.1 the DMC analyses and operations will be formally separated from the sponsor, the","text_display":" 3.1.1 the DMC analyses and operations will be formally separated from the sponsor, the","confidence":1,"confidence_rate":1},{"cnt":[[247,2280],[1780,2280],[1780,2328],[247,2328]],"region":{"top_left_x":246,"top_left_y":2279,"width":1534,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1043603f375f4ae1844b3ad6bb878350","type":"text","conversion_output":true,"text":"investigators and the Steering Committee. The details on its procedures and interactions are","text_display":" investigators and the Steering Committee. The details on its procedures and interactions are","confidence":1,"confidence_rate":1},{"cnt":[[244,2325],[870,2325],[870,2378],[244,2378]],"region":{"top_left_x":244,"top_left_y":2325,"width":627,"height":54},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51ef9147a9fb4cdc8eb482d920bb61e8","type":"text","conversion_output":true,"text":"provided in a separate DMC Charter.","text_display":" provided in a separate DMC Charter.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":35,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d90ae87a5b924f3dbb2778910426b7dd","type":"section_header","conversion_output":false,"children_ids":["3a32617c15f843aabbb6eb427ef5c6c1"],"text":"","text_display":""},{"cnt":[[795,2586],[1300,2586],[1300,2620],[795,2620]],"region":{"top_left_x":794,"top_left_y":2585,"width":506,"height":36},"line":36,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3a32617c15f843aabbb6eb427ef5c6c1","type":"text","conversion_output":true,"parent_id":"d90ae87a5b924f3dbb2778910426b7dd","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":37,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0f479c35794d488e9bd2d94fda90037f","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":38,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"96aade34a0954c588172689093be4985","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-067","page":67,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a191494c30364cc9bc1f50200c2c458b","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"703df24712304132b2e23235ec7bb81e","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,167],[599,167],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":166,"width":353,"height":38},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cb3196a2c6d48f1b43b7081bab6973f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c40aa9f279124d19b6bf013532b75873","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77a5204b9c6348df8704ad17c2d5efc7","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47a2e2e789b74181999ceabc37bccb8a","type":"page_info","conversion_output":false,"text":"Page 67 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1789,338],[1789,386],[244,386]],"region":{"top_left_x":244,"top_left_y":338,"width":1545,"height":49},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9aa4610e6da44499a2aea7ebbb77c2ca","type":"text","conversion_output":true,"text":"according to Haybittle-Peto (East version 5.4), this results in a one-sided alpha of \\(2.12 \\%\\) for","text_display":"\naccording to Haybittle-Peto (East version 5.4), this results in a one-sided alpha of \\(2.12 \\%\\) for","confidence":0.9990236759185791,"confidence_rate":0.9999904235654993},{"cnt":[[244,388],[1789,388],[1789,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1545,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a8726c2be6bb40c890b7e9fa6e1f2668","type":"text","conversion_output":true,"text":"the final analysis. The first test will be on non inferiority of the primary endpoint, in case of","text_display":" the final analysis. The first test will be on non inferiority of the primary endpoint, in case of","confidence":0.9302096366882324,"confidence_rate":0.9992909837998444},{"cnt":[[247,434],[1738,434],[1738,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1493,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6c8abec50c64431082108bac2d7639da","type":"text","conversion_output":true,"text":"significance followed by the superiority tests for the composite CV endpoints outlined in","text_display":" significance followed by the superiority tests for the composite CV endpoints outlined in","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1722,484],[1722,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1477,"height":49},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"248cdd98bd07487bb5c9cf20530e45f6","type":"text","conversion_output":true,"text":"Section 7.2. No confirmatory interim analysis will be performed for the composite renal","text_display":" Section 7.2. No confirmatory interim analysis will be performed for the composite renal","confidence":0.98977469233796,"confidence_rate":0.9998882894438762},{"cnt":[[247,532],[1807,532],[1807,578],[247,578]],"region":{"top_left_x":246,"top_left_y":532,"width":1561,"height":46},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e96c00866f444582a7e8d434e2c7fe75","type":"text","conversion_output":true,"text":"endpoint, i.e. for the renal endpoint superiority will formally be tested only once after regular","text_display":" endpoint, i.e. for the renal endpoint superiority will formally be tested only once after regular","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[247,580],[1665,580],[1665,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1420,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"04bea8cfbdb74dc99b03a032fed35ce6","type":"text","conversion_output":true,"text":"or premature study termination, respectively. In case non inferiority has not yet been","text_display":" or premature study termination, respectively. In case non inferiority has not yet been","confidence":0.9150390625,"confidence_rate":0.9990247777796678},{"cnt":[[247,628],[1814,628],[1814,674],[247,674]],"region":{"top_left_x":246,"top_left_y":628,"width":1568,"height":46},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f1075ceb595a470db49a079600167837","type":"text","conversion_output":true,"text":"demonstrated, the study will be continued as planned unless the interim results indicate major","text_display":" demonstrated, the study will be continued as planned unless the interim results indicate major","confidence":1,"confidence_rate":1},{"cnt":[[247,676],[1748,676],[1748,724],[247,724]],"region":{"top_left_x":246,"top_left_y":676,"width":1502,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e2c4f98aa0fe4e54840b8045d0bafe1c","type":"text","conversion_output":true,"text":"safety concerns. In case of demonstrated superiority of the primary variable at the interim","text_display":" safety concerns. In case of demonstrated superiority of the primary variable at the interim","confidence":0.998046875,"confidence_rate":0.9999796352611579},{"cnt":[[247,722],[1688,722],[1688,770],[247,770]],"region":{"top_left_x":246,"top_left_y":721,"width":1443,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9e022d40341d40079d6f61b3710000f2","type":"text","conversion_output":true,"text":"analysis, the DMC may recommend stopping the study; non-inferiority of the primary","text_display":" analysis, the DMC may recommend stopping the study; non-inferiority of the primary","confidence":0.9990234375,"confidence_rate":0.9999887697222805},{"cnt":[[247,772],[1770,772],[1770,818],[247,818]],"region":{"top_left_x":246,"top_left_y":772,"width":1525,"height":46},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8f97569f4ef944ceb71efcad6b9128c2","type":"text","conversion_output":true,"text":"endpoint may lead to early study termination if the DMC considers it unrealistic to achieve","text_display":" endpoint may lead to early study termination if the DMC considers it unrealistic to achieve","confidence":1,"confidence_rate":1},{"cnt":[[247,818],[1282,818],[1282,866],[247,866]],"region":{"top_left_x":246,"top_left_y":817,"width":1036,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"08b17c38fc1249069fd43fa96b0a3ed3","type":"text","conversion_output":true,"text":"superiority. Further details will be given in the DMC Charter.","text_display":" superiority. Further details will be given in the DMC Charter.","confidence":1,"confidence_rate":1},{"cnt":[[247,909],[1805,909],[1805,957],[247,957]],"region":{"top_left_x":246,"top_left_y":909,"width":1559,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ad201ad051944ddebf8f3290c97ab073","type":"text","conversion_output":true,"text":"Prior to the interim final analysis, the SC will evaluate available external data with relevance","text_display":"\n\nPrior to the interim final analysis, the SC will evaluate available external data with relevance","confidence":0.9785356521606445,"confidence_rate":0.9997851908244455},{"cnt":[[247,957],[1738,957],[1738,1007],[247,1007]],"region":{"top_left_x":246,"top_left_y":957,"width":1493,"height":51},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"93b5601e7e20476ca9000e45d16abaa7","type":"text","conversion_output":true,"text":"for the superiority test strategy and consequently may suggest to the sponsor adapting the","text_display":" for the superiority test strategy and consequently may suggest to the sponsor adapting the","confidence":1,"confidence_rate":1},{"cnt":[[247,1005],[934,1005],[934,1053],[247,1053]],"region":{"top_left_x":246,"top_left_y":1005,"width":689,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2e80428c6f4141639d6a725cbba48ead","type":"text","conversion_output":true,"text":"assumptions and study size, respectively.","text_display":" assumptions and study size, respectively.","confidence":1,"confidence_rate":1},{"cnt":[[244,1092],[1789,1092],[1789,1140],[244,1140]],"region":{"top_left_x":244,"top_left_y":1091,"width":1545,"height":49},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"aeca02a2a67a4773923853529bea99a3","type":"text","conversion_output":true,"text":"In addition there will be interim analyses for safety, based on all adverse events as recorded,","text_display":"\n\nIn addition there will be interim analyses for safety, based on all adverse events as recorded,","confidence":1,"confidence_rate":1},{"cnt":[[247,1142],[1766,1142],[1766,1190],[247,1190]],"region":{"top_left_x":246,"top_left_y":1142,"width":1520,"height":49},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c01490bf84914cfba3a5810b6bacebc1","type":"text","conversion_output":true,"text":"but these interim analyses may not lead to early study termination due to demonstrate non-","text_display":" but these interim analyses may not lead to early study termination due to demonstrate non","confidence":1,"confidence_rate":1},{"cnt":[[247,1190],[1789,1190],[1789,1238],[247,1238]],"region":{"top_left_x":246,"top_left_y":1190,"width":1543,"height":49},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a0bce71b1dc546928f9a9d7dedf77382","type":"text","conversion_output":true,"text":"inferiority or superiority; therefore these interim safety analyses have no negative impact on","text_display":"inferiority or superiority; therefore these interim safety analyses have no negative impact on","confidence":1,"confidence_rate":1},{"cnt":[[247,1238],[507,1238],[507,1286],[247,1286]],"region":{"top_left_x":246,"top_left_y":1238,"width":262,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b8ad8c9baf944c2a8e850e22de70669c","type":"text","conversion_output":true,"text":"the alpha-level.","text_display":" the alpha-level.","confidence":1,"confidence_rate":1},{"cnt":[[242,1325],[875,1325],[875,1380],[242,1380]],"region":{"top_left_x":242,"top_left_y":1324,"width":633,"height":56},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a5c2bc829f444488b13677e80b0ffb11","type":"section_header","conversion_output":false,"children_ids":["e6031cd392a642e389507cd9e518db2f"],"text":"","text_display":""},{"cnt":[[247,1330],[870,1330],[870,1375],[247,1375]],"region":{"top_left_x":246,"top_left_y":1329,"width":625,"height":47},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e6031cd392a642e389507cd9e518db2f","type":"text","conversion_output":true,"parent_id":"a5c2bc829f444488b13677e80b0ffb11","text":"7.3.5 Pharmacokinetic analyses","text_display":"\n\n\\subsection*{7.3.5 Pharmacokinetic analyses}","confidence":1,"confidence_rate":1},{"cnt":[[247,1416],[738,1416],[738,1464],[247,1464]],"region":{"top_left_x":246,"top_left_y":1416,"width":492,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4c76d0d50f444bc081ffcb3d2f774621","type":"text","conversion_output":true,"text":"Not specified in this protocol","text_display":"\n\nNot specified in this protocol","confidence":1,"confidence_rate":1},{"cnt":[[242,1503],[907,1503],[907,1560],[242,1560]],"region":{"top_left_x":242,"top_left_y":1503,"width":665,"height":58},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ca22c7b6b2c54a3780bb18f6b823da02","type":"section_header","conversion_output":false,"children_ids":["23b7502ab8e44f0db411efbed4b6c377"],"text":"","text_display":""},{"cnt":[[247,1508],[902,1508],[902,1556],[247,1556]],"region":{"top_left_x":246,"top_left_y":1507,"width":657,"height":49},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"23b7502ab8e44f0db411efbed4b6c377","type":"text","conversion_output":true,"parent_id":"ca22c7b6b2c54a3780bb18f6b823da02","text":"7.3.6 Pharmacodynamic analyses","text_display":"\n\n\\subsection*{7.3.6 Pharmacodynamic analyses}","confidence":1,"confidence_rate":1},{"cnt":[[244,1594],[740,1594],[740,1647],[244,1647]],"region":{"top_left_x":244,"top_left_y":1594,"width":497,"height":54},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b75f1f46b26040099104e310870b7a54","type":"text","conversion_output":true,"text":"Not specified in this protocol","text_display":"\n\nNot specified in this protocol","confidence":1,"confidence_rate":1},{"cnt":[[242,1684],[902,1684],[902,1738],[242,1738]],"region":{"top_left_x":242,"top_left_y":1683,"width":661,"height":56},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4a3115e1ae4a4e7c9c51164d3078e312","type":"section_header","conversion_output":false,"children_ids":["738648f4f8c7468395dceeed864529c4"],"text":"","text_display":""},{"cnt":[[247,1686],[898,1686],[898,1734],[247,1734]],"region":{"top_left_x":246,"top_left_y":1685,"width":652,"height":49},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"738648f4f8c7468395dceeed864529c4","type":"text","conversion_output":true,"parent_id":"4a3115e1ae4a4e7c9c51164d3078e312","text":"7.3.7 Pharmacogenomic analyses","text_display":"\n\n\\subsection*{7.3.7 Pharmacogenomic analyses}","confidence":1,"confidence_rate":1},{"cnt":[[247,1775],[1140,1775],[1140,1823],[247,1823]],"region":{"top_left_x":246,"top_left_y":1774,"width":894,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9ac3add1388b4db38df3bb1d580ead84","type":"text","conversion_output":true,"text":"No prespecified pharmacogenomic analyses planned.","text_display":"\n\nNo prespecified pharmacogenomic analyses planned.","confidence":1,"confidence_rate":1},{"cnt":[[242,1859],[1030,1859],[1030,1912],[242,1912]],"region":{"top_left_x":242,"top_left_y":1859,"width":789,"height":54},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"740760b761414880b62223b2a242c029","type":"section_header","conversion_output":false,"children_ids":["e2a48406ff5348f5a25420f8530e7c32"],"text":"","text_display":""},{"cnt":[[247,1864],[1026,1864],[1026,1907],[247,1907]],"region":{"top_left_x":246,"top_left_y":1864,"width":780,"height":44},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e2a48406ff5348f5a25420f8530e7c32","type":"text","conversion_output":true,"parent_id":"740760b761414880b62223b2a242c029","text":"7.4 HANDLING OF MISSING DATA","text_display":"\n\n\\subsection*{7.4 HANDLING OF MISSING DATA}","confidence":1,"confidence_rate":1},{"cnt":[[247,1955],[1816,1955],[1816,2003],[247,2003]],"region":{"top_left_x":246,"top_left_y":1955,"width":1571,"height":49},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"558eeba74efc4fcb883efd67ed743b38","type":"text","conversion_output":true,"text":"Patients with temporary or permanent study treatment termination will be followed up for CV","text_display":"\n\nPatients with temporary or permanent study treatment termination will be followed up for CV","confidence":1,"confidence_rate":1},{"cnt":[[247,2003],[1784,2003],[1784,2049],[247,2049]],"region":{"top_left_x":246,"top_left_y":2003,"width":1539,"height":47},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"329d4eefd2a340cebec882cb2a8d84b9","type":"text","conversion_output":true,"text":"events. Details on how to handle missing data will be outlined in detail in the trial statistical","text_display":" events. Details on how to handle missing data will be outlined in detail in the trial statistical","confidence":0.99462890625,"confidence_rate":0.9999472016886584},{"cnt":[[247,2051],[617,2051],[617,2099],[247,2099]],"region":{"top_left_x":246,"top_left_y":2051,"width":371,"height":49},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"369041d293b343c88db7514a51458b30","type":"text","conversion_output":true,"text":"analysis plan (TSAP).","text_display":" analysis plan (TSAP).","confidence":1,"confidence_rate":1},{"cnt":[[247,2138],[1441,2138],[1441,2186],[247,2186]],"region":{"top_left_x":246,"top_left_y":2138,"width":1196,"height":49},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"04fe20eba5ad46e39b679c0c6901202e","type":"text","conversion_output":true,"text":"CV safety and other safety endpoints (including renal safety endpoints)","text_display":"\n\nCV safety and other safety endpoints (including renal safety endpoints)","confidence":1,"confidence_rate":1},{"cnt":[[247,2230],[957,2230],[957,2278],[247,2278]],"region":{"top_left_x":246,"top_left_y":2229,"width":712,"height":49},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c1a6d0dfe10e4eafbfcc75f27895211e","type":"text","conversion_output":true,"text":"It is not planned to impute missing values.","text_display":"\nIt is not planned to impute missing values.","confidence":1,"confidence_rate":1},{"cnt":[[242,2316],[699,2316],[699,2369],[242,2369]],"region":{"top_left_x":242,"top_left_y":2316,"width":458,"height":53},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1ca759192f0749fca1c73fccb1265f21","type":"section_header","conversion_output":false,"children_ids":["f27684660d78464fb26e9edd69744279"],"text":"","text_display":""},{"cnt":[[247,2316],[697,2316],[697,2364],[247,2364]],"region":{"top_left_x":246,"top_left_y":2316,"width":451,"height":49},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f27684660d78464fb26e9edd69744279","type":"text","conversion_output":true,"parent_id":"1ca759192f0749fca1c73fccb1265f21","text":"Diabetes related endpoints","text_display":"\n\n\\section*{Diabetes related endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[247,2408],[1670,2408],[1670,2456],[247,2456]],"region":{"top_left_x":246,"top_left_y":2407,"width":1424,"height":49},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"02387eeead5a481eb92583e514d2756b","type":"text","conversion_output":true,"text":"Missing efficacy data for continuous variables for patients who discontinue the study","text_display":"\n\nMissing efficacy data for continuous variables for patients who discontinue the study","confidence":1,"confidence_rate":1},{"cnt":[[247,2458],[1764,2458],[1764,2506],[247,2506]],"region":{"top_left_x":246,"top_left_y":2457,"width":1518,"height":49},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2bf5c55605f143e591c6eecefd9570be","type":"text","conversion_output":true,"text":"treatment prematurely or miss a visit will be estimated by their last observed data. Missing","text_display":" treatment prematurely or miss a visit will be estimated by their last observed data. Missing","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1a99b75061664fb8b49b99485d00ce93","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99462890625,"confidence_rate":0.9998717803653021},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"220c34511ae34909a64e37418987b8e8","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"04a5d4ffd8524f79b787dd7c299f8243","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-068","page":68,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"365b4731aead416e842b79f63c12f1ee","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8edf68d14144598836a45a2fd7cb13b","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58341e2318794e70ae10ce8393da87eb","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5e12a12e1c14292ae85b2a1ee1d2fe0","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9e4cbfeae4f47c6a84f314a7b579336","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47c5b1599d4f4e13b56fbdb69390b5dd","type":"page_info","conversion_output":false,"text":"Page 68 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1629,338],[1629,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":1383,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31f010a5904a4c029045b08355c9458a","type":"text","conversion_output":true,"text":"data for binary efficacy endpoints for patients who discontinue the study treatment","text_display":"\ndata for binary efficacy endpoints for patients who discontinue the study treatment","confidence":1,"confidence_rate":1},{"cnt":[[244,388],[1455,388],[1455,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1212,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c1c092b81034770bbb403377b238d6f","type":"text","conversion_output":true,"text":"prematurely will be considered as non-responders (worst case-scenario).","text_display":" prematurely will be considered as non-responders (worst case-scenario).","confidence":1,"confidence_rate":1},{"cnt":[[247,477],[1793,477],[1793,523],[247,523]],"region":{"top_left_x":246,"top_left_y":477,"width":1548,"height":47},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9cfbbec6e48e47ea972cda1200b16078","type":"text","conversion_output":true,"text":"Methods to handle any other exceptional cases will be considered before unblinding the data","text_display":"\n\nMethods to handle any other exceptional cases will be considered before unblinding the data","confidence":1,"confidence_rate":1},{"cnt":[[247,525],[1770,525],[1770,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1525,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f843d252bb154d8fa79f0dc4d05189ea","type":"text","conversion_output":true,"text":"and will be applied in a manner consistent with other trials of this type. The evaluability of","text_display":" and will be applied in a manner consistent with other trials of this type. The evaluability of","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[244,571],[1750,571],[1750,624],[244,624]],"region":{"top_left_x":244,"top_left_y":571,"width":1506,"height":53},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8b4ac425d154dfa82e597bd9b586377","type":"text","conversion_output":true,"text":"patients with deviations from the protocol likely to confound the primary endpoint will be","text_display":" patients with deviations from the protocol likely to confound the primary endpoint will be","confidence":1,"confidence_rate":1},{"cnt":[[247,621],[715,621],[715,669],[247,669]],"region":{"top_left_x":246,"top_left_y":621,"width":470,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3d307e4b06e416a994ec82c5f68d0b6","type":"text","conversion_output":true,"text":"decided prior to unblinding.","text_display":" decided prior to unblinding.","confidence":1,"confidence_rate":1},{"cnt":[[247,708],[1704,708],[1704,758],[247,758]],"region":{"top_left_x":246,"top_left_y":708,"width":1459,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e61d454ce1fc4e41a77b4091ee1e02e9","type":"text","conversion_output":true,"text":"The impact of all methods of handling missing data will be analysed using a sensitivity","text_display":"\n\nThe impact of all methods of handling missing data will be analysed using a sensitivity","confidence":1,"confidence_rate":1},{"cnt":[[247,758],[1656,758],[1656,806],[247,806]],"region":{"top_left_x":246,"top_left_y":758,"width":1411,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96cc1d9b215548209bed02128665fad2","type":"text","conversion_output":true,"text":"analysis by performing an analysis of the original data (i.e. without any imputation).","text_display":" analysis by performing an analysis of the original data (i.e. without any imputation).","confidence":0.9723567962646484,"confidence_rate":0.999691998348507},{"cnt":[[242,845],[788,845],[788,893],[242,893]],"region":{"top_left_x":242,"top_left_y":845,"width":547,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb38ff8afd194eee983c2c6cb32d4fe5","type":"section_header","conversion_output":false,"children_ids":["11be4857105d4a49a2a688e5a0d86187"],"text":"","text_display":""},{"cnt":[[247,850],[784,850],[784,889],[247,889]],"region":{"top_left_x":246,"top_left_y":849,"width":538,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11be4857105d4a49a2a688e5a0d86187","type":"text","conversion_output":true,"parent_id":"eb38ff8afd194eee983c2c6cb32d4fe5","text":"7.5 RANDOMIZATION","text_display":"\n\n\\subsection*{7.5 RANDOMIZATION}","confidence":1,"confidence_rate":1},{"cnt":[[244,937],[1768,937],[1768,987],[244,987]],"region":{"top_left_x":244,"top_left_y":936,"width":1525,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d1aa24dc2f74626a7424d30070a3272","type":"text","conversion_output":true,"text":"The sponsor will arrange for the randomization as well as packaging and labelling of study","text_display":"\n\nThe sponsor will arrange for the randomization as well as packaging and labelling of study","confidence":1,"confidence_rate":1},{"cnt":[[247,987],[1775,987],[1775,1035],[247,1035]],"region":{"top_left_x":246,"top_left_y":986,"width":1529,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d0cb2ea42cf46be80cb54d1e68b88e2","type":"text","conversion_output":true,"text":"medication. Eligible patients will be randomly assigned to one of the two treatment groups,","text_display":" medication. Eligible patients will be randomly assigned to one of the two treatment groups,","confidence":1,"confidence_rate":1},{"cnt":[[247,1033],[1821,1033],[1821,1083],[247,1083]],"region":{"top_left_x":246,"top_left_y":1032,"width":1575,"height":51},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1300837d631d47a1aca0e37867da07cc","type":"text","conversion_output":true,"text":"with equal allocation of treatments. The randomization list will be generated using a validated","text_display":" with equal allocation of treatments. The randomization list will be generated using a validated","confidence":1,"confidence_rate":1},{"cnt":[[247,1083],[1757,1083],[1757,1131],[247,1131]],"region":{"top_left_x":246,"top_left_y":1082,"width":1511,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f939a403d0774c05930386f6d44ec023","type":"text","conversion_output":true,"text":"system, which involves a pseudo-random number generator so that the resulting treatment","text_display":" system, which involves a pseudo-random number generator so that the resulting treatment","confidence":1,"confidence_rate":1},{"cnt":[[247,1128],[1190,1128],[1190,1176],[247,1176]],"region":{"top_left_x":246,"top_left_y":1128,"width":945,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87911b7398884b40bcbb6464f68b939c","type":"text","conversion_output":true,"text":"sequence will be both reproducible and non-predictable.","text_display":" sequence will be both reproducible and non-predictable.","confidence":1,"confidence_rate":1},{"cnt":[[247,1218],[1816,1218],[1816,1268],[247,1268]],"region":{"top_left_x":246,"top_left_y":1217,"width":1571,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba2d875676dc4c05be85efa3202180ee","type":"text","conversion_output":true,"text":"The randomization will be performed in blocks. The block size will be reported in the clinical","text_display":"\n\nThe randomization will be performed in blocks. The block size will be reported in the clinical","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[247,1266],[1757,1266],[1757,1318],[247,1318]],"region":{"top_left_x":246,"top_left_y":1265,"width":1511,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c292ff86b6a49099a869a522d741ba2","type":"text","conversion_output":true,"text":"trial report. The allocation process will be performed on visit 2 through IRT. Stratification","text_display":" trial report. The allocation process will be performed on visit 2 through IRT. Stratification","confidence":1,"confidence_rate":1},{"cnt":[[247,1316],[1780,1316],[1780,1364],[247,1364]],"region":{"top_left_x":246,"top_left_y":1315,"width":1534,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"060897b3065d4bac881b350504b75f4e","type":"text","conversion_output":true,"text":"will be by geographical region. Except for the DMC, access to the code will be restricted to","text_display":" will be by geographical region. Except for the DMC, access to the code will be restricted to","confidence":0.99755859375,"confidence_rate":0.9999748004067751},{"cnt":[[247,1361],[1725,1361],[1725,1412],[247,1412]],"region":{"top_left_x":246,"top_left_y":1361,"width":1479,"height":51},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"590a7c8b92c24c9c953cca5e595a4c32","type":"text","conversion_output":true,"text":"dedicated randomization personnel and any exceptional access to the code (in case of an","text_display":" dedicated randomization personnel and any exceptional access to the code (in case of an","confidence":1,"confidence_rate":1},{"cnt":[[247,1412],[1743,1412],[1743,1460],[247,1460]],"region":{"top_left_x":246,"top_left_y":1411,"width":1497,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ebe2ff925e64d8e8724f077626bb426","type":"text","conversion_output":true,"text":"emergency) will be documented according to the sponsor's standard operating procedures","text_display":" emergency) will be documented according to the sponsor's standard operating procedures","confidence":1,"confidence_rate":1},{"cnt":[[247,1457],[381,1457],[381,1505],[247,1505]],"region":{"top_left_x":246,"top_left_y":1457,"width":136,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"09caac86688e4a05a6a7fd9a51fdef4a","type":"text","conversion_output":true,"text":"(SOPs).","text_display":" (SOPs).","confidence":1,"confidence_rate":1},{"cnt":[[247,1549],[1757,1549],[1757,1597],[247,1597]],"region":{"top_left_x":246,"top_left_y":1548,"width":1511,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"587c572fb8e34cffae82540272480412","type":"text","conversion_output":true,"text":"The study will only be unblinded after all CRF / electronic data have been entered into the","text_display":"\n\nThe study will only be unblinded after all CRF / electronic data have been entered into the","confidence":0.56591796875,"confidence_rate":0.9940872770359038},{"cnt":[[247,1594],[1818,1594],[1818,1642],[247,1642]],"region":{"top_left_x":246,"top_left_y":1594,"width":1573,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ac4ba87322a441d8fdab8b7f37b81b5","type":"text","conversion_output":true,"text":"trial database, after queries have been resolved and after the database has been locked. Access","text_display":" trial database, after queries have been resolved and after the database has been locked. Access","confidence":1,"confidence_rate":1},{"cnt":[[247,1640],[1786,1640],[1786,1693],[247,1693]],"region":{"top_left_x":246,"top_left_y":1640,"width":1541,"height":53},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4dd332638a5f4b51916ee504eb39bf4f","type":"text","conversion_output":true,"text":"to the codes will be controlled and documented by a signed confidentiality statement, which","text_display":" to the codes will be controlled and documented by a signed confidentiality statement, which","confidence":1,"confidence_rate":1},{"cnt":[[247,1690],[715,1690],[715,1734],[247,1734]],"region":{"top_left_x":246,"top_left_y":1690,"width":470,"height":44},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a63497ec6d5b4ff9b9cfab21aa146451","type":"text","conversion_output":true,"text":"will be stored in the CTMF.","text_display":" will be stored in the CTMF.","confidence":1,"confidence_rate":1},{"cnt":[[247,1782],[1748,1782],[1748,1830],[247,1830]],"region":{"top_left_x":246,"top_left_y":1781,"width":1502,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b88ca4fae651481195b723c4ecc7842e","type":"text","conversion_output":true,"text":"Practical aspects of the treatment allocation process and methods to carry out blinding are","text_display":"\n\nPractical aspects of the treatment allocation process and methods to carry out blinding are","confidence":1,"confidence_rate":1},{"cnt":[[247,1830],[1067,1830],[1067,1878],[247,1878]],"region":{"top_left_x":246,"top_left_y":1829,"width":821,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ed92ff331e24f7bbddd735ecbc02b50","type":"text","conversion_output":true,"text":"detailed in Sections 4.1.2 and 4.1.5, respectively.","text_display":" detailed in Sections 4.1.2 and 4.1.5, respectively.","confidence":1,"confidence_rate":1},{"cnt":[[242,1914],[1135,1914],[1135,1965],[242,1965]],"region":{"top_left_x":242,"top_left_y":1914,"width":894,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"759512bb27ba406db88943ed36b2bcdc","type":"section_header","conversion_output":false,"children_ids":["d030d2c81810469da1f9493517804ec5"],"text":"","text_display":""},{"cnt":[[247,1919],[1135,1919],[1135,1960],[247,1960]],"region":{"top_left_x":246,"top_left_y":1918,"width":890,"height":42},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d030d2c81810469da1f9493517804ec5","type":"text","conversion_output":true,"parent_id":"759512bb27ba406db88943ed36b2bcdc","text":"7.6 DETERMINATION OF SAMPLE SIZE","text_display":"\n\n\\subsection*{7.6 DETERMINATION OF SAMPLE SIZE}","confidence":1,"confidence_rate":1},{"cnt":[[244,2006],[1784,2006],[1784,2058],[244,2058]],"region":{"top_left_x":244,"top_left_y":2005,"width":1541,"height":54},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a608cd42abb47d3904f036da1d7d5ca","type":"text","conversion_output":true,"text":"The 1 -year event rate for the initially planned primary combined endpoint (CV death, non-","text_display":"\n\nThe 1 -year event rate for the initially planned primary combined endpoint (CV death, non","confidence":0.9200644493103027,"confidence_rate":0.9991502433111992},{"cnt":[[247,2056],[1789,2056],[1789,2104],[247,2104]],"region":{"top_left_x":246,"top_left_y":2055,"width":1543,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f919e11cfe4b4262b5e7cbe1bb322f09","type":"text","conversion_output":true,"text":"fatal MI, non-fatal stroke, hospitalisation for unstable angina pectoris) is was expected to be","text_display":"fatal MI, non-fatal stroke, hospitalisation for unstable angina pectoris) is was expected to be","confidence":1,"confidence_rate":1},{"cnt":[[247,2106],[701,2106],[701,2154],[247,2154]],"region":{"top_left_x":246,"top_left_y":2106,"width":456,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b53d1655842b4808b3b7e30ebece4260","type":"text","conversion_output":true,"text":"\\(3.5 \\%\\) in the placebo group.","text_display":" \\(3.5 \\%\\) in the placebo group.","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[247,2193],[1777,2193],[1777,2241],[247,2241]],"region":{"top_left_x":246,"top_left_y":2193,"width":1532,"height":48},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db1d3a4b22ff4421860d5dd8fd5408fd","type":"text","conversion_output":true,"text":"Assuming a constant hazard over time, the distribution is exponential and the proportion of","text_display":"\n\nAssuming a constant hazard over time, the distribution is exponential and the proportion of","confidence":1,"confidence_rate":1},{"cnt":[[247,2241],[1816,2241],[1816,2291],[247,2291]],"region":{"top_left_x":246,"top_left_y":2240,"width":1571,"height":52},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7cd63c312214d8f83be76c45e6ee211","type":"text","conversion_output":true,"text":"patients with event can be derived as \\(F ( t )=1-\\exp (-\\lambda t )\\). The 1 -year event rate of \\(3.5 \\%\\) translates","text_display":" patients with event can be derived as \\(F ( t )=1-\\exp (-\\lambda t )\\). The 1 -year event rate of \\(3.5 \\%\\) translates","confidence":0.608060359954834,"confidence_rate":0.9959636062272907},{"cnt":[[247,2289],[1775,2289],[1775,2337],[247,2337]],"region":{"top_left_x":246,"top_left_y":2288,"width":1529,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f6028b95b524aea9e3a2d694f199c9c","type":"text","conversion_output":true,"text":"into a \\(\\lambda\\) of 0.0356 and this results in an estimated rate of \\(12.7 \\%\\) patients with primary event","text_display":" into a \\(\\lambda\\) of 0.0356 and this results in an estimated rate of \\(12.7 \\%\\) patients with primary event","confidence":1,"confidence_rate":1},{"cnt":[[247,2335],[498,2335],[498,2387],[247,2387]],"region":{"top_left_x":246,"top_left_y":2334,"width":252,"height":54},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0fa51b369054dc2b68aec674a08e1ae","type":"text","conversion_output":true,"text":"after 3.8 years.","text_display":" after 3.8 years.","confidence":1,"confidence_rate":1},{"cnt":[[247,2426],[1807,2426],[1807,2474],[247,2474]],"region":{"top_left_x":246,"top_left_y":2426,"width":1561,"height":48},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d51ad16ab054e4b98ab5dec6da323b6","type":"text","conversion_output":true,"text":"Assuming the hazard over time in patients on linagliptin is the same as in patients on placebo","text_display":"\n\nAssuming the hazard over time in patients on linagliptin is the same as in patients on placebo","confidence":1,"confidence_rate":1},{"cnt":[[247,2474],[1793,2474],[1793,2524],[247,2524]],"region":{"top_left_x":246,"top_left_y":2473,"width":1548,"height":52},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe1ddb7162be4df292290a1c46aaba87","type":"text","conversion_output":true,"text":"(hazard ratio (HR): \\(\\left.\\lambda_{\\text {linagliptin }} / \\lambda_{\\text {placebo }}=1\\right), 625 6 1 1\\) patients with events will deliver an overall","text_display":" (hazard ratio (HR): \\(\\left.\\lambda_{\\text {linagliptin }} / \\lambda_{\\text {placebo }}=1\\right), 625 6 1 1\\) patients with events will deliver an overall","confidence":0.4905055719090942,"confidence_rate":0.9945772098259325},{"cnt":[[244,2522],[1745,2522],[1745,2572],[244,2572]],"region":{"top_left_x":244,"top_left_y":2521,"width":1502,"height":52},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cc77c0f61574586b4451cc55585c335","type":"text","conversion_output":true,"text":"power of \\(90 \\%\\) in a test to demonstrate non-inferiority of linagliptin vs. placebo within the","text_display":" power of \\(90 \\%\\) in a test to demonstrate non-inferiority of linagliptin vs. placebo within the","confidence":0.9751212539849803,"confidence_rate":0.9997455530573659},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c53e6bf0174648199e29e809f85ce841","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b465174bcaf6477aa51ba513b0ad0844","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a96373cda3bb4f5793f55b91c1832a66","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-069","page":69,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"376e51ada72a4751938adab32a0399e3","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c3d9058583a4d1bb0dda9696c4711e1","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e6fa42b99284253a21e18d9853cd468","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f43c0db6ee7471d8045f75a53c7566e","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011059},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b90254eb65ce4848aa9ef72e972317b0","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56a9267497b2412cb52059499a28d494","type":"page_info","conversion_output":false,"text":"Page 69 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1784,338],[1784,388],[244,388]],"region":{"top_left_x":244,"top_left_y":338,"width":1541,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf361352c19947b1ad1975aa81378c49","type":"text","conversion_output":true,"text":"pre-specified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of","text_display":"\npre-specified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of","confidence":0.7199017812963575,"confidence_rate":0.9970168177289876},{"cnt":[[244,388],[1800,388],[1800,436],[244,436]],"region":{"top_left_x":244,"top_left_y":388,"width":1557,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a617188571e4162aa2decdfd55cbefa","type":"text","conversion_output":true,"text":"\\(2.5 \\%\\) and with one interim analysis at \\(\\alpha=1.0 \\%\\) after \\(70 \\%\\) of the events (calculated with East,","text_display":" \\(2.5 \\%\\) and with one interim analysis at \\(\\alpha=1.0 \\%\\) after \\(70 \\%\\) of the events (calculated with East,","confidence":0.99755859375,"confidence_rate":0.9999757983983905},{"cnt":[[247,434],[1688,434],[1688,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1443,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"177042cbdba34a24ab78f8fea8ccf4d1","type":"text","conversion_output":true,"text":"version 5.4). Assuming a study duration of 3.8 years, recruitment within 3 years and a","text_display":" version 5.4). Assuming a study duration of 3.8 years, recruitment within 3 years and a","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[247,484],[1748,484],[1748,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1502,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40e93e7250a244289be2bbfc3ebd38c7","type":"text","conversion_output":true,"text":"eumulative lost to follow up rate of \\(2.0 \\%\\), 4150 patients per group are required to achieve","text_display":" eumulative lost to follow up rate of \\(2.0 \\%\\), 4150 patients per group are required to achieve","confidence":0.7699876240674439,"confidence_rate":0.9974407233224281},{"cnt":[[247,532],[1757,532],[1757,578],[247,578]],"region":{"top_left_x":246,"top_left_y":532,"width":1511,"height":46},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9cb3d6905e82400aaf785df88b9398f4","type":"text","conversion_output":true,"text":"625 patients with a primary endpoint. The change of the primary variable from 4-point","text_display":" 625 patients with a primary endpoint. The change of the primary variable from 4-point","confidence":0.80322265625,"confidence_rate":0.9975409685748484},{"cnt":[[247,580],[1757,580],[1757,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1511,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58a8b05ac49f4c1dbd4a2daa7f7602a1","type":"text","conversion_output":true,"text":"MACE to 3-point MACE does not affect the required number of patients with event;","text_display":" MACE to 3-point MACE does not affect the required number of patients with event;","confidence":1,"confidence_rate":1},{"cnt":[[247,626],[1729,626],[1729,678],[247,678]],"region":{"top_left_x":246,"top_left_y":625,"width":1484,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c523db2e72ee4708ac7f8c03759162e9","type":"text","conversion_output":true,"text":"the slight reduction from 625 to 611 patients is due to the elimination of the interim","text_display":" the slight reduction from 625 to 611 patients is due to the elimination of the interim","confidence":1,"confidence_rate":1},{"cnt":[[247,676],[1743,676],[1743,724],[247,724]],"region":{"top_left_x":246,"top_left_y":676,"width":1497,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"768c193934f04f6592530edeb86c1c68","type":"text","conversion_output":true,"text":"analysis. Since the event rate is higher than initially assumed the same power can be","text_display":" analysis. Since the event rate is higher than initially assumed the same power can be","confidence":0.9936575889587402,"confidence_rate":0.9999293068368748},{"cnt":[[247,722],[1748,722],[1748,772],[247,772]],"region":{"top_left_x":246,"top_left_y":721,"width":1502,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35555b43cb894899ab61e63039e701f6","type":"text","conversion_output":true,"text":"achieved within the originally planned timelines with a sample size of approximately","text_display":" achieved within the originally planned timelines with a sample size of approximately","confidence":0.98095703125,"confidence_rate":0.9997839938793736},{"cnt":[[247,772],[496,772],[496,820],[247,820]],"region":{"top_left_x":246,"top_left_y":772,"width":250,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4816b1d31df74992b0345e0d1a7fb2d3","type":"text","conversion_output":true,"text":"7000 patients.","text_display":" 7000 patients.","confidence":1,"confidence_rate":1},{"cnt":[[247,859],[1743,859],[1743,907],[247,907]],"region":{"top_left_x":246,"top_left_y":858,"width":1497,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ba5679b89744ba0a86a01fb31b56ecc","type":"text","conversion_output":true,"text":"Out of these, 531 patients are expected to experience CV death, non-fatal MI or non-fatal","text_display":"\n\nOut of these, 531 patients are expected to experience CV death, non-fatal MI or non-fatal","confidence":0.941709041595459,"confidence_rate":0.9993810274656998},{"cnt":[[247,909],[368,909],[368,953],[247,953]],"region":{"top_left_x":246,"top_left_y":909,"width":122,"height":44},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ebfc78ceeaba4ad2a7eecb4ac382f59c","type":"text","conversion_output":true,"text":"stroke.","text_display":" stroke.","confidence":0.97802734375,"confidence_rate":0.998150242040434},{"cnt":[[247,996],[1752,996],[1752,1046],[247,1046]],"region":{"top_left_x":246,"top_left_y":995,"width":1507,"height":52},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"959d0745ed5e41889b0906370392dea8","type":"text","conversion_output":true,"text":"If the event distribution is lower than expected, the impact on the study conduct should be","text_display":"\n\nIf the event distribution is lower than expected, the impact on the study conduct should be","confidence":1,"confidence_rate":1},{"cnt":[[247,1046],[1812,1046],[1812,1094],[247,1094]],"region":{"top_left_x":246,"top_left_y":1046,"width":1566,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"516113bdaf6c4a1cada27f25c86cd493","type":"text","conversion_output":true,"text":"carefully considered. The SC would further monitor the recruitment of the trial with regard to","text_display":" carefully considered. The SC would further monitor the recruitment of the trial with regard to","confidence":1,"confidence_rate":1},{"cnt":[[247,1092],[1782,1092],[1782,1140],[247,1140]],"region":{"top_left_x":246,"top_left_y":1091,"width":1536,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b657f9335614126b403d2d1e11f28b7","type":"text","conversion_output":true,"text":"baseline data for CV complications and renal impairment. The intent is to obtain a balanced","text_display":" baseline data for CV complications and renal impairment. The intent is to obtain a balanced","confidence":0.9951171875,"confidence_rate":0.9999490140875682},{"cnt":[[247,1142],[1812,1142],[1812,1190],[247,1190]],"region":{"top_left_x":246,"top_left_y":1142,"width":1566,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3368a08ad7341cf9b900ed4c1da6467","type":"text","conversion_output":true,"text":"mix of patients with CV complications and albuminuria AND patients with renal impairment.","text_display":" mix of patients with CV complications and albuminuria AND patients with renal impairment.","confidence":1,"confidence_rate":1},{"cnt":[[244,1190],[1387,1190],[1387,1238],[244,1238]],"region":{"top_left_x":244,"top_left_y":1190,"width":1143,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08e8cd41afa04542aef6163939bf5d16","type":"text","conversion_output":true,"text":"As such the SC may recommend to cap specific patient populations.","text_display":" As such the SC may recommend to cap specific patient populations.","confidence":0.9306640625,"confidence_rate":0.9989739995281306},{"cnt":[[247,1279],[1812,1279],[1812,1327],[247,1327]],"region":{"top_left_x":246,"top_left_y":1279,"width":1566,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d66022a6106d4eee80a1f6d93cddbe35","type":"text","conversion_output":true,"text":"If non-inferiority has been demonstrated, then superiority with regard to the primary endpoint","text_display":"\n\nIf non-inferiority has been demonstrated, then superiority with regard to the primary endpoint","confidence":1,"confidence_rate":1},{"cnt":[[247,1327],[1775,1327],[1775,1377],[247,1377]],"region":{"top_left_x":246,"top_left_y":1327,"width":1529,"height":51},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f857b783be64ab69bc2aceaa94cbfe2","type":"text","conversion_output":true,"text":"will be tested. Assuming 625611 patients with event and a hazard rate on linagliptin at any","text_display":" will be tested. Assuming 625611 patients with event and a hazard rate on linagliptin at any","confidence":0.98193359375,"confidence_rate":0.9998158594166987},{"cnt":[[244,1375],[1802,1375],[1802,1428],[244,1428]],"region":{"top_left_x":244,"top_left_y":1375,"width":1559,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"100e1665d70248e7aad66fe71c0058f8","type":"text","conversion_output":true,"text":"time \\(20 \\%\\) less than the risk on placebo (HR: \\(\\lambda_{\\text {linagliptin }} / \\lambda_{\\text {placebe }}=0.02848 / 0.0356=0.80\\) ), then","text_display":" time \\(20 \\%\\) less than the risk on placebo (HR: \\(\\lambda_{\\text {linagliptin }} / \\lambda_{\\text {placebe }}=0.02848 / 0.0356=0.80\\) ), then","confidence":0.9178096155611148,"confidence_rate":0.9993301830188173},{"cnt":[[247,1421],[1768,1421],[1768,1471],[247,1471]],"region":{"top_left_x":246,"top_left_y":1420,"width":1523,"height":52},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e99eeb337d042deaa819e0be1c067b7","type":"text","conversion_output":true,"text":"the resulting power to demonstrate superiority at the final analysis is \\(74 \\% 79 \\%\\) if the for a","text_display":" the resulting power to demonstrate superiority at the final analysis is \\(74 \\% 79 \\%\\) if the for a","confidence":0.8298592332485638,"confidence_rate":0.9981179430815972},{"cnt":[[247,1471],[1821,1471],[1821,1519],[247,1519]],"region":{"top_left_x":246,"top_left_y":1471,"width":1575,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a2a9c7c44c0446db043db3fcdf7a045","type":"text","conversion_output":true,"text":"test ean be performed at the \\(\\alpha\\)-level of \\(1.59 \\% 2 . 5 \\%\\) (cf. Section 7.2) and 69\\% if the test has to","text_display":" test ean be performed at the \\(\\alpha\\)-level of \\(1.59 \\% 2 . 5 \\%\\) (cf. Section 7.2) and 69\\% if the test has to","confidence":0.8071538463006579,"confidence_rate":0.9980364166955519},{"cnt":[[247,1517],[1789,1517],[1789,1567],[247,1567]],"region":{"top_left_x":246,"top_left_y":1516,"width":1543,"height":52},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aca406de499143e8a6bef24ead4999be","type":"text","conversion_output":true,"text":"be performed at the a-level of \\(1.06 \\%\\). If the risk reduction is \\(21.3 \\%\\) (HR: 0.787) and the test","text_display":" be performed at the a-level of \\(1.06 \\%\\). If the risk reduction is \\(21.3 \\%\\) (HR: 0.787) and the test","confidence":0.4527383967268786,"confidence_rate":0.9924813521702239},{"cnt":[[247,1567],[1770,1567],[1770,1615],[247,1615]],"region":{"top_left_x":246,"top_left_y":1567,"width":1525,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57bfc16e302543f2aeb942c952457006","type":"text","conversion_output":true,"text":"ean be performed at the a-level of \\(1.59 \\%\\), the power to demonstrate superiority is \\(80 \\%\\); the","text_display":" ean be performed at the a-level of \\(1.59 \\%\\), the power to demonstrate superiority is \\(80 \\%\\); the","confidence":0.4977894502473357,"confidence_rate":0.9932502796488873},{"cnt":[[244,1613],[1391,1613],[1391,1665],[244,1665]],"region":{"top_left_x":244,"top_left_y":1612,"width":1148,"height":54},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"462a02669d0149a4b6c651bdbd0fc014","type":"text","conversion_output":true,"text":"power is \\(75 \\%\\) if the test has to be performed at the a-level of \\(1.06 \\%\\).","text_display":" power is \\(75 \\%\\) if the test has to be performed at the a-level of \\(1.06 \\%\\).","confidence":0.9709733553518163,"confidence_rate":0.9996364086895732},{"cnt":[[244,1704],[1757,1704],[1757,1752],[244,1752]],"region":{"top_left_x":244,"top_left_y":1704,"width":1513,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79bcc52fd12d43cebe3b627820bef2a9","type":"text","conversion_output":true,"text":"Assuming 432 patients with a composite renal endpoint, a yearly event rate of \\(2.5 \\%\\) in the","text_display":"\n\nAssuming 432 patients with a composite renal endpoint, a yearly event rate of \\(2.5 \\%\\) in the","confidence":1,"confidence_rate":1},{"cnt":[[244,1750],[1686,1750],[1686,1802],[244,1802]],"region":{"top_left_x":244,"top_left_y":1749,"width":1442,"height":54},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f49bcc82d0f4b1cbb4986004b5bd5c4","type":"text","conversion_output":true,"text":"placebo group and a hazard rate HR on linagliptin of 0.75 , then the resulting power to","text_display":" placebo group and a hazard rate HR on linagliptin of 0.75 , then the resulting power to","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[247,1800],[1816,1800],[1816,1848],[247,1848]],"region":{"top_left_x":246,"top_left_y":1800,"width":1571,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9562f68d2a4848c9b282a784ce1a422b","type":"text","conversion_output":true,"text":"demonstrate superiority at the final analysis is \\(80 \\% 8 5 \\%\\) if the test can be performed at the \\(\\alpha\\) -","text_display":" demonstrate superiority at the final analysis is \\(80 \\% 8 5 \\%\\) if the test can be performed at the \\(\\alpha\\) ","confidence":0.9107308387756348,"confidence_rate":0.9991424973861786},{"cnt":[[247,1846],[1766,1846],[1766,1894],[247,1894]],"region":{"top_left_x":246,"top_left_y":1845,"width":1520,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af14534d4d2c40e996a17a412103e950","type":"text","conversion_output":true,"text":"level of \\(1.59 \\%\\) and \\(75 \\%\\) if the test has to be performed at the a-level of \\(1.06 \\% 2.5 \\%\\). If the","text_display":"level of \\(1.59 \\%\\) and \\(75 \\%\\) if the test has to be performed at the a-level of \\(1.06 \\% 2.5 \\%\\). If the","confidence":0.3561809590491181,"confidence_rate":0.9902165875960229},{"cnt":[[247,1896],[1419,1896],[1419,1944],[247,1944]],"region":{"top_left_x":246,"top_left_y":1896,"width":1173,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89189353c113456f870c40b41d67b11d","type":"text","conversion_output":true,"text":"HR is \\(0 . 7 0 , ~ 2 1 0\\) patients with renal event provide a power of \\(7 3 \\%\\).","text_display":" HR is \\(0 . 7 0 , ~ 2 1 0\\) patients with renal event provide a power of \\(7 3 \\%\\).","confidence":0.23703714900595568,"confidence_rate":0.983400496972747},{"cnt":[[247,1987],[1656,1987],[1656,2035],[247,2035]],"region":{"top_left_x":246,"top_left_y":1987,"width":1411,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"186e9505297c4ad18e55de9a332eb655","type":"text","conversion_output":true,"text":"If superiority for the primary endpoint and/or the composite renal endpoint has been","text_display":"\n\nIf superiority for the primary endpoint and/or the composite renal endpoint has been","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[247,2033],[1757,2033],[1757,2081],[247,2081]],"region":{"top_left_x":246,"top_left_y":2033,"width":1511,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f94c47c285c442488b0f816fb3f917b","type":"text","conversion_output":true,"text":"demonstrated, then superiority with regard to the 3 point MACE (CV death, non fatal MI,","text_display":" demonstrated, then superiority with regard to the 3 point MACE (CV death, non fatal MI,","confidence":0.9047572652343661,"confidence_rate":0.9989469907356706},{"cnt":[[244,2079],[1697,2079],[1697,2131],[244,2131]],"region":{"top_left_x":244,"top_left_y":2078,"width":1454,"height":54},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"419bb5a9093445be80d0d408b0422faf","type":"text","conversion_output":true,"text":"non-fatal stroke) will be tested. Assuming 531 patients with event and a hazard rate on","text_display":" non-fatal stroke) will be tested. Assuming 531 patients with event and a hazard rate on","confidence":0.9970703125,"confidence_rate":0.9999691163986473},{"cnt":[[247,2129],[1805,2129],[1805,2177],[247,2177]],"region":{"top_left_x":246,"top_left_y":2129,"width":1559,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"39e627abe1e745a8a3c6eef2407a825b","type":"text","conversion_output":true,"text":"linagliptin at any time \\(20 \\%\\) less than the risk on placebo (HR: 0.80), then the resulting power","text_display":" linagliptin at any time \\(20 \\%\\) less than the risk on placebo (HR: 0.80), then the resulting power","confidence":0.7931113243103027,"confidence_rate":0.9977301126146193},{"cnt":[[244,2177],[1789,2177],[1789,2227],[244,2227]],"region":{"top_left_x":244,"top_left_y":2177,"width":1545,"height":51},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cc3c1b03dca244828cf6f4a2e2024936","type":"text","conversion_output":true,"text":"to demonstrate superiority at the final analysis is 70\\% if the test can be performed at the full","text_display":" to demonstrate superiority at the final analysis is 70\\% if the test can be performed at the full","confidence":0.7090551615624463,"confidence_rate":0.9966016098858838},{"cnt":[[247,2225],[1770,2225],[1770,2273],[247,2273]],"region":{"top_left_x":246,"top_left_y":2224,"width":1525,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a322319439e44ef2aac42f3913408f5f","type":"text","conversion_output":true,"text":"a-level of 2.12\\% (if the primary endpoint and the composite renal endpoint are significant)","text_display":" a-level of 2.12\\% (if the primary endpoint and the composite renal endpoint are significant)","confidence":0.8999509811401367,"confidence_rate":0.9989025299264549},{"cnt":[[247,2271],[1821,2271],[1821,2323],[247,2323]],"region":{"top_left_x":246,"top_left_y":2270,"width":1575,"height":54},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"863983710b9f48589c2fcd9962e8b8ec","type":"text","conversion_output":true,"text":"and \\(50 \\%\\) if the test has to be performed at the a-level of \\(0.53 \\%\\) (if only one of these endpoints","text_display":" and \\(50 \\%\\) if the test has to be performed at the a-level of \\(0.53 \\%\\) (if only one of these endpoints","confidence":0.7484568366173465,"confidence_rate":0.997270319698346},{"cnt":[[247,2321],[1670,2321],[1670,2369],[247,2369]],"region":{"top_left_x":246,"top_left_y":2320,"width":1424,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"82f5bccd1e7a4e84826e4b635beb4cc3","type":"text","conversion_output":true,"text":"is significant). If the risk reduction is \\(21.3 \\%\\) (HR: 0.787), then the resulting power to","text_display":" is significant). If the risk reduction is \\(21.3 \\%\\) (HR: 0.787), then the resulting power to","confidence":0.9622814654471767,"confidence_rate":0.9995995771959753},{"cnt":[[247,2367],[1793,2367],[1793,2417],[247,2417]],"region":{"top_left_x":246,"top_left_y":2366,"width":1548,"height":51},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e2e42df071148b7a6d951bf72fcd8c9","type":"text","conversion_output":true,"text":"demonstrate superiority at the final analysis is \\(76 \\%\\) if the test can be performed at the full a-","text_display":" demonstrate superiority at the final analysis is \\(76 \\%\\) if the test can be performed at the full a","confidence":0.7149994291830808,"confidence_rate":0.9967794899397387},{"cnt":[[244,2415],[1565,2415],[1565,2465],[244,2465]],"region":{"top_left_x":244,"top_left_y":2414,"width":1321,"height":51},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c11c49a6515a4c58b90af908fe809d02","type":"text","conversion_output":true,"text":"level of \\(2.12 \\%\\) and \\(58 \\%\\) if the test has to be performed at the a-level of \\(0.53 \\%\\).","text_display":"level of \\(2.12 \\%\\) and \\(58 \\%\\) if the test has to be performed at the a-level of \\(0.53 \\%\\).","confidence":0.9500626781524488,"confidence_rate":0.9994551769852924},{"cnt":[[790,2586],[1300,2586],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2585,"width":510,"height":36},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"795921115ba14a258358c5862110e85e","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99462890625,"confidence_rate":0.9998717803653022},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cb81112eb43f4b78907bf04db29532fb","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fd66a7325531426eb9232aca703252e5","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-070","page":70,"lines":[{"cnt":[[244,119],[612,119],[612,167],[244,167]],"region":{"top_left_x":244,"top_left_y":118,"width":369,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31c6d5d1e5dd4a7ca977a6cfebe63a09","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2c1335365194ab18a5848bb9cccecc2","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,164],[601,164],[601,206],[242,206]],"region":{"top_left_x":242,"top_left_y":164,"width":359,"height":42},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3ba1f93f1f84616a6e3935b5c74204f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,206],[637,206],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":205,"width":396,"height":44},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a7631fe120a4283876831501f3d5e34","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,206],[1108,206],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":205,"width":240,"height":44},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"346b958344094fed9e4c5a4e5932a045","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,206],[1818,206],[1818,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":205,"width":248,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7c7ab468d8f42d69a9069f544e08771","type":"page_info","conversion_output":false,"text":"Page 70 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,334],[1759,334],[1759,388],[242,388]],"region":{"top_left_x":242,"top_left_y":333,"width":1517,"height":56},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f34c4b81a8b24eb083830943ad35accf","type":"text","conversion_output":true,"text":"All calculations are based on an allocation ratio between treatment groups of \\(1: 1\\) and were","text_display":"\n\nAll calculations are based on an allocation ratio between treatment groups of \\(1: 1\\) and were","confidence":0.9716796875,"confidence_rate":0.9997068892057642},{"cnt":[[242,384],[1770,384],[1770,436],[242,436]],"region":{"top_left_x":242,"top_left_y":383,"width":1529,"height":54},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"857371a301004471ba8403a72a457d2b","type":"text","conversion_output":true,"text":"derived using ADDPLAN (version 6.0.4), East (version 5.4) and nQuery Advisor (version","text_display":" derived using ADDPLAN (version 6.0.4), East (version 5.4) and nQuery Advisor (version","confidence":1,"confidence_rate":1},{"cnt":[[242,434],[359,434],[359,484],[242,484]],"region":{"top_left_x":242,"top_left_y":434,"width":117,"height":51},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24904539f73747a4bb8ecb06c870cae9","type":"text","conversion_output":true,"text":"6.0.1).","text_display":" 6.0.1).","confidence":0.9990234375,"confidence_rate":0.9999185833438636},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b7c55a53b1e34c6e9255843511c48807","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[288,2618],[1800,2618],[1800,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2617,"width":1514,"height":45},"line":11,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"85ee6a866a5b49758853fa17f24fad86","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99267578125,"confidence_rate":0.9999382273489243},{"cnt":[[295,2664],[1770,2664],[1770,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1477,"height":40},"line":12,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8cdf3bcf5e40455dacaf64b7a5d0f4fb","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-071","page":71,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"28502a6956d74a119f1065e505708ec6","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7b192cf6548452c8fc9adbfcb716375","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"46c7ad365b9c4f4b84d8bf1be7ad5a02","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2b1f763a1a64dafba724b1c72449464","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0f8260e50c64429aec86696b3f0c52c","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ffb485a27a844291ad8298c8b89a69e4","type":"page_info","conversion_output":false,"text":"Page 71 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[240,338],[1610,338],[1610,450],[240,450]],"region":{"top_left_x":239,"top_left_y":338,"width":1372,"height":113},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"70ed4853f4df42a683526531a85f9327","type":"section_header","conversion_output":false,"children_ids":["a45afc89c64a436284075da781aa9965","601693b126da405c90c515faada4866c"],"text":"","text_display":""},{"cnt":[[247,343],[1606,343],[1606,395],[247,395]],"region":{"top_left_x":246,"top_left_y":342,"width":1360,"height":54},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a45afc89c64a436284075da781aa9965","type":"text","conversion_output":true,"parent_id":"70ed4853f4df42a683526531a85f9327","text":"8. INFORMED CONSENT, DATA PROTECTION, TRIAL","text_display":"\n\n\\section*{8. INFORMED CONSENT, DATA PROTECTION, TRIAL","confidence":1,"confidence_rate":1},{"cnt":[[402,397],[646,397],[646,445],[402,445]],"region":{"top_left_x":402,"top_left_y":397,"width":245,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"601693b126da405c90c515faada4866c","type":"text","conversion_output":true,"parent_id":"70ed4853f4df42a683526531a85f9327","text":"RECORDS","text_display":" RECORDS}","confidence":1,"confidence_rate":1},{"cnt":[[247,493],[1775,493],[1775,541],[247,541]],"region":{"top_left_x":246,"top_left_y":493,"width":1529,"height":49},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"66ffddc7b06a408487b80b65c9789c61","type":"text","conversion_output":true,"text":"The trial will be carried out in compliance with the protocol, the principles laid down in the","text_display":"\n\nThe trial will be carried out in compliance with the protocol, the principles laid down in the","confidence":1,"confidence_rate":1},{"cnt":[[247,539],[1738,539],[1738,587],[247,587]],"region":{"top_left_x":246,"top_left_y":539,"width":1493,"height":49},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cd531c7979174f659b37378e7c9ca2ba","type":"text","conversion_output":true,"text":"Declaration of Helsinki, in accordance with the ICH Harmonised Tripartite Guideline for","text_display":" Declaration of Helsinki, in accordance with the ICH Harmonised Tripartite Guideline for","confidence":1,"confidence_rate":1},{"cnt":[[247,589],[1725,589],[1725,637],[247,637]],"region":{"top_left_x":246,"top_left_y":589,"width":1479,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"44eafce794ec4b5aa6fa2a5599c2ebbc","type":"text","conversion_output":true,"text":"Good Clinical Practice (GCP), relevant SOPs of the clinical CRO and relevant BI SOPs.","text_display":" Good Clinical Practice (GCP), relevant SOPs of the clinical CRO and relevant BI SOPs.","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[247,635],[1766,635],[1766,683],[247,683]],"region":{"top_left_x":246,"top_left_y":635,"width":1520,"height":49},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4c932909acab4814b5da77bcd5ef8dca","type":"text","conversion_output":true,"text":"Standard medical care (prophylactic, diagnostic and therapeutic procedures) remains in the","text_display":" Standard medical care (prophylactic, diagnostic and therapeutic procedures) remains in the","confidence":1,"confidence_rate":1},{"cnt":[[247,685],[1131,685],[1131,733],[247,733]],"region":{"top_left_x":246,"top_left_y":685,"width":885,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"23eee396c09443ba91233519ae1b09ec","type":"text","conversion_output":true,"text":"responsibility of the treating physician of the patient.","text_display":" responsibility of the treating physician of the patient.","confidence":1,"confidence_rate":1},{"cnt":[[247,754],[1793,754],[1793,802],[247,802]],"region":{"top_left_x":246,"top_left_y":753,"width":1548,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f04fa112f6f44ce7abbea727fc1da95a","type":"text","conversion_output":true,"text":"The investigator should inform the sponsor/CRO immediately of any urgent safety measures","text_display":"\n\nThe investigator should inform the sponsor/CRO immediately of any urgent safety measures","confidence":1,"confidence_rate":1},{"cnt":[[247,800],[1727,800],[1727,848],[247,848]],"region":{"top_left_x":246,"top_left_y":799,"width":1481,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2bb22813453340838d4bae4cc89ec996","type":"text","conversion_output":true,"text":"taken to protect the study subjects against any immediate hazard, and also of any serious","text_display":" taken to protect the study subjects against any immediate hazard, and also of any serious","confidence":1,"confidence_rate":1},{"cnt":[[247,850],[838,850],[838,898],[247,898]],"region":{"top_left_x":246,"top_left_y":849,"width":593,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"05236310f2db4475a8a4f4b84cab65ed","type":"text","conversion_output":true,"text":"breaches of the protocol/ICH GCP.","text_display":" breaches of the protocol/ICH GCP.","confidence":1,"confidence_rate":1},{"cnt":[[247,918],[1812,918],[1812,966],[247,966]],"region":{"top_left_x":246,"top_left_y":918,"width":1566,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"227e665c680f44be9f934ff5aeaf571f","type":"text","conversion_output":true,"text":"<For Japan> and the Japanese GCP regulations (Ministry of Health and Welfare Ordinance","text_display":"\n<For Japan> and the Japanese GCP regulations (Ministry of Health and Welfare Ordinance","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[247,964],[672,964],[672,1012],[247,1012]],"region":{"top_left_x":246,"top_left_y":964,"width":426,"height":48},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b4f5c9b2088d4d959480cfa1a3bec821","type":"text","conversion_output":true,"text":"No. 28, March 27, 1997).","text_display":" No. 28, March 27, 1997).","confidence":1,"confidence_rate":1},{"cnt":[[247,1035],[1770,1035],[1770,1081],[247,1081]],"region":{"top_left_x":246,"top_left_y":1034,"width":1525,"height":47},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"309039c2527b4949a53fd2fa3b113e7a","type":"text","conversion_output":true,"text":"The rights of the investigator and of the sponsor with regard to publication of the results of","text_display":"\n\nThe rights of the investigator and of the sponsor with regard to publication of the results of","confidence":0.99658203125,"confidence_rate":0.9999654165237842},{"cnt":[[247,1083],[1812,1083],[1812,1131],[247,1131]],"region":{"top_left_x":246,"top_left_y":1082,"width":1566,"height":49},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"57a822c97344497d9d00f36254ba1518","type":"text","conversion_output":true,"text":"this trial are described in the investigator contract. As a general rule, no trial results should be","text_display":" this trial are described in the investigator contract. As a general rule, no trial results should be","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[247,1128],[1218,1128],[1218,1179],[247,1179]],"region":{"top_left_x":246,"top_left_y":1128,"width":972,"height":51},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"082bba2dd3984c7e916a8b91cb7e0756","type":"text","conversion_output":true,"text":"published prior to finalisation of the Clinical Trial Report.","text_display":" published prior to finalisation of the Clinical Trial Report.","confidence":1,"confidence_rate":1},{"cnt":[[247,1197],[1780,1197],[1780,1245],[247,1245]],"region":{"top_left_x":246,"top_left_y":1197,"width":1534,"height":48},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2383db8cd3474b83842b3f76435f89ab","type":"text","conversion_output":true,"text":"Insurance Cover: The terms and conditions of the insurance cover are made available to the","text_display":"\nInsurance Cover: The terms and conditions of the insurance cover are made available to the","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[247,1247],[1615,1247],[1615,1295],[247,1295]],"region":{"top_left_x":246,"top_left_y":1247,"width":1370,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5cee2e549d5a45d6a213fa1f4ecf5453","type":"text","conversion_output":true,"text":"investigator and the patients via documentation in the ISF (Investigator Site File).","text_display":" investigator and the patients via documentation in the ISF (Investigator Site File).","confidence":0.9965834617614746,"confidence_rate":0.999961546942339},{"cnt":[[247,1339],[1816,1339],[1816,1382],[247,1382]],"region":{"top_left_x":246,"top_left_y":1338,"width":1571,"height":45},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ffbbd4dc51ad4c13a792a644e966ad26","type":"text","conversion_output":true,"text":"The certificate of insurance cover is made available to the Investigator and the patients, and","text_display":"\n\nThe certificate of insurance cover is made available to the Investigator and the patients, and","confidence":0.9970722198486328,"confidence_rate":0.9999703835246004},{"cnt":[[247,1384],[587,1384],[587,1423],[247,1423]],"region":{"top_left_x":246,"top_left_y":1384,"width":342,"height":40},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"95f7ee6dfcf44667b12905a608c62314","type":"text","conversion_output":true,"text":"is stored in the ISF.","text_display":" is stored in the ISF.","confidence":1,"confidence_rate":1},{"cnt":[[242,1467],[1677,1467],[1677,1563],[242,1563]],"region":{"top_left_x":242,"top_left_y":1466,"width":1435,"height":97},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3e7a8f7e573741598033ddab9fc0e0c7","type":"section_header","conversion_output":false,"children_ids":["ddbd495deb184cef92caeb4e2a25d6a4","4676a09d913744399ffec143e1582628"],"text":"","text_display":""},{"cnt":[[247,1471],[1674,1471],[1674,1515],[247,1515]],"region":{"top_left_x":246,"top_left_y":1471,"width":1429,"height":44},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ddbd495deb184cef92caeb4e2a25d6a4","type":"text","conversion_output":true,"parent_id":"3e7a8f7e573741598033ddab9fc0e0c7","text":"8.1 STUDY APPROVAL, PATIENT INFORMATION, AND INFORMED","text_display":"\n\n\\subsection*{8.1 STUDY APPROVAL, PATIENT INFORMATION, AND INFORMED","confidence":1,"confidence_rate":1},{"cnt":[[404,1521],[610,1521],[610,1558],[404,1558]],"region":{"top_left_x":404,"top_left_y":1521,"width":206,"height":37},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4676a09d913744399ffec143e1582628","type":"text","conversion_output":true,"parent_id":"3e7a8f7e573741598033ddab9fc0e0c7","text":"CONSENT","text_display":" CONSENT}","confidence":1,"confidence_rate":1},{"cnt":[[247,1608],[1786,1608],[1786,1656],[247,1656]],"region":{"top_left_x":246,"top_left_y":1608,"width":1541,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e87844adf20942f1801e12dd1e6a681a","type":"text","conversion_output":true,"text":"This trial will be initiated only after all required legal documentation has been reviewed and","text_display":"\n\nThis trial will be initiated only after all required legal documentation has been reviewed and","confidence":1,"confidence_rate":1},{"cnt":[[247,1656],[1688,1656],[1688,1702],[247,1702]],"region":{"top_left_x":246,"top_left_y":1656,"width":1443,"height":46},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0c76c4025e7943eea7466f4e77b3a532","type":"text","conversion_output":true,"text":"approved by the respective IRB / Independent Ethics Committee (IEC) and competent","text_display":" approved by the respective IRB / Independent Ethics Committee (IEC) and competent","confidence":0.995125050657407,"confidence_rate":0.9999431775369244},{"cnt":[[247,1704],[1780,1704],[1780,1752],[247,1752]],"region":{"top_left_x":246,"top_left_y":1704,"width":1534,"height":49},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"90230fd167b84c22a021c42a96bd4a61","type":"text","conversion_output":true,"text":"authority (CA) according to national and international regulations. The same applies for the","text_display":" authority (CA) according to national and international regulations. The same applies for the","confidence":1,"confidence_rate":1},{"cnt":[[247,1750],[1172,1750],[1172,1798],[247,1798]],"region":{"top_left_x":246,"top_left_y":1749,"width":926,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5e621aad61954e5ebcbe39ed3f7edeae","type":"text","conversion_output":true,"text":"implementation of changes introduced by amendments.","text_display":" implementation of changes introduced by amendments.","confidence":1,"confidence_rate":1},{"cnt":[[247,1818],[1816,1818],[1816,1866],[247,1866]],"region":{"top_left_x":246,"top_left_y":1818,"width":1571,"height":49},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5e4402508c0e4697ad2c105ed6dfe01d","type":"text","conversion_output":true,"text":"Prior to patient participation in the trial, written informed consent must be obtained from each","text_display":"\n\nPrior to patient participation in the trial, written informed consent must be obtained from each","confidence":1,"confidence_rate":1},{"cnt":[[247,1869],[1743,1869],[1743,1917],[247,1917]],"region":{"top_left_x":246,"top_left_y":1868,"width":1497,"height":49},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ed95a5af6d8d48f586a84a3c6a6c4787","type":"text","conversion_output":true,"text":"patient (or the patient's legally accepted representative) according to ICH GCP and to the","text_display":" patient (or the patient's legally accepted representative) according to ICH GCP and to the","confidence":1,"confidence_rate":1},{"cnt":[[247,1914],[1686,1914],[1686,1962],[247,1962]],"region":{"top_left_x":246,"top_left_y":1914,"width":1440,"height":49},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1749943d12b0424f8f1186edad496b0a","type":"text","conversion_output":true,"text":"regulatory and legal requirements of the participating country. Each signature must be","text_display":" regulatory and legal requirements of the participating country. Each signature must be","confidence":1,"confidence_rate":1},{"cnt":[[247,1965],[1720,1965],[1720,2013],[247,2013]],"region":{"top_left_x":246,"top_left_y":1964,"width":1475,"height":49},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"87d316d0d50247309a7bf38082763a6c","type":"text","conversion_output":true,"text":"personally dated by each signatory and the informed consent and any additional patient-","text_display":" personally dated by each signatory and the informed consent and any additional patient","confidence":1,"confidence_rate":1},{"cnt":[[247,2010],[1812,2010],[1812,2058],[247,2058]],"region":{"top_left_x":246,"top_left_y":2010,"width":1566,"height":49},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"493bcdbae9744e84b78bb3cbeb3c1297","type":"text","conversion_output":true,"text":"information form retained by the investigator as part of the trial records. A signed copy of the","text_display":"information form retained by the investigator as part of the trial records. A signed copy of the","confidence":1,"confidence_rate":1},{"cnt":[[247,2061],[1798,2061],[1798,2108],[247,2108]],"region":{"top_left_x":246,"top_left_y":2060,"width":1552,"height":49},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"39c9209aca2b4a1d9d2daadcf605ff09","type":"text","conversion_output":true,"text":"informed consent and any additional patient information must be given to each patient or the","text_display":" informed consent and any additional patient information must be given to each patient or the","confidence":1,"confidence_rate":1},{"cnt":[[247,2106],[927,2106],[927,2154],[247,2154]],"region":{"top_left_x":246,"top_left_y":2106,"width":682,"height":49},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4a6f9dcbd2c74c249c012521c2616f8e","type":"text","conversion_output":true,"text":"patient's legally accepted representative.","text_display":" patient's legally accepted representative.","confidence":1,"confidence_rate":1},{"cnt":[[247,2177],[1738,2177],[1738,2223],[247,2223]],"region":{"top_left_x":246,"top_left_y":2177,"width":1493,"height":46},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3d96c30ecc744a3fbf62fa19f53c7b10","type":"text","conversion_output":true,"text":"The patient must be informed that his/her personal trial-related data will be used by BI in","text_display":"\n\nThe patient must be informed that his/her personal trial-related data will be used by BI in","confidence":1,"confidence_rate":1},{"cnt":[[247,2225],[1800,2225],[1800,2273],[247,2273]],"region":{"top_left_x":246,"top_left_y":2224,"width":1555,"height":49},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2822ef52e2e24d969d096e768d530d97","type":"text","conversion_output":true,"text":"accordance with the local data protection law. The level of disclosure must also be explained","text_display":" accordance with the local data protection law. The level of disclosure must also be explained","confidence":1,"confidence_rate":1},{"cnt":[[247,2275],[477,2275],[477,2319],[247,2319]],"region":{"top_left_x":246,"top_left_y":2275,"width":232,"height":44},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cdeca8ab35f747b6a707f93c5d655456","type":"text","conversion_output":true,"text":"to the patient.","text_display":" to the patient.","confidence":1,"confidence_rate":1},{"cnt":[[247,2339],[1777,2339],[1777,2387],[247,2387]],"region":{"top_left_x":246,"top_left_y":2339,"width":1532,"height":49},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f19e4f869f19439ba28d3e3fc0184b44","type":"text","conversion_output":true,"text":"The patient must be informed that his / her medical records may be examined by authorised","text_display":"\n\nThe patient must be informed that his / her medical records may be examined by authorised","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[247,2389],[1720,2389],[1720,2437],[247,2437]],"region":{"top_left_x":246,"top_left_y":2389,"width":1475,"height":49},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2a8f5f77715642b6b82d71a870993cb2","type":"text","conversion_output":true,"text":"monitors or Clinical Quality Assurance auditors appointed by Boehringer Ingelheim, by","text_display":" monitors or Clinical Quality Assurance auditors appointed by Boehringer Ingelheim, by","confidence":1,"confidence_rate":1},{"cnt":[[247,2435],[1565,2435],[1565,2483],[247,2483]],"region":{"top_left_x":246,"top_left_y":2435,"width":1319,"height":49},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"98c3a8dca129477ca59921ffce7292e2","type":"text","conversion_output":true,"text":"appropriate IRB / IEC members, and by inspectors from regulatory authorities.","text_display":" appropriate IRB / IEC members, and by inspectors from regulatory authorities.","confidence":0.9990234375,"confidence_rate":0.9999880849533282},{"cnt":[[793,2584],[1300,2584],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2583,"width":508,"height":38},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"375678d2b098417c855a626f51100e45","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2659],[292,2659]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":38},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"08dd426e85f1427889a4cfa32c89f897","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999917896164967},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"77819501f3fc4aef94b26c4a50f59bb2","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-072","page":72,"lines":[{"cnt":[[244,119],[612,119],[612,167],[244,167]],"region":{"top_left_x":244,"top_left_y":118,"width":369,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c5ba6581a5e4807ac835fdb03bb40f5","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1818,119],[1818,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":316,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4607022ae8f348be9d9d2ce6d4329b76","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,164],[599,164],[599,203],[244,203]],"region":{"top_left_x":244,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"751c5cda35cd4ff28bf3114218bbfa69","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70ba2f7240674e22917ef8ecfb0b3883","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65696a94db7d4d879287fc5124cef60b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92140a3f6acf4e9093312d91b475a507","type":"page_info","conversion_output":false,"text":"Page 72 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,340],[1044,340],[1044,391],[247,391]],"region":{"top_left_x":246,"top_left_y":340,"width":798,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64dc54fc0b624102add2dd7b4df1ff0c","type":"text","conversion_output":true,"text":"The following text is only applicable for Japan:","text_display":"\n\nThe following text is only applicable for Japan:","confidence":1,"confidence_rate":1},{"cnt":[[247,388],[1697,388],[1697,441],[247,441]],"region":{"top_left_x":246,"top_left_y":388,"width":1452,"height":53},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b02a8edf3224caa9f9747e3d0b9c3a2","type":"text","conversion_output":true,"text":"The investigator must give a full explanation to trial patients including the items listed","text_display":"\nThe investigator must give a full explanation to trial patients including the items listed","confidence":1,"confidence_rate":1},{"cnt":[[247,439],[1812,439],[1812,487],[247,487]],"region":{"top_left_x":246,"top_left_y":438,"width":1566,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd4848d69d1b4ccfa57ca79c59783f16","type":"text","conversion_output":true,"text":"below in association with the use of the patient information form, which is prepared avoiding","text_display":" below in association with the use of the patient information form, which is prepared avoiding","confidence":1,"confidence_rate":1},{"cnt":[[244,484],[1748,484],[1748,532],[244,532]],"region":{"top_left_x":244,"top_left_y":484,"width":1504,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a799367b78b4977a6319b34e8c029e7","type":"text","conversion_output":true,"text":"the use of technical terms and expressions. The patient is given sufficient time to consider","text_display":" the use of technical terms and expressions. The patient is given sufficient time to consider","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[242,532],[1766,532],[1766,583],[242,583]],"region":{"top_left_x":242,"top_left_y":532,"width":1524,"height":51},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e36eed0c4c9244719647cbf3704a7a65","type":"text","conversion_output":true,"text":"participation in the trial. The investigator obtains written consent of the patient's own free","text_display":" participation in the trial. The investigator obtains written consent of the patient's own free","confidence":0.9931671619415283,"confidence_rate":0.9999307469558724},{"cnt":[[244,580],[1668,580],[1668,628],[244,628]],"region":{"top_left_x":244,"top_left_y":580,"width":1424,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a592ae4e139a4910880cc650a138c5a2","type":"text","conversion_output":true,"text":"will with the informed consent form after confirming that the patient understands the","text_display":" will with the informed consent form after confirming that the patient understands the","confidence":1,"confidence_rate":1},{"cnt":[[244,626],[1802,626],[1802,678],[244,678]],"region":{"top_left_x":244,"top_left_y":625,"width":1559,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dbcf9eb6939145e781a6384680ec6b99","type":"text","conversion_output":true,"text":"contents. The investigator must sign (or place a seal on) and date the informed consent form.","text_display":" contents. The investigator must sign (or place a seal on) and date the informed consent form.","confidence":0.9990236759185791,"confidence_rate":0.9999900326925697},{"cnt":[[242,676],[1729,676],[1729,724],[242,724]],"region":{"top_left_x":242,"top_left_y":676,"width":1488,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d3ad646c0934657a46daa5305fa486b","type":"text","conversion_output":true,"text":"If a trial collaborator has given a supplementary explanation, the trial collaborator also","text_display":" If a trial collaborator has given a supplementary explanation, the trial collaborator also","confidence":1,"confidence_rate":1},{"cnt":[[242,722],[1231,722],[1231,774],[242,774]],"region":{"top_left_x":242,"top_left_y":721,"width":990,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b618e155d3db433d9a27dd0c0ef5395d","type":"text","conversion_output":true,"text":"signs (or places a seal on) and dates the informed consent.","text_display":" signs (or places a seal on) and dates the informed consent.","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[247,818],[930,818],[930,870],[247,870]],"region":{"top_left_x":246,"top_left_y":817,"width":684,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51639e2d74e14c108c735c03a33422b1","type":"text","conversion_output":true,"text":"The following items need to be included:","text_display":"\n\nThe following items need to be included:","confidence":1,"confidence_rate":1},{"cnt":[[247,868],[971,868],[971,918],[247,918]],"region":{"top_left_x":246,"top_left_y":868,"width":725,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3bb901c6c132417f96416366fb58ab28","type":"text","conversion_output":true,"text":"1. That the clinical trial is aimed at testing.","text_display":"\n1. That the clinical trial is aimed at testing.","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[247,916],[665,916],[665,966],[247,966]],"region":{"top_left_x":246,"top_left_y":916,"width":419,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a334934fed444d9790f9ddfcb67491af","type":"text","conversion_output":true,"text":"2. Objectives of the trial.","text_display":"\n2. Objectives of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[247,964],[1263,964],[1263,1014],[247,1014]],"region":{"top_left_x":246,"top_left_y":964,"width":1018,"height":51},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd4ec5eec1554d648c27983e8dd307fc","type":"text","conversion_output":true,"text":"3. The name, title, and address of the investigator to contact.","text_display":"\n3. The name, title, and address of the investigator to contact.","confidence":1,"confidence_rate":1},{"cnt":[[244,1014],[583,1014],[583,1062],[244,1062]],"region":{"top_left_x":244,"top_left_y":1014,"width":339,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f79caa6c9314e04a4d0be7335da90b3","type":"text","conversion_output":true,"text":"4. Trial procedures.","text_display":"\n4. Trial procedures.","confidence":1,"confidence_rate":1},{"cnt":[[244,1060],[1770,1060],[1770,1108],[244,1108]],"region":{"top_left_x":244,"top_left_y":1059,"width":1527,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69d31aa97d724b7e92a1c0028373ee87","type":"text","conversion_output":true,"text":"5. Anticipated benefits of the investigational products and anticipated disadvantages to the","text_display":"\n5. Anticipated benefits of the investigational products and anticipated disadvantages to the","confidence":1,"confidence_rate":1},{"cnt":[[283,1110],[418,1110],[418,1158],[283,1158]],"region":{"top_left_x":283,"top_left_y":1110,"width":136,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b4bf44a458e347a88ea81c7959a4a45b","type":"text","conversion_output":true,"text":"patient.","text_display":" patient.","confidence":1,"confidence_rate":1},{"cnt":[[247,1156],[1094,1156],[1094,1204],[247,1204]],"region":{"top_left_x":246,"top_left_y":1155,"width":849,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"731e3ad180f842068b2b3277e2ced71b","type":"text","conversion_output":true,"text":"6. Matters concerning other therapeutic measures.","text_display":"\n6. Matters concerning other therapeutic measures.","confidence":1,"confidence_rate":1},{"cnt":[[247,1202],[1049,1202],[1049,1254],[247,1254]],"region":{"top_left_x":246,"top_left_y":1201,"width":803,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e7ad03ee6fa49eab69b06270ff9918c","type":"text","conversion_output":true,"text":"7. Duration of participation in the clinical trial.","text_display":"\n7. Duration of participation in the clinical trial.","confidence":1,"confidence_rate":1},{"cnt":[[247,1252],[1240,1252],[1240,1300],[247,1300]],"region":{"top_left_x":246,"top_left_y":1251,"width":995,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea5165508d10448ea111f337d1558364","type":"text","conversion_output":true,"text":"8. That the patient may withdraw from the trial at any time.","text_display":"\n8. That the patient may withdraw from the trial at any time.","confidence":0.96240234375,"confidence_rate":0.9994105940909203},{"cnt":[[247,1300],[1775,1300],[1775,1350],[247,1350]],"region":{"top_left_x":246,"top_left_y":1299,"width":1529,"height":52},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0702ab68c24748d69de6fdc0c8168c51","type":"text","conversion_output":true,"text":"9. That patient's refusal of or withdrawal from participation in the trial does not cause any","text_display":"\n9. That patient's refusal of or withdrawal from participation in the trial does not cause any","confidence":1,"confidence_rate":1},{"cnt":[[288,1348],[752,1348],[752,1396],[288,1396]],"region":{"top_left_x":287,"top_left_y":1347,"width":465,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7688b01978a427fb2c3fe2cf02ec193","type":"text","conversion_output":true,"text":"disadvantage to him or her.","text_display":" disadvantage to him or her.","confidence":1,"confidence_rate":1},{"cnt":[[247,1393],[1812,1393],[1812,1446],[247,1446]],"region":{"top_left_x":246,"top_left_y":1393,"width":1566,"height":54},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8dec8752c97439d95bea6126b145ae1","type":"text","conversion_output":true,"text":"10. That the monitors, the auditors, and the institutional review board are given access to the","text_display":"\n10. That the monitors, the auditors, and the institutional review board are given access to the","confidence":0.99658203125,"confidence_rate":0.9999657623526261},{"cnt":[[244,1444],[1748,1444],[1748,1492],[244,1492]],"region":{"top_left_x":244,"top_left_y":1443,"width":1504,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ee6e849a9924ed7aece35a15798bf44","type":"text","conversion_output":true,"text":"relevant source documents on condition that confidentiality of the patient is fully secured.","text_display":" relevant source documents on condition that confidentiality of the patient is fully secured.","confidence":0.9970703125,"confidence_rate":0.9999697531643026},{"cnt":[[247,1492],[882,1492],[882,1542],[247,1542]],"region":{"top_left_x":246,"top_left_y":1491,"width":636,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b649ddb56a04848be26c11592462f3c","type":"text","conversion_output":true,"text":"11. That privacy of the patient is kept.","text_display":"\n11. That privacy of the patient is kept.","confidence":1,"confidence_rate":1},{"cnt":[[247,1540],[1658,1540],[1658,1588],[247,1588]],"region":{"top_left_x":246,"top_left_y":1539,"width":1413,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d91b14488c4643f088e24630a98bd377","type":"text","conversion_output":true,"text":"12. The office of the medical institution to contact in the event of trial-related injury.","text_display":"\n12. The office of the medical institution to contact in the event of trial-related injury.","confidence":0.9975595474243164,"confidence_rate":0.99997427995883},{"cnt":[[247,1585],[1748,1585],[1748,1638],[247,1638]],"region":{"top_left_x":246,"top_left_y":1585,"width":1502,"height":53},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"154b341c1f954f7c99bc5ed15371cd57","type":"text","conversion_output":true,"text":"13. That necessary treatment is available to the patient in the event of trial-related injury.","text_display":"\n13. That necessary treatment is available to the patient in the event of trial-related injury.","confidence":1,"confidence_rate":1},{"cnt":[[247,1636],[1533,1636],[1533,1684],[247,1684]],"region":{"top_left_x":246,"top_left_y":1635,"width":1287,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fedebb721d284eccbb562139529c9996","type":"text","conversion_output":true,"text":"14. Matters concerning compensation in the event of any trial-related injury.","text_display":"\n14. Matters concerning compensation in the event of any trial-related injury.","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[247,1681],[1768,1681],[1768,1732],[247,1732]],"region":{"top_left_x":246,"top_left_y":1681,"width":1523,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc1f702f8820462e93292de6010566e1","type":"text","conversion_output":true,"text":"15. The type of the IRB which is used for the reviews and deliberations on the matters such","text_display":"\n15. The type of the IRB which is used for the reviews and deliberations on the matters such","confidence":1,"confidence_rate":1},{"cnt":[[306,1732],[1688,1732],[1688,1780],[306,1780]],"region":{"top_left_x":306,"top_left_y":1731,"width":1383,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d6d3b59219e4d19bef1026762ea577d","type":"text","conversion_output":true,"text":"as appropriateness of conducting the clinical trial, the matters to be reviewed and","text_display":" as appropriateness of conducting the clinical trial, the matters to be reviewed and","confidence":1,"confidence_rate":1},{"cnt":[[306,1777],[1780,1777],[1780,1830],[306,1830]],"region":{"top_left_x":306,"top_left_y":1777,"width":1474,"height":53},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2847301154174c418eabb6d2e1838b5f","type":"text","conversion_output":true,"text":"deliberated by each IRB, and other matters concerning the IRBs involved in the clinical","text_display":" deliberated by each IRB, and other matters concerning the IRBs involved in the clinical","confidence":1,"confidence_rate":1},{"cnt":[[306,1828],[395,1828],[395,1871],[306,1871]],"region":{"top_left_x":306,"top_left_y":1827,"width":90,"height":44},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49449d92b6bd4c4a8a5552b1c7d6b935","type":"text","conversion_output":true,"text":"trial.","text_display":" trial.","confidence":1,"confidence_rate":1},{"cnt":[[247,1873],[1208,1873],[1208,1923],[247,1923]],"region":{"top_left_x":246,"top_left_y":1873,"width":963,"height":51},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f030772c756e4409a7856f9aed3a6538","type":"text","conversion_output":true,"text":"16. Other necessary matters concerning the clinical trial.","text_display":"\n16. Other necessary matters concerning the clinical trial.","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[242,1960],[1003,1960],[1003,2017],[242,2017]],"region":{"top_left_x":242,"top_left_y":1959,"width":761,"height":59},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1beba8ad2724a08af520434291cba0a","type":"section_header","conversion_output":false,"children_ids":["2e359aafee6d4a87a3b01e0319d75e63"],"text":"","text_display":""},{"cnt":[[247,1965],[998,1965],[998,2013],[247,2013]],"region":{"top_left_x":246,"top_left_y":1964,"width":753,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e359aafee6d4a87a3b01e0319d75e63","type":"text","conversion_output":true,"parent_id":"f1beba8ad2724a08af520434291cba0a","text":"8.2 DATA QUALITY ASSURANCE","text_display":"\n\n\\subsection*{8.2 DATA QUALITY ASSURANCE}","confidence":1,"confidence_rate":1},{"cnt":[[244,2051],[1665,2051],[1665,2104],[244,2104]],"region":{"top_left_x":244,"top_left_y":2051,"width":1422,"height":53},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bfbc8226ce7b4546b8f8c68720a1244d","type":"text","conversion_output":true,"text":"A quality assurance audit/inspection of this trial may be conducted by the sponsor or","text_display":"\n\nA quality assurance audit/inspection of this trial may be conducted by the sponsor or","confidence":1,"confidence_rate":1},{"cnt":[[247,2102],[1720,2102],[1720,2150],[247,2150]],"region":{"top_left_x":246,"top_left_y":2101,"width":1475,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f29f3079d4a4071b77adeb7b4a84da7","type":"text","conversion_output":true,"text":"sponsor's designees or by IRBs/IECs or by regulatory authorities. The quality assurance","text_display":" sponsor's designees or by IRBs/IECs or by regulatory authorities. The quality assurance","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[247,2150],[1690,2150],[1690,2200],[247,2200]],"region":{"top_left_x":246,"top_left_y":2149,"width":1445,"height":51},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9bdab4c8e414f02befc84a0e95eebd0","type":"text","conversion_output":true,"text":"auditor will have access to all medical records, the investigator's trial-related files and","text_display":" auditor will have access to all medical records, the investigator's trial-related files and","confidence":1,"confidence_rate":1},{"cnt":[[247,2198],[1549,2198],[1549,2246],[247,2246]],"region":{"top_left_x":246,"top_left_y":2197,"width":1303,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"654ed262f743452a9acbf704db14d658","type":"text","conversion_output":true,"text":"correspondence, and the informed consent documentation of this clinical trial.","text_display":" correspondence, and the informed consent documentation of this clinical trial.","confidence":1,"confidence_rate":1},{"cnt":[[242,2284],[617,2284],[617,2332],[242,2332]],"region":{"top_left_x":242,"top_left_y":2284,"width":375,"height":49},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d3d131e6c578471c810f6d8a0b354882","type":"section_header","conversion_output":false,"children_ids":["bc53c430c94049678e484edb4fb63bda"],"text":"","text_display":""},{"cnt":[[247,2289],[614,2289],[614,2328],[247,2328]],"region":{"top_left_x":246,"top_left_y":2288,"width":369,"height":40},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bc53c430c94049678e484edb4fb63bda","type":"text","conversion_output":true,"parent_id":"d3d131e6c578471c810f6d8a0b354882","text":"8.3 RECORDS","text_display":"\n\n\\subsection*{8.3 RECORDS}","confidence":1,"confidence_rate":1},{"cnt":[[244,2376],[1780,2376],[1780,2426],[244,2426]],"region":{"top_left_x":244,"top_left_y":2375,"width":1536,"height":52},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15c7aac11d7f49acb668a2eeef940c64","type":"text","conversion_output":true,"text":"CRFs for individual patients will be provided by the sponsor/CRO, via remote data capture.","text_display":"\n\nCRFs for individual patients will be provided by the sponsor/CRO, via remote data capture.","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[247,2424],[1780,2424],[1780,2474],[247,2474]],"region":{"top_left_x":246,"top_left_y":2423,"width":1534,"height":51},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d3a0bb9d18d46f29b8bde4850a79631","type":"text","conversion_output":true,"text":"See Section 4.1.5.2 for rules about emergency code breaks. For drug accountability, refer to","text_display":" See Section 4.1.5.2 for rules about emergency code breaks. For drug accountability, refer to","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[247,2472],[482,2472],[482,2520],[247,2520]],"region":{"top_left_x":246,"top_left_y":2471,"width":237,"height":49},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74909cf854bf4a1f879f3ab8aaf24ecd","type":"text","conversion_output":true,"text":"Section 4.1.8.","text_display":" Section 4.1.8.","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":40},"line":50,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e3cc5ec110c34b30866db0525717409d","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99169921875,"confidence_rate":0.9998015572024007},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":51,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1e537eb941a54e789b24de758d4844ec","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":52,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d62cc384ab13461cb04922c916166dcc","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-073","page":73,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"916e458223784c3faee339137952fec6","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b56ec30f5d84b4d8c94a354a25ecc00","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8db8d1f70c714a15806c2cd30dda0e33","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac06b7fba8c54a4aba1e9f455e8a75a3","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d50986452ff4661b4bb191f68fc5e50","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a3535aeb1e74bb4a291ceea15a6fb4e","type":"page_info","conversion_output":false,"text":"Page 73 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[738,338],[738,386],[242,386]],"region":{"top_left_x":242,"top_left_y":338,"width":496,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"004b87c6e4894ae29861b2f1802b599b","type":"section_header","conversion_output":false,"children_ids":["113ad08a0bc6464787e178061989bbc0"],"text":"","text_display":""},{"cnt":[[247,343],[733,343],[733,381],[247,381]],"region":{"top_left_x":246,"top_left_y":342,"width":488,"height":40},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"113ad08a0bc6464787e178061989bbc0","type":"text","conversion_output":true,"parent_id":"004b87c6e4894ae29861b2f1802b599b","text":"8.3.1 Source documents","text_display":"\n\n\\subsection*{8.3.1 Source documents}","confidence":0.92626953125,"confidence_rate":0.9971673522714272},{"cnt":[[247,429],[1711,429],[1711,477],[247,477]],"region":{"top_left_x":246,"top_left_y":429,"width":1465,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20e5952d21b24ecc8540ca130a62c13c","type":"text","conversion_output":true,"text":"Source documents provide evidence for the existence of the patient and substantiate the","text_display":"\n\nSource documents provide evidence for the existence of the patient and substantiate the","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[247,477],[1633,477],[1633,525],[247,525]],"region":{"top_left_x":246,"top_left_y":477,"width":1388,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d14bcfd9d024ad48d4590baaa3ceaf5","type":"text","conversion_output":true,"text":"integrity of the data collected. Source documents are filed at the investigator's site.","text_display":" integrity of the data collected. Source documents are filed at the investigator's site.","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[247,544],[1713,544],[1713,592],[247,592]],"region":{"top_left_x":246,"top_left_y":543,"width":1468,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"222197a386184f098c80ba5c947bdfe1","type":"text","conversion_output":true,"text":"Data reported entered in the eCRFs that are transcribed from source documents must be","text_display":"\n\nData reported entered in the eCRFs that are transcribed from source documents must be","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[247,594],[1615,594],[1615,642],[247,642]],"region":{"top_left_x":246,"top_left_y":593,"width":1370,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4c235475b03450aa9f71d02450d0312","type":"text","conversion_output":true,"text":"consistent with the source documents or the discrepancies must be explained. The","text_display":" consistent with the source documents or the discrepancies must be explained. The","confidence":1,"confidence_rate":1},{"cnt":[[247,642],[1784,642],[1784,690],[247,690]],"region":{"top_left_x":246,"top_left_y":641,"width":1539,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c8849facdc94903a87bfc1332dbc0fa","type":"text","conversion_output":true,"text":"investigator may need to request previous medical records or transfer records, depending on","text_display":" investigator may need to request previous medical records or transfer records, depending on","confidence":1,"confidence_rate":1},{"cnt":[[247,690],[1720,690],[1720,738],[247,738]],"region":{"top_left_x":246,"top_left_y":689,"width":1475,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a280a5fb88f4353b7e8fb9202d2223a","type":"text","conversion_output":true,"text":"the trial; also current medical records must be available. All possible attempts should be","text_display":" the trial; also current medical records must be available. All possible attempts should be","confidence":1,"confidence_rate":1},{"cnt":[[244,738],[1412,738],[1412,788],[244,788]],"region":{"top_left_x":244,"top_left_y":737,"width":1168,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a3b45812b2a4479a4fa990a233b9c8d","type":"text","conversion_output":true,"text":"made to collect source documents for events that trigger adjudication.","text_display":" made to collect source documents for events that trigger adjudication.","confidence":1,"confidence_rate":1},{"cnt":[[247,827],[1252,827],[1252,870],[247,870]],"region":{"top_left_x":246,"top_left_y":826,"width":1006,"height":45},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1c7a817d8fc4b109129ea6617e30490","type":"text","conversion_output":true,"text":"For eCRFs all data must be derived from source documents.","text_display":"\n\nFor eCRFs all data must be derived from source documents.","confidence":1,"confidence_rate":1},{"cnt":[[242,914],[1183,914],[1183,962],[242,962]],"region":{"top_left_x":242,"top_left_y":913,"width":942,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fa021d45d984781b58ab712c4958b40","type":"section_header","conversion_output":false,"children_ids":["7e559152373e4d8f82b357ce31e630d7"],"text":"","text_display":""},{"cnt":[[247,918],[1181,918],[1181,957],[247,957]],"region":{"top_left_x":246,"top_left_y":918,"width":936,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e559152373e4d8f82b357ce31e630d7","type":"text","conversion_output":true,"parent_id":"7fa021d45d984781b58ab712c4958b40","text":"8.3.2 Direct access to source data and documents","text_display":"\n\n\\subsection*{8.3.2 Direct access to source data and documents}","confidence":0.99365234375,"confidence_rate":0.9998798583820596},{"cnt":[[244,1005],[1757,1005],[1757,1053],[244,1053]],"region":{"top_left_x":244,"top_left_y":1005,"width":1513,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6fc55474276490eacb0aaf60abde156","type":"text","conversion_output":true,"text":"The investigator / institution will permit trial-related monitoring, audits, IRB / IEC review","text_display":"\n\nThe investigator / institution will permit trial-related monitoring, audits, IRB / IEC review","confidence":0.93896484375,"confidence_rate":0.9993575815353783},{"cnt":[[247,1055],[1720,1055],[1720,1103],[247,1103]],"region":{"top_left_x":246,"top_left_y":1055,"width":1475,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29e66e6cad8641f38c0428d4eaaed293","type":"text","conversion_output":true,"text":"and regulatory inspection, providing direct access to all related source data / documents.","text_display":" and regulatory inspection, providing direct access to all related source data / documents.","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[247,1101],[1821,1101],[1821,1154],[247,1154]],"region":{"top_left_x":246,"top_left_y":1101,"width":1575,"height":53},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a165f378b7b04123b21f9862a7a9fb03","type":"text","conversion_output":true,"text":"CRFs/eCRFs and all source documents, including progress notes and copies of laboratory and","text_display":" CRFs/eCRFs and all source documents, including progress notes and copies of laboratory and","confidence":0.9985356330871582,"confidence_rate":0.9999845744332286},{"cnt":[[247,1147],[1727,1147],[1727,1199],[247,1199]],"region":{"top_left_x":246,"top_left_y":1146,"width":1481,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af03784a25804b5eafc0259290f6a5d8","type":"text","conversion_output":true,"text":"medical test results must be available at all times for review by the clinical trial monitor,","text_display":" medical test results must be available at all times for review by the clinical trial monitor,","confidence":1,"confidence_rate":1},{"cnt":[[247,1197],[1729,1197],[1729,1245],[247,1245]],"region":{"top_left_x":246,"top_left_y":1197,"width":1484,"height":48},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9c669df02b644cba8d5bff410cd7ec1","type":"text","conversion_output":true,"text":"auditor and inspection by health authorities (e.g. FDA). The Clinical Research Associate","text_display":" auditor and inspection by health authorities (e.g. FDA). The Clinical Research Associate","confidence":1,"confidence_rate":1},{"cnt":[[247,1245],[1711,1245],[1711,1295],[247,1295]],"region":{"top_left_x":246,"top_left_y":1244,"width":1465,"height":52},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5614bc1eb6d545e7ade9acc48f340728","type":"text","conversion_output":true,"text":"(CRA) / on site monitor and auditor may review all CRFs/eCRFs, and written informed","text_display":" (CRA) / on site monitor and auditor may review all CRFs/eCRFs, and written informed","confidence":1,"confidence_rate":1},{"cnt":[[247,1293],[1786,1293],[1786,1341],[247,1341]],"region":{"top_left_x":246,"top_left_y":1292,"width":1541,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed79d7abac0b41729851b1c8b64cbb91","type":"text","conversion_output":true,"text":"consents. The accuracy of the data will be verified by reviewing the documents described in","text_display":" consents. The accuracy of the data will be verified by reviewing the documents described in","confidence":1,"confidence_rate":1},{"cnt":[[247,1343],[482,1343],[482,1387],[247,1387]],"region":{"top_left_x":246,"top_left_y":1343,"width":237,"height":44},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"532140acfe5d4564ba79cbef58fa714c","type":"text","conversion_output":true,"text":"Section 8.3.1.","text_display":" Section 8.3.1.","confidence":1,"confidence_rate":1},{"cnt":[[242,1430],[752,1430],[752,1483],[242,1483]],"region":{"top_left_x":242,"top_left_y":1430,"width":510,"height":53},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db4acff35e1b4cac8024301ad87beeb6","type":"section_header","conversion_output":false,"children_ids":["6d6a8a5e549a4e96a4566e9a06f1aca7"],"text":"","text_display":""},{"cnt":[[247,1435],[747,1435],[747,1483],[247,1483]],"region":{"top_left_x":246,"top_left_y":1434,"width":501,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d6a8a5e549a4e96a4566e9a06f1aca7","type":"text","conversion_output":true,"parent_id":"db4acff35e1b4cac8024301ad87beeb6","text":"8.3.3 Storage of records","text_display":"\n\n\\subsection*{8.3.3 Storage of records}","confidence":0.994140625,"confidence_rate":0.9997973788584028},{"cnt":[[244,1521],[916,1521],[916,1569],[244,1569]],"region":{"top_left_x":244,"top_left_y":1521,"width":673,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bab21a7f486f48e0ab58c65cdaa438d6","type":"text","conversion_output":true,"text":"For Japan: \"Storage period of records","text_display":"\n\nFor Japan: \"Storage period of records","confidence":1,"confidence_rate":1},{"cnt":[[247,1567],[1798,1567],[1798,1617],[247,1617]],"region":{"top_left_x":246,"top_left_y":1567,"width":1552,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"59b70dc6156d4dd2b92e556c24cb1504","type":"text","conversion_output":true,"text":"Trial site(s):The trial site(s) must retain the source documents and essential documents for a","text_display":"\nTrial site(s):The trial site(s) must retain the source documents and essential documents for a","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[242,1617],[1782,1617],[1782,1665],[242,1665]],"region":{"top_left_x":242,"top_left_y":1617,"width":1540,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8f47a598e3e4a93a2e61b4a503d7832","type":"text","conversion_output":true,"text":"period defined by the Japanese GCP regulation and the sponsor's or designated CRO SOP.","text_display":" period defined by the Japanese GCP regulation and the sponsor's or designated CRO SOP.","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[244,1713],[1775,1713],[1775,1761],[244,1761]],"region":{"top_left_x":244,"top_left_y":1713,"width":1531,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc6cd8a94bc8449aa57f489808b0a8fd","type":"text","conversion_output":true,"text":"Sponsor: The sponsor/CRO must retain the essential documents according to the sponsor's","text_display":"\n\nSponsor: The sponsor/CRO must retain the essential documents according to the sponsor's","confidence":0.9960954189300537,"confidence_rate":0.9999574767318826},{"cnt":[[244,1761],[1816,1761],[1816,1812],[244,1812]],"region":{"top_left_x":244,"top_left_y":1761,"width":1573,"height":51},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8c215a1f4c94f2cb176677056c7fd80","type":"text","conversion_output":true,"text":"or designated CRO SOPs. When it is no longer necessary for the trial site to retain the source","text_display":" or designated CRO SOPs. When it is no longer necessary for the trial site to retain the source","confidence":1,"confidence_rate":1},{"cnt":[[244,1809],[1786,1809],[1786,1857],[244,1857]],"region":{"top_left_x":244,"top_left_y":1809,"width":1543,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea28e200c3b34b299794ab78d51dce2a","type":"text","conversion_output":true,"text":"documents and essential documents, the sponsor representative must notify the head of trial","text_display":" documents and essential documents, the sponsor representative must notify the head of trial","confidence":1,"confidence_rate":1},{"cnt":[[247,1857],[350,1857],[350,1898],[247,1898]],"region":{"top_left_x":246,"top_left_y":1857,"width":104,"height":42},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0d8b76c54914a50bc461b4c013ecd03","type":"text","conversion_output":true,"text":"site.\"","text_display":" site.\"","confidence":1,"confidence_rate":1},{"cnt":[[242,1942],[1743,1942],[1743,1990],[242,1990]],"region":{"top_left_x":242,"top_left_y":1941,"width":1501,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1b4021039a5408e829302f899499d19","type":"section_header","conversion_output":false,"children_ids":["ff1efe5ab15e48398b3f9c24c81b8dfb"],"text":"","text_display":""},{"cnt":[[247,1946],[1738,1946],[1738,1985],[247,1985]],"region":{"top_left_x":246,"top_left_y":1946,"width":1493,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff1efe5ab15e48398b3f9c24c81b8dfb","type":"text","conversion_output":true,"parent_id":"b1b4021039a5408e829302f899499d19","text":"8.4 LISTEDNESS AND EXPEDITED REPORTING OF ADVERSE EVENTS","text_display":"\n\n\\subsection*{8.4 LISTEDNESS AND EXPEDITED REPORTING OF ADVERSE EVENTS}","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[242,2033],[599,2033],[599,2079],[242,2079]],"region":{"top_left_x":242,"top_left_y":2033,"width":357,"height":46},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d61867959d34e788cb4f0503a9f0811","type":"section_header","conversion_output":false,"children_ids":["d143c57b1c0c4f1680c8ce5d25d89f5e"],"text":"","text_display":""},{"cnt":[[247,2035],[596,2035],[596,2076],[247,2076]],"region":{"top_left_x":246,"top_left_y":2035,"width":351,"height":42},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d143c57b1c0c4f1680c8ce5d25d89f5e","type":"text","conversion_output":true,"parent_id":"8d61867959d34e788cb4f0503a9f0811","text":"8.4.1 Listedness","text_display":"\n\n\\subsection*{8.4.1 Listedness}","confidence":0.99462890625,"confidence_rate":0.999743577170879},{"cnt":[[247,2122],[1720,2122],[1720,2172],[247,2172]],"region":{"top_left_x":246,"top_left_y":2122,"width":1475,"height":51},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4cca65675dd4422a36c919913b96b90","type":"text","conversion_output":true,"text":"To fulfil the regulatory requirements for expedited safety reporting, the sponsor or CRO","text_display":"\n\nTo fulfil the regulatory requirements for expedited safety reporting, the sponsor or CRO","confidence":1,"confidence_rate":1},{"cnt":[[247,2170],[1802,2170],[1802,2218],[247,2218]],"region":{"top_left_x":246,"top_left_y":2170,"width":1557,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69b3640663c848e1bb944759f0955ce1","type":"text","conversion_output":true,"text":"evaluates whether a particular adverse event is \"listed\", i.e. is a known side effect of the drug","text_display":" evaluates whether a particular adverse event is \"listed\", i.e. is a known side effect of the drug","confidence":1,"confidence_rate":1},{"cnt":[[247,2220],[1748,2220],[1748,2268],[247,2268]],"region":{"top_left_x":246,"top_left_y":2220,"width":1502,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"853a0ec4cdf94b7e94c5132d8fb438a1","type":"text","conversion_output":true,"text":"or not. Therefore a unique reference document for the evaluation of listedness needs to be","text_display":" or not. Therefore a unique reference document for the evaluation of listedness needs to be","confidence":1,"confidence_rate":1},{"cnt":[[247,2266],[1812,2266],[1812,2314],[247,2314]],"region":{"top_left_x":246,"top_left_y":2266,"width":1566,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a2bf132a741498483c63b0ab3e4e229","type":"text","conversion_output":true,"text":"provided. For linagliptin this is the current version of the Company Core Data Sheet (CCDS).","text_display":" provided. For linagliptin this is the current version of the Company Core Data Sheet (CCDS).","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[247,2314],[1761,2314],[1761,2364],[247,2364]],"region":{"top_left_x":246,"top_left_y":2314,"width":1516,"height":51},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"706a3bf330e2470480222096a990027c","type":"text","conversion_output":true,"text":"No AEs are classified as listed for matching placebo, study design, or invasive procedures.","text_display":" No AEs are classified as listed for matching placebo, study design, or invasive procedures.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c437013952984cacaaf8a65bbc08bac5","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"68155e3ac1f94bfa95f1d718e15b10c8","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5d7dd2af3c1d4335b3d6fbf95e0488fd","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-074","page":74,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"406a070a5e1747ccb12712d7f6bdaffb","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8db5ded0838247d7b71655d1987238be","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79c8e28e4be74d9f9213235e81691abd","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"beea31c9379a4bb284151900b2703144","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"908997702df3463db1d6aa1cc2de8260","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af4f6202577244cf83c8e9b2391dc335","type":"page_info","conversion_output":false,"text":"Page 74 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[1423,338],[1423,393],[242,393]],"region":{"top_left_x":242,"top_left_y":338,"width":1182,"height":55},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ba495ec17036436291cd0d5e085c9bf1","type":"section_header","conversion_output":false,"children_ids":["40f7b4c01c174da194282aec485ab0fa"],"text":"","text_display":""},{"cnt":[[247,343],[1419,343],[1419,388],[247,388]],"region":{"top_left_x":246,"top_left_y":342,"width":1173,"height":47},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"40f7b4c01c174da194282aec485ab0fa","type":"text","conversion_output":true,"parent_id":"ba495ec17036436291cd0d5e085c9bf1","text":"8.4.2 Expedited reporting to health authorities and IECs/IRBs","text_display":"\n\n\\subsection*{8.4.2 Expedited reporting to health authorities and IECs/IRBs}","confidence":1,"confidence_rate":1},{"cnt":[[247,429],[1732,429],[1732,477],[247,477]],"region":{"top_left_x":246,"top_left_y":429,"width":1486,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8712bfc32989458ab0aaf4231ae9d5f7","type":"text","conversion_output":true,"text":"Expedited reporting of serious adverse events, e.g. suspected unexpected serious adverse","text_display":"\n\nExpedited reporting of serious adverse events, e.g. suspected unexpected serious adverse","confidence":1,"confidence_rate":1},{"cnt":[[247,477],[1729,477],[1729,523],[247,523]],"region":{"top_left_x":246,"top_left_y":477,"width":1484,"height":47},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b666b8c96d874707814a0072d1029c1a","type":"text","conversion_output":true,"text":"reactions (SUSARs) to health authorities and IECs/IRBs, will be done according to local","text_display":" reactions (SUSARs) to health authorities and IECs/IRBs, will be done according to local","confidence":1,"confidence_rate":1},{"cnt":[[247,525],[1821,525],[1821,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1575,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c1e6dcfc9134cfd888f7949819fdd30","type":"text","conversion_output":true,"text":"regulatory requirements. Further details regarding this reporting procedure are provided in the","text_display":" regulatory requirements. Further details regarding this reporting procedure are provided in the","confidence":1,"confidence_rate":1},{"cnt":[[247,573],[610,573],[610,619],[247,619]],"region":{"top_left_x":246,"top_left_y":573,"width":364,"height":47},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c58fdb1f993a4edb8d65dca17892c9e9","type":"text","conversion_output":true,"text":"Investigator Site File.","text_display":" Investigator Site File.","confidence":1,"confidence_rate":1},{"cnt":[[242,658],[1154,658],[1154,708],[242,708]],"region":{"top_left_x":242,"top_left_y":657,"width":912,"height":52},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6715a41c08fe4e74894c1e9ec6d70b11","type":"section_header","conversion_output":false,"children_ids":["5a3cf996ae0448ccaf79fbed6694ce2e"],"text":"","text_display":""},{"cnt":[[247,662],[1149,662],[1149,706],[247,706]],"region":{"top_left_x":246,"top_left_y":662,"width":904,"height":44},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5a3cf996ae0448ccaf79fbed6694ce2e","type":"text","conversion_output":true,"parent_id":"6715a41c08fe4e74894c1e9ec6d70b11","text":"8.5 STATEMENT OF CONFIDENTIALITY","text_display":"\n\n\\subsection*{8.5 STATEMENT OF CONFIDENTIALITY}","confidence":1,"confidence_rate":1},{"cnt":[[247,752],[1652,752],[1652,800],[247,800]],"region":{"top_left_x":246,"top_left_y":751,"width":1406,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40c48b2a92b94d5881690f85f4fd7692","type":"text","conversion_output":true,"text":"Individual patient medical information obtained as a result of this trial is considered","text_display":"\n\nIndividual patient medical information obtained as a result of this trial is considered","confidence":1,"confidence_rate":1},{"cnt":[[247,800],[1734,800],[1734,848],[247,848]],"region":{"top_left_x":246,"top_left_y":799,"width":1488,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30ed094af1184df1bb260ff6b791c62e","type":"text","conversion_output":true,"text":"confidential and disclosure to third parties is prohibited with the exceptions noted below.","text_display":" confidential and disclosure to third parties is prohibited with the exceptions noted below.","confidence":1,"confidence_rate":1},{"cnt":[[247,848],[1647,848],[1647,898],[247,898]],"region":{"top_left_x":246,"top_left_y":847,"width":1402,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c8553322ebb4b8ebc4c0915613dd6a3","type":"text","conversion_output":true,"text":"Patient confidentiality will be ensured by using patient identification code numbers.","text_display":" Patient confidentiality will be ensured by using patient identification code numbers.","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[247,918],[1702,918],[1702,966],[247,966]],"region":{"top_left_x":246,"top_left_y":918,"width":1456,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d65d1f2aadb848e38be1a67ebf505b99","type":"text","conversion_output":true,"text":"Treatment data may be given to the patient's personal physician or to other appropriate","text_display":"\n\nTreatment data may be given to the patient's personal physician or to other appropriate","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[247,964],[1798,964],[1798,1012],[247,1012]],"region":{"top_left_x":246,"top_left_y":964,"width":1552,"height":48},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"645d13d18b7642729e1771a5a5c7af65","type":"text","conversion_output":true,"text":"medical personnel responsible for the patient's welfare. Data generated as a result of the trial","text_display":" medical personnel responsible for the patient's welfare. Data generated as a result of the trial","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[247,1014],[1770,1014],[1770,1062],[247,1062]],"region":{"top_left_x":246,"top_left_y":1014,"width":1525,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa63893d64b24fada1e1bb64f0613a2d","type":"text","conversion_output":true,"text":"need to be available for inspection on request by the participating physicians, the sponsor's","text_display":" need to be available for inspection on request by the participating physicians, the sponsor's","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[247,1060],[1652,1060],[1652,1108],[247,1108]],"region":{"top_left_x":246,"top_left_y":1059,"width":1406,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5be297d6256045469fe8049f0f4fa9b8","type":"text","conversion_output":true,"text":"representatives, by the IRB / IEC and the regulatory authorities For EU, i.e. the CA.","text_display":" representatives, by the IRB / IEC and the regulatory authorities For EU, i.e. the CA.","confidence":0.9636863496552905,"confidence_rate":0.9995890911046177},{"cnt":[[242,1147],[916,1147],[916,1195],[242,1195]],"region":{"top_left_x":242,"top_left_y":1146,"width":675,"height":49},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"620a4810c2fd4001978e2ca7d37571b0","type":"section_header","conversion_output":false,"children_ids":["dfdb411c1d404540b2dd7f6ea9b183ae"],"text":"","text_display":""},{"cnt":[[247,1151],[911,1151],[911,1190],[247,1190]],"region":{"top_left_x":246,"top_left_y":1151,"width":666,"height":40},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dfdb411c1d404540b2dd7f6ea9b183ae","type":"text","conversion_output":true,"parent_id":"620a4810c2fd4001978e2ca7d37571b0","text":"8.6 COMPLETION OF TRIAL","text_display":"\n\n\\subsection*{8.6 COMPLETION OF TRIAL}","confidence":1,"confidence_rate":1},{"cnt":[[244,1238],[1770,1238],[1770,1286],[244,1286]],"region":{"top_left_x":244,"top_left_y":1238,"width":1527,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"93fc8d24c55140919d689c2ac2ac0e17","type":"text","conversion_output":true,"text":"For Japan, When the trial is completed, the investigator should inform the head of the trial","text_display":"\n\nFor Japan, When the trial is completed, the investigator should inform the head of the trial","confidence":1,"confidence_rate":1},{"cnt":[[244,1288],[1814,1288],[1814,1336],[244,1336]],"region":{"top_left_x":244,"top_left_y":1288,"width":1570,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c88718e17a1f44a79e036061dc99f71d","type":"text","conversion_output":true,"text":"site of the completion in writing, and the head of the trial site should promptly inform the IRB","text_display":" site of the completion in writing, and the head of the trial site should promptly inform the IRB","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[247,1336],[1250,1336],[1250,1384],[247,1384]],"region":{"top_left_x":246,"top_left_y":1336,"width":1004,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"207b16d1ee504899a27fce737841771e","type":"text","conversion_output":true,"text":"and the sponsor representative of the completion in writing.","text_display":" and the sponsor representative of the completion in writing.","confidence":1,"confidence_rate":1},{"cnt":[[247,1432],[1775,1432],[1775,1480],[247,1480]],"region":{"top_left_x":246,"top_left_y":1432,"width":1529,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e8f32f58a5142dfb8d07a6fec5ae94d","type":"text","conversion_output":true,"text":"For EU member states: The EC/competent authority in each participating EU member state","text_display":"\n\nFor EU member states: The EC/competent authority in each participating EU member state","confidence":1,"confidence_rate":1},{"cnt":[[247,1480],[1784,1480],[1784,1528],[247,1528]],"region":{"top_left_x":246,"top_left_y":1480,"width":1539,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d129cfb2efae4dceb38230d452c7d832","type":"text","conversion_output":true,"text":"needs to be notified about the end of the trial (last patient out, unless specified differently in","text_display":" needs to be notified about the end of the trial (last patient out, unless specified differently in","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[247,1526],[1211,1526],[1211,1574],[247,1574]],"region":{"top_left_x":246,"top_left_y":1525,"width":965,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"53be49f8efd7453ca080a2a27349aca5","type":"text","conversion_output":true,"text":"Section 6.2.3 of the CTP) or early termination of the trial.","text_display":" Section 6.2.3 of the CTP) or early termination of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[242,1613],[927,1613],[927,1665],[242,1665]],"region":{"top_left_x":242,"top_left_y":1612,"width":686,"height":54},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e1f82c0b1bb14a34ad52270d9106191b","type":"section_header","conversion_output":false,"children_ids":["3d95c5280fb94c7786ea730cd6550128"],"text":"","text_display":""},{"cnt":[[247,1617],[925,1617],[925,1661],[247,1661]],"region":{"top_left_x":246,"top_left_y":1617,"width":680,"height":44},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3d95c5280fb94c7786ea730cd6550128","type":"text","conversion_output":true,"parent_id":"e1f82c0b1bb14a34ad52270d9106191b","text":"8.7 PROTOCOL VIOLATIONS","text_display":"\n\n\\subsection*{8.7 PROTOCOL VIOLATIONS}","confidence":0.9990234375,"confidence_rate":0.9999651063356614},{"cnt":[[244,1709],[1697,1709],[1697,1757],[244,1757]],"region":{"top_left_x":244,"top_left_y":1708,"width":1454,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a65cc31bf0543989ab134e01f8b8a3a","type":"text","conversion_output":true,"text":"For Japan: The investigator or sub-investigator should record all CTP violations. The","text_display":"\n\nFor Japan: The investigator or sub-investigator should record all CTP violations. The","confidence":1,"confidence_rate":1},{"cnt":[[247,1754],[1775,1754],[1775,1802],[247,1802]],"region":{"top_left_x":246,"top_left_y":1754,"width":1529,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fbb2477d87d64e879f81bc6104f264e5","type":"text","conversion_output":true,"text":"investigator should provide and submit the sponsor representative and the head of the trial","text_display":" investigator should provide and submit the sponsor representative and the head of the trial","confidence":1,"confidence_rate":1},{"cnt":[[247,1805],[1706,1805],[1706,1853],[247,1853]],"region":{"top_left_x":246,"top_left_y":1804,"width":1461,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1dff889736f64188b977e812eea14915","type":"text","conversion_output":true,"text":"site the records of violations infringing the Japanese GCP or violations to eliminate an","text_display":" site the records of violations infringing the Japanese GCP or violations to eliminate an","confidence":1,"confidence_rate":1},{"cnt":[[247,1850],[1547,1850],[1547,1898],[247,1898]],"region":{"top_left_x":246,"top_left_y":1850,"width":1301,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e2812bcd39a412d8b9cc145625fefd5","type":"text","conversion_output":true,"text":"immediate hazard to trial subjects and for other medically inevitable reasons.","text_display":" immediate hazard to trial subjects and for other medically inevitable reasons.","confidence":1,"confidence_rate":1},{"cnt":[[240,1942],[1761,1942],[1761,2040],[240,2040]],"region":{"top_left_x":239,"top_left_y":1941,"width":1523,"height":99},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b83cad52e7bf4bb2a1796711c0d326ed","type":"section_header","conversion_output":false,"children_ids":["3f7193743c04439c9658bcfa25be3bd6","44fb27e2d50e4545809b0295f5e0aa83"],"text":"","text_display":""},{"cnt":[[247,1946],[1757,1946],[1757,1987],[247,1987]],"region":{"top_left_x":246,"top_left_y":1946,"width":1511,"height":42},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f7193743c04439c9658bcfa25be3bd6","type":"text","conversion_output":true,"parent_id":"b83cad52e7bf4bb2a1796711c0d326ed","text":"8.8 COMPENSATION AVAILABLE TO THE PATIENT IN THE EVENT OF","text_display":"\n\n\\subsection*{8.8 COMPENSATION AVAILABLE TO THE PATIENT IN THE EVENT OF","confidence":1,"confidence_rate":1},{"cnt":[[402,1997],[921,1997],[921,2035],[402,2035]],"region":{"top_left_x":402,"top_left_y":1996,"width":519,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44fb27e2d50e4545809b0295f5e0aa83","type":"text","conversion_output":true,"parent_id":"b83cad52e7bf4bb2a1796711c0d326ed","text":"TRIAL RELATED INJURY","text_display":" TRIAL RELATED INJURY}","confidence":1,"confidence_rate":1},{"cnt":[[244,2083],[1798,2083],[1798,2131],[244,2131]],"region":{"top_left_x":244,"top_left_y":2083,"width":1554,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ac7adf7799047b19bfcdd6ff167691c","type":"text","conversion_output":true,"text":"For Japan: In the event of health injury associated with this trial, the sponsor representative","text_display":"\n\nFor Japan: In the event of health injury associated with this trial, the sponsor representative","confidence":1,"confidence_rate":1},{"cnt":[[247,2134],[1542,2134],[1542,2179],[247,2179]],"region":{"top_left_x":246,"top_left_y":2133,"width":1296,"height":47},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"feea65b9a14a4071b3f250de32a4f59f","type":"text","conversion_output":true,"text":"is responsible for compensation based on the contract signed by the trial site.","text_display":" is responsible for compensation based on the contract signed by the trial site.","confidence":1,"confidence_rate":1},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":41,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"33c70ca132cf44e8882139ffe65767e9","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":42,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ab1dc67b87954442afb8dd445af89056","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2668],[1766,2668],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1470,"height":35},"line":43,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"32db5801f3a9408aa309a2ae2c83ddda","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-075","page":75,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16902af4d1c641b293108f3452f7b5cf","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,121],[1816,121],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":121,"width":314,"height":39},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a13aef83b6ea4807ac9276a39f8c70d9","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,167],[596,167],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":166,"width":351,"height":38},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecf82071e2d24caeb943fba807bb3b39","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b405cb1c124e4878a1f35d6f5a9b5228","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6017d96efdbe4820bfa78b75e4d11295","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f741a1bfd91b452fbd387379b57bc9b8","type":"page_info","conversion_output":false,"text":"Page 75 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,340],[738,338],[738,391],[242,393]],"region":{"top_left_x":241,"top_left_y":337,"width":498,"height":57},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b82874f2a0a64b0aa2ada2b3b00e2e1d","type":"section_header","conversion_output":false,"children_ids":["58809c02697a488b8968bfc3faadd5f7"],"text":"","text_display":""},{"cnt":[[247,343],[738,343],[738,391],[247,391]],"region":{"top_left_x":246,"top_left_y":342,"width":492,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"58809c02697a488b8968bfc3faadd5f7","type":"text","conversion_output":true,"parent_id":"b82874f2a0a64b0aa2ada2b3b00e2e1d","text":"9. REFERENCES","text_display":"\n\n\\section*{9. REFERENCES}","confidence":1,"confidence_rate":1},{"cnt":[[242,434],[943,434],[943,482],[242,482]],"region":{"top_left_x":242,"top_left_y":434,"width":702,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a406192b3cc40f9bf700317bb5ba560","type":"section_header","conversion_output":false,"children_ids":["662817fad4f84033a73058237ecebecc"],"text":"","text_display":""},{"cnt":[[247,439],[939,439],[939,477],[247,477]],"region":{"top_left_x":246,"top_left_y":438,"width":693,"height":40},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"662817fad4f84033a73058237ecebecc","type":"text","conversion_output":true,"parent_id":"0a406192b3cc40f9bf700317bb5ba560","text":"9.1 PUBLISHED REFERENCES","text_display":"\n\n\\subsection*{9.1 PUBLISHED REFERENCES}","confidence":1,"confidence_rate":1},{"cnt":[[247,525],[1738,525],[1738,573],[247,573]],"region":{"top_left_x":246,"top_left_y":525,"width":1493,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8bd767c7072b4de2b2569f340821e524","type":"text","conversion_output":true,"text":"R07-1076 International Diabetes Federation, Clinical Guidelines Task Force. Global","text_display":"\n\nR07-1076 International Diabetes Federation, Clinical Guidelines Task Force. Global","confidence":1,"confidence_rate":1},{"cnt":[[496,576],[1720,576],[1720,624],[496,624]],"region":{"top_left_x":495,"top_left_y":575,"width":1226,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7395723b914d441ab5c05f56e04347a4","type":"text","conversion_output":true,"text":"guideline for type 2 diabetes. Brussels: International Diabetes Federation","text_display":" guideline for type 2 diabetes. Brussels: International Diabetes Federation","confidence":1,"confidence_rate":1},{"cnt":[[498,624],[614,624],[614,669],[498,669]],"region":{"top_left_x":497,"top_left_y":623,"width":118,"height":47},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63fc27f0eea546f99bc26f3184b4c0f1","type":"text","conversion_output":true,"text":"(2005)","text_display":" (2005)","confidence":1,"confidence_rate":1},{"cnt":[[247,713],[1706,713],[1706,761],[247,761]],"region":{"top_left_x":246,"top_left_y":712,"width":1461,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"079255c83ca44a108f1cc5ded15cf104","type":"text","conversion_output":true,"text":"R07-4080 Klein S, Allison DB, Heymsfield SB, Kelley DE, Leibel RL et al. Waist","text_display":"\n\nR07-4080 Klein S, Allison DB, Heymsfield SB, Kelley DE, Leibel RL et al. Waist","confidence":1,"confidence_rate":1},{"cnt":[[496,758],[1793,758],[1793,809],[496,809]],"region":{"top_left_x":495,"top_left_y":758,"width":1299,"height":51},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf5190e3f8ce4002bbc05a60b850f417","type":"text","conversion_output":true,"text":"circumference and cardiometabolic risk: a consensus statement from Shaping","text_display":" circumference and cardiometabolic risk: a consensus statement from Shaping","confidence":1,"confidence_rate":1},{"cnt":[[496,809],[1647,809],[1647,857],[496,857]],"region":{"top_left_x":495,"top_left_y":808,"width":1153,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ac23246fc3c47de80c90176b0cd6201","type":"text","conversion_output":true,"text":"America's Health: Association for Weight Management and Obesity","text_display":" America's Health: Association for Weight Management and Obesity","confidence":1,"confidence_rate":1},{"cnt":[[496,854],[1652,854],[1652,902],[496,902]],"region":{"top_left_x":495,"top_left_y":854,"width":1157,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f28bd22ce934efd991ce96b761c9da8","type":"text","conversion_output":true,"text":"Prevention; NAASO, The Obesity Society; the American Society for","text_display":" Prevention; NAASO, The Obesity Society; the American Society for","confidence":1,"confidence_rate":1},{"cnt":[[493,905],[1629,905],[1629,948],[493,948]],"region":{"top_left_x":493,"top_left_y":904,"width":1136,"height":45},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bda23248aff444f3abcde48dd6b65aef","type":"text","conversion_output":true,"text":"Nutrition; and the American Diabetes Association. Am J Clin Nutr","text_display":" Nutrition; and the American Diabetes Association. Am J Clin Nutr","confidence":1,"confidence_rate":1},{"cnt":[[493,950],[820,950],[820,998],[493,998]],"region":{"top_left_x":493,"top_left_y":950,"width":328,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd2473a39587441a98476430264dbf01","type":"text","conversion_output":true,"text":"2007;85:1197-202.","text_display":" 2007;85:1197-202.","confidence":1,"confidence_rate":1},{"cnt":[[247,1042],[1784,1042],[1784,1085],[247,1085]],"region":{"top_left_x":246,"top_left_y":1041,"width":1539,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c20f50df54ed4afc9ba66cce7b786ea9","type":"text","conversion_output":true,"text":"R08-1310 AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American","text_display":"\n\nR08-1310 AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[496,1090],[1812,1087],[1812,1138],[496,1140]],"region":{"top_left_x":495,"top_left_y":1087,"width":1317,"height":53},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1fe75217926490a8a08b3704b22d6ca","type":"text","conversion_output":true,"text":"association of clinical endocrinologists medical guidelines for clinical practice","text_display":" association of clinical endocrinologists medical guidelines for clinical practice","confidence":1,"confidence_rate":1},{"cnt":[[496,1138],[1181,1138],[1181,1186],[496,1186]],"region":{"top_left_x":495,"top_left_y":1137,"width":687,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67dd8ed416ae4674b030bac3386d3a17","type":"text","conversion_output":true,"text":"for the management of diabetes mellitus.","text_display":" for the management of diabetes mellitus.","confidence":1,"confidence_rate":1},{"cnt":[[496,1183],[1176,1183],[1176,1231],[496,1231]],"region":{"top_left_x":495,"top_left_y":1183,"width":682,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94bd20151cd2480a893259c3c077d811","type":"text","conversion_output":true,"text":"Endocr Pract 13 (Suppl 1), 3-68 (2007)","text_display":"\nEndocr Pract 13 (Suppl 1), 3-68 (2007)","confidence":0.9951171875,"confidence_rate":0.9998935975659943},{"cnt":[[247,1275],[1775,1275],[1775,1323],[247,1323]],"region":{"top_left_x":246,"top_left_y":1274,"width":1529,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"acdb2936524f4e358cd7976855e343fd","type":"text","conversion_output":true,"text":"R09-1164 Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R,","text_display":"\nR09-1164 Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R,","confidence":1,"confidence_rate":1},{"cnt":[[493,1323],[1775,1323],[1775,1373],[493,1373]],"region":{"top_left_x":493,"top_left_y":1322,"width":1282,"height":51},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eba50aeceffa4da58155b1101d8aeb0a","type":"text","conversion_output":true,"text":"Zinman B; American Diabetes Association; European Association for Study","text_display":" Zinman B; American Diabetes Association; European Association for Study","confidence":1,"confidence_rate":1},{"cnt":[[496,1371],[1722,1371],[1722,1419],[496,1419]],"region":{"top_left_x":495,"top_left_y":1370,"width":1228,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"740225437e1c481482fff10134de1656","type":"text","conversion_output":true,"text":"of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a","text_display":" of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a","confidence":1,"confidence_rate":1},{"cnt":[[496,1419],[1789,1419],[1789,1469],[496,1469]],"region":{"top_left_x":495,"top_left_y":1418,"width":1294,"height":51},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"582c80eaf53c469a83db79a7e1da3931","type":"text","conversion_output":true,"text":"consensus algorithm for the initiation and adjustment of therapy: a consensus","text_display":" consensus algorithm for the initiation and adjustment of therapy: a consensus","confidence":1,"confidence_rate":1},{"cnt":[[496,1467],[1816,1467],[1816,1515],[496,1515]],"region":{"top_left_x":495,"top_left_y":1466,"width":1322,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb5e134c0a8b4b5d9116537ffd7c6f6d","type":"text","conversion_output":true,"text":"statement of the American Diabetes Association and the European Association","text_display":" statement of the American Diabetes Association and the European Association","confidence":1,"confidence_rate":1},{"cnt":[[496,1512],[1494,1512],[1494,1560],[496,1560]],"region":{"top_left_x":495,"top_left_y":1512,"width":999,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba16af7181f746e5bb8b096367cbb3e1","type":"text","conversion_output":true,"text":"for the Study of Diabetes. Diabetes Care. 2009;32:193-203.","text_display":" for the Study of Diabetes. Diabetes Care. 2009;32:193-203.","confidence":1,"confidence_rate":1},{"cnt":[[247,1604],[1750,1604],[1750,1652],[247,1652]],"region":{"top_left_x":246,"top_left_y":1603,"width":1504,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e16b5e2e903f40d8bf4f1e4e3594cf2f","type":"text","conversion_output":true,"text":"R09-2151 Guidance for industry: diabetes mellitus - evaluating cardiovascular risk in","text_display":"\n\nR09-2151 Guidance for industry: diabetes mellitus - evaluating cardiovascular risk in","confidence":0.9970703125,"confidence_rate":0.9999674006709831},{"cnt":[[493,1649],[1752,1649],[1752,1702],[493,1702]],"region":{"top_left_x":493,"top_left_y":1649,"width":1260,"height":53},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f53899cfc64947688f1c875cf47a2a54","type":"text","conversion_output":true,"text":"new antidiabetic therapies to treat type 2 diabetes (December 2008). Silver","text_display":" new antidiabetic therapies to treat type 2 diabetes (December 2008). Silver","confidence":1,"confidence_rate":1},{"cnt":[[496,1700],[1704,1700],[1704,1748],[496,1748]],"region":{"top_left_x":495,"top_left_y":1699,"width":1210,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a67c71064554e18aaae9f7c6c685365","type":"text","conversion_output":true,"text":"Spring: U.S.Department of Health and Human Services, Food and Drug","text_display":" Spring: U.S.Department of Health and Human Services, Food and Drug","confidence":1,"confidence_rate":1},{"cnt":[[496,1748],[1709,1748],[1709,1796],[496,1796]],"region":{"top_left_x":495,"top_left_y":1747,"width":1214,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abdb0d4f9f174ecea76b741cfcf5d768","type":"text","conversion_output":true,"text":"Administration, Center for Drug Evaluation and Research (CDER) 2008","text_display":" Administration, Center for Drug Evaluation and Research (CDER) 2008","confidence":1,"confidence_rate":1},{"cnt":[[247,1837],[1816,1837],[1816,1885],[247,1885]],"region":{"top_left_x":246,"top_left_y":1836,"width":1571,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1377f80f69074f98a941d3d43cefa535","type":"text","conversion_output":true,"text":"R09-6397 Asian-Pacific Type 2 Diabetes Policy Group. Type 2 diabetes: practical targets","text_display":"\n\nR09-6397 Asian-Pacific Type 2 Diabetes Policy Group. Type 2 diabetes: practical targets","confidence":0.9941477742982556,"confidence_rate":0.9999401097824777},{"cnt":[[496,1885],[1814,1885],[1814,1933],[496,1933]],"region":{"top_left_x":495,"top_left_y":1884,"width":1319,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aeadf6170b694c809d35dcb609507905","type":"text","conversion_output":true,"text":"and treatments. 4th ed. Melbourne, Singapore: International Diabetes Institute,","text_display":" and treatments. 4th ed. Melbourne, Singapore: International Diabetes Institute,","confidence":1,"confidence_rate":1},{"cnt":[[496,1933],[1163,1933],[1163,1981],[496,1981]],"region":{"top_left_x":495,"top_left_y":1932,"width":668,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e87aadcd8d384fcfa9a74ecaadd80094","type":"text","conversion_output":true,"text":"In Vivo Communications (Asia) (2005)","text_display":" In Vivo Communications (Asia) (2005)","confidence":1,"confidence_rate":1},{"cnt":[[244,2022],[1711,2022],[1711,2067],[244,2067]],"region":{"top_left_x":244,"top_left_y":2021,"width":1467,"height":47},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c06550b561b14db8b23f4a543e437da9","type":"text","conversion_output":true,"text":"R09-6400 Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP,","text_display":"\n\nR09-6400 Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP,","confidence":1,"confidence_rate":1},{"cnt":[[493,2070],[1750,2070],[1750,2118],[493,2118]],"region":{"top_left_x":493,"top_left_y":2069,"width":1257,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3fc143d9f3b4dd9a7667e4366082fb5","type":"text","conversion_output":true,"text":"Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study","text_display":" Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study","confidence":1,"confidence_rate":1},{"cnt":[[496,2115],[1658,2115],[1658,2168],[496,2168]],"region":{"top_left_x":495,"top_left_y":2115,"width":1164,"height":53},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"614064ee7a914b3baa71da3066ff00f9","type":"text","conversion_output":true,"text":"Group. Glycemic durability of rosiglitazone, metformin, or glyburide","text_display":" Group. Glycemic durability of rosiglitazone, metformin, or glyburide","confidence":1,"confidence_rate":1},{"cnt":[[493,2166],[1304,2166],[1304,2214],[493,2214]],"region":{"top_left_x":493,"top_left_y":2165,"width":812,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9666999542e4336ac43707cf486b139","type":"text","conversion_output":true,"text":"monotherapy. N Engl J Med. 2006;355:2427-43","text_display":" monotherapy. N Engl J Med. 2006;355:2427-43","confidence":1,"confidence_rate":1},{"cnt":[[247,2257],[1798,2257],[1798,2305],[247,2305]],"region":{"top_left_x":246,"top_left_y":2256,"width":1552,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fce61ee365d74d36b78d47ee4d449a01","type":"text","conversion_output":true,"text":"R09-6405 Effect of intensive blood-glucose control with metformin on complications in","text_display":"\n\nR09-6405 Effect of intensive blood-glucose control with metformin on complications in","confidence":0.9970729344058782,"confidence_rate":0.9999674298878795},{"cnt":[[496,2303],[1688,2303],[1688,2351],[496,2351]],"region":{"top_left_x":495,"top_left_y":2302,"width":1194,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9e7a01a04ff49f49c259c3bc8ff54f6","type":"text","conversion_output":true,"text":"overweight patients with type 2 diabetes (UKPDS 34). UK Prospective","text_display":" overweight patients with type 2 diabetes (UKPDS 34). UK Prospective","confidence":1,"confidence_rate":1},{"cnt":[[496,2351],[1492,2351],[1492,2401],[496,2401]],"region":{"top_left_x":495,"top_left_y":2350,"width":997,"height":51},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"289fd79a82284a02aae6e690d6433a76","type":"text","conversion_output":true,"text":"Diabetes Study (UKPDS) Group. Lancet. 1998;352:854-65","text_display":" Diabetes Study (UKPDS) Group. Lancet. 1998;352:854-65","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f53a26e373204940bd9221e62aaf6a10","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"10521852bcdb4623909d3eab0fa615a2","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2668],[1766,2668],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2668,"width":1470,"height":35},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"82b3c5e223294815ad4ded820c42b824","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-076","page":76,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2a50e0893a94c9e9c2f331feed3f2ef","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,121],[1816,121],[1816,158],[1503,158]],"region":{"top_left_x":1503,"top_left_y":121,"width":314,"height":37},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d192d5329244b97af8ac94f18b39356","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,167],[596,167],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":166,"width":351,"height":38},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47f4d9bace1245b193f6361f29d57472","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bda4c16c6b2c483891f69804c8f83aa4","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,247],[868,247]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":37},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"846c92f4c304489c88e63676a6ef1eb6","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d70e8ccf9f9941deb51a281cba7fc48d","type":"page_info","conversion_output":false,"text":"Page 76 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1812,338],[1812,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":1566,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78515e5f41ac4d1293884ec0cc243eb3","type":"text","conversion_output":true,"text":"R09-6406 Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up","text_display":"\n\nR09-6406 Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up","confidence":1,"confidence_rate":1},{"cnt":[[496,388],[1812,388],[1812,436],[496,436]],"region":{"top_left_x":495,"top_left_y":388,"width":1317,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0746e3cf82674aec9991a5f206f971e4","type":"text","conversion_output":true,"text":"of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359:1577-","text_display":" of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359:1577","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[496,434],[548,434],[548,480],[496,480]],"region":{"top_left_x":495,"top_left_y":434,"width":54,"height":46},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b0e48dbb485438ca9eca19373804bd0","type":"text","conversion_output":true,"text":"89","text_display":"89","confidence":1,"confidence_rate":1},{"cnt":[[247,523],[1761,523],[1761,573],[247,573]],"region":{"top_left_x":246,"top_left_y":523,"width":1516,"height":51},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5415644cf3124871bedefc32bbbcbf73","type":"text","conversion_output":true,"text":"R09-6407 Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of","text_display":"\n\nR09-6407 Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of","confidence":0.9970703125,"confidence_rate":0.9999662765751441},{"cnt":[[493,571],[1812,571],[1812,624],[493,624]],"region":{"top_left_x":493,"top_left_y":571,"width":1319,"height":53},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c21f3c61b0264be7b2f266b7148a259c","type":"text","conversion_output":true,"text":"Intensive Glucose Lowering in Type 2 Diabetes. N Engl J Med 2008; 358(24):","text_display":" Intensive Glucose Lowering in Type 2 Diabetes. N Engl J Med 2008; 358(24):","confidence":1,"confidence_rate":1},{"cnt":[[493,621],[683,621],[683,662],[493,662]],"region":{"top_left_x":493,"top_left_y":621,"width":191,"height":42},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"619e38002f2c4aff925ebbf52683622f","type":"text","conversion_output":true,"text":"2545-2559","text_display":" 2545-2559","confidence":1,"confidence_rate":1},{"cnt":[[247,708],[1798,708],[1798,756],[247,756]],"region":{"top_left_x":246,"top_left_y":708,"width":1552,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc62e2db91ec4b29b92eb40424434b69","type":"text","conversion_output":true,"text":"R09-6408 Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve","text_display":"\n\nR09-6408 Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve","confidence":1,"confidence_rate":1},{"cnt":[[496,758],[1752,758],[1752,806],[496,806]],"region":{"top_left_x":495,"top_left_y":758,"width":1258,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"041b500e99bd4b64b7a727540fa484fb","type":"text","conversion_output":true,"text":"FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M,","text_display":" FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M,","confidence":0.9970703125,"confidence_rate":0.9999592510047797},{"cnt":[[493,806],[1802,806],[1802,854],[493,854]],"region":{"top_left_x":493,"top_left_y":806,"width":1310,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"62cb9bb1a5aa48cd95d5c34524d8e40e","type":"text","conversion_output":true,"text":"Vitek ME, Henderson WG, Huang GD; VADT Investigators. Glucose control","text_display":" Vitek ME, Henderson WG, Huang GD; VADT Investigators. Glucose control","confidence":1,"confidence_rate":1},{"cnt":[[493,854],[1757,854],[1757,902],[493,902]],"region":{"top_left_x":493,"top_left_y":854,"width":1264,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5b294666f3b4285b22207637afa697c","type":"text","conversion_output":true,"text":"and vascular complications in veterans with type 2 diabetes. N Engl J Med.","text_display":" and vascular complications in veterans with type 2 diabetes. N Engl J Med.","confidence":1,"confidence_rate":1},{"cnt":[[493,902],[957,902],[957,948],[493,948]],"region":{"top_left_x":493,"top_left_y":902,"width":465,"height":47},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"637bcbc94467426290c25b4a95868e96","type":"text","conversion_output":true,"text":"2009 Jan 8;360(2):129-139","text_display":" 2009 Jan 8;360(2):129-139","confidence":1,"confidence_rate":1},{"cnt":[[244,991],[1679,991],[1679,1039],[244,1039]],"region":{"top_left_x":244,"top_left_y":991,"width":1436,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfa77ca1483741799e0ef383bed559f5","type":"text","conversion_output":true,"text":"R09-6409 Meier JJ, Nauck MA. Glucagon-like peptide 1 (GLP-1) in biology and","text_display":"\n\nR09-6409 Meier JJ, Nauck MA. Glucagon-like peptide 1 (GLP-1) in biology and","confidence":1,"confidence_rate":1},{"cnt":[[493,1037],[1387,1037],[1387,1087],[493,1087]],"region":{"top_left_x":493,"top_left_y":1037,"width":894,"height":51},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a21b451c4cdc4c6e82e8cde1b045d5eb","type":"text","conversion_output":true,"text":"pathology. Diabetes Metab Res Rev 2005;21:91-117","text_display":" pathology. Diabetes Metab Res Rev 2005;21:91-117","confidence":1,"confidence_rate":1},{"cnt":[[247,1128],[1775,1128],[1775,1176],[247,1176]],"region":{"top_left_x":246,"top_left_y":1128,"width":1529,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea8b1dba716247848e8570370f3fc99e","type":"text","conversion_output":true,"text":"R09-6410 Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4","text_display":"\n\nR09-6410 Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4","confidence":1,"confidence_rate":1},{"cnt":[[496,1179],[1734,1179],[1734,1227],[496,1227]],"region":{"top_left_x":495,"top_left_y":1178,"width":1239,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ad785dd426a47caa668aa3aff8d73db","type":"text","conversion_output":true,"text":"inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials.","text_display":" inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials.","confidence":1,"confidence_rate":1},{"cnt":[[493,1224],[1716,1224],[1716,1272],[493,1272]],"region":{"top_left_x":493,"top_left_y":1224,"width":1223,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"506dc7304b794769bda8510732716f21","type":"text","conversion_output":true,"text":"Nutrition, Metabolism and Cardiovascular Diseases, article in press, doi:","text_display":" Nutrition, Metabolism and Cardiovascular Diseases, article in press, doi:","confidence":0.99951171875,"confidence_rate":0.9999937384747559},{"cnt":[[498,1270],[1588,1270],[1588,1320],[498,1320]],"region":{"top_left_x":497,"top_left_y":1270,"width":1091,"height":51},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61c64dcdf2624daebc852adbb6cd6160","type":"text","conversion_output":true,"text":"10.1016/j.numecd.2009.03.015 Nutr Metab Cardiovasc Dis 2009","text_display":" 10.1016/j.numecd.2009.03.015 Nutr Metab Cardiovasc Dis 2009","confidence":1,"confidence_rate":1},{"cnt":[[244,1361],[1766,1361],[1766,1409],[244,1409]],"region":{"top_left_x":244,"top_left_y":1361,"width":1522,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"39bf5a6becb34e6ebd7e0e23f8a11739","type":"text","conversion_output":true,"text":"R10-0116 Vaccaro O, Eberly LE, Neaton JD, Yang L, Riccardi G, Stamler J, Multiple","text_display":"\n\nR10-0116 Vaccaro O, Eberly LE, Neaton JD, Yang L, Riccardi G, Stamler J, Multiple","confidence":1,"confidence_rate":1},{"cnt":[[493,1412],[1775,1412],[1775,1460],[493,1460]],"region":{"top_left_x":493,"top_left_y":1411,"width":1282,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e99a38dc2b4443abd5ebaed562eae30","type":"text","conversion_output":true,"text":"Risk Factor Intervention Trial (MRFIT) Research Group. Impact of diabetes","text_display":" Risk Factor Intervention Trial (MRFIT) Research Group. Impact of diabetes","confidence":0.9990236759185791,"confidence_rate":0.9999874769887185},{"cnt":[[493,1457],[1775,1457],[1775,1505],[493,1505]],"region":{"top_left_x":493,"top_left_y":1457,"width":1282,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c3b408122954bbdbf2e8e6aee308a71","type":"text","conversion_output":true,"text":"and previous myocardial infarction on long-term survival: 25-year mortality","text_display":" and previous myocardial infarction on long-term survival: 25-year mortality","confidence":0.99951171875,"confidence_rate":0.9999938950124091},{"cnt":[[493,1508],[1802,1508],[1802,1556],[493,1556]],"region":{"top_left_x":493,"top_left_y":1507,"width":1310,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ff960b759374c2b9de92dea0efd4413","type":"text","conversion_output":true,"text":"follow-up of primary screenees of the Multiple Risk Factor Intervention Trial.","text_display":" follow-up of primary screenees of the Multiple Risk Factor Intervention Trial.","confidence":1,"confidence_rate":1},{"cnt":[[493,1553],[1199,1553],[1199,1601],[493,1601]],"region":{"top_left_x":493,"top_left_y":1553,"width":707,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f9618210614433195e33235e1f58ab0","type":"text","conversion_output":true,"text":"Arch Intern Med 164, 1438-1443 (2004)","text_display":" Arch Intern Med 164, 1438-1443 (2004)","confidence":0.9975600242614746,"confidence_rate":0.9999418360408667},{"cnt":[[244,1645],[1821,1645],[1821,1693],[244,1693]],"region":{"top_left_x":244,"top_left_y":1644,"width":1577,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c67058249d8483e900a51e17f006c39","type":"text","conversion_output":true,"text":"R10-0117 Gu K, Cowie CC, Harris MI. Mortality in adults with and without diabetes in a","text_display":"\n\nR10-0117 Gu K, Cowie CC, Harris MI. Mortality in adults with and without diabetes in a","confidence":0.9990236759185791,"confidence_rate":0.9999892659807285},{"cnt":[[493,1690],[1734,1690],[1734,1741],[493,1741]],"region":{"top_left_x":493,"top_left_y":1690,"width":1241,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c74f1946bd744d3eb134c5d205411949","type":"text","conversion_output":true,"text":"national cohort of the U.S. population, 1971-1993. Diabetes Care 21 (7),","text_display":" national cohort of the U.S. population, 1971-1993. Diabetes Care 21 (7),","confidence":1,"confidence_rate":1},{"cnt":[[498,1741],[834,1741],[834,1789],[498,1789]],"region":{"top_left_x":497,"top_left_y":1740,"width":337,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"124356c2ed58436c87f4514e2fb00e26","type":"text","conversion_output":true,"text":"1138-1145 (1998)","text_display":" 1138-1145 (1998)","confidence":0.99609375,"confidence_rate":0.9998136412088079},{"cnt":[[244,1830],[1812,1830],[1812,1878],[244,1878]],"region":{"top_left_x":244,"top_left_y":1829,"width":1568,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a65bf6373a0145dc97356bcddab7d848","type":"text","conversion_output":true,"text":"R10-0133 Hoerger TJ, Segel JE, Gregg EW, Saaddine JB. Is glycemic control improving","text_display":"\n\nR10-0133 Hoerger TJ, Segel JE, Gregg EW, Saaddine JB. Is glycemic control improving","confidence":1,"confidence_rate":1},{"cnt":[[496,1878],[1250,1878],[1250,1921],[496,1921]],"region":{"top_left_x":495,"top_left_y":1877,"width":755,"height":45},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e86937a68864f388395c3e8f4df8ae7","type":"text","conversion_output":true,"text":"in U.S. adults? Diabetes Care 2008;31:81-86","text_display":" in U.S. adults? Diabetes Care 2008;31:81-86","confidence":1,"confidence_rate":1},{"cnt":[[244,1965],[1802,1965],[1802,2013],[244,2013]],"region":{"top_left_x":244,"top_left_y":1964,"width":1559,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18b65c4c98c44cc09a5a8e1c6646c32b","type":"text","conversion_output":true,"text":"R10-0134 Liebl A, Mata M, Eschwege E, Advisory Board. Evaluation of risk factors for","text_display":"\n\nR10-0134 Liebl A, Mata M, Eschwege E, Advisory Board. Evaluation of risk factors for","confidence":1,"confidence_rate":1},{"cnt":[[493,2015],[1743,2015],[1743,2063],[493,2063]],"region":{"top_left_x":493,"top_left_y":2014,"width":1250,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7cba0498e974464cbb83ba6919d160cb","type":"text","conversion_output":true,"text":"development of complications in Type II diabetes in Europe. Diabetologia","text_display":" development of complications in Type II diabetes in Europe. Diabetologia","confidence":0.9990234375,"confidence_rate":0.9999873112539076},{"cnt":[[493,2061],[752,2061],[752,2108],[493,2108]],"region":{"top_left_x":493,"top_left_y":2060,"width":259,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87dc2da2d35b4a69b23e194766b38a25","type":"text","conversion_output":true,"text":"2002;45:S23-8","text_display":" 2002;45:S23-8","confidence":1,"confidence_rate":1},{"cnt":[[244,2152],[1789,2152],[1789,2200],[244,2200]],"region":{"top_left_x":244,"top_left_y":2151,"width":1545,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"629470f544d048c08946e61a39751b39","type":"text","conversion_output":true,"text":"R10-4077 National Institute for Health and Clinical Excellence. Type 2 diabetes: newer","text_display":"\n\nR10-4077 National Institute for Health and Clinical Excellence. Type 2 diabetes: newer","confidence":0.9072265625,"confidence_rate":0.9989647589259291},{"cnt":[[496,2200],[1818,2198],[1818,2248],[496,2250]],"region":{"top_left_x":495,"top_left_y":2197,"width":1324,"height":54},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06f6468b30254bee873be14af2dc6a25","type":"text","conversion_output":true,"text":"agents for blood glucose control in type 2 diabetes (this short clinical guideline","text_display":" agents for blood glucose control in type 2 diabetes (this short clinical guideline","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[493,2248],[1812,2248],[1812,2296],[493,2296]],"region":{"top_left_x":493,"top_left_y":2247,"width":1319,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa1212e5055c4fe99d02d02e6cde6494","type":"text","conversion_output":true,"text":"partially updates NICE clinical guideline 66. The recommendations have been","text_display":" partially updates NICE clinical guideline 66. The recommendations have been","confidence":1,"confidence_rate":1},{"cnt":[[493,2294],[1734,2294],[1734,2341],[493,2341]],"region":{"top_left_x":493,"top_left_y":2293,"width":1241,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18a3fda551924b44be5244a22822beda","type":"text","conversion_output":true,"text":"combined with unchanged recommendations from CG66 in NICE clinical","text_display":" combined with unchanged recommendations from CG66 in NICE clinical","confidence":1,"confidence_rate":1},{"cnt":[[493,2344],[1674,2344],[1674,2392],[493,2392]],"region":{"top_left_x":493,"top_left_y":2343,"width":1182,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc0a513ebd8241ebae049e621f499213","type":"text","conversion_output":true,"text":"guideline 87 (NICE short clinical guideline 87, issue date: May 2009).","text_display":" guideline 87 (NICE short clinical guideline 87, issue date: May 2009).","confidence":1,"confidence_rate":1},{"cnt":[[493,2389],[1713,2389],[1713,2437],[493,2437]],"region":{"top_left_x":493,"top_left_y":2389,"width":1221,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb54ba2d01e449e0835f4590df53df23","type":"text","conversion_output":true,"text":"weblink: nice.org.uk ; London: National Institute for Health and Clinical","text_display":" weblink: nice.org.uk ; London: National Institute for Health and Clinical","confidence":0.9873444756958634,"confidence_rate":0.9998367275922316},{"cnt":[[493,2440],[806,2440],[806,2488],[493,2488]],"region":{"top_left_x":493,"top_left_y":2439,"width":314,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8cd20803b6354945ad3ed7a670f2537e","type":"text","conversion_output":true,"text":"Excellence (2009)","text_display":" Excellence (2009)","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a4034184dac149de95922d5a5ac844d7","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"017e369bf4bd495f9f9bc69a3304cbe8","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a23720bf411e48e4a6d730cdac6e53f2","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-077","page":77,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f92e772f4baa46ccb26e00cff3ab6cfa","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,121],[1816,121],[1816,158],[1503,158]],"region":{"top_left_x":1503,"top_left_y":121,"width":314,"height":37},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bea66e0eb75b484b90e2a8c4d233552f","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6dfb2a36cd684dbdb345cfcd86d86961","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9fd1989fb3704a4c9d51c1b61fb8c60a","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,247],[868,247]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":37},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7bd92c558c0344cfba3bcb996e4cedd5","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1702cda573140deb7644d08b2a78cb5","type":"page_info","conversion_output":false,"text":"Page 77 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1720,338],[1720,386],[244,386]],"region":{"top_left_x":244,"top_left_y":338,"width":1477,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c82878d238a246b195370721fa1003e2","type":"text","conversion_output":true,"text":"R10-4342 Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The Prevalence of","text_display":"\n\nR10-4342 Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The Prevalence of","confidence":1,"confidence_rate":1},{"cnt":[[493,388],[1821,388],[1821,436],[493,436]],"region":{"top_left_x":493,"top_left_y":388,"width":1328,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"315b15e9d20d45908842f908be2f4da2","type":"text","conversion_output":true,"text":"Comorbid Depression in Adults With Diabetes, a meta-analysis. Diabetes Care","text_display":" Comorbid Depression in Adults With Diabetes, a meta-analysis. Diabetes Care","confidence":1,"confidence_rate":1},{"cnt":[[493,434],[902,434],[902,482],[493,482]],"region":{"top_left_x":493,"top_left_y":434,"width":410,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a9fd7bba0184b3c84456cabe20858f0","type":"text","conversion_output":true,"text":"2001;6(24): 1069-1078.","text_display":" 2001;6(24): 1069-1078.","confidence":1,"confidence_rate":1},{"cnt":[[244,532],[1775,532],[1775,580],[244,580]],"region":{"top_left_x":244,"top_left_y":532,"width":1531,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15991490a4c04187ad9dc803f803ada8","type":"text","conversion_output":true,"text":"R10-6494 Vigneri P, FF, Sciacca L, PG, Vigneri R. Diabetes and cancer. Endocr Relat","text_display":"\n\nR10-6494 Vigneri P, FF, Sciacca L, PG, Vigneri R. Diabetes and cancer. Endocr Relat","confidence":1,"confidence_rate":1},{"cnt":[[493,580],[971,580],[971,628],[493,628]],"region":{"top_left_x":493,"top_left_y":580,"width":478,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9052cadbaa2647049fcc216807d4b0aa","type":"text","conversion_output":true,"text":"Cancer 2009;16:1103-1123.","text_display":" Cancer 2009;16:1103-1123.","confidence":1,"confidence_rate":1},{"cnt":[[247,676],[1697,676],[1697,726],[247,726]],"region":{"top_left_x":246,"top_left_y":676,"width":1452,"height":51},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57c60f97ad1742188646379a8790dbff","type":"text","conversion_output":true,"text":"R10-6495 Hemminki K, Li X, Sundquist J, Sundquist K. Risk of cancer following","text_display":"\n\nR10-6495 Hemminki K, Li X, Sundquist J, Sundquist K. Risk of cancer following","confidence":1,"confidence_rate":1},{"cnt":[[493,724],[1579,724],[1579,774],[493,774]],"region":{"top_left_x":493,"top_left_y":724,"width":1086,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa4ed752431e4ecfbf872f0a87bac954","type":"text","conversion_output":true,"text":"hospitalisation for type 2 diabetes. Oncologist 2010;15:548-555.","text_display":" hospitalisation for type 2 diabetes. Oncologist 2010;15:548-555.","confidence":0.7875131095061079,"confidence_rate":0.9966877855606318},{"cnt":[[247,813],[1668,813],[1668,863],[247,863]],"region":{"top_left_x":246,"top_left_y":813,"width":1422,"height":51},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83af556c719e4559b01c3430e89652d0","type":"text","conversion_output":true,"text":"R10-6496 Giovannucci E, Michaud D. The role of obesity and related metabolic","text_display":"\n\nR10-6496 Giovannucci E, Michaud D. The role of obesity and related metabolic","confidence":1,"confidence_rate":1},{"cnt":[[493,863],[1800,863],[1800,911],[493,911]],"region":{"top_left_x":493,"top_left_y":863,"width":1308,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38240c671e61426d88033b669013646e","type":"text","conversion_output":true,"text":"disturbances in cancers of the colon, prostate, and pancreas. Gastroenterology","text_display":" disturbances in cancers of the colon, prostate, and pancreas. Gastroenterology","confidence":0.99951171875,"confidence_rate":0.999994115673962},{"cnt":[[493,909],[911,909],[911,957],[493,957]],"region":{"top_left_x":493,"top_left_y":909,"width":419,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"53a8b32b057342c4be23a3d3a195960f","type":"text","conversion_output":true,"text":"2007;132(6):2208-2225.","text_display":" 2007;132(6):2208-2225.","confidence":0.99853515625,"confidence_rate":0.9999457082263518},{"cnt":[[247,1001],[1716,1001],[1716,1049],[247,1049]],"region":{"top_left_x":246,"top_left_y":1000,"width":1470,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0959abcf60b0433ba357113a4ff5425d","type":"text","conversion_output":true,"text":"R10-6497 Smith U, Gale EAM. Does diabetes therapy influence the risk of cancer?","text_display":"\n\nR10-6497 Smith U, Gale EAM. Does diabetes therapy influence the risk of cancer?","confidence":1,"confidence_rate":1},{"cnt":[[496,1046],[1067,1046],[1067,1099],[496,1099]],"region":{"top_left_x":495,"top_left_y":1046,"width":572,"height":53},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecffe0d5b2e14c1cb8854afb2a53a887","type":"text","conversion_output":true,"text":"Diabetologia 2009;52:1699-1708.","text_display":" Diabetologia 2009;52:1699-1708.","confidence":1,"confidence_rate":1},{"cnt":[[244,1138],[1706,1138],[1706,1186],[244,1186]],"region":{"top_left_x":244,"top_left_y":1137,"width":1463,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8023f4b6f31a49e581faa59c2a33dd07","type":"text","conversion_output":true,"text":"R10-6498 Xue F, Michels KB. Diabetes, metabolic syndrome, and breast cancer: a","text_display":"\n\nR10-6498 Xue F, Michels KB. Diabetes, metabolic syndrome, and breast cancer: a","confidence":1,"confidence_rate":1},{"cnt":[[493,1183],[1764,1183],[1764,1236],[493,1236]],"region":{"top_left_x":493,"top_left_y":1183,"width":1271,"height":53},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6db96c9e88ea463787a8fb895cfe2fd8","type":"text","conversion_output":true,"text":"review of the current evidence. Am J Clin Nutr 2007;86(Suppl):823S 835S.","text_display":" review of the current evidence. Am J Clin Nutr 2007;86(Suppl):823S 835S.","confidence":0.9990234375,"confidence_rate":0.9999873112539076},{"cnt":[[247,1275],[1725,1275],[1725,1323],[247,1323]],"region":{"top_left_x":246,"top_left_y":1274,"width":1479,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b3c7cdf0c5448538322a06b5d6efb27","type":"text","conversion_output":true,"text":"R10-6536 Hjartaker A, Langseth H, Weiderpass E. Obesity and diabetes epidemics:","text_display":"\n\nR10-6536 Hjartaker A, Langseth H, Weiderpass E. Obesity and diabetes epidemics:","confidence":1,"confidence_rate":1},{"cnt":[[493,1323],[1649,1323],[1649,1373],[493,1373]],"region":{"top_left_x":493,"top_left_y":1322,"width":1157,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c769bd44455844418eea978be2f456cf","type":"text","conversion_output":true,"text":"cancer repercussions. In: Berstein LM, Santen RJ, editors.Innovative","text_display":" cancer repercussions. In: Berstein LM, Santen RJ, editors.Innovative","confidence":1,"confidence_rate":1},{"cnt":[[493,1371],[1579,1371],[1579,1419],[493,1419]],"region":{"top_left_x":493,"top_left_y":1370,"width":1086,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b3735e6846143e2b47cd5e1e3eefe8c","type":"text","conversion_output":true,"text":"endocrinology of cancer.Austin: Landes Bioscience 2008:72-93.","text_display":" endocrinology of cancer.Austin: Landes Bioscience 2008:72-93.","confidence":0.92626953125,"confidence_rate":0.9988402182760029},{"cnt":[[247,1462],[1793,1462],[1793,1510],[247,1510]],"region":{"top_left_x":246,"top_left_y":1462,"width":1548,"height":48},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35bb7436e29e4be8a288e4998410fd6a","type":"text","conversion_output":true,"text":"R10-6638 Giovannucci E, Harlan DM, Archer MC, Bergenstal RM, Gapstur SM, Habel","text_display":"\n\nR10-6638 Giovannucci E, Harlan DM, Archer MC, Bergenstal RM, Gapstur SM, Habel","confidence":0.99951171875,"confidence_rate":0.999994115673962},{"cnt":[[493,1508],[1734,1508],[1734,1556],[493,1556]],"region":{"top_left_x":493,"top_left_y":1507,"width":1241,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3608bfeca0234599bb1937edd42ea510","type":"text","conversion_output":true,"text":"LA, Pollak M, Regensteiner JG, Yee D. Diabetes and cancer: a consensus","text_display":" LA, Pollak M, Regensteiner JG, Yee D. Diabetes and cancer: a consensus","confidence":0.99951171875,"confidence_rate":0.9999934880145616},{"cnt":[[493,1556],[1314,1556],[1314,1606],[493,1606]],"region":{"top_left_x":493,"top_left_y":1555,"width":821,"height":51},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b546cdc858e4ee48711b7265cdc4a70","type":"text","conversion_output":true,"text":"report. Diabetes Care 33 (7), 1674-1685 (2010)","text_display":" report. Diabetes Care 33 (7), 1674-1685 (2010)","confidence":0.9970703125,"confidence_rate":0.9999456683753719},{"cnt":[[244,1654],[1732,1654],[1732,1702],[244,1702]],"region":{"top_left_x":244,"top_left_y":1653,"width":1488,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"baebcd4dc3e34ed79ce3a4fdea7fb857","type":"text","conversion_output":true,"text":"R11-4860 Bennett WL, Maruthur NM, Singh S, Segal JB, Wilson LM, Chatterjee R,","text_display":"\n\nR11-4860 Bennett WL, Maruthur NM, Singh S, Segal JB, Wilson LM, Chatterjee R,","confidence":1,"confidence_rate":1},{"cnt":[[489,1702],[1677,1702],[1677,1750],[489,1750]],"region":{"top_left_x":488,"top_left_y":1701,"width":1189,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69af8597a799447fbf112abb2be58f1d","type":"text","conversion_output":true,"text":"Marinopoulos SS, Puhan MA, Ranasinghe P, Block L, Nicholson WK,","text_display":" Marinopoulos SS, Puhan MA, Ranasinghe P, Block L, Nicholson WK,","confidence":1,"confidence_rate":1},{"cnt":[[489,1750],[1684,1750],[1684,1798],[489,1798]],"region":{"top_left_x":488,"top_left_y":1749,"width":1196,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7b560fc20fc489f89b1d65c70bc5874","type":"text","conversion_output":true,"text":"Hutfless S, Bass EB, Bolen S. Comparative effectiveness and safety of","text_display":" Hutfless S, Bass EB, Bolen S. Comparative effectiveness and safety of","confidence":1,"confidence_rate":1},{"cnt":[[489,1798],[1745,1798],[1745,1848],[489,1848]],"region":{"top_left_x":488,"top_left_y":1797,"width":1258,"height":52},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d3786fb14e44f1ea8e878cb22278ef2","type":"text","conversion_output":true,"text":"medications for type 2 diabetes: an update including new drugs and 2-drug","text_display":" medications for type 2 diabetes: an update including new drugs and 2-drug","confidence":0.9775390625,"confidence_rate":0.9997195822098001},{"cnt":[[489,1846],[1387,1846],[1387,1894],[489,1894]],"region":{"top_left_x":488,"top_left_y":1845,"width":899,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d29d618208e44876add52936a2c7b782","type":"text","conversion_output":true,"text":"combinations. Ann Intern Med 2011;154(9):602-613.","text_display":" combinations. Ann Intern Med 2011;154(9):602-613.","confidence":1,"confidence_rate":1},{"cnt":[[244,1905],[1818,1905],[1818,1953],[244,1953]],"region":{"top_left_x":244,"top_left_y":1905,"width":1575,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca2b2d490bd94bb282c277daa4ed5c37","type":"text","conversion_output":true,"text":"R12-1135 Bartnik M, Ryden L, Ferrari R, Malmberg K, Pyorala K, Simoons M, Standl E,","text_display":"\nR12-1135 Bartnik M, Ryden L, Ferrari R, Malmberg K, Pyorala K, Simoons M, Standl E,","confidence":1,"confidence_rate":1},{"cnt":[[489,1951],[1766,1951],[1766,2001],[489,2001]],"region":{"top_left_x":488,"top_left_y":1950,"width":1278,"height":52},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d5fa64415b7545808e032f56d2102225","type":"text","conversion_output":true,"text":"Soler-Soler J, Ohrvik J, Euro Heart Survey Investigators. The prevalence of","text_display":" Soler-Soler J, Ohrvik J, Euro Heart Survey Investigators. The prevalence of","confidence":1,"confidence_rate":1},{"cnt":[[489,1999],[1752,1999],[1752,2049],[489,2049]],"region":{"top_left_x":488,"top_left_y":1998,"width":1265,"height":52},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b9bf18ef50141f9a0c2ac525ba81c85","type":"text","conversion_output":true,"text":"abnormal glucose regulation in patients with coronary artery disease across","text_display":" abnormal glucose regulation in patients with coronary artery disease across","confidence":1,"confidence_rate":1},{"cnt":[[489,2047],[1647,2047],[1647,2095],[489,2095]],"region":{"top_left_x":488,"top_left_y":2046,"width":1160,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ac7584d55d04d8db0ce95d11f6ff467","type":"text","conversion_output":true,"text":"Europe: the Euro Heart Survey on diabetes and the heart. Eur Heart J","text_display":" Europe: the Euro Heart Survey on diabetes and the heart. Eur Heart J","confidence":1,"confidence_rate":1},{"cnt":[[489,2097],[827,2097],[827,2140],[489,2140]],"region":{"top_left_x":488,"top_left_y":2097,"width":339,"height":44},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08769aae29e740afb3ee2f17e637e963","type":"text","conversion_output":true,"text":"2004;25:1880-1890","text_display":" 2004;25:1880-1890","confidence":1,"confidence_rate":1},{"cnt":[[247,2193],[1704,2193],[1704,2241],[247,2241]],"region":{"top_left_x":246,"top_left_y":2193,"width":1459,"height":48},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d281e6e6c7824036874419d43ebf4f65","type":"text","conversion_output":true,"text":"R12-4087 Dmitrienko A, Tamhane AC, Wiens BL.General multistage gatekeeping","text_display":"\n\nR12-4087 Dmitrienko A, Tamhane AC, Wiens BL.General multistage gatekeeping","confidence":1,"confidence_rate":1},{"cnt":[[489,2239],[1277,2239],[1277,2289],[489,2289]],"region":{"top_left_x":488,"top_left_y":2238,"width":789,"height":51},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfb138f799104aeeaf5ae38293f61fcc","type":"text","conversion_output":true,"text":"procedures. Biometr J 50 (5), 667-677 (2008)","text_display":" procedures. Biometr J 50 (5), 667-677 (2008)","confidence":0.9636964676901698,"confidence_rate":0.9992891200739059},{"cnt":[[244,2344],[1775,2344],[1775,2392],[244,2392]],"region":{"top_left_x":244,"top_left_y":2343,"width":1531,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38db795e781945509aa5847aa5758b4d","type":"text","conversion_output":true,"text":"P08-01788 Ryden L, Standl E, Bartnik M, Berghe G van den, Betteridge J, Boer MJ de,","text_display":"\n\nP08-01788 Ryden L, Standl E, Bartnik M, Berghe G van den, Betteridge J, Boer MJ de,","confidence":1,"confidence_rate":1},{"cnt":[[493,2389],[1693,2389],[1693,2440],[493,2440]],"region":{"top_left_x":493,"top_left_y":2389,"width":1200,"height":51},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ee5be75111e40a189f4207aa37abc06","type":"text","conversion_output":true,"text":"Cosentino F, Jonsson B, Laakso M, Malmberg K, Priori S, Ostergren J,","text_display":" Cosentino F, Jonsson B, Laakso M, Malmberg K, Priori S, Ostergren J,","confidence":1,"confidence_rate":1},{"cnt":[[493,2440],[1693,2440],[1693,2488],[493,2488]],"region":{"top_left_x":493,"top_left_y":2439,"width":1200,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f572a7e778f3409b8433f69972c5a187","type":"text","conversion_output":true,"text":"Tuomilehto J, Thrainsdottir I. Guidelines on diabetes, pre-diabetes, and","text_display":" Tuomilehto J, Thrainsdottir I. Guidelines on diabetes, pre-diabetes, and","confidence":1,"confidence_rate":1},{"cnt":[[493,2488],[1597,2488],[1597,2531],[493,2531]],"region":{"top_left_x":493,"top_left_y":2487,"width":1104,"height":45},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c59d4e045b7a4cb1b095403d2d174657","type":"text","conversion_output":true,"text":"cardiovascular diseases: full text: the Task Force on Diabetes and","text_display":" cardiovascular diseases: full text: the Task Force on Diabetes and","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":43,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c9c03d44464c489480e6477863e745c2","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bf82e6cd8ebc41729127fe618b69c8e2","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"986d3e67ed154c128ffa1ee0642067d9","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-078","page":78,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08ed5877ad4942e1be49d353788a845a","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c89aaa144a5f4b68badd29173323289d","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f285bfb0e794717bfa1e602381bc0ca","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11afc4069a8d4348954c46008638a7da","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,247],[868,247]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":37},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e72268ed484496c8d44d5e1944bf978","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e8c63c7911b45c4b561a61e533c740a","type":"page_info","conversion_output":false,"text":"Page 78 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[496,338],[1802,338],[1802,388],[496,388]],"region":{"top_left_x":495,"top_left_y":338,"width":1308,"height":51},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b56971c27d4449488b6e2f2594176ab4","type":"text","conversion_output":true,"text":"Cardiovascular Diseases of the European Society of Cardiology (ESC) and of","text_display":"\n\nCardiovascular Diseases of the European Society of Cardiology (ESC) and of","confidence":1,"confidence_rate":1},{"cnt":[[493,388],[1738,388],[1738,436],[493,436]],"region":{"top_left_x":493,"top_left_y":388,"width":1246,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a51f068f82584d25a4e117a1c28774ae","type":"text","conversion_output":true,"text":"the European Association for the Study of Diabetes (EASD).Eur Heart J 9","text_display":" the European Association for the Study of Diabetes (EASD).Eur Heart J 9","confidence":0.99853515625,"confidence_rate":0.9999804546219134},{"cnt":[[496,434],[962,434],[962,484],[496,484]],"region":{"top_left_x":495,"top_left_y":434,"width":467,"height":51},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"35abeca1fa404120ae729cab4468e1ea","type":"text","conversion_output":true,"text":"(Suppl C), C3 - C74 (2007)","text_display":" (Suppl C), C3 - C74 (2007)","confidence":0.9033203125,"confidence_rate":0.9967254354392621},{"cnt":[[244,523],[1642,523],[1642,573],[244,573]],"region":{"top_left_x":244,"top_left_y":523,"width":1399,"height":51},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5801acd394e440928384a317bd1011ab","type":"text","conversion_output":true,"text":"P08-06509 Johansen OE. Cardiovascular disease and type 2 diabetes mellitus: a","text_display":"\n\nP08-06509 Johansen OE. Cardiovascular disease and type 2 diabetes mellitus: a","confidence":1,"confidence_rate":1},{"cnt":[[493,571],[1661,571],[1661,624],[493,624]],"region":{"top_left_x":493,"top_left_y":571,"width":1168,"height":53},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"580b4fdc9896420db943493951866d52","type":"text","conversion_output":true,"text":"multifaceted symbiosis. Scand J Clin Lab Invest 2007;67(8):786-800.","text_display":" multifaceted symbiosis. Scand J Clin Lab Invest 2007;67(8):786-800.","confidence":1,"confidence_rate":1},{"cnt":[[247,662],[1624,662],[1624,710],[247,710]],"region":{"top_left_x":246,"top_left_y":662,"width":1379,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"43730bd154a14913a737c2796da85052","type":"text","conversion_output":true,"text":"P10-00533 Canadian Diabetes Association Clinical Practice Guidelines Expert","text_display":"\n\nP10-00533 Canadian Diabetes Association Clinical Practice Guidelines Expert","confidence":1,"confidence_rate":1},{"cnt":[[496,708],[1780,708],[1780,761],[496,761]],"region":{"top_left_x":495,"top_left_y":708,"width":1285,"height":53},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f4fc7b772a2d4a5195c29e40356d9f67","type":"text","conversion_output":true,"text":"Committee. Canadian Diabetes Association 2008 clinical practice guidelines","text_display":" Committee. Canadian Diabetes Association 2008 clinical practice guidelines","confidence":1,"confidence_rate":1},{"cnt":[[496,758],[1738,758],[1738,806],[496,806]],"region":{"top_left_x":495,"top_left_y":758,"width":1244,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"23a3232b4b79497097d057bfdcdb7b97","type":"text","conversion_output":true,"text":"for the prevention and management of diabetes in Canada. Can J Diabetes","text_display":" for the prevention and management of diabetes in Canada. Can J Diabetes","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[493,806],[962,806],[962,857],[493,857]],"region":{"top_left_x":493,"top_left_y":806,"width":469,"height":51},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"423d54e0ebdd4e718ac694499bef9945","type":"text","conversion_output":true,"text":"32(suppl 1), S1-S201. 2008","text_display":" 32(suppl 1), S1-S201. 2008","confidence":1,"confidence_rate":1},{"cnt":[[247,895],[1592,895],[1592,943],[247,943]],"region":{"top_left_x":246,"top_left_y":895,"width":1347,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bb8ae2671b7146748e2b6447b67f7658","type":"text","conversion_output":true,"text":"P12-00933 Johansen OE, Neubacher D, Eynatten M von, Patel S, Woerle HJ","text_display":"\n\nP12-00933 Johansen OE, Neubacher D, Eynatten M von, Patel S, Woerle HJ","confidence":1,"confidence_rate":1},{"cnt":[[496,941],[1812,941],[1812,994],[496,994]],"region":{"top_left_x":495,"top_left_y":941,"width":1317,"height":53},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2b579d35e5464ab28e14f9ec3414f0d5","type":"text","conversion_output":true,"text":"Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus:","text_display":" Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus:","confidence":1,"confidence_rate":1},{"cnt":[[493,991],[1693,991],[1693,1044],[493,1044]],"region":{"top_left_x":493,"top_left_y":991,"width":1200,"height":53},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e9271808e7854a8d947ff04fd419c16a","type":"text","conversion_output":true,"text":"a pre-specified, prospective, and adjudicated meta-analysis of a phase 3","text_display":" a pre-specified, prospective, and adjudicated meta-analysis of a phase 3","confidence":1,"confidence_rate":1},{"cnt":[[493,1037],[1272,1037],[1272,1090],[493,1090]],"region":{"top_left_x":493,"top_left_y":1037,"width":780,"height":53},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"89fff06fb9dd47399fe58cb213c035b3","type":"text","conversion_output":true,"text":"programme. Cardiovasc Diabetol 11, 3 (2012)","text_display":" programme. Cardiovasc Diabetol 11, 3 (2012)","confidence":1,"confidence_rate":1},{"cnt":[[244,1128],[1743,1128],[1743,1179],[244,1179]],"region":{"top_left_x":244,"top_left_y":1128,"width":1499,"height":51},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"02a17628c66445bea9f1a407fb7d4566","type":"text","conversion_output":true,"text":"R16-4473 Bretz F, Maurer W, Brannath W, Posch M (2009) A graphical approach to","text_display":"\n\nR16-4473 Bretz F, Maurer W, Brannath W, Posch M (2009) A graphical approach to","confidence":0.974609375,"confidence_rate":0.9996901862035585},{"cnt":[[493,1176],[1695,1176],[1695,1227],[493,1227]],"region":{"top_left_x":493,"top_left_y":1176,"width":1203,"height":51},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"84a3a44f2abe4f3db95cb7ce7002504f","type":"text","conversion_output":true,"text":"sequentially rejective multiple test procedures. Statist Med; 28:586-604","text_display":" sequentially rejective multiple test procedures. Statist Med; 28:586-604","confidence":0.99853515625,"confidence_rate":0.999980962289239},{"cnt":[[242,1261],[1007,1261],[1007,1314],[242,1314]],"region":{"top_left_x":242,"top_left_y":1260,"width":766,"height":54},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6ed3e61c1d1046b0bd5a9197ed801fe6","type":"section_header","conversion_output":false,"children_ids":["aaae6b38c5e048259866f4da80e61153"],"text":"","text_display":""},{"cnt":[[247,1266],[1003,1266],[1003,1309],[247,1309]],"region":{"top_left_x":246,"top_left_y":1265,"width":757,"height":44},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"aaae6b38c5e048259866f4da80e61153","type":"text","conversion_output":true,"parent_id":"6ed3e61c1d1046b0bd5a9197ed801fe6","text":"9.2 UNPUBLISHED REFERENCES","text_display":"\n\n\\subsection*{9.2 UNPUBLISHED REFERENCES}","confidence":1,"confidence_rate":1},{"cnt":[[247,1355],[1533,1355],[1533,1405],[247,1405]],"region":{"top_left_x":246,"top_left_y":1354,"width":1287,"height":51},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a3694912b127477185526150ea066417","type":"text","conversion_output":true,"text":"U04-1767 -Linagliptin Investigator's Brochure. Current Version.","text_display":"\n\nU04-1767 -Linagliptin Investigator's Brochure. Current Version.","confidence":0.99951171875,"confidence_rate":0.9999928176655267},{"cnt":[[793,2584],[1300,2584],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2583,"width":508,"height":38},"line":25,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0d5ebe4f047344f89a8d74d26018d003","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":26,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fa225834c90c4127842a4e5e305ee6c8","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":27,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5169239d366c43fb8c56e2fcea5af89c","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-079","page":79,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef8aef46a5af486b8684f0d200d4b74b","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e590dc48b7e542d69697d2efcec5ad93","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5db2bb8839274a99a2a98ab7f70935ae","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7d801dc45ea4b4aa312ce303091eec5","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60f57c72745a4990b4d0582e703ca366","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"682cf8c7f34f461691f864b55caf50c8","type":"page_info","conversion_output":false,"text":"Page 79 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,338],[724,338],[724,393],[242,393]],"region":{"top_left_x":242,"top_left_y":338,"width":483,"height":55},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d2cedf3cac3046c193ca0882fe60dfc4","type":"section_header","conversion_output":false,"children_ids":["fbb17d6ebc8d4c448c73315bc64bb804"],"text":"","text_display":""},{"cnt":[[247,343],[720,343],[720,388],[247,388]],"region":{"top_left_x":246,"top_left_y":342,"width":474,"height":47},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fbb17d6ebc8d4c448c73315bc64bb804","type":"text","conversion_output":true,"parent_id":"d2cedf3cac3046c193ca0882fe60dfc4","text":"10. APPENDICES","text_display":"\n\n\\section*{10. APPENDICES}","confidence":1,"confidence_rate":1},{"cnt":[[242,434],[1208,434],[1208,482],[242,482]],"region":{"top_left_x":242,"top_left_y":434,"width":967,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3bbec26a9c7141a39f4adff909b371c3","type":"section_header","conversion_output":false,"children_ids":["dd1e516cb9574f25bd9dd9f22be0c51a"],"text":"","text_display":""},{"cnt":[[247,439],[1204,439],[1204,480],[247,480]],"region":{"top_left_x":246,"top_left_y":438,"width":958,"height":42},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dd1e516cb9574f25bd9dd9f22be0c51a","type":"text","conversion_output":true,"parent_id":"3bbec26a9c7141a39f4adff909b371c3","text":"10.1 INCLUSION OF ILLITERATE PATIENTS","text_display":"\n\n\\subsection*{10.1 INCLUSION OF ILLITERATE PATIENTS}","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[242,525],[980,525],[980,580],[242,580]],"region":{"top_left_x":242,"top_left_y":525,"width":738,"height":56},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11d86df027f2464d8ea6bbc67741c1ea","type":"section_header","conversion_output":false,"children_ids":["7fbe667a65a2498b85846c2fd6c59d78"],"text":"","text_display":""},{"cnt":[[247,525],[978,525],[978,578],[247,578]],"region":{"top_left_x":246,"top_left_y":525,"width":732,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fbe667a65a2498b85846c2fd6c59d78","type":"text","conversion_output":true,"parent_id":"11d86df027f2464d8ea6bbc67741c1ea","text":"10.1.1 Home blood glucose monitoring","text_display":"\n\n\\subsection*{10.1.1 Home blood glucose monitoring}","confidence":1,"confidence_rate":1},{"cnt":[[247,617],[1784,617],[1784,665],[247,665]],"region":{"top_left_x":246,"top_left_y":616,"width":1539,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"721412acc36e4e00b7a75721ddb776c4","type":"text","conversion_output":true,"text":"In the event of recruiting an illiterate patient, the following process should be followed with","text_display":"\n\nIn the event of recruiting an illiterate patient, the following process should be followed with","confidence":1,"confidence_rate":1},{"cnt":[[244,667],[1039,667],[1039,715],[244,715]],"region":{"top_left_x":244,"top_left_y":667,"width":796,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"496a2c1567f44f5f88ae5c5a6c2dc676","type":"text","conversion_output":true,"text":"respect to HBGM and documenting the results:","text_display":" respect to HBGM and documenting the results:","confidence":0.99951171875,"confidence_rate":0.9999900326925697},{"cnt":[[244,754],[1768,754],[1768,804],[244,804]],"region":{"top_left_x":244,"top_left_y":753,"width":1525,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7059eb7283db42a380916d8633b9b0b2","type":"text","conversion_output":true,"text":"- at visit 1 (screening), the person assisting the patient with this process (e.g. the patient's","text_display":"\n- at visit 1 (screening), the person assisting the patient with this process (e.g. the patient's","confidence":0.96923828125,"confidence_rate":0.9996996144224949},{"cnt":[[306,800],[1437,800],[1437,852],[306,852]],"region":{"top_left_x":306,"top_left_y":799,"width":1131,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7520c912b8734972a3fa91fccfe7dd1f","type":"text","conversion_output":true,"text":"caregiver or relative) will attend the clinic together with the patient","text_display":" caregiver or relative) will attend the clinic together with the patient","confidence":1,"confidence_rate":1},{"cnt":[[244,891],[1816,891],[1816,941],[244,941]],"region":{"top_left_x":244,"top_left_y":890,"width":1573,"height":52},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d92ada83694a4457a25e899adcf55eaa","type":"text","conversion_output":true,"text":"- the site staff should confirm that this individual will be present with the patient, whenever","text_display":"\n- the site staff should confirm that this individual will be present with the patient, whenever","confidence":1,"confidence_rate":1},{"cnt":[[306,937],[1021,937],[1021,989],[306,989]],"region":{"top_left_x":306,"top_left_y":936,"width":716,"height":54},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b64e0f7f768642dfa7c301e63192d92d","type":"text","conversion_output":true,"text":"he/she is likely to need to perform HBGM","text_display":" he/she is likely to need to perform HBGM","confidence":0.99951171875,"confidence_rate":0.9999891467144949},{"cnt":[[242,1028],[1716,1028],[1716,1081],[242,1081]],"region":{"top_left_x":242,"top_left_y":1027,"width":1474,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d687cdb895cb42d38139f090d6814105","type":"text","conversion_output":true,"text":"- the site staff should then train both the patient and above-mentioned individual with","text_display":"\n- the site staff should then train both the patient and above-mentioned individual with","confidence":1,"confidence_rate":1},{"cnt":[[306,1074],[1770,1074],[1770,1126],[306,1126]],"region":{"top_left_x":306,"top_left_y":1073,"width":1465,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8840ed55d47a4054a0003673e0943b8d","type":"text","conversion_output":true,"text":"respect to the correct use of the HBGM equipment during each period of the trial. This","text_display":" respect to the correct use of the HBGM equipment during each period of the trial. This","confidence":1,"confidence_rate":1},{"cnt":[[306,1124],[1697,1124],[1697,1172],[306,1172]],"region":{"top_left_x":306,"top_left_y":1123,"width":1392,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90cbeb7c27f04d4d99a1a018a5f184e1","type":"text","conversion_output":true,"text":"will include the use of the glucose meter itself and the test strips, lancet device and","text_display":" will include the use of the glucose meter itself and the test strips, lancet device and","confidence":1,"confidence_rate":1},{"cnt":[[306,1172],[1798,1172],[1798,1222],[306,1222]],"region":{"top_left_x":306,"top_left_y":1171,"width":1492,"height":52},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2e5cfe15f9a4882aa1c4962b45c5306","type":"text","conversion_output":true,"text":"control solution(s). Furthermore, if whole blood referenced test strips are standard in the","text_display":" control solution(s). Furthermore, if whole blood referenced test strips are standard in the","confidence":1,"confidence_rate":1},{"cnt":[[306,1220],[1750,1220],[1750,1268],[306,1268]],"region":{"top_left_x":306,"top_left_y":1219,"width":1444,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"363005059d894d449f6ee148dcdfed9a","type":"text","conversion_output":true,"text":"country(ies) where illiterate patients are being recruited, the site staff must ensure that","text_display":" country(ies) where illiterate patients are being recruited, the site staff must ensure that","confidence":1,"confidence_rate":1},{"cnt":[[306,1266],[1818,1266],[1818,1318],[306,1318]],"region":{"top_left_x":306,"top_left_y":1265,"width":1513,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20cfc367f3354ec9a8da4bb3f24e75e0","type":"text","conversion_output":true,"text":"both the patient and the person assisting the patient with the HBGM, have understood that","text_display":" both the patient and the person assisting the patient with the HBGM, have understood that","confidence":1,"confidence_rate":1},{"cnt":[[306,1316],[1798,1316],[1798,1366],[306,1366]],"region":{"top_left_x":306,"top_left_y":1315,"width":1492,"height":52},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94a9624757534e9fb9023be3bacaf692","type":"text","conversion_output":true,"text":"plasma referenced test strips are used in the trial, and that there may be differences in the","text_display":" plasma referenced test strips are used in the trial, and that there may be differences in the","confidence":1,"confidence_rate":1},{"cnt":[[306,1361],[1704,1361],[1704,1414],[306,1414]],"region":{"top_left_x":306,"top_left_y":1361,"width":1399,"height":54},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01ddefb0e4f54cf88f84a4e12e2b398e","type":"text","conversion_output":true,"text":"results obtained via these two methods. A training letter is available to support this","text_display":" results obtained via these two methods. A training letter is available to support this","confidence":1,"confidence_rate":1},{"cnt":[[306,1416],[441,1416],[441,1464],[306,1464]],"region":{"top_left_x":306,"top_left_y":1416,"width":135,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a888f68f5eab4367b71e5fb0d1e64f58","type":"text","conversion_output":true,"text":"process","text_display":" process","confidence":1,"confidence_rate":1},{"cnt":[[242,1501],[1770,1501],[1770,1551],[242,1551]],"region":{"top_left_x":242,"top_left_y":1500,"width":1529,"height":52},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c33832551d53469ba3fd71ada3109623","type":"text","conversion_output":true,"text":"- the site staff should also train both the patient and the above-mentioned individual with","text_display":"\n- the site staff should also train both the patient and the above-mentioned individual with","confidence":1,"confidence_rate":1},{"cnt":[[306,1549],[1786,1549],[1786,1601],[306,1601]],"region":{"top_left_x":306,"top_left_y":1548,"width":1481,"height":54},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60594221a2224f368e26e89026aa9a4f","type":"text","conversion_output":true,"text":"respect to the completion of the HBGM diary. As for all other patients, the results of all","text_display":" respect to the completion of the HBGM diary. As for all other patients, the results of all","confidence":1,"confidence_rate":1},{"cnt":[[306,1599],[1812,1599],[1812,1647],[306,1647]],"region":{"top_left_x":306,"top_left_y":1599,"width":1506,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79c0b0042e1b4f1c9edd7a3759b6d034","type":"text","conversion_output":true,"text":"per-protocol HBGM that is performed by/on illiterate patients should be documented on a","text_display":" per-protocol HBGM that is performed by/on illiterate patients should be documented on a","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[306,1645],[1770,1645],[1770,1695],[306,1695]],"region":{"top_left_x":306,"top_left_y":1644,"width":1465,"height":52},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc069b58a32948f5b49a4a85d125c8ce","type":"text","conversion_output":true,"text":"HBGM diary that will be included in the patients source document file. In the event of","text_display":" HBGM diary that will be included in the patients source document file. In the event of","confidence":1,"confidence_rate":1},{"cnt":[[306,1693],[1784,1693],[1784,1743],[306,1743]],"region":{"top_left_x":306,"top_left_y":1692,"width":1479,"height":51},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ceeed50ab05e4827a5dce9ce0e58f802","type":"text","conversion_output":true,"text":"hyper or hypoglycaemia, the person assisting the patient should record symptoms on the","text_display":" hyper or hypoglycaemia, the person assisting the patient should record symptoms on the","confidence":1,"confidence_rate":1},{"cnt":[[306,1741],[1272,1741],[1272,1793],[306,1793]],"region":{"top_left_x":306,"top_left_y":1740,"width":967,"height":54},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cfe8b9e99844081a58878cce891b533","type":"text","conversion_output":true,"text":"HBGM diary in accordance with the patients' description","text_display":" HBGM diary in accordance with the patients' description","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[242,1832],[1812,1832],[1812,1880],[242,1880]],"region":{"top_left_x":242,"top_left_y":1832,"width":1570,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"830212252df8415e8a23cc382d188e45","type":"text","conversion_output":true,"text":"HGBM tests can be performed either by the patient him/herself, or by the person assisting the","text_display":"\n\nHGBM tests can be performed either by the patient him/herself, or by the person assisting the","confidence":1,"confidence_rate":1},{"cnt":[[242,1878],[829,1878],[829,1930],[242,1930]],"region":{"top_left_x":242,"top_left_y":1877,"width":588,"height":54},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"052440466b9d489280e13810798f536d","type":"text","conversion_output":true,"text":"patient with this aspect of the trial.","text_display":" patient with this aspect of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[242,1965],[1163,1965],[1163,2017],[242,2017]],"region":{"top_left_x":242,"top_left_y":1964,"width":921,"height":54},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de83b784632644d684d13b8df934bf33","type":"section_header","conversion_output":false,"children_ids":["adfdb437f843420f8cccaabb7896c1d1"],"text":"","text_display":""},{"cnt":[[247,1969],[1158,1969],[1158,2013],[247,2013]],"region":{"top_left_x":246,"top_left_y":1969,"width":913,"height":44},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"adfdb437f843420f8cccaabb7896c1d1","type":"text","conversion_output":true,"parent_id":"de83b784632644d684d13b8df934bf33","text":"10.1.2 Patient information and informed consent","text_display":"\n\n\\subsection*{10.1.2 Patient information and informed consent}","confidence":1,"confidence_rate":1},{"cnt":[[244,2056],[1784,2056],[1784,2108],[244,2108]],"region":{"top_left_x":244,"top_left_y":2055,"width":1541,"height":54},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d69098d90fd4d06a2110f3b68cdb6a8","type":"text","conversion_output":true,"text":"In the event of recruiting an illiterate patient, the following process should be followed with","text_display":"\n\nIn the event of recruiting an illiterate patient, the following process should be followed with","confidence":1,"confidence_rate":1},{"cnt":[[242,2106],[1126,2106],[1126,2159],[242,2159]],"region":{"top_left_x":242,"top_left_y":2106,"width":885,"height":53},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b3f53b627b1494e9dbec8e84dcc7dfc","type":"text","conversion_output":true,"text":"respect to patient information and informed consent:","text_display":" respect to patient information and informed consent:","confidence":1,"confidence_rate":1},{"cnt":[[242,2195],[1816,2195],[1816,2246],[242,2246]],"region":{"top_left_x":242,"top_left_y":2195,"width":1575,"height":51},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2c3666607974c618513c1e505c012ee","type":"text","conversion_output":true,"text":"- The designated site personnel performing the informed consent process will read the trial-","text_display":"\n- The designated site personnel performing the informed consent process will read the trial","confidence":1,"confidence_rate":1},{"cnt":[[306,2243],[1802,2243],[1802,2296],[306,2296]],"region":{"top_left_x":306,"top_left_y":2243,"width":1497,"height":53},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3897c2c3ab84a67a0d913a42a82da17","type":"text","conversion_output":true,"text":"approved patient information sheet and informed consent form to the patient, and explain","text_display":"approved patient information sheet and informed consent form to the patient, and explain","confidence":1,"confidence_rate":1},{"cnt":[[306,2294],[1384,2294],[1384,2341],[306,2341]],"region":{"top_left_x":306,"top_left_y":2293,"width":1079,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"deb2bb8040a844539416ae918c410e1f","type":"text","conversion_output":true,"text":"the details of the trial, all in the presence of an impartial witness","text_display":" the details of the trial, all in the presence of an impartial witness","confidence":1,"confidence_rate":1},{"cnt":[[242,2380],[1798,2380],[1798,2433],[242,2433]],"region":{"top_left_x":242,"top_left_y":2380,"width":1556,"height":53},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3032097934e41cea4a0ff6a7137d2a8","type":"text","conversion_output":true,"text":"- This impartial witness must be literate, and can be the patient's relative or caregiver, or a","text_display":"\n- This impartial witness must be literate, and can be the patient's relative or caregiver, or a","confidence":1,"confidence_rate":1},{"cnt":[[306,2426],[1693,2426],[1693,2479],[306,2479]],"region":{"top_left_x":306,"top_left_y":2426,"width":1387,"height":53},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ebf1c596e5f544808afa8722bcd3cb90","type":"text","conversion_output":true,"text":"member of staff employed by the clinic but not part of the immediate trial team. In","text_display":" member of staff employed by the clinic but not part of the immediate trial team. In","confidence":1,"confidence_rate":1},{"cnt":[[306,2476],[1784,2476],[1784,2529],[306,2529]],"region":{"top_left_x":306,"top_left_y":2476,"width":1479,"height":53},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17b12cf390134fdda0a3740a88cb6969","type":"text","conversion_output":true,"text":"addition, if there are any further local regulations with respect to the consent of illiterate","text_display":" addition, if there are any further local regulations with respect to the consent of illiterate","confidence":1,"confidence_rate":1},{"cnt":[[306,2524],[962,2524],[962,2574],[306,2574]],"region":{"top_left_x":306,"top_left_y":2524,"width":656,"height":51},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e9596c42776450a8e2186c72557fa61","type":"text","conversion_output":true,"text":"patients, these should also be followed","text_display":" patients, these should also be followed","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4ad4d44e39664f3dbc021da25d6b4d26","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.994140625,"confidence_rate":0.999860090538504},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e09e9693c18c443f8d7500ba725e7dae","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"430721be933f453f9d71779f3692e8ad","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-080","page":80,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7529bf152234771bc576adcc68ebccd","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98966cd49efa4a48b23584131c370172","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65d8ff5ea13144de87bc047faa02b2c5","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a9bc4ff82ae41efb5ca6b925e16b290","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ef18b5709744b58abbccd2cc362a76b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5e8c182d7b14298b6efc4ba1d65df87","type":"page_info","conversion_output":false,"text":"Page 80 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,338],[1766,338],[1766,388],[244,388]],"region":{"top_left_x":244,"top_left_y":338,"width":1522,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ab3920c384e4109b5835a785dde6df4","type":"text","conversion_output":true,"text":"- The requirements of the trial will be explained thoroughly and the patient will be given","text_display":"\n- The requirements of the trial will be explained thoroughly and the patient will be given","confidence":0.990234375,"confidence_rate":0.9998967040569899},{"cnt":[[306,388],[1716,388],[1716,436],[306,436]],"region":{"top_left_x":306,"top_left_y":388,"width":1410,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a44f9de8fe094805a2f17be300bb9bd2","type":"text","conversion_output":true,"text":"ample time to ask questions and consider his/her participation. If he/she wishes, the","text_display":" ample time to ask questions and consider his/her participation. If he/she wishes, the","confidence":1,"confidence_rate":1},{"cnt":[[306,434],[1814,434],[1814,482],[306,482]],"region":{"top_left_x":306,"top_left_y":434,"width":1508,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f05ee5bd26fd44d08c6d11412fb75709","type":"text","conversion_output":true,"text":"patient can take the patient information sheet and informed consent form home for further","text_display":" patient can take the patient information sheet and informed consent form home for further","confidence":1,"confidence_rate":1},{"cnt":[[306,484],[541,484],[541,523],[306,523]],"region":{"top_left_x":306,"top_left_y":484,"width":236,"height":40},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"318ff968bc7b4a24876077130d9c1f77","type":"text","conversion_output":true,"text":"consideration","text_display":" consideration","confidence":1,"confidence_rate":1},{"cnt":[[242,571],[1725,571],[1725,624],[242,624]],"region":{"top_left_x":242,"top_left_y":571,"width":1483,"height":53},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2bbe8cf32d2749deb1a66d4139d54be4","type":"text","conversion_output":true,"text":"- If patient agrees to take part in the trial, he/she would then return to the clinic for the","text_display":"\n- If patient agrees to take part in the trial, he/she would then return to the clinic for the","confidence":1,"confidence_rate":1},{"cnt":[[306,621],[1711,621],[1711,669],[306,669]],"region":{"top_left_x":306,"top_left_y":621,"width":1405,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"295e65d3b0d54fbf835d9926f3ea9e97","type":"text","conversion_output":true,"text":"consent process to be completed. The site designated personnel responsible for this","text_display":" consent process to be completed. The site designated personnel responsible for this","confidence":1,"confidence_rate":1},{"cnt":[[306,669],[1789,669],[1789,720],[306,720]],"region":{"top_left_x":306,"top_left_y":669,"width":1483,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52ba9cf3a5e24da0b9e1459eafbbbada","type":"text","conversion_output":true,"text":"process will confirm that the patient has no further questions in the presence of the same","text_display":" process will confirm that the patient has no further questions in the presence of the same","confidence":1,"confidence_rate":1},{"cnt":[[306,717],[1812,717],[1812,765],[306,765]],"region":{"top_left_x":306,"top_left_y":717,"width":1506,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b21731c0e7474e7f96efdcee4f89b81c","type":"text","conversion_output":true,"text":"impartial witness (if the patient returns on another day). If a different impartial witness is","text_display":" impartial witness (if the patient returns on another day). If a different impartial witness is","confidence":1,"confidence_rate":1},{"cnt":[[306,763],[1343,763],[1343,813],[306,813]],"region":{"top_left_x":306,"top_left_y":762,"width":1038,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"174e0fc7c9044e3999556a35812e8c7e","type":"text","conversion_output":true,"text":"present, the entire informed consent process must be repeated","text_display":" present, the entire informed consent process must be repeated","confidence":1,"confidence_rate":1},{"cnt":[[242,854],[1812,854],[1812,902],[242,902]],"region":{"top_left_x":242,"top_left_y":854,"width":1570,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d89aa09667f46c19a79a7dc57f96965","type":"text","conversion_output":true,"text":"- Participating patients will provide a thumb impression or make a mark (or signature if the","text_display":"\n- Participating patients will provide a thumb impression or make a mark (or signature if the","confidence":1,"confidence_rate":1},{"cnt":[[306,902],[1786,902],[1786,953],[306,953]],"region":{"top_left_x":306,"top_left_y":902,"width":1481,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f48e5ac362143278e5c2515489b08ac","type":"text","conversion_output":true,"text":"patient is able to sign him/herself) on the signature section of the informed consent form","text_display":" patient is able to sign him/herself) on the signature section of the informed consent form","confidence":1,"confidence_rate":1},{"cnt":[[242,991],[1789,991],[1789,1044],[242,1044]],"region":{"top_left_x":242,"top_left_y":991,"width":1547,"height":53},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c54ebc6051f46ebb90860a3d65797cf","type":"text","conversion_output":true,"text":"- The date of the patient's signature will be left blank as the patient is illiterate. However,","text_display":"\n- The date of the patient's signature will be left blank as the patient is illiterate. However,","confidence":1,"confidence_rate":1},{"cnt":[[306,1037],[1432,1037],[1432,1090],[306,1090]],"region":{"top_left_x":306,"top_left_y":1037,"width":1127,"height":53},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7da97a612fdf47db9d68cd6f6bfad982","type":"text","conversion_output":true,"text":"if the patient is able, he/she will date the mark/signature personally","text_display":" if the patient is able, he/she will date the mark/signature personally","confidence":1,"confidence_rate":1},{"cnt":[[242,1128],[1784,1128],[1784,1181],[242,1181]],"region":{"top_left_x":242,"top_left_y":1128,"width":1543,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee68cc122489484dbf186be5fcff193a","type":"text","conversion_output":true,"text":"- The impartial witness or the site designated personnel may write the name of the patient","text_display":"\n- The impartial witness or the site designated personnel may write the name of the patient","confidence":1,"confidence_rate":1},{"cnt":[[306,1179],[811,1179],[811,1222],[306,1222]],"region":{"top_left_x":306,"top_left_y":1178,"width":505,"height":45},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d48cdf2e6aa4cb3a5634eca1894c2f3","type":"text","conversion_output":true,"text":"on the informed consent form","text_display":" on the informed consent form","confidence":1,"confidence_rate":1},{"cnt":[[242,1266],[1738,1266],[1738,1318],[242,1318]],"region":{"top_left_x":242,"top_left_y":1265,"width":1497,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48a9cd1a768c46a5865f12302668b16f","type":"text","conversion_output":true,"text":"- The impartial witness should enter his/her name, sign and personally date the witness","text_display":"\n- The impartial witness should enter his/her name, sign and personally date the witness","confidence":1,"confidence_rate":1},{"cnt":[[306,1316],[1802,1316],[1802,1364],[306,1364]],"region":{"top_left_x":306,"top_left_y":1315,"width":1497,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cdbfeb03984404fb2e2bf2b8ec72c02","type":"text","conversion_output":true,"text":"section of the informed consent form. In countries where local data protection regulation","text_display":" section of the informed consent form. In countries where local data protection regulation","confidence":1,"confidence_rate":1},{"cnt":[[306,1361],[1748,1361],[1748,1414],[306,1414]],"region":{"top_left_x":306,"top_left_y":1361,"width":1442,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f3437ed9d5a4dfcb20044a99ffad47e","type":"text","conversion_output":true,"text":"permits it, the address or identification number of the impartial witness should also be","text_display":" permits it, the address or identification number of the impartial witness should also be","confidence":1,"confidence_rate":1},{"cnt":[[306,1412],[1766,1412],[1766,1460],[306,1460]],"region":{"top_left_x":306,"top_left_y":1411,"width":1460,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"843b48a4cb0943ff9eaf310f1f189e9e","type":"text","conversion_output":true,"text":"entered. The signature then attests that the content of the patient information sheet and","text_display":" entered. The signature then attests that the content of the patient information sheet and","confidence":1,"confidence_rate":1},{"cnt":[[306,1457],[1633,1457],[1633,1510],[306,1510]],"region":{"top_left_x":306,"top_left_y":1457,"width":1328,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"82ba2271604846b6b0cee4b2824cadad","type":"text","conversion_output":true,"text":"informed consent form was accurately explained to the patient, who apparently","text_display":" informed consent form was accurately explained to the patient, who apparently","confidence":1,"confidence_rate":1},{"cnt":[[306,1508],[1318,1508],[1318,1556],[306,1556]],"region":{"top_left_x":306,"top_left_y":1507,"width":1013,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"88159ca2ddf64b5dbbde21e67edf2028","type":"text","conversion_output":true,"text":"understood and freely gave consent to participate in the trial","text_display":" understood and freely gave consent to participate in the trial","confidence":1,"confidence_rate":1},{"cnt":[[242,1594],[1786,1594],[1786,1647],[242,1647]],"region":{"top_left_x":242,"top_left_y":1594,"width":1545,"height":54},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"05b4de1993ce44e4b89daaa26b555eb4","type":"text","conversion_output":true,"text":"- The designated site personnel also signs and personally dates the informed consent form","text_display":"\n- The designated site personnel also signs and personally dates the informed consent form","confidence":1,"confidence_rate":1},{"cnt":[[242,1733],[242,1681],[1163,1684],[1163,1735]],"region":{"top_left_x":242,"top_left_y":1681,"width":921,"height":55},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37019f62e7704f228a91e04de39c9073","type":"section_header","conversion_output":false,"children_ids":["5914979668424f9aadce6ac6b2146b6b"],"text":"","text_display":""},{"cnt":[[247,1686],[1160,1686],[1160,1729],[247,1729]],"region":{"top_left_x":246,"top_left_y":1685,"width":915,"height":45},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5914979668424f9aadce6ac6b2146b6b","type":"text","conversion_output":true,"parent_id":"37019f62e7704f228a91e04de39c9073","text":"10.2 DEFINITIONS OF ENDPOINT EVENTS","text_display":"\n\n\\subsection*{10.2 DEFINITIONS OF ENDPOINT EVENTS}","confidence":1,"confidence_rate":1},{"cnt":[[244,1775],[1674,1775],[1674,1825],[244,1825]],"region":{"top_left_x":244,"top_left_y":1774,"width":1431,"height":52},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f0bcee0d37b4109a7a8ce5c8fa2e3c6","type":"text","conversion_output":true,"text":"Definitions of the adjudicated endpoint events and the principles of standardised data","text_display":"\n\nDefinitions of the adjudicated endpoint events and the principles of standardised data","confidence":1,"confidence_rate":1},{"cnt":[[244,1823],[1775,1823],[1775,1875],[244,1875]],"region":{"top_left_x":244,"top_left_y":1822,"width":1531,"height":54},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2eaf7e7a6685465ba3009319269705b0","type":"text","conversion_output":true,"text":"collection in the centralised CEC adjudication process are outlined in the CEC charters and","text_display":" collection in the centralised CEC adjudication process are outlined in the CEC charters and","confidence":1,"confidence_rate":1},{"cnt":[[242,1873],[569,1873],[569,1921],[242,1921]],"region":{"top_left_x":242,"top_left_y":1873,"width":327,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c37dcb1c73d4d21813468bc5b2cd734","type":"text","conversion_output":true,"text":"process guidelines.","text_display":" process guidelines.","confidence":1,"confidence_rate":1},{"cnt":[[242,2006],[1377,2006],[1377,2054],[242,2054]],"region":{"top_left_x":242,"top_left_y":2005,"width":1136,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"154ab8ad8c3141e38ca0845b059059f1","type":"section_header","conversion_output":false,"children_ids":["500bb0cfa0a14adfa479183b890e4e7e"],"text":"","text_display":""},{"cnt":[[247,2010],[1373,2010],[1373,2049],[247,2049]],"region":{"top_left_x":246,"top_left_y":2010,"width":1127,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"500bb0cfa0a14adfa479183b890e4e7e","type":"text","conversion_output":true,"parent_id":"154ab8ad8c3141e38ca0845b059059f1","text":"10.3 BLOOD PRESSURE MEASUREMENT PROCEDURE","text_display":"\n\n\\subsection*{10.3 BLOOD PRESSURE MEASUREMENT PROCEDURE}","confidence":1,"confidence_rate":1},{"cnt":[[244,2097],[1761,2097],[1761,2150],[244,2150]],"region":{"top_left_x":244,"top_left_y":2097,"width":1518,"height":53},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"53d33818d94d4a8aa0043359ad46d210","type":"text","conversion_output":true,"text":"Initially, blood pressure should be taken three times in both arms. The arm with the higher","text_display":"\n\nInitially, blood pressure should be taken three times in both arms. The arm with the higher","confidence":1,"confidence_rate":1},{"cnt":[[244,2147],[1734,2147],[1734,2198],[244,2198]],"region":{"top_left_x":244,"top_left_y":2147,"width":1490,"height":51},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"072baa88c1894445b603494a71841a79","type":"text","conversion_output":true,"text":"pressure (either systolic -if needed to decide- or diastolic) should be used for subsequent","text_display":" pressure (either systolic -if needed to decide- or diastolic) should be used for subsequent","confidence":0.9645077522145584,"confidence_rate":0.9996236394963774},{"cnt":[[242,2198],[500,2198],[500,2236],[242,2236]],"region":{"top_left_x":242,"top_left_y":2197,"width":259,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d90aa18346234bcc8a7977db72bc5411","type":"text","conversion_output":true,"text":"measurements.","text_display":" measurements.","confidence":1,"confidence_rate":1},{"cnt":[[244,2284],[1574,2284],[1574,2332],[244,2332]],"region":{"top_left_x":244,"top_left_y":2284,"width":1330,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a57a508f342469fb572ee50897201d5","type":"text","conversion_output":true,"text":"Blood pressure measurements can be performed with either a standard mercury","text_display":"\n\nBlood pressure measurements can be performed with either a standard mercury","confidence":1,"confidence_rate":1},{"cnt":[[244,2330],[1775,2330],[1775,2383],[244,2383]],"region":{"top_left_x":244,"top_left_y":2330,"width":1531,"height":53},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a36da05125dc449d964cbe9a5c38043d","type":"text","conversion_output":true,"text":"sphygmomanometer or a fully automated blood pressure device, depending on the standard","text_display":" sphygmomanometer or a fully automated blood pressure device, depending on the standard","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[244,2380],[1775,2380],[1775,2428],[244,2428]],"region":{"top_left_x":244,"top_left_y":2380,"width":1531,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55553ac20c794d98980a94ce738a6c48","type":"text","conversion_output":true,"text":"practice at each study site - Note: BI will not provide electronic devices to sites that use the","text_display":" practice at each study site - Note: BI will not provide electronic devices to sites that use the","confidence":1,"confidence_rate":1},{"cnt":[[244,2426],[1812,2426],[1812,2479],[244,2479]],"region":{"top_left_x":244,"top_left_y":2426,"width":1568,"height":53},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15a521d054684272866c2ff169455f8c","type":"text","conversion_output":true,"text":"standard manual sphygmomanometers. The fully automated blood pressure devices should be","text_display":" standard manual sphygmomanometers. The fully automated blood pressure devices should be","confidence":1,"confidence_rate":1},{"cnt":[[244,2476],[1519,2476],[1519,2524],[244,2524]],"region":{"top_left_x":244,"top_left_y":2476,"width":1276,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c5d59c4eff24f579398cfa28314df5c","type":"text","conversion_output":true,"text":"validated by website: dableducational.org. Other devices are not acceptable.","text_display":" validated by website: dableducational.org. Other devices are not acceptable.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"21bc939d9c544853a05e62681e85c3c0","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99755859375,"confidence_rate":0.9999418018997234},{"cnt":[[288,2620],[1798,2620],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2620,"width":1511,"height":42},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"936af7d9e30244f4acbadc149cf04503","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.978515625,"confidence_rate":0.9998175080490214},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"07accc7b38204588a90265bd305c810a","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-081","page":81,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b97bbdb94a548d7891e356602b49022","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35912fa68918413d986d7d7e84186cdc","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"086ee03641cd41a5a1ca0f4a2c466371","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,210],[637,210],[637,249],[247,249]],"region":{"top_left_x":246,"top_left_y":210,"width":392,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"458ace5db56a43d8a8698427cb37e6c8","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6a41d04d6cf4e5c8c02a8e2c839313f","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d443e66761e49c7b68dc3af393619a3","type":"page_info","conversion_output":false,"text":"Page 81 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,338],[1780,338],[1780,388],[247,388]],"region":{"top_left_x":246,"top_left_y":338,"width":1534,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c53e2bbc1a2406fbe07b72baecef79b","type":"text","conversion_output":true,"text":"Blood pressure measurements should be performed on the same arm and, if possible, by the","text_display":"\n\nBlood pressure measurements should be performed on the same arm and, if possible, by the","confidence":1,"confidence_rate":1},{"cnt":[[247,388],[1798,388],[1798,436],[247,436]],"region":{"top_left_x":246,"top_left_y":388,"width":1552,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"068f73d3a5524b1abd562eb54e405a3d","type":"text","conversion_output":true,"text":"same person. The same method must be used throughout the trial, for a given patient, i.e. if a","text_display":" same person. The same method must be used throughout the trial, for a given patient, i.e. if a","confidence":1,"confidence_rate":1},{"cnt":[[247,434],[1786,434],[1786,482],[247,482]],"region":{"top_left_x":246,"top_left_y":434,"width":1541,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2dfc912957f1414dadd54dc4d216e937","type":"text","conversion_output":true,"text":"patient receives the first blood pressure measurement for example with an electronic device,","text_display":" patient receives the first blood pressure measurement for example with an electronic device,","confidence":1,"confidence_rate":1},{"cnt":[[247,484],[1761,484],[1761,532],[247,532]],"region":{"top_left_x":246,"top_left_y":484,"width":1516,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5219dca1027141bd8c8a291938aa1488","type":"text","conversion_output":true,"text":"the same method and a similar type of device should be used throughout the study for this","text_display":" the same method and a similar type of device should be used throughout the study for this","confidence":1,"confidence_rate":1},{"cnt":[[244,532],[1807,532],[1807,578],[244,578]],"region":{"top_left_x":244,"top_left_y":532,"width":1563,"height":46},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3feed0d6fa1c471498de476eaf095396","type":"text","conversion_output":true,"text":"patient (without switching to manual blood pressure measurement). On the other hand, inter-","text_display":" patient (without switching to manual blood pressure measurement). On the other hand, inter","confidence":1,"confidence_rate":1},{"cnt":[[247,580],[1782,580],[1782,628],[247,628]],"region":{"top_left_x":246,"top_left_y":580,"width":1536,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a84219a1d25454782abcb2bcac34377","type":"text","conversion_output":true,"text":"patients variability is acceptable, i.e. a study site is allowed to consistently use an electronic","text_display":"patients variability is acceptable, i.e. a study site is allowed to consistently use an electronic","confidence":0.958984375,"confidence_rate":0.9995934758839607},{"cnt":[[247,628],[1757,628],[1757,678],[247,678]],"region":{"top_left_x":246,"top_left_y":628,"width":1511,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff42d65eefd5485c8cf3bf0f2ac542a7","type":"text","conversion_output":true,"text":"device to measure the blood pressure in a given patient throughout the study and a manual","text_display":" device to measure the blood pressure in a given patient throughout the study and a manual","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[247,676],[724,676],[724,724],[247,724]],"region":{"top_left_x":246,"top_left_y":676,"width":479,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16caf1ae7913437bbe19291743b14f1c","type":"text","conversion_output":true,"text":"technique in another patient.","text_display":" technique in another patient.","confidence":1,"confidence_rate":1},{"cnt":[[247,763],[1814,763],[1814,813],[247,813]],"region":{"top_left_x":246,"top_left_y":762,"width":1568,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd161fbdd8d94ddab4827d34959356e5","type":"text","conversion_output":true,"text":"After patients have rested quietly, in the seated position for five minutes, three blood pressure","text_display":"\n\nAfter patients have rested quietly, in the seated position for five minutes, three blood pressure","confidence":1,"confidence_rate":1},{"cnt":[[247,813],[1784,813],[1784,861],[247,861]],"region":{"top_left_x":246,"top_left_y":813,"width":1539,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f838abf197c44ef69cdc0bfdc3c15c2d","type":"text","conversion_output":true,"text":"measurements will be taken approximately two minutes apart. The seated pulse rate will be","text_display":" measurements will be taken approximately two minutes apart. The seated pulse rate will be","confidence":1,"confidence_rate":1},{"cnt":[[247,859],[1805,859],[1805,909],[247,909]],"region":{"top_left_x":246,"top_left_y":858,"width":1559,"height":52},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a8eed86c73246f3ae16bebef90ab0e8","type":"text","conversion_output":true,"text":"taken during the two-minute interval between the second and third blood pressure reading. If","text_display":" taken during the two-minute interval between the second and third blood pressure reading. If","confidence":1,"confidence_rate":1},{"cnt":[[247,909],[1812,909],[1812,957],[247,957]],"region":{"top_left_x":246,"top_left_y":909,"width":1566,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c98b267fc6c4f96b48f4b9d079e6904","type":"text","conversion_output":true,"text":"an electronic blood pressure device is used the pulse rate at time of the second blood pressure","text_display":" an electronic blood pressure device is used the pulse rate at time of the second blood pressure","confidence":1,"confidence_rate":1},{"cnt":[[244,955],[733,955],[733,1007],[244,1007]],"region":{"top_left_x":244,"top_left_y":954,"width":490,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"efb2e83944b944fea9b91b1afe85f494","type":"text","conversion_output":true,"text":"reading may should be used.","text_display":" reading may should be used.","confidence":1,"confidence_rate":1},{"cnt":[[247,1046],[1732,1046],[1732,1094],[247,1094]],"region":{"top_left_x":246,"top_left_y":1046,"width":1486,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5d34401365f4e17a42b8d83c20aa6f4","type":"text","conversion_output":true,"text":"Blood pressure measurements should be recorded to the nearest 0 or 5 mmHg only when","text_display":"\n\nBlood pressure measurements should be recorded to the nearest 0 or 5 mmHg only when","confidence":1,"confidence_rate":1},{"cnt":[[244,1092],[1775,1092],[1775,1142],[244,1142]],"region":{"top_left_x":244,"top_left_y":1091,"width":1531,"height":52},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6511caeffd7e4d268c8c9cdd7c4c1c83","type":"text","conversion_output":true,"text":"measured with a manual sphygmomanometer; when digital devices are used the value from","text_display":" measured with a manual sphygmomanometer; when digital devices are used the value from","confidence":1,"confidence_rate":1},{"cnt":[[244,1142],[1677,1142],[1677,1190],[244,1190]],"region":{"top_left_x":244,"top_left_y":1142,"width":1433,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ede60ad611ad412c928b0b46963de380","type":"text","conversion_output":true,"text":"the device should be rounded to the nearest 1 mmHg . For calculation of mean values,","text_display":" the device should be rounded to the nearest 1 mmHg . For calculation of mean values,","confidence":0.9990236759185791,"confidence_rate":0.9999896085540316},{"cnt":[[247,1188],[1743,1188],[1743,1238],[247,1238]],"region":{"top_left_x":246,"top_left_y":1187,"width":1497,"height":52},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"adeb61a5baa543f5bb768c0dfefaf1ec","type":"text","conversion_output":true,"text":"decimal places should be rounded to integers (e.g. a DBP of 94.5 would be rounded to 95","text_display":" decimal places should be rounded to integers (e.g. a DBP of 94.5 would be rounded to 95","confidence":1,"confidence_rate":1},{"cnt":[[247,1238],[1706,1238],[1706,1286],[247,1286]],"region":{"top_left_x":246,"top_left_y":1238,"width":1461,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d4fbc6b656b43de9dc96cb0e89fbd6c","type":"text","conversion_output":true,"text":"mmHg and a DBP of 109.4 would be rounded to 109 mmHg or 110 mmHg in case of a","text_display":" mmHg and a DBP of 109.4 would be rounded to 109 mmHg or 110 mmHg in case of a","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[244,1284],[1629,1284],[1629,1336],[244,1336]],"region":{"top_left_x":244,"top_left_y":1283,"width":1385,"height":54},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fba9f4c1d60a4fa9847b85316ccd796d","type":"text","conversion_output":true,"text":"manual sphygmomanometer). The mean value should be recorded in the eCRF.","text_display":" manual sphygmomanometer). The mean value should be recorded in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[242,1366],[1163,1366],[1163,1421],[242,1421]],"region":{"top_left_x":242,"top_left_y":1366,"width":921,"height":55},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"613979d8ea944164a1f076eb705816ee","type":"section_header","conversion_output":false,"children_ids":["16f2ebcf5d244f39b0ea681e0cf07a61"],"text":"","text_display":""},{"cnt":[[247,1373],[1158,1373],[1158,1419],[247,1419]],"region":{"top_left_x":246,"top_left_y":1372,"width":913,"height":47},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16f2ebcf5d244f39b0ea681e0cf07a61","type":"text","conversion_output":true,"parent_id":"613979d8ea944164a1f076eb705816ee","text":"10.4 SILENT MYOCARDIAL INFARCTION","text_display":"\n\n\\subsection*{10.4 SILENT MYOCARDIAL INFARCTION}","confidence":1,"confidence_rate":1},{"cnt":[[233,1594],[1674,1594],[1674,1656],[233,1656]],"region":{"top_left_x":233,"top_left_y":1594,"width":1442,"height":63},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c14a679a6644b7b96097b31fbaac6db","type":"section_header","conversion_output":false,"children_ids":["2ba85b01721840adbd0b1c07681a336e"],"text":"","text_display":""},{"cnt":[[242,1599],[1668,1599],[1668,1652],[242,1652]],"region":{"top_left_x":242,"top_left_y":1599,"width":1426,"height":53},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ba85b01721840adbd0b1c07681a336e","type":"text","conversion_output":true,"parent_id":"9c14a679a6644b7b96097b31fbaac6db","text":"Definition of relevant ECG abnormalities related to silent MI is the presence of:","text_display":"\n\n\\section*{Definition of relevant ECG abnormalities related to silent MI is the presence of:}","confidence":1,"confidence_rate":1},{"cnt":[[306,1693],[1709,1693],[1709,1743],[306,1743]],"region":{"top_left_x":306,"top_left_y":1692,"width":1403,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ad1746001464dc1af0054b9469a928e","type":"text","conversion_output":true,"text":"- Any Q-wave in leads V2-V3 \\(\\geq 0.02\\) seconds or QS complex in leads V2 and V3","text_display":"\n- Any Q-wave in leads V2-V3 \\(\\geq 0.02\\) seconds or QS complex in leads V2 and V3","confidence":0.9990234375,"confidence_rate":0.9999880849533282},{"cnt":[[306,1745],[1816,1745],[1816,1793],[306,1793]],"region":{"top_left_x":306,"top_left_y":1745,"width":1511,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"28513ec1f9f14a5aab756ca9596be4c1","type":"text","conversion_output":true,"text":"- Q-wave \\(\\geq 0.03\\) seconds and \\(\\geq 0.1 mV\\) deep or QS complex in leads I, II, aVL, aVF, or","text_display":"\n- Q-wave \\(\\geq 0.03\\) seconds and \\(\\geq 0.1 mV\\) deep or QS complex in leads I, II, aVL, aVF, or","confidence":1,"confidence_rate":1},{"cnt":[[370,1793],[1821,1793],[1821,1843],[370,1843]],"region":{"top_left_x":370,"top_left_y":1793,"width":1451,"height":51},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04c1a995a4e947f4880da2c2cee9d732","type":"text","conversion_output":true,"text":"V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and","text_display":" V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and","confidence":1,"confidence_rate":1},{"cnt":[[370,1841],[464,1841],[464,1889],[370,1889]],"region":{"top_left_x":370,"top_left_y":1841,"width":94,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"405dfd6add7f4cec94e52f84dc90d08f","type":"text","conversion_output":true,"text":"aVF)","text_display":" aVF)","confidence":1,"confidence_rate":1},{"cnt":[[306,1891],[1775,1891],[1775,1939],[306,1939]],"region":{"top_left_x":306,"top_left_y":1891,"width":1469,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"32bf8b271b074a338bfe3ea205b77b61","type":"text","conversion_output":true,"text":"- R-wave \\(\\geq 0.04\\) seconds in V1-V2 and R/S \\(\\geq 1\\) with a concordant positive T-wave in","text_display":"\n- R-wave \\(\\geq 0.04\\) seconds in V1-V2 and R/S \\(\\geq 1\\) with a concordant positive T-wave in","confidence":0.9926862716674805,"confidence_rate":0.9999184410509075},{"cnt":[[370,1939],[955,1939],[955,1981],[370,1981]],"region":{"top_left_x":370,"top_left_y":1939,"width":585,"height":42},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a82ee4a8508c4908a97b0bac448d71f0","type":"text","conversion_output":true,"text":"the absence of a conduction defect","text_display":" the absence of a conduction defect","confidence":1,"confidence_rate":1},{"cnt":[[244,2006],[1697,2006],[1697,2058],[244,2058]],"region":{"top_left_x":244,"top_left_y":2005,"width":1454,"height":54},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe053aec5ba54fb7b6e0d64ccae5ef34","type":"text","conversion_output":true,"text":"An MI will only be classified as silent if 1) the ECG criteria's are fulfilled, 2) the ECG","text_display":"\n\nAn MI will only be classified as silent if 1) the ECG criteria's are fulfilled, 2) the ECG","confidence":0.99755859375,"confidence_rate":0.9999742698958483},{"cnt":[[247,2056],[1793,2056],[1793,2104],[247,2104]],"region":{"top_left_x":246,"top_left_y":2055,"width":1548,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38a50e16a5a44da98d26f766678eaa01","type":"text","conversion_output":true,"text":"changes were absent from baseline or previous ECGs and 3) no preceding clinical history of","text_display":" changes were absent from baseline or previous ECGs and 3) no preceding clinical history of","confidence":0.7753261108882725,"confidence_rate":0.9973249364825233},{"cnt":[[247,2104],[1697,2104],[1697,2154],[247,2154]],"region":{"top_left_x":246,"top_left_y":2103,"width":1452,"height":52},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5a54a43e80749e485b09417cbe5e894","type":"text","conversion_output":true,"text":"MI (including stent thrombosis and other coronary events) during study follow-up","text_display":" MI (including stent thrombosis and other coronary events) during study follow-up","confidence":1,"confidence_rate":1},{"cnt":[[247,2152],[1149,2152],[1149,2200],[247,2200]],"region":{"top_left_x":246,"top_left_y":2151,"width":904,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0622b2e6f0094f3db4e5d10417101beb","type":"text","conversion_output":true,"text":"occurred and 4) investigator reporting of silent MI.","text_display":" occurred and 4) investigator reporting of silent MI.","confidence":1,"confidence_rate":1},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":40,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"564480461b1340a3ac3fba27cc79312d","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99462890625,"confidence_rate":0.9998717803653021},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":41,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2826990860084e1a9e39e876b1982105","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":42,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"48dc58cecdfd4f90a10d4dd6fd95e9a3","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-082","page":82,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ce03f81a8594beca0042020c2ca72a6","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6907a617add84c478d8954b9c6550ce8","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"879f2a148ea24b0ab74eca60570b3877","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"097adac72aa54ab9a39fb3efec1f1070","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78a4fbb160ca44cd86184d0ea10acc4c","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"682320d64243465ebb15bc8c177d710d","type":"page_info","conversion_output":false,"text":"Page 82 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,336],[1455,336],[1455,404],[242,404]],"region":{"top_left_x":242,"top_left_y":335,"width":1214,"height":70},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"acf0eca71a0b48c8881de32034764827","type":"section_header","conversion_output":false,"children_ids":["ff9131fa0d0343b486e28db9587c3c54"],"text":"","text_display":""},{"cnt":[[247,343],[1451,343],[1451,400],[247,400]],"region":{"top_left_x":246,"top_left_y":342,"width":1205,"height":58},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ff9131fa0d0343b486e28db9587c3c54","type":"text","conversion_output":true,"parent_id":"acf0eca71a0b48c8881de32034764827","text":"11. DESCRIPTION OF GLOBAL AMENDMENT(S)","text_display":"\n\n\\section*{11. DESCRIPTION OF GLOBAL AMENDMENT(S)}","confidence":1,"confidence_rate":1},{"cnt":[[244,429],[1775,429],[1775,2531],[244,2531]],"region":{"top_left_x":244,"top_left_y":429,"width":1531,"height":2103},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","type":"table","conversion_output":true,"children_ids":["43843bf8dd714c67aff950200e6e181a","4e415ca273d942f7aa8f380659e5ace3","bdd012f8da0344d392cdb329fc5de06c","0df250be8b384a84990eaa60a3087ac2","7d246e7eddaa4e38866ed44e45139614","7dee9696025647c98aa4ffe12cba3211","7dbb379e221946f0950a26e35b996511","c8bba0cf5770423e9bd1c03f63d7813a","015d2aec37964d77b58dfeeabe97d939","5d0822e7f2b940d393e72f8f72566896","72d13d0bdada4038bf28e70c76b167eb","eaefc6fa98ab49df82908e175a59eb07","d2a3b88eb8d34fd79194585b9ced1e68","17c1ddcb333d4bb59141de7f6c03cf32","4b63b9e4037240a983119be59f045144","576d8895c92b48f68816601975d37225","b26da27dbcc84b5e8409dceec0de57c8","a58e55a4253d4e558863c23d5b0805f2","6d55c980d7bd463cb3b673d76bfeaf8f","e1648a8ebaaa47119e1c45c3146a608f","8a289d4a761640689e25942c00b5e24a","e2bb72eada5c429d8f72c603b580cf47","347def2e5f1143698c68ddbe2d1d267d","6e92168770a445abb9d6580ed65eb238","dac35f500de54e5e9c96c59141a1a593","704fa44e4f9346e195c90cf525a0ae9a","3ce7fd3aa64f4954889585aa71856276","81766f0c030a4fb28a1b435dd9fc5894","25acbc5574ab4210b8c10031b9a76e40","ffbad228b90d48e48ff2c4f74e356723","23dca678b96f437f879b1fe0a139f1c5","5c1bc591733a4e0aa4c2c049dd77eaa9","1b8e9769c3ce4f25b016cc8819b8a6d5","a06c033c7ea24f2390611c2574236215","f89fd56839ed44af8c3b71418101f991","6e699c2e1de44261a69c835ac516ebf4","ec479dc8d42d491cb037c45b28f0de25","3cfd95f8a57b49dba55d5bc65f3f97f8","7ea655b988314e7e9490589126fcef34","e2d14be2eca54840a4099aa998c15d64","472e619e27404a06aebefc850f8220ad","c84b13212ec145709148bbf15b2fcac1","af17c411c74b4e24970f90ff13d639da","b0b663e7674b4952979f84ffa7c138c8","a41afdab56aa40d4b99d7adb57d15111","d5381af7803f41ecb8cf6c169c0c28f5","f634a65538294057a7c843fa1bd569c3","82429da862e34702b3abddcd3b760fb7"],"text":"\\begin{tabular}{|l|l|}\n\\hline Number of CTP modification & 1 \\\\\n\\hline Date of CTP modification & 24 October 2013 \\\\\n\\hline EudraCT number & 2011-004148-23 \\\\\n\\hline BI Trial number & 1218.22 \\\\\n\\hline BI Investigational Product(s) & Linagliptin (BI 1356) \\\\\n\\hline Title of protocol & A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline To be implemented only after approval of the IRB/IEC/Competent Authorities & ![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-082.jpg?height=51\\&width=56\\&top_left_y=1023\\&top_left_x=939) \\\\\n\\hline To be implemented immediately in order to eliminate hazard IRB / IEC / Competent Authority to be notified of change with request for approval & □ \\\\\n\\hline Can be implemented without IRB/IEC/ Competent Authority approval as changes involve logistical or administrative aspects only & □ \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline Section to be changed & Clinical trial protocol synopsis (objectives) \\\\\n\\hline Description of change & \\begin{tabular}{l}\n....sustained loss in estimated global filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline... \\\\\nWas changed into: \\\\\n....sustained decrease in estimated global filtration rate \\(( eGFR ) \\geq 50 \\%\\) from baseline...\n\\end{tabular} \\\\\n\\hline Rationale for change & To use consistent terminology \\\\\n\\hline Section to be changed & Clinical trial protocol synopsis (criteria for efficacy) \\\\\n\\hline Description of change & Change 1: \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Number of CTP modification & 1 \\\\\n\\hline Date of CTP modification & 24 October 2013 \\\\\n\\hline EudraCT number & 2011-004148-23 \\\\\n\\hline BI Trial number & 1218.22 \\\\\n\\hline BI Investigational Product(s) & Linagliptin (BI 1356) \\\\\n\\hline Title of protocol & A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline To be implemented only after approval of the IRB/IEC/Competent Authorities & ![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-082.jpg?height=51\\&width=56\\&top_left_y=1023\\&top_left_x=939) \\\\\n\\hline To be implemented immediately in order to eliminate hazard IRB / IEC / Competent Authority to be notified of change with request for approval & □ \\\\\n\\hline Can be implemented without IRB/IEC/ Competent Authority approval as changes involve logistical or administrative aspects only & □ \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline Section to be changed & Clinical trial protocol synopsis (objectives) \\\\\n\\hline Description of change & \\begin{tabular}{l}\n....sustained loss in estimated global filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline... \\\\\nWas changed into: \\\\\n....sustained decrease in estimated global filtration rate \\(( eGFR ) \\geq 50 \\%\\) from baseline...\n\\end{tabular} \\\\\n\\hline Rationale for change & To use consistent terminology \\\\\n\\hline Section to be changed & Clinical trial protocol synopsis (criteria for efficacy) \\\\\n\\hline Description of change & Change 1: \\\\\n\\hline\n\\end{tabular}","confidence":0,"confidence_rate":0},{"cnt":[[253,429],[824,429],[824,2531],[253,2531]],"region":{"top_left_x":253,"top_left_y":429,"width":572,"height":2103},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43843bf8dd714c67aff950200e6e181a","type":"table_column","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[921,429],[1764,429],[1764,2531],[921,2531]],"region":{"top_left_x":920,"top_left_y":429,"width":844,"height":2103},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e415ca273d942f7aa8f380659e5ace3","type":"table_column","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,434],[1775,434],[1775,487],[244,487]],"region":{"top_left_x":244,"top_left_y":433,"width":1532,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bdd012f8da0344d392cdb329fc5de06c","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,484],[1775,484],[1775,535],[244,535]],"region":{"top_left_x":244,"top_left_y":484,"width":1532,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0df250be8b384a84990eaa60a3087ac2","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,535],[1775,535],[1775,583],[244,583]],"region":{"top_left_x":244,"top_left_y":534,"width":1532,"height":50},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d246e7eddaa4e38866ed44e45139614","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,586],[1775,586],[1775,634],[244,634]],"region":{"top_left_x":244,"top_left_y":585,"width":1532,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7dee9696025647c98aa4ffe12cba3211","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,634],[1775,634],[1775,689],[244,689]],"region":{"top_left_x":244,"top_left_y":633,"width":1532,"height":57},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7dbb379e221946f0950a26e35b996511","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,682],[1775,682],[1775,979],[244,979]],"region":{"top_left_x":244,"top_left_y":682,"width":1532,"height":298},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8bba0cf5770423e9bd1c03f63d7813a","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,970],[1775,970],[1775,1025],[244,1025]],"region":{"top_left_x":244,"top_left_y":970,"width":1532,"height":56},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"015d2aec37964d77b58dfeeabe97d939","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,1018],[1775,1018],[1775,1216],[244,1216]],"region":{"top_left_x":244,"top_left_y":1018,"width":1532,"height":199},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d0822e7f2b940d393e72f8f72566896","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,1210],[1775,1210],[1775,1560],[244,1560]],"region":{"top_left_x":244,"top_left_y":1209,"width":1532,"height":351},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72d13d0bdada4038bf28e70c76b167eb","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,1553],[1775,1553],[1775,1804],[244,1804]],"region":{"top_left_x":244,"top_left_y":1552,"width":1532,"height":252},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eaefc6fa98ab49df82908e175a59eb07","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,1794],[1775,1794],[1775,1845],[244,1845]],"region":{"top_left_x":244,"top_left_y":1794,"width":1532,"height":52},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2a3b88eb8d34fd79194585b9ced1e68","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,1843],[1775,1843],[1775,1896],[244,1896]],"region":{"top_left_x":244,"top_left_y":1842,"width":1532,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17c1ddcb333d4bb59141de7f6c03cf32","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,1891],[1775,1891],[1775,2186],[244,2186]],"region":{"top_left_x":244,"top_left_y":1891,"width":1532,"height":295},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b63b9e4037240a983119be59f045144","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,2179],[1775,2179],[1775,2227],[244,2227]],"region":{"top_left_x":244,"top_left_y":2178,"width":1532,"height":50},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"576d8895c92b48f68816601975d37225","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,2227],[1775,2227],[1775,2280],[244,2280]],"region":{"top_left_x":244,"top_left_y":2227,"width":1532,"height":54},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b26da27dbcc84b5e8409dceec0de57c8","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[244,2277],[1775,2274],[1775,2333],[244,2337]],"region":{"top_left_x":243,"top_left_y":2274,"width":1533,"height":63},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a58e55a4253d4e558863c23d5b0805f2","type":"table_row","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":""},{"cnt":[[262,438],[792,438],[792,482],[262,482]],"region":{"top_left_x":262,"top_left_y":438,"width":530,"height":44},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d55c980d7bd463cb3b673d76bfeaf8f","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Number of CTP modification","text_display":"Number of CTP modification","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[932,429],[969,429],[969,480],[932,480]],"region":{"top_left_x":932,"top_left_y":429,"width":38,"height":51},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1648a8ebaaa47119e1c45c3146a608f","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"1","text_display":"1","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,489],[730,489],[730,530],[262,530]],"region":{"top_left_x":262,"top_left_y":488,"width":468,"height":43},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a289d4a761640689e25942c00b5e24a","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Date of CTP modification","text_display":"Date of CTP modification","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,489],[1225,489],[1225,530],[939,530]],"region":{"top_left_x":939,"top_left_y":488,"width":286,"height":43},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2bb72eada5c429d8f72c603b580cf47","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"24 October 2013","text_display":"24 October 2013","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,540],[596,540],[596,579],[265,579]],"region":{"top_left_x":264,"top_left_y":539,"width":333,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"347def2e5f1143698c68ddbe2d1d267d","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"EudraCT number","text_display":"EudraCT number","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,540],[1223,540],[1223,579],[939,579]],"region":{"top_left_x":939,"top_left_y":539,"width":284,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e92168770a445abb9d6580ed65eb238","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"2011-004148-23","text_display":"2011-004148-23","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,590],[569,590],[569,629],[265,629]],"region":{"top_left_x":264,"top_left_y":590,"width":305,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dac35f500de54e5e9c96c59141a1a593","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"BI Trial number","text_display":"BI Trial number","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,590],[1082,590],[1082,629],[939,629]],"region":{"top_left_x":939,"top_left_y":590,"width":144,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"704fa44e4f9346e195c90cf525a0ae9a","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"1218.22","text_display":"1218.22","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,641],[790,641],[790,689],[265,689]],"region":{"top_left_x":264,"top_left_y":640,"width":526,"height":50},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ce7fd3aa64f4954889585aa71856276","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"BI Investigational Product(s)","text_display":"BI Investigational Product(s)","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,636],[1305,636],[1305,685],[939,685]],"region":{"top_left_x":939,"top_left_y":636,"width":367,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81766f0c030a4fb28a1b435dd9fc5894","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Linagliptin (BI 1356)","text_display":"Linagliptin (BI 1356)","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,689],[559,689],[559,735],[262,735]],"region":{"top_left_x":262,"top_left_y":689,"width":298,"height":47},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25acbc5574ab4210b8c10031b9a76e40","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Title of protocol","text_display":"Title of protocol","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999778002237774},{"cnt":[[935,682],[1750,682],[1750,977],[935,977]],"region":{"top_left_x":934,"top_left_y":682,"width":816,"height":295},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ffbad228b90d48e48ff2c4f74e356723","type":"complex_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","children_ids":["91086571bf08423784a81cf99f3f5488","a662a4274873461298e7564093747781","228efafd444f44df8c7d354a1999a0d6","d96b412d3be946fe9c7e28249a83da63","a75d23eca1484f9bbc8e15f1afa714ce","f04b0a1acaaa489ba637592e401353ab"],"text":"A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA","text_display":"A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,687],[1637,687],[1637,735],[939,735]],"region":{"top_left_x":939,"top_left_y":686,"width":699,"height":50},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91086571bf08423784a81cf99f3f5488","type":"text","conversion_output":false,"parent_id":"ffbad228b90d48e48ff2c4f74e356723","text":"A multicenter, international, randomized,","text_display":"A multicenter, international, randomized,","confidence":1,"confidence_rate":1},{"cnt":[[939,733],[1748,733],[1748,784],[939,784]],"region":{"top_left_x":939,"top_left_y":732,"width":809,"height":52},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a662a4274873461298e7564093747781","type":"text","conversion_output":false,"parent_id":"ffbad228b90d48e48ff2c4f74e356723","text":"parallel group, double-blind, placebo-controlled","text_display":" parallel group, double-blind, placebo-controlled","confidence":1,"confidence_rate":1},{"cnt":[[939,784],[1738,784],[1738,830],[939,830]],"region":{"top_left_x":939,"top_left_y":783,"width":800,"height":47},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"228efafd444f44df8c7d354a1999a0d6","type":"text","conversion_output":false,"parent_id":"ffbad228b90d48e48ff2c4f74e356723","text":"CArdiovascular Safety \\& Renal Microvascular","text_display":" CArdiovascular Safety \\& Renal Microvascular","confidence":1,"confidence_rate":1},{"cnt":[[939,830],[1701,830],[1701,878],[939,878]],"region":{"top_left_x":939,"top_left_y":829,"width":763,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d96b412d3be946fe9c7e28249a83da63","type":"text","conversion_output":false,"parent_id":"ffbad228b90d48e48ff2c4f74e356723","text":"outcomE study with LINAgliptin, 5 mg once","text_display":" outcomE study with LINAgliptin, 5 mg once","confidence":1,"confidence_rate":1},{"cnt":[[939,878],[1743,878],[1743,929],[939,929]],"region":{"top_left_x":939,"top_left_y":877,"width":804,"height":52},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a75d23eca1484f9bbc8e15f1afa714ce","type":"text","conversion_output":false,"parent_id":"ffbad228b90d48e48ff2c4f74e356723","text":"daily in patients with type 2 diabetes mellitus at","text_display":" daily in patients with type 2 diabetes mellitus at","confidence":1,"confidence_rate":1},{"cnt":[[939,926],[1513,926],[1513,975],[939,975]],"region":{"top_left_x":939,"top_left_y":926,"width":574,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f04b0a1acaaa489ba637592e401353ab","type":"text","conversion_output":false,"parent_id":"ffbad228b90d48e48ff2c4f74e356723","text":"high vascular risk. CARMELINA","text_display":" high vascular risk. CARMELINA","confidence":1,"confidence_rate":1},{"cnt":[[817,965],[1655,967],[1708,970],[1752,972],[1768,974],[1768,1018],[1765,1020],[932,1027],[838,1027],[255,1023],[248,1020],[248,1002],[250,974],[255,970],[292,967],[815,965]],"region":{"top_left_x":248,"top_left_y":965,"width":1520,"height":62},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23dca678b96f437f879b1fe0a139f1c5","type":"table_spanning_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":"","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[258,1023],[799,1023],[799,1214],[258,1214]],"region":{"top_left_x":257,"top_left_y":1023,"width":542,"height":192},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c1bc591733a4e0aa4c2c049dd77eaa9","type":"complex_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","children_ids":["a104b7badaca41fa9a7a219bb34e285f","cbdee41af78d470798244c8bf03ded85","c8f7d794c300489b9bb565de47728738","882fcad2d7cb456783e5c62b8c816283"],"text":"To be implemented only after approval of the IRB/IEC/Competent Authorities","text_display":"To be implemented only after approval of the IRB/IEC/Competent Authorities","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,1028],[799,1028],[799,1076],[262,1076]],"region":{"top_left_x":262,"top_left_y":1027,"width":537,"height":50},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a104b7badaca41fa9a7a219bb34e285f","type":"text","conversion_output":false,"parent_id":"5c1bc591733a4e0aa4c2c049dd77eaa9","text":"To be implemented only after","text_display":"To be implemented only after","confidence":1,"confidence_rate":1},{"cnt":[[262,1076],[543,1076],[543,1122],[262,1122]],"region":{"top_left_x":262,"top_left_y":1076,"width":282,"height":47},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cbdee41af78d470798244c8bf03ded85","type":"text","conversion_output":false,"parent_id":"5c1bc591733a4e0aa4c2c049dd77eaa9","text":"approval of the","text_display":" approval of the","confidence":1,"confidence_rate":1},{"cnt":[[262,1124],[642,1124],[642,1173],[262,1173]],"region":{"top_left_x":262,"top_left_y":1124,"width":381,"height":49},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8f7d794c300489b9bb565de47728738","type":"text","conversion_output":false,"parent_id":"5c1bc591733a4e0aa4c2c049dd77eaa9","text":"IRB/IEC/Competent","text_display":" IRB/IEC/Competent","confidence":1,"confidence_rate":1},{"cnt":[[262,1170],[474,1170],[474,1210],[262,1210]],"region":{"top_left_x":262,"top_left_y":1170,"width":213,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"882fcad2d7cb456783e5c62b8c816283","type":"text","conversion_output":false,"parent_id":"5c1bc591733a4e0aa4c2c049dd77eaa9","text":"Authorities","text_display":" Authorities","confidence":1,"confidence_rate":1},{"cnt":[[939,1021],[997,1021],[997,1078],[939,1078]],"region":{"top_left_x":939,"top_left_y":1020,"width":58,"height":59},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b8e9769c3ce4f25b016cc8819b8a6d5","type":"complex_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","children_ids":["b622a0851cc3499a8ce1bc40756a6f9b"],"text":"![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-082.jpg?height=51\\&width=56\\&top_left_y=1023\\&top_left_x=939)","text_display":"![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-082.jpg?height=51\\&width=56\\&top_left_y=1023\\&top_left_x=939)","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0,"confidence_rate":0},{"cnt":[[939,1023],[995,1023],[995,1074],[939,1074]],"region":{"top_left_x":939,"top_left_y":1023,"width":56,"height":51},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b622a0851cc3499a8ce1bc40756a6f9b","type":"diagram","conversion_output":false,"parent_id":"1b8e9769c3ce4f25b016cc8819b8a6d5","text":"","text_display":"![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-082.jpg?height=51\\&width=56\\&top_left_y=1023\\&top_left_x=939)"},{"cnt":[[258,1216],[748,1216],[748,1560],[258,1560]],"region":{"top_left_x":257,"top_left_y":1216,"width":492,"height":344},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a06c033c7ea24f2390611c2574236215","type":"complex_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","children_ids":["b02ce37db1b943aba2a99847395cff37","7e00728988d4422ea6dea08f054d66f9","607e2c91e4d94cd9b46a161c4ae1c618","3611f3ddb8ad403286ef4fc01df765c2","509e3674c6c445e5a1c140016e89a04c","16fd2ed863494329b904e3366cf021e5","0d84e5ffd9a2408d86c6681c16d5b391"],"text":"To be implemented immediately in order to eliminate hazard IRB / IEC / Competent Authority to be notified of change with request for approval","text_display":"To be implemented immediately in order to eliminate hazard IRB / IEC / Competent Authority to be notified of change with request for approval","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,1221],[615,1221],[615,1269],[262,1269]],"region":{"top_left_x":262,"top_left_y":1221,"width":353,"height":49},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b02ce37db1b943aba2a99847395cff37","type":"text","conversion_output":false,"parent_id":"a06c033c7ea24f2390611c2574236215","text":"To be implemented","text_display":"To be implemented","confidence":1,"confidence_rate":1},{"cnt":[[262,1267],[693,1267],[693,1315],[262,1315]],"region":{"top_left_x":262,"top_left_y":1267,"width":431,"height":49},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e00728988d4422ea6dea08f054d66f9","type":"text","conversion_output":false,"parent_id":"a06c033c7ea24f2390611c2574236215","text":"immediately in order to","text_display":" immediately in order to","confidence":1,"confidence_rate":1},{"cnt":[[262,1315],[605,1315],[605,1357],[262,1357]],"region":{"top_left_x":262,"top_left_y":1315,"width":344,"height":42},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"607e2c91e4d94cd9b46a161c4ae1c618","type":"text","conversion_output":false,"parent_id":"a06c033c7ea24f2390611c2574236215","text":"eliminate hazard -","text_display":" eliminate hazard ","confidence":1,"confidence_rate":1},{"cnt":[[262,1364],[684,1364],[684,1412],[262,1412]],"region":{"top_left_x":262,"top_left_y":1363,"width":422,"height":50},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3611f3ddb8ad403286ef4fc01df765c2","type":"text","conversion_output":false,"parent_id":"a06c033c7ea24f2390611c2574236215","text":"IRB / IEC / Competent","text_display":"IRB / IEC / Competent","confidence":1,"confidence_rate":1},{"cnt":[[262,1412],[744,1412],[744,1463],[262,1463]],"region":{"top_left_x":262,"top_left_y":1412,"width":482,"height":51},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"509e3674c6c445e5a1c140016e89a04c","type":"text","conversion_output":false,"parent_id":"a06c033c7ea24f2390611c2574236215","text":"Authority to be notified of","text_display":" Authority to be notified of","confidence":1,"confidence_rate":1},{"cnt":[[262,1461],[693,1461],[693,1509],[262,1509]],"region":{"top_left_x":262,"top_left_y":1460,"width":431,"height":49},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16fd2ed863494329b904e3366cf021e5","type":"text","conversion_output":false,"parent_id":"a06c033c7ea24f2390611c2574236215","text":"change with request for","text_display":" change with request for","confidence":1,"confidence_rate":1},{"cnt":[[262,1507],[435,1507],[435,1555],[262,1555]],"region":{"top_left_x":262,"top_left_y":1506,"width":174,"height":49},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d84e5ffd9a2408d86c6681c16d5b391","type":"text","conversion_output":false,"parent_id":"a06c033c7ea24f2390611c2574236215","text":"approval","text_display":" approval","confidence":1,"confidence_rate":1},{"cnt":[[939,1214],[995,1214],[995,1267],[939,1267]],"region":{"top_left_x":939,"top_left_y":1214,"width":56,"height":54},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f89fd56839ed44af8c3b71418101f991","type":"complex_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","children_ids":["9bf4ce299ace4c5f81a63c5917bbe713"],"text":"□","text_display":"□","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0,"confidence_rate":0},{"cnt":[[944,1216],[995,1216],[995,1267],[944,1267]],"region":{"top_left_x":943,"top_left_y":1216,"width":52,"height":52},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9bf4ce299ace4c5f81a63c5917bbe713","type":"form_field","conversion_output":false,"parent_id":"f89fd56839ed44af8c3b71418101f991","text":"","text_display":"□","subtype":"checkbox"},{"cnt":[[258,1555],[822,1555],[822,1801],[258,1801]],"region":{"top_left_x":257,"top_left_y":1554,"width":565,"height":248},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e699c2e1de44261a69c835ac516ebf4","type":"complex_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","children_ids":["55ff745706a5468ea50b4dac22f17584","4195eb3643844960ad3edf30c0b9f570","f6b9c33d8778446e9c5dd04ee46b28ea","d644088693c2458781a4546cd12b0069","2148b16a96444266a6ec06b47805987c"],"text":"Can be implemented without IRB/IEC/ Competent Authority approval as changes involve logistical or administrative aspects only","text_display":"Can be implemented without IRB/IEC/ Competent Authority approval as changes involve logistical or administrative aspects only","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9907412528991699,"confidence_rate":0.99991911739537},{"cnt":[[262,1557],[790,1557],[790,1606],[262,1606]],"region":{"top_left_x":262,"top_left_y":1557,"width":528,"height":49},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55ff745706a5468ea50b4dac22f17584","type":"text","conversion_output":false,"parent_id":"6e699c2e1de44261a69c835ac516ebf4","text":"Can be implemented without","text_display":"Can be implemented without","confidence":1,"confidence_rate":1},{"cnt":[[262,1603],[652,1603],[652,1652],[262,1652]],"region":{"top_left_x":262,"top_left_y":1603,"width":390,"height":49},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4195eb3643844960ad3edf30c0b9f570","type":"text","conversion_output":false,"parent_id":"6e699c2e1de44261a69c835ac516ebf4","text":"IRB/IEC/ Competent","text_display":" IRB/IEC/ Competent","confidence":0.9907412528991699,"confidence_rate":0.9995956523915162},{"cnt":[[262,1654],[817,1654],[817,1702],[262,1702]],"region":{"top_left_x":262,"top_left_y":1653,"width":556,"height":50},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6b9c33d8778446e9c5dd04ee46b28ea","type":"text","conversion_output":false,"parent_id":"6e699c2e1de44261a69c835ac516ebf4","text":"Authority approval as changes","text_display":" Authority approval as changes","confidence":1,"confidence_rate":1},{"cnt":[[262,1700],[619,1700],[619,1748],[262,1748]],"region":{"top_left_x":262,"top_left_y":1699,"width":358,"height":50},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d644088693c2458781a4546cd12b0069","type":"text","conversion_output":false,"parent_id":"6e699c2e1de44261a69c835ac516ebf4","text":"involve logistical or","text_display":" involve logistical or","confidence":1,"confidence_rate":1},{"cnt":[[262,1748],[755,1748],[755,1799],[262,1799]],"region":{"top_left_x":262,"top_left_y":1748,"width":494,"height":51},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2148b16a96444266a6ec06b47805987c","type":"text","conversion_output":false,"parent_id":"6e699c2e1de44261a69c835ac516ebf4","text":"administrative aspects only","text_display":" administrative aspects only","confidence":1,"confidence_rate":1},{"cnt":[[939,1548],[995,1548],[995,1608],[939,1608]],"region":{"top_left_x":939,"top_left_y":1548,"width":56,"height":60},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec479dc8d42d491cb037c45b28f0de25","type":"complex_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","children_ids":["1a06a9d35a164f3fa2555a3ee5de0bd1"],"text":"□","text_display":"□","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0,"confidence_rate":0},{"cnt":[[939,1548],[995,1548],[995,1608],[939,1608]],"region":{"top_left_x":939,"top_left_y":1548,"width":56,"height":60},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a06a9d35a164f3fa2555a3ee5de0bd1","type":"form_field","conversion_output":false,"parent_id":"ec479dc8d42d491cb037c45b28f0de25","text":"","text_display":"□","subtype":"checkbox"},{"cnt":[[249,1794],[1768,1794],[1768,1845],[249,1845]],"region":{"top_left_x":248,"top_left_y":1794,"width":1521,"height":52},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3cfd95f8a57b49dba55d5bc65f3f97f8","type":"table_spanning_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"","text_display":"","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[262,1847],[596,1847],[596,1891],[262,1891]],"region":{"top_left_x":262,"top_left_y":1847,"width":335,"height":45},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ea655b988314e7e9490589126fcef34","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Section to be changed","text_display":"Section to be changed","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1847],[1577,1847],[1577,1891],[939,1891]],"region":{"top_left_x":939,"top_left_y":1847,"width":639,"height":45},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2d14be2eca54840a4099aa998c15d64","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Clinical trial protocol synopsis (objectives)","text_display":"Clinical trial protocol synopsis (objectives)","cell_row":11,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,1898],[596,1898],[596,1942],[262,1942]],"region":{"top_left_x":262,"top_left_y":1897,"width":335,"height":45},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"472e619e27404a06aebefc850f8220ad","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Description of change","text_display":"Description of change","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[932,1893],[1757,1893],[1757,2184],[932,2184]],"region":{"top_left_x":932,"top_left_y":1893,"width":825,"height":291},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c84b13212ec145709148bbf15b2fcac1","type":"complex_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","children_ids":["d425fc240d66465f895cfcd723821099","b17cfe20a2a44e5182468d621b0c6de7","1c7fc2820aaa4af98f1686fe7a2e97a6","28d4710dbd174949b878325f00af46b5","e5776bd43cde4ab387d47900b208b9ea"],"text":"\\begin{tabular}{l}\n....sustained loss in estimated global filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline... \\\\\nWas changed into: \\\\\n....sustained decrease in estimated global filtration rate \\(( eGFR ) \\geq 50 \\%\\) from baseline...\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n....sustained loss in estimated global filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline... \\\\\nWas changed into: \\\\\n....sustained decrease in estimated global filtration rate \\(( eGFR ) \\geq 50 \\%\\) from baseline...\n\\end{tabular}","cell_row":12,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.5905577447265387,"confidence_rate":0.9962169003677258},{"cnt":[[939,1898],[1750,1898],[1750,1942],[939,1942]],"region":{"top_left_x":939,"top_left_y":1897,"width":811,"height":45},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d425fc240d66465f895cfcd723821099","type":"text","conversion_output":false,"parent_id":"c84b13212ec145709148bbf15b2fcac1","text":"....sustained loss in estimated global filtration rate (eGFR)","text_display":"....sustained loss in estimated global filtration rate (eGFR)","confidence":1,"confidence_rate":1},{"cnt":[[939,1935],[1269,1935],[1269,1979],[939,1979]],"region":{"top_left_x":939,"top_left_y":1934,"width":330,"height":45},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b17cfe20a2a44e5182468d621b0c6de7","type":"text","conversion_output":false,"parent_id":"c84b13212ec145709148bbf15b2fcac1","text":"\\(\\geq 50 \\%\\) from baseline...","text_display":" \\(\\geq 50 \\%\\) from baseline...","confidence":0.986328125,"confidence_rate":0.9994495037481272},{"cnt":[[939,2018],[1204,2018],[1204,2061],[939,2061]],"region":{"top_left_x":939,"top_left_y":2017,"width":266,"height":45},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c7fc2820aaa4af98f1686fe7a2e97a6","type":"text","conversion_output":false,"parent_id":"c84b13212ec145709148bbf15b2fcac1","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.93798828125,"confidence_rate":0.9970943285952549},{"cnt":[[939,2101],[1704,2101],[1704,2144],[939,2144]],"region":{"top_left_x":939,"top_left_y":2100,"width":765,"height":45},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"28d4710dbd174949b878325f00af46b5","type":"text","conversion_output":false,"parent_id":"c84b13212ec145709148bbf15b2fcac1","text":"....sustained decrease in estimated global filtration rate","text_display":"\n....sustained decrease in estimated global filtration rate","confidence":1,"confidence_rate":1},{"cnt":[[939,2137],[1393,2137],[1393,2181],[939,2181]],"region":{"top_left_x":939,"top_left_y":2137,"width":454,"height":45},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5776bd43cde4ab387d47900b208b9ea","type":"text","conversion_output":false,"parent_id":"c84b13212ec145709148bbf15b2fcac1","text":"\\(( eGFR ) \\geq 50 \\%\\) from baseline...","text_display":" \\(( eGFR ) \\geq 50 \\%\\) from baseline...","confidence":0.5905577447265387,"confidence_rate":0.9846285462205965},{"cnt":[[265,2181],[582,2181],[582,2223],[265,2223]],"region":{"top_left_x":264,"top_left_y":2181,"width":319,"height":42},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af17c411c74b4e24970f90ff13d639da","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Rationale for change","text_display":"Rationale for change","cell_row":13,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2181],[1370,2181],[1370,2223],[939,2223]],"region":{"top_left_x":939,"top_left_y":2181,"width":431,"height":42},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0b663e7674b4952979f84ffa7c138c8","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"To use consistent terminology","text_display":"To use consistent terminology","cell_row":13,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,2230],[596,2230],[596,2273],[262,2273]],"region":{"top_left_x":262,"top_left_y":2229,"width":335,"height":45},"line":84,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a41afdab56aa40d4b99d7adb57d15111","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Section to be changed","text_display":"Section to be changed","cell_row":14,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2230],[1720,2230],[1720,2276],[939,2276]],"region":{"top_left_x":939,"top_left_y":2229,"width":781,"height":47},"line":85,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d5381af7803f41ecb8cf6c169c0c28f5","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Clinical trial protocol synopsis (criteria for efficacy)","text_display":"Clinical trial protocol synopsis (criteria for efficacy)","cell_row":14,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,2285],[596,2285],[596,2329],[262,2329]],"region":{"top_left_x":262,"top_left_y":2284,"width":335,"height":45},"line":86,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f634a65538294057a7c843fa1bd569c3","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Description of change","text_display":"Description of change","cell_row":15,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2285],[1094,2285],[1094,2329],[939,2329]],"region":{"top_left_x":939,"top_left_y":2284,"width":155,"height":45},"line":87,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"82429da862e34702b3abddcd3b760fb7","type":"simple_cell","conversion_output":false,"parent_id":"cbb0f9c2c27e43fc9fe0e3c467ad5e8c","text":"Change 1:","text_display":"Change 1:","cell_row":15,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[793,2581],[1300,2581],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2581,"width":508,"height":40},"line":88,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"545035e8b74d4369ad7241cbe28a84dd","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":89,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e20c0cc56a974f4fac2e1898d0edca98","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":90,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"09d4bd5bae324f90a7f4b5881bde3c07","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-083","page":83,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a02dbe5775b6420bbbee2a9b19f749e4","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0867adc23b74565aa397c991ba75117","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf9cefc8ef694cf38d712697c57bcb04","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,210],[637,210],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":210,"width":396,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e5e685bcaa24f4bb56b77673215c433","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b32c343e55a04a1f8060e897957dd252","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"783eba0ae76a4417a89e0fa6c1c0e354","type":"page_info","conversion_output":false,"text":"Page 83 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1775,331],[1775,2554],[242,2554]],"region":{"top_left_x":242,"top_left_y":331,"width":1533,"height":2223},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0c317852e72432b836c6e3fd0797bb5","type":"table","conversion_output":true,"children_ids":["9637689d98fd46c7936f7b8bc0f3f83e","a1adde2e7e854c5ea36458a48a8cd69f","611abb22c3cb4d66a35ec85e3110435d","51a2bbb4668a4b919dc8deaae36feea4","d8a4c71af07842eb9c2cd40cbc6ab99a","37e33753b1594c48a91f87c6b0ad56e8","8bed652da7af4cba9d8ebbfef3095a0b","92705c5520bb428cbe8f7ce9997dfaeb","5dc2eb5dc1124286a3e123a1a6223768","e81f0d8aecd448089d3957af39558c48","57e637a5fb9b4f1c89f62c032e7f1ae5","6e8184d901894d8db93153a6961b9ae1"],"text":"\\begin{tabular}{|l|l|}\n\\hline Description of change & \\multirow[b]{2}{*}{\\begin{tabular}{l}\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo use consistent terminology. \\\\\nChange 4: \\\\\nTo clarify that endpoint event definitions are outlined in the CEC charters.\n\\end{tabular}} \\\\\n\\hline & \\\\\n\\hline Section to be changed & Clinical trial protocol synopsis (statistical methods) \\\\\n\\hline Description of change & \\begin{tabular}{l}\nb) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated GFR \\(\\geq 50 \\%\\) from baseline) \\\\\nwas changed into:\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Description of change & \\multirow[b]{2}{*}{\\begin{tabular}{l}\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo use consistent terminology. \\\\\nChange 4: \\\\\nTo clarify that endpoint event definitions are outlined in the CEC charters.\n\\end{tabular}} \\\\\n\\hline & \\\\\n\\hline Section to be changed & Clinical trial protocol synopsis (statistical methods) \\\\\n\\hline Description of change & \\begin{tabular}{l}\nb) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated GFR \\(\\geq 50 \\%\\) from baseline) \\\\\nwas changed into:\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.8875299574574456,"confidence_rate":0.9998890334290044},{"cnt":[[240,331],[599,331],[602,2553],[243,2553]],"region":{"top_left_x":240,"top_left_y":330,"width":362,"height":2223},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9637689d98fd46c7936f7b8bc0f3f83e","type":"table_column","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"","text_display":""},{"cnt":[[926,331],[1746,331],[1746,2553],[926,2553]],"region":{"top_left_x":925,"top_left_y":331,"width":821,"height":2222},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a1adde2e7e854c5ea36458a48a8cd69f","type":"table_column","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"","text_display":""},{"cnt":[[242,333],[1775,333],[1775,384],[242,384]],"region":{"top_left_x":242,"top_left_y":333,"width":1534,"height":51},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"611abb22c3cb4d66a35ec85e3110435d","type":"table_row","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"","text_display":""},{"cnt":[[242,1929],[1775,1929],[1775,2297],[242,2297]],"region":{"top_left_x":242,"top_left_y":1928,"width":1534,"height":370},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51a2bbb4668a4b919dc8deaae36feea4","type":"table_row","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"","text_display":""},{"cnt":[[242,2297],[1773,2297],[1773,2343],[242,2343]],"region":{"top_left_x":242,"top_left_y":2297,"width":1532,"height":47},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8a4c71af07842eb9c2cd40cbc6ab99a","type":"table_row","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"","text_display":""},{"cnt":[[242,2346],[1775,2346],[1775,2553],[242,2553]],"region":{"top_left_x":242,"top_left_y":2345,"width":1534,"height":208},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37e33753b1594c48a91f87c6b0ad56e8","type":"table_row","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"","text_display":""},{"cnt":[[265,340],[594,340],[594,382],[265,382]],"region":{"top_left_x":265,"top_left_y":340,"width":330,"height":42},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8bed652da7af4cba9d8ebbfef3095a0b","type":"simple_cell","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"Description of change","text_display":"Description of change","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[940,2300],[942,330],[1743,331],[1740,2301]],"region":{"top_left_x":939,"top_left_y":330,"width":804,"height":1971},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92705c5520bb428cbe8f7ce9997dfaeb","type":"table_spanning_cell","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","children_ids":["f385cb86557649e694ff9ebc583bab35"],"text":"","text_display":"\\begin{tabular}{l}\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo use consistent terminology. \\\\\nChange 4: \\\\\nTo clarify that endpoint event definitions are outlined in the CEC charters.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":2,"cell_col_span":1},{"cnt":[[937,1938],[1729,1938],[1729,2297],[937,2297]],"region":{"top_left_x":937,"top_left_y":1938,"width":793,"height":360},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f385cb86557649e694ff9ebc583bab35","type":"complex_cell","conversion_output":false,"parent_id":"92705c5520bb428cbe8f7ce9997dfaeb","children_ids":["6cdec184a5904099b78c07b97d1c200a","aea9b3c9819e4b3a98b758a9cebee81f","eaa6a8b510334426b63c9fb5647caf45","ed8329e5a6c9408aa273c63f025239c4","f667b4467f08442488927ddd2b017dcf","c6c1e5ae6b9546a8aa33d300f5159853","730a5dc2f2194f83ba1211e5f97932e8"],"text":"\\begin{tabular}{l}\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo use consistent terminology. \\\\\nChange 4: \\\\\nTo clarify that endpoint event definitions are outlined in the CEC charters.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo use consistent terminology. \\\\\nChange 4: \\\\\nTo clarify that endpoint event definitions are outlined in the CEC charters.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":2,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[942,1943],[1087,1943],[1087,1980],[942,1980]],"region":{"top_left_x":941,"top_left_y":1942,"width":147,"height":38},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6cdec184a5904099b78c07b97d1c200a","type":"text","conversion_output":false,"parent_id":"f385cb86557649e694ff9ebc583bab35","text":"Change 2:","text_display":"Change 2:","confidence":1,"confidence_rate":1},{"cnt":[[942,1980],[1179,1980],[1179,2014],[942,2014]],"region":{"top_left_x":941,"top_left_y":1979,"width":239,"height":36},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aea9b3c9819e4b3a98b758a9cebee81f","type":"text","conversion_output":false,"parent_id":"f385cb86557649e694ff9ebc583bab35","text":"For clarification.","text_display":"\nFor clarification.","confidence":1,"confidence_rate":1},{"cnt":[[942,2058],[1087,2058],[1087,2102],[942,2102]],"region":{"top_left_x":941,"top_left_y":2057,"width":147,"height":45},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eaa6a8b510334426b63c9fb5647caf45","type":"text","conversion_output":false,"parent_id":"f385cb86557649e694ff9ebc583bab35","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[942,2099],[1373,2099],[1373,2138],[942,2138]],"region":{"top_left_x":941,"top_left_y":2099,"width":432,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed8329e5a6c9408aa273c63f025239c4","type":"text","conversion_output":false,"parent_id":"f385cb86557649e694ff9ebc583bab35","text":"To use consistent terminology.","text_display":"\nTo use consistent terminology.","confidence":1,"confidence_rate":1},{"cnt":[[942,2178],[1087,2178],[1087,2219],[942,2219]],"region":{"top_left_x":941,"top_left_y":2177,"width":147,"height":43},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f667b4467f08442488927ddd2b017dcf","type":"text","conversion_output":false,"parent_id":"f385cb86557649e694ff9ebc583bab35","text":"Change 4:","text_display":"\nChange 4:","confidence":1,"confidence_rate":1},{"cnt":[[942,2219],[1723,2219],[1723,2258],[942,2258]],"region":{"top_left_x":941,"top_left_y":2219,"width":782,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6c1e5ae6b9546a8aa33d300f5159853","type":"text","conversion_output":false,"parent_id":"f385cb86557649e694ff9ebc583bab35","text":"To clarify that endpoint event definitions are outlined in","text_display":"\nTo clarify that endpoint event definitions are outlined in","confidence":1,"confidence_rate":1},{"cnt":[[942,2260],[1188,2260],[1188,2295],[942,2295]],"region":{"top_left_x":941,"top_left_y":2260,"width":248,"height":36},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"730a5dc2f2194f83ba1211e5f97932e8","type":"text","conversion_output":false,"parent_id":"f385cb86557649e694ff9ebc583bab35","text":"the CEC charters.","text_display":" the CEC charters.","confidence":1,"confidence_rate":1},{"cnt":[[265,2302],[594,2302],[594,2341],[265,2341]],"region":{"top_left_x":265,"top_left_y":2301,"width":330,"height":41},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5dc2eb5dc1124286a3e123a1a6223768","type":"simple_cell","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[942,2302],[1704,2302],[1704,2341],[942,2341]],"region":{"top_left_x":941,"top_left_y":2301,"width":764,"height":41},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e81f0d8aecd448089d3957af39558c48","type":"simple_cell","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"Clinical trial protocol synopsis (statistical methods)","text_display":"Clinical trial protocol synopsis (statistical methods)","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,2353],[594,2353],[594,2392],[265,2392]],"region":{"top_left_x":265,"top_left_y":2352,"width":330,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57e637a5fb9b4f1c89f62c032e7f1ae5","type":"simple_cell","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,2348],[1741,2348],[1741,2548],[937,2548]],"region":{"top_left_x":937,"top_left_y":2347,"width":804,"height":202},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e8184d901894d8db93153a6961b9ae1","type":"complex_cell","conversion_output":false,"parent_id":"a0c317852e72432b836c6e3fd0797bb5","children_ids":["8c19f0d2358e4d22ae6cabbdd0ef18de","8cdb07ad24654cf6b05391b21ce1e551","d3bf5b2f1079470c84b11a2754904375","a38f011863554825ad3bd4a0c7af601c"],"text":"\\begin{tabular}{l}\nb) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated GFR \\(\\geq 50 \\%\\) from baseline) \\\\\nwas changed into:\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nb) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated GFR \\(\\geq 50 \\%\\) from baseline) \\\\\nwas changed into:\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.8875299574574456,"confidence_rate":0.9994452902671577},{"cnt":[[937,2353],[1617,2353],[1617,2392],[937,2392]],"region":{"top_left_x":937,"top_left_y":2352,"width":680,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c19f0d2358e4d22ae6cabbdd0ef18de","type":"text","conversion_output":false,"parent_id":"6e8184d901894d8db93153a6961b9ae1","text":"b) the composite renal endpoint (i.e. renal death,","text_display":"b) the composite renal endpoint (i.e. renal death,","confidence":1,"confidence_rate":1},{"cnt":[[940,2389],[1736,2389],[1736,2433],[940,2433]],"region":{"top_left_x":939,"top_left_y":2389,"width":798,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8cdb07ad24654cf6b05391b21ce1e551","type":"text","conversion_output":false,"parent_id":"6e8184d901894d8db93153a6961b9ae1","text":"sustained ESRD, sustained loss in estimated GFR \\(\\geq 50 \\%\\)","text_display":" sustained ESRD, sustained loss in estimated GFR \\(\\geq 50 \\%\\)","confidence":0.8875299574574456,"confidence_rate":0.9978716787493889},{"cnt":[[937,2431],[1147,2431],[1147,2470],[937,2470]],"region":{"top_left_x":937,"top_left_y":2430,"width":210,"height":41},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3bf5b2f1079470c84b11a2754904375","type":"text","conversion_output":false,"parent_id":"6e8184d901894d8db93153a6961b9ae1","text":"from baseline)","text_display":" from baseline)","confidence":1,"confidence_rate":1},{"cnt":[[942,2509],[1198,2509],[1198,2548],[942,2548]],"region":{"top_left_x":941,"top_left_y":2509,"width":257,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a38f011863554825ad3bd4a0c7af601c","type":"text","conversion_output":false,"parent_id":"6e8184d901894d8db93153a6961b9ae1","text":"was changed into:","text_display":"\nwas changed into:","confidence":0.998046875,"confidence_rate":0.9999111387285874},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":32,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d20f6f24104343a9a79d095b63487ae7","type":"section_header","conversion_output":false,"children_ids":["0760f8022e3d4417806cf4d760e61bb8"],"text":"","text_display":""},{"cnt":[[790,2586],[1300,2586],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2585,"width":510,"height":36},"line":33,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0760f8022e3d4417806cf4d760e61bb8","type":"text","conversion_output":true,"parent_id":"d20f6f24104343a9a79d095b63487ae7","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99609375,"confidence_rate":0.9999068162627995},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":34,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"28284c96d14b4aeea7c523173316da98","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":35,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3684cdca13e44664b61ce4a724e80c50","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-084","page":84,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80ed59fc4514443486976f287b7b34e2","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d51a7d2647bc4bbd842f127bf1472276","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bbab89074d2a420ab3994e436910092d","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49f6e7c5fba242faa3287240fb8fe397","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"052245d288984391a3f044297c47e725","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f8e6a476b404cfe8381d4ff28e4a055","type":"page_info","conversion_output":false,"text":"Page 84 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2570],[244,2570]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2237},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a838d549fef4684a70095c22322a8ab","type":"table","conversion_output":true,"children_ids":["a28f0cd0520844b4b30c97a6f067894c","6d13c8fee14f43e5b0b0a076f6ad8358","4518a8f4554e4231b100aa0d6d92909b","35f311ba143743638a7852840c2ae5fe","8e0fc818319a4826b8cef543d33a192d","77543f91b5c043f7af01043b2fcd3c8d","ee0ebcd64f3c4712be1aeae65c54d559","0b289f894a1a440abd53266d449cb6e2","a2de220698fa4baeba66862f4ee04896","2e603028734b481cb048b984847601a9","37293a81e05243e291d10b6a01a2c60e","176f3057f26a406c8ab6b7f8b73d7975","5ba18770e974487bbef4af11423150f2"],"text":"\\begin{tabular}{|l|l|}\n\\hline & b) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated GFR \\(\\geq\\) 50\\% from baseline \\\\\n\\hline Rationale for change & To use consistent terminology. \\\\\n\\hline Section to be changed & Flowchart \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nAdding pharmacogenetic sampling. \\\\\nChange 2: \\\\\nFootnote C: ...end of trial (EOT visit) was changed into: end of treatment (EOT visit). \\\\\nChange 3: \\\\\nFootnote C: Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nFootnote C: Patients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the pre-defined study visits, with exception of , collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR. \\\\\nChange 4: \\\\\nThe following text under footnote G was deleted:\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & b) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated GFR \\(\\geq\\) 50\\% from baseline \\\\\n\\hline Rationale for change & To use consistent terminology. \\\\\n\\hline Section to be changed & Flowchart \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nAdding pharmacogenetic sampling. \\\\\nChange 2: \\\\\nFootnote C: ...end of trial (EOT visit) was changed into: end of treatment (EOT visit). \\\\\nChange 3: \\\\\nFootnote C: Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nFootnote C: Patients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the pre-defined study visits, with exception of , collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR. \\\\\nChange 4: \\\\\nThe following text under footnote G was deleted:\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.85546875,"confidence_rate":0.9999468206000257},{"cnt":[[251,333],[601,333],[601,2569],[251,2569]],"region":{"top_left_x":250,"top_left_y":333,"width":351,"height":2236},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a28f0cd0520844b4b30c97a6f067894c","type":"table_column","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"","text_display":""},{"cnt":[[930,333],[1764,333],[1764,2569],[930,2569]],"region":{"top_left_x":930,"top_left_y":333,"width":834,"height":2236},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d13c8fee14f43e5b0b0a076f6ad8358","type":"table_column","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"","text_display":""},{"cnt":[[244,336],[1775,334],[1775,457],[244,460]],"region":{"top_left_x":243,"top_left_y":334,"width":1533,"height":126},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4518a8f4554e4231b100aa0d6d92909b","type":"table_row","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"","text_display":""},{"cnt":[[244,462],[1775,462],[1775,506],[244,506]],"region":{"top_left_x":244,"top_left_y":461,"width":1532,"height":45},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35f311ba143743638a7852840c2ae5fe","type":"table_row","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"","text_display":""},{"cnt":[[244,513],[1775,513],[1775,556],[244,556]],"region":{"top_left_x":244,"top_left_y":512,"width":1532,"height":45},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e0fc818319a4826b8cef543d33a192d","type":"table_row","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"","text_display":""},{"cnt":[[244,559],[1775,559],[1775,1615],[244,1615]],"region":{"top_left_x":244,"top_left_y":558,"width":1532,"height":1058},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77543f91b5c043f7af01043b2fcd3c8d","type":"table_row","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"","text_display":""},{"cnt":[[935,338],[1734,338],[1734,455],[935,455]],"region":{"top_left_x":934,"top_left_y":337,"width":800,"height":119},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee0ebcd64f3c4712be1aeae65c54d559","type":"complex_cell","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","children_ids":["ab2955714b61431d85a8501de726af50","6086f758a5154c42a0736ed6a65b2f9a","69e1d7c9c16e4a3ab33d666d4c702a0a"],"text":"b) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated GFR \\(\\geq\\) 50\\% from baseline","text_display":"b) the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated GFR \\(\\geq\\) 50\\% from baseline","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.999997143860815},{"cnt":[[939,342],[1619,342],[1619,381],[939,381]],"region":{"top_left_x":939,"top_left_y":342,"width":680,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab2955714b61431d85a8501de726af50","type":"text","conversion_output":false,"parent_id":"ee0ebcd64f3c4712be1aeae65c54d559","text":"b) the composite renal endpoint (i.e. renal death,","text_display":"b) the composite renal endpoint (i.e. renal death,","confidence":1,"confidence_rate":1},{"cnt":[[939,381],[1729,381],[1729,418],[939,418]],"region":{"top_left_x":939,"top_left_y":381,"width":791,"height":38},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6086f758a5154c42a0736ed6a65b2f9a","type":"text","conversion_output":false,"parent_id":"ee0ebcd64f3c4712be1aeae65c54d559","text":"sustained ESRD, sustained decrease in estimated GFR \\(\\geq\\)","text_display":" sustained ESRD, sustained decrease in estimated GFR \\(\\geq\\)","confidence":0.99951171875,"confidence_rate":0.9999914316069175},{"cnt":[[939,420],[1209,420],[1209,455],[939,455]],"region":{"top_left_x":939,"top_left_y":420,"width":270,"height":36},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69e1d7c9c16e4a3ab33d666d4c702a0a","type":"text","conversion_output":false,"parent_id":"ee0ebcd64f3c4712be1aeae65c54d559","text":"50\\% from baseline","text_display":" 50\\% from baseline","confidence":1,"confidence_rate":1},{"cnt":[[267,464],[578,464],[578,501],[267,501]],"region":{"top_left_x":267,"top_left_y":464,"width":311,"height":38},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b289f894a1a440abd53266d449cb6e2","type":"simple_cell","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,464],[1370,464],[1370,501],[939,501]],"region":{"top_left_x":939,"top_left_y":464,"width":431,"height":38},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2de220698fa4baeba66862f4ee04896","type":"simple_cell","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"To use consistent terminology.","text_display":"To use consistent terminology.","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,513],[592,513],[592,556],[267,556]],"region":{"top_left_x":267,"top_left_y":512,"width":325,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e603028734b481cb048b984847601a9","type":"simple_cell","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,513],[1098,513],[1098,547],[939,547]],"region":{"top_left_x":939,"top_left_y":512,"width":160,"height":36},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37293a81e05243e291d10b6a01a2c60e","type":"simple_cell","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"Flowchart","text_display":"Flowchart","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,563],[592,563],[592,602],[267,602]],"region":{"top_left_x":267,"top_left_y":563,"width":325,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"176f3057f26a406c8ab6b7f8b73d7975","type":"simple_cell","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,559],[1752,559],[1752,1609],[935,1609]],"region":{"top_left_x":934,"top_left_y":558,"width":819,"height":1051},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ba18770e974487bbef4af11423150f2","type":"complex_cell","conversion_output":false,"parent_id":"8a838d549fef4684a70095c22322a8ab","children_ids":["91428a3a82e24223910652e6faedcfce","6dbcaa4657b44b598d9253de83b333a9","874cdefca7ef4626a01fbc4a3fb1d6d6","64dc48f43bf1489f8162bdedab397e5c","1a40bd19183842e29130dec366ab76e7","d5d9a28876cd4187bda66b473491e5a4","da5537d786014eb89417ab50a4492fb0","08a7e523276445c6b68dbca0a17caf18","4fe0b3c26c9b4cbd90b89f48dd3321c4","090bef269d4d445cb18d48aaf051d5ca","48a1eb6aa0974cccba030814d041882e","8fe0d05d2b4c44fa977a894ca5c6cb90","6ef4dd7865be48b091c03a3578686532","1fef276007ed4f3c84d394c88b9eff60","3bb3703ee4f845b6a29381f03defcc63","72334856088e4f64bbf3e047bb62e815","b03edd0e960246069bff5d07337967bd","a678e60c757c435c9c0ef21de846fe77","894b9ca93ad7499a80cb96abe175d56b","fd967352f2764d2281c31f0353071d8a","aa286efe74c341e7ace75f8ee7f44c2b"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nAdding pharmacogenetic sampling. \\\\\nChange 2: \\\\\nFootnote C: ...end of trial (EOT visit) was changed into: end of treatment (EOT visit). \\\\\nChange 3: \\\\\nFootnote C: Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nFootnote C: Patients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the pre-defined study visits, with exception of , collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR. \\\\\nChange 4: \\\\\nThe following text under footnote G was deleted:\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nAdding pharmacogenetic sampling. \\\\\nChange 2: \\\\\nFootnote C: ...end of trial (EOT visit) was changed into: end of treatment (EOT visit). \\\\\nChange 3: \\\\\nFootnote C: Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nFootnote C: Patients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the pre-defined study visits, with exception of , collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR. \\\\\nChange 4: \\\\\nThe following text under footnote G was deleted:\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.85546875,"confidence_rate":0.9996306586682318},{"cnt":[[939,563],[1084,563],[1084,602],[939,602]],"region":{"top_left_x":939,"top_left_y":563,"width":146,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91428a3a82e24223910652e6faedcfce","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Change 1:","text_display":"Change 1:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,602],[1439,602],[1439,639],[939,639]],"region":{"top_left_x":939,"top_left_y":602,"width":501,"height":38},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6dbcaa4657b44b598d9253de83b333a9","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Adding pharmacogenetic sampling.","text_display":"\nAdding pharmacogenetic sampling.","confidence":1,"confidence_rate":1},{"cnt":[[939,683],[1084,683],[1084,722],[939,722]],"region":{"top_left_x":939,"top_left_y":682,"width":146,"height":41},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"874cdefca7ef4626a01fbc4a3fb1d6d6","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,722],[1734,722],[1734,761],[939,761]],"region":{"top_left_x":939,"top_left_y":722,"width":795,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64dc48f43bf1489f8162bdedab397e5c","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Footnote C: ...end of trial (EOT visit) was changed into:","text_display":"\nFootnote C: ...end of trial (EOT visit) was changed into:","confidence":0.9907426834106445,"confidence_rate":0.9998500042853445},{"cnt":[[939,761],[1347,761],[1347,800],[939,800]],"region":{"top_left_x":939,"top_left_y":761,"width":408,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a40bd19183842e29130dec366ab76e7","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"end of treatment (EOT visit).","text_display":" end of treatment (EOT visit).","confidence":1,"confidence_rate":1},{"cnt":[[939,844],[1087,844],[1087,879],[939,879]],"region":{"top_left_x":939,"top_left_y":844,"width":148,"height":35},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d5d9a28876cd4187bda66b473491e5a4","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,881],[1632,881],[1632,920],[939,920]],"region":{"top_left_x":939,"top_left_y":880,"width":694,"height":41},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da5537d786014eb89417ab50a4492fb0","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Footnote C: Patients who discontinue study drug","text_display":"\nFootnote C: Patients who discontinue study drug","confidence":0.9980475902557373,"confidence_rate":0.9999624176642989},{"cnt":[[939,922],[1731,922],[1731,962],[939,962]],"region":{"top_left_x":939,"top_left_y":922,"width":793,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08a7e523276445c6b68dbca0a17caf18","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"prematurely should continue study visits until study end,","text_display":" prematurely should continue study visits until study end,","confidence":1,"confidence_rate":1},{"cnt":[[939,962],[1619,962],[1619,998],[939,998]],"region":{"top_left_x":939,"top_left_y":961,"width":680,"height":38},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4fe0b3c26c9b4cbd90b89f48dd3321c4","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"but no physical examination, vital signs, (safety)","text_display":" but no physical examination, vital signs, (safety)","confidence":1,"confidence_rate":1},{"cnt":[[939,1001],[1748,1001],[1748,1040],[939,1040]],"region":{"top_left_x":939,"top_left_y":1000,"width":809,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"090bef269d4d445cb18d48aaf051d5ca","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"laboratory sampling (including pregnancy test, lipid panel","text_display":" laboratory sampling (including pregnancy test, lipid panel","confidence":1,"confidence_rate":1},{"cnt":[[939,1042],[1669,1042],[1669,1081],[939,1081]],"region":{"top_left_x":939,"top_left_y":1042,"width":731,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48a1eb6aa0974cccba030814d041882e","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"\\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required.","text_display":" \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required.","confidence":0.99853515625,"confidence_rate":0.9999770952985276},{"cnt":[[939,1125],[1204,1125],[1204,1164],[939,1164]],"region":{"top_left_x":939,"top_left_y":1125,"width":266,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fe0d05d2b4c44fa977a894ca5c6cb90","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.85546875,"confidence_rate":0.9929294008394668},{"cnt":[[939,1208],[1623,1208],[1623,1242],[939,1242]],"region":{"top_left_x":939,"top_left_y":1207,"width":685,"height":36},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ef4dd7865be48b091c03a3578686532","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Footnote C: Patients who discontinue study drug","text_display":"\nFootnote C: Patients who discontinue study drug","confidence":0.99755859375,"confidence_rate":0.999952993579033},{"cnt":[[939,1245],[1729,1245],[1729,1284],[939,1284]],"region":{"top_left_x":939,"top_left_y":1244,"width":791,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fef276007ed4f3c84d394c88b9eff60","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"prematurely should continue study visits until study end.","text_display":" prematurely should continue study visits until study end.","confidence":1,"confidence_rate":1},{"cnt":[[939,1286],[1725,1286],[1725,1323],[939,1323]],"region":{"top_left_x":939,"top_left_y":1286,"width":786,"height":38},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3bb3703ee4f845b6a29381f03defcc63","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Study assessments may be omitted if a patient is willing","text_display":" Study assessments may be omitted if a patient is willing","confidence":1,"confidence_rate":1},{"cnt":[[939,1323],[1748,1323],[1748,1362],[939,1362]],"region":{"top_left_x":939,"top_left_y":1323,"width":809,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72334856088e4f64bbf3e047bb62e815","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"to return to the pre-defined study visits, with exception of","text_display":" to return to the pre-defined study visits, with exception of","confidence":1,"confidence_rate":1},{"cnt":[[1264,1365],[1678,1365],[1678,1404],[1264,1404]],"region":{"top_left_x":1264,"top_left_y":1364,"width":415,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b03edd0e960246069bff5d07337967bd","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":", collection of adverse events,","text_display":" , collection of adverse events,","confidence":1,"confidence_rate":1},{"cnt":[[939,1406],[1674,1406],[1674,1445],[939,1445]],"region":{"top_left_x":939,"top_left_y":1405,"width":735,"height":41},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a678e60c757c435c9c0ef21de846fe77","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"outcome events, concomitant therapy and laboratory","text_display":" outcome events, concomitant therapy and laboratory","confidence":1,"confidence_rate":1},{"cnt":[[939,1447],[1669,1447],[1669,1482],[939,1482]],"region":{"top_left_x":939,"top_left_y":1447,"width":731,"height":35},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"894b9ca93ad7499a80cb96abe175d56b","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"testing of creatinine for the calculation of the eGFR.","text_display":" testing of creatinine for the calculation of the eGFR.","confidence":1,"confidence_rate":1},{"cnt":[[939,1526],[1087,1526],[1087,1565],[939,1565]],"region":{"top_left_x":939,"top_left_y":1525,"width":148,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd967352f2764d2281c31f0353071d8a","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"Change 4:","text_display":"\nChange 4:","confidence":1,"confidence_rate":1},{"cnt":[[939,1567],[1628,1567],[1628,1606],[939,1606]],"region":{"top_left_x":939,"top_left_y":1567,"width":689,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa286efe74c341e7ace75f8ee7f44c2b","type":"text","conversion_output":false,"parent_id":"5ba18770e974487bbef4af11423150f2","text":"The following text under footnote G was deleted:","text_display":"\nThe following text under footnote G was deleted:","confidence":0.982421875,"confidence_rate":0.999665443619117},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"989fb781830d4b31831a51abaceafb13","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cca259de2c1f40b4b914fa66749d8523","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d3ec0c31eaf54a71880062727890088f","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-085","page":85,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38f7b49c08ee413b8cbb5a7df75bb79c","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91604358207e4acab1ca8f5603ecfd53","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3e9604f1f8743ca8e45c79b7c3e4121","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aec8a6de278243e4b2258d265ce37b4a","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5cfd904181643e9bd2e54a70287a177","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"060cb12af3ab4740aa628173fc300894","type":"page_info","conversion_output":false,"text":"Page 85 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1775,331],[1775,2543],[242,2543]],"region":{"top_left_x":242,"top_left_y":331,"width":1533,"height":2212},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d17403494a5f4e2cbf4907ad0b57453b","type":"table","conversion_output":true,"children_ids":["68153313d9f74d068503c3a87c73e531","e8c087b6774f48039f594f1c5bdffe4f","57aa5e7c8dd94b25a0044352046881d3","fdc7282b2df04ea1a38a68a7405e0247"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 5: \\\\\nFootnote K: \\\\\nAt visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for eligibility in addition to urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart. \\\\\nWas changed into: \\\\\nAt visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for eligibility in addition to lipase, urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart. \\\\\nChange 6: \\\\\nFootnote L: ...In case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine (eGFR).... \\\\\nWas changed into: \\\\\n...In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine (eGFR).... \\\\\nChange 7: \\\\\nFootnote N : ..... (plus 2 week reserve) was changed into: ...(2 weeks reserve). \\\\\nChange 8: \\\\\nFootnote O: Returned study medication may be redispensed if the time window around the patient visit schedule requires this. \\\\\nWas changed into: \\\\\nFootnote O : The protocol allows a time window of \\(+/-7\\) days for visit 3 and +/- 14 days for all scheduled visits in the treatment period after visit 3. To ensure sufficient medication, visits after visit 3 should be scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2 . \\\\\nChange 9: \\\\\nFootnote P was added: To allow possible retrospective pharmacogenetic analyses, all patients eligible for randomization will be asked for a blood sample with a separate informed consent. The pharmacogenetic sample should preferably be taken at visit 2, but could also be taken at any later visit, depending on availability of the respective informed consent. Pharmacogenetic sampling is voluntary and is not a prerequisite for participation in the study.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 5: \\\\\nFootnote K: \\\\\nAt visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for eligibility in addition to urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart. \\\\\nWas changed into: \\\\\nAt visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for eligibility in addition to lipase, urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart. \\\\\nChange 6: \\\\\nFootnote L: ...In case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine (eGFR).... \\\\\nWas changed into: \\\\\n...In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine (eGFR).... \\\\\nChange 7: \\\\\nFootnote N : ..... (plus 2 week reserve) was changed into: ...(2 weeks reserve). \\\\\nChange 8: \\\\\nFootnote O: Returned study medication may be redispensed if the time window around the patient visit schedule requires this. \\\\\nWas changed into: \\\\\nFootnote O : The protocol allows a time window of \\(+/-7\\) days for visit 3 and +/- 14 days for all scheduled visits in the treatment period after visit 3. To ensure sufficient medication, visits after visit 3 should be scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2 . \\\\\nChange 9: \\\\\nFootnote P was added: To allow possible retrospective pharmacogenetic analyses, all patients eligible for randomization will be asked for a blood sample with a separate informed consent. The pharmacogenetic sample should preferably be taken at visit 2, but could also be taken at any later visit, depending on availability of the respective informed consent. Pharmacogenetic sampling is voluntary and is not a prerequisite for participation in the study.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.5140750731218718,"confidence_rate":0.9993291889076305},{"cnt":[[242,331],[841,331],[841,2539],[242,2539]],"region":{"top_left_x":242,"top_left_y":331,"width":599,"height":2209},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68153313d9f74d068503c3a87c73e531","type":"table_column","conversion_output":false,"parent_id":"d17403494a5f4e2cbf4907ad0b57453b","text":"","text_display":""},{"cnt":[[930,331],[1759,331],[1759,2541],[930,2541]],"region":{"top_left_x":930,"top_left_y":331,"width":830,"height":2211},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e8c087b6774f48039f594f1c5bdffe4f","type":"table_column","conversion_output":false,"parent_id":"d17403494a5f4e2cbf4907ad0b57453b","text":"","text_display":""},{"cnt":[[242,331],[1775,331],[1775,2544],[242,2544]],"region":{"top_left_x":242,"top_left_y":331,"width":1534,"height":2213},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57aa5e7c8dd94b25a0044352046881d3","type":"table_row","conversion_output":false,"parent_id":"d17403494a5f4e2cbf4907ad0b57453b","text":"","text_display":""},{"cnt":[[933,336],[1750,336],[1750,2539],[933,2539]],"region":{"top_left_x":932,"top_left_y":335,"width":819,"height":2205},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fdc7282b2df04ea1a38a68a7405e0247","type":"complex_cell","conversion_output":false,"parent_id":"d17403494a5f4e2cbf4907ad0b57453b","children_ids":["331193c39e584d5c8698076479beb5fe","be2f19f0e5ca480ca4fcca1836469ff6","79228a5f5f2448d1bba4248a08a36b38","b00fc6eaab2b43d99d952330260e4570","038d87d0cd134485b680ece34017f022","5e9ae34deaa04583bdee055d67d25639","599c4b83eb354236bf29ee7ba20fe985","2461c2e12cc84cd7a4d9bd18d1174c07","0f7642145c8e44eb9fd6211ee8f81a2c","48c9da5d66f442fb81db9762fe552f52","cfe6d3a9705a441997cdc4124d3fb7f8","7b86c5e981df4203b8fb8db1bfefb2da","a58fca94630344a0a7c7781a7d000857","42b034d41a4945078b1bff447f85c5d0","41fb1ae455f04fbabbf0ad091ef282ca","4436c9c36a4d495d94cbedcbdc636df0","a5a6b92851f740da8fb08bdb3a564db8","9f488bf43c2743f69e1db3cbe3f3a9e4","d4309e04c92e4dcb96dc42a37dd9b988","9aaf122613034ee0895023e6ad7aa8b5","8e68c66d8e264d3b81431e77c301abd0","08701435c315439d92cfa6f22e8cf927","e06dbd0633cc4279accce113efab67f7","f2b08ebb60064918811bbbc1f4e87bfc","e1080247e9c54e718b3fb4e23fe81ff9","6b20e78f38d9405988ab7f5dcd2506c1","41fa1a3ce3c44ca98be04ad43ddbbabf","17912f86815e4049a962b75035abe0b5","62704c16e16c47c88eec4c873dfa71fb","e71015506a5740d0a6c52225b3aee9af","2076b228c0b74a81aefe5184c2fe55da","f5622a4cd5864d4292818efc71d55978","a7951cf118874d06878008d827069c6a","0d8a3353f11c415db4268bf100c55fb8","20341819387b4e0999c702f6730cebd0","0434e8370cd84bc3ae0f76f7afa604bc","8d1bf9d3e9504eca9a73a95ce660886f","c4d88d31f304478182a3ce92a1d7e9f3","1ab0d94964e943dbab5e96862b473200","ea3f60e2747b4169b2372097c94da117","c0d631030c3c4a4395488866503b09f5","8e8a4c18ddbb4c858864d4e2781c5969","5eb79adf5a7441ca86a13bfc74717b56","de83bde631a04278a36fd82d1c3527cc","a7503b0ae3b3457691fad736cc6d1604","1c15adf3b1d240b8bc24944d9d8a2ddb"],"text":"\\begin{tabular}{l}\nChange 5: \\\\\nFootnote K: \\\\\nAt visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for eligibility in addition to urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart. \\\\\nWas changed into: \\\\\nAt visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for eligibility in addition to lipase, urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart. \\\\\nChange 6: \\\\\nFootnote L: ...In case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine (eGFR).... \\\\\nWas changed into: \\\\\n...In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine (eGFR).... \\\\\nChange 7: \\\\\nFootnote N : ..... (plus 2 week reserve) was changed into: ...(2 weeks reserve). \\\\\nChange 8: \\\\\nFootnote O: Returned study medication may be redispensed if the time window around the patient visit schedule requires this. \\\\\nWas changed into: \\\\\nFootnote O : The protocol allows a time window of \\(+/-7\\) days for visit 3 and +/- 14 days for all scheduled visits in the treatment period after visit 3. To ensure sufficient medication, visits after visit 3 should be scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2 . \\\\\nChange 9: \\\\\nFootnote P was added: To allow possible retrospective pharmacogenetic analyses, all patients eligible for randomization will be asked for a blood sample with a separate informed consent. The pharmacogenetic sample should preferably be taken at visit 2, but could also be taken at any later visit, depending on availability of the respective informed consent. Pharmacogenetic sampling is voluntary and is not a prerequisite for participation in the study.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 5: \\\\\nFootnote K: \\\\\nAt visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for eligibility in addition to urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart. \\\\\nWas changed into: \\\\\nAt visit 1 safety laboratory includes ALT, AST, alkaline phosphatase and creatinine to check for eligibility in addition to lipase, urine albumin, urine creatinine and \\(HbA _{1 c }\\) as specified in the flow chart. \\\\\nChange 6: \\\\\nFootnote L: ...In case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine (eGFR).... \\\\\nWas changed into: \\\\\n...In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled to collect a blood sample for repeat analysis of creatinine (eGFR).... \\\\\nChange 7: \\\\\nFootnote N : ..... (plus 2 week reserve) was changed into: ...(2 weeks reserve). \\\\\nChange 8: \\\\\nFootnote O: Returned study medication may be redispensed if the time window around the patient visit schedule requires this. \\\\\nWas changed into: \\\\\nFootnote O : The protocol allows a time window of \\(+/-7\\) days for visit 3 and +/- 14 days for all scheduled visits in the treatment period after visit 3. To ensure sufficient medication, visits after visit 3 should be scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2 . \\\\\nChange 9: \\\\\nFootnote P was added: To allow possible retrospective pharmacogenetic analyses, all patients eligible for randomization will be asked for a blood sample with a separate informed consent. The pharmacogenetic sample should preferably be taken at visit 2, but could also be taken at any later visit, depending on availability of the respective informed consent. Pharmacogenetic sampling is voluntary and is not a prerequisite for participation in the study.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.5140750731218718,"confidence_rate":0.9993291889076305},{"cnt":[[942,340],[1087,340],[1087,379],[942,379]],"region":{"top_left_x":941,"top_left_y":340,"width":147,"height":40},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"331193c39e584d5c8698076479beb5fe","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Change 5:","text_display":"Change 5:","confidence":1,"confidence_rate":1},{"cnt":[[937,382],[1110,382],[1110,416],[937,416]],"region":{"top_left_x":937,"top_left_y":381,"width":174,"height":36},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be2f19f0e5ca480ca4fcca1836469ff6","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Footnote K:","text_display":"\nFootnote K:","confidence":0.9941432476043701,"confidence_rate":0.9996329442295395},{"cnt":[[937,418],[1729,418],[1729,462],[937,462]],"region":{"top_left_x":937,"top_left_y":418,"width":793,"height":45},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79228a5f5f2448d1bba4248a08a36b38","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"At visit 1 safety laboratory includes ALT, AST, alkaline","text_display":"\nAt visit 1 safety laboratory includes ALT, AST, alkaline","confidence":1,"confidence_rate":1},{"cnt":[[937,460],[1676,460],[1676,501],[937,501]],"region":{"top_left_x":937,"top_left_y":459,"width":740,"height":43},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b00fc6eaab2b43d99d952330260e4570","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"phosphatase and creatinine to check for eligibility in","text_display":" phosphatase and creatinine to check for eligibility in","confidence":1,"confidence_rate":1},{"cnt":[[937,501],[1732,501],[1732,541],[937,541]],"region":{"top_left_x":937,"top_left_y":501,"width":795,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"038d87d0cd134485b680ece34017f022","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"addition to urine albumin, urine creatinine and \\(HbA _{1 c }\\) as","text_display":" addition to urine albumin, urine creatinine and \\(HbA _{1 c }\\) as","confidence":0.99951171875,"confidence_rate":0.9999936571565041},{"cnt":[[937,538],[1317,538],[1317,582],[937,582]],"region":{"top_left_x":937,"top_left_y":538,"width":381,"height":44},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e9ae34deaa04583bdee055d67d25639","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"specified in the flow chart.","text_display":" specified in the flow chart.","confidence":1,"confidence_rate":1},{"cnt":[[937,621],[1207,621],[1207,660],[937,660]],"region":{"top_left_x":937,"top_left_y":621,"width":270,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"599c4b83eb354236bf29ee7ba20fe985","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Was changed into:","text_display":"\nWas changed into:","confidence":1,"confidence_rate":1},{"cnt":[[937,658],[1729,658],[1729,702],[937,702]],"region":{"top_left_x":937,"top_left_y":657,"width":793,"height":45},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2461c2e12cc84cd7a4d9bd18d1174c07","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"At visit 1 safety laboratory includes ALT, AST, alkaline","text_display":"\nAt visit 1 safety laboratory includes ALT, AST, alkaline","confidence":1,"confidence_rate":1},{"cnt":[[937,699],[1676,699],[1676,743],[937,743]],"region":{"top_left_x":937,"top_left_y":699,"width":740,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f7642145c8e44eb9fd6211ee8f81a2c","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"phosphatase and creatinine to check for eligibility in","text_display":" phosphatase and creatinine to check for eligibility in","confidence":1,"confidence_rate":1},{"cnt":[[937,741],[1690,741],[1690,780],[937,780]],"region":{"top_left_x":937,"top_left_y":740,"width":754,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48c9da5d66f442fb81db9762fe552f52","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"addition to lipase, urine albumin, urine creatinine and","text_display":" addition to lipase, urine albumin, urine creatinine and","confidence":1,"confidence_rate":1},{"cnt":[[937,780],[1455,780],[1455,821],[937,821]],"region":{"top_left_x":937,"top_left_y":779,"width":519,"height":43},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfe6d3a9705a441997cdc4124d3fb7f8","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"\\(HbA _{1 c }\\) as specified in the flow chart.","text_display":" \\(HbA _{1 c }\\) as specified in the flow chart.","confidence":0.99951171875,"confidence_rate":0.9999909555872323},{"cnt":[[937,861],[1087,861],[1087,900],[937,900]],"region":{"top_left_x":937,"top_left_y":860,"width":151,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b86c5e981df4203b8fb8db1bfefb2da","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Change 6:","text_display":"\nChange 6:","confidence":1,"confidence_rate":1},{"cnt":[[937,897],[1702,897],[1702,941],[937,941]],"region":{"top_left_x":937,"top_left_y":897,"width":765,"height":45},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a58fca94630344a0a7c7781a7d000857","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Footnote L: ...In case of an eGFR loss of \\(\\geq 50 \\%\\) since","text_display":"\nFootnote L: ...In case of an eGFR loss of \\(\\geq 50 \\%\\) since","confidence":0.9556088447570801,"confidence_rate":0.9992435094856272},{"cnt":[[937,939],[1630,939],[1630,978],[937,978]],"region":{"top_left_x":937,"top_left_y":938,"width":694,"height":41},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42b034d41a4945078b1bff447f85c5d0","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"baseline (visit 2) an additional visit 4 weeks after","text_display":" baseline (visit 2) an additional visit 4 weeks after","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[937,980],[1718,980],[1718,1019],[937,1019]],"region":{"top_left_x":937,"top_left_y":980,"width":781,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41fb1ae455f04fbabbf0ad091ef282ca","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"detection should be scheduled to collect a blood sample","text_display":" detection should be scheduled to collect a blood sample","confidence":1,"confidence_rate":1},{"cnt":[[937,1019],[1543,1019],[1543,1061],[937,1061]],"region":{"top_left_x":937,"top_left_y":1019,"width":606,"height":42},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4436c9c36a4d495d94cbedcbdc636df0","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"for repeat analysis of creatinine (eGFR)....","text_display":" for repeat analysis of creatinine (eGFR)....","confidence":0.99853515625,"confidence_rate":0.9999700837601018},{"cnt":[[937,1100],[1207,1100],[1207,1139],[937,1139]],"region":{"top_left_x":937,"top_left_y":1100,"width":270,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5a6b92851f740da8fb08bdb3a564db8","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99951171875,"confidence_rate":0.9999778002237774},{"cnt":[[937,1178],[1727,1178],[1727,1217],[937,1217]],"region":{"top_left_x":937,"top_left_y":1178,"width":791,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f488bf43c2743f69e1db3cbe3f3a9e4","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"...In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline","text_display":"\n...In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline","confidence":0.998046875,"confidence_rate":0.9999679507621811},{"cnt":[[937,1220],[1741,1220],[1741,1259],[937,1259]],"region":{"top_left_x":937,"top_left_y":1219,"width":804,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4309e04c92e4dcb96dc42a37dd9b988","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"(visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\)","text_display":" (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\)","confidence":0.99951171875,"confidence_rate":0.9999917220597181},{"cnt":[[937,1259],[1711,1259],[1711,1300],[937,1300]],"region":{"top_left_x":937,"top_left_y":1258,"width":774,"height":43},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9aaf122613034ee0895023e6ad7aa8b5","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"since baseline (visit 2) an additional visit 4 weeks after","text_display":" since baseline (visit 2) an additional visit 4 weeks after","confidence":0.99267578125,"confidence_rate":0.9998886248006924},{"cnt":[[937,1298],[1720,1298],[1720,1339],[937,1339]],"region":{"top_left_x":937,"top_left_y":1298,"width":784,"height":42},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e68c66d8e264d3b81431e77c301abd0","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"detection should be scheduled to collect a blood sample","text_display":" detection should be scheduled to collect a blood sample","confidence":1,"confidence_rate":1},{"cnt":[[937,1339],[1543,1339],[1543,1383],[937,1383]],"region":{"top_left_x":937,"top_left_y":1339,"width":606,"height":45},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08701435c315439d92cfa6f22e8cf927","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"for repeat analysis of creatinine (eGFR)....","text_display":" for repeat analysis of creatinine (eGFR)....","confidence":0.9965834617614746,"confidence_rate":0.9999301577873891},{"cnt":[[937,1418],[1087,1418],[1087,1457],[937,1457]],"region":{"top_left_x":937,"top_left_y":1417,"width":151,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e06dbd0633cc4279accce113efab67f7","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Change 7:","text_display":"\nChange 7:","confidence":0.99853515625,"confidence_rate":0.9998952970758412},{"cnt":[[937,1459],[1741,1459],[1741,1498],[937,1498]],"region":{"top_left_x":937,"top_left_y":1459,"width":804,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2b08ebb60064918811bbbc1f4e87bfc","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Footnote N : ..... (plus 2 week reserve) was changed into:","text_display":"\nFootnote N : ..... (plus 2 week reserve) was changed into:","confidence":0.5140750731218718,"confidence_rate":0.9908010993879452},{"cnt":[[942,1498],[1234,1498],[1234,1540],[942,1540]],"region":{"top_left_x":941,"top_left_y":1498,"width":294,"height":42},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1080247e9c54e718b3fb4e23fe81ff9","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"...(2 weeks reserve).","text_display":" ...(2 weeks reserve).","confidence":0.99853515625,"confidence_rate":0.9999436201400772},{"cnt":[[937,1579],[1087,1579],[1087,1618],[937,1618]],"region":{"top_left_x":937,"top_left_y":1578,"width":151,"height":41},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b20e78f38d9405988ab7f5dcd2506c1","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Change 8:","text_display":"\nChange 8:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[937,1616],[1653,1616],[1653,1660],[937,1660]],"region":{"top_left_x":937,"top_left_y":1615,"width":717,"height":45},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41fa1a3ce3c44ca98be04ad43ddbbabf","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Footnote O: Returned study medication may be re-","text_display":"\nFootnote O: Returned study medication may be re","confidence":1,"confidence_rate":1},{"cnt":[[937,1657],[1686,1657],[1686,1701],[937,1701]],"region":{"top_left_x":937,"top_left_y":1657,"width":749,"height":44},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17912f86815e4049a962b75035abe0b5","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"dispensed if the time window around the patient visit","text_display":"dispensed if the time window around the patient visit","confidence":1,"confidence_rate":1},{"cnt":[[937,1699],[1253,1699],[1253,1738],[937,1738]],"region":{"top_left_x":937,"top_left_y":1698,"width":316,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"62704c16e16c47c88eec4c873dfa71fb","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"schedule requires this.","text_display":" schedule requires this.","confidence":1,"confidence_rate":1},{"cnt":[[937,1800],[1207,1800],[1207,1844],[937,1844]],"region":{"top_left_x":937,"top_left_y":1799,"width":270,"height":45},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e71015506a5740d0a6c52225b3aee9af","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99853515625,"confidence_rate":0.9999333695979722},{"cnt":[[937,1860],[1727,1860],[1727,1901],[937,1901]],"region":{"top_left_x":937,"top_left_y":1859,"width":791,"height":43},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2076b228c0b74a81aefe5184c2fe55da","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Footnote O : The protocol allows a time window of \\(+/-7\\)","text_display":"\nFootnote O : The protocol allows a time window of \\(+/-7\\)","confidence":0.7623995482418877,"confidence_rate":0.9957701505076206},{"cnt":[[937,1899],[1736,1899],[1736,1940],[937,1940]],"region":{"top_left_x":937,"top_left_y":1899,"width":800,"height":42},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5622a4cd5864d4292818efc71d55978","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"days for visit 3 and +/- 14 days for all scheduled visits in","text_display":" days for visit 3 and +/- 14 days for all scheduled visits in","confidence":1,"confidence_rate":1},{"cnt":[[937,1938],[1690,1938],[1690,1980],[937,1980]],"region":{"top_left_x":937,"top_left_y":1938,"width":754,"height":42},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7951cf118874d06878008d827069c6a","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"the treatment period after visit 3. To ensure sufficient","text_display":" the treatment period after visit 3. To ensure sufficient","confidence":0.97314453125,"confidence_rate":0.999553826352839},{"cnt":[[937,1980],[1746,1980],[1746,2019],[937,2019]],"region":{"top_left_x":937,"top_left_y":1979,"width":809,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d8a3353f11c415db4268bf100c55fb8","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"medication, visits after visit 3 should be scheduled within","text_display":" medication, visits after visit 3 should be scheduled within","confidence":1,"confidence_rate":1},{"cnt":[[942,2019],[1589,2019],[1589,2060],[942,2060]],"region":{"top_left_x":941,"top_left_y":2018,"width":648,"height":43},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20341819387b4e0999c702f6730cebd0","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"182 days and visit 3 should take place no later","text_display":" 182 days and visit 3 should take place no later","confidence":1,"confidence_rate":1},{"cnt":[[937,2058],[1294,2058],[1294,2102],[937,2102]],"region":{"top_left_x":937,"top_left_y":2057,"width":358,"height":45},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0434e8370cd84bc3ae0f76f7afa604bc","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"than 91 days after visit 2 .","text_display":" than 91 days after visit 2 .","confidence":0.55419921875,"confidence_rate":0.9849798157471342},{"cnt":[[937,2141],[1087,2141],[1087,2180],[937,2180]],"region":{"top_left_x":937,"top_left_y":2140,"width":151,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d1bf9d3e9504eca9a73a95ce660886f","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Change 9:","text_display":"\nChange 9:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[937,2180],[1704,2180],[1704,2221],[937,2221]],"region":{"top_left_x":937,"top_left_y":2179,"width":768,"height":43},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c4d88d31f304478182a3ce92a1d7e9f3","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"Footnote P was added: To allow possible retrospective","text_display":"\nFootnote P was added: To allow possible retrospective","confidence":0.9965834617614746,"confidence_rate":0.9999465266183007},{"cnt":[[937,2219],[1644,2219],[1644,2260],[937,2260]],"region":{"top_left_x":937,"top_left_y":2219,"width":708,"height":42},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ab0d94964e943dbab5e96862b473200","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"pharmacogenetic analyses, all patients eligible for","text_display":" pharmacogenetic analyses, all patients eligible for","confidence":1,"confidence_rate":1},{"cnt":[[937,2260],[1702,2260],[1702,2300],[937,2300]],"region":{"top_left_x":937,"top_left_y":2260,"width":765,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea3f60e2747b4169b2372097c94da117","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"randomization will be asked for a blood sample with a","text_display":" randomization will be asked for a blood sample with a","confidence":1,"confidence_rate":1},{"cnt":[[937,2297],[1736,2297],[1736,2341],[937,2341]],"region":{"top_left_x":937,"top_left_y":2297,"width":800,"height":45},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0d631030c3c4a4395488866503b09f5","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"separate informed consent. The pharmacogenetic sample","text_display":" separate informed consent. The pharmacogenetic sample","confidence":1,"confidence_rate":1},{"cnt":[[937,2339],[1699,2339],[1699,2380],[937,2380]],"region":{"top_left_x":937,"top_left_y":2338,"width":763,"height":43},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e8a4c18ddbb4c858864d4e2781c5969","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"should preferably be taken at visit 2, but could also be","text_display":" should preferably be taken at visit 2, but could also be","confidence":1,"confidence_rate":1},{"cnt":[[937,2378],[1713,2378],[1713,2419],[937,2419]],"region":{"top_left_x":937,"top_left_y":2377,"width":777,"height":43},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5eb79adf5a7441ca86a13bfc74717b56","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"taken at any later visit, depending on availability of the","text_display":" taken at any later visit, depending on availability of the","confidence":1,"confidence_rate":1},{"cnt":[[937,2417],[1732,2417],[1732,2461],[937,2461]],"region":{"top_left_x":937,"top_left_y":2417,"width":795,"height":44},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de83bde631a04278a36fd82d1c3527cc","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"respective informed consent. Pharmacogenetic sampling","text_display":" respective informed consent. Pharmacogenetic sampling","confidence":1,"confidence_rate":1},{"cnt":[[937,2459],[1723,2459],[1723,2500],[937,2500]],"region":{"top_left_x":937,"top_left_y":2458,"width":786,"height":42},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7503b0ae3b3457691fad736cc6d1604","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"is voluntary and is not a prerequisite for participation in","text_display":" is voluntary and is not a prerequisite for participation in","confidence":1,"confidence_rate":1},{"cnt":[[937,2500],[1078,2500],[1078,2539],[937,2539]],"region":{"top_left_x":937,"top_left_y":2499,"width":141,"height":41},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c15adf3b1d240b8bc24944d9d8a2ddb","type":"text","conversion_output":false,"parent_id":"fdc7282b2df04ea1a38a68a7405e0247","text":"the study.","text_display":" the study.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":58,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"27ff2d90a6fc4985a625ef06d8c53b76","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":59,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9dc1fe68fe544e679017cf5f866b7680","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":60,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2f80945e4ef54850bed8e8d41bb36e98","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-086","page":86,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfecfe8aa5174edbba4b66e62a1a5342","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a2dd401d0604efbaae70efb1b5656a2","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2e022db44b649889902fbca0645c0fc","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3811c3e3fbc74159af781df2800bddf4","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5c1f4240a834022b2887cfc500b8e44","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c49d74af0a44a1b890ac37dd60e4094","type":"page_info","conversion_output":false,"text":"Page 86 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2554],[244,2554]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2221},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca73851f6f9f4ff3b07ba6fdd857a04d","type":"table","conversion_output":true,"children_ids":["6f8f2021743e4271bfe8150f5d0798c1","eff89480098544cab809fd3400130704","fab26581558d4036879f93c5b22c7d86","3c815e9011b8489c81af719c98325fd9","ed6f61102eef42d39c4d60794b4d15ad","20a45fe3ab9b4df39a7558ffd7a828bd","6c8223f5a2b84950994b08cd1ae6704f","f7211656e2e94839a1a6b090f014ba35","213ec461d9144193a766a532f22bbe23","435d117aa374435f9d1f8353efd1b2a1","0200454973674bf2bfa847d69fe352e8","7f4db0da3ab44593b4d5101974bc0dd9","ae9bd99de07445818b57e44b69a828b3","6b316bdd8ad54fe68e94ac0ae6b82c77","ed4ead75621f400d8949c76d2804926f","216dcb92d51f4f348d564a94f1698a3f"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 10: \\\\\nFootnote Q was added: Urine Albumin Creatinine Ratio (UACR) will be calculated at the central lab, and should be measured on a first morning void specimen wherever possible.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo allow possible retrospective pharmacogenetic analyses. \\\\\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nFor clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint). \\\\\nChange 5: \\\\\nTo add lipase to the laboratory assessment schedule. \\\\\nChange 7: \\\\\nCorrection of typographical error. \\\\\nChange 8: \\\\\nTo clarify the allowed time window between study visits in relation to the available study medication dispensed. \\\\\nChange 9: \\\\\nTo add an explanatory footnote for the pharmacogenetic sampling added to the flowchart. \\\\\nChange 10: \\\\\nFor clarification in line with section 5.2.3 of the clinical trial protocol.\n\\end{tabular} \\\\\n\\hline Section to be changed & Abbreviations \\\\\n\\hline Description of change & \\begin{tabular}{l}\nThe following abbreviation was added: \\\\\nDNA - Deoxyribonucleic Acid \\\\\nIn addition: \\\\\nEOT - End of Trial was changed into: EOT - End of Treatment.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nAbbreviation added.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 10: \\\\\nFootnote Q was added: Urine Albumin Creatinine Ratio (UACR) will be calculated at the central lab, and should be measured on a first morning void specimen wherever possible.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo allow possible retrospective pharmacogenetic analyses. \\\\\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nFor clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint). \\\\\nChange 5: \\\\\nTo add lipase to the laboratory assessment schedule. \\\\\nChange 7: \\\\\nCorrection of typographical error. \\\\\nChange 8: \\\\\nTo clarify the allowed time window between study visits in relation to the available study medication dispensed. \\\\\nChange 9: \\\\\nTo add an explanatory footnote for the pharmacogenetic sampling added to the flowchart. \\\\\nChange 10: \\\\\nFor clarification in line with section 5.2.3 of the clinical trial protocol.\n\\end{tabular} \\\\\n\\hline Section to be changed & Abbreviations \\\\\n\\hline Description of change & \\begin{tabular}{l}\nThe following abbreviation was added: \\\\\nDNA - Deoxyribonucleic Acid \\\\\nIn addition: \\\\\nEOT - End of Trial was changed into: EOT - End of Treatment.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nAbbreviation added.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.99609375,"confidence_rate":0.9999895303742741},{"cnt":[[251,333],[603,333],[603,2555],[251,2555]],"region":{"top_left_x":250,"top_left_y":333,"width":354,"height":2222},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f8f2021743e4271bfe8150f5d0798c1","type":"table_column","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"","text_display":""},{"cnt":[[921,333],[1748,333],[1748,2555],[921,2555]],"region":{"top_left_x":920,"top_left_y":333,"width":828,"height":2222},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eff89480098544cab809fd3400130704","type":"table_column","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"","text_display":""},{"cnt":[[244,333],[1775,333],[1775,543],[244,543]],"region":{"top_left_x":244,"top_left_y":333,"width":1532,"height":210},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fab26581558d4036879f93c5b22c7d86","type":"table_row","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"","text_display":""},{"cnt":[[244,540],[1773,540],[1773,2145],[244,2145]],"region":{"top_left_x":244,"top_left_y":540,"width":1529,"height":1606},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c815e9011b8489c81af719c98325fd9","type":"table_row","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"","text_display":""},{"cnt":[[244,2140],[1771,2140],[1771,2187],[244,2187]],"region":{"top_left_x":244,"top_left_y":2140,"width":1527,"height":47},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed6f61102eef42d39c4d60794b4d15ad","type":"table_row","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"","text_display":""},{"cnt":[[244,2187],[1775,2187],[1775,2431],[244,2431]],"region":{"top_left_x":244,"top_left_y":2186,"width":1532,"height":245},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20a45fe3ab9b4df39a7558ffd7a828bd","type":"table_row","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"","text_display":""},{"cnt":[[244,2428],[1775,2428],[1775,2525],[244,2525]],"region":{"top_left_x":244,"top_left_y":2428,"width":1532,"height":97},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c8223f5a2b84950994b08cd1ae6704f","type":"table_row","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"","text_display":""},{"cnt":[[935,338],[1715,338],[1715,543],[935,543]],"region":{"top_left_x":934,"top_left_y":337,"width":782,"height":206},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7211656e2e94839a1a6b090f014ba35","type":"complex_cell","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","children_ids":["bff53bdbddb24141804afb432ca35f27","e18c6a42671f4737aa4ee99037f7019e","f5252b87e2dc4ea2bd0c083a592c301c","12d18053df9e43e88645d12a8b4300a0","3429755b4c874c358f86b957ae54cd2a"],"text":"\\begin{tabular}{l}\nChange 10: \\\\\nFootnote Q was added: Urine Albumin Creatinine Ratio (UACR) will be calculated at the central lab, and should be measured on a first morning void specimen wherever possible.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 10: \\\\\nFootnote Q was added: Urine Albumin Creatinine Ratio (UACR) will be calculated at the central lab, and should be measured on a first morning void specimen wherever possible.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99609375,"confidence_rate":0.9999794161667666},{"cnt":[[939,342],[1105,342],[1105,381],[939,381]],"region":{"top_left_x":939,"top_left_y":342,"width":167,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bff53bdbddb24141804afb432ca35f27","type":"text","conversion_output":false,"parent_id":"f7211656e2e94839a1a6b090f014ba35","text":"Change 10:","text_display":"Change 10:","confidence":1,"confidence_rate":1},{"cnt":[[939,381],[1642,381],[1642,418],[939,418]],"region":{"top_left_x":939,"top_left_y":381,"width":703,"height":38},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e18c6a42671f4737aa4ee99037f7019e","type":"text","conversion_output":false,"parent_id":"f7211656e2e94839a1a6b090f014ba35","text":"Footnote Q was added: Urine Albumin Creatinine","text_display":"\nFootnote Q was added: Urine Albumin Creatinine","confidence":0.99609375,"confidence_rate":0.9999232598207344},{"cnt":[[939,420],[1711,420],[1711,460],[939,460]],"region":{"top_left_x":939,"top_left_y":420,"width":772,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5252b87e2dc4ea2bd0c083a592c301c","type":"text","conversion_output":false,"parent_id":"f7211656e2e94839a1a6b090f014ba35","text":"Ratio (UACR) will be calculated at the central lab, and","text_display":" Ratio (UACR) will be calculated at the central lab, and","confidence":1,"confidence_rate":1},{"cnt":[[939,462],[1690,462],[1690,501],[939,501]],"region":{"top_left_x":939,"top_left_y":461,"width":751,"height":41},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12d18053df9e43e88645d12a8b4300a0","type":"text","conversion_output":false,"parent_id":"f7211656e2e94839a1a6b090f014ba35","text":"should be measured on a first morning void specimen","text_display":" should be measured on a first morning void specimen","confidence":0.99853515625,"confidence_rate":0.9999738232411441},{"cnt":[[939,503],[1204,503],[1204,538],[939,538]],"region":{"top_left_x":939,"top_left_y":503,"width":266,"height":35},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3429755b4c874c358f86b957ae54cd2a","type":"text","conversion_output":false,"parent_id":"f7211656e2e94839a1a6b090f014ba35","text":"wherever possible.","text_display":" wherever possible.","confidence":1,"confidence_rate":1},{"cnt":[[267,545],[580,545],[580,584],[267,584]],"region":{"top_left_x":267,"top_left_y":544,"width":314,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"213ec461d9144193a766a532f22bbe23","type":"simple_cell","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,540],[1736,540],[1736,2143],[935,2143]],"region":{"top_left_x":934,"top_left_y":540,"width":803,"height":1603},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"435d117aa374435f9d1f8353efd1b2a1","type":"complex_cell","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","children_ids":["053425af5a114f6d806c9e8ba77870bf","eb3eddd714664c0f854d8fcf379bb846","3c63a6f70f934d82b45d13e61361930a","4896318e7822437aa38792178a4cfaeb","1a9b0c3489a841a889872017692cdb68","25fc28432a2c46e18e0afc73d2bcecc6","45757aa7534748bc870d8d893dbe8d5c","ddd40eee79304447929af7b48cd27be1","875de917e0ad415cbefac754c9de8dd4","ef46e061d1fe46d0b4bbba3e433b3073","b290ee201d674f30964d86ae2f4efc7b","571da82cabac43da866e5c9f34bdcc9e","cc2bb4e579bc4cf99c300af9de0956f6","3011d20d53964861b56cbc63e7c89c47","72e19e43be744279aed2aca21a730ee6","47a2d6dd85934026abb81409e8ed5733","33d2ca84a9d04474a492ae2edbc62a51","397e7d01b9fb4b88a43da2ae3e2e09e6","b6b30e22d5ed46e69fdb8350b5c7cacb","b046e9fe55ed49f3bf7981c04b07ef95","84178ecc3f5f4cb08e07b4931499d6e6","244477a7edf94778960f2fe754d1263f","b084b7e7f1254877987ccf5ce9b30eb8","a3c6b42a61214f1faae1d955a317f2fa"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nTo allow possible retrospective pharmacogenetic analyses. \\\\\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nFor clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint). \\\\\nChange 5: \\\\\nTo add lipase to the laboratory assessment schedule. \\\\\nChange 7: \\\\\nCorrection of typographical error. \\\\\nChange 8: \\\\\nTo clarify the allowed time window between study visits in relation to the available study medication dispensed. \\\\\nChange 9: \\\\\nTo add an explanatory footnote for the pharmacogenetic sampling added to the flowchart. \\\\\nChange 10: \\\\\nFor clarification in line with section 5.2.3 of the clinical trial protocol.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nTo allow possible retrospective pharmacogenetic analyses. \\\\\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nFor clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint). \\\\\nChange 5: \\\\\nTo add lipase to the laboratory assessment schedule. \\\\\nChange 7: \\\\\nCorrection of typographical error. \\\\\nChange 8: \\\\\nTo clarify the allowed time window between study visits in relation to the available study medication dispensed. \\\\\nChange 9: \\\\\nTo add an explanatory footnote for the pharmacogenetic sampling added to the flowchart. \\\\\nChange 10: \\\\\nFor clarification in line with section 5.2.3 of the clinical trial protocol.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.998046875,"confidence_rate":0.9999874817368672},{"cnt":[[939,545],[1089,545],[1089,582],[939,582]],"region":{"top_left_x":939,"top_left_y":544,"width":151,"height":38},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"053425af5a114f6d806c9e8ba77870bf","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,582],[1628,582],[1628,621],[939,621]],"region":{"top_left_x":939,"top_left_y":581,"width":689,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb3eddd714664c0f854d8fcf379bb846","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"To allow possible retrospective pharmacogenetic","text_display":"\nTo allow possible retrospective pharmacogenetic","confidence":1,"confidence_rate":1},{"cnt":[[939,623],[1071,623],[1071,662],[939,662]],"region":{"top_left_x":939,"top_left_y":623,"width":132,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c63a6f70f934d82b45d13e61361930a","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"analyses.","text_display":" analyses.","confidence":1,"confidence_rate":1},{"cnt":[[939,704],[1087,704],[1087,741],[939,741]],"region":{"top_left_x":939,"top_left_y":703,"width":148,"height":38},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4896318e7822437aa38792178a4cfaeb","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,743],[1177,743],[1177,777],[939,777]],"region":{"top_left_x":939,"top_left_y":742,"width":238,"height":36},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a9b0c3489a841a889872017692cdb68","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"For clarification.","text_display":"\nFor clarification.","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[939,821],[1087,821],[1087,860],[939,860]],"region":{"top_left_x":939,"top_left_y":821,"width":148,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25fc28432a2c46e18e0afc73d2bcecc6","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"Change 3:","text_display":"\nChange 3:","confidence":0.998046875,"confidence_rate":0.9998603644045428},{"cnt":[[939,863],[1720,863],[1720,897],[939,897]],"region":{"top_left_x":939,"top_left_y":862,"width":781,"height":36},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45757aa7534748bc870d8d893dbe8d5c","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"For clarification and to add creatinine for calculation of","text_display":"\nFor clarification and to add creatinine for calculation of","confidence":1,"confidence_rate":1},{"cnt":[[939,904],[1715,904],[1715,943],[939,943]],"region":{"top_left_x":939,"top_left_y":904,"width":777,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ddd40eee79304447929af7b48cd27be1","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"eGFR to the assessments for patients who pre-maturely","text_display":" eGFR to the assessments for patients who pre-maturely","confidence":1,"confidence_rate":1},{"cnt":[[939,941],[1734,941],[1734,980],[939,980]],"region":{"top_left_x":939,"top_left_y":940,"width":795,"height":41},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"875de917e0ad415cbefac754c9de8dd4","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"discontinue study medication, but are willing to return to","text_display":" discontinue study medication, but are willing to return to","confidence":1,"confidence_rate":1},{"cnt":[[939,982],[1734,982],[1734,1021],[939,1021]],"region":{"top_left_x":939,"top_left_y":982,"width":795,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef46e061d1fe46d0b4bbba3e433b3073","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"the pre-defined study visits (ITT principle, primary renal","text_display":" the pre-defined study visits (ITT principle, primary renal","confidence":1,"confidence_rate":1},{"cnt":[[939,1024],[1084,1024],[1084,1063],[939,1063]],"region":{"top_left_x":939,"top_left_y":1023,"width":146,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b290ee201d674f30964d86ae2f4efc7b","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"endpoint).","text_display":" endpoint).","confidence":1,"confidence_rate":1},{"cnt":[[939,1263],[1087,1263],[1087,1302],[939,1302]],"region":{"top_left_x":939,"top_left_y":1263,"width":148,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"571da82cabac43da866e5c9f34bdcc9e","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"Change 5:","text_display":"\nChange 5:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[939,1302],[1669,1302],[1669,1339],[939,1339]],"region":{"top_left_x":939,"top_left_y":1302,"width":731,"height":38},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cc2bb4e579bc4cf99c300af9de0956f6","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"To add lipase to the laboratory assessment schedule.","text_display":"\nTo add lipase to the laboratory assessment schedule.","confidence":1,"confidence_rate":1},{"cnt":[[939,1581],[1089,1581],[1089,1620],[939,1620]],"region":{"top_left_x":939,"top_left_y":1580,"width":151,"height":41},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3011d20d53964861b56cbc63e7c89c47","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"Change 7:","text_display":"\nChange 7:","confidence":1,"confidence_rate":1},{"cnt":[[939,1622],[1416,1622],[1416,1662],[939,1662]],"region":{"top_left_x":939,"top_left_y":1622,"width":477,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72e19e43be744279aed2aca21a730ee6","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"Correction of typographical error.","text_display":"\nCorrection of typographical error.","confidence":1,"confidence_rate":1},{"cnt":[[939,1701],[1089,1701],[1089,1740],[939,1740]],"region":{"top_left_x":939,"top_left_y":1700,"width":151,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47a2d6dd85934026abb81409e8ed5733","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"Change 8:","text_display":"\nChange 8:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1742],[1734,1742],[1734,1781],[939,1781]],"region":{"top_left_x":939,"top_left_y":1742,"width":795,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"33d2ca84a9d04474a492ae2edbc62a51","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"To clarify the allowed time window between study visits","text_display":"\nTo clarify the allowed time window between study visits","confidence":1,"confidence_rate":1},{"cnt":[[939,1784],[1706,1784],[1706,1823],[939,1823]],"region":{"top_left_x":939,"top_left_y":1783,"width":768,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"397e7d01b9fb4b88a43da2ae3e2e09e6","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"in relation to the available study medication dispensed.","text_display":" in relation to the available study medication dispensed.","confidence":1,"confidence_rate":1},{"cnt":[[939,1862],[1087,1862],[1087,1901],[939,1901]],"region":{"top_left_x":939,"top_left_y":1861,"width":148,"height":41},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6b30e22d5ed46e69fdb8350b5c7cacb","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"Change 9:","text_display":"\nChange 9:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1901],[1729,1901],[1729,1940],[939,1940]],"region":{"top_left_x":939,"top_left_y":1901,"width":791,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b046e9fe55ed49f3bf7981c04b07ef95","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"To add an explanatory footnote for the pharmacogenetic","text_display":"\nTo add an explanatory footnote for the pharmacogenetic","confidence":1,"confidence_rate":1},{"cnt":[[939,1940],[1400,1940],[1400,1979],[939,1979]],"region":{"top_left_x":939,"top_left_y":1940,"width":461,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84178ecc3f5f4cb08e07b4931499d6e6","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"sampling added to the flowchart.","text_display":" sampling added to the flowchart.","confidence":1,"confidence_rate":1},{"cnt":[[939,2023],[1103,2023],[1103,2058],[939,2058]],"region":{"top_left_x":939,"top_left_y":2023,"width":164,"height":35},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"244477a7edf94778960f2fe754d1263f","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"Change 10:","text_display":"\nChange 10:","confidence":1,"confidence_rate":1},{"cnt":[[939,2060],[1720,2060],[1720,2094],[939,2094]],"region":{"top_left_x":939,"top_left_y":2059,"width":781,"height":36},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b084b7e7f1254877987ccf5ce9b30eb8","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"For clarification in line with section 5.2.3 of the clinical","text_display":"\nFor clarification in line with section 5.2.3 of the clinical","confidence":1,"confidence_rate":1},{"cnt":[[939,2101],[1135,2101],[1135,2140],[939,2140]],"region":{"top_left_x":939,"top_left_y":2101,"width":197,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3c6b42a61214f1faae1d955a317f2fa","type":"text","conversion_output":false,"parent_id":"435d117aa374435f9d1f8353efd1b2a1","text":"trial protocol.","text_display":" trial protocol.","confidence":1,"confidence_rate":1},{"cnt":[[267,2145],[592,2145],[592,2182],[267,2182]],"region":{"top_left_x":267,"top_left_y":2145,"width":325,"height":37},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0200454973674bf2bfa847d69fe352e8","type":"simple_cell","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2147],[1153,2147],[1153,2177],[939,2177]],"region":{"top_left_x":939,"top_left_y":2147,"width":215,"height":31},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f4db0da3ab44593b4d5101974bc0dd9","type":"simple_cell","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"Abbreviations","text_display":"Abbreviations","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2193],[592,2193],[592,2233],[267,2233]],"region":{"top_left_x":267,"top_left_y":2193,"width":325,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae9bd99de07445818b57e44b69a828b3","type":"simple_cell","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2189],[1690,2189],[1690,2428],[935,2428]],"region":{"top_left_x":934,"top_left_y":2188,"width":756,"height":241},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b316bdd8ad54fe68e94ac0ae6b82c77","type":"complex_cell","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","children_ids":["e3560ad85fb44410874d7acc18743dd8","9651e132188a40dfa5cd91ec3752a9f9","73ec941a3e4a4db3bc583113a12793b6","d4ce48236c294ed9a23b28363fa6cda0","4f88390705dd4111ab6335a69d8b358d"],"text":"\\begin{tabular}{l}\nThe following abbreviation was added: \\\\\nDNA - Deoxyribonucleic Acid \\\\\nIn addition: \\\\\nEOT - End of Trial was changed into: EOT - End of Treatment.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe following abbreviation was added: \\\\\nDNA - Deoxyribonucleic Acid \\\\\nIn addition: \\\\\nEOT - End of Trial was changed into: EOT - End of Treatment.\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2191],[1490,2191],[1490,2233],[939,2233]],"region":{"top_left_x":939,"top_left_y":2191,"width":551,"height":42},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3560ad85fb44410874d7acc18743dd8","type":"text","conversion_output":false,"parent_id":"6b316bdd8ad54fe68e94ac0ae6b82c77","text":"The following abbreviation was added:","text_display":"The following abbreviation was added:","confidence":1,"confidence_rate":1},{"cnt":[[939,2233],[1381,2233],[1381,2272],[939,2272]],"region":{"top_left_x":939,"top_left_y":2232,"width":443,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9651e132188a40dfa5cd91ec3752a9f9","type":"text","conversion_output":false,"parent_id":"6b316bdd8ad54fe68e94ac0ae6b82c77","text":"DNA - Deoxyribonucleic Acid","text_display":"\nDNA - Deoxyribonucleic Acid","confidence":1,"confidence_rate":1},{"cnt":[[939,2313],[1105,2313],[1105,2348],[939,2348]],"region":{"top_left_x":939,"top_left_y":2313,"width":167,"height":35},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73ec941a3e4a4db3bc583113a12793b6","type":"text","conversion_output":false,"parent_id":"6b316bdd8ad54fe68e94ac0ae6b82c77","text":"In addition:","text_display":"\nIn addition:","confidence":1,"confidence_rate":1},{"cnt":[[939,2352],[1683,2352],[1683,2389],[939,2389]],"region":{"top_left_x":939,"top_left_y":2352,"width":745,"height":38},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4ce48236c294ed9a23b28363fa6cda0","type":"text","conversion_output":false,"parent_id":"6b316bdd8ad54fe68e94ac0ae6b82c77","text":"EOT - End of Trial was changed into: EOT - End of","text_display":"\nEOT - End of Trial was changed into: EOT - End of","confidence":1,"confidence_rate":1},{"cnt":[[939,2391],[1094,2391],[1094,2426],[939,2426]],"region":{"top_left_x":939,"top_left_y":2391,"width":155,"height":35},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f88390705dd4111ab6335a69d8b358d","type":"text","conversion_output":false,"parent_id":"6b316bdd8ad54fe68e94ac0ae6b82c77","text":"Treatment.","text_display":" Treatment.","confidence":1,"confidence_rate":1},{"cnt":[[267,2435],[582,2435],[582,2477],[267,2477]],"region":{"top_left_x":267,"top_left_y":2435,"width":316,"height":42},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed4ead75621f400d8949c76d2804926f","type":"simple_cell","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","text":"Rationale for change","text_display":"Rationale for change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,2433],[1232,2433],[1232,2509],[937,2509]],"region":{"top_left_x":937,"top_left_y":2432,"width":295,"height":77},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"216dcb92d51f4f348d564a94f1698a3f","type":"complex_cell","conversion_output":false,"parent_id":"ca73851f6f9f4ff3b07ba6fdd857a04d","children_ids":["d40995e948414bbc944bd30a96e39f8f","dba80f682a394a69be8719881c74bd6e"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nAbbreviation added.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nAbbreviation added.\n\\end{tabular}","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9970703125,"confidence_rate":0.999938877129854},{"cnt":[[939,2435],[1089,2435],[1089,2472],[939,2472]],"region":{"top_left_x":939,"top_left_y":2435,"width":151,"height":38},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d40995e948414bbc944bd30a96e39f8f","type":"text","conversion_output":false,"parent_id":"216dcb92d51f4f348d564a94f1698a3f","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2474],[1227,2474],[1227,2509],[939,2509]],"region":{"top_left_x":939,"top_left_y":2474,"width":289,"height":35},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dba80f682a394a69be8719881c74bd6e","type":"text","conversion_output":false,"parent_id":"216dcb92d51f4f348d564a94f1698a3f","text":"Abbreviation added.","text_display":"\nAbbreviation added.","confidence":0.9970703125,"confidence_rate":0.9998777579957132},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":60,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4b8041bf88854dbc8b46e0d52b78bd24","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[288,2620],[1798,2620],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2620,"width":1511,"height":42},"line":61,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e57ee7cb028d4b359025c655601e65b6","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.9794921875,"confidence_rate":0.9998258889604521},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":62,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"05b9ac1fde604a208edc993794da2760","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-087","page":87,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2fd2929686f4217a48b4ae9d0be335c","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58b1416988cf475f8a7f52bee844566a","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,164],[599,164],[599,203],[244,203]],"region":{"top_left_x":244,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"576699b9749849e187e96046165fd4f1","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08a0cb0ec5ff47398d7abb73521d94f8","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ffb3e44a1ac4277a2fefc15ed971d15","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2ebf36c497f4aedaf19622286be36e5","type":"page_info","conversion_output":false,"text":"Page 87 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2543],[244,2543]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2210},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f90d379baa34c37ad70a309ae3ad58f","type":"table","conversion_output":true,"children_ids":["a22f1112fdbb4b859b0d952a0193d51d","e0d239f248d94734897acea77d590101","a0550ec759da40f1ad11d89234cd3fb1","72d659b4d03149f4b8bcbf38ea728611","13e144d876484bfa9cedb57089f54b15","2918b891943249df9a48d110980dab73","c6c25db6467543d2a14db9dc4a8b80b3","4a9d2ba117544342bfa57c2747177e9b","aeb40a2b244a4a81b54a832f7fb32c6e","ff3c975310d24665bba5fa483290c969","06c1e4d813b7403a9b0391a0e61b863f","4149dce0a0214ee99c766244b607a54e","3800585b3fe74500b92f2ff9e218b699","d8829e7ecfe3403f9b3793e6c923b8e8","c6bdae00f28b4530986ca85d685e0b60","24ef6d1f997d4181935524d3d69add9f","22c7e4ac141f40219f2a84fe75e0acaf","1157faafb5e24db4b05a712a999fb0f1","b028d8b3b8ac4a4ab31c0d70cd1781aa","b5deb35e811d4e2d8ca822ef359c41de","c8750f11edf343c086a9944e63842c11","357e7b015fd543d29c0812dfbdd0ffcd","7eb582778fe548cc95b23c07832a772e","b2d72deaf2054f72b7836667a2471d76","a4628a01441a4c3c9a0d32dd5c670042","fae32ce1b0274e288ec4eaf73fe1d937","c680f7c71efd410c98f76d35b06e9343","f16feaa3bf334e79990d004e5bbaebe9","ca7e8686498547029ddb05c825030df3","26f755e2b50b40a98bcbe2dbcd5849be","512ce86d220f4e8fbb9d25d09f126e35"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 2: \\\\\nFor clarification.\n\\end{tabular} \\\\\n\\hline Section to be changed & 1.1 Medical background \\\\\n\\hline Description of change & \\begin{tabular}{l}\nIn this large-scale intervention trial we will test the impact of treatment with the DPP-4 inhibitor linagliptin head-to-head versus placebo on long-term CV safety. \\\\\nWas changed into: \\\\\nIn this large-scale intervention trial we will test the impact of treatment with the DPP-4 inhibitor linagliptin head-to-head versus placebo on long-term CV safety as well as the potential preventive impact on CV and renal complications.\n\\end{tabular} \\\\\n\\hline Rationale for change & To underscore the importance of the renal aspects in the study. \\\\\n\\hline Section to be changed & 2.1 Rationale for performing the trial \\\\\n\\hline Description of change & \\begin{tabular}{l}\nParagraph 5: \\\\\n...predefined urin albumin ...was changed into ....predefined urine albumin.\n\\end{tabular} \\\\\n\\hline Rationale for change & Correction of typographical error. \\\\\n\\hline Section to be changed & 3.1 Overall trial design and plan \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nEnd of Trial..... was changed into: End of Treatment.... \\\\\nChange 2: \\\\\n....Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nFor clarification. \\\\\nChange 2: \\\\\nFor clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint).\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 2: \\\\\nFor clarification.\n\\end{tabular} \\\\\n\\hline Section to be changed & 1.1 Medical background \\\\\n\\hline Description of change & \\begin{tabular}{l}\nIn this large-scale intervention trial we will test the impact of treatment with the DPP-4 inhibitor linagliptin head-to-head versus placebo on long-term CV safety. \\\\\nWas changed into: \\\\\nIn this large-scale intervention trial we will test the impact of treatment with the DPP-4 inhibitor linagliptin head-to-head versus placebo on long-term CV safety as well as the potential preventive impact on CV and renal complications.\n\\end{tabular} \\\\\n\\hline Rationale for change & To underscore the importance of the renal aspects in the study. \\\\\n\\hline Section to be changed & 2.1 Rationale for performing the trial \\\\\n\\hline Description of change & \\begin{tabular}{l}\nParagraph 5: \\\\\n...predefined urin albumin ...was changed into ....predefined urine albumin.\n\\end{tabular} \\\\\n\\hline Rationale for change & Correction of typographical error. \\\\\n\\hline Section to be changed & 3.1 Overall trial design and plan \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nEnd of Trial..... was changed into: End of Treatment.... \\\\\nChange 2: \\\\\n....Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nFor clarification. \\\\\nChange 2: \\\\\nFor clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint).\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.6338442398493953,"confidence_rate":0.9999648084941},{"cnt":[[251,333],[603,333],[606,2541],[253,2541]],"region":{"top_left_x":250,"top_left_y":332,"width":356,"height":2210},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a22f1112fdbb4b859b0d952a0193d51d","type":"table_column","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[914,333],[1750,333],[1750,2541],[914,2541]],"region":{"top_left_x":914,"top_left_y":333,"width":836,"height":2209},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0d239f248d94734897acea77d590101","type":"table_column","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,338],[1775,333],[1775,420],[244,425]],"region":{"top_left_x":243,"top_left_y":333,"width":1533,"height":92},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0550ec759da40f1ad11d89234cd3fb1","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,437],[1775,437],[1775,483],[244,483]],"region":{"top_left_x":244,"top_left_y":436,"width":1532,"height":47},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72d659b4d03149f4b8bcbf38ea728611","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,483],[1775,483],[1775,893],[244,893]],"region":{"top_left_x":244,"top_left_y":482,"width":1532,"height":411},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13e144d876484bfa9cedb57089f54b15","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,888],[1775,888],[1775,973],[244,973]],"region":{"top_left_x":244,"top_left_y":887,"width":1532,"height":87},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2918b891943249df9a48d110980dab73","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,968],[1775,968],[1775,1017],[244,1017]],"region":{"top_left_x":244,"top_left_y":968,"width":1532,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6c25db6467543d2a14db9dc4a8b80b3","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,1019],[1775,1019],[1775,1146],[244,1146]],"region":{"top_left_x":244,"top_left_y":1019,"width":1532,"height":127},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a9d2ba117544342bfa57c2747177e9b","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,1139],[1775,1139],[1775,1190],[244,1190]],"region":{"top_left_x":244,"top_left_y":1138,"width":1532,"height":52},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aeb40a2b244a4a81b54a832f7fb32c6e","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,1203],[1775,1203],[1775,1252],[244,1252]],"region":{"top_left_x":244,"top_left_y":1203,"width":1532,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff3c975310d24665bba5fa483290c969","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,1249],[1775,1249],[1775,2021],[244,2021]],"region":{"top_left_x":244,"top_left_y":1249,"width":1532,"height":772},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06c1e4d813b7403a9b0391a0e61b863f","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[244,2014],[1775,2014],[1775,2396],[244,2396]],"region":{"top_left_x":244,"top_left_y":2013,"width":1532,"height":384},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4149dce0a0214ee99c766244b607a54e","type":"table_row","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"","text_display":""},{"cnt":[[935,338],[1181,338],[1181,418],[935,418]],"region":{"top_left_x":934,"top_left_y":337,"width":248,"height":82},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3800585b3fe74500b92f2ff9e218b699","type":"complex_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","children_ids":["ec4a570a380b4b5b8e2b0ba32c47f2ab","530534b480174aae97977650f9c54112"],"text":"\\begin{tabular}{l}\nChange 2: \\\\\nFor clarification.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 2: \\\\\nFor clarification.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,342],[1087,342],[1087,381],[939,381]],"region":{"top_left_x":939,"top_left_y":342,"width":148,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec4a570a380b4b5b8e2b0ba32c47f2ab","type":"text","conversion_output":false,"parent_id":"3800585b3fe74500b92f2ff9e218b699","text":"Change 2:","text_display":"Change 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,381],[1177,381],[1177,414],[939,414]],"region":{"top_left_x":939,"top_left_y":381,"width":238,"height":33},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"530534b480174aae97977650f9c54112","type":"text","conversion_output":false,"parent_id":"3800585b3fe74500b92f2ff9e218b699","text":"For clarification.","text_display":"\nFor clarification.","confidence":1,"confidence_rate":1},{"cnt":[[265,439],[592,439],[592,483],[265,483]],"region":{"top_left_x":264,"top_left_y":438,"width":328,"height":45},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8829e7ecfe3403f9b3793e6c923b8e8","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Section to be changed","text_display":"Section to be changed","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,439],[1305,439],[1305,483],[939,483]],"region":{"top_left_x":939,"top_left_y":438,"width":367,"height":45},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6bdae00f28b4530986ca85d685e0b60","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"1.1 Medical background","text_display":"1.1 Medical background","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,490],[596,490],[596,531],[265,531]],"region":{"top_left_x":264,"top_left_y":489,"width":333,"height":43},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24ef6d1f997d4181935524d3d69add9f","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Description of change","text_display":"Description of change","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,485],[1729,485],[1729,893],[935,893]],"region":{"top_left_x":934,"top_left_y":484,"width":796,"height":409},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22c7e4ac141f40219f2a84fe75e0acaf","type":"complex_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","children_ids":["f24db23248c0424c9fbd75a2c12bc8b2","d1cf217720204278a8eb72d2f040bed1","c21aea5057434e1eb7bc74f576eda85d","2f264dc2b1ff4b9bb5938074ed0b20f4","9dd4d7ff6dbc45a08a4c49241ab8eba2","050a30b7b7fe4166acda39f2bb714903","0ea1c5a43ef74718b8d08b6528483cb7","2fe5d4056b824c0084809a731aaf3e82","99a537e9a6274acfb4b7d7cd0c1084f0"],"text":"\\begin{tabular}{l}\nIn this large-scale intervention trial we will test the impact of treatment with the DPP-4 inhibitor linagliptin head-to-head versus placebo on long-term CV safety. \\\\\nWas changed into: \\\\\nIn this large-scale intervention trial we will test the impact of treatment with the DPP-4 inhibitor linagliptin head-to-head versus placebo on long-term CV safety as well as the potential preventive impact on CV and renal complications.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nIn this large-scale intervention trial we will test the impact of treatment with the DPP-4 inhibitor linagliptin head-to-head versus placebo on long-term CV safety. \\\\\nWas changed into: \\\\\nIn this large-scale intervention trial we will test the impact of treatment with the DPP-4 inhibitor linagliptin head-to-head versus placebo on long-term CV safety as well as the potential preventive impact on CV and renal complications.\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99853515625,"confidence_rate":0.999991691964486},{"cnt":[[939,490],[1655,490],[1655,529],[939,529]],"region":{"top_left_x":939,"top_left_y":489,"width":717,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f24db23248c0424c9fbd75a2c12bc8b2","type":"text","conversion_output":false,"parent_id":"22c7e4ac141f40219f2a84fe75e0acaf","text":"In this large-scale intervention trial we will test the","text_display":"In this large-scale intervention trial we will test the","confidence":1,"confidence_rate":1},{"cnt":[[939,526],[1720,526],[1720,570],[939,570]],"region":{"top_left_x":939,"top_left_y":526,"width":781,"height":45},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1cf217720204278a8eb72d2f040bed1","type":"text","conversion_output":false,"parent_id":"22c7e4ac141f40219f2a84fe75e0acaf","text":"impact of treatment with the DPP-4 inhibitor linagliptin","text_display":" impact of treatment with the DPP-4 inhibitor linagliptin","confidence":1,"confidence_rate":1},{"cnt":[[939,568],[1688,568],[1688,612],[939,612]],"region":{"top_left_x":939,"top_left_y":567,"width":749,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c21aea5057434e1eb7bc74f576eda85d","type":"text","conversion_output":false,"parent_id":"22c7e4ac141f40219f2a84fe75e0acaf","text":"head-to-head versus placebo on long-term CV safety.","text_display":" head-to-head versus placebo on long-term CV safety.","confidence":1,"confidence_rate":1},{"cnt":[[939,648],[1204,648],[1204,690],[939,690]],"region":{"top_left_x":939,"top_left_y":648,"width":266,"height":42},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f264dc2b1ff4b9bb5938074ed0b20f4","type":"text","conversion_output":false,"parent_id":"22c7e4ac141f40219f2a84fe75e0acaf","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99853515625,"confidence_rate":0.9999333695979722},{"cnt":[[939,688],[1655,688],[1655,727],[939,727]],"region":{"top_left_x":939,"top_left_y":687,"width":717,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9dd4d7ff6dbc45a08a4c49241ab8eba2","type":"text","conversion_output":false,"parent_id":"22c7e4ac141f40219f2a84fe75e0acaf","text":"In this large-scale intervention trial we will test the","text_display":"\nIn this large-scale intervention trial we will test the","confidence":1,"confidence_rate":1},{"cnt":[[939,729],[1720,729],[1720,768],[939,768]],"region":{"top_left_x":939,"top_left_y":729,"width":781,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"050a30b7b7fe4166acda39f2bb714903","type":"text","conversion_output":false,"parent_id":"22c7e4ac141f40219f2a84fe75e0acaf","text":"impact of treatment with the DPP-4 inhibitor linagliptin","text_display":" impact of treatment with the DPP-4 inhibitor linagliptin","confidence":1,"confidence_rate":1},{"cnt":[[939,768],[1720,768],[1720,810],[939,810]],"region":{"top_left_x":939,"top_left_y":768,"width":781,"height":42},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ea1c5a43ef74718b8d08b6528483cb7","type":"text","conversion_output":false,"parent_id":"22c7e4ac141f40219f2a84fe75e0acaf","text":"head-to-head versus placebo on long-term CV safety as","text_display":" head-to-head versus placebo on long-term CV safety as","confidence":1,"confidence_rate":1},{"cnt":[[939,807],[1720,807],[1720,851],[939,851]],"region":{"top_left_x":939,"top_left_y":807,"width":781,"height":45},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fe5d4056b824c0084809a731aaf3e82","type":"text","conversion_output":false,"parent_id":"22c7e4ac141f40219f2a84fe75e0acaf","text":"well as the potential preventive impact on CV and renal","text_display":" well as the potential preventive impact on CV and renal","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[939,849],[1149,849],[1149,888],[939,888]],"region":{"top_left_x":939,"top_left_y":848,"width":210,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99a537e9a6274acfb4b7d7cd0c1084f0","type":"text","conversion_output":false,"parent_id":"22c7e4ac141f40219f2a84fe75e0acaf","text":"complications.","text_display":" complications.","confidence":1,"confidence_rate":1},{"cnt":[[265,890],[582,890],[582,932],[265,932]],"region":{"top_left_x":264,"top_left_y":890,"width":319,"height":42},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1157faafb5e24db4b05a712a999fb0f1","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Rationale for change","text_display":"Rationale for change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,888],[1729,888],[1729,971],[935,971]],"region":{"top_left_x":934,"top_left_y":887,"width":796,"height":84},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b028d8b3b8ac4a4ab31c0d70cd1781aa","type":"complex_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","children_ids":["e321cdbe085d4d5099877343269d3f50","030e75ab4fa142f79161f50cff2b94f8"],"text":"To underscore the importance of the renal aspects in the study.","text_display":"To underscore the importance of the renal aspects in the study.","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,890],[1725,890],[1725,929],[939,929]],"region":{"top_left_x":939,"top_left_y":890,"width":786,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e321cdbe085d4d5099877343269d3f50","type":"text","conversion_output":false,"parent_id":"b028d8b3b8ac4a4ab31c0d70cd1781aa","text":"To underscore the importance of the renal aspects in the","text_display":"To underscore the importance of the renal aspects in the","confidence":1,"confidence_rate":1},{"cnt":[[939,932],[1029,932],[1029,971],[939,971]],"region":{"top_left_x":939,"top_left_y":931,"width":91,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"030e75ab4fa142f79161f50cff2b94f8","type":"text","conversion_output":false,"parent_id":"b028d8b3b8ac4a4ab31c0d70cd1781aa","text":"study.","text_display":" study.","confidence":1,"confidence_rate":1},{"cnt":[[265,973],[596,973],[596,1012],[265,1012]],"region":{"top_left_x":264,"top_left_y":973,"width":333,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5deb35e811d4e2d8ca822ef359c41de","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Section to be changed","text_display":"Section to be changed","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,973],[1503,973],[1503,1012],[939,1012]],"region":{"top_left_x":939,"top_left_y":973,"width":565,"height":40},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8750f11edf343c086a9944e63842c11","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"2.1 Rationale for performing the trial","text_display":"2.1 Rationale for performing the trial","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,1024],[596,1024],[596,1063],[265,1063]],"region":{"top_left_x":264,"top_left_y":1023,"width":333,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"357e7b015fd543d29c0812dfbdd0ffcd","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Description of change","text_display":"Description of change","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1019],[1605,1019],[1605,1146],[935,1146]],"region":{"top_left_x":934,"top_left_y":1019,"width":671,"height":127},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7eb582778fe548cc95b23c07832a772e","type":"complex_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","children_ids":["8ed452b5677c43f89c9a3accdd60d8b3","800e7a1c393c4ca1865ace69aafdad94","b039c01db0a64177880ca1e4ebb5afa9"],"text":"\\begin{tabular}{l}\nParagraph 5: \\\\\n...predefined urin albumin ...was changed into ....predefined urine albumin.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nParagraph 5: \\\\\n...predefined urin albumin ...was changed into ....predefined urine albumin.\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9897630155319348,"confidence_rate":0.9999327490407961},{"cnt":[[939,1024],[1121,1024],[1121,1063],[939,1063]],"region":{"top_left_x":939,"top_left_y":1023,"width":183,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ed452b5677c43f89c9a3accdd60d8b3","type":"text","conversion_output":false,"parent_id":"7eb582778fe548cc95b23c07832a772e","text":"Paragraph 5:","text_display":"Paragraph 5:","confidence":1,"confidence_rate":1},{"cnt":[[939,1061],[1600,1061],[1600,1102],[939,1102]],"region":{"top_left_x":939,"top_left_y":1060,"width":662,"height":43},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"800e7a1c393c4ca1865ace69aafdad94","type":"text","conversion_output":false,"parent_id":"7eb582778fe548cc95b23c07832a772e","text":"...predefined urin albumin ...was changed into","text_display":"\n...predefined urin albumin ...was changed into","confidence":0.9897630155319348,"confidence_rate":0.9997982606901585},{"cnt":[[939,1102],[1347,1102],[1347,1141],[939,1141]],"region":{"top_left_x":939,"top_left_y":1102,"width":408,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b039c01db0a64177880ca1e4ebb5afa9","type":"text","conversion_output":false,"parent_id":"7eb582778fe548cc95b23c07832a772e","text":"....predefined urine albumin.","text_display":" ....predefined urine albumin.","confidence":1,"confidence_rate":1},{"cnt":[[265,1143],[582,1143],[582,1187],[265,1187]],"region":{"top_left_x":264,"top_left_y":1143,"width":319,"height":45},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b2d72deaf2054f72b7836667a2471d76","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Rationale for change","text_display":"Rationale for change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1143],[1416,1143],[1416,1187],[939,1187]],"region":{"top_left_x":939,"top_left_y":1143,"width":477,"height":45},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4628a01441a4c3c9a0d32dd5c670042","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Correction of typographical error.","text_display":"Correction of typographical error.","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,1208],[596,1208],[596,1249],[265,1249]],"region":{"top_left_x":264,"top_left_y":1207,"width":333,"height":43},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fae32ce1b0274e288ec4eaf73fe1d937","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Section to be changed","text_display":"Section to be changed","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1208],[1425,1208],[1425,1247],[939,1247]],"region":{"top_left_x":939,"top_left_y":1207,"width":487,"height":41},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c680f7c71efd410c98f76d35b06e9343","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"3.1 Overall trial design and plan","text_display":"3.1 Overall trial design and plan","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,1259],[596,1259],[596,1298],[265,1298]],"region":{"top_left_x":264,"top_left_y":1258,"width":333,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f16feaa3bf334e79990d004e5bbaebe9","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Description of change","text_display":"Description of change","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1254],[1743,1254],[1743,2018],[935,2018]],"region":{"top_left_x":934,"top_left_y":1254,"width":809,"height":765},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca7e8686498547029ddb05c825030df3","type":"complex_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","children_ids":["6cbaee00d15348fca135d7b0292c7044","64b273e6524a429aad47cd600385f9ac","a853274a9b4244e9b41fcf61752b4374","076972a610f64fa59275e651c222c935","f81fdfc2264e4964a00a6c4ec2c1bd3c","c920713818544cec8de626c2f93a9945","b9251b0b8d214948a99ca20a08fbee7a","1bcd541efe1b4563beebc717d5338b80","29fd0922cced4fe082a9b59f63900f62","991f627245504c0ea6f45297663de45e","2f81c21f11a8403f8144a071ff76095d","caedf1da995b47f3a45622994480ba89","0801a345ee3f45cbb5dadbc3e09d4e86","1c0b26de19a046cfaeb81551cac80483","6b4b3435af2a47f09dec8cff9329eea3","a36bafe62d8441268eb4875c6b53b76f"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nEnd of Trial..... was changed into: End of Treatment.... \\\\\nChange 2: \\\\\n....Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nEnd of Trial..... was changed into: End of Treatment.... \\\\\nChange 2: \\\\\n....Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular}","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.6338442398493953,"confidence_rate":0.9994070867556675},{"cnt":[[939,1259],[1089,1259],[1089,1293],[939,1293]],"region":{"top_left_x":939,"top_left_y":1258,"width":151,"height":36},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6cbaee00d15348fca135d7b0292c7044","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1295],[1729,1295],[1729,1335],[939,1335]],"region":{"top_left_x":939,"top_left_y":1295,"width":791,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64b273e6524a429aad47cd600385f9ac","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"End of Trial..... was changed into: End of Treatment....","text_display":"\nEnd of Trial..... was changed into: End of Treatment....","confidence":0.6338442398493953,"confidence_rate":0.9925532420317865},{"cnt":[[939,1374],[1089,1374],[1089,1415],[939,1415]],"region":{"top_left_x":939,"top_left_y":1373,"width":151,"height":43},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a853274a9b4244e9b41fcf61752b4374","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,1415],[1669,1415],[1669,1459],[939,1459]],"region":{"top_left_x":939,"top_left_y":1415,"width":731,"height":44},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"076972a610f64fa59275e651c222c935","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"....Patients who discontinue study drug prematurely","text_display":"\n....Patients who discontinue study drug prematurely","confidence":1,"confidence_rate":1},{"cnt":[[939,1457],[1655,1457],[1655,1496],[939,1496]],"region":{"top_left_x":939,"top_left_y":1456,"width":717,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f81fdfc2264e4964a00a6c4ec2c1bd3c","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"should continue study visits until study end, but no","text_display":" should continue study visits until study end, but no","confidence":1,"confidence_rate":1},{"cnt":[[939,1496],[1676,1496],[1676,1537],[939,1537]],"region":{"top_left_x":939,"top_left_y":1495,"width":738,"height":43},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c920713818544cec8de626c2f93a9945","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"physical examination, vital signs, (safety) laboratory","text_display":" physical examination, vital signs, (safety) laboratory","confidence":1,"confidence_rate":1},{"cnt":[[939,1535],[1715,1535],[1715,1579],[939,1579]],"region":{"top_left_x":939,"top_left_y":1534,"width":777,"height":45},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b9251b0b8d214948a99ca20a08fbee7a","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\),","text_display":" sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\),","confidence":0.9931640625,"confidence_rate":0.9999097486840676},{"cnt":[[939,1576],[1559,1576],[1559,1615],[939,1615]],"region":{"top_left_x":939,"top_left_y":1576,"width":620,"height":40},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1bcd541efe1b4563beebc717d5338b80","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"UACR and eGFR) or ECG will be required.","text_display":" UACR and eGFR) or ECG will be required.","confidence":0.97216796875,"confidence_rate":0.9993586902249113},{"cnt":[[939,1655],[1204,1655],[1204,1698],[939,1698]],"region":{"top_left_x":939,"top_left_y":1654,"width":266,"height":45},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29fd0922cced4fe082a9b59f63900f62","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.97216796875,"confidence_rate":0.9987177917280503},{"cnt":[[939,1738],[1729,1738],[1729,1781],[939,1781]],"region":{"top_left_x":939,"top_left_y":1737,"width":791,"height":45},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"991f627245504c0ea6f45297663de45e","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"Patients who discontinue study drug prematurely should","text_display":"\nPatients who discontinue study drug prematurely should","confidence":1,"confidence_rate":1},{"cnt":[[939,1779],[1725,1779],[1725,1818],[939,1818]],"region":{"top_left_x":939,"top_left_y":1778,"width":786,"height":41},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f81c21f11a8403f8144a071ff76095d","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"continue study visits until study end. Study assessments","text_display":" continue study visits until study end. Study assessments","confidence":1,"confidence_rate":1},{"cnt":[[939,1818],[1738,1818],[1738,1860],[939,1860]],"region":{"top_left_x":939,"top_left_y":1818,"width":800,"height":42},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"caedf1da995b47f3a45622994480ba89","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"may be omitted if a patient is willing to return to the pre-","text_display":" may be omitted if a patient is willing to return to the pre","confidence":1,"confidence_rate":1},{"cnt":[[939,1857],[1480,1857],[1480,1901],[939,1901]],"region":{"top_left_x":939,"top_left_y":1857,"width":542,"height":45},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0801a345ee3f45cbb5dadbc3e09d4e86","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"defined study visits, with exception of","text_display":"defined study visits, with exception of","confidence":1,"confidence_rate":1},{"cnt":[[1018,1899],[1655,1899],[1655,1938],[1018,1938]],"region":{"top_left_x":1017,"top_left_y":1898,"width":639,"height":40},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c0b26de19a046cfaeb81551cac80483","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"collection of adverse events, outcome events,","text_display":" collection of adverse events, outcome events,","confidence":1,"confidence_rate":1},{"cnt":[[939,1938],[1729,1938],[1729,1979],[939,1979]],"region":{"top_left_x":939,"top_left_y":1937,"width":791,"height":43},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b4b3435af2a47f09dec8cff9329eea3","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"concomitant therapy and laboratory testing of creatinine","text_display":" concomitant therapy and laboratory testing of creatinine","confidence":1,"confidence_rate":1},{"cnt":[[939,1977],[1388,1977],[1388,2016],[939,2016]],"region":{"top_left_x":939,"top_left_y":1976,"width":450,"height":41},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a36bafe62d8441268eb4875c6b53b76f","type":"text","conversion_output":false,"parent_id":"ca7e8686498547029ddb05c825030df3","text":"for the calculation of the eGFR.","text_display":" for the calculation of the eGFR.","confidence":1,"confidence_rate":1},{"cnt":[[265,2018],[582,2018],[582,2062],[265,2062]],"region":{"top_left_x":264,"top_left_y":2018,"width":319,"height":45},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"26f755e2b50b40a98bcbe2dbcd5849be","type":"simple_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","text":"Rationale for change","text_display":"Rationale for change","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[932,2016],[1743,2016],[1743,2385],[932,2385]],"region":{"top_left_x":932,"top_left_y":2016,"width":811,"height":369},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"512ce86d220f4e8fbb9d25d09f126e35","type":"complex_cell","conversion_output":false,"parent_id":"7f90d379baa34c37ad70a309ae3ad58f","children_ids":["63330a7e25bc4a9286683446d154aab5","9f6b797304054e8db8fb8ba0e4f255db","c34cb6964c014ac1a925f300647d2120","74f53670f59e40c4ba5e9f915a7d998e","58b9b5d936b54cf6b6b2fad9d8b20e6a","1995ce2085e54ae8bfc1f568e556bcc1","b7ce8a490b9c498ba80ab856a2c3a7bb","51aeae92b9be4af6b5d2d1a07958052f"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nFor clarification. \\\\\nChange 2: \\\\\nFor clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nFor clarification. \\\\\nChange 2: \\\\\nFor clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint).\n\\end{tabular}","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2021],[1089,2021],[1089,2058],[939,2058]],"region":{"top_left_x":939,"top_left_y":2020,"width":151,"height":38},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63330a7e25bc4a9286683446d154aab5","type":"text","conversion_output":false,"parent_id":"512ce86d220f4e8fbb9d25d09f126e35","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2060],[1179,2060],[1179,2097],[939,2097]],"region":{"top_left_x":939,"top_left_y":2059,"width":240,"height":38},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f6b797304054e8db8fb8ba0e4f255db","type":"text","conversion_output":false,"parent_id":"512ce86d220f4e8fbb9d25d09f126e35","text":"For clarification.","text_display":"\nFor clarification.","confidence":1,"confidence_rate":1},{"cnt":[[939,2138],[1089,2138],[1089,2182],[939,2182]],"region":{"top_left_x":939,"top_left_y":2138,"width":151,"height":44},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c34cb6964c014ac1a925f300647d2120","type":"text","conversion_output":false,"parent_id":"512ce86d220f4e8fbb9d25d09f126e35","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2180],[1720,2180],[1720,2219],[939,2219]],"region":{"top_left_x":939,"top_left_y":2179,"width":781,"height":40},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74f53670f59e40c4ba5e9f915a7d998e","type":"text","conversion_output":false,"parent_id":"512ce86d220f4e8fbb9d25d09f126e35","text":"For clarification and to add creatinine for calculation of","text_display":"\nFor clarification and to add creatinine for calculation of","confidence":1,"confidence_rate":1},{"cnt":[[939,2219],[1720,2219],[1720,2260],[939,2260]],"region":{"top_left_x":939,"top_left_y":2218,"width":781,"height":43},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58b9b5d936b54cf6b6b2fad9d8b20e6a","type":"text","conversion_output":false,"parent_id":"512ce86d220f4e8fbb9d25d09f126e35","text":"eGFR to the assessments for patients who pre-maturely","text_display":" eGFR to the assessments for patients who pre-maturely","confidence":1,"confidence_rate":1},{"cnt":[[939,2258],[1738,2258],[1738,2302],[939,2302]],"region":{"top_left_x":939,"top_left_y":2257,"width":800,"height":45},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1995ce2085e54ae8bfc1f568e556bcc1","type":"text","conversion_output":false,"parent_id":"512ce86d220f4e8fbb9d25d09f126e35","text":"discontinue study medication, but are willing to return to","text_display":" discontinue study medication, but are willing to return to","confidence":1,"confidence_rate":1},{"cnt":[[939,2299],[1738,2299],[1738,2343],[939,2343]],"region":{"top_left_x":939,"top_left_y":2299,"width":800,"height":45},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7ce8a490b9c498ba80ab856a2c3a7bb","type":"text","conversion_output":false,"parent_id":"512ce86d220f4e8fbb9d25d09f126e35","text":"the pre-defined study visits (ITT principle, primary renal","text_display":" the pre-defined study visits (ITT principle, primary renal","confidence":1,"confidence_rate":1},{"cnt":[[939,2341],[1089,2341],[1089,2380],[939,2380]],"region":{"top_left_x":939,"top_left_y":2340,"width":151,"height":40},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51aeae92b9be4af6b5d2d1a07958052f","type":"text","conversion_output":false,"parent_id":"512ce86d220f4e8fbb9d25d09f126e35","text":"endpoint).","text_display":" endpoint).","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":79,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9742f458963f43f6bc1ef0b02a41f199","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[288,2622],[1798,2622],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2622,"width":1511,"height":40},"line":80,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f1fb19d2b91a4b69ba4c13b680fb8e13","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":81,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"79ef75f0eb2e40c5b8e74bdc587237da","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-088","page":88,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3ae447f888346ee8788102911b1c566","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ca95918e0d84c7293818c6c834c1f3f","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e8517bfece64459ab326a9947c01c9d","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c3b75898aa94e0eaa631dbe5f95a660","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0e3baf9f8984c469b3ea2e3807caf32","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d89cb67d22b477f99441485f4e452bb","type":"page_info","conversion_output":false,"text":"Page 88 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2561],[244,2561]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2230},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2000c7f69c9549d390bf3742a9f20fba","type":"table","conversion_output":true,"children_ids":["8fe79f78202e4161ad256584e2597cd8","f443d0278bf54ef9bc07914f2a636542","fd99e9efa9a9420384823d443338a264","a27052521e874974b5bfca2d301ce603","4368e10c4f9a489497b8cdc744c6190b","ac406cd425274645a574b8b68b914a78","57ef52bb46c84bb892f5c1ed3baaaa45","9b319c8978e140d4bf783c8164ac4337","58f9500db3c045cda222eff4515978d0","b1c683d2a3594ab69ef2b095d87d6fc2","59a993089d414d6f8101327ceadac7e9","23cd0bfdc9e848c29d5825f761f1df2d","a54bf4ae94d748269075333dd125e97a","901a1ae7ac904fcabfccd7dc80fe45a4","62beeb2b8349438aa587532a873a875e","205fd6aada294c70a07902e846a9ed85","c39f171216a7435fa421133e2e04418e","0f740dbdc7ff46649d6ab67e5ad051c1","86860d31dba14b388dc02f04ba354ac8","13f418fa64bc4aea91ee5c6eb4b32a49"],"text":"\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 3.1.1 Administrative structure of the trial \\\\\n\\hline Description of change & \\begin{tabular}{l}\nAdditionally, a separate independent, blinded, external committee will be set up for adjudication of renal events. The adjudication process for renal events will be clarified separately in a CEC charter. \\\\\nWas changed into: \\\\\nAdditionally, separate independent, blinded, external committees will be set up for adjudication of renal events and pancreatic events. The adjudication process for renal events and pancreatic events will be clarified in a separate CEC charter.\n\\end{tabular} \\\\\n\\hline Rationale for change & To add independent adjudication of pancreatic events. \\\\\n\\hline Section to be changed & 3.3.2 inclusion criteria \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nInclusion criterion number 8: the definition of albuminuria \\(\\geq 30 mg / l\\) (milligram albumin per litre of urine) was removed. \\\\\nChange 2: \\\\\nInclusion criterion number 8: Impaired renal function (as defined by MDRD formula) with an eGFR: 15-45 \\(mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR. \\\\\nWas changed into: \\\\\nImpaired renal function (as defined by MDRD formula) with an eGFR: \\(15-<45 mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR. \\\\\nChange 3: \\\\\nInclusion criterion number 8: the definition of UACR \\(\\geq 200 mg / l\\) (milligram albumin per litre of urine) was removed. \\\\\nChange 4: \\\\\nInclusion criterion number 8: MRI angiography was added as clinical test and clinical tests were added to the second bullet under inclusion criterion 8b and 8c.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo reflect the definition KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. \\\\\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo reflect the definition KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. \\\\\nChange 4: \\\\\nTo add MRI angiography as clinical test and to clarify\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 3.1.1 Administrative structure of the trial \\\\\n\\hline Description of change & \\begin{tabular}{l}\nAdditionally, a separate independent, blinded, external committee will be set up for adjudication of renal events. The adjudication process for renal events will be clarified separately in a CEC charter. \\\\\nWas changed into: \\\\\nAdditionally, separate independent, blinded, external committees will be set up for adjudication of renal events and pancreatic events. The adjudication process for renal events and pancreatic events will be clarified in a separate CEC charter.\n\\end{tabular} \\\\\n\\hline Rationale for change & To add independent adjudication of pancreatic events. \\\\\n\\hline Section to be changed & 3.3.2 inclusion criteria \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nInclusion criterion number 8: the definition of albuminuria \\(\\geq 30 mg / l\\) (milligram albumin per litre of urine) was removed. \\\\\nChange 2: \\\\\nInclusion criterion number 8: Impaired renal function (as defined by MDRD formula) with an eGFR: 15-45 \\(mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR. \\\\\nWas changed into: \\\\\nImpaired renal function (as defined by MDRD formula) with an eGFR: \\(15-<45 mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR. \\\\\nChange 3: \\\\\nInclusion criterion number 8: the definition of UACR \\(\\geq 200 mg / l\\) (milligram albumin per litre of urine) was removed. \\\\\nChange 4: \\\\\nInclusion criterion number 8: MRI angiography was added as clinical test and clinical tests were added to the second bullet under inclusion criterion 8b and 8c.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo reflect the definition KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. \\\\\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo reflect the definition KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. \\\\\nChange 4: \\\\\nTo add MRI angiography as clinical test and to clarify\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.94283127784729,"confidence_rate":0.9999909823498571},{"cnt":[[251,331],[601,331],[601,2562],[251,2562]],"region":{"top_left_x":250,"top_left_y":331,"width":351,"height":2232},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fe79f78202e4161ad256584e2597cd8","type":"table_column","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"","text_display":""},{"cnt":[[921,331],[1768,331],[1768,2562],[921,2562]],"region":{"top_left_x":920,"top_left_y":331,"width":849,"height":2232},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f443d0278bf54ef9bc07914f2a636542","type":"table_column","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"","text_display":""},{"cnt":[[244,336],[1775,336],[1775,384],[244,384]],"region":{"top_left_x":244,"top_left_y":335,"width":1532,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd99e9efa9a9420384823d443338a264","type":"table_row","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"","text_display":""},{"cnt":[[244,382],[1775,382],[1775,879],[244,879]],"region":{"top_left_x":244,"top_left_y":381,"width":1532,"height":498},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a27052521e874974b5bfca2d301ce603","type":"table_row","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"","text_display":""},{"cnt":[[244,884],[1775,884],[1775,934],[244,934]],"region":{"top_left_x":244,"top_left_y":883,"width":1532,"height":52},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4368e10c4f9a489497b8cdc744c6190b","type":"table_row","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"","text_display":""},{"cnt":[[244,943],[1775,943],[1775,992],[244,992]],"region":{"top_left_x":244,"top_left_y":943,"width":1532,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac406cd425274645a574b8b68b914a78","type":"table_row","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"","text_display":""},{"cnt":[[244,987],[1775,987],[1775,1959],[244,1959]],"region":{"top_left_x":244,"top_left_y":987,"width":1532,"height":972},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57ef52bb46c84bb892f5c1ed3baaaa45","type":"table_row","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"","text_display":""},{"cnt":[[244,1952],[1775,1952],[1775,2562],[244,2562]],"region":{"top_left_x":244,"top_left_y":1951,"width":1532,"height":612},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b319c8978e140d4bf783c8164ac4337","type":"table_row","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"","text_display":""},{"cnt":[[267,340],[592,340],[592,379],[267,379]],"region":{"top_left_x":267,"top_left_y":340,"width":325,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58f9500db3c045cda222eff4515978d0","type":"simple_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"Section to be changed","text_display":"Section to be changed","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,340],[1559,340],[1559,375],[939,375]],"region":{"top_left_x":939,"top_left_y":340,"width":620,"height":35},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1c683d2a3594ab69ef2b095d87d6fc2","type":"simple_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"3.1.1 Administrative structure of the trial","text_display":"3.1.1 Administrative structure of the trial","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,391],[592,391],[592,430],[267,430]],"region":{"top_left_x":267,"top_left_y":390,"width":325,"height":41},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"59a993089d414d6f8101327ceadac7e9","type":"simple_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"Description of change","text_display":"Description of change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,389],[1750,389],[1750,877],[935,877]],"region":{"top_left_x":934,"top_left_y":388,"width":816,"height":489},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23cd0bfdc9e848c29d5825f761f1df2d","type":"complex_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","children_ids":["6de3be99e2b64a4aa9154bcb5ad76c2c","cb21f422792c49269059a7ab9b2662cd","68b2d2f7d7964150bd89a113c06cd3d3","faf5ba94b07e48389f7d2327c65f889a","18ce298f527346c9a237711a55db5760","bc18ae95ae664bd6834e4eec52fe0aa3","763d3a5127564a15a19b9db5bee1a744","c0c7d6bed9e44a5088755796d3d65162","511951e1ff044b20abe9fba69721de75","3dba69415a4e43b7ab11ecf66fce6840"],"text":"\\begin{tabular}{l}\nAdditionally, a separate independent, blinded, external committee will be set up for adjudication of renal events. The adjudication process for renal events will be clarified separately in a CEC charter. \\\\\nWas changed into: \\\\\nAdditionally, separate independent, blinded, external committees will be set up for adjudication of renal events and pancreatic events. The adjudication process for renal events and pancreatic events will be clarified in a separate CEC charter.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAdditionally, a separate independent, blinded, external committee will be set up for adjudication of renal events. The adjudication process for renal events will be clarified separately in a CEC charter. \\\\\nWas changed into: \\\\\nAdditionally, separate independent, blinded, external committees will be set up for adjudication of renal events and pancreatic events. The adjudication process for renal events and pancreatic events will be clarified in a separate CEC charter.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9951171875,"confidence_rate":0.9999777512821576},{"cnt":[[939,391],[1706,391],[1706,430],[939,430]],"region":{"top_left_x":939,"top_left_y":390,"width":768,"height":41},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6de3be99e2b64a4aa9154bcb5ad76c2c","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"Additionally, a separate independent, blinded, external","text_display":"Additionally, a separate independent, blinded, external","confidence":1,"confidence_rate":1},{"cnt":[[939,432],[1738,432],[1738,471],[939,471]],"region":{"top_left_x":939,"top_left_y":432,"width":800,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb21f422792c49269059a7ab9b2662cd","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"committee will be set up for adjudication of renal events.","text_display":" committee will be set up for adjudication of renal events.","confidence":1,"confidence_rate":1},{"cnt":[[939,469],[1745,469],[1745,508],[939,508]],"region":{"top_left_x":939,"top_left_y":469,"width":807,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68b2d2f7d7964150bd89a113c06cd3d3","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"The adjudication process for renal events will be clarified","text_display":" The adjudication process for renal events will be clarified","confidence":1,"confidence_rate":1},{"cnt":[[939,511],[1333,511],[1333,550],[939,550]],"region":{"top_left_x":939,"top_left_y":510,"width":395,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"faf5ba94b07e48389f7d2327c65f889a","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"separately in a CEC charter.","text_display":" separately in a CEC charter.","confidence":1,"confidence_rate":1},{"cnt":[[939,593],[1204,593],[1204,633],[939,633]],"region":{"top_left_x":939,"top_left_y":593,"width":266,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18ce298f527346c9a237711a55db5760","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9951171875,"confidence_rate":0.9997775350954998},{"cnt":[[939,672],[1683,672],[1683,713],[939,713]],"region":{"top_left_x":939,"top_left_y":671,"width":745,"height":43},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc18ae95ae664bd6834e4eec52fe0aa3","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"Additionally, separate independent, blinded, external","text_display":"\nAdditionally, separate independent, blinded, external","confidence":1,"confidence_rate":1},{"cnt":[[939,713],[1743,713],[1743,752],[939,752]],"region":{"top_left_x":939,"top_left_y":713,"width":804,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"763d3a5127564a15a19b9db5bee1a744","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"committees will be set up for adjudication of renal events","text_display":" committees will be set up for adjudication of renal events","confidence":1,"confidence_rate":1},{"cnt":[[939,755],[1738,755],[1738,794],[939,794]],"region":{"top_left_x":939,"top_left_y":754,"width":800,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0c7d6bed9e44a5088755796d3d65162","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"and pancreatic events. The adjudication process for renal","text_display":" and pancreatic events. The adjudication process for renal","confidence":1,"confidence_rate":1},{"cnt":[[939,796],[1632,796],[1632,833],[939,833]],"region":{"top_left_x":939,"top_left_y":796,"width":694,"height":37},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"511951e1ff044b20abe9fba69721de75","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"events and pancreatic events will be clarified in a","text_display":" events and pancreatic events will be clarified in a","confidence":1,"confidence_rate":1},{"cnt":[[939,835],[1248,835],[1248,872],[939,872]],"region":{"top_left_x":939,"top_left_y":835,"width":309,"height":38},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3dba69415a4e43b7ab11ecf66fce6840","type":"text","conversion_output":false,"parent_id":"23cd0bfdc9e848c29d5825f761f1df2d","text":"separate CEC charter.","text_display":" separate CEC charter.","confidence":1,"confidence_rate":1},{"cnt":[[267,891],[578,891],[578,927],[267,927]],"region":{"top_left_x":267,"top_left_y":890,"width":311,"height":38},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a54bf4ae94d748269075333dd125e97a","type":"simple_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"Rationale for change","text_display":"Rationale for change","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,888],[1695,888],[1695,927],[939,927]],"region":{"top_left_x":939,"top_left_y":888,"width":756,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"901a1ae7ac904fcabfccd7dc80fe45a4","type":"simple_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"To add independent adjudication of pancreatic events.","text_display":"To add independent adjudication of pancreatic events.","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,948],[592,948],[592,987],[267,987]],"region":{"top_left_x":267,"top_left_y":948,"width":325,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"62beeb2b8349438aa587532a873a875e","type":"simple_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"Section to be changed","text_display":"Section to be changed","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,948],[1273,948],[1273,983],[939,983]],"region":{"top_left_x":939,"top_left_y":948,"width":335,"height":35},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"205fd6aada294c70a07902e846a9ed85","type":"simple_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"3.3.2 inclusion criteria","text_display":"3.3.2 inclusion criteria","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,999],[592,999],[592,1038],[267,1038]],"region":{"top_left_x":267,"top_left_y":998,"width":325,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c39f171216a7435fa421133e2e04418e","type":"simple_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"Description of change","text_display":"Description of change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,994],[1748,994],[1748,1954],[935,1954]],"region":{"top_left_x":934,"top_left_y":994,"width":814,"height":961},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f740dbdc7ff46649d6ab67e5ad051c1","type":"complex_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","children_ids":["f98ab39a302d4656be878f1d7126a275","2e6152b524974c15adcd9b4436c599c2","b43dcac575214ed48837fca68390b12f","1d876199a7014ce390182bb779317fc6","52cfef1a91cc45e68900af27fd7e4359","10026c7289de42e4857026dcf1a5e1bc","94d4d9a0ade44f2f9d11c1f6346f0062","dc3947e889fa462b9c3a65fe5a5c603a","8482c5f7626d402989fcb3337e7bb708","2777303cade84cbeaaea2e243b7615fa","7d8af4e377dd43779eebda1263cfecca","158c69b2ccc64f049b45326ced5d8809","beea265eeeb2493c85586bc926b6f89f","b8b18663e6344ba58041b0fa8ec4480a","649f7539b19046178c9d683f4eb28357","594bab832f0c49f7bde1f0446dee586b","67d1bb3e8d9347f1862fd982c2f25fa9","966d9f38116143589326e3a170dd9342","d34be314498b42ec94ecb20d5d2b9004","def40760c8c843cf81cad102a33a07cc"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nInclusion criterion number 8: the definition of albuminuria \\(\\geq 30 mg / l\\) (milligram albumin per litre of urine) was removed. \\\\\nChange 2: \\\\\nInclusion criterion number 8: Impaired renal function (as defined by MDRD formula) with an eGFR: 15-45 \\(mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR. \\\\\nWas changed into: \\\\\nImpaired renal function (as defined by MDRD formula) with an eGFR: \\(15-<45 mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR. \\\\\nChange 3: \\\\\nInclusion criterion number 8: the definition of UACR \\(\\geq 200 mg / l\\) (milligram albumin per litre of urine) was removed. \\\\\nChange 4: \\\\\nInclusion criterion number 8: MRI angiography was added as clinical test and clinical tests were added to the second bullet under inclusion criterion 8b and 8c.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nInclusion criterion number 8: the definition of albuminuria \\(\\geq 30 mg / l\\) (milligram albumin per litre of urine) was removed. \\\\\nChange 2: \\\\\nInclusion criterion number 8: Impaired renal function (as defined by MDRD formula) with an eGFR: 15-45 \\(mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR. \\\\\nWas changed into: \\\\\nImpaired renal function (as defined by MDRD formula) with an eGFR: \\(15-<45 mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR. \\\\\nChange 3: \\\\\nInclusion criterion number 8: the definition of UACR \\(\\geq 200 mg / l\\) (milligram albumin per litre of urine) was removed. \\\\\nChange 4: \\\\\nInclusion criterion number 8: MRI angiography was added as clinical test and clinical tests were added to the second bullet under inclusion criterion 8b and 8c.\n\\end{tabular}","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.94283127784729,"confidence_rate":0.9999219238461831},{"cnt":[[939,999],[1089,999],[1089,1033],[939,1033]],"region":{"top_left_x":939,"top_left_y":998,"width":151,"height":36},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f98ab39a302d4656be878f1d7126a275","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1036],[1586,1036],[1586,1070],[939,1070]],"region":{"top_left_x":939,"top_left_y":1035,"width":648,"height":36},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e6152b524974c15adcd9b4436c599c2","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Inclusion criterion number 8: the definition of","text_display":"\nInclusion criterion number 8: the definition of","confidence":1,"confidence_rate":1},{"cnt":[[939,1077],[1706,1077],[1706,1116],[939,1116]],"region":{"top_left_x":939,"top_left_y":1077,"width":768,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b43dcac575214ed48837fca68390b12f","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"albuminuria \\(\\geq 30 mg / l\\) (milligram albumin per litre of","text_display":" albuminuria \\(\\geq 30 mg / l\\) (milligram albumin per litre of","confidence":1,"confidence_rate":1},{"cnt":[[939,1118],[1227,1118],[1227,1153],[939,1153]],"region":{"top_left_x":939,"top_left_y":1118,"width":289,"height":35},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d876199a7014ce390182bb779317fc6","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"urine) was removed.","text_display":" urine) was removed.","confidence":1,"confidence_rate":1},{"cnt":[[939,1197],[1087,1197],[1087,1236],[939,1236]],"region":{"top_left_x":939,"top_left_y":1196,"width":148,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52cfef1a91cc45e68900af27fd7e4359","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,1238],[1738,1238],[1738,1275],[939,1275]],"region":{"top_left_x":939,"top_left_y":1238,"width":800,"height":38},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10026c7289de42e4857026dcf1a5e1bc","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Inclusion criterion number 8: Impaired renal function (as","text_display":"\nInclusion criterion number 8: Impaired renal function (as","confidence":1,"confidence_rate":1},{"cnt":[[939,1275],[1646,1275],[1646,1314],[939,1314]],"region":{"top_left_x":939,"top_left_y":1275,"width":708,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94d4d9a0ade44f2f9d11c1f6346f0062","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"defined by MDRD formula) with an eGFR: 15-45","text_display":" defined by MDRD formula) with an eGFR: 15-45","confidence":1,"confidence_rate":1},{"cnt":[[939,1312],[1720,1312],[1720,1356],[939,1356]],"region":{"top_left_x":939,"top_left_y":1311,"width":781,"height":45},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc3947e889fa462b9c3a65fe5a5c603a","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"\\(mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR.","text_display":" \\(mL / min / 1.73 m^{2}\\) at Visit 1 (screening) with any UACR.","confidence":0.99560546875,"confidence_rate":0.9999404853442438},{"cnt":[[939,1395],[1204,1395],[1204,1439],[939,1439]],"region":{"top_left_x":939,"top_left_y":1394,"width":266,"height":45},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8482c5f7626d402989fcb3337e7bb708","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99169921875,"confidence_rate":0.9996211888316656},{"cnt":[[939,1436],[1720,1436],[1720,1475],[939,1475]],"region":{"top_left_x":939,"top_left_y":1436,"width":781,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2777303cade84cbeaaea2e243b7615fa","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Impaired renal function (as defined by MDRD formula)","text_display":"\nImpaired renal function (as defined by MDRD formula)","confidence":1,"confidence_rate":1},{"cnt":[[939,1473],[1639,1473],[1639,1512],[939,1512]],"region":{"top_left_x":939,"top_left_y":1473,"width":701,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d8af4e377dd43779eebda1263cfecca","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"with an eGFR: \\(15-<45 mL / min / 1.73 m^{2}\\) at Visit 1","text_display":" with an eGFR: \\(15-<45 mL / min / 1.73 m^{2}\\) at Visit 1","confidence":0.94283127784729,"confidence_rate":0.999121760013229},{"cnt":[[939,1517],[1342,1517],[1342,1556],[939,1556]],"region":{"top_left_x":939,"top_left_y":1516,"width":404,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"158c69b2ccc64f049b45326ced5d8809","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"(screening) with any UACR.","text_display":" (screening) with any UACR.","confidence":1,"confidence_rate":1},{"cnt":[[939,1597],[1089,1597],[1089,1634],[939,1634]],"region":{"top_left_x":939,"top_left_y":1597,"width":151,"height":38},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"beea265eeeb2493c85586bc926b6f89f","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Change 3:","text_display":"\nChange 3:","confidence":1,"confidence_rate":1},{"cnt":[[939,1639],[1688,1639],[1688,1671],[939,1671]],"region":{"top_left_x":939,"top_left_y":1638,"width":749,"height":34},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8b18663e6344ba58041b0fa8ec4480a","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Inclusion criterion number 8: the definition of UACR","text_display":"\nInclusion criterion number 8: the definition of UACR","confidence":1,"confidence_rate":1},{"cnt":[[939,1678],[1688,1678],[1688,1715],[939,1715]],"region":{"top_left_x":939,"top_left_y":1677,"width":749,"height":38},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"649f7539b19046178c9d683f4eb28357","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"\\(\\geq 200 mg / l\\) (milligram albumin per litre of urine) was","text_display":" \\(\\geq 200 mg / l\\) (milligram albumin per litre of urine) was","confidence":1,"confidence_rate":1},{"cnt":[[939,1717],[1075,1717],[1075,1752],[939,1752]],"region":{"top_left_x":939,"top_left_y":1717,"width":137,"height":35},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"594bab832f0c49f7bde1f0446dee586b","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"removed.","text_display":" removed.","confidence":1,"confidence_rate":1},{"cnt":[[939,1795],[1084,1795],[1084,1835],[939,1835]],"region":{"top_left_x":939,"top_left_y":1795,"width":146,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67d1bb3e8d9347f1862fd982c2f25fa9","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Change 4:","text_display":"\nChange 4:","confidence":0.99658203125,"confidence_rate":0.9997554710913859},{"cnt":[[939,1837],[1669,1837],[1669,1876],[939,1876]],"region":{"top_left_x":939,"top_left_y":1836,"width":731,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"966d9f38116143589326e3a170dd9342","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"Inclusion criterion number 8: MRI angiography was","text_display":"\nInclusion criterion number 8: MRI angiography was","confidence":1,"confidence_rate":1},{"cnt":[[939,1874],[1729,1874],[1729,1911],[939,1911]],"region":{"top_left_x":939,"top_left_y":1873,"width":791,"height":38},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d34be314498b42ec94ecb20d5d2b9004","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"added as clinical test and clinical tests were added to the","text_display":" added as clinical test and clinical tests were added to the","confidence":1,"confidence_rate":1},{"cnt":[[939,1915],[1632,1915],[1632,1950],[939,1950]],"region":{"top_left_x":939,"top_left_y":1915,"width":694,"height":35},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"def40760c8c843cf81cad102a33a07cc","type":"text","conversion_output":false,"parent_id":"0f740dbdc7ff46649d6ab67e5ad051c1","text":"second bullet under inclusion criterion 8b and 8c.","text_display":" second bullet under inclusion criterion 8b and 8c.","confidence":1,"confidence_rate":1},{"cnt":[[267,1961],[580,1961],[580,1998],[267,1998]],"region":{"top_left_x":267,"top_left_y":1961,"width":314,"height":38},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"86860d31dba14b388dc02f04ba354ac8","type":"simple_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","text":"Rationale for change","text_display":"Rationale for change","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1957],[1750,1957],[1750,2558],[935,2558]],"region":{"top_left_x":934,"top_left_y":1956,"width":816,"height":602},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13f418fa64bc4aea91ee5c6eb4b32a49","type":"complex_cell","conversion_output":false,"parent_id":"2000c7f69c9549d390bf3742a9f20fba","children_ids":["832c21e1a8704c86ad99c663b1126fb6","0df508d75f2e4f559e3579a1db88a0d5","bbed19c8e6af4c2a81d2b8b90df6623e","d877dc42a34546539c2b66347fea82ef","39e4b20085984c9cb36a6d68f22d88a7","b5de54ae59b74e27a0d3fc7a2a52446b","07ee258e140848cba98c4bc7fd42e7eb","dab22047788f42689d6b43bcf802b38c","00bd7aaddde14a1b825867c74b97b04b","09f52085ab4647a1b68b4f9c859056c5","7af77b0114e348c8b85e1b2bd794a5f3","e470ab2ab6e946fdbae59c69268d5388"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nTo reflect the definition KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. \\\\\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo reflect the definition KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. \\\\\nChange 4: \\\\\nTo add MRI angiography as clinical test and to clarify\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nTo reflect the definition KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. \\\\\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo reflect the definition KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. \\\\\nChange 4: \\\\\nTo add MRI angiography as clinical test and to clarify\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999921159087208},{"cnt":[[939,1959],[1089,1959],[1089,1996],[939,1996]],"region":{"top_left_x":939,"top_left_y":1958,"width":151,"height":38},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"832c21e1a8704c86ad99c663b1126fb6","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1998],[1637,1998],[1637,2033],[939,2033]],"region":{"top_left_x":939,"top_left_y":1998,"width":699,"height":35},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0df508d75f2e4f559e3579a1db88a0d5","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"To reflect the definition KDIGO Clinical Practice","text_display":"\nTo reflect the definition KDIGO Clinical Practice","confidence":1,"confidence_rate":1},{"cnt":[[939,2039],[1748,2039],[1748,2076],[939,2076]],"region":{"top_left_x":939,"top_left_y":2039,"width":809,"height":38},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bbed19c8e6af4c2a81d2b8b90df6623e","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"Guideline for the Evaluation and Management of Chronic","text_display":" Guideline for the Evaluation and Management of Chronic","confidence":0.99951171875,"confidence_rate":0.9999917220597181},{"cnt":[[939,2076],[1172,2076],[1172,2115],[939,2115]],"region":{"top_left_x":939,"top_left_y":2076,"width":233,"height":40},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d877dc42a34546539c2b66347fea82ef","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"Kidney Disease.","text_display":" Kidney Disease.","confidence":1,"confidence_rate":1},{"cnt":[[939,2159],[1087,2159],[1087,2194],[939,2194]],"region":{"top_left_x":939,"top_left_y":2159,"width":148,"height":35},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"39e4b20085984c9cb36a6d68f22d88a7","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2196],[1177,2196],[1177,2231],[939,2231]],"region":{"top_left_x":939,"top_left_y":2196,"width":238,"height":35},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5de54ae59b74e27a0d3fc7a2a52446b","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"For clarification.","text_display":"\nFor clarification.","confidence":1,"confidence_rate":1},{"cnt":[[939,2279],[1087,2279],[1087,2313],[939,2313]],"region":{"top_left_x":939,"top_left_y":2278,"width":148,"height":36},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07ee258e140848cba98c4bc7fd42e7eb","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,2316],[1637,2316],[1637,2350],[939,2350]],"region":{"top_left_x":939,"top_left_y":2315,"width":699,"height":36},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dab22047788f42689d6b43bcf802b38c","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"To reflect the definition KDIGO Clinical Practice","text_display":"\nTo reflect the definition KDIGO Clinical Practice","confidence":1,"confidence_rate":1},{"cnt":[[939,2357],[1748,2357],[1748,2396],[939,2396]],"region":{"top_left_x":939,"top_left_y":2357,"width":809,"height":40},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00bd7aaddde14a1b825867c74b97b04b","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"Guideline for the Evaluation and Management of Chronic","text_display":" Guideline for the Evaluation and Management of Chronic","confidence":0.9990234375,"confidence_rate":0.9999834401430849},{"cnt":[[939,2399],[1172,2399],[1172,2438],[939,2438]],"region":{"top_left_x":939,"top_left_y":2398,"width":233,"height":40},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"09f52085ab4647a1b68b4f9c859056c5","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"Kidney Disease.","text_display":" Kidney Disease.","confidence":1,"confidence_rate":1},{"cnt":[[939,2477],[1084,2477],[1084,2516],[939,2516]],"region":{"top_left_x":939,"top_left_y":2476,"width":146,"height":41},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7af77b0114e348c8b85e1b2bd794a5f3","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"Change 4:","text_display":"\nChange 4:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,2518],[1697,2518],[1697,2558],[939,2558]],"region":{"top_left_x":939,"top_left_y":2518,"width":758,"height":40},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e470ab2ab6e946fdbae59c69268d5388","type":"text","conversion_output":false,"parent_id":"13f418fa64bc4aea91ee5c6eb4b32a49","text":"To add MRI angiography as clinical test and to clarify","text_display":"\nTo add MRI angiography as clinical test and to clarify","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":70,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3d5e7044820248be84e9361d86ccb838","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":71,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a9b7cb488a71439b8ce9e098aa84f560","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":72,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f50d2ba7b1ff4ddfb60bcdef43f22d9d","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-089","page":89,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d39d483580294af09f79e28cfb0f1c59","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0766fab818634bbba1044352fe4babe2","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4fe295ed56b041f2a0df350a661b8445","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ecfac2324e94a16a9af1706fd4d8a9d","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25fbde0d1fea43feaee6414f9a8d283f","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b513157b0934faa9d96587a899cb24b","type":"page_info","conversion_output":false,"text":"Page 89 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2558],[244,2558]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2228},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cc2718ffdda748a6ad6b1d80906d5acf","type":"table","conversion_output":true,"children_ids":["918503c7e8b6427eaccd40ac509a472c","fc21ee54e76a42a8968f0bc3ea41c295","f4094546cef04dc99b3e8236c93489f7","a20479ab18964b07ab96a54af5ff641c","7d9eb3adfef342219c0bc670cb439f5e","62e389eddcc14765a97de2e022451ac7","cfe30b4abb354e778f5ef92fd03a2d66","ae3c255eff214ef08f195b3a22d96ae4","b014eab796fd4f658ebe97de3a17fd93","2490b2e801bf4c4ca1a67f79247da7c4","a2ed0c48f2474c49958601bea51efa9e","e7cf1696296442adad4c0eef265e840c","079ede5d7c4d4141a833595662ab44d9","8b830c4bb24046998c4f873099f628d7","ca3ec7d98f374bf095b201efd7386f03","7ed33921766d438bb4b1d3737adf770e","ed7212d7535e45f8bb37456f08c00948","d8c1263e90244f4386d3b9e99ac9d476","b7a1a085eea846018c9ba49721e21a25","2e97136ffaeb48098219eb894b29b2be","45e71c000b1943b0b04165dbf606a0fc","975d7f319fe542b798742181c757d8c3","01201cab1e8f41a7b480014a9ce3e129","6f54d33598fd4ed892ce682f335346a4","d9b0cc859a4e479682ac0e7ff0a5cbd6","6f1beed26841482fb5cbcbda2537bb9b","f37cea116d3040beb51323b02a2f558d","b311e6d8b4a148cd83ebe533a4119e0b","df3dd073b5cc4d17835cc3bfe3a55d2f","55b28dd36dcb458da90a0455726ab958","3cd3cc816387419cab965f956a4c6f7b"],"text":"\\begin{tabular}{|l|l|}\n\\hline & allowed clinical testing for inclusion criterion 8b and 8c. \\\\\n\\hline Section to be changed & 3.3.3 exclusion criteria \\\\\n\\hline Description of change & Exclusion criterion number 5: ..(open or laparascopic) ..was changed into... (open or laparoscopic)... \\\\\n\\hline Rationale for change & Correction of typographical error. \\\\\n\\hline Section to be changed & 3.3.4.1 Removal of individual patient \\\\\n\\hline Description of change & \\begin{tabular}{l}\n....Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of , collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint). \\\\\n\\hline Section to be changed & 4.1.4 Drug assignment and administration of doses for each patient \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nParagraph 4: .....Returned study medication may be redispensed if the time window around the patient visit schedule requires this. \\\\\nWas changed into: \\\\\nThe protocol allows a time window of +/- 7 days for visit 3 and +/- 14 days for all scheduled visits in the treatment period after visit 3. To ensure sufficient medication, visits after visit 3 should be scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2. \\\\\nChange 2: \\\\\nParagraph 4..... (plus 2 week reserve) was changed into: ...(2 weeks reserve).\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo clarify the allowed time window between study visits in relation to the available study medication dispensed. \\\\\nChange 2: \\\\\nTo correct a typographical error\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & allowed clinical testing for inclusion criterion 8b and 8c. \\\\\n\\hline Section to be changed & 3.3.3 exclusion criteria \\\\\n\\hline Description of change & Exclusion criterion number 5: ..(open or laparascopic) ..was changed into... (open or laparoscopic)... \\\\\n\\hline Rationale for change & Correction of typographical error. \\\\\n\\hline Section to be changed & 3.3.4.1 Removal of individual patient \\\\\n\\hline Description of change & \\begin{tabular}{l}\n....Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of , collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint). \\\\\n\\hline Section to be changed & 4.1.4 Drug assignment and administration of doses for each patient \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nParagraph 4: .....Returned study medication may be redispensed if the time window around the patient visit schedule requires this. \\\\\nWas changed into: \\\\\nThe protocol allows a time window of +/- 7 days for visit 3 and +/- 14 days for all scheduled visits in the treatment period after visit 3. To ensure sufficient medication, visits after visit 3 should be scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2. \\\\\nChange 2: \\\\\nParagraph 4..... (plus 2 week reserve) was changed into: ...(2 weeks reserve).\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo clarify the allowed time window between study visits in relation to the available study medication dispensed. \\\\\nChange 2: \\\\\nTo correct a typographical error\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.6298828125,"confidence_rate":0.9999368957861527},{"cnt":[[248,331],[603,331],[606,2560],[251,2560]],"region":{"top_left_x":248,"top_left_y":330,"width":358,"height":2231},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"918503c7e8b6427eaccd40ac509a472c","type":"table_column","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[930,331],[1768,331],[1768,2560],[930,2560]],"region":{"top_left_x":930,"top_left_y":331,"width":839,"height":2229},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc21ee54e76a42a8968f0bc3ea41c295","type":"table_column","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,336],[1775,336],[1775,384],[244,384]],"region":{"top_left_x":244,"top_left_y":335,"width":1532,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4094546cef04dc99b3e8236c93489f7","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,386],[1775,386],[1775,435],[244,435]],"region":{"top_left_x":244,"top_left_y":386,"width":1532,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a20479ab18964b07ab96a54af5ff641c","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,442],[1775,442],[1775,531],[244,531]],"region":{"top_left_x":244,"top_left_y":441,"width":1532,"height":91},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d9eb3adfef342219c0bc670cb439f5e","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,538],[1775,538],[1775,591],[244,591]],"region":{"top_left_x":244,"top_left_y":538,"width":1532,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"62e389eddcc14765a97de2e022451ac7","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,591],[1775,589],[1775,638],[244,641]],"region":{"top_left_x":243,"top_left_y":588,"width":1533,"height":53},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfe30b4abb354e778f5ef92fd03a2d66","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,635],[1775,635],[1775,1247],[244,1247]],"region":{"top_left_x":244,"top_left_y":634,"width":1532,"height":614},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae3c255eff214ef08f195b3a22d96ae4","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,1240],[1775,1240],[1775,1452],[244,1452]],"region":{"top_left_x":244,"top_left_y":1240,"width":1532,"height":213},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b014eab796fd4f658ebe97de3a17fd93","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,1448],[1775,1448],[1775,1540],[244,1540]],"region":{"top_left_x":244,"top_left_y":1447,"width":1532,"height":93},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2490b2e801bf4c4ca1a67f79247da7c4","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,1542],[1775,1542],[1775,2198],[244,2198]],"region":{"top_left_x":244,"top_left_y":1542,"width":1532,"height":657},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2ed0c48f2474c49958601bea51efa9e","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[244,2191],[1775,2191],[1775,2447],[244,2447]],"region":{"top_left_x":244,"top_left_y":2191,"width":1532,"height":257},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7cf1696296442adad4c0eef265e840c","type":"table_row","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"","text_display":""},{"cnt":[[939,340],[1731,340],[1731,379],[939,379]],"region":{"top_left_x":939,"top_left_y":340,"width":793,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"079ede5d7c4d4141a833595662ab44d9","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"allowed clinical testing for inclusion criterion 8b and 8c.","text_display":"allowed clinical testing for inclusion criterion 8b and 8c.","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99853515625,"confidence_rate":0.9999770952985276},{"cnt":[[265,391],[592,391],[592,430],[265,430]],"region":{"top_left_x":264,"top_left_y":390,"width":328,"height":41},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b830c4bb24046998c4f873099f628d7","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Section to be changed","text_display":"Section to be changed","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,391],[1278,391],[1278,425],[939,425]],"region":{"top_left_x":939,"top_left_y":390,"width":339,"height":36},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca3ec7d98f374bf095b201efd7386f03","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"3.3.3 exclusion criteria","text_display":"3.3.3 exclusion criteria","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,451],[592,451],[592,490],[267,490]],"region":{"top_left_x":267,"top_left_y":450,"width":325,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ed33921766d438bb4b1d3737adf770e","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Description of change","text_display":"Description of change","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,446],[1701,446],[1701,529],[937,529]],"region":{"top_left_x":937,"top_left_y":446,"width":765,"height":84},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed7212d7535e45f8bb37456f08c00948","type":"complex_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","children_ids":["a60229e9ce6640529ec9f6d4f11c1605","bc0482ce0cf94f68b4882b84f9484ac0"],"text":"Exclusion criterion number 5: ..(open or laparascopic) ..was changed into... (open or laparoscopic)...","text_display":"Exclusion criterion number 5: ..(open or laparascopic) ..was changed into... (open or laparoscopic)...","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9829335138201714,"confidence_rate":0.9998344964172862},{"cnt":[[939,448],[1697,448],[1697,488],[939,488]],"region":{"top_left_x":939,"top_left_y":448,"width":758,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a60229e9ce6640529ec9f6d4f11c1605","type":"text","conversion_output":false,"parent_id":"ed7212d7535e45f8bb37456f08c00948","text":"Exclusion criterion number 5: ..(open or laparascopic)","text_display":"Exclusion criterion number 5: ..(open or laparascopic)","confidence":1,"confidence_rate":1},{"cnt":[[939,488],[1593,488],[1593,527],[939,527]],"region":{"top_left_x":939,"top_left_y":487,"width":655,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc0482ce0cf94f68b4882b84f9484ac0","type":"text","conversion_output":false,"parent_id":"ed7212d7535e45f8bb37456f08c00948","text":"..was changed into... (open or laparoscopic)...","text_display":" ..was changed into... (open or laparoscopic)...","confidence":0.9829335138201714,"confidence_rate":0.9996690202260083},{"cnt":[[267,547],[578,547],[578,584],[267,584]],"region":{"top_left_x":267,"top_left_y":547,"width":311,"height":38},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8c1263e90244f4386d3b9e99ac9d476","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Rationale for change","text_display":"Rationale for change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,545],[1414,545],[1414,584],[939,584]],"region":{"top_left_x":939,"top_left_y":545,"width":475,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7a1a085eea846018c9ba49721e21a25","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Correction of typographical error.","text_display":"Correction of typographical error.","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,596],[592,596],[592,633],[267,633]],"region":{"top_left_x":267,"top_left_y":595,"width":325,"height":38},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e97136ffaeb48098219eb894b29b2be","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Section to be changed","text_display":"Section to be changed","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,596],[1490,596],[1490,633],[939,633]],"region":{"top_left_x":939,"top_left_y":595,"width":551,"height":38},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45e71c000b1943b0b04165dbf606a0fc","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"3.3.4.1 Removal of individual patient","text_display":"3.3.4.1 Removal of individual patient","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,644],[592,644],[592,683],[267,683]],"region":{"top_left_x":267,"top_left_y":644,"width":325,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"975d7f319fe542b798742181c757d8c3","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Description of change","text_display":"Description of change","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,640],[1743,640],[1743,1243],[935,1243]],"region":{"top_left_x":934,"top_left_y":639,"width":809,"height":604},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01201cab1e8f41a7b480014a9ce3e129","type":"complex_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","children_ids":["345bad967ff64c918da55bfb8bf74b14","18982690142e4acbae24b50712990fa3","95a0bb9c0abe4d69a489f78ccbf106e3","6c00e1e56c4346b3b67836c3ddbe82e3","4c844cc6366443d099c7a194fa7d17e3","a6d0c251419a481cb3d0800d43fa3c23","e428972c86b34cc7be94b0181dcd1ee1","c1ec70fe91884a879792fb4cea4fb535","1d40032abf064535ba1a0bdf699e1cc5","832fbd3a178a4872a91df0d8b6e971a4","d9fad149cbb3499dae600fc684e76804","3822febea12b47d793a74390dd0d6067","3e4602aad7c34038a75af8eb83af3fb5"],"text":"\\begin{tabular}{l}\n....Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of , collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n....Patients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of , collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.966796875,"confidence_rate":0.9998952391796477},{"cnt":[[939,644],[1669,644],[1669,683],[939,683]],"region":{"top_left_x":939,"top_left_y":644,"width":731,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"345bad967ff64c918da55bfb8bf74b14","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"....Patients who discontinue study drug prematurely","text_display":"....Patients who discontinue study drug prematurely","confidence":1,"confidence_rate":1},{"cnt":[[939,686],[1651,686],[1651,725],[939,725]],"region":{"top_left_x":939,"top_left_y":685,"width":712,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18982690142e4acbae24b50712990fa3","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"should continue study visits until study end, but no","text_display":" should continue study visits until study end, but no","confidence":1,"confidence_rate":1},{"cnt":[[939,725],[1674,725],[1674,762],[939,762]],"region":{"top_left_x":939,"top_left_y":724,"width":735,"height":38},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95a0bb9c0abe4d69a489f78ccbf106e3","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"physical examination, vital signs, (safety) laboratory","text_display":" physical examination, vital signs, (safety) laboratory","confidence":1,"confidence_rate":1},{"cnt":[[939,764],[1715,764],[1715,803],[939,803]],"region":{"top_left_x":939,"top_left_y":763,"width":777,"height":41},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c00e1e56c4346b3b67836c3ddbe82e3","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\),","text_display":" sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\),","confidence":0.966796875,"confidence_rate":0.9995557978650097},{"cnt":[[939,805],[1554,805],[1554,842],[939,842]],"region":{"top_left_x":939,"top_left_y":805,"width":616,"height":38},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c844cc6366443d099c7a194fa7d17e3","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"UACR and eGFR) or ECG will be required.","text_display":" UACR and eGFR) or ECG will be required.","confidence":0.99609375,"confidence_rate":0.9999110516988362},{"cnt":[[939,886],[1204,886],[1204,923],[939,923]],"region":{"top_left_x":939,"top_left_y":885,"width":266,"height":38},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6d0c251419a481cb3d0800d43fa3c23","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.98193359375,"confidence_rate":0.9991716343577381},{"cnt":[[939,966],[1727,966],[1727,1006],[939,1006]],"region":{"top_left_x":939,"top_left_y":966,"width":788,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e428972c86b34cc7be94b0181dcd1ee1","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"Patients who discontinue study drug prematurely should","text_display":"\nPatients who discontinue study drug prematurely should","confidence":1,"confidence_rate":1},{"cnt":[[939,1008],[1720,1008],[1720,1047],[939,1047]],"region":{"top_left_x":939,"top_left_y":1007,"width":781,"height":41},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1ec70fe91884a879792fb4cea4fb535","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"continue study visits until study end. Study assessments","text_display":" continue study visits until study end. Study assessments","confidence":1,"confidence_rate":1},{"cnt":[[939,1045],[1738,1045],[1738,1084],[939,1084]],"region":{"top_left_x":939,"top_left_y":1044,"width":800,"height":40},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d40032abf064535ba1a0bdf699e1cc5","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"may be omitted if a patient is willing to return to the pre-","text_display":" may be omitted if a patient is willing to return to the pre","confidence":1,"confidence_rate":1},{"cnt":[[939,1086],[1480,1086],[1480,1125],[939,1125]],"region":{"top_left_x":939,"top_left_y":1086,"width":542,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"832fbd3a178a4872a91df0d8b6e971a4","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"defined study visits, with exception of","text_display":"defined study visits, with exception of","confidence":1,"confidence_rate":1},{"cnt":[[1002,1128],[1653,1128],[1653,1162],[1002,1162]],"region":{"top_left_x":1001,"top_left_y":1127,"width":653,"height":36},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9fad149cbb3499dae600fc684e76804","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":", collection of adverse events, outcome events,","text_display":" , collection of adverse events, outcome events,","confidence":1,"confidence_rate":1},{"cnt":[[939,1165],[1725,1165],[1725,1204],[939,1204]],"region":{"top_left_x":939,"top_left_y":1164,"width":786,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3822febea12b47d793a74390dd0d6067","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"concomitant therapy and laboratory testing of creatinine","text_display":" concomitant therapy and laboratory testing of creatinine","confidence":1,"confidence_rate":1},{"cnt":[[939,1206],[1388,1206],[1388,1240],[939,1240]],"region":{"top_left_x":939,"top_left_y":1205,"width":450,"height":36},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e4602aad7c34038a75af8eb83af3fb5","type":"text","conversion_output":false,"parent_id":"01201cab1e8f41a7b480014a9ce3e129","text":"for the calculation of the eGFR.","text_display":" for the calculation of the eGFR.","confidence":1,"confidence_rate":1},{"cnt":[[267,1247],[580,1247],[580,1287],[267,1287]],"region":{"top_left_x":267,"top_left_y":1247,"width":314,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f54d33598fd4ed892ce682f335346a4","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Rationale for change","text_display":"Rationale for change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1245],[1743,1245],[1743,1448],[935,1448]],"region":{"top_left_x":934,"top_left_y":1245,"width":809,"height":203},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9b0cc859a4e479682ac0e7ff0a5cbd6","type":"complex_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","children_ids":["d26f70dff20c43ff841916777bf98a3f","d469f98b17204708a7eca5a43b7b47b4","11ef01384f28443ea0b72e88909d9a70","2cec1e0327bb499ca732776c9db14fa7","d564bfb9eeae4ddf9aab693e4c27f46c"],"text":"For clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint).","text_display":"For clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principle, primary renal endpoint).","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1247],[1720,1247],[1720,1282],[939,1282]],"region":{"top_left_x":939,"top_left_y":1247,"width":781,"height":35},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d26f70dff20c43ff841916777bf98a3f","type":"text","conversion_output":false,"parent_id":"d9b0cc859a4e479682ac0e7ff0a5cbd6","text":"For clarification and to add creatinine for calculation of","text_display":"For clarification and to add creatinine for calculation of","confidence":1,"confidence_rate":1},{"cnt":[[939,1289],[1713,1289],[1713,1328],[939,1328]],"region":{"top_left_x":939,"top_left_y":1288,"width":774,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d469f98b17204708a7eca5a43b7b47b4","type":"text","conversion_output":false,"parent_id":"d9b0cc859a4e479682ac0e7ff0a5cbd6","text":"eGFR to the assessments for patients who pre-maturely","text_display":" eGFR to the assessments for patients who pre-maturely","confidence":1,"confidence_rate":1},{"cnt":[[939,1330],[1738,1330],[1738,1367],[939,1367]],"region":{"top_left_x":939,"top_left_y":1330,"width":800,"height":38},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11ef01384f28443ea0b72e88909d9a70","type":"text","conversion_output":false,"parent_id":"d9b0cc859a4e479682ac0e7ff0a5cbd6","text":"discontinue study medication, but are willing to return to","text_display":" discontinue study medication, but are willing to return to","confidence":1,"confidence_rate":1},{"cnt":[[939,1367],[1734,1367],[1734,1406],[939,1406]],"region":{"top_left_x":939,"top_left_y":1367,"width":795,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2cec1e0327bb499ca732776c9db14fa7","type":"text","conversion_output":false,"parent_id":"d9b0cc859a4e479682ac0e7ff0a5cbd6","text":"the pre-defined study visits (ITT principle, primary renal","text_display":" the pre-defined study visits (ITT principle, primary renal","confidence":1,"confidence_rate":1},{"cnt":[[939,1409],[1084,1409],[1084,1448],[939,1448]],"region":{"top_left_x":939,"top_left_y":1408,"width":146,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d564bfb9eeae4ddf9aab693e4c27f46c","type":"text","conversion_output":false,"parent_id":"d9b0cc859a4e479682ac0e7ff0a5cbd6","text":"endpoint).","text_display":" endpoint).","confidence":1,"confidence_rate":1},{"cnt":[[267,1455],[592,1455],[592,1494],[267,1494]],"region":{"top_left_x":267,"top_left_y":1454,"width":325,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f1beed26841482fb5cbcbda2537bb9b","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Section to be changed","text_display":"Section to be changed","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1450],[1750,1450],[1750,1535],[935,1535]],"region":{"top_left_x":934,"top_left_y":1450,"width":816,"height":86},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f37cea116d3040beb51323b02a2f558d","type":"complex_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","children_ids":["f3e7b2a297e94a778e4502447b36945e","7952c64d42444329a4d782870ef71666"],"text":"4.1.4 Drug assignment and administration of doses for each patient","text_display":"4.1.4 Drug assignment and administration of doses for each patient","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1455],[1748,1455],[1748,1494],[939,1494]],"region":{"top_left_x":939,"top_left_y":1454,"width":809,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3e7b2a297e94a778e4502447b36945e","type":"text","conversion_output":false,"parent_id":"f37cea116d3040beb51323b02a2f558d","text":"4.1.4 Drug assignment and administration of doses for","text_display":"4.1.4 Drug assignment and administration of doses for","confidence":1,"confidence_rate":1},{"cnt":[[939,1496],[1126,1496],[1126,1531],[939,1531]],"region":{"top_left_x":939,"top_left_y":1496,"width":187,"height":35},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7952c64d42444329a4d782870ef71666","type":"text","conversion_output":false,"parent_id":"f37cea116d3040beb51323b02a2f558d","text":"each patient","text_display":" each patient","confidence":1,"confidence_rate":1},{"cnt":[[267,1551],[592,1551],[592,1590],[267,1590]],"region":{"top_left_x":267,"top_left_y":1551,"width":325,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b311e6d8b4a148cd83ebe533a4119e0b","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Description of change","text_display":"Description of change","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1549],[1757,1549],[1757,2196],[935,2196]],"region":{"top_left_x":934,"top_left_y":1549,"width":823,"height":648},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"df3dd073b5cc4d17835cc3bfe3a55d2f","type":"complex_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","children_ids":["7e551469d40e4f549d94b868ee76e54e","c84193b5370f4e9b9e764be5e599d0da","945f25fe037f4147b65b6a2d63e91c87","a5061f438944451ba42c78b32884297e","dc65b2fc17eb4ee1b7d5592078ea3cd5","c57280a59afe41cd9a5aff935c382722","7b18ad2c3ca34efd951aca0afdf64ec3","b97eb29bebfa4f88b86b14fb89f35a32","76c449dec2f441dc9e2136e1be49bd96","c5e6267353974cf49a540449767a7baa","e7f3a5d4dd2e41daba498b94ee1f1182","2412922dd13341fa94bd618b8877edc9","0252589cf88d4cc6ba2bf1cdad54baaa"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nParagraph 4: .....Returned study medication may be redispensed if the time window around the patient visit schedule requires this. \\\\\nWas changed into: \\\\\nThe protocol allows a time window of +/- 7 days for visit 3 and +/- 14 days for all scheduled visits in the treatment period after visit 3. To ensure sufficient medication, visits after visit 3 should be scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2. \\\\\nChange 2: \\\\\nParagraph 4..... (plus 2 week reserve) was changed into: ...(2 weeks reserve).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nParagraph 4: .....Returned study medication may be redispensed if the time window around the patient visit schedule requires this. \\\\\nWas changed into: \\\\\nThe protocol allows a time window of +/- 7 days for visit 3 and +/- 14 days for all scheduled visits in the treatment period after visit 3. To ensure sufficient medication, visits after visit 3 should be scheduled within 182 days and visit 3 should take place no later than 91 days after visit 2. \\\\\nChange 2: \\\\\nParagraph 4..... (plus 2 week reserve) was changed into: ...(2 weeks reserve).\n\\end{tabular}","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.6298828125,"confidence_rate":0.9990945807963966},{"cnt":[[939,1551],[1087,1551],[1087,1590],[939,1590]],"region":{"top_left_x":939,"top_left_y":1551,"width":148,"height":40},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e551469d40e4f549d94b868ee76e54e","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1593],[1725,1593],[1725,1632],[939,1632]],"region":{"top_left_x":939,"top_left_y":1592,"width":786,"height":40},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c84193b5370f4e9b9e764be5e599d0da","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"Paragraph 4: .....Returned study medication may be re-","text_display":"\nParagraph 4: .....Returned study medication may be re","confidence":0.9707803726196289,"confidence_rate":0.9994974987863442},{"cnt":[[939,1632],[1683,1632],[1683,1669],[939,1669]],"region":{"top_left_x":939,"top_left_y":1631,"width":745,"height":38},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"945f25fe037f4147b65b6a2d63e91c87","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"dispensed if the time window around the patient visit","text_display":"dispensed if the time window around the patient visit","confidence":1,"confidence_rate":1},{"cnt":[[939,1671],[1255,1671],[1255,1710],[939,1710]],"region":{"top_left_x":939,"top_left_y":1671,"width":316,"height":40},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5061f438944451ba42c78b32884297e","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"schedule requires this.","text_display":" schedule requires this.","confidence":1,"confidence_rate":1},{"cnt":[[939,1754],[1204,1754],[1204,1793],[939,1793]],"region":{"top_left_x":939,"top_left_y":1753,"width":266,"height":41},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc65b2fc17eb4ee1b7d5592078ea3cd5","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99609375,"confidence_rate":0.9998221113094726},{"cnt":[[939,1835],[1743,1835],[1743,1871],[939,1871]],"region":{"top_left_x":939,"top_left_y":1834,"width":804,"height":38},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c57280a59afe41cd9a5aff935c382722","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"The protocol allows a time window of +/- 7 days for visit","text_display":"\nThe protocol allows a time window of +/- 7 days for visit","confidence":0.99951171875,"confidence_rate":0.9999924861744118},{"cnt":[[939,1874],[1738,1874],[1738,1913],[939,1913]],"region":{"top_left_x":939,"top_left_y":1873,"width":800,"height":40},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b18ad2c3ca34efd951aca0afdf64ec3","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"3 and +/- 14 days for all scheduled visits in the treatment","text_display":" 3 and +/- 14 days for all scheduled visits in the treatment","confidence":1,"confidence_rate":1},{"cnt":[[939,1915],[1750,1915],[1750,1954],[939,1954]],"region":{"top_left_x":939,"top_left_y":1915,"width":811,"height":40},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b97eb29bebfa4f88b86b14fb89f35a32","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"period after visit 3. To ensure sufficient medication, visits","text_display":" period after visit 3. To ensure sufficient medication, visits","confidence":0.6298828125,"confidence_rate":0.9930211104570709},{"cnt":[[939,1957],[1752,1957],[1752,1991],[939,1991]],"region":{"top_left_x":939,"top_left_y":1956,"width":814,"height":36},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76c449dec2f441dc9e2136e1be49bd96","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"after visit 3 should be scheduled within 182 days and visit","text_display":" after visit 3 should be scheduled within 182 days and visit","confidence":1,"confidence_rate":1},{"cnt":[[939,1993],[1685,1993],[1685,2033],[939,2033]],"region":{"top_left_x":939,"top_left_y":1993,"width":747,"height":40},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5e6267353974cf49a540449767a7baa","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"3 should take place no later than 91 days after visit 2.","text_display":" 3 should take place no later than 91 days after visit 2.","confidence":0.8154296875,"confidence_rate":0.9967144402587165},{"cnt":[[939,2076],[1089,2076],[1089,2111],[939,2111]],"region":{"top_left_x":939,"top_left_y":2076,"width":151,"height":35},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7f3a5d4dd2e41daba498b94ee1f1182","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2113],[1734,2113],[1734,2152],[939,2152]],"region":{"top_left_x":939,"top_left_y":2113,"width":795,"height":40},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2412922dd13341fa94bd618b8877edc9","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"Paragraph 4..... (plus 2 week reserve) was changed into:","text_display":"\nParagraph 4..... (plus 2 week reserve) was changed into:","confidence":0.9596840743906796,"confidence_rate":0.9993572201425034},{"cnt":[[939,2155],[1232,2155],[1232,2194],[939,2194]],"region":{"top_left_x":939,"top_left_y":2154,"width":293,"height":40},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0252589cf88d4cc6ba2bf1cdad54baaa","type":"text","conversion_output":false,"parent_id":"df3dd073b5cc4d17835cc3bfe3a55d2f","text":"...(2 weeks reserve).","text_display":" ...(2 weeks reserve).","confidence":0.9960966110229492,"confidence_rate":0.9998495871945784},{"cnt":[[267,2196],[580,2196],[580,2235],[267,2235]],"region":{"top_left_x":267,"top_left_y":2196,"width":314,"height":40},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55b28dd36dcb458da90a0455726ab958","type":"simple_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","text":"Rationale for change","text_display":"Rationale for change","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2194],[1741,2194],[1741,2438],[935,2438]],"region":{"top_left_x":934,"top_left_y":2193,"width":807,"height":245},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3cd3cc816387419cab965f956a4c6f7b","type":"complex_cell","conversion_output":false,"parent_id":"cc2718ffdda748a6ad6b1d80906d5acf","children_ids":["f8ae4f6467a643ccb7fd54f8db6ff09f","e9a52e0e537e483b9c0570e131c5cdbe","8c5ff0aa97324d4bbde2b0aa955149fb","fe807950729049afbc536378a52d8203","fe049e76c0f343399838a894d8176e5d"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nTo clarify the allowed time window between study visits in relation to the available study medication dispensed. \\\\\nChange 2: \\\\\nTo correct a typographical error\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nTo clarify the allowed time window between study visits in relation to the available study medication dispensed. \\\\\nChange 2: \\\\\nTo correct a typographical error\n\\end{tabular}","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2196],[1089,2196],[1089,2235],[939,2235]],"region":{"top_left_x":939,"top_left_y":2196,"width":151,"height":40},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8ae4f6467a643ccb7fd54f8db6ff09f","type":"text","conversion_output":false,"parent_id":"3cd3cc816387419cab965f956a4c6f7b","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2237],[1734,2237],[1734,2274],[939,2274]],"region":{"top_left_x":939,"top_left_y":2237,"width":795,"height":38},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9a52e0e537e483b9c0570e131c5cdbe","type":"text","conversion_output":false,"parent_id":"3cd3cc816387419cab965f956a4c6f7b","text":"To clarify the allowed time window between study visits","text_display":"\nTo clarify the allowed time window between study visits","confidence":1,"confidence_rate":1},{"cnt":[[939,2274],[1706,2274],[1706,2313],[939,2313]],"region":{"top_left_x":939,"top_left_y":2274,"width":768,"height":40},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c5ff0aa97324d4bbde2b0aa955149fb","type":"text","conversion_output":false,"parent_id":"3cd3cc816387419cab965f956a4c6f7b","text":"in relation to the available study medication dispensed.","text_display":" in relation to the available study medication dispensed.","confidence":1,"confidence_rate":1},{"cnt":[[939,2357],[1089,2357],[1089,2396],[939,2396]],"region":{"top_left_x":939,"top_left_y":2357,"width":151,"height":40},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe807950729049afbc536378a52d8203","type":"text","conversion_output":false,"parent_id":"3cd3cc816387419cab965f956a4c6f7b","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2396],[1391,2396],[1391,2433],[939,2433]],"region":{"top_left_x":939,"top_left_y":2396,"width":452,"height":38},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe049e76c0f343399838a894d8176e5d","type":"text","conversion_output":false,"parent_id":"3cd3cc816387419cab965f956a4c6f7b","text":"To correct a typographical error","text_display":"\nTo correct a typographical error","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":79,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4323e65c0ce2417a803cefa9e6cb736a","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[288,2620],[1798,2620],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2620,"width":1511,"height":42},"line":80,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f5068424b2ef47ccb459c6b7ad89d146","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.9794921875,"confidence_rate":0.9998258889604521},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":81,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"85e2e5fc43a442a1a4218543bb57a1bb","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-090","page":90,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65b37f38a5db468db9a00d173d98bc17","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e1092d389084b13b3c9d0fe4da47489","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"21135fefdf6546619f595bf1b4b7cd0c","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"983905b9a85d46e59bac6b6ebca0b369","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7ee417b0b96485dbe93eebe46e52c01","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9be6200d45a46b8bb0d7804b949668d","type":"page_info","conversion_output":false,"text":"Page 90 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1775,331],[1775,2554],[242,2554]],"region":{"top_left_x":242,"top_left_y":331,"width":1533,"height":2223},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6438d4f629d34a1ca21444dcc5aa50bf","type":"table","conversion_output":true,"children_ids":["ec16b12f935d49fdbb81412d8961600c","2f1e574f962844868a91b4a11a0af327","4c78411c09d44130a9d9f359db1ddf5b","b318b9da75a04fe39231ddcebe72f090","491a904c9fc243a99f918bc5d0943b3e","c488dc7f24eb437e9f43d65cc60d1a62","b1907ee90201418a89f5f7381940212f","e8503e9e54e14fa8a2349ec6bf879ae7","6346464d1fac4ff3b0299cc9517eccc8"],"text":"\\begin{tabular}{|l|l|}\n\\hline Section to be changed & \\\\\n\\hline & \\begin{tabular}{l}\n5.1.1 Endpoint(s) of efficacy \\\\\nChange 2: \\\\\nAlbuminuria change over time was changed into: UACR change over time. \\\\\nChange 3: \\\\\nSustained loss of \\(50 \\%\\) or more in eGFR was changed into: Sustained decrease of 50\\% or more in eGFR. \\\\\nIn addition: \\\\\nComposite microvascular outcome (50\\% loss of eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nwas changed into: \\\\\nComposite microvascular outcome (50\\% decrease or more in eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nChange 4: \\\\\nThe following text was added: Definitions of the adjudicated endpoint events are outlined in the CEC charters.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo use consistent terminology. \\\\\nChange 4: \\\\\nTo clarify that endpoint event definitions are outlined in the CEC charters.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Section to be changed & \\\\\n\\hline & \\begin{tabular}{l}\n5.1.1 Endpoint(s) of efficacy \\\\\nChange 2: \\\\\nAlbuminuria change over time was changed into: UACR change over time. \\\\\nChange 3: \\\\\nSustained loss of \\(50 \\%\\) or more in eGFR was changed into: Sustained decrease of 50\\% or more in eGFR. \\\\\nIn addition: \\\\\nComposite microvascular outcome (50\\% loss of eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nwas changed into: \\\\\nComposite microvascular outcome (50\\% decrease or more in eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nChange 4: \\\\\nThe following text was added: Definitions of the adjudicated endpoint events are outlined in the CEC charters.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo use consistent terminology. \\\\\nChange 4: \\\\\nTo clarify that endpoint event definitions are outlined in the CEC charters.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.9129670258355135,"confidence_rate":0.9999614239579424},{"cnt":[[249,331],[599,331],[599,2553],[249,2553]],"region":{"top_left_x":248,"top_left_y":331,"width":351,"height":2222},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec16b12f935d49fdbb81412d8961600c","type":"table_column","conversion_output":false,"parent_id":"6438d4f629d34a1ca21444dcc5aa50bf","text":"","text_display":""},{"cnt":[[919,331],[1766,331],[1766,2553],[919,2553]],"region":{"top_left_x":918,"top_left_y":331,"width":849,"height":2222},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f1e574f962844868a91b4a11a0af327","type":"table_column","conversion_output":false,"parent_id":"6438d4f629d34a1ca21444dcc5aa50bf","text":"","text_display":""},{"cnt":[[242,336],[1775,336],[1775,384],[242,384]],"region":{"top_left_x":242,"top_left_y":335,"width":1534,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c78411c09d44130a9d9f359db1ddf5b","type":"table_row","conversion_output":false,"parent_id":"6438d4f629d34a1ca21444dcc5aa50bf","text":"","text_display":""},{"cnt":[[242,386],[1771,386],[1771,1929],[242,1929]],"region":{"top_left_x":242,"top_left_y":386,"width":1529,"height":1543},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b318b9da75a04fe39231ddcebe72f090","type":"table_row","conversion_output":false,"parent_id":"6438d4f629d34a1ca21444dcc5aa50bf","text":"","text_display":""},{"cnt":[[242,1947],[1775,1947],[1775,2514],[242,2514]],"region":{"top_left_x":242,"top_left_y":1947,"width":1534,"height":567},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"491a904c9fc243a99f918bc5d0943b3e","type":"table_row","conversion_output":false,"parent_id":"6438d4f629d34a1ca21444dcc5aa50bf","text":"","text_display":""},{"cnt":[[265,340],[594,340],[594,379],[265,379]],"region":{"top_left_x":265,"top_left_y":340,"width":330,"height":40},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c488dc7f24eb437e9f43d65cc60d1a62","type":"simple_cell","conversion_output":false,"parent_id":"6438d4f629d34a1ca21444dcc5aa50bf","text":"Section to be changed","text_display":"Section to be changed","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[933,338],[1746,338],[1746,1927],[933,1927]],"region":{"top_left_x":932,"top_left_y":337,"width":814,"height":1590},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1907ee90201418a89f5f7381940212f","type":"complex_cell","conversion_output":false,"parent_id":"6438d4f629d34a1ca21444dcc5aa50bf","children_ids":["3f1a2c33ed434858ad8f0f1ea3837115","959249e2ec1943088a0387d8eac9bf73","abfe9920c55e43f88cb185b9d0daa7c6","613f1cd7d0d54f7f90281397d9fc886f","4a80e42219e74c4caeb7b1af5881f412","daaf0b94bbbe40beb0090a57b1f7adad","79881557d1634a7eb9a25784488559ad","a9483974c8c9461fbb0c295a2601b0b3","efc0598c5c30449ebc3f39e2276f856b","375b876ac4db44eca240af4bc82ad49c","50c7b35a3a68447cb5fcc8d9b5b83404","1c66f5546cda45498d29b245a8cf4ad1","22c7795c038a4875a8422c1f0920718a","abb51ce8a5544b448a13ab4af57624e7","e316c8f9863e4789a2d354a815be6b31","3b1e2789516147b99c48ef843ce3fcc8","9fa04c5d40074f04a605912adbfc800b","de3b2097c04f4c14bab4ad1c47bf615a","221449c2ec1e4c8c8125373757b9f427","e3502b0510db4577a2da3ed3daf30552","1c5043b09dac45758c3d62241e2c078f","336a69c4599041dbb08605978015bd61","de32c3734e0444a3a8b25458a7690e6a"],"text":"\\begin{tabular}{l}\n5.1.1 Endpoint(s) of efficacy \\\\\nChange 2: \\\\\nAlbuminuria change over time was changed into: UACR change over time. \\\\\nChange 3: \\\\\nSustained loss of \\(50 \\%\\) or more in eGFR was changed into: Sustained decrease of 50\\% or more in eGFR. \\\\\nIn addition: \\\\\nComposite microvascular outcome (50\\% loss of eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nwas changed into: \\\\\nComposite microvascular outcome (50\\% decrease or more in eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nChange 4: \\\\\nThe following text was added: Definitions of the adjudicated endpoint events are outlined in the CEC charters.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n5.1.1 Endpoint(s) of efficacy \\\\\nChange 2: \\\\\nAlbuminuria change over time was changed into: UACR change over time. \\\\\nChange 3: \\\\\nSustained loss of \\(50 \\%\\) or more in eGFR was changed into: Sustained decrease of 50\\% or more in eGFR. \\\\\nIn addition: \\\\\nComposite microvascular outcome (50\\% loss of eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nwas changed into: \\\\\nComposite microvascular outcome (50\\% decrease or more in eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nChange 4: \\\\\nThe following text was added: Definitions of the adjudicated endpoint events are outlined in the CEC charters.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9129670258355135,"confidence_rate":0.9998706342375543},{"cnt":[[937,340],[1361,340],[1361,382],[937,382]],"region":{"top_left_x":937,"top_left_y":340,"width":425,"height":42},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f1a2c33ed434858ad8f0f1ea3837115","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"5.1.1 Endpoint(s) of efficacy","text_display":"5.1.1 Endpoint(s) of efficacy","confidence":1,"confidence_rate":1},{"cnt":[[937,909],[1092,909],[1092,950],[937,950]],"region":{"top_left_x":937,"top_left_y":908,"width":155,"height":43},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"959249e2ec1943088a0387d8eac9bf73","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[937,948],[1741,948],[1741,992],[937,992]],"region":{"top_left_x":937,"top_left_y":948,"width":804,"height":44},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abfe9920c55e43f88cb185b9d0daa7c6","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"Albuminuria change over time was changed into: UACR","text_display":"\nAlbuminuria change over time was changed into: UACR","confidence":1,"confidence_rate":1},{"cnt":[[937,990],[1193,990],[1193,1029],[937,1029]],"region":{"top_left_x":937,"top_left_y":989,"width":256,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"613f1cd7d0d54f7f90281397d9fc886f","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"change over time.","text_display":" change over time.","confidence":1,"confidence_rate":1},{"cnt":[[937,1049],[1087,1049],[1087,1089],[937,1089]],"region":{"top_left_x":937,"top_left_y":1049,"width":151,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a80e42219e74c4caeb7b1af5881f412","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99853515625,"confidence_rate":0.9998952970758412},{"cnt":[[940,1091],[1690,1091],[1690,1130],[940,1130]],"region":{"top_left_x":939,"top_left_y":1090,"width":752,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"daaf0b94bbbe40beb0090a57b1f7adad","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"Sustained loss of \\(50 \\%\\) or more in eGFR was changed","text_display":"\nSustained loss of \\(50 \\%\\) or more in eGFR was changed","confidence":0.9129670258355135,"confidence_rate":0.9984038100872884},{"cnt":[[937,1130],[1644,1130],[1644,1167],[937,1167]],"region":{"top_left_x":937,"top_left_y":1129,"width":708,"height":38},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79881557d1634a7eb9a25784488559ad","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"into: Sustained decrease of 50\\% or more in eGFR.","text_display":" into: Sustained decrease of 50\\% or more in eGFR.","confidence":0.9682917594909668,"confidence_rate":0.9993922256624103},{"cnt":[[937,1211],[1110,1211],[1110,1250],[937,1250]],"region":{"top_left_x":937,"top_left_y":1210,"width":174,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9483974c8c9461fbb0c295a2601b0b3","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"In addition:","text_display":"\nIn addition:","confidence":1,"confidence_rate":1},{"cnt":[[937,1250],[1723,1250],[1723,1291],[937,1291]],"region":{"top_left_x":937,"top_left_y":1249,"width":786,"height":43},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"efc0598c5c30449ebc3f39e2276f856b","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"Composite microvascular outcome (50\\% loss of eGFR,","text_display":"\nComposite microvascular outcome (50\\% loss of eGFR,","confidence":0.96875,"confidence_rate":0.9994229175159202},{"cnt":[[937,1289],[1598,1289],[1598,1328],[937,1328]],"region":{"top_left_x":937,"top_left_y":1288,"width":662,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"375b876ac4db44eca240af4bc82ad49c","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"albuminuria progression, requirement for renal","text_display":" albuminuria progression, requirement for renal","confidence":1,"confidence_rate":1},{"cnt":[[937,1330],[1727,1330],[1727,1369],[937,1369]],"region":{"top_left_x":937,"top_left_y":1330,"width":791,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50c7b35a3a68447cb5fcc8d9b5b83404","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"replacement therapy or death due to renal failure, use of","text_display":" replacement therapy or death due to renal failure, use of","confidence":1,"confidence_rate":1},{"cnt":[[937,1372],[1709,1372],[1709,1411],[937,1411]],"region":{"top_left_x":937,"top_left_y":1371,"width":772,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c66f5546cda45498d29b245a8cf4ad1","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"retinal photocoagulation or intravitreal injections of an","text_display":" retinal photocoagulation or intravitreal injections of an","confidence":1,"confidence_rate":1},{"cnt":[[937,1409],[1566,1409],[1566,1450],[937,1450]],"region":{"top_left_x":937,"top_left_y":1408,"width":629,"height":43},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22c7795c038a4875a8422c1f0920718a","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"anti-VEGF therapy for diabetic retinopathy).","text_display":" anti-VEGF therapy for diabetic retinopathy).","confidence":1,"confidence_rate":1},{"cnt":[[937,1487],[1202,1487],[1202,1531],[937,1531]],"region":{"top_left_x":937,"top_left_y":1486,"width":266,"height":45},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abb51ce8a5544b448a13ab4af57624e7","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"was changed into:","text_display":"\nwas changed into:","confidence":1,"confidence_rate":1},{"cnt":[[937,1528],[1681,1528],[1681,1567],[937,1567]],"region":{"top_left_x":937,"top_left_y":1528,"width":745,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e316c8f9863e4789a2d354a815be6b31","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"Composite microvascular outcome (50\\% decrease or","text_display":"\nComposite microvascular outcome (50\\% decrease or","confidence":0.9990234375,"confidence_rate":0.9999815654595818},{"cnt":[[937,1570],[1736,1570],[1736,1609],[937,1609]],"region":{"top_left_x":937,"top_left_y":1569,"width":800,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b1e2789516147b99c48ef843ce3fcc8","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"more in eGFR, albuminuria progression, requirement for","text_display":" more in eGFR, albuminuria progression, requirement for","confidence":1,"confidence_rate":1},{"cnt":[[937,1611],[1709,1611],[1709,1650],[937,1650]],"region":{"top_left_x":937,"top_left_y":1611,"width":772,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9fa04c5d40074f04a605912adbfc800b","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"renal replacement therapy or death due to renal failure,","text_display":" renal replacement therapy or death due to renal failure,","confidence":1,"confidence_rate":1},{"cnt":[[937,1648],[1718,1648],[1718,1689],[937,1689]],"region":{"top_left_x":937,"top_left_y":1648,"width":781,"height":42},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de3b2097c04f4c14bab4ad1c47bf615a","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"use of retinal photocoagulation or intravitreal injections","text_display":" use of retinal photocoagulation or intravitreal injections","confidence":1,"confidence_rate":1},{"cnt":[[937,1689],[1644,1689],[1644,1729],[937,1729]],"region":{"top_left_x":937,"top_left_y":1689,"width":708,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"221449c2ec1e4c8c8125373757b9f427","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"of an anti-VEGF therapy for diabetic retinopathy).","text_display":" of an anti-VEGF therapy for diabetic retinopathy).","confidence":1,"confidence_rate":1},{"cnt":[[937,1768],[1087,1768],[1087,1807],[937,1807]],"region":{"top_left_x":937,"top_left_y":1767,"width":151,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3502b0510db4577a2da3ed3daf30552","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"Change 4:","text_display":"\nChange 4:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[937,1809],[1626,1809],[1626,1848],[937,1848]],"region":{"top_left_x":937,"top_left_y":1809,"width":689,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c5043b09dac45758c3d62241e2c078f","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"The following text was added: Definitions of the","text_display":"\nThe following text was added: Definitions of the","confidence":1,"confidence_rate":1},{"cnt":[[937,1848],[1672,1848],[1672,1890],[937,1890]],"region":{"top_left_x":937,"top_left_y":1848,"width":735,"height":42},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"336a69c4599041dbb08605978015bd61","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"adjudicated endpoint events are outlined in the CEC","text_display":" adjudicated endpoint events are outlined in the CEC","confidence":1,"confidence_rate":1},{"cnt":[[937,1887],[1064,1887],[1064,1922],[937,1922]],"region":{"top_left_x":937,"top_left_y":1887,"width":127,"height":36},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de32c3734e0444a3a8b25458a7690e6a","type":"text","conversion_output":false,"parent_id":"b1907ee90201418a89f5f7381940212f","text":"charters.","text_display":" charters.","confidence":1,"confidence_rate":1},{"cnt":[[265,1952],[580,1952],[580,1991],[265,1991]],"region":{"top_left_x":265,"top_left_y":1951,"width":316,"height":41},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e8503e9e54e14fa8a2349ec6bf879ae7","type":"simple_cell","conversion_output":false,"parent_id":"6438d4f629d34a1ca21444dcc5aa50bf","text":"Rationale for change","text_display":"Rationale for change","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[933,2145],[1732,2145],[1732,2509],[933,2509]],"region":{"top_left_x":932,"top_left_y":2145,"width":800,"height":365},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6346464d1fac4ff3b0299cc9517eccc8","type":"complex_cell","conversion_output":false,"parent_id":"6438d4f629d34a1ca21444dcc5aa50bf","children_ids":["936d4f02dacf4fec9098274536e219cf","07f38166967d4fe7bdd0c17f7f1189fa","9a424e296af7432d8718991c95d10a07","4ec4601a8b1842d6ba5f5f0bddc94fe6","b8e0f36cd92b406f8765cda3a87ac32b","e4ac43c136b84c6882185bc34ac995da","de496c5617b0431d8fc9e612cfba8b51"],"text":"\\begin{tabular}{l}\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo use consistent terminology. \\\\\nChange 4: \\\\\nTo clarify that endpoint event definitions are outlined in the CEC charters.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 2: \\\\\nFor clarification. \\\\\nChange 3: \\\\\nTo use consistent terminology. \\\\\nChange 4: \\\\\nTo clarify that endpoint event definitions are outlined in the CEC charters.\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.998046875,"confidence_rate":0.9999750672972136},{"cnt":[[937,2150],[1087,2150],[1087,2189],[937,2189]],"region":{"top_left_x":937,"top_left_y":2149,"width":151,"height":41},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"936d4f02dacf4fec9098274536e219cf","type":"text","conversion_output":false,"parent_id":"6346464d1fac4ff3b0299cc9517eccc8","text":"Change 2:","text_display":"Change 2:","confidence":1,"confidence_rate":1},{"cnt":[[937,2191],[1179,2191],[1179,2226],[937,2226]],"region":{"top_left_x":937,"top_left_y":2191,"width":243,"height":35},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07f38166967d4fe7bdd0c17f7f1189fa","type":"text","conversion_output":false,"parent_id":"6346464d1fac4ff3b0299cc9517eccc8","text":"For clarification.","text_display":"\nFor clarification.","confidence":1,"confidence_rate":1},{"cnt":[[937,2270],[1087,2270],[1087,2309],[937,2309]],"region":{"top_left_x":937,"top_left_y":2269,"width":151,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a424e296af7432d8718991c95d10a07","type":"text","conversion_output":false,"parent_id":"6346464d1fac4ff3b0299cc9517eccc8","text":"Change 3:","text_display":"\nChange 3:","confidence":0.998046875,"confidence_rate":0.9998603644045428},{"cnt":[[937,2311],[1373,2311],[1373,2350],[937,2350]],"region":{"top_left_x":937,"top_left_y":2311,"width":436,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ec4601a8b1842d6ba5f5f0bddc94fe6","type":"text","conversion_output":false,"parent_id":"6346464d1fac4ff3b0299cc9517eccc8","text":"To use consistent terminology.","text_display":"\nTo use consistent terminology.","confidence":1,"confidence_rate":1},{"cnt":[[937,2389],[1087,2389],[1087,2433],[937,2433]],"region":{"top_left_x":937,"top_left_y":2389,"width":151,"height":45},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8e0f36cd92b406f8765cda3a87ac32b","type":"text","conversion_output":false,"parent_id":"6346464d1fac4ff3b0299cc9517eccc8","text":"Change 4:","text_display":"\nChange 4:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[937,2431],[1727,2431],[1727,2470],[937,2470]],"region":{"top_left_x":937,"top_left_y":2430,"width":791,"height":41},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e4ac43c136b84c6882185bc34ac995da","type":"text","conversion_output":false,"parent_id":"6346464d1fac4ff3b0299cc9517eccc8","text":"To clarify that endpoint event definitions are outlined in","text_display":"\nTo clarify that endpoint event definitions are outlined in","confidence":1,"confidence_rate":1},{"cnt":[[937,2470],[1191,2470],[1191,2507],[937,2507]],"region":{"top_left_x":937,"top_left_y":2470,"width":254,"height":37},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de496c5617b0431d8fc9e612cfba8b51","type":"text","conversion_output":false,"parent_id":"6346464d1fac4ff3b0299cc9517eccc8","text":"the CEC charters.","text_display":" the CEC charters.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2cb7974fb2714183be58ef0dc82c2209","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[288,2622],[1798,2622],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2622,"width":1511,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fe0cca81d8da49a3923ccbf14aa2bcac","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.99072265625,"confidence_rate":0.9999216783081981},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"014b4f07ffa7417eaa62e4a2813ec0bf","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-091","page":91,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2264ab72b21e4e26970aaba536491d32","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7148986a68af40baae91ae0131ff6c66","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"28eb33bdd42a45f489c0fa13144b1119","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b502946af34147718d8556e7316c5485","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"335a20650cb94de4bd89d157bd0617ec","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"335dd0044881415ea142d807a7b76d66","type":"page_info","conversion_output":false,"text":"Page 91 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2565],[244,2565]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2235},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca4f3eb862674221abc4a4d5411d3f78","type":"table","conversion_output":true,"children_ids":["f51bc0e289f74b8b9410c673ed4ad427","a2780d9fd9b1440e8401d903d01ab32e","1e4ef181aa60441d9e50495852619c77","43c5756764f54a3a914fa1cf319e8c7a","0f3a9771b4174a84a53671d08d071475","ca028457def14a078c2935b69a78c21d","de4796f7f1774535b7882c6104aa6369","4e299ba9264d464aa3bedf1faf839df6","d8119f36e5bb4220bfde9b3d2b4b1a13","504c714e2c004f178b7c8a662f47bdd5","ef75c1971ff7474f86b95f66aae18836"],"text":"\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 5.2.2.1 Definitions of adverse events \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nA list of terms that must be documented as AESI for each topic is provided in the ISF. Renal events will be adjudicated by an independent adjudication committee. \\\\\nWas changed into: \\\\\nA list of terms that must be documented as AESI for each topic is provided in the ISF. Renal events and pancreatic events will be adjudicated by independent adjudication committees. \\\\\nChange 2: \\\\\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq\\) 2 fold ULN measured in the same blood sample need to be followed up locally. \\\\\nWas changed into: \\\\\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq\\) 2 fold ULN measured in the same blood sample need to be followed up locally according to the \"DILI checklist\" provided in ISF. \\\\\nChange 3: \\\\\nIn case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (Visit 2) an additional visit 4 weeks after detection should be scheduled (unless detected at the EOT visit at study end) to collect a blood sample for repeat analysis of creatinine for calculation of the eGFR. \\\\\nWas changed into: \\\\\nIn case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled (unless detected at the EOT visit at study end) to collect a blood sample for repeat analysis of creatinine for calculation of the eGFR.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nAdjudication of pancreatic events added. \\\\\nChange 2: \\\\\nTo provide additional guidance for follow-up of patient showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq 2\\) fold ULN. \\\\\nChange 3: \\\\\nTo add an additional trigger for repeat analysis of eGFR in line with the newly added tertiary endpoints.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 5.2.2.1 Definitions of adverse events \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nA list of terms that must be documented as AESI for each topic is provided in the ISF. Renal events will be adjudicated by an independent adjudication committee. \\\\\nWas changed into: \\\\\nA list of terms that must be documented as AESI for each topic is provided in the ISF. Renal events and pancreatic events will be adjudicated by independent adjudication committees. \\\\\nChange 2: \\\\\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq\\) 2 fold ULN measured in the same blood sample need to be followed up locally. \\\\\nWas changed into: \\\\\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq\\) 2 fold ULN measured in the same blood sample need to be followed up locally according to the \"DILI checklist\" provided in ISF. \\\\\nChange 3: \\\\\nIn case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (Visit 2) an additional visit 4 weeks after detection should be scheduled (unless detected at the EOT visit at study end) to collect a blood sample for repeat analysis of creatinine for calculation of the eGFR. \\\\\nWas changed into: \\\\\nIn case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled (unless detected at the EOT visit at study end) to collect a blood sample for repeat analysis of creatinine for calculation of the eGFR.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nAdjudication of pancreatic events added. \\\\\nChange 2: \\\\\nTo provide additional guidance for follow-up of patient showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq 2\\) fold ULN. \\\\\nChange 3: \\\\\nTo add an additional trigger for repeat analysis of eGFR in line with the newly added tertiary endpoints.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.96142578125,"confidence_rate":0.9999884805357614},{"cnt":[[249,331],[599,331],[599,2567],[249,2567]],"region":{"top_left_x":248,"top_left_y":331,"width":351,"height":2236},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f51bc0e289f74b8b9410c673ed4ad427","type":"table_column","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","text":"","text_display":""},{"cnt":[[921,331],[1768,331],[1768,2567],[921,2567]],"region":{"top_left_x":920,"top_left_y":331,"width":849,"height":2236},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2780d9fd9b1440e8401d903d01ab32e","type":"table_column","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","text":"","text_display":""},{"cnt":[[244,336],[1775,336],[1775,389],[244,389]],"region":{"top_left_x":244,"top_left_y":335,"width":1532,"height":54},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e4ef181aa60441d9e50495852619c77","type":"table_row","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","text":"","text_display":""},{"cnt":[[244,393],[1775,393],[1775,1966],[244,1966]],"region":{"top_left_x":244,"top_left_y":393,"width":1532,"height":1573},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43c5756764f54a3a914fa1cf319e8c7a","type":"table_row","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","text":"","text_display":""},{"cnt":[[243,1957],[1775,1954],[1776,2456],[244,2458]],"region":{"top_left_x":243,"top_left_y":1954,"width":1533,"height":505},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f3a9771b4174a84a53671d08d071475","type":"table_row","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","text":"","text_display":""},{"cnt":[[267,340],[592,340],[592,382],[267,382]],"region":{"top_left_x":267,"top_left_y":340,"width":325,"height":42},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca028457def14a078c2935b69a78c21d","type":"simple_cell","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","text":"Section to be changed","text_display":"Section to be changed","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,340],[1474,340],[1474,375],[939,375]],"region":{"top_left_x":939,"top_left_y":340,"width":535,"height":35},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de4796f7f1774535b7882c6104aa6369","type":"simple_cell","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","text":"5.2.2.1 Definitions of adverse events","text_display":"5.2.2.1 Definitions of adverse events","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,400],[596,400],[596,439],[267,439]],"region":{"top_left_x":267,"top_left_y":400,"width":330,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e299ba9264d464aa3bedf1faf839df6","type":"simple_cell","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","text":"Description of change","text_display":"Description of change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,395],[1752,395],[1752,1963],[935,1963]],"region":{"top_left_x":934,"top_left_y":395,"width":819,"height":1569},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8119f36e5bb4220bfde9b3d2b4b1a13","type":"complex_cell","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","children_ids":["94032046e0dd4685b9ff78ad9ddaf8c7","d936b7eb24ef46f692cffc42c6ec1b1a","a0575a1b3b294f65b49b914c8f4b9b57","2d2d228e2e3c4363aafa236aaf0ff9d6","6155a297126540ab9581ac3c80b3a3b9","259596a22eb044c4bcec6e216e3f423c","be26ae79d4234a48bd7d55f85c5beeed","3a078f41fe1f40129cc40031a3f54554","f4d1791f8cf5449b904a0cbc559d0700","9dcbcea321744e9c864fcd184dda44e9","7f4015dcc7c142728f3f03db5ae4bbac","c23847fab06e45768e481b8c13e9cda0","ee8e8c596281451985256d9bceddc0b8","e8a8b0efc0ca4855951a31bb2bd99755","95c323881b334b8c8613282030a50046","a7248dbf88f040c0bd08fa6201698a24","1e75b04aef0545369ba6759dcf05c9c2","8af2c0ac9f274164ab09b60cb65f07ec","15653269eb6543419520949e7da70cd1","518b1975e7de425585d4ce879efba86d","786b577806724306b1bd699e5cd0d482","17c69e981c344725905b46061b83cc7c","e3d32ca35669476a81c4ef28b1504e27","e120ec4b06fe4a3a8e352b2117ccde15","03a68b7ec5a34f9887f4e3d0a49af966","bf28053e60f244f0a60d017868f86f46","7359c1314acf4f1eaec087f76156eae3","9aca6b0fe827443e98cdc10d491f88fe","91870c9988154ad0bb72ffc1cf2c45f8","4326575c3267481fbcc08867a48828c3","663e9916c36544db9825f7911f657151","7dda5f76734b47b8982164e871ae00bb","7900f4126c6447338ea1a8d94cdf724a"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nA list of terms that must be documented as AESI for each topic is provided in the ISF. Renal events will be adjudicated by an independent adjudication committee. \\\\\nWas changed into: \\\\\nA list of terms that must be documented as AESI for each topic is provided in the ISF. Renal events and pancreatic events will be adjudicated by independent adjudication committees. \\\\\nChange 2: \\\\\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq\\) 2 fold ULN measured in the same blood sample need to be followed up locally. \\\\\nWas changed into: \\\\\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq\\) 2 fold ULN measured in the same blood sample need to be followed up locally according to the \"DILI checklist\" provided in ISF. \\\\\nChange 3: \\\\\nIn case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (Visit 2) an additional visit 4 weeks after detection should be scheduled (unless detected at the EOT visit at study end) to collect a blood sample for repeat analysis of creatinine for calculation of the eGFR. \\\\\nWas changed into: \\\\\nIn case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled (unless detected at the EOT visit at study end) to collect a blood sample for repeat analysis of creatinine for calculation of the eGFR.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nA list of terms that must be documented as AESI for each topic is provided in the ISF. Renal events will be adjudicated by an independent adjudication committee. \\\\\nWas changed into: \\\\\nA list of terms that must be documented as AESI for each topic is provided in the ISF. Renal events and pancreatic events will be adjudicated by independent adjudication committees. \\\\\nChange 2: \\\\\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq\\) 2 fold ULN measured in the same blood sample need to be followed up locally. \\\\\nWas changed into: \\\\\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq\\) 2 fold ULN measured in the same blood sample need to be followed up locally according to the \"DILI checklist\" provided in ISF. \\\\\nChange 3: \\\\\nIn case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (Visit 2) an additional visit 4 weeks after detection should be scheduled (unless detected at the EOT visit at study end) to collect a blood sample for repeat analysis of creatinine for calculation of the eGFR. \\\\\nWas changed into: \\\\\nIn case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\) since baseline (visit 2) an additional visit 4 weeks after detection should be scheduled (unless detected at the EOT visit at study end) to collect a blood sample for repeat analysis of creatinine for calculation of the eGFR.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.96142578125,"confidence_rate":0.9999343735449675},{"cnt":[[939,400],[1089,400],[1089,439],[939,439]],"region":{"top_left_x":939,"top_left_y":400,"width":151,"height":40},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94032046e0dd4685b9ff78ad9ddaf8c7","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,437],[1748,437],[1748,474],[939,474]],"region":{"top_left_x":939,"top_left_y":436,"width":809,"height":38},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d936b7eb24ef46f692cffc42c6ec1b1a","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"A list of terms that must be documented as AESI for each","text_display":"\nA list of terms that must be documented as AESI for each","confidence":1,"confidence_rate":1},{"cnt":[[939,478],[1632,478],[1632,518],[939,518]],"region":{"top_left_x":939,"top_left_y":478,"width":694,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0575a1b3b294f65b49b914c8f4b9b57","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"topic is provided in the ISF. Renal events will be","text_display":" topic is provided in the ISF. Renal events will be","confidence":1,"confidence_rate":1},{"cnt":[[939,520],[1711,520],[1711,559],[939,559]],"region":{"top_left_x":939,"top_left_y":519,"width":772,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d2d228e2e3c4363aafa236aaf0ff9d6","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"adjudicated by an independent adjudication committee.","text_display":" adjudicated by an independent adjudication committee.","confidence":1,"confidence_rate":1},{"cnt":[[939,603],[1204,603],[1204,642],[939,642]],"region":{"top_left_x":939,"top_left_y":602,"width":266,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6155a297126540ab9581ac3c80b3a3b9","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.97705078125,"confidence_rate":0.9989452542913471},{"cnt":[[939,681],[1748,681],[1748,716],[939,716]],"region":{"top_left_x":939,"top_left_y":680,"width":809,"height":36},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"259596a22eb044c4bcec6e216e3f423c","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"A list of terms that must be documented as AESI for each","text_display":"\nA list of terms that must be documented as AESI for each","confidence":1,"confidence_rate":1},{"cnt":[[939,722],[1738,722],[1738,762],[939,762]],"region":{"top_left_x":939,"top_left_y":722,"width":800,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be26ae79d4234a48bd7d55f85c5beeed","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"topic is provided in the ISF. Renal events and pancreatic","text_display":" topic is provided in the ISF. Renal events and pancreatic","confidence":1,"confidence_rate":1},{"cnt":[[939,764],[1711,764],[1711,801],[939,801]],"region":{"top_left_x":939,"top_left_y":763,"width":772,"height":38},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a078f41fe1f40129cc40031a3f54554","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"events will be adjudicated by independent adjudication","text_display":" events will be adjudicated by independent adjudication","confidence":1,"confidence_rate":1},{"cnt":[[939,805],[1112,805],[1112,835],[939,835]],"region":{"top_left_x":939,"top_left_y":805,"width":174,"height":31},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4d1791f8cf5449b904a0cbc559d0700","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"committees.","text_display":" committees.","confidence":1,"confidence_rate":1},{"cnt":[[939,884],[1087,884],[1087,923],[939,923]],"region":{"top_left_x":939,"top_left_y":883,"width":148,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9dcbcea321744e9c864fcd184dda44e9","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,925],[1697,925],[1697,964],[939,964]],"region":{"top_left_x":939,"top_left_y":925,"width":758,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f4015dcc7c142728f3f03db5ae4bbac","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"Patients showing an elevation of AST and/or ALT \\(\\geq 3\\)","text_display":"\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\)","confidence":1,"confidence_rate":1},{"cnt":[[939,964],[1748,964],[1748,1001],[939,1001]],"region":{"top_left_x":939,"top_left_y":964,"width":809,"height":38},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c23847fab06e45768e481b8c13e9cda0","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"fold ULN combined with an elevation of total bilirubin \\(\\geq\\)","text_display":" fold ULN combined with an elevation of total bilirubin \\(\\geq\\)","confidence":1,"confidence_rate":1},{"cnt":[[939,1003],[1720,1003],[1720,1042],[939,1042]],"region":{"top_left_x":939,"top_left_y":1003,"width":781,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee8e8c596281451985256d9bceddc0b8","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"2 fold ULN measured in the same blood sample need to","text_display":" 2 fold ULN measured in the same blood sample need to","confidence":1,"confidence_rate":1},{"cnt":[[939,1045],[1264,1045],[1264,1084],[939,1084]],"region":{"top_left_x":939,"top_left_y":1044,"width":326,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e8a8b0efc0ca4855951a31bb2bd99755","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"be followed up locally.","text_display":" be followed up locally.","confidence":1,"confidence_rate":1},{"cnt":[[939,1123],[1204,1123],[1204,1162],[939,1162]],"region":{"top_left_x":939,"top_left_y":1123,"width":266,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95c323881b334b8c8613282030a50046","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99755859375,"confidence_rate":0.9998888974749892},{"cnt":[[939,1165],[1697,1165],[1697,1204],[939,1204]],"region":{"top_left_x":939,"top_left_y":1164,"width":758,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7248dbf88f040c0bd08fa6201698a24","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"Patients showing an elevation of AST and/or ALT \\(\\geq 3\\)","text_display":"\nPatients showing an elevation of AST and/or ALT \\(\\geq 3\\)","confidence":1,"confidence_rate":1},{"cnt":[[939,1204],[1741,1204],[1741,1240],[939,1240]],"region":{"top_left_x":939,"top_left_y":1203,"width":802,"height":38},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e75b04aef0545369ba6759dcf05c9c2","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"fold ULN combined with an elevation of total bilirubin \\(\\geq\\)","text_display":" fold ULN combined with an elevation of total bilirubin \\(\\geq\\)","confidence":1,"confidence_rate":1},{"cnt":[[939,1243],[1720,1243],[1720,1282],[939,1282]],"region":{"top_left_x":939,"top_left_y":1242,"width":781,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8af2c0ac9f274164ab09b60cb65f07ec","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"2 fold ULN measured in the same blood sample need to","text_display":" 2 fold ULN measured in the same blood sample need to","confidence":1,"confidence_rate":1},{"cnt":[[939,1284],[1729,1284],[1729,1323],[939,1323]],"region":{"top_left_x":939,"top_left_y":1284,"width":791,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15653269eb6543419520949e7da70cd1","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"be followed up locally according to the \"DILI checklist\"","text_display":" be followed up locally according to the \"DILI checklist\"","confidence":1,"confidence_rate":1},{"cnt":[[939,1321],[1172,1321],[1172,1365],[939,1365]],"region":{"top_left_x":939,"top_left_y":1321,"width":233,"height":44},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"518b1975e7de425585d4ce879efba86d","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"provided in ISF.","text_display":" provided in ISF.","confidence":1,"confidence_rate":1},{"cnt":[[939,1404],[1087,1404],[1087,1443],[939,1443]],"region":{"top_left_x":939,"top_left_y":1403,"width":148,"height":41},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"786b577806724306b1bd699e5cd0d482","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"Change 3:","text_display":"\nChange 3:","confidence":0.998046875,"confidence_rate":0.9998603644045428},{"cnt":[[939,1443],[1748,1443],[1748,1485],[939,1485]],"region":{"top_left_x":939,"top_left_y":1443,"width":809,"height":42},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17c69e981c344725905b46061b83cc7c","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"In case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (Visit 2)","text_display":"\nIn case of an eGFR loss of \\(\\geq 50 \\%\\) since baseline (Visit 2)","confidence":1,"confidence_rate":1},{"cnt":[[939,1482],[1665,1482],[1665,1517],[939,1517]],"region":{"top_left_x":939,"top_left_y":1482,"width":726,"height":35},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3d32ca35669476a81c4ef28b1504e27","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"an additional visit 4 weeks after detection should be","text_display":" an additional visit 4 weeks after detection should be","confidence":0.9990234375,"confidence_rate":0.9999839830848651},{"cnt":[[939,1524],[1734,1524],[1734,1563],[939,1563]],"region":{"top_left_x":939,"top_left_y":1523,"width":795,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e120ec4b06fe4a3a8e352b2117ccde15","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"scheduled (unless detected at the EOT visit at study end)","text_display":" scheduled (unless detected at the EOT visit at study end)","confidence":1,"confidence_rate":1},{"cnt":[[939,1561],[1738,1561],[1738,1604],[939,1604]],"region":{"top_left_x":939,"top_left_y":1560,"width":800,"height":45},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03a68b7ec5a34f9887f4e3d0a49af966","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"to collect a blood sample for repeat analysis of creatinine","text_display":" to collect a blood sample for repeat analysis of creatinine","confidence":1,"confidence_rate":1},{"cnt":[[939,1602],[1333,1602],[1333,1637],[939,1637]],"region":{"top_left_x":939,"top_left_y":1601,"width":395,"height":36},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf28053e60f244f0a60d017868f86f46","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"for calculation of the eGFR.","text_display":" for calculation of the eGFR.","confidence":0.9990234375,"confidence_rate":0.9999703931762353},{"cnt":[[939,1683],[1204,1683],[1204,1722],[939,1722]],"region":{"top_left_x":939,"top_left_y":1682,"width":266,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7359c1314acf4f1eaec087f76156eae3","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99853515625,"confidence_rate":0.9999333695979722},{"cnt":[[939,1722],[1692,1722],[1692,1761],[939,1761]],"region":{"top_left_x":939,"top_left_y":1721,"width":754,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9aca6b0fe827443e98cdc10d491f88fe","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"In case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline","text_display":"\nIn case of an eGFR decrease of \\(\\geq 40 \\%\\) since baseline","confidence":0.9931640625,"confidence_rate":0.9998817413111981},{"cnt":[[939,1763],[1748,1763],[1748,1802],[939,1802]],"region":{"top_left_x":939,"top_left_y":1763,"width":809,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91870c9988154ad0bb72ffc1cf2c45f8","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"(visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\)","text_display":" (visit 2) and again in case of an eGFR decrease of \\(\\geq 50 \\%\\)","confidence":0.998046875,"confidence_rate":0.9999668643653395},{"cnt":[[939,1800],[1711,1800],[1711,1844],[939,1844]],"region":{"top_left_x":939,"top_left_y":1799,"width":772,"height":45},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4326575c3267481fbcc08867a48828c3","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"since baseline (visit 2) an additional visit 4 weeks after","text_display":" since baseline (visit 2) an additional visit 4 weeks after","confidence":0.96142578125,"confidence_rate":0.9994041486881189},{"cnt":[[939,1841],[1678,1841],[1678,1881],[939,1881]],"region":{"top_left_x":939,"top_left_y":1841,"width":740,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"663e9916c36544db9825f7911f657151","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"detection should be scheduled (unless detected at the","text_display":" detection should be scheduled (unless detected at the","confidence":1,"confidence_rate":1},{"cnt":[[939,1883],[1676,1883],[1676,1922],[939,1922]],"region":{"top_left_x":939,"top_left_y":1882,"width":738,"height":41},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7dda5f76734b47b8982164e871ae00bb","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"EOT visit at study end) to collect a blood sample for","text_display":" EOT visit at study end) to collect a blood sample for","confidence":1,"confidence_rate":1},{"cnt":[[939,1924],[1731,1924],[1731,1963],[939,1963]],"region":{"top_left_x":939,"top_left_y":1924,"width":793,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7900f4126c6447338ea1a8d94cdf724a","type":"text","conversion_output":false,"parent_id":"d8119f36e5bb4220bfde9b3d2b4b1a13","text":"repeat analysis of creatinine for calculation of the eGFR.","text_display":" repeat analysis of creatinine for calculation of the eGFR.","confidence":1,"confidence_rate":1},{"cnt":[[267,1966],[582,1966],[582,2005],[267,2005]],"region":{"top_left_x":267,"top_left_y":1965,"width":316,"height":40},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"504c714e2c004f178b7c8a662f47bdd5","type":"simple_cell","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","text":"Rationale for change","text_display":"Rationale for change","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1961],[1734,1961],[1734,2447],[935,2447]],"region":{"top_left_x":934,"top_left_y":1961,"width":800,"height":487},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef75c1971ff7474f86b95f66aae18836","type":"complex_cell","conversion_output":false,"parent_id":"ca4f3eb862674221abc4a4d5411d3f78","children_ids":["cd22b10d544d4aa8b8a07767694eef07","c3d4162b735e4d08a1e42c621e3cfead","13f808d5090c4b7c9cbbbea714fca32b","8c4234411b074d5e9d1c8ab8b6882465","b5aab5c5a7dd4bcfb9aac6355d3be83c","bff55dfeb8b3464d893df99b0d6d11ff","006da1dc9aaf454c8eb73ad8080b06bc","43817faa3fff4b1c8cd42fb7446b63d2","10e76373d4da41d4830e67b080cba3dc","92be2df54ebd4827a273f9a3d9cc0f72"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nAdjudication of pancreatic events added. \\\\\nChange 2: \\\\\nTo provide additional guidance for follow-up of patient showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq 2\\) fold ULN. \\\\\nChange 3: \\\\\nTo add an additional trigger for repeat analysis of eGFR in line with the newly added tertiary endpoints.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nAdjudication of pancreatic events added. \\\\\nChange 2: \\\\\nTo provide additional guidance for follow-up of patient showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN combined with an elevation of total bilirubin \\(\\geq 2\\) fold ULN. \\\\\nChange 3: \\\\\nTo add an additional trigger for repeat analysis of eGFR in line with the newly added tertiary endpoints.\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999965114310986},{"cnt":[[939,1966],[1096,1966],[1096,2005],[939,2005]],"region":{"top_left_x":939,"top_left_y":1965,"width":157,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd22b10d544d4aa8b8a07767694eef07","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2003],[1513,2003],[1513,2046],[939,2046]],"region":{"top_left_x":939,"top_left_y":2002,"width":574,"height":45},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3d4162b735e4d08a1e42c621e3cfead","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"Adjudication of pancreatic events added.","text_display":"\nAdjudication of pancreatic events added.","confidence":1,"confidence_rate":1},{"cnt":[[939,2083],[1089,2083],[1089,2122],[939,2122]],"region":{"top_left_x":939,"top_left_y":2083,"width":151,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13f808d5090c4b7c9cbbbea714fca32b","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2122],[1720,2122],[1720,2164],[939,2164]],"region":{"top_left_x":939,"top_left_y":2122,"width":781,"height":42},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c4234411b074d5e9d1c8ab8b6882465","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"To provide additional guidance for follow-up of patient","text_display":"\nTo provide additional guidance for follow-up of patient","confidence":1,"confidence_rate":1},{"cnt":[[939,2164],[1725,2164],[1725,2203],[939,2203]],"region":{"top_left_x":939,"top_left_y":2163,"width":786,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5aab5c5a7dd4bcfb9aac6355d3be83c","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN","text_display":" showing an elevation of AST and/or ALT \\(\\geq 3\\) fold ULN","confidence":1,"confidence_rate":1},{"cnt":[[939,2203],[1688,2203],[1688,2240],[939,2240]],"region":{"top_left_x":939,"top_left_y":2202,"width":749,"height":38},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bff55dfeb8b3464d893df99b0d6d11ff","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"combined with an elevation of total bilirubin \\(\\geq 2\\) fold","text_display":" combined with an elevation of total bilirubin \\(\\geq 2\\) fold","confidence":1,"confidence_rate":1},{"cnt":[[939,2242],[1027,2242],[1027,2279],[939,2279]],"region":{"top_left_x":939,"top_left_y":2242,"width":88,"height":37},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"006da1dc9aaf454c8eb73ad8080b06bc","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"ULN.","text_display":" ULN.","confidence":1,"confidence_rate":1},{"cnt":[[939,2325],[1087,2325],[1087,2360],[939,2360]],"region":{"top_left_x":939,"top_left_y":2324,"width":148,"height":36},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43817faa3fff4b1c8cd42fb7446b63d2","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,2364],[1725,2364],[1725,2403],[939,2403]],"region":{"top_left_x":939,"top_left_y":2364,"width":786,"height":40},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10e76373d4da41d4830e67b080cba3dc","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"To add an additional trigger for repeat analysis of eGFR","text_display":"\nTo add an additional trigger for repeat analysis of eGFR","confidence":1,"confidence_rate":1},{"cnt":[[939,2403],[1600,2403],[1600,2445],[939,2445]],"region":{"top_left_x":939,"top_left_y":2403,"width":662,"height":42},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92be2df54ebd4827a273f9a3d9cc0f72","type":"text","conversion_output":false,"parent_id":"ef75c1971ff7474f86b95f66aae18836","text":"in line with the newly added tertiary endpoints.","text_display":" in line with the newly added tertiary endpoints.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":62,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1ee3dd8fe9c24101b0bc07445d5e1830","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":63,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"889d751fa0f24082a3ce9c83f682c4db","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":64,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"11f81a5375f54edd997099986a1f0d48","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-092","page":92,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"696d2dc4c2f44e0c925c70f0ba23350a","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba48a46f513d4ef7a56f4b5860c8c145","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"065573736d6d4a138bdfb37e6d9a8f01","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36027f65bb9f4c96ab793b7ad2d65982","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c6a2d07ac704e228ea53587e70a7d83","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73fc9a0536ac441ba6648aafcbe229ee","type":"page_info","conversion_output":false,"text":"Page 92 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1777,331],[1777,2543],[242,2543]],"region":{"top_left_x":242,"top_left_y":331,"width":1536,"height":2212},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ab70ca43a7b4397a7f41fce28ea5bfa","type":"table","conversion_output":true,"children_ids":["d41af2b076dd410e9b63af0a3f527248","6a3d65f22cb14833a819d0c9beffafc4","3cd778efc4e348ebbdaecb4eb0383021","8bc917dbd64049a08a5dc629ac76ef9c","2f99c612c32e4dec9850397a75cc295f","fa83a6ae99224182abe3d75db689e130","f89475311721477e95824ea14a721d18","f01c424be97e43f5a3f69eff654511fb"],"text":"\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 5.2.2.2 Adverse event and serious adverse event reporting \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nAll adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through 1 week residual effect period) will be collected, documented and reported to the sponsor/CRO by the investigator on the appropriate CRF(s) / eCRFs/ SAE reporting forms. The investigator should report any SAEs which occurred to a subject after the residual effect period/follow-up period. \\\\\nWas changed into: \\\\\nAll adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through the last per protocol visit) will be collected, documented and reported to the sponsor/CRO by the investigator on the appropriate CRF(s) / eCRFs/ SAE reporting forms. The investigator does not need to actively monitor patients for adverse events once the clinical trial has ended. However, if the investigator becomes aware of an SAE(s) that occurred after the last per protocol visit, it should be reported by the investigator to the sponsor if considered relevant by the investigator. \\\\\nChange 2: \\\\\nIf not stipulated differently in the ISF, the investigator must report the following events, using the CRO electronic submission process immediately (within 24 hours or the next business day whichever is shorter) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported SAE or AESI. \\\\\nThe investigator must document immediately (within 24 hours or the next business day whichever is shorter).......... \\\\\nWas changed into: \\\\\nThe investigator must report the following events, immediately (within 24 hours of awareness) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported SAE or AESI. \\\\\nThe investigator must document immediately (within 24 hours of awareness).... \\\\\nChange 3: \\\\\n..... or by using the electronic submission process was deleted. \\\\\nChange 4: \\\\\nDrug exposure during pregnancy has to be reported immediately (within 24 hours or next business day whichever is shorter)...\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 5.2.2.2 Adverse event and serious adverse event reporting \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nAll adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through 1 week residual effect period) will be collected, documented and reported to the sponsor/CRO by the investigator on the appropriate CRF(s) / eCRFs/ SAE reporting forms. The investigator should report any SAEs which occurred to a subject after the residual effect period/follow-up period. \\\\\nWas changed into: \\\\\nAll adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through the last per protocol visit) will be collected, documented and reported to the sponsor/CRO by the investigator on the appropriate CRF(s) / eCRFs/ SAE reporting forms. The investigator does not need to actively monitor patients for adverse events once the clinical trial has ended. However, if the investigator becomes aware of an SAE(s) that occurred after the last per protocol visit, it should be reported by the investigator to the sponsor if considered relevant by the investigator. \\\\\nChange 2: \\\\\nIf not stipulated differently in the ISF, the investigator must report the following events, using the CRO electronic submission process immediately (within 24 hours or the next business day whichever is shorter) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported SAE or AESI. \\\\\nThe investigator must document immediately (within 24 hours or the next business day whichever is shorter).......... \\\\\nWas changed into: \\\\\nThe investigator must report the following events, immediately (within 24 hours of awareness) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported SAE or AESI. \\\\\nThe investigator must document immediately (within 24 hours of awareness).... \\\\\nChange 3: \\\\\n..... or by using the electronic submission process was deleted. \\\\\nChange 4: \\\\\nDrug exposure during pregnancy has to be reported immediately (within 24 hours or next business day whichever is shorter)...\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.9755859375,"confidence_rate":0.9999898138017785},{"cnt":[[249,331],[599,331],[599,2544],[249,2544]],"region":{"top_left_x":248,"top_left_y":331,"width":351,"height":2213},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d41af2b076dd410e9b63af0a3f527248","type":"table_column","conversion_output":false,"parent_id":"1ab70ca43a7b4397a7f41fce28ea5bfa","text":"","text_display":""},{"cnt":[[930,331],[1764,331],[1764,2544],[930,2544]],"region":{"top_left_x":930,"top_left_y":331,"width":834,"height":2213},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a3d65f22cb14833a819d0c9beffafc4","type":"table_column","conversion_output":false,"parent_id":"1ab70ca43a7b4397a7f41fce28ea5bfa","text":"","text_display":""},{"cnt":[[242,336],[1778,336],[1778,425],[242,425]],"region":{"top_left_x":242,"top_left_y":335,"width":1536,"height":91},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3cd778efc4e348ebbdaecb4eb0383021","type":"table_row","conversion_output":false,"parent_id":"1ab70ca43a7b4397a7f41fce28ea5bfa","text":"","text_display":""},{"cnt":[[242,418],[1778,418],[1778,2541],[242,2541]],"region":{"top_left_x":242,"top_left_y":418,"width":1536,"height":2124},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8bc917dbd64049a08a5dc629ac76ef9c","type":"table_row","conversion_output":false,"parent_id":"1ab70ca43a7b4397a7f41fce28ea5bfa","text":"","text_display":""},{"cnt":[[265,340],[594,340],[594,382],[265,382]],"region":{"top_left_x":265,"top_left_y":340,"width":330,"height":42},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f99c612c32e4dec9850397a75cc295f","type":"simple_cell","conversion_output":false,"parent_id":"1ab70ca43a7b4397a7f41fce28ea5bfa","text":"Section to be changed","text_display":"Section to be changed","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,340],[1653,340],[1653,421],[935,421]],"region":{"top_left_x":935,"top_left_y":340,"width":719,"height":81},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa83a6ae99224182abe3d75db689e130","type":"complex_cell","conversion_output":false,"parent_id":"1ab70ca43a7b4397a7f41fce28ea5bfa","children_ids":["4c81f8a0d68c4b6db602128728fed00e","87f9c4f2c8e540cea6855cd7552e7de2"],"text":"5.2.2.2 Adverse event and serious adverse event reporting","text_display":"5.2.2.2 Adverse event and serious adverse event reporting","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,340],[1649,340],[1649,377],[937,377]],"region":{"top_left_x":937,"top_left_y":340,"width":712,"height":38},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c81f8a0d68c4b6db602128728fed00e","type":"text","conversion_output":false,"parent_id":"fa83a6ae99224182abe3d75db689e130","text":"5.2.2.2 Adverse event and serious adverse event","text_display":"5.2.2.2 Adverse event and serious adverse event","confidence":1,"confidence_rate":1},{"cnt":[[937,382],[1087,382],[1087,421],[937,421]],"region":{"top_left_x":937,"top_left_y":381,"width":151,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87f9c4f2c8e540cea6855cd7552e7de2","type":"text","conversion_output":false,"parent_id":"fa83a6ae99224182abe3d75db689e130","text":"reporting","text_display":" reporting","confidence":1,"confidence_rate":1},{"cnt":[[265,423],[594,423],[594,462],[265,462]],"region":{"top_left_x":265,"top_left_y":423,"width":330,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f89475311721477e95824ea14a721d18","type":"simple_cell","conversion_output":false,"parent_id":"1ab70ca43a7b4397a7f41fce28ea5bfa","text":"Description of change","text_display":"Description of change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[933,418],[1757,418],[1757,2537],[933,2537]],"region":{"top_left_x":932,"top_left_y":418,"width":826,"height":2119},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f01c424be97e43f5a3f69eff654511fb","type":"complex_cell","conversion_output":false,"parent_id":"1ab70ca43a7b4397a7f41fce28ea5bfa","children_ids":["1aa1983eb56a469fa66e8d8903ed368d","58d85b864feb475bbbcda5f2482ce30f","ee9b5ea1383f4ea5a8a1befd24e339aa","af6caa1ad586482caf50aa5a19785a38","f7c19b98a556450d95bea72da45979d1","9392943b4c73438a93d911ef829ae3a7","7f6cc7b5475a4978879c2489dbc27991","3b2c4ce1083d42968e1b05cbfa19f049","c3f949b7b8d1411f9c7a5095d7b843df","f92718ebdece43409d37190dc821efce","fb5f91e655664179a4b02d4b1959d604","db4fdca440dd4972a0d2abeb48533c83","80fd260b0464457fb8bf435ec6dd1ddd","e984e99395c54c09a31abd1d512cd0fa","db03374611cd48d3959ac5d3802b9711","989a04e31e824df797782c10e83c35b1","7a64bae0fa764b5ca83cc7141f382b83","17b4c047896d41c290040944da534965","080c9cbf8a47431db7a36d426ee198c0","b55183cf3d7e45459d307426e08bb5ec","4146fcdf5ecb4e6a9e01ed191d18aac2","3104d9b0792749109f7970230b8e2750","fe7f011ef4f249d88bd85be157377f53","e42b17b81b5243cda0a44ec825c73c7a","5e1994f5374e42ceb222965cbdc9a3f6","e0127d75f31c4d3f966a3e5894a09dfe","02ace2ba643c4d4a8025771198c15a0b","e03e7201120e462b94b0c859c8fea704","731784fa90e54fe1b876c0220aa147c7","ef4075b3f35d4c51b580555dea67f34f","9946c4dd05234f67abac49649fb74dee","7f117594d7c5463ab62556f1c6bcbdb3","92e10d0c65234299b30b58e97160f057","368e7240c86f4c15823f3b79b8c4e400","2f6a098cf7524fd8b1f7649274088b07","b3c32bbf00114575a3d32fbe780edefa","82a25be218664209b078d785e058ba3b","3be58ff28c8d4be18e7555a1cc9238d2","5e63a7915415489da043e16077ba569b","370090aa79d6405aaadf662c9e19b07e","45f49af0326e41589a6984292cfcf6ec","e856ff38c90a4897b5a69722fc9f199b","8b6f6408c0454092ba7f663af585289f","6740afb14d38473887f6f70274e1e254","2c320c296e7944909b599b2f3dd6269c","853a6e028aa548b48cee5862f081d215"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nAll adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through 1 week residual effect period) will be collected, documented and reported to the sponsor/CRO by the investigator on the appropriate CRF(s) / eCRFs/ SAE reporting forms. The investigator should report any SAEs which occurred to a subject after the residual effect period/follow-up period. \\\\\nWas changed into: \\\\\nAll adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through the last per protocol visit) will be collected, documented and reported to the sponsor/CRO by the investigator on the appropriate CRF(s) / eCRFs/ SAE reporting forms. The investigator does not need to actively monitor patients for adverse events once the clinical trial has ended. However, if the investigator becomes aware of an SAE(s) that occurred after the last per protocol visit, it should be reported by the investigator to the sponsor if considered relevant by the investigator. \\\\\nChange 2: \\\\\nIf not stipulated differently in the ISF, the investigator must report the following events, using the CRO electronic submission process immediately (within 24 hours or the next business day whichever is shorter) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported SAE or AESI. \\\\\nThe investigator must document immediately (within 24 hours or the next business day whichever is shorter).......... \\\\\nWas changed into: \\\\\nThe investigator must report the following events, immediately (within 24 hours of awareness) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported SAE or AESI. \\\\\nThe investigator must document immediately (within 24 hours of awareness).... \\\\\nChange 3: \\\\\n..... or by using the electronic submission process was deleted. \\\\\nChange 4: \\\\\nDrug exposure during pregnancy has to be reported immediately (within 24 hours or next business day whichever is shorter)...\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nAll adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through 1 week residual effect period) will be collected, documented and reported to the sponsor/CRO by the investigator on the appropriate CRF(s) / eCRFs/ SAE reporting forms. The investigator should report any SAEs which occurred to a subject after the residual effect period/follow-up period. \\\\\nWas changed into: \\\\\nAll adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through the last per protocol visit) will be collected, documented and reported to the sponsor/CRO by the investigator on the appropriate CRF(s) / eCRFs/ SAE reporting forms. The investigator does not need to actively monitor patients for adverse events once the clinical trial has ended. However, if the investigator becomes aware of an SAE(s) that occurred after the last per protocol visit, it should be reported by the investigator to the sponsor if considered relevant by the investigator. \\\\\nChange 2: \\\\\nIf not stipulated differently in the ISF, the investigator must report the following events, using the CRO electronic submission process immediately (within 24 hours or the next business day whichever is shorter) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported SAE or AESI. \\\\\nThe investigator must document immediately (within 24 hours or the next business day whichever is shorter).......... \\\\\nWas changed into: \\\\\nThe investigator must report the following events, immediately (within 24 hours of awareness) to the sponsor/CRO: SAEs, AESI and non-serious AEs relevant for the reported SAE or AESI. \\\\\nThe investigator must document immediately (within 24 hours of awareness).... \\\\\nChange 3: \\\\\n..... or by using the electronic submission process was deleted. \\\\\nChange 4: \\\\\nDrug exposure during pregnancy has to be reported immediately (within 24 hours or next business day whichever is shorter)...\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9755859375,"confidence_rate":0.9999592558296619},{"cnt":[[937,423],[1087,423],[1087,462],[937,462]],"region":{"top_left_x":937,"top_left_y":423,"width":151,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1aa1983eb56a469fa66e8d8903ed368d","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"Change 1:","text_display":"Change 1:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[937,462],[1699,462],[1699,504],[937,504]],"region":{"top_left_x":937,"top_left_y":462,"width":763,"height":42},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58d85b864feb475bbbcda5f2482ce30f","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"All adverse events, serious and non-serious, occurring","text_display":"\nAll adverse events, serious and non-serious, occurring","confidence":1,"confidence_rate":1},{"cnt":[[937,501],[1709,501],[1709,543],[937,543]],"region":{"top_left_x":937,"top_left_y":501,"width":772,"height":42},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee9b5ea1383f4ea5a8a1befd24e339aa","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"during the course of the clinical trial (i.e., from signing","text_display":" during the course of the clinical trial (i.e., from signing","confidence":1,"confidence_rate":1},{"cnt":[[937,543],[1709,543],[1709,582],[937,582]],"region":{"top_left_x":937,"top_left_y":542,"width":772,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af6caa1ad586482caf50aa5a19785a38","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"the informed consent onwards through 1 week residual","text_display":" the informed consent onwards through 1 week residual","confidence":1,"confidence_rate":1},{"cnt":[[937,580],[1743,580],[1743,623],[937,623]],"region":{"top_left_x":937,"top_left_y":579,"width":807,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7c19b98a556450d95bea72da45979d1","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"effect period) will be collected, documented and reported","text_display":" effect period) will be collected, documented and reported","confidence":1,"confidence_rate":1},{"cnt":[[937,621],[1750,621],[1750,665],[937,665]],"region":{"top_left_x":937,"top_left_y":621,"width":814,"height":44},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9392943b4c73438a93d911ef829ae3a7","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"to the sponsor/CRO by the investigator on the appropriate","text_display":" to the sponsor/CRO by the investigator on the appropriate","confidence":1,"confidence_rate":1},{"cnt":[[937,663],[1727,663],[1727,704],[937,704]],"region":{"top_left_x":937,"top_left_y":662,"width":791,"height":43},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f6cc7b5475a4978879c2489dbc27991","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"CRF(s) / eCRFs/ SAE reporting forms. The investigator","text_display":" CRF(s) / eCRFs/ SAE reporting forms. The investigator","confidence":0.9985356330871582,"confidence_rate":0.9999747341097753},{"cnt":[[937,702],[1741,702],[1741,743],[937,743]],"region":{"top_left_x":937,"top_left_y":701,"width":804,"height":43},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b2c4ce1083d42968e1b05cbfa19f049","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"should report any SAEs which occurred to a subject after","text_display":" should report any SAEs which occurred to a subject after","confidence":1,"confidence_rate":1},{"cnt":[[937,741],[1543,741],[1543,785],[937,785]],"region":{"top_left_x":937,"top_left_y":740,"width":606,"height":45},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3f949b7b8d1411f9c7a5095d7b843df","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"the residual effect period/follow-up period.","text_display":" the residual effect period/follow-up period.","confidence":1,"confidence_rate":1},{"cnt":[[937,819],[1202,819],[1202,863],[937,863]],"region":{"top_left_x":937,"top_left_y":819,"width":266,"height":44},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f92718ebdece43409d37190dc821efce","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9755859375,"confidence_rate":0.9988771296661693},{"cnt":[[937,861],[1699,861],[1699,902],[937,902]],"region":{"top_left_x":937,"top_left_y":860,"width":763,"height":43},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb5f91e655664179a4b02d4b1959d604","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"All adverse events, serious and non-serious, occurring","text_display":"\nAll adverse events, serious and non-serious, occurring","confidence":1,"confidence_rate":1},{"cnt":[[937,902],[1709,902],[1709,941],[937,941]],"region":{"top_left_x":937,"top_left_y":902,"width":772,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db4fdca440dd4972a0d2abeb48533c83","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"during the course of the clinical trial (i.e., from signing","text_display":" during the course of the clinical trial (i.e., from signing","confidence":1,"confidence_rate":1},{"cnt":[[937,941],[1644,941],[1644,983],[937,983]],"region":{"top_left_x":937,"top_left_y":941,"width":708,"height":42},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80fd260b0464457fb8bf435ec6dd1ddd","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"the informed consent onwards through the last per","text_display":" the informed consent onwards through the last per","confidence":1,"confidence_rate":1},{"cnt":[[937,980],[1750,980],[1750,1024],[937,1024]],"region":{"top_left_x":937,"top_left_y":980,"width":814,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e984e99395c54c09a31abd1d512cd0fa","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"protocol visit) will be collected, documented and reported","text_display":" protocol visit) will be collected, documented and reported","confidence":1,"confidence_rate":1},{"cnt":[[937,1022],[1750,1022],[1750,1061],[937,1061]],"region":{"top_left_x":937,"top_left_y":1021,"width":814,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db03374611cd48d3959ac5d3802b9711","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"to the sponsor/CRO by the investigator on the appropriate","text_display":" to the sponsor/CRO by the investigator on the appropriate","confidence":1,"confidence_rate":1},{"cnt":[[937,1061],[1725,1061],[1725,1102],[937,1102]],"region":{"top_left_x":937,"top_left_y":1060,"width":788,"height":43},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"989a04e31e824df797782c10e83c35b1","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"CRF(s) / eCRFs/ SAE reporting forms. The investigator","text_display":" CRF(s) / eCRFs/ SAE reporting forms. The investigator","confidence":0.99853515625,"confidence_rate":0.9999747258765944},{"cnt":[[937,1100],[1690,1100],[1690,1144],[937,1144]],"region":{"top_left_x":937,"top_left_y":1100,"width":754,"height":44},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a64bae0fa764b5ca83cc7141f382b83","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"does not need to actively monitor patients for adverse","text_display":" does not need to actively monitor patients for adverse","confidence":1,"confidence_rate":1},{"cnt":[[937,1141],[1718,1141],[1718,1181],[937,1181]],"region":{"top_left_x":937,"top_left_y":1141,"width":781,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17b4c047896d41c290040944da534965","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"events once the clinical trial has ended. However, if the","text_display":" events once the clinical trial has ended. However, if the","confidence":1,"confidence_rate":1},{"cnt":[[937,1181],[1713,1181],[1713,1222],[937,1222]],"region":{"top_left_x":937,"top_left_y":1180,"width":777,"height":43},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"080c9cbf8a47431db7a36d426ee198c0","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"investigator becomes aware of an SAE(s) that occurred","text_display":" investigator becomes aware of an SAE(s) that occurred","confidence":1,"confidence_rate":1},{"cnt":[[937,1220],[1713,1220],[1713,1264],[937,1264]],"region":{"top_left_x":937,"top_left_y":1219,"width":777,"height":45},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b55183cf3d7e45459d307426e08bb5ec","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"after the last per protocol visit, it should be reported by","text_display":" after the last per protocol visit, it should be reported by","confidence":1,"confidence_rate":1},{"cnt":[[937,1261],[1718,1261],[1718,1300],[937,1300]],"region":{"top_left_x":937,"top_left_y":1261,"width":781,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4146fcdf5ecb4e6a9e01ed191d18aac2","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"the investigator to the sponsor if considered relevant by","text_display":" the investigator to the sponsor if considered relevant by","confidence":1,"confidence_rate":1},{"cnt":[[937,1300],[1170,1300],[1170,1342],[937,1342]],"region":{"top_left_x":937,"top_left_y":1300,"width":233,"height":42},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3104d9b0792749109f7970230b8e2750","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"the investigator.","text_display":" the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[937,1376],[1087,1376],[1087,1420],[937,1420]],"region":{"top_left_x":937,"top_left_y":1376,"width":151,"height":45},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe7f011ef4f249d88bd85be157377f53","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[937,1420],[1699,1420],[1699,1462],[937,1462]],"region":{"top_left_x":937,"top_left_y":1420,"width":763,"height":42},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e42b17b81b5243cda0a44ec825c73c7a","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"If not stipulated differently in the ISF, the investigator","text_display":"\nIf not stipulated differently in the ISF, the investigator","confidence":1,"confidence_rate":1},{"cnt":[[937,1459],[1621,1459],[1621,1503],[937,1503]],"region":{"top_left_x":937,"top_left_y":1459,"width":685,"height":44},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e1994f5374e42ceb222965cbdc9a3f6","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"must report the following events, using the CRO","text_display":" must report the following events, using the CRO","confidence":1,"confidence_rate":1},{"cnt":[[937,1501],[1695,1501],[1695,1540],[937,1540]],"region":{"top_left_x":937,"top_left_y":1500,"width":758,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0127d75f31c4d3f966a3e5894a09dfe","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"electronic submission process immediately (within 24","text_display":" electronic submission process immediately (within 24","confidence":1,"confidence_rate":1},{"cnt":[[937,1540],[1704,1540],[1704,1581],[937,1581]],"region":{"top_left_x":937,"top_left_y":1539,"width":768,"height":43},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02ace2ba643c4d4a8025771198c15a0b","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"hours or the next business day whichever is shorter) to","text_display":" hours or the next business day whichever is shorter) to","confidence":1,"confidence_rate":1},{"cnt":[[937,1579],[1676,1579],[1676,1623],[937,1623]],"region":{"top_left_x":937,"top_left_y":1578,"width":740,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e03e7201120e462b94b0c859c8fea704","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"the sponsor/CRO: SAEs, AESI and non-serious AEs","text_display":" the sponsor/CRO: SAEs, AESI and non-serious AEs","confidence":1,"confidence_rate":1},{"cnt":[[937,1620],[1488,1620],[1488,1662],[937,1662]],"region":{"top_left_x":937,"top_left_y":1620,"width":551,"height":42},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"731784fa90e54fe1b876c0220aa147c7","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"relevant for the reported SAE or AESI.","text_display":" relevant for the reported SAE or AESI.","confidence":1,"confidence_rate":1},{"cnt":[[937,1699],[1729,1699],[1729,1742],[937,1742]],"region":{"top_left_x":937,"top_left_y":1698,"width":793,"height":45},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef4075b3f35d4c51b580555dea67f34f","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"The investigator must document immediately (within 24","text_display":"\nThe investigator must document immediately (within 24","confidence":1,"confidence_rate":1},{"cnt":[[937,1740],[1552,1740],[1552,1782],[937,1782]],"region":{"top_left_x":937,"top_left_y":1740,"width":616,"height":42},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9946c4dd05234f67abac49649fb74dee","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"hours or the next business day whichever is","text_display":" hours or the next business day whichever is","confidence":1,"confidence_rate":1},{"cnt":[[937,1782],[1165,1782],[1165,1821],[937,1821]],"region":{"top_left_x":937,"top_left_y":1781,"width":229,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f117594d7c5463ab62556f1c6bcbdb3","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"shorter)..........","text_display":" shorter)..........","confidence":0.9980480668600649,"confidence_rate":0.9999150540148952},{"cnt":[[937,1860],[1204,1860],[1204,1901],[937,1901]],"region":{"top_left_x":937,"top_left_y":1859,"width":268,"height":43},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92e10d0c65234299b30b58e97160f057","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9921875,"confidence_rate":0.9996435554750392},{"cnt":[[937,1901],[1640,1901],[1640,1940],[937,1940]],"region":{"top_left_x":937,"top_left_y":1901,"width":703,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"368e7240c86f4c15823f3b79b8c4e400","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"The investigator must report the following events,","text_display":"\nThe investigator must report the following events,","confidence":1,"confidence_rate":1},{"cnt":[[937,1938],[1644,1938],[1644,1980],[937,1980]],"region":{"top_left_x":937,"top_left_y":1938,"width":708,"height":42},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f6a098cf7524fd8b1f7649274088b07","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"immediately (within 24 hours of awareness) to the","text_display":" immediately (within 24 hours of awareness) to the","confidence":1,"confidence_rate":1},{"cnt":[[937,1980],[1746,1980],[1746,2021],[937,2021]],"region":{"top_left_x":937,"top_left_y":1979,"width":809,"height":43},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3c32bbf00114575a3d32fbe780edefa","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"sponsor/CRO: SAEs, AESI and non-serious AEs relevant","text_display":" sponsor/CRO: SAEs, AESI and non-serious AEs relevant","confidence":1,"confidence_rate":1},{"cnt":[[937,2019],[1368,2019],[1368,2060],[937,2060]],"region":{"top_left_x":937,"top_left_y":2018,"width":431,"height":43},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"82a25be218664209b078d785e058ba3b","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"for the reported SAE or AESI.","text_display":" for the reported SAE or AESI.","confidence":1,"confidence_rate":1},{"cnt":[[937,2099],[1729,2099],[1729,2141],[937,2141]],"region":{"top_left_x":937,"top_left_y":2099,"width":793,"height":42},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3be58ff28c8d4be18e7555a1cc9238d2","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"The investigator must document immediately (within 24","text_display":"\nThe investigator must document immediately (within 24","confidence":1,"confidence_rate":1},{"cnt":[[937,2141],[1267,2141],[1267,2180],[937,2180]],"region":{"top_left_x":937,"top_left_y":2140,"width":330,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e63a7915415489da043e16077ba569b","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"hours of awareness)....","text_display":" hours of awareness)....","confidence":0.9990234375,"confidence_rate":0.9999651063356614},{"cnt":[[937,2219],[1087,2219],[1087,2258],[937,2258]],"region":{"top_left_x":937,"top_left_y":2219,"width":151,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"370090aa79d6405aaadf662c9e19b07e","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"Change 3:","text_display":"\nChange 3:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[937,2260],[1699,2260],[1699,2302],[937,2302]],"region":{"top_left_x":937,"top_left_y":2260,"width":763,"height":42},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45f49af0326e41589a6984292cfcf6ec","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"..... or by using the electronic submission process was","text_display":"\n..... or by using the electronic submission process was","confidence":0.9980475902557373,"confidence_rate":0.9999674285607841},{"cnt":[[937,2297],[1055,2297],[1055,2336],[937,2336]],"region":{"top_left_x":937,"top_left_y":2297,"width":118,"height":40},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e856ff38c90a4897b5a69722fc9f199b","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"deleted.","text_display":" deleted.","confidence":1,"confidence_rate":1},{"cnt":[[937,2378],[1087,2378],[1087,2419],[937,2419]],"region":{"top_left_x":937,"top_left_y":2377,"width":151,"height":43},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b6f6408c0454092ba7f663af585289f","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"Change 4:","text_display":"\nChange 4:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[937,2417],[1663,2417],[1663,2461],[937,2461]],"region":{"top_left_x":937,"top_left_y":2417,"width":726,"height":44},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6740afb14d38473887f6f70274e1e254","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"Drug exposure during pregnancy has to be reported","text_display":"\nDrug exposure during pregnancy has to be reported","confidence":1,"confidence_rate":1},{"cnt":[[937,2459],[1649,2459],[1649,2500],[937,2500]],"region":{"top_left_x":937,"top_left_y":2458,"width":712,"height":42},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c320c296e7944909b599b2f3dd6269c","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"immediately (within 24 hours or next business day","text_display":" immediately (within 24 hours or next business day","confidence":1,"confidence_rate":1},{"cnt":[[937,2498],[1271,2498],[1271,2539],[937,2539]],"region":{"top_left_x":937,"top_left_y":2497,"width":335,"height":43},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"853a6e028aa548b48cee5862f081d215","type":"text","conversion_output":false,"parent_id":"f01c424be97e43f5a3f69eff654511fb","text":"whichever is shorter)...","text_display":" whichever is shorter)...","confidence":0.99951171875,"confidence_rate":0.9999831587453291},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":64,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2db8fa1d7ea24d7aad11605ffdce2112","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":65,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5bc71e0f6dc74994835de79cb034af39","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":66,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"694aec44b389452984ef4d57fc62935b","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-093","page":93,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"827a6e7484e84fe4a8f331bc87806a24","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15a1ba30b9a540eb8604e9ad2482e7c8","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5800e71439b543659d1bd9d7cc64938f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc5f44789f064a6780e5468ed727e5ba","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d885552e931c4e1a87a12ced1b07365e","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"529266a7673e4a9f9bf053b85936fcca","type":"page_info","conversion_output":false,"text":"Page 93 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2545],[244,2545]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2214},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45d176a7d7c446f9a762602247ca89c4","type":"table","conversion_output":true,"children_ids":["c6523f42e97541b596580faf2b4aa89f","c8fcd6e7ae1d4ccf99a233aa068930c0","9a2c555050864fd6a2a246e917d22af5","1d875ffcde4349b88db71627a6f760ba","ba87ee8c1964435d81ebec1b385a722f","831b4c9dd7f545128765d8b4e95233a7","5ee5ecda2a2449cf849162e2fda2ea14","116f8c8f3e4c4b66b3af9eda4e7c1c0b","af84ca79d0c24a069418d9a31762c825","0bc9be1b67c444a6b78bb7fb416c24e6","d25504652a0945c6b51d919c19a56d86","da4458703003494798683ed82fe06c90","4a7b24012904442e99d13f2bca09ac20","d0efd67bbf71454d8b31df6f262e251a","24d3ad9b3b034b3c9f849759aaa27476","6fcf4bbf541d478a82f8832781ca2c2d"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nWas changed into: \\\\\nDrug exposure during pregnancy has to be reported immediately (within 24 hours of awareness)....\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo clarify that AEs are collected even after the residual effect period for patients who pre-maturely discontinue study medication and to clarify that SAEs which occurred to a subject after the last per protocol should be reported if considered relevant by the investigator. \\\\\nChange 2: \\\\\nTo reflect the paper based reporting process and to update the definition of immediately. \\\\\nChange 3: \\\\\nTo reflect the paper based reporting process and to update the definition of immediately. \\\\\nChange 4: \\\\\nTo update the definition of immediately.\n\\end{tabular} \\\\\n\\hline Section to be changed & 5.2.3 Assessment of safety laboratory parameters \\\\\n\\hline Description of change & \\begin{tabular}{l}\nLipase added to visit 1 and visit 2 \\\\\nIn addition: \\\\\nVisit 3 -EOT \\\\\n- Clinical chemistry: creatinine \\\\\n- Urine analysis: albumin and creatinine (Visit 4, Visit 6 and thereafter yearly). \\\\\n- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and triglycerides (Visit 4, Visit 6 and thereafter yearly) \\\\\n\\(HbA _{1 c }\\) will be determined at all scheduled visits. \\\\\nWas changed into: \\\\\nVisit 3 - EOT - FU \\\\\n- Clinical chemistry: creatinine and lipase \\\\\n- Urine analysis: albumin and creatinine (Visit 4, Visit 6 and thereafter yearly). \\\\\n- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and triglycerides (Visit 4, Visit 6 and thereafter yearly) \\\\\n\\(HbA _{1 c }\\) will be determined at all scheduled visits, with exception of the FU visit.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification and to add lipase to the laboratory assessment schedule. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nWas changed into: \\\\\nDrug exposure during pregnancy has to be reported immediately (within 24 hours of awareness)....\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo clarify that AEs are collected even after the residual effect period for patients who pre-maturely discontinue study medication and to clarify that SAEs which occurred to a subject after the last per protocol should be reported if considered relevant by the investigator. \\\\\nChange 2: \\\\\nTo reflect the paper based reporting process and to update the definition of immediately. \\\\\nChange 3: \\\\\nTo reflect the paper based reporting process and to update the definition of immediately. \\\\\nChange 4: \\\\\nTo update the definition of immediately.\n\\end{tabular} \\\\\n\\hline Section to be changed & 5.2.3 Assessment of safety laboratory parameters \\\\\n\\hline Description of change & \\begin{tabular}{l}\nLipase added to visit 1 and visit 2 \\\\\nIn addition: \\\\\nVisit 3 -EOT \\\\\n- Clinical chemistry: creatinine \\\\\n- Urine analysis: albumin and creatinine (Visit 4, Visit 6 and thereafter yearly). \\\\\n- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and triglycerides (Visit 4, Visit 6 and thereafter yearly) \\\\\n\\(HbA _{1 c }\\) will be determined at all scheduled visits. \\\\\nWas changed into: \\\\\nVisit 3 - EOT - FU \\\\\n- Clinical chemistry: creatinine and lipase \\\\\n- Urine analysis: albumin and creatinine (Visit 4, Visit 6 and thereafter yearly). \\\\\n- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and triglycerides (Visit 4, Visit 6 and thereafter yearly) \\\\\n\\(HbA _{1 c }\\) will be determined at all scheduled visits, with exception of the FU visit.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification and to add lipase to the laboratory assessment schedule. \\\\\n\\hline\n\\end{tabular}","confidence":0.8701803684234619,"confidence_rate":0.9999447964059809},{"cnt":[[249,331],[601,331],[601,2546],[249,2546]],"region":{"top_left_x":248,"top_left_y":331,"width":353,"height":2216},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6523f42e97541b596580faf2b4aa89f","type":"table_column","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"","text_display":""},{"cnt":[[919,331],[1768,331],[1768,2546],[919,2546]],"region":{"top_left_x":918,"top_left_y":331,"width":851,"height":2216},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8fcd6e7ae1d4ccf99a233aa068930c0","type":"table_column","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"","text_display":""},{"cnt":[[244,331],[1775,331],[1775,467],[244,467]],"region":{"top_left_x":244,"top_left_y":331,"width":1532,"height":136},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a2c555050864fd6a2a246e917d22af5","type":"table_row","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"","text_display":""},{"cnt":[[244,460],[1775,460],[1775,1146],[244,1146]],"region":{"top_left_x":244,"top_left_y":459,"width":1532,"height":688},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d875ffcde4349b88db71627a6f760ba","type":"table_row","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"","text_display":""},{"cnt":[[244,1141],[1775,1141],[1775,1190],[244,1190]],"region":{"top_left_x":244,"top_left_y":1141,"width":1532,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba87ee8c1964435d81ebec1b385a722f","type":"table_row","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"","text_display":""},{"cnt":[[244,1208],[1775,1208],[1775,2385],[244,2385]],"region":{"top_left_x":244,"top_left_y":1208,"width":1532,"height":1177},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"831b4c9dd7f545128765d8b4e95233a7","type":"table_row","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"","text_display":""},{"cnt":[[244,2378],[1775,2378],[1775,2470],[244,2470]],"region":{"top_left_x":244,"top_left_y":2377,"width":1532,"height":94},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ee5ecda2a2449cf849162e2fda2ea14","type":"table_row","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"","text_display":""},{"cnt":[[934,465],[935,334],[1667,337],[1667,468]],"region":{"top_left_x":934,"top_left_y":334,"width":734,"height":134},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"116f8c8f3e4c4b66b3af9eda4e7c1c0b","type":"complex_cell","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","children_ids":["cdd4b5b8e68f440c82081c37526abd30","3fef1b2beb944a76a12bc976f25ddaeb","20a7c19cd5334a3d96c0d4fdc70d5597"],"text":"\\begin{tabular}{l}\nWas changed into: \\\\\nDrug exposure during pregnancy has to be reported immediately (within 24 hours of awareness)....\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nWas changed into: \\\\\nDrug exposure during pregnancy has to be reported immediately (within 24 hours of awareness)....\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999851964785456},{"cnt":[[939,340],[1204,340],[1204,379],[939,379]],"region":{"top_left_x":939,"top_left_y":340,"width":266,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cdd4b5b8e68f440c82081c37526abd30","type":"text","conversion_output":false,"parent_id":"116f8c8f3e4c4b66b3af9eda4e7c1c0b","text":"Was changed into:","text_display":"Was changed into:","confidence":0.9990234375,"confidence_rate":0.9999555900930661},{"cnt":[[939,382],[1660,382],[1660,421],[939,421]],"region":{"top_left_x":939,"top_left_y":381,"width":722,"height":40},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3fef1b2beb944a76a12bc976f25ddaeb","type":"text","conversion_output":false,"parent_id":"116f8c8f3e4c4b66b3af9eda4e7c1c0b","text":"Drug exposure during pregnancy has to be reported","text_display":"\nDrug exposure during pregnancy has to be reported","confidence":1,"confidence_rate":1},{"cnt":[[939,418],[1600,418],[1600,462],[939,462]],"region":{"top_left_x":939,"top_left_y":418,"width":662,"height":45},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20a7c19cd5334a3d96c0d4fdc70d5597","type":"text","conversion_output":false,"parent_id":"116f8c8f3e4c4b66b3af9eda4e7c1c0b","text":"immediately (within 24 hours of awareness)....","text_display":" immediately (within 24 hours of awareness)....","confidence":1,"confidence_rate":1},{"cnt":[[267,465],[582,465],[582,504],[267,504]],"region":{"top_left_x":267,"top_left_y":464,"width":316,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af84ca79d0c24a069418d9a31762c825","type":"simple_cell","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,462],[1759,462],[1759,1144],[935,1144]],"region":{"top_left_x":934,"top_left_y":462,"width":826,"height":682},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0bc9be1b67c444a6b78bb7fb416c24e6","type":"complex_cell","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","children_ids":["071577a4eb9a44a69e937d99048037a7","895e7ce4f167488b835592d75630a5a9","7aaaf62bf56940ceb0eb3adfe542b3ab","f34da28b8f2a4ca18dc4f8fcab939c75","f0246584aaa84c29b5230646d4118de1","88f2a28602d54d939a6aa6fa560609ff","87dfa911e4d94568a6c0446f7ebbfa4d","7371d009b2334fa9bd404b428ec4b640","40349576b50b43edb3ec959bc1cff20c","8e37c13b030b4ee5b9e75d0323240fcd","95d52dbcbebd48ff88d3663cfe11f3d8","7f042d14cc014983950ef6f8bb22fc01","7eeba93b38e64a35b1657869722e5741","14132e46906245e8972b400aab9b7d97"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nTo clarify that AEs are collected even after the residual effect period for patients who pre-maturely discontinue study medication and to clarify that SAEs which occurred to a subject after the last per protocol should be reported if considered relevant by the investigator. \\\\\nChange 2: \\\\\nTo reflect the paper based reporting process and to update the definition of immediately. \\\\\nChange 3: \\\\\nTo reflect the paper based reporting process and to update the definition of immediately. \\\\\nChange 4: \\\\\nTo update the definition of immediately.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nTo clarify that AEs are collected even after the residual effect period for patients who pre-maturely discontinue study medication and to clarify that SAEs which occurred to a subject after the last per protocol should be reported if considered relevant by the investigator. \\\\\nChange 2: \\\\\nTo reflect the paper based reporting process and to update the definition of immediately. \\\\\nChange 3: \\\\\nTo reflect the paper based reporting process and to update the definition of immediately. \\\\\nChange 4: \\\\\nTo update the definition of immediately.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999909724487263},{"cnt":[[939,465],[1089,465],[1089,499],[939,499]],"region":{"top_left_x":939,"top_left_y":464,"width":151,"height":36},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"071577a4eb9a44a69e937d99048037a7","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"Change 1:","text_display":"Change 1:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[939,501],[1715,501],[1715,543],[939,543]],"region":{"top_left_x":939,"top_left_y":501,"width":777,"height":42},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"895e7ce4f167488b835592d75630a5a9","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"To clarify that AEs are collected even after the residual","text_display":"\nTo clarify that AEs are collected even after the residual","confidence":1,"confidence_rate":1},{"cnt":[[939,543],[1713,543],[1713,582],[939,582]],"region":{"top_left_x":939,"top_left_y":542,"width":774,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7aaaf62bf56940ceb0eb3adfe542b3ab","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"effect period for patients who pre-maturely discontinue","text_display":" effect period for patients who pre-maturely discontinue","confidence":1,"confidence_rate":1},{"cnt":[[939,584],[1752,584],[1752,623],[939,623]],"region":{"top_left_x":939,"top_left_y":584,"width":814,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f34da28b8f2a4ca18dc4f8fcab939c75","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"study medication and to clarify that SAEs which occurred","text_display":" study medication and to clarify that SAEs which occurred","confidence":1,"confidence_rate":1},{"cnt":[[939,621],[1729,621],[1729,665],[939,665]],"region":{"top_left_x":939,"top_left_y":621,"width":791,"height":44},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0246584aaa84c29b5230646d4118de1","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"to a subject after the last per protocol should be reported","text_display":" to a subject after the last per protocol should be reported","confidence":1,"confidence_rate":1},{"cnt":[[939,663],[1522,663],[1522,702],[939,702]],"region":{"top_left_x":939,"top_left_y":662,"width":583,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"88f2a28602d54d939a6aa6fa560609ff","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"if considered relevant by the investigator.","text_display":" if considered relevant by the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[939,741],[1089,741],[1089,785],[939,785]],"region":{"top_left_x":939,"top_left_y":740,"width":151,"height":45},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87dfa911e4d94568a6c0446f7ebbfa4d","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,782],[1752,782],[1752,821],[939,821]],"region":{"top_left_x":939,"top_left_y":782,"width":814,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7371d009b2334fa9bd404b428ec4b640","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"To reflect the paper based reporting process and to update","text_display":"\nTo reflect the paper based reporting process and to update","confidence":1,"confidence_rate":1},{"cnt":[[939,824],[1358,824],[1358,863],[939,863]],"region":{"top_left_x":939,"top_left_y":823,"width":420,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40349576b50b43edb3ec959bc1cff20c","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"the definition of immediately.","text_display":" the definition of immediately.","confidence":1,"confidence_rate":1},{"cnt":[[939,902],[1089,902],[1089,941],[939,941]],"region":{"top_left_x":939,"top_left_y":902,"width":151,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e37c13b030b4ee5b9e75d0323240fcd","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,943],[1750,943],[1750,983],[939,983]],"region":{"top_left_x":939,"top_left_y":943,"width":811,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95d52dbcbebd48ff88d3663cfe11f3d8","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"To reflect the paper based reporting process and to update","text_display":"\nTo reflect the paper based reporting process and to update","confidence":1,"confidence_rate":1},{"cnt":[[939,983],[1358,983],[1358,1022],[939,1022]],"region":{"top_left_x":939,"top_left_y":982,"width":420,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f042d14cc014983950ef6f8bb22fc01","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"the definition of immediately.","text_display":" the definition of immediately.","confidence":1,"confidence_rate":1},{"cnt":[[939,1063],[1087,1063],[1087,1102],[939,1102]],"region":{"top_left_x":939,"top_left_y":1063,"width":148,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7eeba93b38e64a35b1657869722e5741","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"Change 4:","text_display":"\nChange 4:","confidence":1,"confidence_rate":1},{"cnt":[[939,1100],[1508,1100],[1508,1144],[939,1144]],"region":{"top_left_x":939,"top_left_y":1100,"width":570,"height":44},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14132e46906245e8972b400aab9b7d97","type":"text","conversion_output":false,"parent_id":"0bc9be1b67c444a6b78bb7fb416c24e6","text":"To update the definition of immediately.","text_display":"\nTo update the definition of immediately.","confidence":0.9990234375,"confidence_rate":0.9999782882435296},{"cnt":[[265,1146],[592,1146],[592,1185],[265,1185]],"region":{"top_left_x":264,"top_left_y":1146,"width":328,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d25504652a0945c6b51d919c19a56d86","type":"simple_cell","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1146],[1672,1146],[1672,1185],[939,1185]],"region":{"top_left_x":939,"top_left_y":1146,"width":733,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da4458703003494798683ed82fe06c90","type":"simple_cell","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"5.2.3 Assessment of safety laboratory parameters","text_display":"5.2.3 Assessment of safety laboratory parameters","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1215],[596,1215],[596,1257],[267,1257]],"region":{"top_left_x":267,"top_left_y":1215,"width":330,"height":42},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a7b24012904442e99d13f2bca09ac20","type":"simple_cell","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1211],[1752,1211],[1752,2383],[935,2383]],"region":{"top_left_x":934,"top_left_y":1210,"width":819,"height":1173},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0efd67bbf71454d8b31df6f262e251a","type":"complex_cell","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","children_ids":["636d63d5a057497fb97746db7e320cf5","a77491ae76034c998296bb39a922c8ab","03d99420b68d4bd0bda844bbaa42c24f","969369ba98aa4bc2a05be15cd5a358a8","806b6b7aa63343ccbfc3dd726a093527","ec07dc8529b74b5f8d39f8873280c1b2","7134f2b2c46c4754b70ea951f75efc51","252d80858141461ba1b396b5012e276f","633e99d3310346c2854a34b91a4bcbd3","b60d5647d3c949d8beff5128d4670a7d","cbfec63d0d2b474884f29f86a278782a","e1c8bd924fab48429f70b35c6711b4e2","f59817d86e294a09bc4a46cc67fe98de","f319d88df9e64314bd397b12fa0032b3","9a9230db8f374062b1734adad8b90701","78192e9d9d344b9d85965e190b7c2a6e","569ee2e1c1fe4ba5a506853d1fcf5326","22a528b260d541cfb5aa17d6460ea8d7","959cae88672d44c9bd2edf41f6e8093f","9220649552c64cc492dd3648c9f1a042"],"text":"\\begin{tabular}{l}\nLipase added to visit 1 and visit 2 \\\\\nIn addition: \\\\\nVisit 3 -EOT \\\\\n- Clinical chemistry: creatinine \\\\\n- Urine analysis: albumin and creatinine (Visit 4, Visit 6 and thereafter yearly). \\\\\n- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and triglycerides (Visit 4, Visit 6 and thereafter yearly) \\\\\n\\(HbA _{1 c }\\) will be determined at all scheduled visits. \\\\\nWas changed into: \\\\\nVisit 3 - EOT - FU \\\\\n- Clinical chemistry: creatinine and lipase \\\\\n- Urine analysis: albumin and creatinine (Visit 4, Visit 6 and thereafter yearly). \\\\\n- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and triglycerides (Visit 4, Visit 6 and thereafter yearly) \\\\\n\\(HbA _{1 c }\\) will be determined at all scheduled visits, with exception of the FU visit.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nLipase added to visit 1 and visit 2 \\\\\nIn addition: \\\\\nVisit 3 -EOT \\\\\n- Clinical chemistry: creatinine \\\\\n- Urine analysis: albumin and creatinine (Visit 4, Visit 6 and thereafter yearly). \\\\\n- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and triglycerides (Visit 4, Visit 6 and thereafter yearly) \\\\\n\\(HbA _{1 c }\\) will be determined at all scheduled visits. \\\\\nWas changed into: \\\\\nVisit 3 - EOT - FU \\\\\n- Clinical chemistry: creatinine and lipase \\\\\n- Urine analysis: albumin and creatinine (Visit 4, Visit 6 and thereafter yearly). \\\\\n- Clinical chemistry: cholesterol (total), HDL cholesterol, LDL cholesterol and triglycerides (Visit 4, Visit 6 and thereafter yearly) \\\\\n\\(HbA _{1 c }\\) will be determined at all scheduled visits, with exception of the FU visit.\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.8701803684234619,"confidence_rate":0.9995270970167888},{"cnt":[[939,1215],[1414,1215],[1414,1254],[939,1254]],"region":{"top_left_x":939,"top_left_y":1215,"width":475,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"636d63d5a057497fb97746db7e320cf5","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"Lipase added to visit 1 and visit 2","text_display":"Lipase added to visit 1 and visit 2","confidence":1,"confidence_rate":1},{"cnt":[[939,1293],[1107,1293],[1107,1328],[939,1328]],"region":{"top_left_x":939,"top_left_y":1293,"width":169,"height":35},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a77491ae76034c998296bb39a922c8ab","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"In addition:","text_display":"\nIn addition:","confidence":1,"confidence_rate":1},{"cnt":[[939,1376],[1140,1376],[1140,1409],[939,1409]],"region":{"top_left_x":939,"top_left_y":1376,"width":201,"height":33},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03d99420b68d4bd0bda844bbaa42c24f","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"Visit 3 -EOT","text_display":"\nVisit 3 -EOT","confidence":0.8701803684234619,"confidence_rate":0.9930713759268605},{"cnt":[[939,1459],[1421,1459],[1421,1498],[939,1498]],"region":{"top_left_x":939,"top_left_y":1459,"width":482,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"969369ba98aa4bc2a05be15cd5a358a8","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"- Clinical chemistry: creatinine","text_display":"\n- Clinical chemistry: creatinine","confidence":1,"confidence_rate":1},{"cnt":[[939,1501],[1745,1501],[1745,1540],[939,1540]],"region":{"top_left_x":939,"top_left_y":1500,"width":807,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"806b6b7aa63343ccbfc3dd726a093527","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"- Urine analysis: albumin and creatinine (Visit 4, Visit","text_display":"\n- Urine analysis: albumin and creatinine (Visit 4, Visit","confidence":1,"confidence_rate":1},{"cnt":[[999,1542],[1340,1542],[1340,1581],[999,1581]],"region":{"top_left_x":999,"top_left_y":1542,"width":341,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec07dc8529b74b5f8d39f8873280c1b2","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"6 and thereafter yearly).","text_display":" 6 and thereafter yearly).","confidence":1,"confidence_rate":1},{"cnt":[[939,1588],[1619,1588],[1619,1630],[939,1630]],"region":{"top_left_x":939,"top_left_y":1588,"width":680,"height":42},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7134f2b2c46c4754b70ea951f75efc51","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"- Clinical chemistry: cholesterol (total), HDL","text_display":"\n- Clinical chemistry: cholesterol (total), HDL","confidence":1,"confidence_rate":1},{"cnt":[[1002,1630],[1738,1630],[1738,1669],[1002,1669]],"region":{"top_left_x":1001,"top_left_y":1629,"width":738,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"252d80858141461ba1b396b5012e276f","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"cholesterol, LDL cholesterol and triglycerides (Visit","text_display":" cholesterol, LDL cholesterol and triglycerides (Visit","confidence":1,"confidence_rate":1},{"cnt":[[1002,1671],[1444,1671],[1444,1710],[1002,1710]],"region":{"top_left_x":1001,"top_left_y":1671,"width":443,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"633e99d3310346c2854a34b91a4bcbd3","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"4, Visit 6 and thereafter yearly)","text_display":" 4, Visit 6 and thereafter yearly)","confidence":0.97607421875,"confidence_rate":0.9994095243589337},{"cnt":[[939,1759],[1614,1759],[1614,1798],[939,1798]],"region":{"top_left_x":939,"top_left_y":1758,"width":675,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b60d5647d3c949d8beff5128d4670a7d","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"\\(HbA _{1 c }\\) will be determined at all scheduled visits.","text_display":"\n\\(HbA _{1 c }\\) will be determined at all scheduled visits.","confidence":1,"confidence_rate":1},{"cnt":[[939,1837],[1204,1837],[1204,1881],[939,1881]],"region":{"top_left_x":939,"top_left_y":1836,"width":266,"height":45},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cbfec63d0d2b474884f29f86a278782a","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9892578125,"confidence_rate":0.9995091976942041},{"cnt":[[939,1917],[1216,1917],[1216,1954],[939,1954]],"region":{"top_left_x":939,"top_left_y":1917,"width":277,"height":38},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1c8bd924fab48429f70b35c6711b4e2","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"Visit 3 - EOT - FU","text_display":"\nVisit 3 - EOT - FU","confidence":0.9765625,"confidence_rate":0.9990882418036603},{"cnt":[[939,2003],[1568,2003],[1568,2042],[939,2042]],"region":{"top_left_x":939,"top_left_y":2002,"width":629,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f59817d86e294a09bc4a46cc67fe98de","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"- Clinical chemistry: creatinine and lipase","text_display":"\n- Clinical chemistry: creatinine and lipase","confidence":1,"confidence_rate":1},{"cnt":[[939,2044],[1743,2044],[1743,2083],[939,2083]],"region":{"top_left_x":939,"top_left_y":2044,"width":804,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f319d88df9e64314bd397b12fa0032b3","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"- Urine analysis: albumin and creatinine (Visit 4, Visit","text_display":"\n- Urine analysis: albumin and creatinine (Visit 4, Visit","confidence":1,"confidence_rate":1},{"cnt":[[1002,2086],[1340,2086],[1340,2125],[1002,2125]],"region":{"top_left_x":1001,"top_left_y":2085,"width":339,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a9230db8f374062b1734adad8b90701","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"6 and thereafter yearly).","text_display":" 6 and thereafter yearly).","confidence":1,"confidence_rate":1},{"cnt":[[939,2132],[1619,2132],[1619,2175],[939,2175]],"region":{"top_left_x":939,"top_left_y":2131,"width":680,"height":45},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78192e9d9d344b9d85965e190b7c2a6e","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"- Clinical chemistry: cholesterol (total), HDL","text_display":"\n- Clinical chemistry: cholesterol (total), HDL","confidence":1,"confidence_rate":1},{"cnt":[[1002,2173],[1738,2173],[1738,2212],[1002,2212]],"region":{"top_left_x":1001,"top_left_y":2173,"width":738,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"569ee2e1c1fe4ba5a506853d1fcf5326","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"cholesterol, LDL cholesterol and triglycerides (Visit","text_display":" cholesterol, LDL cholesterol and triglycerides (Visit","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[1002,2214],[1444,2214],[1444,2254],[1002,2254]],"region":{"top_left_x":1001,"top_left_y":2214,"width":443,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22a528b260d541cfb5aa17d6460ea8d7","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"4, Visit 6 and thereafter yearly)","text_display":" 4, Visit 6 and thereafter yearly)","confidence":0.9794921875,"confidence_rate":0.9994947370142692},{"cnt":[[939,2302],[1688,2302],[1688,2341],[939,2341]],"region":{"top_left_x":939,"top_left_y":2301,"width":749,"height":41},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"959cae88672d44c9bd2edf41f6e8093f","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"\\(HbA _{1 c }\\) will be determined at all scheduled visits, with","text_display":"\n\\(HbA _{1 c }\\) will be determined at all scheduled visits, with","confidence":1,"confidence_rate":1},{"cnt":[[939,2343],[1299,2343],[1299,2380],[939,2380]],"region":{"top_left_x":939,"top_left_y":2343,"width":360,"height":38},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9220649552c64cc492dd3648c9f1a042","type":"text","conversion_output":false,"parent_id":"d0efd67bbf71454d8b31df6f262e251a","text":"exception of the FU visit.","text_display":" exception of the FU visit.","confidence":1,"confidence_rate":1},{"cnt":[[267,2385],[582,2385],[582,2424],[267,2424]],"region":{"top_left_x":267,"top_left_y":2384,"width":316,"height":40},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24d3ad9b3b034b3c9f849759aaa27476","type":"simple_cell","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","text":"Rationale for change","text_display":"Rationale for change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2380],[1655,2380],[1655,2461],[935,2461]],"region":{"top_left_x":934,"top_left_y":2380,"width":722,"height":81},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fcf4bbf541d478a82f8832781ca2c2d","type":"complex_cell","conversion_output":false,"parent_id":"45d176a7d7c446f9a762602247ca89c4","children_ids":["a9b131b3d5ce49a0873a019f415c3e9f","d0ff802a951a4860ba2d3f55c362f894"],"text":"For clarification and to add lipase to the laboratory assessment schedule.","text_display":"For clarification and to add lipase to the laboratory assessment schedule.","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2385],[1651,2385],[1651,2424],[939,2424]],"region":{"top_left_x":939,"top_left_y":2384,"width":712,"height":40},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9b131b3d5ce49a0873a019f415c3e9f","type":"text","conversion_output":false,"parent_id":"6fcf4bbf541d478a82f8832781ca2c2d","text":"For clarification and to add lipase to the laboratory","text_display":"For clarification and to add lipase to the laboratory","confidence":1,"confidence_rate":1},{"cnt":[[939,2425],[1236,2423],[1237,2456],[939,2459]],"region":{"top_left_x":939,"top_left_y":2422,"width":298,"height":37},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0ff802a951a4860ba2d3f55c362f894","type":"text","conversion_output":false,"parent_id":"6fcf4bbf541d478a82f8832781ca2c2d","text":"assessment schedule.","text_display":" assessment schedule.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":63,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6eadee8b1a494e48a2ccdb840df009c3","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":64,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4a2efb905f244f58accc538c608d628f","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":65,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c5536a8b7f13469c8b2480e6a4fe30b8","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-094","page":94,"lines":[{"cnt":[[244,119],[610,119],[610,167],[244,167]],"region":{"top_left_x":244,"top_left_y":118,"width":366,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c593ff0251b143bfa608ebce5a5742b1","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45511ddc0dea49f882a949369bb2bf7b","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,164],[599,164],[599,203],[244,203]],"region":{"top_left_x":244,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00f7bc4a252b413d99a6ec2ccb0170a4","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[637,208],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":396,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0d0b518805c4617b6d600817877b2e2","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3359c454b17e4e748f9b78b685dbd96c","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ec9b52e39b64bee9d06a815b1daca08","type":"page_info","conversion_output":false,"text":"Page 94 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,334],[1775,334],[1775,2568],[242,2568]],"region":{"top_left_x":242,"top_left_y":333,"width":1533,"height":2235},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c148ccf8621544538781a0dab8fa7516","type":"table","conversion_output":true,"children_ids":["373b9ce7e6164b2381cd0870a1e690e3","bec9d1e4067849a6b4b12512ea764897","72e61b27fa424462b4ffc9d2579bc1f4","eabf269dee0b4cce9d2671ae3d8be49a","7b55b9f02dd142cc9d129a0b2d63b299","c32b1c822142415fbb553e6724d320d5","5cda8b30f2be499db482e68d6de38555","1e592d6b101746f2b2377dc32df67226","b48bd6b221124b5786d68641d9da957a","476b5f285f984be0aaaa9a2124055ff1","f3fc58090a9d481d94cd07088ec15aaa","3320d8f7da8d485b9e659b6d5a0bb594","6e5cf675bd854f17bcb98124fbc533d3","fc36da289c834247ba8dc68a2bf1cfa8","209a6576b0684b26b80ada1b476cc2cc","0a57470ef6004587b08dbafcead15456","a307ba6cc4e544abbb80aa9702704aa2","8bfe8571ce1244dfa41618acc0e1e7be","f01af0418eb44912b346f2ec339d533a","7dc3d1466b354f1c93b372e1543cfc01","0aafd719a5e84a57a970a01b9a249e96","244c88e4c3d44340ba2601fbf667223a","c288176b831f4854bc6e7b6938f4d8dd","2d7980927be849a5bf3842218c0873f9","ff6a96d61f8a423e9e152d1f870e1eda","b1ecef702d184cf79deee5f7b5f4a002"],"text":"\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 5.2.5 Assessment of other safety parameters \\\\\n\\hline Description of change & ......If not stipulated differently in the ISF, patient ... was deleted. \\\\\n\\hline Rationale for change & Following confirmation that a paper diary is used. \\\\\n\\hline Section to be changed & \\\\\n\\hline & \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: To reflect recruitment planning per country following completion of feasibility. \\\\\nChange 2: For clarification.\n\\end{tabular} \\\\\n\\hline Section to be changed & 5.3.3 Pharmacogenomic evaluation \\\\\n\\hline Description of change & Section 5.3.3 was added. \\\\\n\\hline Rationale for change & To allow possible retrospective pharmacogenetic analyses. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 5.2.5 Assessment of other safety parameters \\\\\n\\hline Description of change & ......If not stipulated differently in the ISF, patient ... was deleted. \\\\\n\\hline Rationale for change & Following confirmation that a paper diary is used. \\\\\n\\hline Section to be changed & \\\\\n\\hline & \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: To reflect recruitment planning per country following completion of feasibility. \\\\\nChange 2: For clarification.\n\\end{tabular} \\\\\n\\hline Section to be changed & 5.3.3 Pharmacogenomic evaluation \\\\\n\\hline Description of change & Section 5.3.3 was added. \\\\\n\\hline Rationale for change & To allow possible retrospective pharmacogenetic analyses. \\\\\n\\hline\n\\end{tabular}","confidence":0.62255859375,"confidence_rate":0.9996806602416657},{"cnt":[[242,333],[601,333],[601,2569],[242,2569]],"region":{"top_left_x":242,"top_left_y":333,"width":360,"height":2236},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"373b9ce7e6164b2381cd0870a1e690e3","type":"table_column","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[930,333],[1709,333],[1709,2569],[930,2569]],"region":{"top_left_x":930,"top_left_y":333,"width":779,"height":2236},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bec9d1e4067849a6b4b12512ea764897","type":"table_column","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[242,338],[1775,338],[1775,386],[242,386]],"region":{"top_left_x":242,"top_left_y":337,"width":1534,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72e61b27fa424462b4ffc9d2579bc1f4","type":"table_row","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[242,395],[1775,395],[1775,478],[242,478]],"region":{"top_left_x":242,"top_left_y":395,"width":1534,"height":84},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eabf269dee0b4cce9d2671ae3d8be49a","type":"table_row","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[242,490],[1773,490],[1773,533],[242,533]],"region":{"top_left_x":242,"top_left_y":489,"width":1532,"height":45},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b55b9f02dd142cc9d129a0b2d63b299","type":"table_row","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[242,547],[1773,547],[1773,595],[242,595]],"region":{"top_left_x":242,"top_left_y":547,"width":1532,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c32b1c822142415fbb553e6724d320d5","type":"table_row","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[242,593],[1773,593],[1773,2081],[242,2081]],"region":{"top_left_x":242,"top_left_y":593,"width":1532,"height":1488},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cda8b30f2be499db482e68d6de38555","type":"table_row","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[242,2083],[1773,2083],[1773,2253],[242,2253]],"region":{"top_left_x":242,"top_left_y":2082,"width":1532,"height":172},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e592d6b101746f2b2377dc32df67226","type":"table_row","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[242,2368],[1773,2368],[1773,2412],[242,2412]],"region":{"top_left_x":242,"top_left_y":2368,"width":1532,"height":45},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b48bd6b221124b5786d68641d9da957a","type":"table_row","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[242,2419],[1773,2419],[1773,2463],[242,2463]],"region":{"top_left_x":242,"top_left_y":2419,"width":1532,"height":44},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"476b5f285f984be0aaaa9a2124055ff1","type":"table_row","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[242,2470],[1775,2470],[1775,2555],[242,2555]],"region":{"top_left_x":242,"top_left_y":2469,"width":1534,"height":86},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3fc58090a9d481d94cd07088ec15aaa","type":"table_row","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"","text_display":""},{"cnt":[[265,342],[590,342],[590,381],[265,381]],"region":{"top_left_x":265,"top_left_y":342,"width":325,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3320d8f7da8d485b9e659b6d5a0bb594","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Section to be changed","text_display":"Section to be changed","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[942,342],[1591,342],[1591,381],[942,381]],"region":{"top_left_x":941,"top_left_y":342,"width":651,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e5cf675bd854f17bcb98124fbc533d3","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"5.2.5 Assessment of other safety parameters","text_display":"5.2.5 Assessment of other safety parameters","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,402],[594,402],[594,439],[265,439]],"region":{"top_left_x":265,"top_left_y":402,"width":330,"height":37},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc36da289c834247ba8dc68a2bf1cfa8","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Description of change","text_display":"Description of change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,397],[1693,397],[1693,473],[937,473]],"region":{"top_left_x":937,"top_left_y":397,"width":756,"height":77},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"209a6576b0684b26b80ada1b476cc2cc","type":"complex_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","children_ids":["c78130375d294bb486f43494f03fbb2b","198edf81ac984d1c921a9bfd38207b4d"],"text":"......If not stipulated differently in the ISF, patient ... was deleted.","text_display":"......If not stipulated differently in the ISF, patient ... was deleted.","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.999996184378388},{"cnt":[[942,402],[1690,402],[1690,441],[942,441]],"region":{"top_left_x":941,"top_left_y":402,"width":750,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c78130375d294bb486f43494f03fbb2b","type":"text","conversion_output":false,"parent_id":"209a6576b0684b26b80ada1b476cc2cc","text":"......If not stipulated differently in the ISF, patient ...","text_display":"......If not stipulated differently in the ISF, patient ...","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[942,439],[1115,439],[1115,473],[942,473]],"region":{"top_left_x":941,"top_left_y":438,"width":174,"height":36},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"198edf81ac984d1c921a9bfd38207b4d","type":"text","conversion_output":false,"parent_id":"209a6576b0684b26b80ada1b476cc2cc","text":"was deleted.","text_display":" was deleted.","confidence":1,"confidence_rate":1},{"cnt":[[265,494],[580,494],[580,529],[265,529]],"region":{"top_left_x":265,"top_left_y":494,"width":316,"height":35},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a57470ef6004587b08dbafcead15456","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Rationale for change","text_display":"Rationale for change","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[942,490],[1640,490],[1640,529],[942,529]],"region":{"top_left_x":941,"top_left_y":489,"width":699,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a307ba6cc4e544abbb80aa9702704aa2","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Following confirmation that a paper diary is used.","text_display":"Following confirmation that a paper diary is used.","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,554],[590,554],[590,589],[267,589]],"region":{"top_left_x":267,"top_left_y":554,"width":323,"height":35},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8bfe8571ce1244dfa41618acc0e1e7be","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Section to be changed","text_display":"Section to be changed","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,2092],[580,2092],[580,2127],[265,2127]],"region":{"top_left_x":265,"top_left_y":2092,"width":316,"height":35},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f01af0418eb44912b346f2ec339d533a","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Rationale for change","text_display":"Rationale for change","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,2088],[1702,2088],[1702,2251],[937,2251]],"region":{"top_left_x":937,"top_left_y":2087,"width":765,"height":164},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7dc3d1466b354f1c93b372e1543cfc01","type":"complex_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","children_ids":["4879267f30fe443f9ae5f87ff562bc90","8b420f9b484c4cdd97f6bedb51ad0513","cb92134c7b7148668baf2531485a5123"],"text":"\\begin{tabular}{l}\nChange 1: To reflect recruitment planning per country following completion of feasibility. \\\\\nChange 2: For clarification.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: To reflect recruitment planning per country following completion of feasibility. \\\\\nChange 2: For clarification.\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.62255859375,"confidence_rate":0.9952243938990638},{"cnt":[[942,2090],[1699,2090],[1699,2127],[942,2127]],"region":{"top_left_x":941,"top_left_y":2089,"width":759,"height":38},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4879267f30fe443f9ae5f87ff562bc90","type":"text","conversion_output":false,"parent_id":"7dc3d1466b354f1c93b372e1543cfc01","text":"Change 1: To reflect recruitment planning per country","text_display":"Change 1: To reflect recruitment planning per country","confidence":1,"confidence_rate":1},{"cnt":[[942,2129],[1437,2129],[1437,2168],[942,2168]],"region":{"top_left_x":941,"top_left_y":2128,"width":497,"height":41},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b420f9b484c4cdd97f6bedb51ad0513","type":"text","conversion_output":false,"parent_id":"7dc3d1466b354f1c93b372e1543cfc01","text":"following completion of feasibility.","text_display":" following completion of feasibility.","confidence":1,"confidence_rate":1},{"cnt":[[942,2207],[1326,2207],[1326,2246],[942,2246]],"region":{"top_left_x":941,"top_left_y":2207,"width":386,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb92134c7b7148668baf2531485a5123","type":"text","conversion_output":false,"parent_id":"7dc3d1466b354f1c93b372e1543cfc01","text":"Change 2: For clarification.","text_display":"\nChange 2: For clarification.","confidence":0.62255859375,"confidence_rate":0.9857414920236374},{"cnt":[[265,2373],[590,2373],[590,2408],[265,2408]],"region":{"top_left_x":265,"top_left_y":2373,"width":325,"height":35},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0aafd719a5e84a57a970a01b9a249e96","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Section to be changed","text_display":"Section to be changed","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[942,2373],[1460,2373],[1460,2408],[942,2408]],"region":{"top_left_x":941,"top_left_y":2373,"width":520,"height":35},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"244c88e4c3d44340ba2601fbf667223a","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"5.3.3 Pharmacogenomic evaluation","text_display":"5.3.3 Pharmacogenomic evaluation","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,2424],[590,2424],[590,2458],[265,2458]],"region":{"top_left_x":265,"top_left_y":2423,"width":325,"height":36},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c288176b831f4854bc6e7b6938f4d8dd","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Description of change","text_display":"Description of change","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[942,2424],[1290,2424],[1290,2454],[942,2454]],"region":{"top_left_x":941,"top_left_y":2423,"width":349,"height":31},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d7980927be849a5bf3842218c0873f9","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Section 5.3.3 was added.","text_display":"Section 5.3.3 was added.","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2472],[578,2472],[578,2509],[267,2509]],"region":{"top_left_x":267,"top_left_y":2472,"width":312,"height":37},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff6a96d61f8a423e9e152d1f870e1eda","type":"simple_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","text":"Rationale for change","text_display":"Rationale for change","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,2470],[1628,2470],[1628,2550],[937,2550]],"region":{"top_left_x":937,"top_left_y":2469,"width":692,"height":82},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1ecef702d184cf79deee5f7b5f4a002","type":"complex_cell","conversion_output":false,"parent_id":"c148ccf8621544538781a0dab8fa7516","children_ids":["3a71e72ec2284556bbe98be3330d83d5","2d78a1c2d83f4f82b763d3155d33bab0"],"text":"To allow possible retrospective pharmacogenetic analyses.","text_display":"To allow possible retrospective pharmacogenetic analyses.","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[942,2470],[1626,2470],[1626,2509],[942,2509]],"region":{"top_left_x":941,"top_left_y":2469,"width":685,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a71e72ec2284556bbe98be3330d83d5","type":"text","conversion_output":false,"parent_id":"b1ecef702d184cf79deee5f7b5f4a002","text":"To allow possible retrospective pharmacogenetic","text_display":"To allow possible retrospective pharmacogenetic","confidence":1,"confidence_rate":1},{"cnt":[[942,2511],[1069,2511],[1069,2546],[942,2546]],"region":{"top_left_x":941,"top_left_y":2511,"width":128,"height":35},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d78a1c2d83f4f82b763d3155d33bab0","type":"text","conversion_output":false,"parent_id":"b1ecef702d184cf79deee5f7b5f4a002","text":"analyses.","text_display":" analyses.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":41,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"946e34189ede48ddafae3d0d38f7fe9f","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[288,2620],[1798,2620],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2620,"width":1511,"height":42},"line":42,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"360dc38d0e8d49059e02b4fefb5451f5","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.9794921875,"confidence_rate":0.9998258889604521},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":43,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d6029b15118e4fd0a16a72b2f3d4eb82","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-095","page":95,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ba7e06cb233400daae7b82d1f1171b2","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ddac3a9db1b644edb58f37270ee598be","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab2225277edd45688a5a03bd36eb90c7","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb36eef8adbc405fbb6401f8a8403919","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24444ab6f8864319902b3b449c224582","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91024c5556204654958df9025770be97","type":"page_info","conversion_output":false,"text":"Page 95 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2556],[244,2556]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2224},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8be62905851b42d497116332867b4ef0","type":"table","conversion_output":true,"children_ids":["830069ad09c24326804be15666a5fb16","935bf18495cd476a9d6147f0978d65c2","98ceee50f43747e19921e7eb6b8ff6d2","f20a611455004f84aa61b85fb27cc833","c533dc40360e4ffd8a7cc81b5bc3bf60","2746c355df684691ac4aa97d62f0cf6e","e503af8d73684235bb242b9ad17f00fa","cb1753b985d242cdbcb03e6349003495","433e871af52b4782beb40e96324dfe64","0735dd660f614592b07eff0b9f7c8a12","8e7b8165e09f4bcf8f39378aa5b677ed","ef9a842c60dc4ab99ec71b0e5d400b5d","7e47be401dfe4b64b380ec8b6cd4740b","36ac0cfc16044aedae8ffc442812030f","3ed1b1e151684919942ef2522e4c6016","e428b6189e164eba917176a1d6521cc1","af2fa678685a4c21964e1a0ec0de269d","a36af98c595343bb8ac31db7f3dd12bd","9e7b70c9b66a4537b3afa403369a651b","9b820af6bd7144b39c341ed3f31c1bc0","4d0131b63cbe4f9694ce3a8ff632d6e9","31dd0fb56f674622808a4efc9c46916f","20100d1b301741b697da722abed7c69d","c9487a1fcdef4e0bbf9dd70411e3f38b","92a52385b74b447ab265900f8e761b0c","400ca524301c4316ab9f7ad4fa8a38d8"],"text":"\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 6.2.3 End of trial and follow-up period \\\\\n\\hline Description of change & \\begin{tabular}{l}\nSub header was changed into end of treatment and follow-up. \\\\\nIn addition: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principles, primary renal endpoint). \\\\\n\\hline Section to be changed & 7.1 Statistical design -model \\\\\n\\hline Description of change & \\begin{tabular}{l}\nIf a patient dies without a primary outcome event, the patient will be censored at the date of death. \\\\\nWas changed into: \\\\\nIf any measurement of laboratory data or ECG is available after the last visit of a patient, the date of the respective measurement will be used for censoring of the CV endpoint. If any measurement of eGFR is available after the last visit of a patient, the date of the respective measurement will be used for censoring of the renal endpoint. For all endpoints including the component CV (renal) death, adjudicated CV (renal) death will be counted even if occurred thereafter.\n\\end{tabular} \\\\\n\\hline Rationale for change & To add more specific information regarding censoring of the CV and renal endpoint, respectively. \\\\\n\\hline Section to be changed & 7.3 Planned analyses \\\\\n\\hline Description of change & \\begin{tabular}{l}\nAdditional analyses will be explored in specific subgroups, e.g. depending on characteristics at baseline with respect to the primary and secondary endpoints. Covariates that will be explored include: \\\\\n- Region (North America, Europe, Asia etc.) \\\\\n- Age (<65, \\(\\geq 65\\) years) \\\\\n- Systolic and diastolic blood pressure ( \\(\\leq 160 / 100 mmHg ,>160 / 100 mmHg\\), other) \\\\\n- Gender (male, female)\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Section to be changed & 6.2.3 End of trial and follow-up period \\\\\n\\hline Description of change & \\begin{tabular}{l}\nSub header was changed into end of treatment and follow-up. \\\\\nIn addition: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principles, primary renal endpoint). \\\\\n\\hline Section to be changed & 7.1 Statistical design -model \\\\\n\\hline Description of change & \\begin{tabular}{l}\nIf a patient dies without a primary outcome event, the patient will be censored at the date of death. \\\\\nWas changed into: \\\\\nIf any measurement of laboratory data or ECG is available after the last visit of a patient, the date of the respective measurement will be used for censoring of the CV endpoint. If any measurement of eGFR is available after the last visit of a patient, the date of the respective measurement will be used for censoring of the renal endpoint. For all endpoints including the component CV (renal) death, adjudicated CV (renal) death will be counted even if occurred thereafter.\n\\end{tabular} \\\\\n\\hline Rationale for change & To add more specific information regarding censoring of the CV and renal endpoint, respectively. \\\\\n\\hline Section to be changed & 7.3 Planned analyses \\\\\n\\hline Description of change & \\begin{tabular}{l}\nAdditional analyses will be explored in specific subgroups, e.g. depending on characteristics at baseline with respect to the primary and secondary endpoints. Covariates that will be explored include: \\\\\n- Region (North America, Europe, Asia etc.) \\\\\n- Age (<65, \\(\\geq 65\\) years) \\\\\n- Systolic and diastolic blood pressure ( \\(\\leq 160 / 100 mmHg ,>160 / 100 mmHg\\), other) \\\\\n- Gender (male, female)\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.91943359375,"confidence_rate":0.999948637425962},{"cnt":[[256,333],[601,333],[601,2557],[256,2557]],"region":{"top_left_x":255,"top_left_y":333,"width":346,"height":2225},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"830069ad09c24326804be15666a5fb16","type":"table_column","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[921,333],[1764,333],[1764,2557],[921,2557]],"region":{"top_left_x":920,"top_left_y":333,"width":844,"height":2225},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"935bf18495cd476a9d6147f0978d65c2","type":"table_column","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[244,338],[1775,338],[1775,386],[244,386]],"region":{"top_left_x":244,"top_left_y":337,"width":1532,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98ceee50f43747e19921e7eb6b8ff6d2","type":"table_row","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[244,384],[1775,384],[1775,1196],[244,1196]],"region":{"top_left_x":244,"top_left_y":383,"width":1532,"height":814},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f20a611455004f84aa61b85fb27cc833","type":"table_row","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[244,1192],[1775,1192],[1775,1404],[244,1404]],"region":{"top_left_x":244,"top_left_y":1191,"width":1532,"height":213},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c533dc40360e4ffd8a7cc81b5bc3bf60","type":"table_row","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[244,1397],[1775,1397],[1775,1445],[244,1445]],"region":{"top_left_x":244,"top_left_y":1396,"width":1532,"height":50},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2746c355df684691ac4aa97d62f0cf6e","type":"table_row","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[244,1443],[1775,1443],[1775,2014],[244,2014]],"region":{"top_left_x":244,"top_left_y":1442,"width":1532,"height":572},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e503af8d73684235bb242b9ad17f00fa","type":"table_row","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[244,2009],[1775,2009],[1775,2099],[244,2099]],"region":{"top_left_x":244,"top_left_y":2009,"width":1532,"height":91},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb1753b985d242cdbcb03e6349003495","type":"table_row","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[244,2092],[1775,2092],[1775,2140],[244,2140]],"region":{"top_left_x":244,"top_left_y":2092,"width":1532,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"433e871af52b4782beb40e96324dfe64","type":"table_row","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[244,2138],[1775,2138],[1775,2557],[244,2557]],"region":{"top_left_x":244,"top_left_y":2138,"width":1532,"height":420},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0735dd660f614592b07eff0b9f7c8a12","type":"table_row","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"","text_display":""},{"cnt":[[267,342],[592,342],[592,381],[267,381]],"region":{"top_left_x":267,"top_left_y":342,"width":325,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e7b8165e09f4bcf8f39378aa5b677ed","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"Section to be changed","text_display":"Section to be changed","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,342],[1513,342],[1513,381],[939,381]],"region":{"top_left_x":939,"top_left_y":342,"width":574,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef9a842c60dc4ab99ec71b0e5d400b5d","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"6.2.3 End of trial and follow-up period","text_display":"6.2.3 End of trial and follow-up period","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,393],[592,393],[592,432],[267,432]],"region":{"top_left_x":267,"top_left_y":392,"width":325,"height":41},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e47be401dfe4b64b380ec8b6cd4740b","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"Description of change","text_display":"Description of change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,388],[1748,388],[1748,1192],[935,1192]],"region":{"top_left_x":934,"top_left_y":388,"width":814,"height":804},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36ac0cfc16044aedae8ffc442812030f","type":"complex_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","children_ids":["14d55b4529ff4923badc051996387043","f43209bcb88d490d91ecac7872231446","48b5b6d2c54b42d89d49f354f5342a85","6d8e480f64874b4c9b38e570eeea979e","3bbe3cfe238f4d44afb6dd31fc30b289","9ae464f59c434269976d530acdddb1e8","47b9d8e837a24c2190fbb7e4657ef77a","ba507c20446d4396b3b9d268d0e00f4f","fafe71f5341f4372b303c0015bef7387","54f058bd73854982915ba052b28f7519","c09ea657f1434c009f359f98f2912f84","b709633216044c1b9e5ca9f4e485f5b6","49d813e9686c4a6db545bda45a46b9ce","0080475c882645b18a456cad20ee3517","0d9e7f2b9d534612a3d18418e24d3fa9","5dfc683d87fd48d48b9d504e4bbc5fa8"],"text":"\\begin{tabular}{l}\nSub header was changed into end of treatment and follow-up. \\\\\nIn addition: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nSub header was changed into end of treatment and follow-up. \\\\\nIn addition: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end, but no physical examination, vital signs, (safety) laboratory sampling (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and eGFR) or ECG will be required. \\\\\nWas changed into: \\\\\nPatients who discontinue study drug prematurely should continue study visits until study end. Study assessments may be omitted if a patient is willing to return to the predefined study visits, with exception of collection of adverse events, outcome events, concomitant therapy and laboratory testing of creatinine for the calculation of the eGFR.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.98193359375,"confidence_rate":0.9999356278845253},{"cnt":[[939,393],[1646,393],[1646,430],[939,430]],"region":{"top_left_x":939,"top_left_y":392,"width":708,"height":38},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14d55b4529ff4923badc051996387043","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"Sub header was changed into end of treatment and","text_display":"Sub header was changed into end of treatment and","confidence":1,"confidence_rate":1},{"cnt":[[939,430],[1089,430],[1089,469],[939,469]],"region":{"top_left_x":939,"top_left_y":429,"width":151,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f43209bcb88d490d91ecac7872231446","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"follow-up.","text_display":" follow-up.","confidence":1,"confidence_rate":1},{"cnt":[[939,513],[1107,513],[1107,547],[939,547]],"region":{"top_left_x":939,"top_left_y":512,"width":169,"height":36},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48b5b6d2c54b42d89d49f354f5342a85","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"In addition:","text_display":"\nIn addition:","confidence":1,"confidence_rate":1},{"cnt":[[939,595],[1725,595],[1725,635],[939,635]],"region":{"top_left_x":939,"top_left_y":595,"width":786,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d8e480f64874b4c9b38e570eeea979e","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"Patients who discontinue study drug prematurely should","text_display":"\nPatients who discontinue study drug prematurely should","confidence":1,"confidence_rate":1},{"cnt":[[939,635],[1674,635],[1674,671],[939,671]],"region":{"top_left_x":939,"top_left_y":634,"width":735,"height":38},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3bbe3cfe238f4d44afb6dd31fc30b289","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"continue study visits until study end, but no physical","text_display":" continue study visits until study end, but no physical","confidence":1,"confidence_rate":1},{"cnt":[[939,674],[1688,674],[1688,713],[939,713]],"region":{"top_left_x":939,"top_left_y":673,"width":749,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ae464f59c434269976d530acdddb1e8","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"examination, vital signs, (safety) laboratory sampling","text_display":" examination, vital signs, (safety) laboratory sampling","confidence":1,"confidence_rate":1},{"cnt":[[939,715],[1743,715],[1743,754],[939,754]],"region":{"top_left_x":939,"top_left_y":715,"width":804,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47b9d8e837a24c2190fbb7e4657ef77a","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"(including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and","text_display":" (including pregnancy test, lipid panel \\(HbA _{1 c }\\), UACR and","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[939,757],[1388,757],[1388,791],[939,791]],"region":{"top_left_x":939,"top_left_y":756,"width":450,"height":36},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba507c20446d4396b3b9d268d0e00f4f","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"eGFR) or ECG will be required.","text_display":" eGFR) or ECG will be required.","confidence":0.9936623573303223,"confidence_rate":0.9998183647609823},{"cnt":[[939,837],[1204,837],[1204,874],[939,874]],"region":{"top_left_x":939,"top_left_y":837,"width":266,"height":38},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fafe71f5341f4372b303c0015bef7387","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.98193359375,"confidence_rate":0.9991716343577381},{"cnt":[[939,918],[1725,918],[1725,957],[939,957]],"region":{"top_left_x":939,"top_left_y":917,"width":786,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54f058bd73854982915ba052b28f7519","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"Patients who discontinue study drug prematurely should","text_display":"\nPatients who discontinue study drug prematurely should","confidence":1,"confidence_rate":1},{"cnt":[[939,959],[1720,959],[1720,998],[939,998]],"region":{"top_left_x":939,"top_left_y":959,"width":781,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c09ea657f1434c009f359f98f2912f84","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"continue study visits until study end. Study assessments","text_display":" continue study visits until study end. Study assessments","confidence":1,"confidence_rate":1},{"cnt":[[939,998],[1738,998],[1738,1035],[939,1035]],"region":{"top_left_x":939,"top_left_y":998,"width":800,"height":38},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b709633216044c1b9e5ca9f4e485f5b6","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"may be omitted if a patient is willing to return to the pre-","text_display":" may be omitted if a patient is willing to return to the pre","confidence":1,"confidence_rate":1},{"cnt":[[939,1038],[1480,1038],[1480,1077],[939,1077]],"region":{"top_left_x":939,"top_left_y":1037,"width":542,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49d813e9686c4a6db545bda45a46b9ce","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"defined study visits, with exception of","text_display":"defined study visits, with exception of","confidence":1,"confidence_rate":1},{"cnt":[[1018,1079],[1653,1079],[1653,1114],[1018,1114]],"region":{"top_left_x":1017,"top_left_y":1079,"width":637,"height":35},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0080475c882645b18a456cad20ee3517","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"collection of adverse events, outcome events,","text_display":" collection of adverse events, outcome events,","confidence":1,"confidence_rate":1},{"cnt":[[939,1116],[1725,1116],[1725,1155],[939,1155]],"region":{"top_left_x":939,"top_left_y":1115,"width":786,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d9e7f2b9d534612a3d18418e24d3fa9","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"concomitant therapy and laboratory testing of creatinine","text_display":" concomitant therapy and laboratory testing of creatinine","confidence":1,"confidence_rate":1},{"cnt":[[939,1157],[1384,1157],[1384,1192],[939,1192]],"region":{"top_left_x":939,"top_left_y":1157,"width":445,"height":35},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5dfc683d87fd48d48b9d504e4bbc5fa8","type":"text","conversion_output":false,"parent_id":"36ac0cfc16044aedae8ffc442812030f","text":"for the calculation of the eGFR.","text_display":" for the calculation of the eGFR.","confidence":0.99951171875,"confidence_rate":0.9999868000736574},{"cnt":[[267,1199],[578,1199],[578,1238],[267,1238]],"region":{"top_left_x":267,"top_left_y":1198,"width":311,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ed1b1e151684919942ef2522e4c6016","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"Rationale for change","text_display":"Rationale for change","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,1194],[1750,1194],[1750,1397],[937,1397]],"region":{"top_left_x":937,"top_left_y":1194,"width":813,"height":203},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e428b6189e164eba917176a1d6521cc1","type":"complex_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","children_ids":["34a564d7aebb4c769f0bda128b8171a6","04eaac360576414b990eeb1c2575c982","115a04cfa2bc45d3a424999babe8c347","91bb413e98574d1aa52b47fe5f068217","b0f87a568bfb4692926f8c7f7b7c4c9f"],"text":"For clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principles, primary renal endpoint).","text_display":"For clarification and to add creatinine for calculation of eGFR to the assessments for patients who pre-maturely discontinue study medication, but are willing to return to the pre-defined study visits (ITT principles, primary renal endpoint).","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1199],[1720,1199],[1720,1233],[939,1233]],"region":{"top_left_x":939,"top_left_y":1198,"width":781,"height":36},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34a564d7aebb4c769f0bda128b8171a6","type":"text","conversion_output":false,"parent_id":"e428b6189e164eba917176a1d6521cc1","text":"For clarification and to add creatinine for calculation of","text_display":"For clarification and to add creatinine for calculation of","confidence":1,"confidence_rate":1},{"cnt":[[939,1240],[1713,1240],[1713,1277],[939,1277]],"region":{"top_left_x":939,"top_left_y":1240,"width":774,"height":38},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04eaac360576414b990eeb1c2575c982","type":"text","conversion_output":false,"parent_id":"e428b6189e164eba917176a1d6521cc1","text":"eGFR to the assessments for patients who pre-maturely","text_display":" eGFR to the assessments for patients who pre-maturely","confidence":1,"confidence_rate":1},{"cnt":[[939,1279],[1734,1279],[1734,1316],[939,1316]],"region":{"top_left_x":939,"top_left_y":1279,"width":795,"height":38},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"115a04cfa2bc45d3a424999babe8c347","type":"text","conversion_output":false,"parent_id":"e428b6189e164eba917176a1d6521cc1","text":"discontinue study medication, but are willing to return to","text_display":" discontinue study medication, but are willing to return to","confidence":1,"confidence_rate":1},{"cnt":[[939,1318],[1748,1318],[1748,1358],[939,1358]],"region":{"top_left_x":939,"top_left_y":1318,"width":809,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91bb413e98574d1aa52b47fe5f068217","type":"text","conversion_output":false,"parent_id":"e428b6189e164eba917176a1d6521cc1","text":"the pre-defined study visits (ITT principles, primary renal","text_display":" the pre-defined study visits (ITT principles, primary renal","confidence":1,"confidence_rate":1},{"cnt":[[939,1360],[1084,1360],[1084,1397],[939,1397]],"region":{"top_left_x":939,"top_left_y":1359,"width":146,"height":38},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0f87a568bfb4692926f8c7f7b7c4c9f","type":"text","conversion_output":false,"parent_id":"e428b6189e164eba917176a1d6521cc1","text":"endpoint).","text_display":" endpoint).","confidence":1,"confidence_rate":1},{"cnt":[[267,1401],[592,1401],[592,1441],[267,1441]],"region":{"top_left_x":267,"top_left_y":1401,"width":325,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af2fa678685a4c21964e1a0ec0de269d","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"Section to be changed","text_display":"Section to be changed","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1401],[1363,1401],[1363,1441],[939,1441]],"region":{"top_left_x":939,"top_left_y":1401,"width":425,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a36af98c595343bb8ac31db7f3dd12bd","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"7.1 Statistical design -model","text_display":"7.1 Statistical design -model","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9873046875,"confidence_rate":0.9996242886389913},{"cnt":[[267,1452],[592,1452],[592,1489],[267,1489]],"region":{"top_left_x":267,"top_left_y":1452,"width":325,"height":37},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e7b70c9b66a4537b3afa403369a651b","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"Description of change","text_display":"Description of change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1447],[1748,1447],[1748,2012],[935,2012]],"region":{"top_left_x":934,"top_left_y":1447,"width":814,"height":565},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b820af6bd7144b39c341ed3f31c1bc0","type":"complex_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","children_ids":["67929e988338483986d4315d0e1fe29f","eff948afe3b8466e852f5fe49b5661fc","dc77b4e29c774aaebb91e31771cd9bc9","923afd838cd64e9793d086df7c3bfbd0","5a8c6d2ad2c84b7592e4ff9e9641ecf8","13985b90304c41029817c48a6c7023d9","1ab816729b1742559239277fcbba22bd","6f0f8a5b255d442084f05aa04e8e524f","7b58f0c7ea91487bb73f8fc15736046c","3e85e253fbfc4e07b99901a337ee5734","a00a8abbc1444c779727a2e754c9ec63","0b06990df02241d39af553cb03863f24"],"text":"\\begin{tabular}{l}\nIf a patient dies without a primary outcome event, the patient will be censored at the date of death. \\\\\nWas changed into: \\\\\nIf any measurement of laboratory data or ECG is available after the last visit of a patient, the date of the respective measurement will be used for censoring of the CV endpoint. If any measurement of eGFR is available after the last visit of a patient, the date of the respective measurement will be used for censoring of the renal endpoint. For all endpoints including the component CV (renal) death, adjudicated CV (renal) death will be counted even if occurred thereafter.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nIf a patient dies without a primary outcome event, the patient will be censored at the date of death. \\\\\nWas changed into: \\\\\nIf any measurement of laboratory data or ECG is available after the last visit of a patient, the date of the respective measurement will be used for censoring of the CV endpoint. If any measurement of eGFR is available after the last visit of a patient, the date of the respective measurement will be used for censoring of the renal endpoint. For all endpoints including the component CV (renal) death, adjudicated CV (renal) death will be counted even if occurred thereafter.\n\\end{tabular}","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99755859375,"confidence_rate":0.9999907409847522},{"cnt":[[939,1452],[1688,1452],[1688,1487],[939,1487]],"region":{"top_left_x":939,"top_left_y":1452,"width":749,"height":35},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67929e988338483986d4315d0e1fe29f","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"If a patient dies without a primary outcome event, the","text_display":"If a patient dies without a primary outcome event, the","confidence":1,"confidence_rate":1},{"cnt":[[939,1489],[1554,1489],[1554,1528],[939,1528]],"region":{"top_left_x":939,"top_left_y":1488,"width":616,"height":41},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eff948afe3b8466e852f5fe49b5661fc","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"patient will be censored at the date of death.","text_display":" patient will be censored at the date of death.","confidence":1,"confidence_rate":1},{"cnt":[[939,1572],[1204,1572],[1204,1611],[939,1611]],"region":{"top_left_x":939,"top_left_y":1571,"width":266,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc77b4e29c774aaebb91e31771cd9bc9","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99755859375,"confidence_rate":0.9998888974749892},{"cnt":[[939,1655],[1623,1655],[1623,1691],[939,1691]],"region":{"top_left_x":939,"top_left_y":1654,"width":685,"height":38},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"923afd838cd64e9793d086df7c3bfbd0","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"If any measurement of laboratory data or ECG is","text_display":"\nIf any measurement of laboratory data or ECG is","confidence":1,"confidence_rate":1},{"cnt":[[939,1691],[1701,1691],[1701,1731],[939,1731]],"region":{"top_left_x":939,"top_left_y":1691,"width":763,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a8c6d2ad2c84b7592e4ff9e9641ecf8","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"available after the last visit of a patient, the date of the","text_display":" available after the last visit of a patient, the date of the","confidence":1,"confidence_rate":1},{"cnt":[[939,1733],[1738,1733],[1738,1772],[939,1772]],"region":{"top_left_x":939,"top_left_y":1732,"width":800,"height":41},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13985b90304c41029817c48a6c7023d9","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"respective measurement will be used for censoring of the","text_display":" respective measurement will be used for censoring of the","confidence":1,"confidence_rate":1},{"cnt":[[939,1774],[1711,1774],[1711,1814],[939,1814]],"region":{"top_left_x":939,"top_left_y":1774,"width":772,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ab816729b1742559239277fcbba22bd","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"CV endpoint. If any measurement of eGFR is available","text_display":" CV endpoint. If any measurement of eGFR is available","confidence":1,"confidence_rate":1},{"cnt":[[939,1811],[1713,1811],[1713,1850],[939,1850]],"region":{"top_left_x":939,"top_left_y":1811,"width":774,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f0f8a5b255d442084f05aa04e8e524f","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"after the last visit of a patient, the date of the respective","text_display":" after the last visit of a patient, the date of the respective","confidence":1,"confidence_rate":1},{"cnt":[[939,1853],[1665,1853],[1665,1892],[939,1892]],"region":{"top_left_x":939,"top_left_y":1852,"width":726,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b58f0c7ea91487bb73f8fc15736046c","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"measurement will be used for censoring of the renal","text_display":" measurement will be used for censoring of the renal","confidence":1,"confidence_rate":1},{"cnt":[[939,1894],[1729,1894],[1729,1933],[939,1933]],"region":{"top_left_x":939,"top_left_y":1894,"width":791,"height":40},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e85e253fbfc4e07b99901a337ee5734","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"endpoint. For all endpoints including the component CV","text_display":" endpoint. For all endpoints including the component CV","confidence":1,"confidence_rate":1},{"cnt":[[939,1931],[1655,1931],[1655,1972],[939,1972]],"region":{"top_left_x":939,"top_left_y":1930,"width":717,"height":43},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a00a8abbc1444c779727a2e754c9ec63","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"(renal) death, adjudicated CV (renal) death will be","text_display":" (renal) death, adjudicated CV (renal) death will be","confidence":1,"confidence_rate":1},{"cnt":[[939,1972],[1439,1972],[1439,2007],[939,2007]],"region":{"top_left_x":939,"top_left_y":1972,"width":501,"height":35},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b06990df02241d39af553cb03863f24","type":"text","conversion_output":false,"parent_id":"9b820af6bd7144b39c341ed3f31c1bc0","text":"counted even if occurred thereafter.","text_display":" counted even if occurred thereafter.","confidence":1,"confidence_rate":1},{"cnt":[[267,2014],[578,2014],[578,2053],[267,2053]],"region":{"top_left_x":267,"top_left_y":2013,"width":311,"height":40},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d0131b63cbe4f9694ce3a8ff632d6e9","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"Rationale for change","text_display":"Rationale for change","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,2014],[1743,2014],[1743,2094],[937,2094]],"region":{"top_left_x":937,"top_left_y":2013,"width":806,"height":82},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31dd0fb56f674622808a4efc9c46916f","type":"complex_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","children_ids":["c20f2f50a83b4fe4a2c89ad7c752209b","756fded612894fa389d13b27ae4ec47a"],"text":"To add more specific information regarding censoring of the CV and renal endpoint, respectively.","text_display":"To add more specific information regarding censoring of the CV and renal endpoint, respectively.","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.998046875,"confidence_rate":0.9999782776266475},{"cnt":[[939,2014],[1738,2014],[1738,2053],[939,2053]],"region":{"top_left_x":939,"top_left_y":2013,"width":800,"height":40},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c20f2f50a83b4fe4a2c89ad7c752209b","type":"text","conversion_output":false,"parent_id":"31dd0fb56f674622808a4efc9c46916f","text":"To add more specific information regarding censoring of","text_display":"To add more specific information regarding censoring of","confidence":1,"confidence_rate":1},{"cnt":[[939,2055],[1503,2055],[1503,2094],[939,2094]],"region":{"top_left_x":939,"top_left_y":2055,"width":565,"height":40},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"756fded612894fa389d13b27ae4ec47a","type":"text","conversion_output":false,"parent_id":"31dd0fb56f674622808a4efc9c46916f","text":"the CV and renal endpoint, respectively.","text_display":" the CV and renal endpoint, respectively.","confidence":0.998046875,"confidence_rate":0.9999565557251564},{"cnt":[[267,2097],[592,2097],[592,2136],[267,2136]],"region":{"top_left_x":267,"top_left_y":2096,"width":325,"height":40},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20100d1b301741b697da722abed7c69d","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"Section to be changed","text_display":"Section to be changed","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2097],[1250,2097],[1250,2136],[939,2136]],"region":{"top_left_x":939,"top_left_y":2096,"width":312,"height":40},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9487a1fcdef4e0bbf9dd70411e3f38b","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"7.3 Planned analyses","text_display":"7.3 Planned analyses","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2147],[592,2147],[592,2187],[267,2187]],"region":{"top_left_x":267,"top_left_y":2147,"width":325,"height":40},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92a52385b74b447ab265900f8e761b0c","type":"simple_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","text":"Description of change","text_display":"Description of change","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2143],[1734,2143],[1734,2555],[935,2555]],"region":{"top_left_x":934,"top_left_y":2142,"width":800,"height":413},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"400ca524301c4316ab9f7ad4fa8a38d8","type":"complex_cell","conversion_output":false,"parent_id":"8be62905851b42d497116332867b4ef0","children_ids":["cd6bda15d4064c2cb4fd05570f80edbe","25d8c6976f974d9f9162e769445d7fde","d01261fc4fa342bb9de2a267a7c3854c","3e88dfde682242b8ae5e494029c2a4b0","8247b743c91a406aab99afd101456de0","a95101b926184acfb8555658590d833d","b7d76ecde1404d4f8b8344ff7d9bd1a8","c79575586def4079919bfbc4ded4e361","7dcfd0b3e6544e64a1ad96e8740d3be1"],"text":"\\begin{tabular}{l}\nAdditional analyses will be explored in specific subgroups, e.g. depending on characteristics at baseline with respect to the primary and secondary endpoints. Covariates that will be explored include: \\\\\n- Region (North America, Europe, Asia etc.) \\\\\n- Age (<65, \\(\\geq 65\\) years) \\\\\n- Systolic and diastolic blood pressure ( \\(\\leq 160 / 100 mmHg ,>160 / 100 mmHg\\), other) \\\\\n- Gender (male, female)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAdditional analyses will be explored in specific subgroups, e.g. depending on characteristics at baseline with respect to the primary and secondary endpoints. Covariates that will be explored include: \\\\\n- Region (North America, Europe, Asia etc.) \\\\\n- Age (<65, \\(\\geq 65\\) years) \\\\\n- Systolic and diastolic blood pressure ( \\(\\leq 160 / 100 mmHg ,>160 / 100 mmHg\\), other) \\\\\n- Gender (male, female)\n\\end{tabular}","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.91943359375,"confidence_rate":0.9996493770054236},{"cnt":[[939,2147],[1605,2147],[1605,2187],[939,2187]],"region":{"top_left_x":939,"top_left_y":2147,"width":666,"height":40},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd6bda15d4064c2cb4fd05570f80edbe","type":"text","conversion_output":false,"parent_id":"400ca524301c4316ab9f7ad4fa8a38d8","text":"Additional analyses will be explored in specific","text_display":"Additional analyses will be explored in specific","confidence":1,"confidence_rate":1},{"cnt":[[939,2184],[1715,2184],[1715,2223],[939,2223]],"region":{"top_left_x":939,"top_left_y":2184,"width":777,"height":40},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25d8c6976f974d9f9162e769445d7fde","type":"text","conversion_output":false,"parent_id":"400ca524301c4316ab9f7ad4fa8a38d8","text":"subgroups, e.g. depending on characteristics at baseline","text_display":" subgroups, e.g. depending on characteristics at baseline","confidence":1,"confidence_rate":1},{"cnt":[[939,2226],[1678,2226],[1678,2265],[939,2265]],"region":{"top_left_x":939,"top_left_y":2225,"width":740,"height":40},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d01261fc4fa342bb9de2a267a7c3854c","type":"text","conversion_output":false,"parent_id":"400ca524301c4316ab9f7ad4fa8a38d8","text":"with respect to the primary and secondary endpoints.","text_display":" with respect to the primary and secondary endpoints.","confidence":1,"confidence_rate":1},{"cnt":[[939,2262],[1508,2262],[1508,2306],[939,2306]],"region":{"top_left_x":939,"top_left_y":2262,"width":570,"height":45},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e88dfde682242b8ae5e494029c2a4b0","type":"text","conversion_output":false,"parent_id":"400ca524301c4316ab9f7ad4fa8a38d8","text":"Covariates that will be explored include:","text_display":" Covariates that will be explored include:","confidence":1,"confidence_rate":1},{"cnt":[[1064,2345],[1727,2345],[1727,2385],[1064,2385]],"region":{"top_left_x":1063,"top_left_y":2345,"width":664,"height":40},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8247b743c91a406aab99afd101456de0","type":"text","conversion_output":false,"parent_id":"400ca524301c4316ab9f7ad4fa8a38d8","text":"- Region (North America, Europe, Asia etc.)","text_display":"\n- Region (North America, Europe, Asia etc.)","confidence":1,"confidence_rate":1},{"cnt":[[1066,2389],[1439,2389],[1439,2426],[1066,2426]],"region":{"top_left_x":1065,"top_left_y":2389,"width":375,"height":37},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a95101b926184acfb8555658590d833d","type":"text","conversion_output":false,"parent_id":"400ca524301c4316ab9f7ad4fa8a38d8","text":"- Age (<65, \\(\\geq 65\\) years)","text_display":"\n- Age (<65, \\(\\geq 65\\) years)","confidence":0.9931640625,"confidence_rate":0.9997713791527},{"cnt":[[1066,2433],[1683,2433],[1683,2472],[1066,2472]],"region":{"top_left_x":1065,"top_left_y":2432,"width":619,"height":41},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7d76ecde1404d4f8b8344ff7d9bd1a8","type":"text","conversion_output":false,"parent_id":"400ca524301c4316ab9f7ad4fa8a38d8","text":"- Systolic and diastolic blood pressure ( \\(\\leq\\)","text_display":"\n- Systolic and diastolic blood pressure ( \\(\\leq","confidence":0.91943359375,"confidence_rate":0.9982144161082708},{"cnt":[[1130,2474],[1725,2474],[1725,2513],[1130,2513]],"region":{"top_left_x":1130,"top_left_y":2474,"width":595,"height":40},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c79575586def4079919bfbc4ded4e361","type":"text","conversion_output":false,"parent_id":"400ca524301c4316ab9f7ad4fa8a38d8","text":"\\(160 / 100 mmHg ,>160 / 100 mmHg\\), other)","text_display":" 160 / 100 mmHg ,>160 / 100 mmHg\\), other)","confidence":0.9521484375,"confidence_rate":0.9988603165701909},{"cnt":[[1066,2516],[1444,2516],[1444,2553],[1066,2553]],"region":{"top_left_x":1065,"top_left_y":2515,"width":379,"height":38},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7dcfd0b3e6544e64a1ad96e8740d3be1","type":"text","conversion_output":false,"parent_id":"400ca524301c4316ab9f7ad4fa8a38d8","text":"- Gender (male, female)","text_display":"\n- Gender (male, female)","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":78,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cd6b52028fe34621b2465ec1191e4be9","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[288,2620],[1798,2620],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2620,"width":1511,"height":42},"line":79,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0d241c91fb0d4820811e2786cf24e092","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.9794921875,"confidence_rate":0.9998258889604521},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":80,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2a80ef0b7a3b46bda15279315d261550","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-096","page":96,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a1deaede68ed46a0af2cd5820da22ef6","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67c1364fc8eb45d6af8ab5b03824179c","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14cbafe90f144c39a7a9e68d90150d99","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61b87801f417478084662cdca50a1aee","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b53730bbde704334850d32f1f0182f68","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,210],[1816,210],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":210,"width":246,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf9afc6fce0f48eaad3828f606cdfa9c","type":"page_info","conversion_output":false,"text":"Page 96 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2554],[244,2554]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2221},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"93365fb1725f4010ba487d07c7d66c1e","type":"table","conversion_output":true,"children_ids":["71408ddfa10f439aa487f745c528038d","51557f67303e4509b611fccfed30be43","43486d0bec78426b955d3739ef9d1f19","07970757902f4cfb967a5af5ef0f396d","7133af1b4d504a91af7a93b833d8e461","02316d31be9b4cf7b5974b64724849bd","41260486658a47cabaa95b70a2b77f91","56320400af934e72b7f6bc0bd2ed3cb5","80ad3dcc0e9844429dce841cb2fffa86","a7635678e75c4673b47f45f08441ddea","eaa132c067f9404e9228030a1c73ba15","3c93ea404cc8400aa322d853be917b46","a6a07b36007c45ef99e639611dae59b1"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\n- Prior anti-diabetic treatment (none, monotherapy, combination therapy) \\\\\nwas changed to: \\\\\nAdditional analyses will be explored in specific subgroups, e.g. depending on characteristics at baseline with respect to the primary and key secondary endpoints. Covariates that will be explored include: \\\\\n- Region (North America, Europe, Asia etc.) \\\\\n- Age (<65, \\(\\geq 65\\) years) \\\\\n- Systolic and diastolic blood pressure \\((\\leq 160\\) and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) ) \\\\\n- Gender (male, female) \\\\\n- Prior anti-diabetic treatment (none, monotherapy, combination therapy) \\\\\n- \\(eGFR <60 mL / min / 1.73 m^{2}\\) at baseline\n\\end{tabular} \\\\\n\\hline Rational for change & To reflect definitions regarding systolic and diastolic blood pressure subgroups in other outcome studies and to add a subgroup analysis reflecting the renal status. \\\\\n\\hline Section to be changed & 7.3.2 Secondary analyses \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nComposite renal endpoint (i.e. renal death, sustained ESRD, sustained loss of 50\\% or more in eGFR) \\\\\nwas changed into: \\\\\nComposite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR)\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\n- Prior anti-diabetic treatment (none, monotherapy, combination therapy) \\\\\nwas changed to: \\\\\nAdditional analyses will be explored in specific subgroups, e.g. depending on characteristics at baseline with respect to the primary and key secondary endpoints. Covariates that will be explored include: \\\\\n- Region (North America, Europe, Asia etc.) \\\\\n- Age (<65, \\(\\geq 65\\) years) \\\\\n- Systolic and diastolic blood pressure \\((\\leq 160\\) and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) ) \\\\\n- Gender (male, female) \\\\\n- Prior anti-diabetic treatment (none, monotherapy, combination therapy) \\\\\n- \\(eGFR <60 mL / min / 1.73 m^{2}\\) at baseline\n\\end{tabular} \\\\\n\\hline Rational for change & To reflect definitions regarding systolic and diastolic blood pressure subgroups in other outcome studies and to add a subgroup analysis reflecting the renal status. \\\\\n\\hline Section to be changed & 7.3.2 Secondary analyses \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nComposite renal endpoint (i.e. renal death, sustained ESRD, sustained loss of 50\\% or more in eGFR) \\\\\nwas changed into: \\\\\nComposite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR)\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.3979516978142783,"confidence_rate":0.9995123562461615},{"cnt":[[251,333],[603,333],[603,2555],[251,2555]],"region":{"top_left_x":250,"top_left_y":333,"width":354,"height":2222},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71408ddfa10f439aa487f745c528038d","type":"table_column","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"","text_display":""},{"cnt":[[928,333],[1759,333],[1759,2555],[928,2555]],"region":{"top_left_x":927,"top_left_y":333,"width":833,"height":2222},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51557f67303e4509b611fccfed30be43","type":"table_column","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"","text_display":""},{"cnt":[[244,338],[1775,338],[1775,1042],[244,1042]],"region":{"top_left_x":244,"top_left_y":337,"width":1532,"height":706},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43486d0bec78426b955d3739ef9d1f19","type":"table_row","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"","text_display":""},{"cnt":[[244,1185],[244,1054],[1775,1056],[1775,1187]],"region":{"top_left_x":243,"top_left_y":1053,"width":1533,"height":135},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07970757902f4cfb967a5af5ef0f396d","type":"table_row","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"","text_display":""},{"cnt":[[244,1180],[1775,1180],[1775,1226],[244,1226]],"region":{"top_left_x":244,"top_left_y":1180,"width":1532,"height":47},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7133af1b4d504a91af7a93b833d8e461","type":"table_row","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"","text_display":""},{"cnt":[[244,1226],[1775,1226],[1775,2555],[244,2555]],"region":{"top_left_x":244,"top_left_y":1226,"width":1532,"height":1329},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02316d31be9b4cf7b5974b64724849bd","type":"table_row","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"","text_display":""},{"cnt":[[935,340],[1748,340],[1748,1038],[935,1038]],"region":{"top_left_x":934,"top_left_y":339,"width":814,"height":699},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41260486658a47cabaa95b70a2b77f91","type":"complex_cell","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","children_ids":["5d36087f5eb64bab9bf125241153f404","9e8500b0261e48bbb52ad1e96663820d","6a8fc48c8df34f1082161cc746042f36","2516bd0a749e45f69986a9f1f618bcf4","5a6bfd1052e64c508d9da634dc745c5a","255da8551af043a7a6c6f2bc24dee698","6374328173a541cc930d7859cc19286c","0a4819d432a4430c945b08165d8f15ce","d8eaeb8181f8410faa71bae61b122aab","2a424b53171b48ddb28f4032051f796a","b78043fd96fa41b1904f8cc22b9ada6c","4a95b904d74742d6a12f93d0ce408173","b32a0b6afe8944f8b0d17d5455313622","28026e379d2a4fc6a9f2f83e8b0ccbd9","42ba8425894d47cf8592debdd17acf1c"],"text":"\\begin{tabular}{l}\n- Prior anti-diabetic treatment (none, monotherapy, combination therapy) \\\\\nwas changed to: \\\\\nAdditional analyses will be explored in specific subgroups, e.g. depending on characteristics at baseline with respect to the primary and key secondary endpoints. Covariates that will be explored include: \\\\\n- Region (North America, Europe, Asia etc.) \\\\\n- Age (<65, \\(\\geq 65\\) years) \\\\\n- Systolic and diastolic blood pressure \\((\\leq 160\\) and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) ) \\\\\n- Gender (male, female) \\\\\n- Prior anti-diabetic treatment (none, monotherapy, combination therapy) \\\\\n- \\(eGFR <60 mL / min / 1.73 m^{2}\\) at baseline\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- Prior anti-diabetic treatment (none, monotherapy, combination therapy) \\\\\nwas changed to: \\\\\nAdditional analyses will be explored in specific subgroups, e.g. depending on characteristics at baseline with respect to the primary and key secondary endpoints. Covariates that will be explored include: \\\\\n- Region (North America, Europe, Asia etc.) \\\\\n- Age (<65, \\(\\geq 65\\) years) \\\\\n- Systolic and diastolic blood pressure \\((\\leq 160\\) and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) ) \\\\\n- Gender (male, female) \\\\\n- Prior anti-diabetic treatment (none, monotherapy, combination therapy) \\\\\n- \\(eGFR <60 mL / min / 1.73 m^{2}\\) at baseline\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.3979516978142783,"confidence_rate":0.998346244924839},{"cnt":[[1064,342],[1621,342],[1621,381],[1064,381]],"region":{"top_left_x":1063,"top_left_y":342,"width":558,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d36087f5eb64bab9bf125241153f404","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"- Prior anti-diabetic treatment (none,","text_display":"- Prior anti-diabetic treatment (none,","confidence":1,"confidence_rate":1},{"cnt":[[1128,384],[1628,384],[1628,423],[1128,423]],"region":{"top_left_x":1128,"top_left_y":383,"width":500,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e8500b0261e48bbb52ad1e96663820d","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"monotherapy, combination therapy)","text_display":" monotherapy, combination therapy)","confidence":1,"confidence_rate":1},{"cnt":[[939,462],[1172,462],[1172,501],[939,501]],"region":{"top_left_x":939,"top_left_y":461,"width":233,"height":41},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a8fc48c8df34f1082161cc746042f36","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"was changed to:","text_display":"\nwas changed to:","confidence":1,"confidence_rate":1},{"cnt":[[939,503],[1609,503],[1609,543],[939,543]],"region":{"top_left_x":939,"top_left_y":503,"width":671,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2516bd0a749e45f69986a9f1f618bcf4","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"Additional analyses will be explored in specific","text_display":"\nAdditional analyses will be explored in specific","confidence":1,"confidence_rate":1},{"cnt":[[939,545],[1715,545],[1715,584],[939,584]],"region":{"top_left_x":939,"top_left_y":544,"width":777,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a6bfd1052e64c508d9da634dc745c5a","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"subgroups, e.g. depending on characteristics at baseline","text_display":" subgroups, e.g. depending on characteristics at baseline","confidence":1,"confidence_rate":1},{"cnt":[[939,584],[1738,584],[1738,623],[939,623]],"region":{"top_left_x":939,"top_left_y":583,"width":800,"height":41},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"255da8551af043a7a6c6f2bc24dee698","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"with respect to the primary and key secondary endpoints.","text_display":" with respect to the primary and key secondary endpoints.","confidence":1,"confidence_rate":1},{"cnt":[[939,623],[1508,623],[1508,665],[939,665]],"region":{"top_left_x":939,"top_left_y":623,"width":570,"height":42},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6374328173a541cc930d7859cc19286c","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"Covariates that will be explored include:","text_display":" Covariates that will be explored include:","confidence":1,"confidence_rate":1},{"cnt":[[1064,706],[1729,706],[1729,745],[1064,745]],"region":{"top_left_x":1063,"top_left_y":706,"width":667,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a4819d432a4430c945b08165d8f15ce","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"- Region (North America, Europe, Asia etc.)","text_display":"\n- Region (North America, Europe, Asia etc.)","confidence":1,"confidence_rate":1},{"cnt":[[1064,747],[1439,747],[1439,787],[1064,787]],"region":{"top_left_x":1063,"top_left_y":747,"width":377,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8eaeb8181f8410faa71bae61b122aab","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"- Age (<65, \\(\\geq 65\\) years)","text_display":"\n- Age (<65, \\(\\geq 65\\) years)","confidence":0.99609375,"confidence_rate":0.9998695451992631},{"cnt":[[1064,789],[1743,789],[1743,833],[1064,833]],"region":{"top_left_x":1063,"top_left_y":788,"width":680,"height":45},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a424b53171b48ddb28f4032051f796a","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"- Systolic and diastolic blood pressure \\((\\leq 160\\)","text_display":"\n- Systolic and diastolic blood pressure \\((\\leq 160\\)","confidence":0.69287109375,"confidence_rate":0.9925399792241109},{"cnt":[[1128,830],[1727,830],[1727,872],[1128,872]],"region":{"top_left_x":1128,"top_left_y":830,"width":599,"height":42},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b78043fd96fa41b1904f8cc22b9ada6c","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) )","text_display":" and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) )","confidence":0.9039797782897949,"confidence_rate":0.9978991206097682},{"cnt":[[1064,872],[1446,872],[1446,911],[1064,911]],"region":{"top_left_x":1063,"top_left_y":871,"width":383,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a95b904d74742d6a12f93d0ce408173","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"- Gender (male, female)","text_display":"\n- Gender (male, female)","confidence":1,"confidence_rate":1},{"cnt":[[1064,918],[1621,915],[1621,955],[1064,957]],"region":{"top_left_x":1063,"top_left_y":914,"width":558,"height":44},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b32a0b6afe8944f8b0d17d5455313622","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"- Prior anti-diabetic treatment (none,","text_display":"\n- Prior anti-diabetic treatment (none,","confidence":1,"confidence_rate":1},{"cnt":[[1128,955],[1632,955],[1632,994],[1128,994]],"region":{"top_left_x":1128,"top_left_y":954,"width":505,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"28026e379d2a4fc6a9f2f83e8b0ccbd9","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"monotherapy, combination therapy)","text_display":" monotherapy, combination therapy)","confidence":1,"confidence_rate":1},{"cnt":[[1064,992],[1688,992],[1688,1035],[1064,1035]],"region":{"top_left_x":1063,"top_left_y":991,"width":625,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42ba8425894d47cf8592debdd17acf1c","type":"text","conversion_output":false,"parent_id":"41260486658a47cabaa95b70a2b77f91","text":"- \\(eGFR <60 mL / min / 1.73 m^{2}\\) at baseline","text_display":"\n- \\(eGFR <60 mL / min / 1.73 m^{2}\\) at baseline","confidence":0.3979516978142783,"confidence_rate":0.9850081910853435},{"cnt":[[267,1061],[564,1061],[564,1100],[267,1100]],"region":{"top_left_x":267,"top_left_y":1060,"width":298,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56320400af934e72b7f6bc0bd2ed3cb5","type":"simple_cell","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"Rational for change","text_display":"Rational for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1056],[1748,1056],[1748,1183],[935,1183]],"region":{"top_left_x":934,"top_left_y":1055,"width":814,"height":128},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80ad3dcc0e9844429dce841cb2fffa86","type":"complex_cell","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","children_ids":["e312cdddc45d4b56a31f6b27a217e110","8f8ffe1eddce4ef086f159a9da20f4e6","e53f79714d384cfcaad725e65f04ec2c"],"text":"To reflect definitions regarding systolic and diastolic blood pressure subgroups in other outcome studies and to add a subgroup analysis reflecting the renal status.","text_display":"To reflect definitions regarding systolic and diastolic blood pressure subgroups in other outcome studies and to add a subgroup analysis reflecting the renal status.","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1061],[1683,1061],[1683,1100],[939,1100]],"region":{"top_left_x":939,"top_left_y":1060,"width":745,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e312cdddc45d4b56a31f6b27a217e110","type":"text","conversion_output":false,"parent_id":"80ad3dcc0e9844429dce841cb2fffa86","text":"To reflect definitions regarding systolic and diastolic","text_display":"To reflect definitions regarding systolic and diastolic","confidence":1,"confidence_rate":1},{"cnt":[[939,1100],[1745,1100],[1745,1141],[939,1141]],"region":{"top_left_x":939,"top_left_y":1099,"width":807,"height":43},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f8ffe1eddce4ef086f159a9da20f4e6","type":"text","conversion_output":false,"parent_id":"80ad3dcc0e9844429dce841cb2fffa86","text":"blood pressure subgroups in other outcome studies and to","text_display":" blood pressure subgroups in other outcome studies and to","confidence":1,"confidence_rate":1},{"cnt":[[939,1139],[1646,1139],[1646,1183],[939,1183]],"region":{"top_left_x":939,"top_left_y":1138,"width":708,"height":45},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e53f79714d384cfcaad725e65f04ec2c","type":"text","conversion_output":false,"parent_id":"80ad3dcc0e9844429dce841cb2fffa86","text":"add a subgroup analysis reflecting the renal status.","text_display":" add a subgroup analysis reflecting the renal status.","confidence":1,"confidence_rate":1},{"cnt":[[267,1185],[592,1185],[592,1224],[267,1224]],"region":{"top_left_x":267,"top_left_y":1184,"width":325,"height":41},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7635678e75c4673b47f45f08441ddea","type":"simple_cell","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1185],[1315,1185],[1315,1224],[939,1224]],"region":{"top_left_x":939,"top_left_y":1184,"width":376,"height":41},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eaa132c067f9404e9228030a1c73ba15","type":"simple_cell","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"7.3.2 Secondary analyses","text_display":"7.3.2 Secondary analyses","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,1231],[596,1231],[596,1275],[265,1275]],"region":{"top_left_x":264,"top_left_y":1230,"width":333,"height":45},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c93ea404cc8400aa322d853be917b46","type":"simple_cell","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1226],[1690,1226],[1690,1516],[935,1516]],"region":{"top_left_x":934,"top_left_y":1226,"width":756,"height":291},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6a07b36007c45ef99e639611dae59b1","type":"complex_cell","conversion_output":false,"parent_id":"93365fb1725f4010ba487d07c7d66c1e","children_ids":["58aa9ccb2bb747c9936751e0400dd634","2f810a9e8b7c4460b83c5fb977e41bf3","b4d83ebfd09342218b4561435a19fa42","13fe8e17f431435592095e80e1c82ed9","13b38f4780794077b85c830a1d585a3e","bf94f7085acb459e8905bd995c75259b"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nComposite renal endpoint (i.e. renal death, sustained ESRD, sustained loss of 50\\% or more in eGFR) \\\\\nwas changed into: \\\\\nComposite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nComposite renal endpoint (i.e. renal death, sustained ESRD, sustained loss of 50\\% or more in eGFR) \\\\\nwas changed into: \\\\\nComposite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR)\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.6710500717163086,"confidence_rate":0.9982423317138672},{"cnt":[[939,1231],[1089,1231],[1089,1270],[939,1270]],"region":{"top_left_x":939,"top_left_y":1230,"width":151,"height":41},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58aa9ccb2bb747c9936751e0400dd634","type":"text","conversion_output":false,"parent_id":"a6a07b36007c45ef99e639611dae59b1","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1272],[1678,1272],[1678,1312],[939,1312]],"region":{"top_left_x":939,"top_left_y":1272,"width":740,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f810a9e8b7c4460b83c5fb977e41bf3","type":"text","conversion_output":false,"parent_id":"a6a07b36007c45ef99e639611dae59b1","text":"Composite renal endpoint (i.e. renal death, sustained","text_display":"\nComposite renal endpoint (i.e. renal death, sustained","confidence":1,"confidence_rate":1},{"cnt":[[939,1312],[1619,1312],[1619,1353],[939,1353]],"region":{"top_left_x":939,"top_left_y":1311,"width":680,"height":43},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b4d83ebfd09342218b4561435a19fa42","type":"text","conversion_output":false,"parent_id":"a6a07b36007c45ef99e639611dae59b1","text":"ESRD, sustained loss of 50\\% or more in eGFR)","text_display":" ESRD, sustained loss of 50\\% or more in eGFR)","confidence":0.8624384077265859,"confidence_rate":0.9969843207323215},{"cnt":[[939,1392],[1200,1392],[1200,1431],[939,1431]],"region":{"top_left_x":939,"top_left_y":1392,"width":261,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13fe8e17f431435592095e80e1c82ed9","type":"text","conversion_output":false,"parent_id":"a6a07b36007c45ef99e639611dae59b1","text":"was changed into:","text_display":"\nwas changed into:","confidence":1,"confidence_rate":1},{"cnt":[[939,1431],[1678,1431],[1678,1473],[939,1473]],"region":{"top_left_x":939,"top_left_y":1431,"width":740,"height":42},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13b38f4780794077b85c830a1d585a3e","type":"text","conversion_output":false,"parent_id":"a6a07b36007c45ef99e639611dae59b1","text":"Composite renal endpoint (i.e. renal death, sustained","text_display":"\nComposite renal endpoint (i.e. renal death, sustained","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[939,1470],[1683,1470],[1683,1510],[939,1510]],"region":{"top_left_x":939,"top_left_y":1470,"width":745,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf94f7085acb459e8905bd995c75259b","type":"text","conversion_output":false,"parent_id":"a6a07b36007c45ef99e639611dae59b1","text":"ESRD, sustained decrease of 50\\% or more in eGFR)","text_display":" ESRD, sustained decrease of 50\\% or more in eGFR)","confidence":0.6710500717163086,"confidence_rate":0.9925016216720822},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f525efaa61024f65bdfc09d5149fdb18","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bc48e97a79d34d1c84872e53175f26b3","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5fcb365004fe41db9a07a3f01a85d7d8","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-097","page":97,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf674ca4fcd5473c949c321e75e7d6d3","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c7fa22caae14eb788359c018c8eedf0","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e7d146f7e5e4ce1b1464b99905fd937","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f183baafb2194a7a87ac0c8909d1bf00","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"097611d3494e4ce9b63f5d765d4d3e23","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca83a55e761e4e5395a3f66f3ca69da9","type":"page_info","conversion_output":false,"text":"Page 97 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2545],[244,2545]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2212},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a98e0a9852946d389bba05d4448ce89","type":"table","conversion_output":true,"children_ids":["5d276d1949b049ce91b63152d30ed53c","385ec2d0995f42e6950a39bcf30e23f0","b277b78926104a298814a943e77d2400","739e3863e3fb43608683699487cd8e13","8f902a911f6c4a0393bab28cec47e2c6","a8118153075d4e618edf1cbdeae84907","7b005f5176ab4801a6f9b6514597b5fc","33ab4735cbc84327986e81b51ff1c9b4","5af09588f4ad43d097890834665cab7c","34412481f7ef453aa2da4cae718c9eed","cc8bf9fa795b4558a30e2dbc4ce5a75d","1938696860744f00a5b95240f8b7fdee","2a4136257de449ce84d9bc54ca641d77","8725323f12da45508be9065e6c2ecadc","ea9a8c334714419aa7632a46a490c1a3","3d22e612f5804ef1b0f9b9e07b1dc01a","373494adfe434fb891476c30675eba79","e50c52ca40534c4186f4ff7eabda2b11","344a54512b3c404f870e9b2905b70fd0","5acff15fab784a4c83d0da8635d9b9ec","5ea9e7c3f9ae4fddaa38365bf46bb729","915d073365bc4135b006876e8bc07ecf","76c10932188a41d4b462ab4efb1d64b8","ecdb2d8d765a429b888707d857655616","183451c470b7456a826fef0bb232164a"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nwas changed into: \\\\\nComposite microvascular outcome (50\\% decrease or more in eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nChange 5: \\\\\nClopper and Pearson confidence intervals was changed into: Wilson confidence intervals. \\\\\nChange 6: \\\\\nThe following text was deleted: \\\\\nPatients without occurrence of a specific endpoint will be considered censored at the end of study or lost to followup, whichever comes first. \\\\\nChange 7: \\\\\nLast paragraph: secondary was changed into: key secondary.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 3: \\\\\nFor clarification. \\\\\nChange 4: \\\\\nTo use consistent terminology. \\\\\nChange 5: \\\\\nWilson confidence intervals are less conservative. \\\\\nChange 6: \\\\\nCensoring has been addressed more specifically in section 7.1. \\\\\nChange7: \\\\\nFor clarification/consistency\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.3.7 Pharmacogenomic analyses \\\\\n\\hline Description of change & Not specified in this protocol was changed into: No prespecified pharmacogenomics analyses planned. \\\\\n\\hline Rationale for change & To allow possible retrospective pharmacogenetic analyses. \\\\\n\\hline Section to be changed & 8.3.1 Source documents \\\\\n\\hline Description of change & The following text was added: All possible attempts should be made to collect source documents for events that trigger adjudication. \\\\\n\\hline Rationale for change & To emphasise the importance of source documents for adjudication of events. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nwas changed into: \\\\\nComposite microvascular outcome (50\\% decrease or more in eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nChange 5: \\\\\nClopper and Pearson confidence intervals was changed into: Wilson confidence intervals. \\\\\nChange 6: \\\\\nThe following text was deleted: \\\\\nPatients without occurrence of a specific endpoint will be considered censored at the end of study or lost to followup, whichever comes first. \\\\\nChange 7: \\\\\nLast paragraph: secondary was changed into: key secondary.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 3: \\\\\nFor clarification. \\\\\nChange 4: \\\\\nTo use consistent terminology. \\\\\nChange 5: \\\\\nWilson confidence intervals are less conservative. \\\\\nChange 6: \\\\\nCensoring has been addressed more specifically in section 7.1. \\\\\nChange7: \\\\\nFor clarification/consistency\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.3.7 Pharmacogenomic analyses \\\\\n\\hline Description of change & Not specified in this protocol was changed into: No prespecified pharmacogenomics analyses planned. \\\\\n\\hline Rationale for change & To allow possible retrospective pharmacogenetic analyses. \\\\\n\\hline Section to be changed & 8.3.1 Source documents \\\\\n\\hline Description of change & The following text was added: All possible attempts should be made to collect source documents for events that trigger adjudication. \\\\\n\\hline Rationale for change & To emphasise the importance of source documents for adjudication of events. \\\\\n\\hline\n\\end{tabular}","confidence":0.94580078125,"confidence_rate":0.9999725009308649},{"cnt":[[251,333],[603,333],[603,2546],[251,2546]],"region":{"top_left_x":250,"top_left_y":333,"width":354,"height":2213},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d276d1949b049ce91b63152d30ed53c","type":"table_column","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[930,333],[1761,333],[1761,2546],[930,2546]],"region":{"top_left_x":930,"top_left_y":333,"width":832,"height":2213},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"385ec2d0995f42e6950a39bcf30e23f0","type":"table_column","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[244,333],[1775,333],[1775,1111],[244,1111]],"region":{"top_left_x":244,"top_left_y":333,"width":1532,"height":779},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b277b78926104a298814a943e77d2400","type":"table_row","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[244,1118],[1775,1118],[1775,2048],[244,2048]],"region":{"top_left_x":244,"top_left_y":1118,"width":1532,"height":931},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"739e3863e3fb43608683699487cd8e13","type":"table_row","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[244,2041],[1775,2041],[1775,2090],[244,2090]],"region":{"top_left_x":244,"top_left_y":2041,"width":1532,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f902a911f6c4a0393bab28cec47e2c6","type":"table_row","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[244,2088],[1775,2088],[1775,2182],[244,2182]],"region":{"top_left_x":244,"top_left_y":2087,"width":1532,"height":95},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8118153075d4e618edf1cbdeae84907","type":"table_row","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[244,2177],[1775,2177],[1775,2269],[244,2269]],"region":{"top_left_x":244,"top_left_y":2177,"width":1532,"height":93},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b005f5176ab4801a6f9b6514597b5fc","type":"table_row","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[244,2269],[1775,2269],[1775,2318],[244,2318]],"region":{"top_left_x":244,"top_left_y":2269,"width":1532,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"33ab4735cbc84327986e81b51ff1c9b4","type":"table_row","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[244,2322],[1775,2322],[1775,2449],[244,2449]],"region":{"top_left_x":244,"top_left_y":2322,"width":1532,"height":128},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5af09588f4ad43d097890834665cab7c","type":"table_row","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[244,2444],[1775,2440],[1775,2536],[244,2540]],"region":{"top_left_x":243,"top_left_y":2440,"width":1533,"height":101},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34412481f7ef453aa2da4cae718c9eed","type":"table_row","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"","text_display":""},{"cnt":[[935,338],[1750,338],[1750,1104],[935,1104]],"region":{"top_left_x":934,"top_left_y":337,"width":816,"height":768},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","type":"complex_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","children_ids":["bce65f9c61e9464c8d446e7491a85ce7","de7f0087175e45e9ac17a72903d81c3b","6ed75944711e49afbde274d791864ff8","b3d78c34864243b7b1ca03d007d4ef67","10568e0a7e8a45c8a1bb75b8df58a791","878eb757ed1545319334542c0b36f3a0","123e6606e04b4dff902d77e22bc2cd28","f5a68b78c3994413ab09f0e6f870b9c1","5c865fc1dc034e2daf0cdb5622c67aaf","b235128e6dc54b37babecf08ac21c48a","496a32b6a491477e813af887772183e3","f6fdd3e3cb53462ca0451706e6cbf8fd","d25e4355c0a942ffa421467b11bffe43","d001d8d868b74f97ad033cd41e05e0b1","cd6d4cd071724b58bb0bfac4cc3d42c4","996587da999f4333a28ec3d0f755701b","f7879742593c412babb48537b488f886"],"text":"\\begin{tabular}{l}\nwas changed into: \\\\\nComposite microvascular outcome (50\\% decrease or more in eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nChange 5: \\\\\nClopper and Pearson confidence intervals was changed into: Wilson confidence intervals. \\\\\nChange 6: \\\\\nThe following text was deleted: \\\\\nPatients without occurrence of a specific endpoint will be considered censored at the end of study or lost to followup, whichever comes first. \\\\\nChange 7: \\\\\nLast paragraph: secondary was changed into: key secondary.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nwas changed into: \\\\\nComposite microvascular outcome (50\\% decrease or more in eGFR, albuminuria progression, requirement for renal replacement therapy or death due to renal failure, use of retinal photocoagulation or intravitreal injections of an anti-VEGF therapy for diabetic retinopathy). \\\\\nChange 5: \\\\\nClopper and Pearson confidence intervals was changed into: Wilson confidence intervals. \\\\\nChange 6: \\\\\nThe following text was deleted: \\\\\nPatients without occurrence of a specific endpoint will be considered censored at the end of study or lost to followup, whichever comes first. \\\\\nChange 7: \\\\\nLast paragraph: secondary was changed into: key secondary.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990236759185791,"confidence_rate":0.9999970454225968},{"cnt":[[939,342],[1200,342],[1200,381],[939,381]],"region":{"top_left_x":939,"top_left_y":342,"width":261,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bce65f9c61e9464c8d446e7491a85ce7","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"was changed into:","text_display":"was changed into:","confidence":0.99951171875,"confidence_rate":0.9999778002237774},{"cnt":[[939,381],[1683,381],[1683,418],[939,418]],"region":{"top_left_x":939,"top_left_y":381,"width":745,"height":38},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de7f0087175e45e9ac17a72903d81c3b","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"Composite microvascular outcome (50\\% decrease or","text_display":"\nComposite microvascular outcome (50\\% decrease or","confidence":1,"confidence_rate":1},{"cnt":[[939,420],[1738,420],[1738,460],[939,460]],"region":{"top_left_x":939,"top_left_y":420,"width":800,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ed75944711e49afbde274d791864ff8","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"more in eGFR, albuminuria progression, requirement for","text_display":" more in eGFR, albuminuria progression, requirement for","confidence":1,"confidence_rate":1},{"cnt":[[939,462],[1708,462],[1708,501],[939,501]],"region":{"top_left_x":939,"top_left_y":461,"width":770,"height":41},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3d78c34864243b7b1ca03d007d4ef67","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"renal replacement therapy or death due to renal failure,","text_display":" renal replacement therapy or death due to renal failure,","confidence":1,"confidence_rate":1},{"cnt":[[939,501],[1720,501],[1720,540],[939,540]],"region":{"top_left_x":939,"top_left_y":501,"width":781,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10568e0a7e8a45c8a1bb75b8df58a791","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"use of retinal photocoagulation or intravitreal injections","text_display":" use of retinal photocoagulation or intravitreal injections","confidence":1,"confidence_rate":1},{"cnt":[[939,540],[1646,540],[1646,579],[939,579]],"region":{"top_left_x":939,"top_left_y":540,"width":708,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"878eb757ed1545319334542c0b36f3a0","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"of an anti-VEGF therapy for diabetic retinopathy).","text_display":" of an anti-VEGF therapy for diabetic retinopathy).","confidence":1,"confidence_rate":1},{"cnt":[[939,600],[1089,600],[1089,639],[939,639]],"region":{"top_left_x":939,"top_left_y":600,"width":151,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"123e6606e04b4dff902d77e22bc2cd28","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"Change 5:","text_display":"\nChange 5:","confidence":1,"confidence_rate":1},{"cnt":[[939,642],[1725,642],[1725,681],[939,681]],"region":{"top_left_x":939,"top_left_y":641,"width":786,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5a68b78c3994413ab09f0e6f870b9c1","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"Clopper and Pearson confidence intervals was changed","text_display":"\nClopper and Pearson confidence intervals was changed","confidence":1,"confidence_rate":1},{"cnt":[[939,683],[1416,683],[1416,718],[939,718]],"region":{"top_left_x":939,"top_left_y":682,"width":477,"height":36},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c865fc1dc034e2daf0cdb5622c67aaf","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"into: Wilson confidence intervals.","text_display":" into: Wilson confidence intervals.","confidence":0.99951171875,"confidence_rate":0.9999874769887185},{"cnt":[[939,743],[1089,743],[1089,782],[939,782]],"region":{"top_left_x":939,"top_left_y":742,"width":151,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b235128e6dc54b37babecf08ac21c48a","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"Change 6:","text_display":"\nChange 6:","confidence":1,"confidence_rate":1},{"cnt":[[939,784],[1384,784],[1384,821],[939,821]],"region":{"top_left_x":939,"top_left_y":784,"width":445,"height":38},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"496a32b6a491477e813af887772183e3","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"The following text was deleted:","text_display":"\nThe following text was deleted:","confidence":1,"confidence_rate":1},{"cnt":[[939,821],[1743,821],[1743,860],[939,860]],"region":{"top_left_x":939,"top_left_y":821,"width":804,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6fdd3e3cb53462ca0451706e6cbf8fd","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"Patients without occurrence of a specific endpoint will be","text_display":"\nPatients without occurrence of a specific endpoint will be","confidence":0.9990236759185791,"confidence_rate":0.9999844953424807},{"cnt":[[939,863],[1738,863],[1738,902],[939,902]],"region":{"top_left_x":939,"top_left_y":862,"width":800,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d25e4355c0a942ffa421467b11bffe43","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"considered censored at the end of study or lost to follow-","text_display":" considered censored at the end of study or lost to follow","confidence":1,"confidence_rate":1},{"cnt":[[939,904],[1310,904],[1310,943],[939,943]],"region":{"top_left_x":939,"top_left_y":904,"width":372,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d001d8d868b74f97ad033cd41e05e0b1","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"up, whichever comes first.","text_display":"up, whichever comes first.","confidence":1,"confidence_rate":1},{"cnt":[[939,982],[1084,982],[1084,1021],[939,1021]],"region":{"top_left_x":939,"top_left_y":982,"width":146,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd6d4cd071724b58bb0bfac4cc3d42c4","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"Change 7:","text_display":"\nChange 7:","confidence":1,"confidence_rate":1},{"cnt":[[939,1024],[1635,1024],[1635,1063],[939,1063]],"region":{"top_left_x":939,"top_left_y":1023,"width":696,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"996587da999f4333a28ec3d0f755701b","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"Last paragraph: secondary was changed into: key","text_display":"\nLast paragraph: secondary was changed into: key","confidence":1,"confidence_rate":1},{"cnt":[[939,1065],[1094,1065],[1094,1100],[939,1100]],"region":{"top_left_x":939,"top_left_y":1065,"width":155,"height":35},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7879742593c412babb48537b488f886","type":"text","conversion_output":false,"parent_id":"cc8bf9fa795b4558a30e2dbc4ce5a75d","text":"secondary.","text_display":" secondary.","confidence":1,"confidence_rate":1},{"cnt":[[267,1125],[580,1125],[580,1164],[267,1164]],"region":{"top_left_x":267,"top_left_y":1125,"width":314,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1938696860744f00a5b95240f8b7fdee","type":"simple_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1443],[1653,1443],[1653,2044],[935,2044]],"region":{"top_left_x":934,"top_left_y":1442,"width":720,"height":602},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a4136257de449ce84d9bc54ca641d77","type":"complex_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","children_ids":["3edd7bcc21ff402195fa7c4092bae941","dc9f364baa1441a7a52ece026fd41cdd","3baae739f63d4bdca46c5aee7cc21324","251cb0f51b6c49ad878d427aa894c089","2fddb632e04a459c97773dcf18077a30","5db4c153a5574c9da083d0eb755be8d6","678d7e8585ef40ae9b0f0b0a208bd99a","5caf7d10dd4d4898a3e9708cbbbc5cff","f271fa2aa229432193e83836c593869b","3c1cad12fbbc40659228f37fbd381220","51063be265d643f5a27eeed8412eae8d"],"text":"\\begin{tabular}{l}\nChange 3: \\\\\nFor clarification. \\\\\nChange 4: \\\\\nTo use consistent terminology. \\\\\nChange 5: \\\\\nWilson confidence intervals are less conservative. \\\\\nChange 6: \\\\\nCensoring has been addressed more specifically in section 7.1. \\\\\nChange7: \\\\\nFor clarification/consistency\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 3: \\\\\nFor clarification. \\\\\nChange 4: \\\\\nTo use consistent terminology. \\\\\nChange 5: \\\\\nWilson confidence intervals are less conservative. \\\\\nChange 6: \\\\\nCensoring has been addressed more specifically in section 7.1. \\\\\nChange7: \\\\\nFor clarification/consistency\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.94580078125,"confidence_rate":0.9995945483736528},{"cnt":[[939,1443],[1084,1443],[1084,1482],[939,1482]],"region":{"top_left_x":939,"top_left_y":1442,"width":146,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3edd7bcc21ff402195fa7c4092bae941","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"Change 3:","text_display":"Change 3:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[939,1484],[1177,1484],[1177,1519],[939,1519]],"region":{"top_left_x":939,"top_left_y":1484,"width":238,"height":35},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc9f364baa1441a7a52ece026fd41cdd","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"For clarification.","text_display":"\nFor clarification.","confidence":1,"confidence_rate":1},{"cnt":[[939,1563],[1084,1563],[1084,1606],[939,1606]],"region":{"top_left_x":939,"top_left_y":1562,"width":146,"height":45},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3baae739f63d4bdca46c5aee7cc21324","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"Change 4:","text_display":"\nChange 4:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[939,1604],[1372,1604],[1372,1643],[939,1643]],"region":{"top_left_x":939,"top_left_y":1603,"width":434,"height":41},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"251cb0f51b6c49ad878d427aa894c089","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"To use consistent terminology.","text_display":"\nTo use consistent terminology.","confidence":1,"confidence_rate":1},{"cnt":[[939,1685],[1089,1685],[1089,1726],[939,1726]],"region":{"top_left_x":939,"top_left_y":1684,"width":151,"height":43},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fddb632e04a459c97773dcf18077a30","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"Change 5:","text_display":"\nChange 5:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1724],[1637,1724],[1637,1758],[939,1758]],"region":{"top_left_x":939,"top_left_y":1723,"width":699,"height":36},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5db4c153a5574c9da083d0eb755be8d6","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"Wilson confidence intervals are less conservative.","text_display":"\nWilson confidence intervals are less conservative.","confidence":1,"confidence_rate":1},{"cnt":[[939,1802],[1089,1802],[1089,1841],[939,1841]],"region":{"top_left_x":939,"top_left_y":1801,"width":151,"height":41},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"678d7e8585ef40ae9b0f0b0a208bd99a","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"Change 6:","text_display":"\nChange 6:","confidence":1,"confidence_rate":1},{"cnt":[[939,1843],[1646,1843],[1646,1883],[939,1883]],"region":{"top_left_x":939,"top_left_y":1843,"width":708,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5caf7d10dd4d4898a3e9708cbbbc5cff","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"Censoring has been addressed more specifically in","text_display":"\nCensoring has been addressed more specifically in","confidence":1,"confidence_rate":1},{"cnt":[[939,1885],[1103,1885],[1103,1919],[939,1919]],"region":{"top_left_x":939,"top_left_y":1884,"width":164,"height":36},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f271fa2aa229432193e83836c593869b","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"section 7.1.","text_display":" section 7.1.","confidence":1,"confidence_rate":1},{"cnt":[[939,1963],[1080,1963],[1080,2002],[939,2002]],"region":{"top_left_x":939,"top_left_y":1963,"width":141,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c1cad12fbbc40659228f37fbd381220","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"Change7:","text_display":"\nChange7:","confidence":0.94580078125,"confidence_rate":0.995722764098597},{"cnt":[[939,2005],[1342,2005],[1342,2044],[939,2044]],"region":{"top_left_x":939,"top_left_y":2004,"width":404,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51063be265d643f5a27eeed8412eae8d","type":"text","conversion_output":false,"parent_id":"2a4136257de449ce84d9bc54ca641d77","text":"For clarification/consistency","text_display":"\nFor clarification/consistency","confidence":1,"confidence_rate":1},{"cnt":[[267,2046],[592,2046],[592,2085],[267,2085]],"region":{"top_left_x":267,"top_left_y":2046,"width":325,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8725323f12da45508be9065e6c2ecadc","type":"simple_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2046],[1430,2046],[1430,2085],[939,2085]],"region":{"top_left_x":939,"top_left_y":2046,"width":491,"height":40},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea9a8c334714419aa7632a46a490c1a3","type":"simple_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"7.3.7 Pharmacogenomic analyses","text_display":"7.3.7 Pharmacogenomic analyses","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2097],[596,2097],[596,2136],[267,2136]],"region":{"top_left_x":267,"top_left_y":2096,"width":330,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d22e612f5804ef1b0f9b9e07b1dc01a","type":"simple_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,2094],[1731,2094],[1731,2173],[937,2173]],"region":{"top_left_x":937,"top_left_y":2094,"width":795,"height":79},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"373494adfe434fb891476c30675eba79","type":"complex_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","children_ids":["37a6a971b40b4591a36f9163454c38a1","98581f8efa614a7dacb82d86526599c2"],"text":"Not specified in this protocol was changed into: No prespecified pharmacogenomics analyses planned.","text_display":"Not specified in this protocol was changed into: No prespecified pharmacogenomics analyses planned.","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999959967252418},{"cnt":[[939,2097],[1729,2097],[1729,2136],[939,2136]],"region":{"top_left_x":939,"top_left_y":2096,"width":791,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37a6a971b40b4591a36f9163454c38a1","type":"text","conversion_output":false,"parent_id":"373494adfe434fb891476c30675eba79","text":"Not specified in this protocol was changed into: No pre-","text_display":"Not specified in this protocol was changed into: No pre","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[939,2134],[1600,2134],[1600,2173],[939,2173]],"region":{"top_left_x":939,"top_left_y":2133,"width":662,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98581f8efa614a7dacb82d86526599c2","type":"text","conversion_output":false,"parent_id":"373494adfe434fb891476c30675eba79","text":"specified pharmacogenomics analyses planned.","text_display":"specified pharmacogenomics analyses planned.","confidence":1,"confidence_rate":1},{"cnt":[[267,2184],[580,2184],[580,2223],[267,2223]],"region":{"top_left_x":267,"top_left_y":2184,"width":314,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e50c52ca40534c4186f4ff7eabda2b11","type":"simple_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"Rationale for change","text_display":"Rationale for change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2182],[1628,2182],[1628,2265],[939,2265]],"region":{"top_left_x":939,"top_left_y":2181,"width":689,"height":84},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"344a54512b3c404f870e9b2905b70fd0","type":"complex_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","children_ids":["90ad107461b94ba09a6c3b69a6859e64","29b389e3087b44aea34a3fa6fe5beff1"],"text":"To allow possible retrospective pharmacogenetic analyses.","text_display":"To allow possible retrospective pharmacogenetic analyses.","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2184],[1628,2184],[1628,2223],[939,2223]],"region":{"top_left_x":939,"top_left_y":2184,"width":689,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90ad107461b94ba09a6c3b69a6859e64","type":"text","conversion_output":false,"parent_id":"344a54512b3c404f870e9b2905b70fd0","text":"To allow possible retrospective pharmacogenetic","text_display":"To allow possible retrospective pharmacogenetic","confidence":1,"confidence_rate":1},{"cnt":[[939,2226],[1071,2226],[1071,2262],[939,2262]],"region":{"top_left_x":939,"top_left_y":2225,"width":132,"height":38},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29b389e3087b44aea34a3fa6fe5beff1","type":"text","conversion_output":false,"parent_id":"344a54512b3c404f870e9b2905b70fd0","text":"analyses.","text_display":" analyses.","confidence":1,"confidence_rate":1},{"cnt":[[267,2276],[592,2276],[592,2313],[267,2313]],"region":{"top_left_x":267,"top_left_y":2276,"width":325,"height":38},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5acff15fab784a4c83d0da8635d9b9ec","type":"simple_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"Section to be changed","text_display":"Section to be changed","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2276],[1296,2276],[1296,2306],[939,2306]],"region":{"top_left_x":939,"top_left_y":2276,"width":358,"height":31},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ea9e7c3f9ae4fddaa38365bf46bb729","type":"simple_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"8.3.1 Source documents","text_display":"8.3.1 Source documents","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2327],[592,2327],[592,2366],[267,2366]],"region":{"top_left_x":267,"top_left_y":2326,"width":325,"height":41},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"915d073365bc4135b006876e8bc07ecf","type":"simple_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"Description of change","text_display":"Description of change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,2327],[1708,2327],[1708,2449],[937,2449]],"region":{"top_left_x":937,"top_left_y":2326,"width":772,"height":124},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76c10932188a41d4b462ab4efb1d64b8","type":"complex_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","children_ids":["6629cb4ceb61403d93b59580500fe897","26113ed90b4e44d38ec08e99c24d4bbe","e6c7ee5090354d5d89da6d4b12fabe4a"],"text":"The following text was added: All possible attempts should be made to collect source documents for events that trigger adjudication.","text_display":"The following text was added: All possible attempts should be made to collect source documents for events that trigger adjudication.","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2327],[1669,2327],[1669,2366],[939,2366]],"region":{"top_left_x":939,"top_left_y":2326,"width":731,"height":41},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6629cb4ceb61403d93b59580500fe897","type":"text","conversion_output":false,"parent_id":"76c10932188a41d4b462ab4efb1d64b8","text":"The following text was added: All possible attempts","text_display":"The following text was added: All possible attempts","confidence":1,"confidence_rate":1},{"cnt":[[939,2368],[1706,2368],[1706,2403],[939,2403]],"region":{"top_left_x":939,"top_left_y":2368,"width":768,"height":35},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"26113ed90b4e44d38ec08e99c24d4bbe","type":"text","conversion_output":false,"parent_id":"76c10932188a41d4b462ab4efb1d64b8","text":"should be made to collect source documents for events","text_display":" should be made to collect source documents for events","confidence":1,"confidence_rate":1},{"cnt":[[939,2405],[1287,2405],[1287,2444],[939,2444]],"region":{"top_left_x":939,"top_left_y":2405,"width":349,"height":40},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e6c7ee5090354d5d89da6d4b12fabe4a","type":"text","conversion_output":false,"parent_id":"76c10932188a41d4b462ab4efb1d64b8","text":"that trigger adjudication.","text_display":" that trigger adjudication.","confidence":1,"confidence_rate":1},{"cnt":[[267,2447],[580,2447],[580,2490],[267,2490]],"region":{"top_left_x":267,"top_left_y":2446,"width":314,"height":45},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecdb2d8d765a429b888707d857655616","type":"simple_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","text":"Rationale for change","text_display":"Rationale for change","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2447],[1701,2447],[1701,2532],[935,2532]],"region":{"top_left_x":934,"top_left_y":2446,"width":768,"height":86},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"183451c470b7456a826fef0bb232164a","type":"complex_cell","conversion_output":false,"parent_id":"0a98e0a9852946d389bba05d4448ce89","children_ids":["280c858e5631443d98d16891b7bd7dfd","3c2b6ee381514ca9a11a358e0515c7f0"],"text":"To emphasise the importance of source documents for adjudication of events.","text_display":"To emphasise the importance of source documents for adjudication of events.","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2447],[1701,2447],[1701,2486],[939,2486]],"region":{"top_left_x":939,"top_left_y":2446,"width":763,"height":40},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"280c858e5631443d98d16891b7bd7dfd","type":"text","conversion_output":false,"parent_id":"183451c470b7456a826fef0bb232164a","text":"To emphasise the importance of source documents for","text_display":"To emphasise the importance of source documents for","confidence":1,"confidence_rate":1},{"cnt":[[939,2488],[1259,2488],[1259,2527],[939,2527]],"region":{"top_left_x":939,"top_left_y":2488,"width":321,"height":40},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c2b6ee381514ca9a11a358e0515c7f0","type":"text","conversion_output":false,"parent_id":"183451c470b7456a826fef0bb232164a","text":"adjudication of events.","text_display":" adjudication of events.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":70,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2f640b4b76894e7d804aa903526d8f48","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[288,2620],[1798,2620],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2620,"width":1511,"height":42},"line":71,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"deec6abe910d4b76aa47ba49b9d0d050","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.97900390625,"confidence_rate":0.9998216995409567},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":72,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d3e2cf09187d4fdc8c7014df7e09243e","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-098","page":98,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5113ab46cb74d03be6e025030818475","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c19ba05def0e4ddfa29ae7254764d714","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7cfffda5e454cfeb78f24a6887e297d","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73164ec095db4d7dbdf1823b6e2237d4","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2102ba8722b045aea1e7aab43c9865c7","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1574,210],[1816,210],[1816,254],[1574,254]],"region":{"top_left_x":1573,"top_left_y":210,"width":244,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84b9bbf505a147e29db74e7390e80738","type":"page_info","conversion_output":false,"text":"Page 98 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2558],[244,2558]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2226},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f5fb7a61fd6464ab45990df93244745","type":"table","conversion_output":true,"children_ids":["7fd2a7622bfc4166815e5efe1b3b1917","62613e6f66e74f7ab2ed3d9e678b8c16","9320dcc215174664810baf05ab52e8cc","51c6f9fc48c14d82b4f4b0cfd3e1f39f","1d51bf338d164d9cb1213dbb84dca1a9","730641a4bf6640f5a4eaa91b69dc8622","bdce8ff099354de6b18d0a72b0e68cce","6f7b12e0051d4f9a9b2d36ec8469731c","897d58c1d0564ba6850f8453d1ef4583","d1535b786c4c4bc3b8c478b5344c615c","04f471456abc43569418f6773a3043e0","69b22b3d16f3414a9ade92962ca55390","176262c99f034d74a2ad43806d4bc635","c6c239a344484fc7a673aa73602e99fd","5e5ad3c30ce543fab1ba7ade7543fc37","e37cc21cecdd4b5faa668a45dba7c2ab","6c061d42c7284c778d31a54ab1e099a9","b091662c22794277bbb1d817a16fd301","7494d37c30cd4faa83cef582d8585652","9ac268320b8644fc88ef358da18db987","4b89f4fe24044303857243d4fbe1a936","7ee145ed62544499bd28d60030b97131","5cda1ed65aa045c4987abd92702e0212","8f70c3b0bc804caa91bb3790672765c9","6c378fdc0b82419d83468def47dbad10","b6e050fc572e4c89bf64047f551a83ea","25a659f006094a43a06ed1b87c75e9e4","6a6762a1d300409794989c4607f20ebb","024293df374b4adca12c3143d576ed75","e4b097cfca904f8685bb27174d957ffb","fa49b15c2e834745bf8d03848b443be9","8ceb2066f0514bd1b5e4ec69f593f042","02a55b77f80246019e24e23ec9d44466","00ab21e435c64329aed4dd5885a15551","bbfed644aa304189a05c88495952e65f","10c4ce28bfe543a3ab3d1faba1b380cc","a6ae13f1abc3499b9f2f8d4da2e016a0","528337b062ca4960be33a3fbd83209b7","ed0b007e2ec74dfbbbcbec33bd3add59","356207b3cb7142728c593a715c0250ec","f671e856c62e4bbaad097be648dd4dfe","f90f722f95c54c97a6088c289046fdc6","843b87a45f7044c2af6f983071f7e906","69ae748557ce4aeeba71f85552ec5f6f","8a1360e8f09f430ea5b7ca8d613cf700","01da7ac27d7d44b9bfce2ed5d03946a7"],"text":"\\begin{tabular}{|l|l|}\n\\hline Number of CTP modification & 2 \\\\\n\\hline Date of CTP modification & 22 November 2016 \\\\\n\\hline EudraCT number & 2011-004148-23 \\\\\n\\hline BI Trial number & 1218.22 \\\\\n\\hline BI Investigational Product(s) & Linagliptin (BI 1356) \\\\\n\\hline Title of protocol & A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline To be implemented only after approval of the IRB/IEC/Competent Authorities & ![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-098.jpg?height=51\\&width=52\\&top_left_y=927\\&top_left_x=943) \\\\\n\\hline To be implemented immediately in order to eliminate hazard IRB / IEC / Competent Authority to be notified of change with request for approval & □ \\\\\n\\hline Can be implemented without IRB/IEC/ Competent Authority approval as changes involve logistical or administrative aspects only & □ \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline Section to be changed & \\multirow[t]{4}{*}{\\begin{tabular}{l}\nTitle page \\\\\nadded as TCM \\\\\nadded as TCM\n\\end{tabular}} \\\\\n\\hline Description of change & \\\\\n\\hline Rationale for change & \\\\\n\\hline Section to be changed & \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nChange 2: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Number of CTP modification & 2 \\\\\n\\hline Date of CTP modification & 22 November 2016 \\\\\n\\hline EudraCT number & 2011-004148-23 \\\\\n\\hline BI Trial number & 1218.22 \\\\\n\\hline BI Investigational Product(s) & Linagliptin (BI 1356) \\\\\n\\hline Title of protocol & A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline To be implemented only after approval of the IRB/IEC/Competent Authorities & ![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-098.jpg?height=51\\&width=52\\&top_left_y=927\\&top_left_x=943) \\\\\n\\hline To be implemented immediately in order to eliminate hazard IRB / IEC / Competent Authority to be notified of change with request for approval & □ \\\\\n\\hline Can be implemented without IRB/IEC/ Competent Authority approval as changes involve logistical or administrative aspects only & □ \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline Section to be changed & \\multirow[t]{4}{*}{\\begin{tabular}{l}\nTitle page \\\\\nadded as TCM \\\\\nadded as TCM\n\\end{tabular}} \\\\\n\\hline Description of change & \\\\\n\\hline Rationale for change & \\\\\n\\hline Section to be changed & \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nChange 2: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0,"confidence_rate":0},{"cnt":[[253,333],[822,333],[822,2560],[253,2560]],"region":{"top_left_x":253,"top_left_y":333,"width":569,"height":2227},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fd2a7622bfc4166815e5efe1b3b1917","type":"table_column","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[930,333],[1759,333],[1759,2560],[930,2560]],"region":{"top_left_x":930,"top_left_y":333,"width":830,"height":2227},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"62613e6f66e74f7ab2ed3d9e678b8c16","type":"table_column","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,338],[1775,338],[1775,386],[244,386]],"region":{"top_left_x":244,"top_left_y":337,"width":1532,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9320dcc215174664810baf05ab52e8cc","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,388],[1775,388],[1775,434],[244,434]],"region":{"top_left_x":244,"top_left_y":388,"width":1532,"height":47},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51c6f9fc48c14d82b4f4b0cfd3e1f39f","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,439],[1775,439],[1775,485],[244,485]],"region":{"top_left_x":244,"top_left_y":438,"width":1532,"height":47},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d51bf338d164d9cb1213dbb84dca1a9","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,487],[1775,487],[1775,538],[244,538]],"region":{"top_left_x":244,"top_left_y":487,"width":1532,"height":51},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"730641a4bf6640f5a4eaa91b69dc8622","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,538],[1775,538],[1775,593],[244,593]],"region":{"top_left_x":244,"top_left_y":537,"width":1532,"height":57},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bdce8ff099354de6b18d0a72b0e68cce","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,584],[1775,584],[1775,881],[244,881]],"region":{"top_left_x":244,"top_left_y":583,"width":1532,"height":298},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f7b12e0051d4f9a9b2d36ec8469731c","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,872],[1775,872],[1775,927],[244,927]],"region":{"top_left_x":244,"top_left_y":871,"width":1532,"height":57},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"897d58c1d0564ba6850f8453d1ef4583","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,922],[1775,922],[1775,1118],[244,1118]],"region":{"top_left_x":244,"top_left_y":922,"width":1532,"height":197},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1535b786c4c4bc3b8c478b5344c615c","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,1116],[1775,1116],[1775,1464],[244,1464]],"region":{"top_left_x":244,"top_left_y":1115,"width":1532,"height":349},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04f471456abc43569418f6773a3043e0","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,1452],[1775,1452],[1775,1708],[244,1708]],"region":{"top_left_x":244,"top_left_y":1452,"width":1532,"height":256},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69b22b3d16f3414a9ade92962ca55390","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,1698],[1775,1698],[1775,1747],[244,1747]],"region":{"top_left_x":244,"top_left_y":1698,"width":1532,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"176262c99f034d74a2ad43806d4bc635","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,1744],[1775,1744],[1775,1797],[244,1797]],"region":{"top_left_x":244,"top_left_y":1744,"width":1532,"height":54},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6c239a344484fc7a673aa73602e99fd","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,1795],[1775,1795],[1775,1850],[244,1850]],"region":{"top_left_x":244,"top_left_y":1795,"width":1532,"height":56},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e5ad3c30ce543fab1ba7ade7543fc37","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,1846],[1775,1846],[1775,1901],[244,1901]],"region":{"top_left_x":244,"top_left_y":1845,"width":1532,"height":57},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e37cc21cecdd4b5faa668a45dba7c2ab","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,1899],[1775,1899],[1775,1952],[244,1952]],"region":{"top_left_x":244,"top_left_y":1898,"width":1532,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c061d42c7284c778d31a54ab1e099a9","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[244,1947],[1775,1947],[1775,2560],[244,2560]],"region":{"top_left_x":244,"top_left_y":1947,"width":1532,"height":613},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b091662c22794277bbb1d817a16fd301","type":"table_row","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":""},{"cnt":[[262,342],[792,342],[792,384],[262,384]],"region":{"top_left_x":262,"top_left_y":342,"width":530,"height":42},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7494d37c30cd4faa83cef582d8585652","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Number of CTP modification","text_display":"Number of CTP modification","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[932,333],[969,333],[969,384],[932,384]],"region":{"top_left_x":932,"top_left_y":333,"width":38,"height":51},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ac268320b8644fc88ef358da18db987","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"2","text_display":"2","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,393],[730,393],[730,432],[265,432]],"region":{"top_left_x":264,"top_left_y":392,"width":466,"height":41},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b89f4fe24044303857243d4fbe1a936","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Date of CTP modification","text_display":"Date of CTP modification","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,393],[1269,393],[1269,432],[939,432]],"region":{"top_left_x":939,"top_left_y":392,"width":330,"height":41},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ee145ed62544499bd28d60030b97131","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"22 November 2016","text_display":"22 November 2016","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,444],[596,444],[596,483],[265,483]],"region":{"top_left_x":264,"top_left_y":443,"width":333,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cda1ed65aa045c4987abd92702e0212","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"EudraCT number","text_display":"EudraCT number","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,439],[1223,439],[1223,483],[939,483]],"region":{"top_left_x":939,"top_left_y":438,"width":284,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f70c3b0bc804caa91bb3790672765c9","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"2011-004148-23","text_display":"2011-004148-23","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,494],[569,494],[569,533],[265,533]],"region":{"top_left_x":264,"top_left_y":494,"width":305,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c378fdc0b82419d83468def47dbad10","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"BI Trial number","text_display":"BI Trial number","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,492],[1082,492],[1082,531],[939,531]],"region":{"top_left_x":939,"top_left_y":491,"width":144,"height":41},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6e050fc572e4c89bf64047f551a83ea","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"1218.22","text_display":"1218.22","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,540],[787,540],[787,589],[267,589]],"region":{"top_left_x":267,"top_left_y":540,"width":521,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25a659f006094a43a06ed1b87c75e9e4","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"BI Investigational Product(s)","text_display":"BI Investigational Product(s)","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,540],[1305,540],[1305,589],[939,589]],"region":{"top_left_x":939,"top_left_y":540,"width":367,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a6762a1d300409794989c4607f20ebb","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Linagliptin (BI 1356)","text_display":"Linagliptin (BI 1356)","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,591],[559,591],[559,639],[265,639]],"region":{"top_left_x":264,"top_left_y":590,"width":296,"height":50},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"024293df374b4adca12c3143d576ed75","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Title of protocol","text_display":"Title of protocol","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999555900930661},{"cnt":[[935,586],[1750,586],[1750,879],[935,879]],"region":{"top_left_x":934,"top_left_y":586,"width":816,"height":293},"line":37,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"e4b097cfca904f8685bb27174d957ffb","type":"complex_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","children_ids":["82303703bbb24e0c880ecd6e5593a675","280b33107cc842f2b12caf04c1b1af98","4ea43659b72941aca78eca30fc55677a","b39069dc9c0448988cae48b2ee882e4f","5200c8339a0449ee9b3c18471faa446b","ce7abffd052d4eb4a3911b1532c65682"],"text":"A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA","text_display":"A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,591],[1637,591],[1637,637],[939,637]],"region":{"top_left_x":939,"top_left_y":590,"width":699,"height":47},"line":38,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"82303703bbb24e0c880ecd6e5593a675","type":"text","conversion_output":false,"parent_id":"e4b097cfca904f8685bb27174d957ffb","text":"A multicenter, international, randomized,","text_display":"A multicenter, international, randomized,","confidence":1,"confidence_rate":1},{"cnt":[[939,637],[1748,637],[1748,685],[939,685]],"region":{"top_left_x":939,"top_left_y":636,"width":809,"height":50},"line":39,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"280b33107cc842f2b12caf04c1b1af98","type":"text","conversion_output":false,"parent_id":"e4b097cfca904f8685bb27174d957ffb","text":"parallel group, double-blind, placebo-controlled","text_display":" parallel group, double-blind, placebo-controlled","confidence":1,"confidence_rate":1},{"cnt":[[939,688],[1738,688],[1738,734],[939,734]],"region":{"top_left_x":939,"top_left_y":687,"width":800,"height":47},"line":40,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"4ea43659b72941aca78eca30fc55677a","type":"text","conversion_output":false,"parent_id":"e4b097cfca904f8685bb27174d957ffb","text":"CArdiovascular Safety \\& Renal Microvascular","text_display":" CArdiovascular Safety \\& Renal Microvascular","confidence":1,"confidence_rate":1},{"cnt":[[939,734],[1701,734],[1701,782],[939,782]],"region":{"top_left_x":939,"top_left_y":733,"width":763,"height":49},"line":41,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"b39069dc9c0448988cae48b2ee882e4f","type":"text","conversion_output":false,"parent_id":"e4b097cfca904f8685bb27174d957ffb","text":"outcomE study with LINAgliptin, 5 mg once","text_display":" outcomE study with LINAgliptin, 5 mg once","confidence":1,"confidence_rate":1},{"cnt":[[939,782],[1743,782],[1743,828],[939,828]],"region":{"top_left_x":939,"top_left_y":781,"width":804,"height":48},"line":42,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"5200c8339a0449ee9b3c18471faa446b","type":"text","conversion_output":false,"parent_id":"e4b097cfca904f8685bb27174d957ffb","text":"daily in patients with type 2 diabetes mellitus at","text_display":" daily in patients with type 2 diabetes mellitus at","confidence":1,"confidence_rate":1},{"cnt":[[939,830],[1513,830],[1513,879],[939,879]],"region":{"top_left_x":939,"top_left_y":830,"width":574,"height":49},"line":43,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"ce7abffd052d4eb4a3911b1532c65682","type":"text","conversion_output":false,"parent_id":"e4b097cfca904f8685bb27174d957ffb","text":"high vascular risk. CARMELINA","text_display":" high vascular risk. CARMELINA","confidence":1,"confidence_rate":1},{"cnt":[[249,869],[1771,869],[1771,927],[249,927]],"region":{"top_left_x":248,"top_left_y":869,"width":1523,"height":59},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa49b15c2e834745bf8d03848b443be9","type":"table_spanning_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":"","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[262,927],[799,927],[799,1116],[262,1116]],"region":{"top_left_x":262,"top_left_y":927,"width":537,"height":189},"line":45,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"8ceb2066f0514bd1b5e4ec69f593f042","type":"complex_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","children_ids":["cd9d0a8375974335951aa2f1f55fd1e5","62d60624141748b08014691c830ec61a","cce44577e8ed4119982d2fe239b58b69","65050d58d089465a81c7abb9868c0ab3"],"text":"To be implemented only after approval of the IRB/IEC/Competent Authorities","text_display":"To be implemented only after approval of the IRB/IEC/Competent Authorities","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,932],[794,932],[794,980],[265,980]],"region":{"top_left_x":264,"top_left_y":931,"width":531,"height":50},"line":46,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"cd9d0a8375974335951aa2f1f55fd1e5","type":"text","conversion_output":false,"parent_id":"8ceb2066f0514bd1b5e4ec69f593f042","text":"To be implemented only after","text_display":"To be implemented only after","confidence":1,"confidence_rate":1},{"cnt":[[265,978],[541,978],[541,1026],[265,1026]],"region":{"top_left_x":264,"top_left_y":977,"width":278,"height":50},"line":47,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"62d60624141748b08014691c830ec61a","type":"text","conversion_output":false,"parent_id":"8ceb2066f0514bd1b5e4ec69f593f042","text":"approval of the","text_display":" approval of the","confidence":1,"confidence_rate":1},{"cnt":[[267,1024],[640,1024],[640,1072],[267,1072]],"region":{"top_left_x":267,"top_left_y":1023,"width":374,"height":50},"line":48,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"cce44577e8ed4119982d2fe239b58b69","type":"text","conversion_output":false,"parent_id":"8ceb2066f0514bd1b5e4ec69f593f042","text":"IRB/IEC/Competent","text_display":" IRB/IEC/Competent","confidence":1,"confidence_rate":1},{"cnt":[[267,1074],[472,1074],[472,1114],[267,1114]],"region":{"top_left_x":267,"top_left_y":1074,"width":205,"height":40},"line":49,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"65050d58d089465a81c7abb9868c0ab3","type":"text","conversion_output":false,"parent_id":"8ceb2066f0514bd1b5e4ec69f593f042","text":"Authorities","text_display":" Authorities","confidence":1,"confidence_rate":1},{"cnt":[[939,927],[995,927],[995,982],[939,982]],"region":{"top_left_x":939,"top_left_y":927,"width":56,"height":56},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02a55b77f80246019e24e23ec9d44466","type":"complex_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","children_ids":["894f89b9422943b88face4f918b3bf63"],"text":"![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-098.jpg?height=51\\&width=52\\&top_left_y=927\\&top_left_x=943)","text_display":"![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-098.jpg?height=51\\&width=52\\&top_left_y=927\\&top_left_x=943)","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0,"confidence_rate":0},{"cnt":[[944,927],[995,927],[995,978],[944,978]],"region":{"top_left_x":943,"top_left_y":927,"width":52,"height":51},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"894f89b9422943b88face4f918b3bf63","type":"diagram","conversion_output":false,"parent_id":"02a55b77f80246019e24e23ec9d44466","text":"","text_display":"![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-098.jpg?height=51\\&width=52\\&top_left_y=927\\&top_left_x=943)"},{"cnt":[[258,1120],[748,1120],[748,1461],[258,1461]],"region":{"top_left_x":257,"top_left_y":1120,"width":492,"height":342},"line":52,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"00ab21e435c64329aed4dd5885a15551","type":"complex_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","children_ids":["74962ab4626849719177437743972ead","91167a929c8943578135e2584e44d832","4eccf4f267c04853b9b1ac1c5e6c5a55","aea8f17bdda0452884716884b4645425","daff8258335543a5b8ef6aedd62f4f34","1dd34044943e44bbb7ab39c674519101","a4594583e8824eb2a154075e62308fef"],"text":"To be implemented immediately in order to eliminate hazard IRB / IEC / Competent Authority to be notified of change with request for approval","text_display":"To be implemented immediately in order to eliminate hazard IRB / IEC / Competent Authority to be notified of change with request for approval","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,1125],[615,1125],[615,1171],[265,1171]],"region":{"top_left_x":264,"top_left_y":1125,"width":351,"height":47},"line":53,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"74962ab4626849719177437743972ead","type":"text","conversion_output":false,"parent_id":"00ab21e435c64329aed4dd5885a15551","text":"To be implemented","text_display":"To be implemented","confidence":1,"confidence_rate":1},{"cnt":[[265,1171],[693,1171],[693,1219],[265,1219]],"region":{"top_left_x":264,"top_left_y":1171,"width":429,"height":49},"line":54,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"91167a929c8943578135e2584e44d832","type":"text","conversion_output":false,"parent_id":"00ab21e435c64329aed4dd5885a15551","text":"immediately in order to","text_display":" immediately in order to","confidence":1,"confidence_rate":1},{"cnt":[[267,1222],[605,1222],[605,1261],[267,1261]],"region":{"top_left_x":267,"top_left_y":1221,"width":339,"height":40},"line":55,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"4eccf4f267c04853b9b1ac1c5e6c5a55","type":"text","conversion_output":false,"parent_id":"00ab21e435c64329aed4dd5885a15551","text":"eliminate hazard -","text_display":" eliminate hazard ","confidence":1,"confidence_rate":1},{"cnt":[[267,1268],[684,1268],[684,1316],[267,1316]],"region":{"top_left_x":267,"top_left_y":1267,"width":417,"height":50},"line":56,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"aea8f17bdda0452884716884b4645425","type":"text","conversion_output":false,"parent_id":"00ab21e435c64329aed4dd5885a15551","text":"IRB / IEC / Competent","text_display":"IRB / IEC / Competent","confidence":1,"confidence_rate":1},{"cnt":[[267,1316],[744,1316],[744,1362],[267,1362]],"region":{"top_left_x":267,"top_left_y":1316,"width":477,"height":47},"line":57,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"daff8258335543a5b8ef6aedd62f4f34","type":"text","conversion_output":false,"parent_id":"00ab21e435c64329aed4dd5885a15551","text":"Authority to be notified of","text_display":" Authority to be notified of","confidence":1,"confidence_rate":1},{"cnt":[[267,1365],[693,1365],[693,1413],[267,1413]],"region":{"top_left_x":267,"top_left_y":1364,"width":426,"height":49},"line":58,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"1dd34044943e44bbb7ab39c674519101","type":"text","conversion_output":false,"parent_id":"00ab21e435c64329aed4dd5885a15551","text":"change with request for","text_display":" change with request for","confidence":1,"confidence_rate":1},{"cnt":[[267,1411],[433,1411],[433,1459],[267,1459]],"region":{"top_left_x":267,"top_left_y":1410,"width":166,"height":49},"line":59,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"a4594583e8824eb2a154075e62308fef","type":"text","conversion_output":false,"parent_id":"00ab21e435c64329aed4dd5885a15551","text":"approval","text_display":" approval","confidence":1,"confidence_rate":1},{"cnt":[[939,1116],[995,1116],[995,1171],[939,1171]],"region":{"top_left_x":939,"top_left_y":1115,"width":56,"height":57},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bbfed644aa304189a05c88495952e65f","type":"complex_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","children_ids":["eef7cf22586f43c9b5da25d827852991"],"text":"□","text_display":"□","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0,"confidence_rate":0},{"cnt":[[944,1120],[995,1120],[995,1171],[944,1171]],"region":{"top_left_x":943,"top_left_y":1120,"width":52,"height":52},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eef7cf22586f43c9b5da25d827852991","type":"form_field","conversion_output":false,"parent_id":"bbfed644aa304189a05c88495952e65f","text":"","text_display":"□","subtype":"checkbox"},{"cnt":[[262,1459],[820,1459],[820,1703],[262,1703]],"region":{"top_left_x":262,"top_left_y":1458,"width":558,"height":245},"line":62,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"10c4ce28bfe543a3ab3d1faba1b380cc","type":"complex_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","children_ids":["dd6888f4b2d448b08c96aa3a6532ca95","6a48e058370b4375a258d8934c99c9aa","19d3620404aa43adbb9e1a613e336a68","98b5b67051a646f388749a92cc56e443","bd1b2217e4064705bcbc7f9a1aa50f00"],"text":"Can be implemented without IRB/IEC/ Competent Authority approval as changes involve logistical or administrative aspects only","text_display":"Can be implemented without IRB/IEC/ Competent Authority approval as changes involve logistical or administrative aspects only","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[267,1461],[787,1461],[787,1507],[267,1507]],"region":{"top_left_x":267,"top_left_y":1461,"width":521,"height":47},"line":63,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"dd6888f4b2d448b08c96aa3a6532ca95","type":"text","conversion_output":false,"parent_id":"10c4ce28bfe543a3ab3d1faba1b380cc","text":"Can be implemented without","text_display":"Can be implemented without","confidence":1,"confidence_rate":1},{"cnt":[[267,1507],[652,1507],[652,1556],[267,1556]],"region":{"top_left_x":267,"top_left_y":1507,"width":385,"height":49},"line":64,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"6a48e058370b4375a258d8934c99c9aa","type":"text","conversion_output":false,"parent_id":"10c4ce28bfe543a3ab3d1faba1b380cc","text":"IRB/IEC/ Competent","text_display":" IRB/IEC/ Competent","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[267,1558],[817,1558],[817,1606],[267,1606]],"region":{"top_left_x":267,"top_left_y":1557,"width":551,"height":50},"line":65,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"19d3620404aa43adbb9e1a613e336a68","type":"text","conversion_output":false,"parent_id":"10c4ce28bfe543a3ab3d1faba1b380cc","text":"Authority approval as changes","text_display":" Authority approval as changes","confidence":1,"confidence_rate":1},{"cnt":[[267,1604],[617,1604],[617,1652],[267,1652]],"region":{"top_left_x":267,"top_left_y":1603,"width":351,"height":50},"line":66,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"98b5b67051a646f388749a92cc56e443","type":"text","conversion_output":false,"parent_id":"10c4ce28bfe543a3ab3d1faba1b380cc","text":"involve logistical or","text_display":" involve logistical or","confidence":1,"confidence_rate":1},{"cnt":[[267,1655],[755,1655],[755,1703],[267,1703]],"region":{"top_left_x":267,"top_left_y":1654,"width":489,"height":49},"line":67,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"bd1b2217e4064705bcbc7f9a1aa50f00","type":"text","conversion_output":false,"parent_id":"10c4ce28bfe543a3ab3d1faba1b380cc","text":"administrative aspects only","text_display":" administrative aspects only","confidence":1,"confidence_rate":1},{"cnt":[[939,1452],[995,1452],[995,1507],[939,1507]],"region":{"top_left_x":939,"top_left_y":1452,"width":56,"height":56},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6ae13f1abc3499b9f2f8d4da2e016a0","type":"complex_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","children_ids":["ca2fc9e5e04a46c38d8c4e82c3ddf93c"],"text":"□","text_display":"□","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0,"confidence_rate":0},{"cnt":[[944,1452],[995,1452],[995,1507],[944,1507]],"region":{"top_left_x":943,"top_left_y":1452,"width":52,"height":56},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca2fc9e5e04a46c38d8c4e82c3ddf93c","type":"form_field","conversion_output":false,"parent_id":"a6ae13f1abc3499b9f2f8d4da2e016a0","text":"","text_display":"□","subtype":"checkbox"},{"cnt":[[249,1698],[1768,1698],[1768,1749],[249,1749]],"region":{"top_left_x":248,"top_left_y":1698,"width":1521,"height":52},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"528337b062ca4960be33a3fbd83209b7","type":"table_spanning_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"","text_display":"","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[267,1751],[592,1751],[592,1790],[267,1790]],"region":{"top_left_x":267,"top_left_y":1751,"width":325,"height":40},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed0b007e2ec74dfbbbcbec33bd3add59","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Section to be changed","text_display":"Section to be changed","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1908],[1398,1908],[1398,1947],[939,1947]],"region":{"top_left_x":939,"top_left_y":1907,"width":459,"height":41},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"356207b3cb7142728c593a715c0250ec","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Clinical trial protocol synopsis","text_display":"Clinical trial protocol synopsis","cell_row":11,"cell_column":1,"cell_row_span":4,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[932,1751],[1759,1751],[1759,1931],[932,1931]],"region":{"top_left_x":932,"top_left_y":1751,"width":828,"height":180},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f671e856c62e4bbaad097be648dd4dfe","type":"table_spanning_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","children_ids":["f441de153522481e9d4fcc3510fdf86c"],"text":"","text_display":"\\begin{tabular}{l}\nTitle page \\\\\nadded as TCM \\\\\nadded as TCM\n\\end{tabular}","cell_row":11,"cell_column":1,"cell_row_span":4,"cell_col_span":1},{"cnt":[[939,1751],[1352,1751],[1352,1890],[939,1890]],"region":{"top_left_x":939,"top_left_y":1751,"width":413,"height":139},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f441de153522481e9d4fcc3510fdf86c","type":"complex_cell","conversion_output":false,"parent_id":"f671e856c62e4bbaad097be648dd4dfe","children_ids":["5f46f2800dfe473fbb6bcafe2c3fbf79","c59c4d7fa7e446e1871563dd5c7ebb36","b62c9f6899104a6b9709795e3bc0895a"],"text":"\\begin{tabular}{l}\nTitle page \\\\\nadded as TCM \\\\\nadded as TCM\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTitle page \\\\\nadded as TCM \\\\\nadded as TCM\n\\end{tabular}","cell_row":11,"cell_column":1,"cell_row_span":4,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1751],[1094,1751],[1094,1790],[939,1790]],"region":{"top_left_x":939,"top_left_y":1751,"width":155,"height":40},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f46f2800dfe473fbb6bcafe2c3fbf79","type":"text","conversion_output":false,"parent_id":"f441de153522481e9d4fcc3510fdf86c","text":"Title page","text_display":"Title page","cell_row":11,"cell_column":1,"cell_row_span":4,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1137,1802],[1352,1802],[1352,1837],[1137,1837]],"region":{"top_left_x":1137,"top_left_y":1801,"width":215,"height":36},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c59c4d7fa7e446e1871563dd5c7ebb36","type":"text","conversion_output":false,"parent_id":"f441de153522481e9d4fcc3510fdf86c","text":"added as TCM","text_display":"\nadded as TCM","cell_row":11,"cell_column":1,"cell_row_span":4,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1137,1853],[1352,1853],[1352,1889],[1137,1889]],"region":{"top_left_x":1137,"top_left_y":1852,"width":215,"height":38},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b62c9f6899104a6b9709795e3bc0895a","type":"text","conversion_output":false,"parent_id":"f441de153522481e9d4fcc3510fdf86c","text":"added as TCM","text_display":"\nadded as TCM","cell_row":11,"cell_column":1,"cell_row_span":4,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1802],[596,1802],[596,1846],[267,1846]],"region":{"top_left_x":267,"top_left_y":1801,"width":330,"height":45},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f90f722f95c54c97a6088c289046fdc6","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Description of change","text_display":"Description of change","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1857],[582,1857],[582,1894],[267,1894]],"region":{"top_left_x":267,"top_left_y":1857,"width":316,"height":38},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"843b87a45f7044c2af6f983071f7e906","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Rationale for change","text_display":"Rationale for change","cell_row":13,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1908],[596,1908],[596,1947],[267,1947]],"region":{"top_left_x":267,"top_left_y":1907,"width":330,"height":41},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69ae748557ce4aeeba71f85552ec5f6f","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Section to be changed","text_display":"Section to be changed","cell_row":14,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1959],[596,1959],[596,1998],[267,1998]],"region":{"top_left_x":267,"top_left_y":1958,"width":330,"height":40},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a1360e8f09f430ea5b7ca8d613cf700","type":"simple_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","text":"Description of change","text_display":"Description of change","cell_row":15,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1954],[1748,1954],[1748,2557],[935,2557]],"region":{"top_left_x":934,"top_left_y":1953,"width":814,"height":605},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01da7ac27d7d44b9bfce2ed5d03946a7","type":"complex_cell","conversion_output":false,"parent_id":"5f5fb7a61fd6464ab45990df93244745","children_ids":["f5143a4e656a4a719d2aca70135f11b4","e4413e99efe0471b9d10b1828ebc069d","863321dfd44d47abb8c070cf93e88613","dbc2b18856de4c5fa03eb9b4d99e2c9e","f8db52c6eb834da28027c561477d365b","b5c5092297b54b99a2a08c70c02b8ee6","31aa7e71c75c4df5933b6f1d99f0bed3","f9db7a8b349c46fd8065a5d0e2a9a2da","08d2036d6bde40f8999b961297d22174","9f6c129a56914af18169cb5fa066b579","1893339ed5cd4885bb97c47dc1388d7e","81de6a47007548aca0ee550d129f5eb1","fd2f11f023f84c0f9b5eab0cbe020273","3a4afcce95de44b9a164ed3d3d80b7ba"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nChange 2: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nChange 2: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal\n\\end{tabular}","cell_row":15,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.82666015625,"confidence_rate":0.9997596435246972},{"cnt":[[939,1956],[1089,1956],[1089,1998],[939,1998]],"region":{"top_left_x":939,"top_left_y":1956,"width":151,"height":42},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5143a4e656a4a719d2aca70135f11b4","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1995],[1743,1995],[1743,2037],[939,2037]],"region":{"top_left_x":939,"top_left_y":1995,"width":804,"height":42},"line":84,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e4413e99efe0471b9d10b1828ebc069d","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"The primary endpoint changed from 4-point MACE to 3-","text_display":"\nThe primary endpoint changed from 4-point MACE to 3","confidence":1,"confidence_rate":1},{"cnt":[[939,2037],[1135,2037],[1135,2076],[939,2076]],"region":{"top_left_x":939,"top_left_y":2036,"width":197,"height":40},"line":85,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"863321dfd44d47abb8c070cf93e88613","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"point MACE.","text_display":"point MACE.","confidence":1,"confidence_rate":1},{"cnt":[[939,2078],[1738,2078],[1738,2117],[939,2117]],"region":{"top_left_x":939,"top_left_y":2078,"width":800,"height":40},"line":86,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dbc2b18856de4c5fa03eb9b4d99e2c9e","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"The key secondary endpoints were changed from 3-point","text_display":"\nThe key secondary endpoints were changed from 3-point","confidence":1,"confidence_rate":1},{"cnt":[[939,2115],[1646,2115],[1646,2159],[939,2159]],"region":{"top_left_x":939,"top_left_y":2115,"width":708,"height":44},"line":87,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8db52c6eb834da28027c561477d365b","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"MACE and composite renal endpoint (renal death,","text_display":" MACE and composite renal endpoint (renal death,","confidence":1,"confidence_rate":1},{"cnt":[[939,2157],[1711,2157],[1711,2196],[939,2196]],"region":{"top_left_x":939,"top_left_y":2156,"width":772,"height":40},"line":88,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5c5092297b54b99a2a08c70c02b8ee6","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"sustained ESRD, sustained decrease of 50\\% or more in","text_display":" sustained ESRD, sustained decrease of 50\\% or more in","confidence":0.82666015625,"confidence_rate":0.9966658932555231},{"cnt":[[939,2198],[1616,2198],[1616,2237],[939,2237]],"region":{"top_left_x":939,"top_left_y":2198,"width":678,"height":40},"line":89,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31aa7e71c75c4df5933b6f1d99f0bed3","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"eGFR) to composite renal endpoint (renal death,","text_display":" eGFR) to composite renal endpoint (renal death,","confidence":1,"confidence_rate":1},{"cnt":[[939,2237],[1711,2237],[1711,2274],[939,2274]],"region":{"top_left_x":939,"top_left_y":2237,"width":772,"height":38},"line":90,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9db7a8b349c46fd8065a5d0e2a9a2da","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"sustained ESRD, sustained decrease of 40\\% or more in","text_display":" sustained ESRD, sustained decrease of 40\\% or more in","confidence":0.99853515625,"confidence_rate":0.9999742824766222},{"cnt":[[939,2276],[1048,2276],[1048,2315],[939,2315]],"region":{"top_left_x":939,"top_left_y":2276,"width":109,"height":40},"line":91,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08d2036d6bde40f8999b961297d22174","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"eGFR).","text_display":" eGFR).","confidence":1,"confidence_rate":1},{"cnt":[[939,2355],[1089,2355],[1089,2398],[939,2398]],"region":{"top_left_x":939,"top_left_y":2354,"width":151,"height":45},"line":92,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f6c129a56914af18169cb5fa066b579","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2396],[1637,2396],[1637,2435],[939,2435]],"region":{"top_left_x":939,"top_left_y":2396,"width":699,"height":40},"line":93,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1893339ed5cd4885bb97c47dc1388d7e","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"If non-inferiority has been demonstrated, then the","text_display":"\nIf non-inferiority has been demonstrated, then the","confidence":1,"confidence_rate":1},{"cnt":[[939,2437],[1738,2437],[1738,2477],[939,2477]],"region":{"top_left_x":939,"top_left_y":2437,"width":800,"height":40},"line":94,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81de6a47007548aca0ee550d129f5eb1","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"primary composite endpoint will be tested for superiority","text_display":" primary composite endpoint will be tested for superiority","confidence":1,"confidence_rate":1},{"cnt":[[939,2474],[1734,2474],[1734,2516],[939,2516]],"region":{"top_left_x":939,"top_left_y":2474,"width":795,"height":42},"line":95,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd2f11f023f84c0f9b5eab0cbe020273","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"and the other objective, to assess the impact of treatment","text_display":" and the other objective, to assess the impact of treatment","confidence":1,"confidence_rate":1},{"cnt":[[939,2516],[1701,2516],[1701,2555],[939,2555]],"region":{"top_left_x":939,"top_left_y":2515,"width":763,"height":40},"line":96,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a4afcce95de44b9a164ed3d3d80b7ba","type":"text","conversion_output":false,"parent_id":"01da7ac27d7d44b9bfce2ed5d03946a7","text":"with respect to the composite renal endpoint (i.e. renal","text_display":" with respect to the composite renal endpoint (i.e. renal","confidence":1,"confidence_rate":1},{"cnt":[[790,2586],[1300,2586],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2585,"width":510,"height":36},"line":97,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"64bafc49a1f34b12a618484ac3f9d084","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":98,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5fe32f6e948b47b29f061e3308253c07","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":99,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ce740a76139d448f9276a05af2c27334","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-099","page":99,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6ad8700132847ee92e13ab41b13a2c6","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,121],[1816,121],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":121,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c86eb65d1a384c6eae4429248dac183d","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[596,164],[596,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":351,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb4ea50d6bfc4a87a51afbf7abb482fc","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65d98d7b5ff04d138fe3891c5cd134c1","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"158847ecc771428ba011633a8ba6bf5b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1572,208],[1816,208],[1816,254],[1572,254]],"region":{"top_left_x":1571,"top_left_y":207,"width":246,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aceb73b492dc448c829eaacd5b1d69ce","type":"page_info","conversion_output":false,"text":"Page 99 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2574],[244,2574]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2244},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b25f3ef33e5450d8cc958bdee2ba82f","type":"table","conversion_output":true,"children_ids":["ce5cffb6a50542c081ba4bc913e2347e","2deb595e6dc54cc6bc10f117b5d2fde8","7e95aac983c14002afcf87a6ad9d4ac2","0e46825227ee426999381fc802b63720"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\ndeath, sustained end-stage renal disease (ESRD), sustained decrease in estimated global filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated separately with a test on superiority. \\\\\nWas changed into: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal disease (ESRD), sustained decrease in estimated glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated separately with a test on superiority \\\\\nChange 3: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\nChange 4: \\\\\nNumber of patients with primary endpoint events decreased from 625 to 611 and estimated treatment period increased from 48 to 54 months. \\\\\nChange 5: \\\\\nThe primary endpoint (4-point MACE) will be tested for non-inferiority. Thereafter the 4-point MACE and the combined composite renal endpoint will be tested separately (= in parallel) for superiority. In case the 4point MACE and/or the composite renal endpoint is significantly superior, the 3-point MACE will be tested for superiority. \\\\\nWas changed into: \\\\\nThe primary endpoint (3-point MACE) will be tested for non-inferiority. Thereafter if non-inferiority has been demonstrated the 3-point MACE and the combined composite renal endpoint will be tested separately for superiority.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\ndeath, sustained end-stage renal disease (ESRD), sustained decrease in estimated global filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated separately with a test on superiority. \\\\\nWas changed into: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal disease (ESRD), sustained decrease in estimated glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated separately with a test on superiority \\\\\nChange 3: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\nChange 4: \\\\\nNumber of patients with primary endpoint events decreased from 625 to 611 and estimated treatment period increased from 48 to 54 months. \\\\\nChange 5: \\\\\nThe primary endpoint (4-point MACE) will be tested for non-inferiority. Thereafter the 4-point MACE and the combined composite renal endpoint will be tested separately (= in parallel) for superiority. In case the 4point MACE and/or the composite renal endpoint is significantly superior, the 3-point MACE will be tested for superiority. \\\\\nWas changed into: \\\\\nThe primary endpoint (3-point MACE) will be tested for non-inferiority. Thereafter if non-inferiority has been demonstrated the 3-point MACE and the combined composite renal endpoint will be tested separately for superiority.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.9819579124450684,"confidence_rate":0.9999740419790538},{"cnt":[[244,331],[840,331],[840,2576],[244,2576]],"region":{"top_left_x":244,"top_left_y":331,"width":597,"height":2245},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce5cffb6a50542c081ba4bc913e2347e","type":"table_column","conversion_output":false,"parent_id":"3b25f3ef33e5450d8cc958bdee2ba82f","text":"","text_display":""},{"cnt":[[930,331],[1750,331],[1750,2574],[930,2574]],"region":{"top_left_x":930,"top_left_y":331,"width":820,"height":2243},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2deb595e6dc54cc6bc10f117b5d2fde8","type":"table_column","conversion_output":false,"parent_id":"3b25f3ef33e5450d8cc958bdee2ba82f","text":"","text_display":""},{"cnt":[[244,333],[1775,333],[1775,2014],[244,2014]],"region":{"top_left_x":244,"top_left_y":333,"width":1532,"height":1682},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e95aac983c14002afcf87a6ad9d4ac2","type":"table_row","conversion_output":false,"parent_id":"3b25f3ef33e5450d8cc958bdee2ba82f","text":"","text_display":""},{"cnt":[[932,338],[1748,338],[1748,2003],[932,2003]],"region":{"top_left_x":932,"top_left_y":337,"width":816,"height":1666},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e46825227ee426999381fc802b63720","type":"complex_cell","conversion_output":false,"parent_id":"3b25f3ef33e5450d8cc958bdee2ba82f","children_ids":["1edfc1e6d60a4b9bad89f6e03acef450","76df4d0aba3241749791b46eeecf4ae5","c43ecc7b451d41b493acda0dc530d3b1","f6e748e8d8ef4ce988e5b12bed4c6294","2c9cec2dfabd405e973761e404ab8af8","3f20e5d60513433ba979303390d1730a","c6df6b7da9ed4e6597b7144979f1ed9c","9bc22338d8b04c2c8078b70b92ec7a77","febeb1b7ceba4c6eaa42cfaad3d311f4","3caae10113784cd4b95bb0795aa8954f","c1769e7125164fb4b10d437a54d08543","06f965b7bd3743dcbafc9a430f0f43ac","223ebcb22262443ab2bac8cd5ffe1de5","f4a2d3473c464a88aa0e8930e228f4f2","a6a5a7f41a514849812cea759ee5b269","ea105865059446e28f623958f37030ca","8885a05e895f4543baab0bbcaa2e2ed8","3a519b299fcb4b0a940c31ffab7a8493","bec67c1e5d884c9d8a3fedfe05e1ca00","6c005b1670cb4d068a8921ce649058ef","63a2415e5bd4445e946cf921adde8257","274229ad16c047df93caef92af7a63fc","c990b97e5b9d4359afa3dc287285d4ad","e9893fc696914b50b92e404298c2d9c7","8a31c3b6219a4ffb8e95b6ee91430bbb","fe12d5f53aa64dbfa32d3634189f6b8c","aaeca33848564ef682de39b79e608107","2a32e09bf17e49a4a337bf0235f96701","40b2dea9cf37424a9e9d5922b5e0390a","75371e612b3f4a1aa00f96be2301e5f1","64337a2814664974882a61d0dc86b81f","b1cd0449a443419bbc61b5749723f44f","4eb4463c44234f0a9029779555aa913d","1c067deae4384221abb24d9de0be8a24","5b5dbfd4273841a1917a78c8986e15d2"],"text":"\\begin{tabular}{l}\ndeath, sustained end-stage renal disease (ESRD), sustained decrease in estimated global filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated separately with a test on superiority. \\\\\nWas changed into: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal disease (ESRD), sustained decrease in estimated glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated separately with a test on superiority \\\\\nChange 3: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\nChange 4: \\\\\nNumber of patients with primary endpoint events decreased from 625 to 611 and estimated treatment period increased from 48 to 54 months. \\\\\nChange 5: \\\\\nThe primary endpoint (4-point MACE) will be tested for non-inferiority. Thereafter the 4-point MACE and the combined composite renal endpoint will be tested separately (= in parallel) for superiority. In case the 4point MACE and/or the composite renal endpoint is significantly superior, the 3-point MACE will be tested for superiority. \\\\\nWas changed into: \\\\\nThe primary endpoint (3-point MACE) will be tested for non-inferiority. Thereafter if non-inferiority has been demonstrated the 3-point MACE and the combined composite renal endpoint will be tested separately for superiority.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\ndeath, sustained end-stage renal disease (ESRD), sustained decrease in estimated global filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated separately with a test on superiority. \\\\\nWas changed into: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained end-stage renal disease (ESRD), sustained decrease in estimated glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated separately with a test on superiority \\\\\nChange 3: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\nChange 4: \\\\\nNumber of patients with primary endpoint events decreased from 625 to 611 and estimated treatment period increased from 48 to 54 months. \\\\\nChange 5: \\\\\nThe primary endpoint (4-point MACE) will be tested for non-inferiority. Thereafter the 4-point MACE and the combined composite renal endpoint will be tested separately (= in parallel) for superiority. In case the 4point MACE and/or the composite renal endpoint is significantly superior, the 3-point MACE will be tested for superiority. \\\\\nWas changed into: \\\\\nThe primary endpoint (3-point MACE) will be tested for non-inferiority. Thereafter if non-inferiority has been demonstrated the 3-point MACE and the combined composite renal endpoint will be tested separately for superiority.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9819579124450684,"confidence_rate":0.9999740419790538},{"cnt":[[939,340],[1628,340],[1628,379],[939,379]],"region":{"top_left_x":939,"top_left_y":340,"width":689,"height":40},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1edfc1e6d60a4b9bad89f6e03acef450","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"death, sustained end-stage renal disease (ESRD),","text_display":"death, sustained end-stage renal disease (ESRD),","confidence":1,"confidence_rate":1},{"cnt":[[939,382],[1669,382],[1669,421],[939,421]],"region":{"top_left_x":939,"top_left_y":381,"width":731,"height":40},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76df4d0aba3241749791b46eeecf4ae5","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"sustained decrease in estimated global filtration rate","text_display":" sustained decrease in estimated global filtration rate","confidence":1,"confidence_rate":1},{"cnt":[[939,418],[1653,418],[1653,462],[939,462]],"region":{"top_left_x":939,"top_left_y":418,"width":715,"height":45},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c43ecc7b451d41b493acda0dc530d3b1","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"(eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated","text_display":" (eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated","confidence":0.994631290435791,"confidence_rate":0.9999038765331059},{"cnt":[[939,460],[1448,460],[1448,504],[939,504]],"region":{"top_left_x":939,"top_left_y":459,"width":510,"height":45},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6e748e8d8ef4ce988e5b12bed4c6294","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"separately with a test on superiority.","text_display":" separately with a test on superiority.","confidence":1,"confidence_rate":1},{"cnt":[[939,538],[1206,538],[1206,582],[939,582]],"region":{"top_left_x":939,"top_left_y":538,"width":268,"height":44},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c9cec2dfabd405e973761e404ab8af8","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99755859375,"confidence_rate":0.9998888974749892},{"cnt":[[939,619],[1637,619],[1637,660],[939,660]],"region":{"top_left_x":939,"top_left_y":618,"width":699,"height":43},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f20e5d60513433ba979303390d1730a","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"If non-inferiority has been demonstrated, then the","text_display":"\nIf non-inferiority has been demonstrated, then the","confidence":1,"confidence_rate":1},{"cnt":[[939,658],[1738,658],[1738,702],[939,702]],"region":{"top_left_x":939,"top_left_y":657,"width":800,"height":45},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6df6b7da9ed4e6597b7144979f1ed9c","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"primary composite endpoint will be tested for superiority","text_display":" primary composite endpoint will be tested for superiority","confidence":1,"confidence_rate":1},{"cnt":[[939,702],[1734,702],[1734,743],[939,743]],"region":{"top_left_x":939,"top_left_y":701,"width":795,"height":43},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9bc22338d8b04c2c8078b70b92ec7a77","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"and the other objective, to assess the impact of treatment","text_display":" and the other objective, to assess the impact of treatment","confidence":1,"confidence_rate":1},{"cnt":[[939,741],[1701,741],[1701,780],[939,780]],"region":{"top_left_x":939,"top_left_y":740,"width":763,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"febeb1b7ceba4c6eaa42cfaad3d311f4","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"with respect to the composite renal endpoint (i.e. renal","text_display":" with respect to the composite renal endpoint (i.e. renal","confidence":1,"confidence_rate":1},{"cnt":[[939,780],[1628,780],[1628,821],[939,821]],"region":{"top_left_x":939,"top_left_y":779,"width":689,"height":43},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3caae10113784cd4b95bb0795aa8954f","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"death, sustained end-stage renal disease (ESRD),","text_display":" death, sustained end-stage renal disease (ESRD),","confidence":1,"confidence_rate":1},{"cnt":[[939,819],[1734,819],[1734,863],[939,863]],"region":{"top_left_x":939,"top_left_y":819,"width":795,"height":44},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1769e7125164fb4b10d437a54d08543","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"sustained decrease in estimated glomerular filtration rate","text_display":" sustained decrease in estimated glomerular filtration rate","confidence":1,"confidence_rate":1},{"cnt":[[939,861],[1651,861],[1651,904],[939,904]],"region":{"top_left_x":939,"top_left_y":860,"width":712,"height":45},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06f965b7bd3743dcbafc9a430f0f43ac","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"(eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated","text_display":" (eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated","confidence":0.99658203125,"confidence_rate":0.9999388621663229},{"cnt":[[939,902],[1444,902],[1444,941],[939,941]],"region":{"top_left_x":939,"top_left_y":902,"width":505,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"223ebcb22262443ab2bac8cd5ffe1de5","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"separately with a test on superiority","text_display":" separately with a test on superiority","confidence":1,"confidence_rate":1},{"cnt":[[939,980],[1089,980],[1089,1019],[939,1019]],"region":{"top_left_x":939,"top_left_y":980,"width":151,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4a2d3473c464a88aa0e8930e228f4f2","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1019],[1725,1019],[1725,1061],[939,1061]],"region":{"top_left_x":939,"top_left_y":1019,"width":786,"height":42},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6a5a7f41a514849812cea759ee5b269","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"Number of randomized patients decreased from 8300 to","text_display":"\nNumber of randomized patients decreased from 8300 to","confidence":1,"confidence_rate":1},{"cnt":[[939,1059],[1628,1059],[1628,1100],[939,1100]],"region":{"top_left_x":939,"top_left_y":1058,"width":689,"height":43},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea105865059446e28f623958f37030ca","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"7000 and number of patients per treatment group","text_display":" 7000 and number of patients per treatment group","confidence":1,"confidence_rate":1},{"cnt":[[939,1100],[1361,1100],[1361,1135],[939,1135]],"region":{"top_left_x":939,"top_left_y":1100,"width":422,"height":35},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8885a05e895f4543baab0bbcaa2e2ed8","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"decreased from 4150 to 3500.","text_display":" decreased from 4150 to 3500.","confidence":1,"confidence_rate":1},{"cnt":[[939,1178],[1089,1178],[1089,1217],[939,1217]],"region":{"top_left_x":939,"top_left_y":1178,"width":151,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a519b299fcb4b0a940c31ffab7a8493","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"Change 4:","text_display":"\nChange 4:","confidence":1,"confidence_rate":1},{"cnt":[[939,1220],[1632,1220],[1632,1259],[939,1259]],"region":{"top_left_x":939,"top_left_y":1219,"width":694,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bec67c1e5d884c9d8a3fedfe05e1ca00","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"Number of patients with primary endpoint events","text_display":"\nNumber of patients with primary endpoint events","confidence":1,"confidence_rate":1},{"cnt":[[939,1261],[1660,1261],[1660,1296],[939,1296]],"region":{"top_left_x":939,"top_left_y":1261,"width":722,"height":35},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c005b1670cb4d068a8921ce649058ef","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"decreased from 625 to 611 and estimated treatment","text_display":" decreased from 625 to 611 and estimated treatment","confidence":1,"confidence_rate":1},{"cnt":[[939,1298],[1490,1298],[1490,1342],[939,1342]],"region":{"top_left_x":939,"top_left_y":1298,"width":551,"height":44},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63a2415e5bd4445e946cf921adde8257","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"period increased from 48 to 54 months.","text_display":" period increased from 48 to 54 months.","confidence":1,"confidence_rate":1},{"cnt":[[939,1376],[1089,1376],[1089,1420],[939,1420]],"region":{"top_left_x":939,"top_left_y":1376,"width":151,"height":45},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"274229ad16c047df93caef92af7a63fc","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"Change 5:","text_display":"\nChange 5:","confidence":1,"confidence_rate":1},{"cnt":[[939,1418],[1734,1418],[1734,1459],[939,1459]],"region":{"top_left_x":939,"top_left_y":1417,"width":795,"height":43},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c990b97e5b9d4359afa3dc287285d4ad","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"The primary endpoint (4-point MACE) will be tested for","text_display":"\nThe primary endpoint (4-point MACE) will be tested for","confidence":0.9990234375,"confidence_rate":0.9999834401430849},{"cnt":[[939,1459],[1692,1459],[1692,1498],[939,1498]],"region":{"top_left_x":939,"top_left_y":1459,"width":754,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9893fc696914b50b92e404298c2d9c7","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"non-inferiority. Thereafter the 4-point MACE and the","text_display":" non-inferiority. Thereafter the 4-point MACE and the","confidence":0.9956073760986328,"confidence_rate":0.9999227696522547},{"cnt":[[939,1501],[1637,1501],[1637,1540],[939,1540]],"region":{"top_left_x":939,"top_left_y":1500,"width":699,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a31c3b6219a4ffb8e95b6ee91430bbb","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"combined composite renal endpoint will be tested","text_display":" combined composite renal endpoint will be tested","confidence":1,"confidence_rate":1},{"cnt":[[939,1538],[1701,1538],[1701,1581],[939,1581]],"region":{"top_left_x":939,"top_left_y":1537,"width":763,"height":45},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe12d5f53aa64dbfa32d3634189f6b8c","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"separately (= in parallel) for superiority. In case the 4-","text_display":" separately (= in parallel) for superiority. In case the 4","confidence":0.9819579124450684,"confidence_rate":0.9997110444451702},{"cnt":[[939,1579],[1665,1579],[1665,1618],[939,1618]],"region":{"top_left_x":939,"top_left_y":1578,"width":726,"height":41},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aaeca33848564ef682de39b79e608107","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"point MACE and/or the composite renal endpoint is","text_display":"point MACE and/or the composite renal endpoint is","confidence":1,"confidence_rate":1},{"cnt":[[939,1616],[1715,1616],[1715,1660],[939,1660]],"region":{"top_left_x":939,"top_left_y":1615,"width":777,"height":45},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a32e09bf17e49a4a337bf0235f96701","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"significantly superior, the 3-point MACE will be tested","text_display":" significantly superior, the 3-point MACE will be tested","confidence":1,"confidence_rate":1},{"cnt":[[939,1657],[1153,1657],[1153,1701],[939,1701]],"region":{"top_left_x":939,"top_left_y":1657,"width":215,"height":44},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40b2dea9cf37424a9e9d5922b5e0390a","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"for superiority.","text_display":" for superiority.","confidence":1,"confidence_rate":1},{"cnt":[[939,1719],[1204,1719],[1204,1761],[939,1761]],"region":{"top_left_x":939,"top_left_y":1719,"width":266,"height":42},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"75371e612b3f4a1aa00f96be2301e5f1","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9951171875,"confidence_rate":0.9997775350954998},{"cnt":[[939,1798],[1734,1798],[1734,1844],[939,1844]],"region":{"top_left_x":939,"top_left_y":1797,"width":795,"height":47},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64337a2814664974882a61d0dc86b81f","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"The primary endpoint (3-point MACE) will be tested for","text_display":"\nThe primary endpoint (3-point MACE) will be tested for","confidence":1,"confidence_rate":1},{"cnt":[[939,1841],[1685,1841],[1685,1881],[939,1881]],"region":{"top_left_x":939,"top_left_y":1841,"width":747,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1cd0449a443419bbc61b5749723f44f","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"non-inferiority. Thereafter if non-inferiority has been","text_display":" non-inferiority. Thereafter if non-inferiority has been","confidence":1,"confidence_rate":1},{"cnt":[[939,1878],[1658,1878],[1658,1922],[939,1922]],"region":{"top_left_x":939,"top_left_y":1878,"width":719,"height":45},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4eb4463c44234f0a9029779555aa913d","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"demonstrated the 3-point MACE and the combined","text_display":" demonstrated the 3-point MACE and the combined","confidence":1,"confidence_rate":1},{"cnt":[[939,1920],[1692,1920],[1692,1959],[939,1959]],"region":{"top_left_x":939,"top_left_y":1919,"width":754,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c067deae4384221abb24d9de0be8a24","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"composite renal endpoint will be tested separately for","text_display":" composite renal endpoint will be tested separately for","confidence":1,"confidence_rate":1},{"cnt":[[939,1961],[1103,1961],[1103,2000],[939,2000]],"region":{"top_left_x":939,"top_left_y":1961,"width":164,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b5dbfd4273841a1917a78c8986e15d2","type":"text","conversion_output":false,"parent_id":"0e46825227ee426999381fc802b63720","text":"superiority.","text_display":" superiority.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2622],[790,2622]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":42},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0480e741298745efba10f6bc9894e525","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"93ab762e0fd9472ab1848a327f46834e","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1bc86cbfc7ed4e3293fa154effe888c3","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-100","page":100,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f88146da3b743fc9e711935e03490d4","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,117],[1816,160],[1503,162]],"region":{"top_left_x":1502,"top_left_y":116,"width":315,"height":47},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d30126557e0c49208bfc268d458cf465","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81ab2f539a02435e87385ea2a24ea593","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[637,208],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":396,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92b955fcd770424dadf34a0df7d93fc1","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5527df5f803e458db561c5f3d13ee07b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2ec8a86982541528d9c6f097897daa8","type":"page_info","conversion_output":false,"text":"Page 100 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1775,331],[1775,2563],[242,2563]],"region":{"top_left_x":242,"top_left_y":331,"width":1533,"height":2233},"line":7,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2530aacc897340c9bbfb130c631767e8","type":"text","conversion_output":true,"text":"\\begin{tabular}{|l|l|l|}\n\\hline & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\\begin{tabular}{|l|l|l|}\n\\hline & & \\\\\n\\hline\n\\end{tabular}","confidence":0.44456453663387013,"confidence_rate":0.9667865889003388},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":8,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8a5c7fd87712493ea818d4353bdded1e","type":"section_header","conversion_output":false,"children_ids":["72983fa5d60a4a67a233effd9b121809"],"text":"","text_display":""},{"cnt":[[790,2586],[1300,2586],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2585,"width":510,"height":36},"line":9,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"72983fa5d60a4a67a233effd9b121809","type":"text","conversion_output":true,"parent_id":"8a5c7fd87712493ea818d4353bdded1e","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4ee2e27e37494914a504c183725955b0","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":11,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b455df69391647c4aaf05f3b53341d16","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-101","page":101,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17000bcc66b04a34a09f5584c2d5b01a","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,121],[1816,118],[1816,160],[1503,162]],"region":{"top_left_x":1502,"top_left_y":118,"width":315,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e7cebc4493840e1afd0904e822e14f4","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,164],[599,164],[599,203],[244,203]],"region":{"top_left_x":244,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ee8953f01ad4e21ab733cd704437cda","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[637,208],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":396,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a99358ec988413a9f1309c86fe94d00","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c700a4df6f547dbb7b5342cf97552da","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d45dd8c57284a5bb9bd4ee33e33de4e","type":"page_info","conversion_output":false,"text":"Page 101 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,2547],[244,330],[1074,331],[1071,2548]],"region":{"top_left_x":242,"top_left_y":330,"width":832,"height":2218},"line":7,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4b65dbec28c84851b4181e1e5a32763a","type":"table","conversion_output":true,"text":"","text_display":"\n\n![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-101.jpg?height=2218&width=832&top_left_y=330&top_left_x=242)"},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":8,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cbac2fac1774429a8f834bcd2117d0a8","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2620],[1798,2620],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2620,"width":1506,"height":42},"line":9,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d565480497f340cca979757012e0fb1a","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0537a94cc8d64118b68b547c6214f60d","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-102","page":102,"lines":[{"cnt":[[247,119],[610,119],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":118,"width":364,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2fb6a210962431190e8ed7cf3b72608","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,120],[1816,118],[1816,160],[1503,162]],"region":{"top_left_x":1502,"top_left_y":117,"width":315,"height":46},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"198189f3accb422682b226df0ea58dd9","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"924adca371a54f19b3f2f345582f766d","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[637,208],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":396,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a132f1ec7be64d9bab4d9288b3379180","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c46c91bde79b408ea8f608b4905d84eb","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8878911fc9544fb3ba3228ef0831e6e3","type":"page_info","conversion_output":false,"text":"Page 102 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1071,331],[1071,2552],[242,2552]],"region":{"top_left_x":242,"top_left_y":331,"width":830,"height":2221},"line":7,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4208560ba500472891ab45be20257459","type":"table","conversion_output":true,"text":"","text_display":"\n\n![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-102.jpg?height=2221&width=830&top_left_y=331&top_left_x=242)"},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":8,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3705d0fd8bb04f59bbd11390a9e9edc6","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[288,2618],[1800,2618],[1800,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2617,"width":1514,"height":45},"line":9,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0f315d5a300f464db1e9500e111f1c83","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99267578125,"confidence_rate":0.9999382273489243},{"cnt":[[295,2664],[1770,2664],[1770,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1477,"height":40},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fc710df57a064d8d87b3e68dfee97172","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-103","page":103,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45c95554dd9d4d9e8083685362b70520","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d729d567ab554a839c7fdbc58973c578","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f648927beec42528abe26267a2fe492","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34f40d1f1a8f453fbcd09bbbcfa10201","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf9c2b9126354bcbaa0f54f0561a520d","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce3eb589e45d4884919fb22590cb06aa","type":"page_info","conversion_output":false,"text":"Page 103 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2554],[244,2554]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2223},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f04de95687d4689a526e573faf4be8e","type":"table","conversion_output":true,"children_ids":["bccd14f5a9a447bda1cd44c8937116b9","3e23c6df2d834781b8aecf66ab12189d","d1a95eea985c4cf18dbdf25266b237cc","bb10172c358c495b88a409a4e46d2a96","35184047820645a086978d0d7b5ee035","f6bb71e9dfaf4642a4f32e88724234ab","36614b134453411ab8082b1b65875312"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 8: \\\\\nStatistical methods: The primary analyses will be performed on the full analysis set... \\\\\nWas changed into: \\\\\nThe primary analyses will be performed on the Treated Set... \\\\\nChange 9: \\\\\nStatistical methods: ... then two separate hypothesis tests for \\\\\n- the primary composite endpoint \\\\\n- the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated GFR \\(\\geq 50 \\%\\) from baseline) \\\\\nwill be tested for superiority in parallel, each with the Cox proportional hazards regression model for time to first event. \\\\\nWas changed into: \\\\\nStatistical methods: ... then two separate hypothesis tests for \\\\\n- the primary composite endpoint \\\\\n- the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated \\(GFR \\geq 40 \\%\\) from baseline) \\\\\nwill be tested for superiority, each with the Cox proportional hazards regression model for time to first event. \\\\\nAnd the following text was added: \\\\\nTo adjust for multiplicity a sequentially rejective multiple test procedure will be applied.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\nChange 2: \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 8: \\\\\nStatistical methods: The primary analyses will be performed on the full analysis set... \\\\\nWas changed into: \\\\\nThe primary analyses will be performed on the Treated Set... \\\\\nChange 9: \\\\\nStatistical methods: ... then two separate hypothesis tests for \\\\\n- the primary composite endpoint \\\\\n- the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated GFR \\(\\geq 50 \\%\\) from baseline) \\\\\nwill be tested for superiority in parallel, each with the Cox proportional hazards regression model for time to first event. \\\\\nWas changed into: \\\\\nStatistical methods: ... then two separate hypothesis tests for \\\\\n- the primary composite endpoint \\\\\n- the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated \\(GFR \\geq 40 \\%\\) from baseline) \\\\\nwill be tested for superiority, each with the Cox proportional hazards regression model for time to first event. \\\\\nAnd the following text was added: \\\\\nTo adjust for multiplicity a sequentially rejective multiple test procedure will be applied.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\nChange 2: \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.52734375,"confidence_rate":0.9996016948044874},{"cnt":[[253,331],[587,331],[587,2553],[253,2553]],"region":{"top_left_x":253,"top_left_y":331,"width":335,"height":2222},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bccd14f5a9a447bda1cd44c8937116b9","type":"table_column","conversion_output":false,"parent_id":"2f04de95687d4689a526e573faf4be8e","text":"","text_display":""},{"cnt":[[930,331],[1766,331],[1766,2553],[930,2553]],"region":{"top_left_x":930,"top_left_y":331,"width":836,"height":2222},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e23c6df2d834781b8aecf66ab12189d","type":"table_column","conversion_output":false,"parent_id":"2f04de95687d4689a526e573faf4be8e","text":"","text_display":""},{"cnt":[[244,393],[1775,393],[1775,1987],[244,1987]],"region":{"top_left_x":244,"top_left_y":393,"width":1532,"height":1594},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1a95eea985c4cf18dbdf25266b237cc","type":"table_row","conversion_output":false,"parent_id":"2f04de95687d4689a526e573faf4be8e","text":"","text_display":""},{"cnt":[[244,2021],[1775,2021],[1775,2553],[244,2553]],"region":{"top_left_x":244,"top_left_y":2021,"width":1532,"height":532},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb10172c358c495b88a409a4e46d2a96","type":"table_row","conversion_output":false,"parent_id":"2f04de95687d4689a526e573faf4be8e","text":"","text_display":""},{"cnt":[[930,1984],[932,394],[1760,395],[1757,1985]],"region":{"top_left_x":930,"top_left_y":394,"width":830,"height":1592},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35184047820645a086978d0d7b5ee035","type":"complex_cell","conversion_output":false,"parent_id":"2f04de95687d4689a526e573faf4be8e","children_ids":["9262d5fb7c334e7a80306ec10248af9e","b20a81ec7daa456fa647019e7db7bcbb","4626774199854fb6b9d43e724fe9df87","c5adb55e5fdf443f95785400b1a94cf4","d3aff8dd3d4946349d390b4204658925","de462c0410f74dac86dda93040eeedd0","0b27ac5a84e0410f9ba28f6d4174e432","e5bffd5d43274a3a895fe639b92fe7ea","4b4bf449b21748eca31ea27f5dcb5185","c7344bd89de84bc2b53e2363bff2c28b","b91a4244c18d4237b627996914ec226c","4def960ca453461b8b40b1c6e76d3415","f02a2a65c95444fcae140f43b97076c7","339bde2a23024efb9a24da51573b4512","1428de5865aa428b97f05e11d4bee9d9","54d56660077a4e30a4cffeec7b9fac36","ab3feab00bd34b658369c250a85d2325","9523fd7218d840d7b19245b04fa77a21","91154152a37d4d2ebd5bd7f30c72ee85","08f0d29f1fae43c5a788905eb105adf4","eb5373b6055a4d95a42fd31cbc1ca356","9d8cab5d7d574e0897b16b217e7c7c9f","82181cc05bb949639552ffba7a493b3f","d3e4e5aca5b945308e3bca8c63270358","f1d82c22bdf842cfbdaa3377de7c1427","13b8bbdf7566406989db50a904065f6e","5712e40641e342a88e21f9c2046da920","ba85a30409834ba3ab2bd28bf2e2d17d","20808608f9a64a4eb36e9aeaf4cdc54b"],"text":"\\begin{tabular}{l}\nChange 8: \\\\\nStatistical methods: The primary analyses will be performed on the full analysis set... \\\\\nWas changed into: \\\\\nThe primary analyses will be performed on the Treated Set... \\\\\nChange 9: \\\\\nStatistical methods: ... then two separate hypothesis tests for \\\\\n- the primary composite endpoint \\\\\n- the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated GFR \\(\\geq 50 \\%\\) from baseline) \\\\\nwill be tested for superiority in parallel, each with the Cox proportional hazards regression model for time to first event. \\\\\nWas changed into: \\\\\nStatistical methods: ... then two separate hypothesis tests for \\\\\n- the primary composite endpoint \\\\\n- the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated \\(GFR \\geq 40 \\%\\) from baseline) \\\\\nwill be tested for superiority, each with the Cox proportional hazards regression model for time to first event. \\\\\nAnd the following text was added: \\\\\nTo adjust for multiplicity a sequentially rejective multiple test procedure will be applied.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 8: \\\\\nStatistical methods: The primary analyses will be performed on the full analysis set... \\\\\nWas changed into: \\\\\nThe primary analyses will be performed on the Treated Set... \\\\\nChange 9: \\\\\nStatistical methods: ... then two separate hypothesis tests for \\\\\n- the primary composite endpoint \\\\\n- the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated GFR \\(\\geq 50 \\%\\) from baseline) \\\\\nwill be tested for superiority in parallel, each with the Cox proportional hazards regression model for time to first event. \\\\\nWas changed into: \\\\\nStatistical methods: ... then two separate hypothesis tests for \\\\\n- the primary composite endpoint \\\\\n- the composite renal endpoint (i.e. renal death, sustained ESRD, sustained decrease in estimated \\(GFR \\geq 40 \\%\\) from baseline) \\\\\nwill be tested for superiority, each with the Cox proportional hazards regression model for time to first event. \\\\\nAnd the following text was added: \\\\\nTo adjust for multiplicity a sequentially rejective multiple test procedure will be applied.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.52734375,"confidence_rate":0.9988088164811179},{"cnt":[[939,400],[1089,400],[1089,444],[939,444]],"region":{"top_left_x":939,"top_left_y":400,"width":151,"height":44},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9262d5fb7c334e7a80306ec10248af9e","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"Change 8:","text_display":"Change 8:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,444],[1632,444],[1632,485],[939,485]],"region":{"top_left_x":939,"top_left_y":443,"width":694,"height":43},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b20a81ec7daa456fa647019e7db7bcbb","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"Statistical methods: The primary analyses will be","text_display":"\nStatistical methods: The primary analyses will be","confidence":1,"confidence_rate":1},{"cnt":[[939,485],[1444,485],[1444,527],[939,527]],"region":{"top_left_x":939,"top_left_y":485,"width":505,"height":42},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4626774199854fb6b9d43e724fe9df87","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"performed on the full analysis set...","text_display":" performed on the full analysis set...","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[939,580],[1204,580],[1204,623],[939,623]],"region":{"top_left_x":939,"top_left_y":579,"width":266,"height":45},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5adb55e5fdf443f95785400b1a94cf4","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99560546875,"confidence_rate":0.9997998284195073},{"cnt":[[939,676],[1713,676],[1713,720],[939,720]],"region":{"top_left_x":939,"top_left_y":676,"width":774,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3aff8dd3d4946349d390b4204658925","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"The primary analyses will be performed on the Treated","text_display":"\nThe primary analyses will be performed on the Treated","confidence":1,"confidence_rate":1},{"cnt":[[939,718],[1027,718],[1027,759],[939,759]],"region":{"top_left_x":939,"top_left_y":717,"width":88,"height":43},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de462c0410f74dac86dda93040eeedd0","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"Set...","text_display":" Set...","confidence":0.99951171875,"confidence_rate":0.9999556009403848},{"cnt":[[939,819],[1089,819],[1089,858],[939,858]],"region":{"top_left_x":939,"top_left_y":819,"width":151,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b27ac5a84e0410f9ba28f6d4174e432","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"Change 9:","text_display":"\nChange 9:","confidence":1,"confidence_rate":1},{"cnt":[[939,861],[1743,861],[1743,904],[939,904]],"region":{"top_left_x":939,"top_left_y":860,"width":804,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5bffd5d43274a3a895fe639b92fe7ea","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"Statistical methods: ... then two separate hypothesis tests","text_display":"\nStatistical methods: ... then two separate hypothesis tests","confidence":1,"confidence_rate":1},{"cnt":[[932,902],[990,902],[990,939],[932,939]],"region":{"top_left_x":932,"top_left_y":902,"width":59,"height":37},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b4bf449b21748eca31ea27f5dcb5185","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"for","text_display":" for","confidence":1,"confidence_rate":1},{"cnt":[[1004,953],[1517,953],[1517,992],[1004,992]],"region":{"top_left_x":1003,"top_left_y":952,"width":515,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7344bd89de84bc2b53e2363bff2c28b","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"- the primary composite endpoint","text_display":"\n- the primary composite endpoint","confidence":1,"confidence_rate":1},{"cnt":[[1004,1003],[1706,1003],[1706,1042],[1004,1042]],"region":{"top_left_x":1003,"top_left_y":1003,"width":704,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b91a4244c18d4237b627996914ec226c","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"- the composite renal endpoint (i.e. renal death,","text_display":"\n- the composite renal endpoint (i.e. renal death,","confidence":1,"confidence_rate":1},{"cnt":[[1064,1045],[1752,1045],[1752,1082],[1064,1082]],"region":{"top_left_x":1063,"top_left_y":1044,"width":690,"height":38},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4def960ca453461b8b40b1c6e76d3415","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"sustained ESRD, sustained decrease in estimated","text_display":" sustained ESRD, sustained decrease in estimated","confidence":1,"confidence_rate":1},{"cnt":[[1064,1082],[1448,1082],[1448,1125],[1064,1125]],"region":{"top_left_x":1063,"top_left_y":1081,"width":386,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f02a2a65c95444fcae140f43b97076c7","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"GFR \\(\\geq 50 \\%\\) from baseline)","text_display":" GFR \\(\\geq 50 \\%\\) from baseline)","confidence":0.689453125,"confidence_rate":0.9880762845175703},{"cnt":[[939,1137],[1695,1137],[1695,1181],[939,1181]],"region":{"top_left_x":939,"top_left_y":1136,"width":756,"height":45},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"339bde2a23024efb9a24da51573b4512","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"will be tested for superiority in parallel, each with the","text_display":"\nwill be tested for superiority in parallel, each with the","confidence":1,"confidence_rate":1},{"cnt":[[939,1178],[1701,1178],[1701,1217],[939,1217]],"region":{"top_left_x":939,"top_left_y":1178,"width":763,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1428de5865aa428b97f05e11d4bee9d9","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"Cox proportional hazards regression model for time to","text_display":" Cox proportional hazards regression model for time to","confidence":1,"confidence_rate":1},{"cnt":[[939,1220],[1094,1220],[1094,1254],[939,1254]],"region":{"top_left_x":939,"top_left_y":1219,"width":155,"height":36},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54d56660077a4e30a4cffeec7b9fac36","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"first event.","text_display":" first event.","confidence":1,"confidence_rate":1},{"cnt":[[939,1316],[1204,1316],[1204,1356],[939,1356]],"region":{"top_left_x":939,"top_left_y":1316,"width":266,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab3feab00bd34b658369c250a85d2325","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99609375,"confidence_rate":0.9998221113094726},{"cnt":[[939,1413],[1743,1413],[1743,1452],[939,1452]],"region":{"top_left_x":939,"top_left_y":1413,"width":804,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9523fd7218d840d7b19245b04fa77a21","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"Statistical methods: ... then two separate hypothesis tests","text_display":"\nStatistical methods: ... then two separate hypothesis tests","confidence":1,"confidence_rate":1},{"cnt":[[932,1445],[990,1445],[990,1487],[932,1487]],"region":{"top_left_x":932,"top_left_y":1445,"width":59,"height":42},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91154152a37d4d2ebd5bd7f30c72ee85","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"for","text_display":" for","confidence":1,"confidence_rate":1},{"cnt":[[1004,1501],[1517,1501],[1517,1544],[1004,1544]],"region":{"top_left_x":1003,"top_left_y":1500,"width":515,"height":45},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08f0d29f1fae43c5a788905eb105adf4","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"- the primary composite endpoint","text_display":"\n- the primary composite endpoint","confidence":1,"confidence_rate":1},{"cnt":[[1004,1551],[1706,1551],[1706,1593],[1004,1593]],"region":{"top_left_x":1003,"top_left_y":1551,"width":704,"height":42},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb5373b6055a4d95a42fd31cbc1ca356","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"- the composite renal endpoint (i.e. renal death,","text_display":"\n- the composite renal endpoint (i.e. renal death,","confidence":1,"confidence_rate":1},{"cnt":[[1064,1593],[1752,1593],[1752,1632],[1064,1632]],"region":{"top_left_x":1063,"top_left_y":1592,"width":690,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d8cab5d7d574e0897b16b217e7c7c9f","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"sustained ESRD, sustained decrease in estimated","text_display":" sustained ESRD, sustained decrease in estimated","confidence":1,"confidence_rate":1},{"cnt":[[1064,1634],[1448,1634],[1448,1673],[1064,1673]],"region":{"top_left_x":1063,"top_left_y":1634,"width":386,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"82181cc05bb949639552ffba7a493b3f","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"\\(GFR \\geq 40 \\%\\) from baseline)","text_display":" \\(GFR \\geq 40 \\%\\) from baseline)","confidence":0.52734375,"confidence_rate":0.9781760556229816},{"cnt":[[939,1680],[1609,1680],[1609,1722],[939,1722]],"region":{"top_left_x":939,"top_left_y":1680,"width":671,"height":42},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3e4e5aca5b945308e3bca8c63270358","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"will be tested for superiority, each with the Cox","text_display":"\nwill be tested for superiority, each with the Cox","confidence":1,"confidence_rate":1},{"cnt":[[939,1722],[1701,1722],[1701,1761],[939,1761]],"region":{"top_left_x":939,"top_left_y":1721,"width":763,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1d82c22bdf842cfbdaa3377de7c1427","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"proportional hazards regression model for time to first","text_display":" proportional hazards regression model for time to first","confidence":1,"confidence_rate":1},{"cnt":[[939,1763],[1031,1763],[1031,1795],[939,1795]],"region":{"top_left_x":939,"top_left_y":1763,"width":93,"height":33},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13b8bbdf7566406989db50a904065f6e","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"event.","text_display":" event.","confidence":1,"confidence_rate":1},{"cnt":[[939,1855],[1425,1855],[1425,1899],[939,1899]],"region":{"top_left_x":939,"top_left_y":1855,"width":487,"height":45},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5712e40641e342a88e21f9c2046da920","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"And the following text was added:","text_display":"\nAnd the following text was added:","confidence":1,"confidence_rate":1},{"cnt":[[939,1901],[1750,1901],[1750,1940],[939,1940]],"region":{"top_left_x":939,"top_left_y":1901,"width":811,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba85a30409834ba3ab2bd28bf2e2d17d","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"To adjust for multiplicity a sequentially rejective multiple","text_display":"\nTo adjust for multiplicity a sequentially rejective multiple","confidence":1,"confidence_rate":1},{"cnt":[[939,1943],[1365,1943],[1365,1982],[939,1982]],"region":{"top_left_x":939,"top_left_y":1942,"width":427,"height":40},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20808608f9a64a4eb36e9aeaf4cdc54b","type":"text","conversion_output":false,"parent_id":"35184047820645a086978d0d7b5ee035","text":"test procedure will be applied.","text_display":" test procedure will be applied.","confidence":1,"confidence_rate":1},{"cnt":[[265,2030],[582,2030],[582,2072],[265,2072]],"region":{"top_left_x":264,"top_left_y":2030,"width":319,"height":42},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6bb71e9dfaf4642a4f32e88724234ab","type":"simple_cell","conversion_output":false,"parent_id":"2f04de95687d4689a526e573faf4be8e","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2028],[1752,2028],[1752,2551],[935,2551]],"region":{"top_left_x":934,"top_left_y":2027,"width":819,"height":524},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36614b134453411ab8082b1b65875312","type":"complex_cell","conversion_output":false,"parent_id":"2f04de95687d4689a526e573faf4be8e","children_ids":["be6113573f8243de8a603eb6b7502b78","884d3050fc8b45f088c7fbe8d5f82189","4b633d1e103d4fd7b9353813080fded9","35d3188f5fa945f7816701a12e2b3b2d","ad73bc33262a468ba595f06d6f981d1c","1e2eb15d9d114e098679a0f066764afa","da4fe22ef00d4da6918ca34c5edf4c7a","b94ad415d34f48f4821ede126305fce2","1e43b8f67d9947ab9e204bf9131031fe","27309fddd1554990b80c0e6ff2977115","0925e401389b43578a6e102611ef9de9","69a1d4fc786543ecb1a57161ebb8514b"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\nChange 2: \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\nChange 2: \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999967399268953},{"cnt":[[939,2030],[1089,2030],[1089,2069],[939,2069]],"region":{"top_left_x":939,"top_left_y":2030,"width":151,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be6113573f8243de8a603eb6b7502b78","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2072],[1692,2072],[1692,2111],[939,2111]],"region":{"top_left_x":939,"top_left_y":2071,"width":754,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"884d3050fc8b45f088c7fbe8d5f82189","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"Based on review of recently published cardiovascular","text_display":"\nBased on review of recently published cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[939,2109],[1711,2109],[1711,2150],[939,2150]],"region":{"top_left_x":939,"top_left_y":2108,"width":772,"height":42},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b633d1e103d4fd7b9353813080fded9","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"outcome trials, changing the protocol definitions of the","text_display":" outcome trials, changing the protocol definitions of the","confidence":1,"confidence_rate":1},{"cnt":[[939,2150],[1743,2150],[1743,2189],[939,2189]],"region":{"top_left_x":939,"top_left_y":2149,"width":804,"height":41},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35d3188f5fa945f7816701a12e2b3b2d","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"primary and secondary endpoints, essentially substituting","text_display":" primary and secondary endpoints, essentially substituting","confidence":1,"confidence_rate":1},{"cnt":[[939,2191],[1720,2191],[1720,2231],[939,2231]],"region":{"top_left_x":939,"top_left_y":2191,"width":781,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad73bc33262a468ba595f06d6f981d1c","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"4-Point MACE (Cardiovascular (CV) Death, Non-Fatal","text_display":" 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal","confidence":1,"confidence_rate":1},{"cnt":[[939,2231],[1550,2231],[1550,2270],[939,2270]],"region":{"top_left_x":939,"top_left_y":2230,"width":611,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e2eb15d9d114e098679a0f066764afa","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"Stoke, Non-fatal Myocardial Infarction and","text_display":" Stoke, Non-fatal Myocardial Infarction and","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[939,2270],[1752,2270],[1752,2309],[939,2309]],"region":{"top_left_x":939,"top_left_y":2269,"width":814,"height":40},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da4fe22ef00d4da6918ca34c5edf4c7a","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"Hospitalization for Unstable Angina) with 3-Point MACE","text_display":" Hospitalization for Unstable Angina) with 3-Point MACE","confidence":1,"confidence_rate":1},{"cnt":[[939,2311],[1665,2311],[1665,2350],[939,2350]],"region":{"top_left_x":939,"top_left_y":2311,"width":726,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b94ad415d34f48f4821ede126305fce2","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"(CV Death, Non-Fatal Stoke, Non-fatal Myocardial","text_display":" (CV Death, Non-Fatal Stoke, Non-fatal Myocardial","confidence":1,"confidence_rate":1},{"cnt":[[939,2348],[1103,2348],[1103,2387],[939,2387]],"region":{"top_left_x":939,"top_left_y":2347,"width":164,"height":41},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e43b8f67d9947ab9e204bf9131031fe","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"Infarction).","text_display":" Infarction).","confidence":0.99951171875,"confidence_rate":0.9999712709716212},{"cnt":[[939,2426],[1089,2426],[1089,2470],[939,2470]],"region":{"top_left_x":939,"top_left_y":2426,"width":151,"height":45},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27309fddd1554990b80c0e6ff2977115","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2468],[1655,2468],[1655,2509],[939,2509]],"region":{"top_left_x":939,"top_left_y":2467,"width":717,"height":43},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0925e401389b43578a6e102611ef9de9","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"eGFR cut off changed in response to the NIH/FDA","text_display":"\neGFR cut off changed in response to the NIH/FDA","confidence":1,"confidence_rate":1},{"cnt":[[939,2509],[1706,2509],[1706,2548],[939,2548]],"region":{"top_left_x":939,"top_left_y":2509,"width":768,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69a1d4fc786543ecb1a57161ebb8514b","type":"text","conversion_output":false,"parent_id":"36614b134453411ab8082b1b65875312","text":"scientific workshop on GFR decline as an endpoint for","text_display":" scientific workshop on GFR decline as an endpoint for","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":56,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f6d60e5873bb4b6eb93f2102b4fe5103","type":"section_header","conversion_output":false,"children_ids":["ae28c420f623425d9e0892cad5becb4c"],"text":"","text_display":""},{"cnt":[[790,2586],[1300,2586],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2585,"width":510,"height":36},"line":57,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ae28c420f623425d9e0892cad5becb4c","type":"text","conversion_output":true,"parent_id":"f6d60e5873bb4b6eb93f2102b4fe5103","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99609375,"confidence_rate":0.9999068162627995},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":58,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b3b21fd2c4344743afae25a83707fe04","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":59,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b54332bc466d429aa2b3413d8670d217","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-104","page":104,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e551ba3c0b1460eb3f7db7b25f7b238","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"576376d230bc4539a78d8dbe3cfcb977","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"317f4491f02c45a388c58096a1c233c2","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf525a8c69a94e3baaa32ccf6b831389","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81cf495fbe744014bdf40c419558fa01","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c91bd4ed683348f2a96d6cd288e41e0c","type":"page_info","conversion_output":false,"text":"Page 104 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2558],[244,2558]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2228},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","type":"table","conversion_output":true,"children_ids":["eea2de46b1c44df8945c8eecb3b6a655","69a54382e6c8483a882f9793486e6e89","a23c4cbc294248a4b5b97d508d765f75","72a1f05ee5a04c11819ab0465f8f1fdb","7492482a68044648a01b29597f1f9936","3ed4100416e7451bbb58d7c368758d73","6eb65d94ab2340ed9a87a197b08f8fe6","6f9300856e3b446eb12405c264204713","0300fbced2374c798efc4be8e3c1fbea","3e049c04a7424f3fb9988ef20512fc3b"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nclinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 3: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. \\\\\nChange 4: \\\\\nSince the interim analysis for efficacy was deleted, the required number of patients with primary endpoint to achieve a power of \\(90 \\%\\) for non-inferiority is reduced from 625 to 611. The estimated trial duration increased slightly due to the change of the primary endpoint while ensuring a sufficiently long drug exposure for the last recruited patients. \\\\\nChange 5: \\\\\nSince the primary endpoint was changed to 3-point MACE it is no longer listed as key secondary endpoint.\n\\end{tabular} \\\\\n\\hline Section to be changed & Flow chart \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nChange in follow-up period from 7 to 30 days \\\\\nChange 2: \\\\\nGuidance revised on the timing of the EOT visit after study stop announcement after 611 endpoint events are reached \\\\\nIn addition \\\\\n- ...changes since last visit might be recorded \\\\\nWas changed into \\\\\n- ...changes since last visit should be recorded\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nclinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 3: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. \\\\\nChange 4: \\\\\nSince the interim analysis for efficacy was deleted, the required number of patients with primary endpoint to achieve a power of \\(90 \\%\\) for non-inferiority is reduced from 625 to 611. The estimated trial duration increased slightly due to the change of the primary endpoint while ensuring a sufficiently long drug exposure for the last recruited patients. \\\\\nChange 5: \\\\\nSince the primary endpoint was changed to 3-point MACE it is no longer listed as key secondary endpoint.\n\\end{tabular} \\\\\n\\hline Section to be changed & Flow chart \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nChange in follow-up period from 7 to 30 days \\\\\nChange 2: \\\\\nGuidance revised on the timing of the EOT visit after study stop announcement after 611 endpoint events are reached \\\\\nIn addition \\\\\n- ...changes since last visit might be recorded \\\\\nWas changed into \\\\\n- ...changes since last visit should be recorded\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.98291015625,"confidence_rate":0.9999914536586864},{"cnt":[[249,331],[601,331],[601,2560],[249,2560]],"region":{"top_left_x":248,"top_left_y":331,"width":353,"height":2229},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eea2de46b1c44df8945c8eecb3b6a655","type":"table_column","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","text":"","text_display":""},{"cnt":[[930,331],[1761,331],[1761,2560],[930,2560]],"region":{"top_left_x":930,"top_left_y":331,"width":832,"height":2229},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69a54382e6c8483a882f9793486e6e89","type":"table_column","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","text":"","text_display":""},{"cnt":[[244,333],[1775,333],[1775,1862],[244,1862]],"region":{"top_left_x":244,"top_left_y":333,"width":1532,"height":1530},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a23c4cbc294248a4b5b97d508d765f75","type":"table_row","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","text":"","text_display":""},{"cnt":[[244,1855],[1775,1855],[1775,1904],[244,1904]],"region":{"top_left_x":244,"top_left_y":1855,"width":1532,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72a1f05ee5a04c11819ab0465f8f1fdb","type":"table_row","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","text":"","text_display":""},{"cnt":[[244,1906],[1775,1906],[1775,2484],[244,2484]],"region":{"top_left_x":244,"top_left_y":1905,"width":1532,"height":579},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7492482a68044648a01b29597f1f9936","type":"table_row","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","text":"","text_display":""},{"cnt":[[932,336],[1759,336],[1759,1185],[932,1185]],"region":{"top_left_x":932,"top_left_y":335,"width":828,"height":851},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ed4100416e7451bbb58d7c368758d73","type":"complex_cell","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","children_ids":["49b7c261324746cdb9249202130edffd","a75a4f7b61c24c788c460c1f5f31b884","9e7274d3ce1a40a4ad1028c9fbde3b03","8346060ec8644c80997283c5fdd97bb5","b7a6b01f65854ef5a42846c1f102f3f2","e93b6de6a47c4064bcc89221e749f8a9","aa5b7d0529e840f094d72272ec7b190d","e11eadabe15449caa0e21b883f5e4f65","a8208c88e0cf411ea889082724455267","f5ad2793548f4a8684e1c0aed5f31067","36d8799ef8c34f408695437129504dd8","27ce0b727c2748ff86e14fd86f467dde","81ef716383f545529c334cc47092f99c","cd2aad278597496b8055b6963e581502","1ff7aa79cd734dbc9f43f9eb40152ad8","3db20cb898644c3a954c0aa1126972c6","632735cc9c004309a155e8735fb1fd08","e93608daaeb74ed8b983bf889c1f1ae0"],"text":"\\begin{tabular}{l}\nclinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 3: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. \\\\\nChange 4: \\\\\nSince the interim analysis for efficacy was deleted, the required number of patients with primary endpoint to achieve a power of \\(90 \\%\\) for non-inferiority is reduced from 625 to 611. The estimated trial duration increased slightly due to the change of the primary endpoint while ensuring a sufficiently long drug exposure for the last recruited patients. \\\\\nChange 5: \\\\\nSince the primary endpoint was changed to 3-point MACE it is no longer listed as key secondary endpoint.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nclinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 3: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. \\\\\nChange 4: \\\\\nSince the interim analysis for efficacy was deleted, the required number of patients with primary endpoint to achieve a power of \\(90 \\%\\) for non-inferiority is reduced from 625 to 611. The estimated trial duration increased slightly due to the change of the primary endpoint while ensuring a sufficiently long drug exposure for the last recruited patients. \\\\\nChange 5: \\\\\nSince the primary endpoint was changed to 3-point MACE it is no longer listed as key secondary endpoint.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.98291015625,"confidence_rate":0.9999572690238253},{"cnt":[[939,340],[1715,340],[1715,379],[939,379]],"region":{"top_left_x":939,"top_left_y":340,"width":777,"height":40},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49b7c261324746cdb9249202130edffd","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"clinical trials in CKD and the current clinical landscape","text_display":"clinical trials in CKD and the current clinical landscape","confidence":1,"confidence_rate":1},{"cnt":[[939,382],[1678,382],[1678,421],[939,421]],"region":{"top_left_x":939,"top_left_y":381,"width":740,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a75a4f7b61c24c788c460c1f5f31b884","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"on decline in estimated glomerular filtration rate and","text_display":" on decline in estimated glomerular filtration rate and","confidence":1,"confidence_rate":1},{"cnt":[[939,421],[1725,421],[1725,462],[939,462]],"region":{"top_left_x":939,"top_left_y":420,"width":786,"height":43},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e7274d3ce1a40a4ad1028c9fbde3b03","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"subsequent risk of end stage renal disease and mortality.","text_display":" subsequent risk of end stage renal disease and mortality.","confidence":1,"confidence_rate":1},{"cnt":[[939,501],[1089,501],[1089,541],[939,541]],"region":{"top_left_x":939,"top_left_y":501,"width":151,"height":40},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8346060ec8644c80997283c5fdd97bb5","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,543],[1651,543],[1651,580],[939,580]],"region":{"top_left_x":939,"top_left_y":542,"width":712,"height":38},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7a6b01f65854ef5a42846c1f102f3f2","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"Overall MACE event rates are higher than initially","text_display":"\nOverall MACE event rates are higher than initially","confidence":0.99658203125,"confidence_rate":0.9999377506039459},{"cnt":[[939,580],[1752,580],[1752,619],[939,619]],"region":{"top_left_x":939,"top_left_y":579,"width":814,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e93b6de6a47c4064bcc89221e749f8a9","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"expected and this allows reducing the sample size without","text_display":" expected and this allows reducing the sample size without","confidence":1,"confidence_rate":1},{"cnt":[[939,621],[1388,621],[1388,660],[939,660]],"region":{"top_left_x":939,"top_left_y":621,"width":450,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa5b7d0529e840f094d72272ec7b190d","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"major impact on study duration.","text_display":" major impact on study duration.","confidence":1,"confidence_rate":1},{"cnt":[[939,699],[1084,699],[1084,739],[939,739]],"region":{"top_left_x":939,"top_left_y":699,"width":146,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e11eadabe15449caa0e21b883f5e4f65","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"Change 4:","text_display":"\nChange 4:","confidence":0.998046875,"confidence_rate":0.9998603644045428},{"cnt":[[939,741],[1706,741],[1706,780],[939,780]],"region":{"top_left_x":939,"top_left_y":740,"width":768,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8208c88e0cf411ea889082724455267","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"Since the interim analysis for efficacy was deleted, the","text_display":"\nSince the interim analysis for efficacy was deleted, the","confidence":1,"confidence_rate":1},{"cnt":[[939,782],[1683,782],[1683,821],[939,821]],"region":{"top_left_x":939,"top_left_y":782,"width":745,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5ad2793548f4a8684e1c0aed5f31067","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"required number of patients with primary endpoint to","text_display":" required number of patients with primary endpoint to","confidence":1,"confidence_rate":1},{"cnt":[[939,821],[1692,821],[1692,858],[939,858]],"region":{"top_left_x":939,"top_left_y":821,"width":754,"height":38},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36d8799ef8c34f408695437129504dd8","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"achieve a power of \\(90 \\%\\) for non-inferiority is reduced","text_display":" achieve a power of \\(90 \\%\\) for non-inferiority is reduced","confidence":0.98291015625,"confidence_rate":0.999717456963466},{"cnt":[[939,861],[1711,861],[1711,895],[939,895]],"region":{"top_left_x":939,"top_left_y":860,"width":772,"height":36},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27ce0b727c2748ff86e14fd86f467dde","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"from 625 to 611. The estimated trial duration increased","text_display":" from 625 to 611. The estimated trial duration increased","confidence":0.99609375,"confidence_rate":0.999937876543692},{"cnt":[[939,902],[1727,902],[1727,941],[939,941]],"region":{"top_left_x":939,"top_left_y":902,"width":788,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81ef716383f545529c334cc47092f99c","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"slightly due to the change of the primary endpoint while","text_display":" slightly due to the change of the primary endpoint while","confidence":0.99072265625,"confidence_rate":0.9998472141920621},{"cnt":[[939,941],[1692,941],[1692,978],[939,978]],"region":{"top_left_x":939,"top_left_y":941,"width":754,"height":38},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd2aad278597496b8055b6963e581502","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"ensuring a sufficiently long drug exposure for the last","text_display":" ensuring a sufficiently long drug exposure for the last","confidence":1,"confidence_rate":1},{"cnt":[[939,980],[1190,980],[1190,1019],[939,1019]],"region":{"top_left_x":939,"top_left_y":980,"width":252,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ff7aa79cd734dbc9f43f9eb40152ad8","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"recruited patients.","text_display":" recruited patients.","confidence":1,"confidence_rate":1},{"cnt":[[939,1059],[1089,1059],[1089,1098],[939,1098]],"region":{"top_left_x":939,"top_left_y":1058,"width":151,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3db20cb898644c3a954c0aa1126972c6","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"Change 5:","text_display":"\nChange 5:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1100],[1655,1100],[1655,1139],[939,1139]],"region":{"top_left_x":939,"top_left_y":1100,"width":717,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"632735cc9c004309a155e8735fb1fd08","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"Since the primary endpoint was changed to 3-point","text_display":"\nSince the primary endpoint was changed to 3-point","confidence":1,"confidence_rate":1},{"cnt":[[939,1141],[1713,1141],[1713,1181],[939,1181]],"region":{"top_left_x":939,"top_left_y":1141,"width":774,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e93608daaeb74ed8b983bf889c1f1ae0","type":"text","conversion_output":false,"parent_id":"3ed4100416e7451bbb58d7c368758d73","text":"MACE it is no longer listed as key secondary endpoint.","text_display":" MACE it is no longer listed as key secondary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[267,1862],[592,1862],[592,1899],[267,1899]],"region":{"top_left_x":267,"top_left_y":1862,"width":325,"height":38},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6eb65d94ab2340ed9a87a197b08f8fe6","type":"simple_cell","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","text":"Section to be changed","text_display":"Section to be changed","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1862],[1107,1862],[1107,1894],[939,1894]],"region":{"top_left_x":939,"top_left_y":1862,"width":169,"height":33},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f9300856e3b446eb12405c264204713","type":"simple_cell","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","text":"Flow chart","text_display":"Flow chart","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1915],[592,1915],[592,1954],[267,1954]],"region":{"top_left_x":267,"top_left_y":1915,"width":325,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0300fbced2374c798efc4be8e3c1fbea","type":"simple_cell","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","text":"Description of change","text_display":"Description of change","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1911],[1715,1911],[1715,2479],[935,2479]],"region":{"top_left_x":934,"top_left_y":1910,"width":782,"height":570},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e049c04a7424f3fb9988ef20512fc3b","type":"complex_cell","conversion_output":false,"parent_id":"ee0b0ed1e7ef46b4bffde9b3ba76c0a7","children_ids":["fdb1700c87a44fca921e0b9fa5c5de7c","1fe8dfed10324333ad9e828ada4f88f6","b3ba280e5b624160bdc402d0cc9a9718","eb9d07ca7bbb4facbcec504155ead5da","5d293dcb09844e9b9ff210450da7aee4","75bc914bd03f4791943c7d555fc84b0b","e97ddfe784724e61a7203dd7701382f6","6c50f48f40ca454387b6fe9954714c4c","b0fdf7b6f0f44d4680f1dbb1653856aa","c92f2b1851fb41fab004a2831f48956f"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nChange in follow-up period from 7 to 30 days \\\\\nChange 2: \\\\\nGuidance revised on the timing of the EOT visit after study stop announcement after 611 endpoint events are reached \\\\\nIn addition \\\\\n- ...changes since last visit might be recorded \\\\\nWas changed into \\\\\n- ...changes since last visit should be recorded\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nChange in follow-up period from 7 to 30 days \\\\\nChange 2: \\\\\nGuidance revised on the timing of the EOT visit after study stop announcement after 611 endpoint events are reached \\\\\nIn addition \\\\\n- ...changes since last visit might be recorded \\\\\nWas changed into \\\\\n- ...changes since last visit should be recorded\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1911],[1089,1911],[1089,1954],[939,1954]],"region":{"top_left_x":939,"top_left_y":1910,"width":151,"height":45},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fdb1700c87a44fca921e0b9fa5c5de7c","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1952],[1584,1952],[1584,1991],[939,1991]],"region":{"top_left_x":939,"top_left_y":1951,"width":646,"height":41},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fe8dfed10324333ad9e828ada4f88f6","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"Change in follow-up period from 7 to 30 days","text_display":"\nChange in follow-up period from 7 to 30 days","confidence":1,"confidence_rate":1},{"cnt":[[939,2030],[1089,2030],[1089,2074],[939,2074]],"region":{"top_left_x":939,"top_left_y":2030,"width":151,"height":44},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3ba280e5b624160bdc402d0cc9a9718","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2072],[1688,2072],[1688,2111],[939,2111]],"region":{"top_left_x":939,"top_left_y":2071,"width":749,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb9d07ca7bbb4facbcec504155ead5da","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"Guidance revised on the timing of the EOT visit after","text_display":"\nGuidance revised on the timing of the EOT visit after","confidence":1,"confidence_rate":1},{"cnt":[[939,2113],[1711,2113],[1711,2152],[939,2152]],"region":{"top_left_x":939,"top_left_y":2113,"width":772,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d293dcb09844e9b9ff210450da7aee4","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"study stop announcement after 611 endpoint events are","text_display":" study stop announcement after 611 endpoint events are","confidence":1,"confidence_rate":1},{"cnt":[[939,2150],[1057,2150],[1057,2185],[939,2185]],"region":{"top_left_x":939,"top_left_y":2149,"width":118,"height":36},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"75bc914bd03f4791943c7d555fc84b0b","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"reached","text_display":" reached","confidence":1,"confidence_rate":1},{"cnt":[[939,2233],[1098,2233],[1098,2267],[939,2267]],"region":{"top_left_x":939,"top_left_y":2232,"width":160,"height":36},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e97ddfe784724e61a7203dd7701382f6","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"In addition","text_display":"\nIn addition","confidence":1,"confidence_rate":1},{"cnt":[[1004,2274],[1678,2274],[1678,2313],[1004,2313]],"region":{"top_left_x":1003,"top_left_y":2274,"width":676,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c50f48f40ca454387b6fe9954714c4c","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"- ...changes since last visit might be recorded","text_display":"\n- ...changes since last visit might be recorded","confidence":1,"confidence_rate":1},{"cnt":[[939,2353],[1195,2353],[1195,2396],[939,2396]],"region":{"top_left_x":939,"top_left_y":2352,"width":256,"height":45},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0fdf7b6f0f44d4680f1dbb1653856aa","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"Was changed into","text_display":"\nWas changed into","confidence":1,"confidence_rate":1},{"cnt":[[1004,2435],[1688,2435],[1688,2475],[1004,2475]],"region":{"top_left_x":1003,"top_left_y":2435,"width":685,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c92f2b1851fb41fab004a2831f48956f","type":"text","conversion_output":false,"parent_id":"3e049c04a7424f3fb9988ef20512fc3b","text":"- ...changes since last visit should be recorded","text_display":"\n- ...changes since last visit should be recorded","confidence":1,"confidence_rate":1},{"cnt":[[788,2579],[1300,2579],[1300,2625],[788,2625]],"region":{"top_left_x":788,"top_left_y":2579,"width":512,"height":46},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"23f93d13d4174086927c19581b7cac16","type":"section_header","conversion_output":false,"children_ids":["bdcdcf8290c045e49944d2daeb3de026"],"text":"","text_display":""},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bdcdcf8290c045e49944d2daeb3de026","type":"text","conversion_output":true,"parent_id":"23f93d13d4174086927c19581b7cac16","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"abf9d9fe3e5145cfb4a012590b9cd416","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ada97c457fb8430d9a1c7e476f83356d","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-105","page":105,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f40576af039e4f3a89117bf1d55264d1","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb38d4ac41a2426caf30609999d8e7d8","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aba0d7d166b44e588341e14759ad4b7c","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2896b55639648f299549873ae8442d2","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa18822caa1b4aaea4098753c5439ff1","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83162f5a39ab42f9887862158901546e","type":"page_info","conversion_output":false,"text":"Page 105 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2554],[244,2554]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2221},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"896459702add42bf9d5f9b33b7b8912d","type":"table","conversion_output":true,"children_ids":["7fff5364a3f348a9898adc4956f798d2","91fe0526926548c69dd84ce72189a0dd","8444b45dfa7a4548a1de34c5a6ba6306","5af8a045eda749a385db3e4e04d53ddb","69eaa439bac54b7ab8315b36e1cf6f5f","5a10772116844c998297b740e910402f","48179be78a8745f6804d28d386286118","c78b93cd985147fbb84e69db813989b4","cf43cc3a543b497b86522334db7e75c5","c2889380634c4124a6b91268b4d09082","124150a9ff0d4633b1180bfbd18d4213","2dc13e381cfd4141bc24a42698542a6d","64587b39a9704872a3f9e8c610ff7ab6","0a40a18c693744b7b712e9f76410ed56","656cbd80f5be4dea9600699376a7a376","7fbbc9ac6c604ad895eee0fead72dda4","bf109f787f564f5da3e3cbc3df2b2db8","1673859828e94a8ca00bcba606e3a279","423031da694d44fc9374f9bacbab3152","7d00047d25df4cce8bed89c334204399","1fa548baa47a4566acdbc961dbf187ac","0a5daed4d333419aa1e6fd8049c88b72","47021b150da64af78312acf3846a54ad","0df315b0903d4d629b111df50876b778","4876f69a9b0940da97d470b09d3ef99f","6d3b2227fdb94d619d246b9f62a81d03","c414e363336e488cb16e1bbe503bff83","da7d15e18a004e7d8735cdd1c46e115d","35640c40e6af468c9e47098e221fa494","25dece18672c4379a86f88e573a841af","b17b6353355149d585903f02dbb2b739"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 3: \\\\\nFootnote L: estimated creatinine clearance \\\\\nWas changed into: \\\\\nEstimated glomerular filtration rate\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo allow for outcome event data collection up to 30 days after EOT \\\\\nChange 2: \\\\\nTo clarify the respective actions to stop the trial when 611 endpoint events are reached \\\\\nChange 3: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & Abbreviations \\\\\n\\hline Description of change & \\begin{tabular}{l}\nCHC - Congestive Heart Failure and VEGF - Vascular endothelial growth factor deleted OS - On-treatment Set and \\\\\nTS - Treated Set were added\n\\end{tabular} \\\\\n\\hline Rationale for change & Due to change in the text. \\\\\n\\hline Section to be changed & 1.2 Drug profile \\\\\n\\hline Description of change & Drug profile section updated \\\\\n\\hline Rationale for change & For clarification per current version of the investigator brochure. \\\\\n\\hline Section to be changed & 2.2 trial objectives \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nChange 2: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated with a test on superiority. The CV and renal superiority tests will be performed separately, with no upfront imbalance regarding the assigned alpha-levels. \\\\\nIf linagliptin is superior with regard to the primary endpoint and/or the composite renal endpoint, a further\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 3: \\\\\nFootnote L: estimated creatinine clearance \\\\\nWas changed into: \\\\\nEstimated glomerular filtration rate\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo allow for outcome event data collection up to 30 days after EOT \\\\\nChange 2: \\\\\nTo clarify the respective actions to stop the trial when 611 endpoint events are reached \\\\\nChange 3: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & Abbreviations \\\\\n\\hline Description of change & \\begin{tabular}{l}\nCHC - Congestive Heart Failure and VEGF - Vascular endothelial growth factor deleted OS - On-treatment Set and \\\\\nTS - Treated Set were added\n\\end{tabular} \\\\\n\\hline Rationale for change & Due to change in the text. \\\\\n\\hline Section to be changed & 1.2 Drug profile \\\\\n\\hline Description of change & Drug profile section updated \\\\\n\\hline Rationale for change & For clarification per current version of the investigator brochure. \\\\\n\\hline Section to be changed & 2.2 trial objectives \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nChange 2: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated with a test on superiority. The CV and renal superiority tests will be performed separately, with no upfront imbalance regarding the assigned alpha-levels. \\\\\nIf linagliptin is superior with regard to the primary endpoint and/or the composite renal endpoint, a further\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.953125,"confidence_rate":0.9999927870717379},{"cnt":[[251,333],[603,333],[603,2555],[251,2555]],"region":{"top_left_x":250,"top_left_y":333,"width":354,"height":2222},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fff5364a3f348a9898adc4956f798d2","type":"table_column","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[930,333],[1748,333],[1748,2555],[930,2555]],"region":{"top_left_x":930,"top_left_y":333,"width":818,"height":2222},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91fe0526926548c69dd84ce72189a0dd","type":"table_column","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,335],[1775,335],[1775,586],[244,586]],"region":{"top_left_x":244,"top_left_y":335,"width":1532,"height":252},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8444b45dfa7a4548a1de34c5a6ba6306","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,616],[1775,616],[1775,1026],[244,1026]],"region":{"top_left_x":244,"top_left_y":616,"width":1532,"height":411},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5af8a045eda749a385db3e4e04d53ddb","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,1061],[1775,1061],[1775,1104],[244,1104]],"region":{"top_left_x":244,"top_left_y":1060,"width":1532,"height":45},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69eaa439bac54b7ab8315b36e1cf6f5f","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,1111],[1775,1111],[1775,1275],[244,1275]],"region":{"top_left_x":244,"top_left_y":1111,"width":1532,"height":164},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a10772116844c998297b740e910402f","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,1275],[1775,1275],[1775,1321],[244,1321]],"region":{"top_left_x":244,"top_left_y":1274,"width":1532,"height":47},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48179be78a8745f6804d28d386286118","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,1328],[1775,1328],[1775,1371],[244,1371]],"region":{"top_left_x":244,"top_left_y":1327,"width":1532,"height":45},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c78b93cd985147fbb84e69db813989b4","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,1378],[1775,1378],[1775,1422],[244,1422]],"region":{"top_left_x":244,"top_left_y":1378,"width":1532,"height":45},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf43cc3a543b497b86522334db7e75c5","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,1429],[1775,1429],[1775,1510],[244,1510]],"region":{"top_left_x":244,"top_left_y":1428,"width":1532,"height":82},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2889380634c4124a6b91268b4d09082","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,1512],[1775,1512],[1775,1556],[244,1556]],"region":{"top_left_x":244,"top_left_y":1511,"width":1532,"height":45},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"124150a9ff0d4633b1180bfbd18d4213","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[244,1560],[1775,1560],[1775,2555],[244,2555]],"region":{"top_left_x":244,"top_left_y":1560,"width":1532,"height":995},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2dc13e381cfd4141bc24a42698542a6d","type":"table_row","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"","text_display":""},{"cnt":[[935,338],[1540,338],[1540,584],[935,584]],"region":{"top_left_x":934,"top_left_y":337,"width":607,"height":247},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64587b39a9704872a3f9e8c610ff7ab6","type":"complex_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","children_ids":["506b8043202a4555b2593c3c80fcda35","a4733ab398c340c0a104a8eb9f8a67b8","076871ba20cc4bdd99a176f536949134","89ca78b9ed754802a5a3d52c92122fd1"],"text":"\\begin{tabular}{l}\nChange 3: \\\\\nFootnote L: estimated creatinine clearance \\\\\nWas changed into: \\\\\nEstimated glomerular filtration rate\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 3: \\\\\nFootnote L: estimated creatinine clearance \\\\\nWas changed into: \\\\\nEstimated glomerular filtration rate\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99755859375,"confidence_rate":0.9999722232114437},{"cnt":[[939,342],[1084,342],[1084,381],[939,381]],"region":{"top_left_x":939,"top_left_y":342,"width":146,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"506b8043202a4555b2593c3c80fcda35","type":"text","conversion_output":false,"parent_id":"64587b39a9704872a3f9e8c610ff7ab6","text":"Change 3:","text_display":"Change 3:","confidence":1,"confidence_rate":1},{"cnt":[[939,381],[1536,381],[1536,414],[939,414]],"region":{"top_left_x":939,"top_left_y":381,"width":597,"height":33},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4733ab398c340c0a104a8eb9f8a67b8","type":"text","conversion_output":false,"parent_id":"64587b39a9704872a3f9e8c610ff7ab6","text":"Footnote L: estimated creatinine clearance","text_display":"\nFootnote L: estimated creatinine clearance","confidence":1,"confidence_rate":1},{"cnt":[[939,462],[1204,462],[1204,501],[939,501]],"region":{"top_left_x":939,"top_left_y":461,"width":266,"height":41},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"076871ba20cc4bdd99a176f536949134","type":"text","conversion_output":false,"parent_id":"64587b39a9704872a3f9e8c610ff7ab6","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99755859375,"confidence_rate":0.9998888974749892},{"cnt":[[939,540],[1434,540],[1434,579],[939,579]],"region":{"top_left_x":939,"top_left_y":540,"width":496,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89ca78b9ed754802a5a3d52c92122fd1","type":"text","conversion_output":false,"parent_id":"64587b39a9704872a3f9e8c610ff7ab6","text":"Estimated glomerular filtration rate","text_display":"\nEstimated glomerular filtration rate","confidence":1,"confidence_rate":1},{"cnt":[[267,623],[580,623],[580,662],[267,662]],"region":{"top_left_x":267,"top_left_y":623,"width":314,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a40a18c693744b7b712e9f76410ed56","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,621],[1743,621],[1743,1021],[935,1021]],"region":{"top_left_x":934,"top_left_y":620,"width":809,"height":402},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"656cbd80f5be4dea9600699376a7a376","type":"complex_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","children_ids":["f2d22552986d49c5b0fa66e55baaade4","c0ea6ea33cd7485cacadf96eb620f177","9194af7e33ce45a3aae2c2c60a9bd4e6","2fb8a3dca8654018b2a90cd0916f703d","b64d442045224446b4c9b56f6fb171f5","7a7856dc11144dca99125feb10b0181d","4bdaa1e1cbfa4a0d8f784b633e88cf0e","00f0d7202c384e14825142545fa51a64"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nTo allow for outcome event data collection up to 30 days after EOT \\\\\nChange 2: \\\\\nTo clarify the respective actions to stop the trial when 611 endpoint events are reached \\\\\nChange 3: \\\\\nFor clarification\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nTo allow for outcome event data collection up to 30 days after EOT \\\\\nChange 2: \\\\\nTo clarify the respective actions to stop the trial when 611 endpoint events are reached \\\\\nChange 3: \\\\\nFor clarification\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.998046875,"confidence_rate":0.9999825444841725},{"cnt":[[939,623],[1089,623],[1089,662],[939,662]],"region":{"top_left_x":939,"top_left_y":623,"width":151,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2d22552986d49c5b0fa66e55baaade4","type":"text","conversion_output":false,"parent_id":"656cbd80f5be4dea9600699376a7a376","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,665],[1738,665],[1738,704],[939,704]],"region":{"top_left_x":939,"top_left_y":664,"width":800,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0ea6ea33cd7485cacadf96eb620f177","type":"text","conversion_output":false,"parent_id":"656cbd80f5be4dea9600699376a7a376","text":"To allow for outcome event data collection up to 30 days","text_display":"\nTo allow for outcome event data collection up to 30 days","confidence":1,"confidence_rate":1},{"cnt":[[939,701],[1084,701],[1084,736],[939,736]],"region":{"top_left_x":939,"top_left_y":701,"width":146,"height":35},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9194af7e33ce45a3aae2c2c60a9bd4e6","type":"text","conversion_output":false,"parent_id":"656cbd80f5be4dea9600699376a7a376","text":"after EOT","text_display":" after EOT","confidence":1,"confidence_rate":1},{"cnt":[[939,782],[1087,782],[1087,821],[939,821]],"region":{"top_left_x":939,"top_left_y":781,"width":148,"height":41},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fb8a3dca8654018b2a90cd0916f703d","type":"text","conversion_output":false,"parent_id":"656cbd80f5be4dea9600699376a7a376","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,821],[1692,821],[1692,860],[939,860]],"region":{"top_left_x":939,"top_left_y":821,"width":754,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b64d442045224446b4c9b56f6fb171f5","type":"text","conversion_output":false,"parent_id":"656cbd80f5be4dea9600699376a7a376","text":"To clarify the respective actions to stop the trial when","text_display":"\nTo clarify the respective actions to stop the trial when","confidence":1,"confidence_rate":1},{"cnt":[[939,863],[1393,863],[1393,902],[939,902]],"region":{"top_left_x":939,"top_left_y":862,"width":454,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a7856dc11144dca99125feb10b0181d","type":"text","conversion_output":false,"parent_id":"656cbd80f5be4dea9600699376a7a376","text":"611 endpoint events are reached","text_display":" 611 endpoint events are reached","confidence":1,"confidence_rate":1},{"cnt":[[939,941],[1087,941],[1087,980],[939,980]],"region":{"top_left_x":939,"top_left_y":940,"width":148,"height":41},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4bdaa1e1cbfa4a0d8f784b633e88cf0e","type":"text","conversion_output":false,"parent_id":"656cbd80f5be4dea9600699376a7a376","text":"Change 3:","text_display":"\nChange 3:","confidence":0.998046875,"confidence_rate":0.9998603644045428},{"cnt":[[939,982],[1170,982],[1170,1017],[939,1017]],"region":{"top_left_x":939,"top_left_y":982,"width":231,"height":35},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00f0d7202c384e14825142545fa51a64","type":"text","conversion_output":false,"parent_id":"656cbd80f5be4dea9600699376a7a376","text":"For clarification","text_display":"\nFor clarification","confidence":1,"confidence_rate":1},{"cnt":[[267,1065],[592,1065],[592,1104],[267,1104]],"region":{"top_left_x":267,"top_left_y":1065,"width":325,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fbbc9ac6c604ad895eee0fead72dda4","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1065],[1153,1065],[1153,1097],[939,1097]],"region":{"top_left_x":939,"top_left_y":1065,"width":215,"height":33},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf109f787f564f5da3e3cbc3df2b2db8","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Abbreviations","text_display":"Abbreviations","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1116],[592,1116],[592,1155],[267,1155]],"region":{"top_left_x":267,"top_left_y":1115,"width":325,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1673859828e94a8ca00bcba606e3a279","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,1114],[1660,1114],[1660,1270],[937,1270]],"region":{"top_left_x":937,"top_left_y":1113,"width":724,"height":158},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"423031da694d44fc9374f9bacbab3152","type":"complex_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","children_ids":["c798e640c03541b39cee82e385c6595e","761795e1f8f94bab87c55d083b807596","8a295f9d8b82471eb5cc638ed7345331","940e5d8b5c5f422890fcb183071d671f"],"text":"\\begin{tabular}{l}\nCHC - Congestive Heart Failure and VEGF - Vascular endothelial growth factor deleted OS - On-treatment Set and \\\\\nTS - Treated Set were added\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nCHC - Congestive Heart Failure and VEGF - Vascular endothelial growth factor deleted OS - On-treatment Set and \\\\\nTS - Treated Set were added\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1116],[1462,1116],[1462,1155],[939,1155]],"region":{"top_left_x":939,"top_left_y":1115,"width":524,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c798e640c03541b39cee82e385c6595e","type":"text","conversion_output":false,"parent_id":"423031da694d44fc9374f9bacbab3152","text":"CHC - Congestive Heart Failure and","text_display":"CHC - Congestive Heart Failure and","confidence":1,"confidence_rate":1},{"cnt":[[939,1155],[1660,1155],[1660,1192],[939,1192]],"region":{"top_left_x":939,"top_left_y":1154,"width":722,"height":38},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"761795e1f8f94bab87c55d083b807596","type":"text","conversion_output":false,"parent_id":"423031da694d44fc9374f9bacbab3152","text":"VEGF - Vascular endothelial growth factor deleted","text_display":" VEGF - Vascular endothelial growth factor deleted","confidence":1,"confidence_rate":1},{"cnt":[[939,1194],[1315,1194],[1315,1229],[939,1229]],"region":{"top_left_x":939,"top_left_y":1194,"width":376,"height":35},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a295f9d8b82471eb5cc638ed7345331","type":"text","conversion_output":false,"parent_id":"423031da694d44fc9374f9bacbab3152","text":"OS - On-treatment Set and","text_display":" OS - On-treatment Set and","confidence":1,"confidence_rate":1},{"cnt":[[939,1236],[1347,1236],[1347,1270],[939,1270]],"region":{"top_left_x":939,"top_left_y":1235,"width":408,"height":36},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"940e5d8b5c5f422890fcb183071d671f","type":"text","conversion_output":false,"parent_id":"423031da694d44fc9374f9bacbab3152","text":"TS - Treated Set were added","text_display":"\nTS - Treated Set were added","confidence":1,"confidence_rate":1},{"cnt":[[267,1277],[578,1277],[578,1316],[267,1316]],"region":{"top_left_x":267,"top_left_y":1277,"width":311,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d00047d25df4cce8bed89c334204399","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Rationale for change","text_display":"Rationale for change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1277],[1301,1277],[1301,1316],[939,1316]],"region":{"top_left_x":939,"top_left_y":1277,"width":362,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fa548baa47a4566acdbc961dbf187ac","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Due to change in the text.","text_display":"Due to change in the text.","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1330],[592,1330],[592,1367],[267,1367]],"region":{"top_left_x":267,"top_left_y":1329,"width":325,"height":38},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a5daed4d333419aa1e6fd8049c88b72","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Section to be changed","text_display":"Section to be changed","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1330],[1181,1330],[1181,1367],[939,1367]],"region":{"top_left_x":939,"top_left_y":1329,"width":243,"height":38},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47021b150da64af78312acf3846a54ad","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"1.2 Drug profile","text_display":"1.2 Drug profile","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1383],[592,1383],[592,1422],[267,1422]],"region":{"top_left_x":267,"top_left_y":1382,"width":325,"height":41},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0df315b0903d4d629b111df50876b778","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Description of change","text_display":"Description of change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1378],[1342,1378],[1342,1422],[939,1422]],"region":{"top_left_x":939,"top_left_y":1378,"width":404,"height":45},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4876f69a9b0940da97d470b09d3ef99f","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Drug profile section updated","text_display":"Drug profile section updated","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1434],[580,1434],[580,1473],[267,1473]],"region":{"top_left_x":267,"top_left_y":1433,"width":314,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d3b2227fdb94d619d246b9f62a81d03","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Rationale for change","text_display":"Rationale for change","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,1429],[1706,1429],[1706,1505],[937,1505]],"region":{"top_left_x":937,"top_left_y":1428,"width":770,"height":77},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c414e363336e488cb16e1bbe503bff83","type":"complex_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","children_ids":["f497ae07c0384a6ab53af4be71ba35ff","d250f5fcf0dd4554bbff74337972332a"],"text":"For clarification per current version of the investigator brochure.","text_display":"For clarification per current version of the investigator brochure.","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1434],[1701,1434],[1701,1468],[939,1468]],"region":{"top_left_x":939,"top_left_y":1433,"width":763,"height":36},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f497ae07c0384a6ab53af4be71ba35ff","type":"text","conversion_output":false,"parent_id":"c414e363336e488cb16e1bbe503bff83","text":"For clarification per current version of the investigator","text_display":"For clarification per current version of the investigator","confidence":1,"confidence_rate":1},{"cnt":[[939,1470],[1075,1470],[1075,1505],[939,1505]],"region":{"top_left_x":939,"top_left_y":1470,"width":137,"height":35},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d250f5fcf0dd4554bbff74337972332a","type":"text","conversion_output":false,"parent_id":"c414e363336e488cb16e1bbe503bff83","text":"brochure.","text_display":" brochure.","confidence":1,"confidence_rate":1},{"cnt":[[267,1516],[592,1516],[592,1551],[267,1551]],"region":{"top_left_x":267,"top_left_y":1516,"width":325,"height":36},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da7d15e18a004e7d8735cdd1c46e115d","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Section to be changed","text_display":"Section to be changed","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1516],[1218,1516],[1218,1551],[939,1551]],"region":{"top_left_x":939,"top_left_y":1516,"width":279,"height":36},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35640c40e6af468c9e47098e221fa494","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"2.2 trial objectives","text_display":"2.2 trial objectives","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1567],[592,1567],[592,1606],[267,1606]],"region":{"top_left_x":267,"top_left_y":1567,"width":325,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25dece18672c4379a86f88e573a841af","type":"simple_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","text":"Description of change","text_display":"Description of change","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1563],[1743,1563],[1743,2553],[935,2553]],"region":{"top_left_x":934,"top_left_y":1562,"width":809,"height":991},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b17b6353355149d585903f02dbb2b739","type":"complex_cell","conversion_output":false,"parent_id":"896459702add42bf9d5f9b33b7b8912d","children_ids":["785c0a46244947b9b1a4a1fc853f0549","0bc234dfe6c8403daf4a0cf673956628","3ca4d9a182094bddba0f48d52c55618f","1da79e8431824fe48894d04ae83f9fdd","ce73af8c04214749b5241de7abf12307","73b08ca468864e2eb0803adb546047aa","0ce128bacb9547d7ae3d95aebb2cdd53","6d2c4d03ecc6475996011b2ab635e7bb","31153a52339e474e8a9f65043014ba4d","83981e0e11f342be92a39823cc3fb56d","242c76f971044cffb0949c16afbf4558","e5cc124da441482fb25e24546de71c65","f32fb188a4504bfe8efa7f467da307b1","526ccd71b5864194ba8112a933344990","f4cd885570a14fdaa7a8b47e3f939a6d","c322952c66fa4f318e565747d4005714","6bf9dba27703491189243892187e09fe","d8daa64f2d004c1da1c84f039dd05d26","c0287228e54d4d6499e34d570f11ae09","d77a103eba17498cbaf706ae1c3c67df","2ccdbd8330cf4ebb941f62916e6c82b3","b31dc013fbc44ae48967230dc71578c7"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nChange 2: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated with a test on superiority. The CV and renal superiority tests will be performed separately, with no upfront imbalance regarding the assigned alpha-levels. \\\\\nIf linagliptin is superior with regard to the primary endpoint and/or the composite renal endpoint, a further\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nChange 2: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline), will be investigated with a test on superiority. The CV and renal superiority tests will be performed separately, with no upfront imbalance regarding the assigned alpha-levels. \\\\\nIf linagliptin is superior with regard to the primary endpoint and/or the composite renal endpoint, a further\n\\end{tabular}","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.953125,"confidence_rate":0.9999081909259927},{"cnt":[[939,1563],[1087,1563],[1087,1602],[939,1602]],"region":{"top_left_x":939,"top_left_y":1562,"width":148,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"785c0a46244947b9b1a4a1fc853f0549","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1604],[1738,1604],[1738,1643],[939,1643]],"region":{"top_left_x":939,"top_left_y":1603,"width":800,"height":41},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0bc234dfe6c8403daf4a0cf673956628","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"The primary endpoint changed from 4-point MACE to 3-","text_display":"\nThe primary endpoint changed from 4-point MACE to 3","confidence":0.99951171875,"confidence_rate":0.9999914316069175},{"cnt":[[939,1645],[1133,1645],[1133,1685],[939,1685]],"region":{"top_left_x":939,"top_left_y":1645,"width":194,"height":40},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ca4d9a182094bddba0f48d52c55618f","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"point MACE.","text_display":"point MACE.","confidence":1,"confidence_rate":1},{"cnt":[[939,1687],[1738,1687],[1738,1721],[939,1721]],"region":{"top_left_x":939,"top_left_y":1686,"width":800,"height":36},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1da79e8431824fe48894d04ae83f9fdd","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"The key secondary endpoints were changed from 3-point","text_display":"\nThe key secondary endpoints were changed from 3-point","confidence":1,"confidence_rate":1},{"cnt":[[939,1724],[1646,1724],[1646,1763],[939,1763]],"region":{"top_left_x":939,"top_left_y":1723,"width":708,"height":40},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce73af8c04214749b5241de7abf12307","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"MACE and composite renal endpoint (renal death,","text_display":" MACE and composite renal endpoint (renal death,","confidence":1,"confidence_rate":1},{"cnt":[[939,1765],[1711,1765],[1711,1802],[939,1802]],"region":{"top_left_x":939,"top_left_y":1765,"width":772,"height":37},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73b08ca468864e2eb0803adb546047aa","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"sustained ESRD, sustained decrease of 50\\% or more in","text_display":" sustained ESRD, sustained decrease of 50\\% or more in","confidence":0.96142578125,"confidence_rate":0.9993100993625313},{"cnt":[[939,1846],[939,1802],[1614,1804],[1614,1848]],"region":{"top_left_x":939,"top_left_y":1801,"width":676,"height":48},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ce128bacb9547d7ae3d95aebb2cdd53","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"eGFR) to composite renal endpoint (renal death,","text_display":" eGFR) to composite renal endpoint (renal death,","confidence":1,"confidence_rate":1},{"cnt":[[939,1843],[1711,1843],[1711,1883],[939,1883]],"region":{"top_left_x":939,"top_left_y":1843,"width":772,"height":40},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d2c4d03ecc6475996011b2ab635e7bb","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"sustained ESRD, sustained decrease of 40\\% or more in","text_display":" sustained ESRD, sustained decrease of 40\\% or more in","confidence":0.953125,"confidence_rate":0.9991580876040179},{"cnt":[[939,1885],[1048,1885],[1048,1924],[939,1924]],"region":{"top_left_x":939,"top_left_y":1884,"width":109,"height":41},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31153a52339e474e8a9f65043014ba4d","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"eGFR).","text_display":" eGFR).","confidence":0.998046875,"confidence_rate":0.9998222853535005},{"cnt":[[939,1963],[1089,1963],[1089,2002],[939,2002]],"region":{"top_left_x":939,"top_left_y":1963,"width":151,"height":40},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83981e0e11f342be92a39823cc3fb56d","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2005],[1635,2005],[1635,2048],[939,2048]],"region":{"top_left_x":939,"top_left_y":2004,"width":696,"height":45},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"242c76f971044cffb0949c16afbf4558","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"If non-inferiority has been demonstrated, then the","text_display":"\nIf non-inferiority has been demonstrated, then the","confidence":1,"confidence_rate":1},{"cnt":[[939,2046],[1738,2046],[1738,2088],[939,2088]],"region":{"top_left_x":939,"top_left_y":2046,"width":800,"height":42},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5cc124da441482fb25e24546de71c65","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"primary composite endpoint will be tested for superiority","text_display":" primary composite endpoint will be tested for superiority","confidence":1,"confidence_rate":1},{"cnt":[[939,2088],[1734,2088],[1734,2127],[939,2127]],"region":{"top_left_x":939,"top_left_y":2087,"width":795,"height":40},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f32fb188a4504bfe8efa7f467da307b1","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"and the other objective, to assess the impact of treatment","text_display":" and the other objective, to assess the impact of treatment","confidence":1,"confidence_rate":1},{"cnt":[[939,2129],[1701,2129],[1701,2168],[939,2168]],"region":{"top_left_x":939,"top_left_y":2128,"width":763,"height":41},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"526ccd71b5864194ba8112a933344990","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"with respect to the composite renal endpoint (i.e. renal","text_display":" with respect to the composite renal endpoint (i.e. renal","confidence":1,"confidence_rate":1},{"cnt":[[939,2166],[1651,2166],[1651,2205],[939,2205]],"region":{"top_left_x":939,"top_left_y":2165,"width":712,"height":40},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4cd885570a14fdaa7a8b47e3f939a6d","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"death, sustained ESRD, sustained loss in estimated","text_display":" death, sustained ESRD, sustained loss in estimated","confidence":1,"confidence_rate":1},{"cnt":[[939,2207],[1720,2207],[1720,2246],[939,2246]],"region":{"top_left_x":939,"top_left_y":2207,"width":781,"height":40},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c322952c66fa4f318e565747d4005714","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"glomerular filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline),","text_display":" glomerular filtration rate (eGFR) \\(\\geq 50 \\%\\) from baseline),","confidence":0.9814996316651445,"confidence_rate":0.9996988576017808},{"cnt":[[939,2246],[1577,2246],[1577,2288],[939,2288]],"region":{"top_left_x":939,"top_left_y":2246,"width":639,"height":42},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6bf9dba27703491189243892187e09fe","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"will be investigated with a test on superiority.","text_display":" will be investigated with a test on superiority.","confidence":1,"confidence_rate":1},{"cnt":[[939,2295],[1683,2295],[1683,2334],[939,2334]],"region":{"top_left_x":939,"top_left_y":2294,"width":745,"height":40},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d8daa64f2d004c1da1c84f039dd05d26","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"The CV and renal superiority tests will be performed","text_display":" The CV and renal superiority tests will be performed","confidence":1,"confidence_rate":1},{"cnt":[[939,2336],[1665,2336],[1665,2375],[939,2375]],"region":{"top_left_x":939,"top_left_y":2336,"width":726,"height":40},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0287228e54d4d6499e34d570f11ae09","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"separately, with no upfront imbalance regarding the","text_display":" separately, with no upfront imbalance regarding the","confidence":1,"confidence_rate":1},{"cnt":[[939,2373],[1250,2373],[1250,2417],[939,2417]],"region":{"top_left_x":939,"top_left_y":2373,"width":312,"height":44},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d77a103eba17498cbaf706ae1c3c67df","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"assigned alpha-levels.","text_display":" assigned alpha-levels.","confidence":1,"confidence_rate":1},{"cnt":[[939,2470],[1646,2470],[1646,2509],[939,2509]],"region":{"top_left_x":939,"top_left_y":2469,"width":708,"height":40},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ccdbd8330cf4ebb941f62916e6c82b3","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"If linagliptin is superior with regard to the primary","text_display":"\nIf linagliptin is superior with regard to the primary","confidence":1,"confidence_rate":1},{"cnt":[[939,2511],[1711,2511],[1711,2550],[939,2550]],"region":{"top_left_x":939,"top_left_y":2511,"width":772,"height":40},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b31dc013fbc44ae48967230dc71578c7","type":"text","conversion_output":false,"parent_id":"b17b6353355149d585903f02dbb2b739","text":"endpoint and/or the composite renal endpoint, a further","text_display":" endpoint and/or the composite renal endpoint, a further","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":79,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9a3b5a339ab44a678ccf5838f8915aa6","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[292,2620],[1798,2620],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2620,"width":1506,"height":42},"line":80,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6dd8416500e2462282920d5e9fd9a4cf","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":81,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ba8847186f574ae2b117b3e6f740ac9b","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-106","page":106,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a243fde44ec64f9b80dbaa9a54f2fe39","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17b2edad40a84142add6b7bdd4b8521b","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"680ee0cb9f3140a9a4f3a1e4ba9556cc","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68e796a2c3ab46da874650b9d662da5e","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad83bc91765a43208377184db1ceb9d8","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea798f12edbf4387801ec2930f7e5183","type":"page_info","conversion_output":false,"text":"Page 106 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2561],[244,2561]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2230},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8416be89f05f4ac4948f5687a4cd9695","type":"table","conversion_output":true,"children_ids":["975561f6372b49cbbaadada1f9865cab","4e02428c70734485a1a05b47f143a4f2","9064a9718c5f463392399aae6158a4e7","8d88ddda825b47598952298ebe22229d","cdd9942dfa2b4c8ea35a34646144165d","720d2fee2fa44e2c829252d59ae6cf8c","b39de2730bdd41df9bfac8bba954c48d","146642ffdb114021bd1d6de16ec1cdc4","df100934993d45dea652bf3ee3491262","ecfbe8803d5d48dd8525ec157fa2c431","e7346fffc81348a9994d553cd41fae1e","f4d9ef62b09746f4a732efccaab2a123","d122671f915142acbcee727eb3f91d8c"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\ntest will evaluate the superiority of linagliptin with regard to the 3-component Major Adverse Cardiovascular Events (MACE) endpoint (CV death [including fatal stroke, fatal MI and sudden death], non-fatal stroke, nonfatal MI [excluding silent MI]). \\\\\nWas changed into: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated with a test on superiority. The CV and renal superiority tests will be performed separately, with an upfront imbalance regarding the assigned alpha-levels.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 2: \\\\\nA higher alpha-level will be assigned to the composite renal endpoint, the endpoint with the expected higher power for superiority. Nevertheless, this strategy allows testing both, 3-point MACE and the renal endpoint for superiority, independently of each other.\n\\end{tabular} \\\\\n\\hline Section to be changed & 3.1 Overall trial design and plan \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\nChange 2: \\\\\nNumber of endpoint events decreased from 625 to 611 and estimated treatment period increased from 48 to 54 months. \\\\\nChange 3: \\\\\nGuidance revised on the timing of the EOT visit after\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\ntest will evaluate the superiority of linagliptin with regard to the 3-component Major Adverse Cardiovascular Events (MACE) endpoint (CV death [including fatal stroke, fatal MI and sudden death], non-fatal stroke, nonfatal MI [excluding silent MI]). \\\\\nWas changed into: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated with a test on superiority. The CV and renal superiority tests will be performed separately, with an upfront imbalance regarding the assigned alpha-levels.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 2: \\\\\nA higher alpha-level will be assigned to the composite renal endpoint, the endpoint with the expected higher power for superiority. Nevertheless, this strategy allows testing both, 3-point MACE and the renal endpoint for superiority, independently of each other.\n\\end{tabular} \\\\\n\\hline Section to be changed & 3.1 Overall trial design and plan \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\nChange 2: \\\\\nNumber of endpoint events decreased from 625 to 611 and estimated treatment period increased from 48 to 54 months. \\\\\nChange 3: \\\\\nGuidance revised on the timing of the EOT visit after\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.9736328125,"confidence_rate":0.9999827742715828},{"cnt":[[251,331],[601,331],[601,2562],[251,2562]],"region":{"top_left_x":250,"top_left_y":331,"width":351,"height":2232},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"975561f6372b49cbbaadada1f9865cab","type":"table_column","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"","text_display":""},{"cnt":[[928,331],[1764,331],[1764,2562],[928,2562]],"region":{"top_left_x":927,"top_left_y":331,"width":837,"height":2232},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e02428c70734485a1a05b47f143a4f2","type":"table_column","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"","text_display":""},{"cnt":[[244,331],[1775,331],[1775,1091],[244,1091]],"region":{"top_left_x":244,"top_left_y":331,"width":1532,"height":760},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9064a9718c5f463392399aae6158a4e7","type":"table_row","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"","text_display":""},{"cnt":[[244,1137],[1775,1137],[1775,1996],[244,1996]],"region":{"top_left_x":244,"top_left_y":1136,"width":1532,"height":860},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d88ddda825b47598952298ebe22229d","type":"table_row","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"","text_display":""},{"cnt":[[244,2021],[1775,2021],[1775,2074],[244,2074]],"region":{"top_left_x":244,"top_left_y":2021,"width":1532,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cdd9942dfa2b4c8ea35a34646144165d","type":"table_row","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"","text_display":""},{"cnt":[[244,2069],[1775,2069],[1775,2562],[244,2562]],"region":{"top_left_x":244,"top_left_y":2069,"width":1532,"height":494},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"720d2fee2fa44e2c829252d59ae6cf8c","type":"table_row","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"","text_display":""},{"cnt":[[935,336],[1752,336],[1752,1084],[935,1084]],"region":{"top_left_x":934,"top_left_y":335,"width":819,"height":749},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b39de2730bdd41df9bfac8bba954c48d","type":"complex_cell","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","children_ids":["6bbba0a68e6f41e29d071e5a8c86b4f3","6aaeffa8265c406c8cae18348783c23f","636e5616344b4bf7b2edaaa8e5cee103","927ba35df0754c4da356a5c73bb28a42","685bea77c9ba4b518545bd3616a01aad","79621137331845149934575b4e9b7920","3364837c949c44b1997b140d2a7f00be","c92f57fbe6a2451d8546b99bb6b9c1c2","af3ebde45dd94fe2be7e897ed17295c1","23b6f22a16fd4315bbd8a8d9a7b5e115","eb5685342cd04670b3ac6f4c21c705aa","681795973910460d8d228fbbde709d57","673fcc8dba884dceba73b731eb6f4b47","3d5a2a87b97f4d569fb9eff0603ae3f5","68faf0aae0884bf78d3a0de3f02bc6d0","53236363573849a087d8160b01cdc5c0"],"text":"\\begin{tabular}{l}\ntest will evaluate the superiority of linagliptin with regard to the 3-component Major Adverse Cardiovascular Events (MACE) endpoint (CV death [including fatal stroke, fatal MI and sudden death], non-fatal stroke, nonfatal MI [excluding silent MI]). \\\\\nWas changed into: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated with a test on superiority. The CV and renal superiority tests will be performed separately, with an upfront imbalance regarding the assigned alpha-levels.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\ntest will evaluate the superiority of linagliptin with regard to the 3-component Major Adverse Cardiovascular Events (MACE) endpoint (CV death [including fatal stroke, fatal MI and sudden death], non-fatal stroke, nonfatal MI [excluding silent MI]). \\\\\nWas changed into: \\\\\nIf non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the other objective, to assess the impact of treatment with respect to the composite renal endpoint (i.e. renal death, sustained ESRD, sustained loss in estimated glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline), will be investigated with a test on superiority. The CV and renal superiority tests will be performed separately, with an upfront imbalance regarding the assigned alpha-levels.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9736328125,"confidence_rate":0.999891608987894},{"cnt":[[939,340],[1750,340],[1750,379],[939,379]],"region":{"top_left_x":939,"top_left_y":340,"width":811,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6bbba0a68e6f41e29d071e5a8c86b4f3","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"test will evaluate the superiority of linagliptin with regard","text_display":"test will evaluate the superiority of linagliptin with regard","confidence":1,"confidence_rate":1},{"cnt":[[939,382],[1653,382],[1653,421],[939,421]],"region":{"top_left_x":939,"top_left_y":381,"width":715,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6aaeffa8265c406c8cae18348783c23f","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"to the 3-component Major Adverse Cardiovascular","text_display":" to the 3-component Major Adverse Cardiovascular","confidence":0.99755859375,"confidence_rate":0.999952993579033},{"cnt":[[939,418],[1676,418],[1676,462],[939,462]],"region":{"top_left_x":939,"top_left_y":418,"width":738,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"636e5616344b4bf7b2edaaa8e5cee103","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"Events (MACE) endpoint (CV death [including fatal","text_display":" Events (MACE) endpoint (CV death [including fatal","confidence":0.9990234375,"confidence_rate":0.9999819068368716},{"cnt":[[939,460],[1741,460],[1741,499],[939,499]],"region":{"top_left_x":939,"top_left_y":459,"width":802,"height":41},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"927ba35df0754c4da356a5c73bb28a42","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"stroke, fatal MI and sudden death], non-fatal stroke, non-","text_display":" stroke, fatal MI and sudden death], non-fatal stroke, non","confidence":1,"confidence_rate":1},{"cnt":[[939,501],[1381,501],[1381,541],[939,541]],"region":{"top_left_x":939,"top_left_y":501,"width":443,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"685bea77c9ba4b518545bd3616a01aad","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"fatal MI [excluding silent MI]).","text_display":"fatal MI [excluding silent MI]).","confidence":0.99169921875,"confidence_rate":0.9997747436286482},{"cnt":[[939,589],[1204,589],[1204,628],[939,628]],"region":{"top_left_x":939,"top_left_y":588,"width":266,"height":41},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79621137331845149934575b4e9b7920","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9736328125,"confidence_rate":0.998786144789979},{"cnt":[[939,672],[1637,672],[1637,711],[939,711]],"region":{"top_left_x":939,"top_left_y":671,"width":699,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3364837c949c44b1997b140d2a7f00be","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"If non-inferiority has been demonstrated, then the","text_display":"\nIf non-inferiority has been demonstrated, then the","confidence":1,"confidence_rate":1},{"cnt":[[939,713],[1738,713],[1738,752],[939,752]],"region":{"top_left_x":939,"top_left_y":713,"width":800,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c92f57fbe6a2451d8546b99bb6b9c1c2","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"primary composite endpoint will be tested for superiority","text_display":" primary composite endpoint will be tested for superiority","confidence":1,"confidence_rate":1},{"cnt":[[939,755],[1734,755],[1734,794],[939,794]],"region":{"top_left_x":939,"top_left_y":754,"width":795,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af3ebde45dd94fe2be7e897ed17295c1","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"and the other objective, to assess the impact of treatment","text_display":" and the other objective, to assess the impact of treatment","confidence":1,"confidence_rate":1},{"cnt":[[939,792],[1701,792],[1701,831],[939,831]],"region":{"top_left_x":939,"top_left_y":791,"width":763,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23b6f22a16fd4315bbd8a8d9a7b5e115","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"with respect to the composite renal endpoint (i.e. renal","text_display":" with respect to the composite renal endpoint (i.e. renal","confidence":1,"confidence_rate":1},{"cnt":[[939,833],[1653,833],[1653,872],[939,872]],"region":{"top_left_x":939,"top_left_y":832,"width":715,"height":41},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb5685342cd04670b3ac6f4c21c705aa","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"death, sustained ESRD, sustained loss in estimated","text_display":" death, sustained ESRD, sustained loss in estimated","confidence":1,"confidence_rate":1},{"cnt":[[939,870],[1725,870],[1725,914],[939,914]],"region":{"top_left_x":939,"top_left_y":869,"width":786,"height":45},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"681795973910460d8d228fbbde709d57","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline),","text_display":" glomerular filtration rate (eGFR) \\(\\geq 40 \\%\\) from baseline),","confidence":0.9858793905004859,"confidence_rate":0.999770651242044},{"cnt":[[939,911],[1577,911],[1577,953],[939,953]],"region":{"top_left_x":939,"top_left_y":911,"width":639,"height":42},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"673fcc8dba884dceba73b731eb6f4b47","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"will be investigated with a test on superiority.","text_display":" will be investigated with a test on superiority.","confidence":1,"confidence_rate":1},{"cnt":[[939,960],[1683,960],[1683,1001],[939,1001]],"region":{"top_left_x":939,"top_left_y":959,"width":745,"height":43},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d5a2a87b97f4d569fb9eff0603ae3f5","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"The CV and renal superiority tests will be performed","text_display":" The CV and renal superiority tests will be performed","confidence":1,"confidence_rate":1},{"cnt":[[939,1001],[1665,1001],[1665,1042],[939,1042]],"region":{"top_left_x":939,"top_left_y":1001,"width":726,"height":42},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68faf0aae0884bf78d3a0de3f02bc6d0","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"separately, with an upfront imbalance regarding the","text_display":" separately, with an upfront imbalance regarding the","confidence":1,"confidence_rate":1},{"cnt":[[939,1040],[1250,1040],[1250,1079],[939,1079]],"region":{"top_left_x":939,"top_left_y":1040,"width":312,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"53236363573849a087d8160b01cdc5c0","type":"text","conversion_output":false,"parent_id":"b39de2730bdd41df9bfac8bba954c48d","text":"assigned alpha-levels.","text_display":" assigned alpha-levels.","confidence":1,"confidence_rate":1},{"cnt":[[265,1146],[582,1146],[582,1185],[265,1185]],"region":{"top_left_x":264,"top_left_y":1146,"width":319,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"146642ffdb114021bd1d6de16ec1cdc4","type":"simple_cell","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1144],[1752,1144],[1752,1991],[935,1991]],"region":{"top_left_x":934,"top_left_y":1143,"width":819,"height":849},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"df100934993d45dea652bf3ee3491262","type":"complex_cell","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","children_ids":["02495255b22549a68fe2ab5a9fb17b2c","f9ec9576820f4485a9cb9ba9bccfa601","b4c5b3d6244e4a3fabb577bb9bd46b69","46a9e36c2c6b4984a295b939deb93374","7a765a88dd9b4789a219c503b159a82f","1be472386c38451bb5916a9d2f3b78bc","b50fc1287f854e4096d10705912a9c71","b3a60f6dca6343dc97e90e5225f6ad89","c7c5ce18be364c3cafe388ad53c50daf","7c10937ee36b470182a21d547d99bba4","8b14b53128b94cb88f0274c0193e113f","c07b770c87384ddaac9fa68c704b0b2a","0f8c604408a648ab857a93462ada3f89","dbd2934c66674758b7ae12b34c5a7a37","57165eccbcf9403c963ca78a09a2e9eb","f6c6dc0905324fc282dcbb9023d4e4db","c3e7b38bb47a4561bd62a9698b662b02","f0737a97b975458ab09763b4c438e45b","205874893ec34000b9a4801f8d503b6d","94598eb36ea3449990bb6b295220b784"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 2: \\\\\nA higher alpha-level will be assigned to the composite renal endpoint, the endpoint with the expected higher power for superiority. Nevertheless, this strategy allows testing both, 3-point MACE and the renal endpoint for superiority, independently of each other.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 2: \\\\\nA higher alpha-level will be assigned to the composite renal endpoint, the endpoint with the expected higher power for superiority. Nevertheless, this strategy allows testing both, 3-point MACE and the renal endpoint for superiority, independently of each other.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9892578125,"confidence_rate":0.9999878158235919},{"cnt":[[939,1146],[1089,1146],[1089,1185],[939,1185]],"region":{"top_left_x":939,"top_left_y":1146,"width":151,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02495255b22549a68fe2ab5a9fb17b2c","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1188],[1692,1188],[1692,1227],[939,1227]],"region":{"top_left_x":939,"top_left_y":1187,"width":754,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9ec9576820f4485a9cb9ba9bccfa601","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"Based on review of recently published cardiovascular","text_display":"\nBased on review of recently published cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[939,1224],[1711,1224],[1711,1266],[939,1266]],"region":{"top_left_x":939,"top_left_y":1224,"width":772,"height":42},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b4c5b3d6244e4a3fabb577bb9bd46b69","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"outcome trials, changing the protocol definitions of the","text_display":" outcome trials, changing the protocol definitions of the","confidence":1,"confidence_rate":1},{"cnt":[[939,1266],[1743,1266],[1743,1305],[939,1305]],"region":{"top_left_x":939,"top_left_y":1265,"width":804,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"46a9e36c2c6b4984a295b939deb93374","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"primary and secondary endpoints, essentially substituting","text_display":" primary and secondary endpoints, essentially substituting","confidence":1,"confidence_rate":1},{"cnt":[[939,1307],[1715,1307],[1715,1346],[939,1346]],"region":{"top_left_x":939,"top_left_y":1307,"width":777,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a765a88dd9b4789a219c503b159a82f","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"4-point MACE (Cardiovascular (CV) Death, Non-Fatal","text_display":" 4-point MACE (Cardiovascular (CV) Death, Non-Fatal","confidence":1,"confidence_rate":1},{"cnt":[[939,1346],[1550,1346],[1550,1386],[939,1386]],"region":{"top_left_x":939,"top_left_y":1346,"width":611,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1be472386c38451bb5916a9d2f3b78bc","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"Stoke, Non-fatal Myocardial Infarction and","text_display":" Stoke, Non-fatal Myocardial Infarction and","confidence":1,"confidence_rate":1},{"cnt":[[939,1386],[1750,1386],[1750,1425],[939,1425]],"region":{"top_left_x":939,"top_left_y":1385,"width":811,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b50fc1287f854e4096d10705912a9c71","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"Hospitalization for Unstable Angina) with 3-point MACE","text_display":" Hospitalization for Unstable Angina) with 3-point MACE","confidence":1,"confidence_rate":1},{"cnt":[[939,1427],[1665,1427],[1665,1466],[939,1466]],"region":{"top_left_x":939,"top_left_y":1426,"width":726,"height":41},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3a60f6dca6343dc97e90e5225f6ad89","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"(CV Death, Non-Fatal Stoke, Non-fatal Myocardial","text_display":" (CV Death, Non-Fatal Stoke, Non-fatal Myocardial","confidence":1,"confidence_rate":1},{"cnt":[[939,1468],[1103,1468],[1103,1503],[939,1503]],"region":{"top_left_x":939,"top_left_y":1468,"width":164,"height":35},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7c5ce18be364c3cafe388ad53c50daf","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"Infarction).","text_display":" Infarction).","confidence":0.9990234375,"confidence_rate":0.9999425287310763},{"cnt":[[939,1505],[1655,1505],[1655,1547],[939,1547]],"region":{"top_left_x":939,"top_left_y":1505,"width":717,"height":42},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c10937ee36b470182a21d547d99bba4","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"eGFR cut off changed in response to the NIH/FDA","text_display":"\neGFR cut off changed in response to the NIH/FDA","confidence":1,"confidence_rate":1},{"cnt":[[939,1547],[1708,1547],[1708,1586],[939,1586]],"region":{"top_left_x":939,"top_left_y":1546,"width":770,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b14b53128b94cb88f0274c0193e113f","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"scientific workshop on GFR decline as an endpoint for","text_display":" scientific workshop on GFR decline as an endpoint for","confidence":1,"confidence_rate":1},{"cnt":[[939,1588],[1720,1588],[1720,1627],[939,1627]],"region":{"top_left_x":939,"top_left_y":1588,"width":781,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c07b770c87384ddaac9fa68c704b0b2a","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"clinical trials in CKD and the current clinical landscape","text_display":" clinical trials in CKD and the current clinical landscape","confidence":1,"confidence_rate":1},{"cnt":[[939,1625],[1678,1625],[1678,1666],[939,1666]],"region":{"top_left_x":939,"top_left_y":1625,"width":740,"height":42},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f8c604408a648ab857a93462ada3f89","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"on decline in estimated glomerular filtration rate and","text_display":" on decline in estimated glomerular filtration rate and","confidence":1,"confidence_rate":1},{"cnt":[[939,1666],[1725,1666],[1725,1706],[939,1706]],"region":{"top_left_x":939,"top_left_y":1666,"width":786,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dbd2934c66674758b7ae12b34c5a7a37","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"subsequent risk of end stage renal disease and mortality.","text_display":" subsequent risk of end stage renal disease and mortality.","confidence":1,"confidence_rate":1},{"cnt":[[939,1745],[1089,1745],[1089,1788],[939,1788]],"region":{"top_left_x":939,"top_left_y":1744,"width":151,"height":45},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57165eccbcf9403c963ca78a09a2e9eb","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,1786],[1701,1786],[1701,1825],[939,1825]],"region":{"top_left_x":939,"top_left_y":1786,"width":763,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6c6dc0905324fc282dcbb9023d4e4db","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"A higher alpha-level will be assigned to the composite","text_display":"\nA higher alpha-level will be assigned to the composite","confidence":1,"confidence_rate":1},{"cnt":[[939,1828],[1688,1828],[1688,1867],[939,1867]],"region":{"top_left_x":939,"top_left_y":1827,"width":749,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3e7b38bb47a4561bd62a9698b662b02","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"renal endpoint, the endpoint with the expected higher","text_display":" renal endpoint, the endpoint with the expected higher","confidence":1,"confidence_rate":1},{"cnt":[[939,1864],[1725,1864],[1725,1908],[939,1908]],"region":{"top_left_x":939,"top_left_y":1864,"width":786,"height":45},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0737a97b975458ab09763b4c438e45b","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"power for superiority. Nevertheless, this strategy allows","text_display":" power for superiority. Nevertheless, this strategy allows","confidence":1,"confidence_rate":1},{"cnt":[[939,1906],[1706,1906],[1706,1945],[939,1945]],"region":{"top_left_x":939,"top_left_y":1905,"width":768,"height":41},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"205874893ec34000b9a4801f8d503b6d","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"testing both, 3-point MACE and the renal endpoint for","text_display":" testing both, 3-point MACE and the renal endpoint for","confidence":0.9892578125,"confidence_rate":0.9998138052441409},{"cnt":[[939,1947],[1508,1947],[1508,1987],[939,1987]],"region":{"top_left_x":939,"top_left_y":1947,"width":570,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94598eb36ea3449990bb6b295220b784","type":"text","conversion_output":false,"parent_id":"df100934993d45dea652bf3ee3491262","text":"superiority, independently of each other.","text_display":" superiority, independently of each other.","confidence":1,"confidence_rate":1},{"cnt":[[265,2030],[592,2030],[592,2069],[265,2069]],"region":{"top_left_x":264,"top_left_y":2030,"width":328,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecfbe8803d5d48dd8525ec157fa2c431","type":"simple_cell","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2030],[1425,2030],[1425,2069],[939,2069]],"region":{"top_left_x":939,"top_left_y":2030,"width":487,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7346fffc81348a9994d553cd41fae1e","type":"simple_cell","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"3.1 Overall trial design and plan","text_display":"3.1 Overall trial design and plan","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,2081],[596,2081],[596,2120],[265,2120]],"region":{"top_left_x":264,"top_left_y":2080,"width":333,"height":41},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4d9ef62b09746f4a732efccaab2a123","type":"simple_cell","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2076],[1727,2076],[1727,2562],[935,2562]],"region":{"top_left_x":934,"top_left_y":2076,"width":793,"height":487},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d122671f915142acbcee727eb3f91d8c","type":"complex_cell","conversion_output":false,"parent_id":"8416be89f05f4ac4948f5687a4cd9695","children_ids":["5ccd62b4af8f4715aae7a2f7fc8f3684","294df5a482464ca8b2d216608d55ed60","a62bc7af7f224b3898179ee50a6da29d","cc0bfe61a66b4c5eb926e0bcbb347597","9f342ecec8b0412c823eef5ea13430f1","dd2c1e1d728447439958042b999cb202","8c86ddbb09994fc1b3a490c0186b3144","15d33689d39c470b9b2c973ce52441b8","c21add7f8ff5424a9e69dadec8430617","853de2208c1344fcb9e1a0cecbb8f3b6"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\nChange 2: \\\\\nNumber of endpoint events decreased from 625 to 611 and estimated treatment period increased from 48 to 54 months. \\\\\nChange 3: \\\\\nGuidance revised on the timing of the EOT visit after\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\nChange 2: \\\\\nNumber of endpoint events decreased from 625 to 611 and estimated treatment period increased from 48 to 54 months. \\\\\nChange 3: \\\\\nGuidance revised on the timing of the EOT visit after\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2076],[1089,2076],[1089,2120],[939,2120]],"region":{"top_left_x":939,"top_left_y":2076,"width":151,"height":45},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ccd62b4af8f4715aae7a2f7fc8f3684","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2118],[1722,2118],[1722,2161],[939,2161]],"region":{"top_left_x":939,"top_left_y":2117,"width":784,"height":45},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"294df5a482464ca8b2d216608d55ed60","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"Number of randomized patients decreased from 8300 to","text_display":"\nNumber of randomized patients decreased from 8300 to","confidence":1,"confidence_rate":1},{"cnt":[[939,2159],[1628,2159],[1628,2198],[939,2198]],"region":{"top_left_x":939,"top_left_y":2159,"width":689,"height":40},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a62bc7af7f224b3898179ee50a6da29d","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"7000 and number of patients per treatment group","text_display":" 7000 and number of patients per treatment group","confidence":1,"confidence_rate":1},{"cnt":[[939,2201],[1361,2201],[1361,2235],[939,2235]],"region":{"top_left_x":939,"top_left_y":2200,"width":422,"height":36},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cc0bfe61a66b4c5eb926e0bcbb347597","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"decreased from 4150 to 3500.","text_display":" decreased from 4150 to 3500.","confidence":1,"confidence_rate":1},{"cnt":[[939,2279],[1089,2279],[1089,2318],[939,2318]],"region":{"top_left_x":939,"top_left_y":2278,"width":151,"height":41},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f342ecec8b0412c823eef5ea13430f1","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2320],[1701,2320],[1701,2360],[939,2360]],"region":{"top_left_x":939,"top_left_y":2320,"width":763,"height":40},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd2c1e1d728447439958042b999cb202","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"Number of endpoint events decreased from 625 to 611","text_display":"\nNumber of endpoint events decreased from 625 to 611","confidence":1,"confidence_rate":1},{"cnt":[[939,2360],[1715,2360],[1715,2399],[939,2399]],"region":{"top_left_x":939,"top_left_y":2359,"width":777,"height":40},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c86ddbb09994fc1b3a490c0186b3144","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"and estimated treatment period increased from 48 to 54","text_display":" and estimated treatment period increased from 48 to 54","confidence":1,"confidence_rate":1},{"cnt":[[939,2399],[1057,2399],[1057,2433],[939,2433]],"region":{"top_left_x":939,"top_left_y":2398,"width":118,"height":36},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15d33689d39c470b9b2c973ce52441b8","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"months.","text_display":" months.","confidence":1,"confidence_rate":1},{"cnt":[[939,2479],[1089,2475],[1090,2516],[939,2519]],"region":{"top_left_x":938,"top_left_y":2475,"width":152,"height":45},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c21add7f8ff5424a9e69dadec8430617","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"Change 3:","text_display":"\nChange 3:","confidence":1,"confidence_rate":1},{"cnt":[[939,2518],[1688,2518],[1688,2558],[939,2558]],"region":{"top_left_x":939,"top_left_y":2518,"width":749,"height":40},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"853de2208c1344fcb9e1a0cecbb8f3b6","type":"text","conversion_output":false,"parent_id":"d122671f915142acbcee727eb3f91d8c","text":"Guidance revised on the timing of the EOT visit after","text_display":"\nGuidance revised on the timing of the EOT visit after","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":67,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e82dec647fef49558165119c1ab8a4ac","type":"section_header","conversion_output":false,"children_ids":["a09ead8e73b642ab97844a41b6e14ddc"],"text":"","text_display":""},{"cnt":[[790,2586],[1300,2586],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2585,"width":510,"height":36},"line":68,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a09ead8e73b642ab97844a41b6e14ddc","type":"text","conversion_output":true,"parent_id":"e82dec647fef49558165119c1ab8a4ac","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.998046875,"confidence_rate":0.9999534526348907},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":69,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8e5ebfc113f44b8eada96d5a7194bf07","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":70,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"981d9f0dacee4b82af253d19c2bbee55","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-107","page":107,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a496294cdbb4d2f98481f18b16c7aa5","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a975b7b9a3ed4ea4b9ac4c1d8fbf4995","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2747650798544afabebe79bd28831322","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd89438b3dc4406a8af7fe0c006783ac","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d633e3a87824c04ae3a8c3f93ec4f2b","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b4e8daed398c4cafbcf178d3fa1dc269","type":"page_info","conversion_output":false,"text":"Page 107 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2554],[244,2554]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2221},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0578e0fc1c704c779baa2b4ca2f1a115","type":"table","conversion_output":true,"children_ids":["151df1052a6c430685c4b924552c2122","4e9fef95541847ce8b35a598997eefcb","09b24328729f424cb18e0013e969d8b3","028866718dd3483fbf4015a719c4d674","d38a8294be4249ecbed3e81cfe366ff4","3883a3f0b00645e8a342a1f8030c4afa","3b70b7ea582b497bb1b3170f6c3b7184","d39a87bf5a3740a3b8db339b801e65de","a431aebd4111456093d9f69c6c90cc90","0781d8b7cc2949ac88286d12211c5069","a2a295f3402749be907defef860104c1","64e786e9dd394c638bc61f1a4194882c","34917b07135a4c46b24b420932724646","b95e374c949a4c70b0d1d7b690b6d2a2","8aee6d05c4e54b668d7b8eb7b2e78929","f1eaee6d18954a7c941d39566eb6b16e","13051f7bdfad4478b120023bed65995b","0cd79ad34d524cd59e5b754243cea6d5","1f85b97367444375af22ac2af49d7e59","1338ac489a0c43f7bfaffb825799fcd7","92ad660a7fa749b3a1557569ae784e36","8541d5ef1d564d4da26359947f0c6fa9","47c0f3f718ac46dd94781278d968ae8b","fc20e77cc167442c9ba8246b699ece09","c0ef64065d834650a836c94cfca07b06","12f1d69569b34e97a6eb56def99d9c6e","64e22d448b184a5bb552308c3b532ec9","a48a891043954525a36d98834c6e8f50","9e424016112e4349817334210105b253","f23b1debd05f4ef68c6024ba002b3325","d352f397439846eabac258c4b3a9bb38","00e24f85708c42c2b7921088c1436919","a2bf031a496a41e99034c0c4609c4bb3","c379432c4f294ac78dde99218ee82e93","6468426d97df45b7888a6058ca34a07f","9f368690ba4d4e44bc5d553ac6296ae0","1af62aafe1524185ad9b903c048efca9","798ec94e8ecb4df0891d7cc888e3a465","03993d16e796417994063bccd80a4462","628b5bd54faf43c1ad38bdc4700c187f"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nstudy stop announcement after 611 endpoint events are reached. \\\\\nChange 4: \\\\\nChange in follow-up period from 7 to 30 days \\\\\nChange 5: \\\\\n...in a separate CEC charter \\\\\nWas changed into: \\\\\n...in the CEC charter\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. \\\\\nChange 2: \\\\\nSince the interim analysis for efficacy was deleted, the required number of patients with primary endpoint to achieve a power of \\(90 \\%\\) for non-inferiority is reduced from 625 to 611. The estimated trial duration increased slightly due to the change of the primary endpoint while ensuring a sufficiently long drug exposure for the last recruited patients. \\\\\nChange 3: \\\\\nTo clarify the respective actions to stop the trial when 611 endpoint events are reached. \\\\\nChange 4: \\\\\nTo allow for outcome event data collection up to 30 days after EOT \\\\\nChange 5: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 3.3 Selection of trial population \\\\\n\\hline Description of change & Number of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\n\\hline Rationale for change & Overall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration \\\\\n\\hline Section to be changed & 3.3.3 Exclusion criteria \\\\\n\\hline Description of change & Exclusion criterion 4: corrections of eGFR unit. \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 3.3.4.1 Removal of individual patients \\\\\n\\hline Description of change & Patient retention language revised \\\\\n\\hline Rationale for change & To optimize retention language \\\\\n\\hline Section to be changed & 4.1.1 identity of BI investigational product and comparator product(s) \\\\\n\\hline Description of change & Film-coated added to tablets under pharmaceutical form \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nstudy stop announcement after 611 endpoint events are reached. \\\\\nChange 4: \\\\\nChange in follow-up period from 7 to 30 days \\\\\nChange 5: \\\\\n...in a separate CEC charter \\\\\nWas changed into: \\\\\n...in the CEC charter\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. \\\\\nChange 2: \\\\\nSince the interim analysis for efficacy was deleted, the required number of patients with primary endpoint to achieve a power of \\(90 \\%\\) for non-inferiority is reduced from 625 to 611. The estimated trial duration increased slightly due to the change of the primary endpoint while ensuring a sufficiently long drug exposure for the last recruited patients. \\\\\nChange 3: \\\\\nTo clarify the respective actions to stop the trial when 611 endpoint events are reached. \\\\\nChange 4: \\\\\nTo allow for outcome event data collection up to 30 days after EOT \\\\\nChange 5: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 3.3 Selection of trial population \\\\\n\\hline Description of change & Number of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500. \\\\\n\\hline Rationale for change & Overall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration \\\\\n\\hline Section to be changed & 3.3.3 Exclusion criteria \\\\\n\\hline Description of change & Exclusion criterion 4: corrections of eGFR unit. \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 3.3.4.1 Removal of individual patients \\\\\n\\hline Description of change & Patient retention language revised \\\\\n\\hline Rationale for change & To optimize retention language \\\\\n\\hline Section to be changed & 4.1.1 identity of BI investigational product and comparator product(s) \\\\\n\\hline Description of change & Film-coated added to tablets under pharmaceutical form \\\\\n\\hline\n\\end{tabular}","confidence":0.98974609375,"confidence_rate":0.9999939226119005},{"cnt":[[251,333],[603,333],[603,2555],[251,2555]],"region":{"top_left_x":250,"top_left_y":333,"width":354,"height":2222},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"151df1052a6c430685c4b924552c2122","type":"table_column","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[930,333],[1766,333],[1766,2555],[930,2555]],"region":{"top_left_x":930,"top_left_y":333,"width":836,"height":2222},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e9fef95541847ce8b35a598997eefcb","type":"table_column","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,333],[1775,333],[1775,821],[244,821]],"region":{"top_left_x":244,"top_left_y":333,"width":1532,"height":489},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"09b24328729f424cb18e0013e969d8b3","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,817],[1771,817],[1771,1781],[244,1781]],"region":{"top_left_x":244,"top_left_y":816,"width":1527,"height":966},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"028866718dd3483fbf4015a719c4d674","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,1779],[1775,1779],[1775,1827],[244,1827]],"region":{"top_left_x":244,"top_left_y":1778,"width":1532,"height":50},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d38a8294be4249ecbed3e81cfe366ff4","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,1830],[1775,1830],[1775,1956],[244,1956]],"region":{"top_left_x":244,"top_left_y":1829,"width":1532,"height":128},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3883a3f0b00645e8a342a1f8030c4afa","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,1949],[1775,1949],[1775,2078],[244,2078]],"region":{"top_left_x":244,"top_left_y":1949,"width":1532,"height":130},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b70b7ea582b497bb1b3170f6c3b7184","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,2074],[1775,2074],[1775,2122],[244,2122]],"region":{"top_left_x":244,"top_left_y":2073,"width":1532,"height":50},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d39a87bf5a3740a3b8db339b801e65de","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,2127],[1775,2127],[1775,2173],[244,2173]],"region":{"top_left_x":244,"top_left_y":2126,"width":1532,"height":47},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a431aebd4111456093d9f69c6c90cc90","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,2207],[1775,2207],[1775,2260],[244,2260]],"region":{"top_left_x":244,"top_left_y":2207,"width":1532,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0781d8b7cc2949ac88286d12211c5069","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,2262],[1775,2262],[1775,2311],[244,2311]],"region":{"top_left_x":244,"top_left_y":2262,"width":1532,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2a295f3402749be907defef860104c1","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,2313],[1775,2313],[1775,2364],[244,2364]],"region":{"top_left_x":244,"top_left_y":2313,"width":1532,"height":51},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64e786e9dd394c638bc61f1a4194882c","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,2364],[1775,2364],[1775,2417],[244,2417]],"region":{"top_left_x":244,"top_left_y":2363,"width":1532,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34917b07135a4c46b24b420932724646","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,2417],[1775,2417],[1775,2509],[244,2509]],"region":{"top_left_x":244,"top_left_y":2416,"width":1532,"height":93},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b95e374c949a4c70b0d1d7b690b6d2a2","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[244,2500],[1775,2500],[1775,2550],[244,2550]],"region":{"top_left_x":244,"top_left_y":2499,"width":1532,"height":52},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8aee6d05c4e54b668d7b8eb7b2e78929","type":"table_row","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"","text_display":""},{"cnt":[[935,338],[1715,338],[1715,819],[935,819]],"region":{"top_left_x":934,"top_left_y":337,"width":782,"height":482},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1eaee6d18954a7c941d39566eb6b16e","type":"complex_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","children_ids":["2700dc72ae3d4b03be1d6ed39bef6630","c4bfc28fe962417491a7835bc83bb09c","4b4e26aecfe14c5ea9426c31b1a154e0","0aa46e59337549b6b5da5e9239d221d1","b307f2fc95e44347aa87eb1856f742db","a9664746ffa3410fbdbbb8518c97840c","32320f5596b94ae5997b0055088eedf7","8f8c65f293644218beb339f03ec95b24"],"text":"\\begin{tabular}{l}\nstudy stop announcement after 611 endpoint events are reached. \\\\\nChange 4: \\\\\nChange in follow-up period from 7 to 30 days \\\\\nChange 5: \\\\\n...in a separate CEC charter \\\\\nWas changed into: \\\\\n...in the CEC charter\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nstudy stop announcement after 611 endpoint events are reached. \\\\\nChange 4: \\\\\nChange in follow-up period from 7 to 30 days \\\\\nChange 5: \\\\\n...in a separate CEC charter \\\\\nWas changed into: \\\\\n...in the CEC charter\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99267578125,"confidence_rate":0.9999265522825811},{"cnt":[[939,342],[1711,342],[1711,381],[939,381]],"region":{"top_left_x":939,"top_left_y":342,"width":772,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2700dc72ae3d4b03be1d6ed39bef6630","type":"text","conversion_output":false,"parent_id":"f1eaee6d18954a7c941d39566eb6b16e","text":"study stop announcement after 611 endpoint events are","text_display":"study stop announcement after 611 endpoint events are","confidence":1,"confidence_rate":1},{"cnt":[[939,381],[1061,381],[1061,414],[939,414]],"region":{"top_left_x":939,"top_left_y":381,"width":123,"height":33},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c4bfc28fe962417491a7835bc83bb09c","type":"text","conversion_output":false,"parent_id":"f1eaee6d18954a7c941d39566eb6b16e","text":"reached.","text_display":" reached.","confidence":1,"confidence_rate":1},{"cnt":[[939,457],[1087,457],[1087,501],[939,501]],"region":{"top_left_x":939,"top_left_y":457,"width":148,"height":45},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b4e26aecfe14c5ea9426c31b1a154e0","type":"text","conversion_output":false,"parent_id":"f1eaee6d18954a7c941d39566eb6b16e","text":"Change 4:","text_display":"\nChange 4:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[939,501],[1584,501],[1584,543],[939,543]],"region":{"top_left_x":939,"top_left_y":501,"width":646,"height":42},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0aa46e59337549b6b5da5e9239d221d1","type":"text","conversion_output":false,"parent_id":"f1eaee6d18954a7c941d39566eb6b16e","text":"Change in follow-up period from 7 to 30 days","text_display":"\nChange in follow-up period from 7 to 30 days","confidence":1,"confidence_rate":1},{"cnt":[[939,582],[1089,582],[1089,621],[939,621]],"region":{"top_left_x":939,"top_left_y":581,"width":151,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b307f2fc95e44347aa87eb1856f742db","type":"text","conversion_output":false,"parent_id":"f1eaee6d18954a7c941d39566eb6b16e","text":"Change 5:","text_display":"\nChange 5:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,621],[1338,621],[1338,662],[939,662]],"region":{"top_left_x":939,"top_left_y":620,"width":399,"height":43},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9664746ffa3410fbdbbb8518c97840c","type":"text","conversion_output":false,"parent_id":"f1eaee6d18954a7c941d39566eb6b16e","text":"...in a separate CEC charter","text_display":"\n...in a separate CEC charter","confidence":1,"confidence_rate":1},{"cnt":[[939,701],[1204,701],[1204,741],[939,741]],"region":{"top_left_x":939,"top_left_y":701,"width":266,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"32320f5596b94ae5997b0055088eedf7","type":"text","conversion_output":false,"parent_id":"f1eaee6d18954a7c941d39566eb6b16e","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99560546875,"confidence_rate":0.9997998284195073},{"cnt":[[939,780],[1241,780],[1241,814],[939,814]],"region":{"top_left_x":939,"top_left_y":779,"width":302,"height":36},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f8c65f293644218beb339f03ec95b24","type":"text","conversion_output":false,"parent_id":"f1eaee6d18954a7c941d39566eb6b16e","text":"...in the CEC charter","text_display":"\n...in the CEC charter","confidence":0.99267578125,"confidence_rate":0.9997173025614129},{"cnt":[[267,821],[582,821],[582,863],[267,863]],"region":{"top_left_x":267,"top_left_y":821,"width":316,"height":42},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13051f7bdfad4478b120023bed65995b","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,817],[1752,817],[1752,1781],[935,1781]],"region":{"top_left_x":934,"top_left_y":816,"width":819,"height":966},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0cd79ad34d524cd59e5b754243cea6d5","type":"complex_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","children_ids":["851068a4856f4df590fc22c4e4824346","6aca105f542c4e4482655137aff7731a","3e4b6a5a87f14cbf9ccd9ef46329354c","d82e7dda1984426facfb788a3bb75bd1","c9d904a9928b4563a9dc8f8ed71a8629","35590a539e9d43d0baf0ed11525306f2","8e7cd0d5ee304b6e936d735dc5f060b8","3508aa97229f49638d94aa9ce80ab23d","ef27db1bc50f4a03ad4838cf45d571b9","6215fdff0ad64133a258615ef9ce23de","7723809adddf4ee7985ae6ba55ab97ce","f67694ff2c9d4101a5bba3015918d4d7","97070a2470b541a18a00ba9b9bb7ebf1","5181c8f0b29c45ad8a134f10b8bcebfd","ac5542c2fd6f4f60b5bfd2c34abb0dbd","bf9f6d62641849afaa2b14b9065f9681","e2ec4b8d7b4d4b2aa4548cf90ebcfe81","407e8377b71644feab2a008766940fe5","dd81c6a77e664ee7a03aed239333a4b4","59d50b708256463f98976bafaeecaa02"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. \\\\\nChange 2: \\\\\nSince the interim analysis for efficacy was deleted, the required number of patients with primary endpoint to achieve a power of \\(90 \\%\\) for non-inferiority is reduced from 625 to 611. The estimated trial duration increased slightly due to the change of the primary endpoint while ensuring a sufficiently long drug exposure for the last recruited patients. \\\\\nChange 3: \\\\\nTo clarify the respective actions to stop the trial when 611 endpoint events are reached. \\\\\nChange 4: \\\\\nTo allow for outcome event data collection up to 30 days after EOT \\\\\nChange 5: \\\\\nFor clarification\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. \\\\\nChange 2: \\\\\nSince the interim analysis for efficacy was deleted, the required number of patients with primary endpoint to achieve a power of \\(90 \\%\\) for non-inferiority is reduced from 625 to 611. The estimated trial duration increased slightly due to the change of the primary endpoint while ensuring a sufficiently long drug exposure for the last recruited patients. \\\\\nChange 3: \\\\\nTo clarify the respective actions to stop the trial when 611 endpoint events are reached. \\\\\nChange 4: \\\\\nTo allow for outcome event data collection up to 30 days after EOT \\\\\nChange 5: \\\\\nFor clarification\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.98974609375,"confidence_rate":0.9999839810741633},{"cnt":[[939,821],[1089,821],[1089,860],[939,860]],"region":{"top_left_x":939,"top_left_y":821,"width":151,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"851068a4856f4df590fc22c4e4824346","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,863],[1651,863],[1651,902],[939,902]],"region":{"top_left_x":939,"top_left_y":862,"width":712,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6aca105f542c4e4482655137aff7731a","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"Overall MACE event rates are higher than initially","text_display":"\nOverall MACE event rates are higher than initially","confidence":0.9990234375,"confidence_rate":0.999982235800552},{"cnt":[[939,899],[1752,899],[1752,943],[939,943]],"region":{"top_left_x":939,"top_left_y":899,"width":814,"height":45},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e4b6a5a87f14cbf9ccd9ef46329354c","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"expected and this allows reducing the sample size without","text_display":" expected and this allows reducing the sample size without","confidence":1,"confidence_rate":1},{"cnt":[[939,941],[1388,941],[1388,982],[939,982]],"region":{"top_left_x":939,"top_left_y":940,"width":450,"height":43},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d82e7dda1984426facfb788a3bb75bd1","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"major impact on study duration.","text_display":" major impact on study duration.","confidence":1,"confidence_rate":1},{"cnt":[[939,1024],[1089,1024],[1089,1063],[939,1063]],"region":{"top_left_x":939,"top_left_y":1023,"width":151,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9d904a9928b4563a9dc8f8ed71a8629","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,1061],[1706,1061],[1706,1100],[939,1100]],"region":{"top_left_x":939,"top_left_y":1060,"width":768,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35590a539e9d43d0baf0ed11525306f2","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"Since the interim analysis for efficacy was deleted, the","text_display":"\nSince the interim analysis for efficacy was deleted, the","confidence":1,"confidence_rate":1},{"cnt":[[939,1102],[1683,1102],[1683,1141],[939,1141]],"region":{"top_left_x":939,"top_left_y":1102,"width":745,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e7cd0d5ee304b6e936d735dc5f060b8","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"required number of patients with primary endpoint to","text_display":" required number of patients with primary endpoint to","confidence":1,"confidence_rate":1},{"cnt":[[939,1143],[1692,1143],[1692,1183],[939,1183]],"region":{"top_left_x":939,"top_left_y":1143,"width":754,"height":40},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3508aa97229f49638d94aa9ce80ab23d","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"achieve a power of \\(90 \\%\\) for non-inferiority is reduced","text_display":" achieve a power of \\(90 \\%\\) for non-inferiority is reduced","confidence":0.98974609375,"confidence_rate":0.9998310496883445},{"cnt":[[939,1183],[1713,1183],[1713,1219],[939,1219]],"region":{"top_left_x":939,"top_left_y":1182,"width":774,"height":38},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef27db1bc50f4a03ad4838cf45d571b9","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"from 625 to 611. The estimated trial duration increased","text_display":" from 625 to 611. The estimated trial duration increased","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[939,1222],[1725,1222],[1725,1261],[939,1261]],"region":{"top_left_x":939,"top_left_y":1221,"width":786,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6215fdff0ad64133a258615ef9ce23de","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"slightly due to the change of the primary endpoint while","text_display":" slightly due to the change of the primary endpoint while","confidence":0.99658203125,"confidence_rate":0.9999438733235289},{"cnt":[[939,1263],[1692,1263],[1692,1302],[939,1302]],"region":{"top_left_x":939,"top_left_y":1263,"width":754,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7723809adddf4ee7985ae6ba55ab97ce","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"ensuring a sufficiently long drug exposure for the last","text_display":" ensuring a sufficiently long drug exposure for the last","confidence":1,"confidence_rate":1},{"cnt":[[939,1302],[1193,1302],[1193,1339],[939,1339]],"region":{"top_left_x":939,"top_left_y":1302,"width":254,"height":38},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f67694ff2c9d4101a5bba3015918d4d7","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"recruited patients.","text_display":" recruited patients.","confidence":1,"confidence_rate":1},{"cnt":[[939,1378],[1089,1378],[1089,1422],[939,1422]],"region":{"top_left_x":939,"top_left_y":1378,"width":151,"height":45},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97070a2470b541a18a00ba9b9bb7ebf1","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1420],[1692,1420],[1692,1461],[939,1461]],"region":{"top_left_x":939,"top_left_y":1419,"width":754,"height":43},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5181c8f0b29c45ad8a134f10b8bcebfd","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"To clarify the respective actions to stop the trial when","text_display":"\nTo clarify the respective actions to stop the trial when","confidence":1,"confidence_rate":1},{"cnt":[[939,1461],[1402,1461],[1402,1500],[939,1500]],"region":{"top_left_x":939,"top_left_y":1461,"width":464,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac5542c2fd6f4f60b5bfd2c34abb0dbd","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"611 endpoint events are reached.","text_display":" 611 endpoint events are reached.","confidence":1,"confidence_rate":1},{"cnt":[[939,1540],[1089,1540],[1089,1581],[939,1581]],"region":{"top_left_x":939,"top_left_y":1539,"width":151,"height":42},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf9f6d62641849afaa2b14b9065f9681","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"Change 4:","text_display":"\nChange 4:","confidence":1,"confidence_rate":1},{"cnt":[[939,1581],[1738,1581],[1738,1622],[939,1622]],"region":{"top_left_x":939,"top_left_y":1580,"width":800,"height":43},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2ec4b8d7b4d4b2aa4548cf90ebcfe81","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"To allow for outcome event data collection up to 30 days","text_display":"\nTo allow for outcome event data collection up to 30 days","confidence":1,"confidence_rate":1},{"cnt":[[939,1622],[1087,1622],[1087,1657],[939,1657]],"region":{"top_left_x":939,"top_left_y":1622,"width":148,"height":35},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"407e8377b71644feab2a008766940fe5","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"after EOT","text_display":" after EOT","confidence":1,"confidence_rate":1},{"cnt":[[939,1701],[1089,1701],[1089,1740],[939,1740]],"region":{"top_left_x":939,"top_left_y":1700,"width":151,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd81c6a77e664ee7a03aed239333a4b4","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"Change 5:","text_display":"\nChange 5:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1742],[1172,1742],[1172,1777],[939,1777]],"region":{"top_left_x":939,"top_left_y":1742,"width":233,"height":35},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"59d50b708256463f98976bafaeecaa02","type":"text","conversion_output":false,"parent_id":"0cd79ad34d524cd59e5b754243cea6d5","text":"For clarification","text_display":"\nFor clarification","confidence":1,"confidence_rate":1},{"cnt":[[265,1784],[592,1784],[592,1823],[265,1823]],"region":{"top_left_x":264,"top_left_y":1783,"width":328,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f85b97367444375af22ac2af49d7e59","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1784],[1409,1784],[1409,1823],[939,1823]],"region":{"top_left_x":939,"top_left_y":1783,"width":471,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1338ac489a0c43f7bfaffb825799fcd7","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"3.3 Selection of trial population","text_display":"3.3 Selection of trial population","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1834],[596,1834],[596,1876],[267,1876]],"region":{"top_left_x":267,"top_left_y":1834,"width":330,"height":42},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92ad660a7fa749b3a1557569ae784e36","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,1832],[1729,1832],[1729,1952],[937,1952]],"region":{"top_left_x":937,"top_left_y":1831,"width":793,"height":121},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8541d5ef1d564d4da26359947f0c6fa9","type":"complex_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","children_ids":["f046155a0ff3481d9eeeb12851ff0969","f9460b1bdf524394b500694789874b05","8c11928ec809402ab0c8914ba08128c5"],"text":"Number of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500.","text_display":"Number of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500.","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1834],[1720,1834],[1720,1873],[939,1873]],"region":{"top_left_x":939,"top_left_y":1834,"width":781,"height":40},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f046155a0ff3481d9eeeb12851ff0969","type":"text","conversion_output":false,"parent_id":"8541d5ef1d564d4da26359947f0c6fa9","text":"Number of randomized patients decreased from 8300 to","text_display":"Number of randomized patients decreased from 8300 to","confidence":1,"confidence_rate":1},{"cnt":[[939,1876],[1628,1876],[1628,1915],[939,1915]],"region":{"top_left_x":939,"top_left_y":1875,"width":689,"height":40},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9460b1bdf524394b500694789874b05","type":"text","conversion_output":false,"parent_id":"8541d5ef1d564d4da26359947f0c6fa9","text":"7000 and number of patients per treatment group","text_display":" 7000 and number of patients per treatment group","confidence":1,"confidence_rate":1},{"cnt":[[939,1913],[1361,1913],[1361,1949],[939,1949]],"region":{"top_left_x":939,"top_left_y":1912,"width":422,"height":38},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c11928ec809402ab0c8914ba08128c5","type":"text","conversion_output":false,"parent_id":"8541d5ef1d564d4da26359947f0c6fa9","text":"decreased from 4150 to 3500.","text_display":" decreased from 4150 to 3500.","confidence":1,"confidence_rate":1},{"cnt":[[267,1954],[582,1954],[582,1998],[267,1998]],"region":{"top_left_x":267,"top_left_y":1953,"width":316,"height":45},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47c0f3f718ac46dd94781278d968ae8b","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Rationale for change","text_display":"Rationale for change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,1954],[1757,1954],[1757,2076],[937,2076]],"region":{"top_left_x":937,"top_left_y":1953,"width":820,"height":123},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc20e77cc167442c9ba8246b699ece09","type":"complex_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","children_ids":["32157d4e3bea496ebc43f20af4cf5051","f46f484c610d4169b61ab0294e7fdf79","e6e92805872149e598423ca0acca97bf"],"text":"Overall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration","text_display":"Overall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.98974609375,"confidence_rate":0.9999375362557446},{"cnt":[[939,1956],[1651,1954],[1651,1995],[939,1998]],"region":{"top_left_x":939,"top_left_y":1953,"width":712,"height":45},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"32157d4e3bea496ebc43f20af4cf5051","type":"text","conversion_output":false,"parent_id":"fc20e77cc167442c9ba8246b699ece09","text":"Overall MACE event rates are higher than initially","text_display":"Overall MACE event rates are higher than initially","confidence":0.98974609375,"confidence_rate":0.999812620472148},{"cnt":[[939,1995],[1752,1995],[1752,2035],[939,2035]],"region":{"top_left_x":939,"top_left_y":1995,"width":814,"height":40},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f46f484c610d4169b61ab0294e7fdf79","type":"text","conversion_output":false,"parent_id":"fc20e77cc167442c9ba8246b699ece09","text":"expected and this allows reducing the sample size without","text_display":" expected and this allows reducing the sample size without","confidence":1,"confidence_rate":1},{"cnt":[[939,2037],[1384,2037],[1384,2076],[939,2076]],"region":{"top_left_x":939,"top_left_y":2036,"width":445,"height":40},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e6e92805872149e598423ca0acca97bf","type":"text","conversion_output":false,"parent_id":"fc20e77cc167442c9ba8246b699ece09","text":"major impact on study duration","text_display":" major impact on study duration","confidence":1,"confidence_rate":1},{"cnt":[[267,2078],[592,2078],[592,2117],[267,2117]],"region":{"top_left_x":267,"top_left_y":2078,"width":325,"height":40},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0ef64065d834650a836c94cfca07b06","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Section to be changed","text_display":"Section to be changed","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2078],[1287,2078],[1287,2113],[939,2113]],"region":{"top_left_x":939,"top_left_y":2078,"width":349,"height":35},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12f1d69569b34e97a6eb56def99d9c6e","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"3.3.3 Exclusion criteria","text_display":"3.3.3 Exclusion criteria","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2129],[596,2129],[596,2170],[267,2170]],"region":{"top_left_x":267,"top_left_y":2128,"width":330,"height":43},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64e22d448b184a5bb552308c3b532ec9","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Description of change","text_display":"Description of change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2134],[1609,2134],[1609,2168],[939,2168]],"region":{"top_left_x":939,"top_left_y":2133,"width":671,"height":36},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a48a891043954525a36d98834c6e8f50","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Exclusion criterion 4: corrections of eGFR unit.","text_display":"Exclusion criterion 4: corrections of eGFR unit.","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2216],[582,2216],[582,2256],[267,2256]],"region":{"top_left_x":267,"top_left_y":2216,"width":316,"height":40},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e424016112e4349817334210105b253","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Rationale for change","text_display":"Rationale for change","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2216],[1172,2216],[1172,2251],[939,2251]],"region":{"top_left_x":939,"top_left_y":2216,"width":233,"height":35},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f23b1debd05f4ef68c6024ba002b3325","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"For clarification","text_display":"For clarification","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2267],[592,2267],[592,2309],[267,2309]],"region":{"top_left_x":267,"top_left_y":2267,"width":325,"height":42},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d352f397439846eabac258c4b3a9bb38","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Section to be changed","text_display":"Section to be changed","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2267],[1503,2267],[1503,2309],[939,2309]],"region":{"top_left_x":939,"top_left_y":2267,"width":565,"height":42},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00e24f85708c42c2b7921088c1436919","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"3.3.4.1 Removal of individual patients","text_display":"3.3.4.1 Removal of individual patients","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2318],[592,2318],[592,2362],[267,2362]],"region":{"top_left_x":267,"top_left_y":2317,"width":325,"height":45},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2bf031a496a41e99034c0c4609c4bb3","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Description of change","text_display":"Description of change","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2318],[1418,2318],[1418,2362],[939,2362]],"region":{"top_left_x":939,"top_left_y":2317,"width":480,"height":45},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c379432c4f294ac78dde99218ee82e93","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Patient retention language revised","text_display":"Patient retention language revised","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2371],[582,2371],[582,2412],[267,2412]],"region":{"top_left_x":267,"top_left_y":2370,"width":316,"height":43},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6468426d97df45b7888a6058ca34a07f","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Rationale for change","text_display":"Rationale for change","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2371],[1381,2371],[1381,2412],[939,2412]],"region":{"top_left_x":939,"top_left_y":2370,"width":443,"height":43},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f368690ba4d4e44bc5d553ac6296ae0","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"To optimize retention language","text_display":"To optimize retention language","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2424],[596,2424],[596,2463],[267,2463]],"region":{"top_left_x":267,"top_left_y":2423,"width":330,"height":40},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1af62aafe1524185ad9b903c048efca9","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Section to be changed","text_display":"Section to be changed","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2419],[1639,2419],[1639,2504],[939,2504]],"region":{"top_left_x":939,"top_left_y":2419,"width":701,"height":86},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"798ec94e8ecb4df0891d7cc888e3a465","type":"complex_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","children_ids":["95709a75438446038d2cca23047d5a23","d364bf86642643adaf85912336f6a863"],"text":"4.1.1 identity of BI investigational product and comparator product(s)","text_display":"4.1.1 identity of BI investigational product and comparator product(s)","cell_row":11,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2424],[1637,2424],[1637,2463],[939,2463]],"region":{"top_left_x":939,"top_left_y":2423,"width":699,"height":40},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95709a75438446038d2cca23047d5a23","type":"text","conversion_output":false,"parent_id":"798ec94e8ecb4df0891d7cc888e3a465","text":"4.1.1 identity of BI investigational product and","text_display":"4.1.1 identity of BI investigational product and","confidence":1,"confidence_rate":1},{"cnt":[[939,2465],[1282,2465],[1282,2502],[939,2502]],"region":{"top_left_x":939,"top_left_y":2465,"width":344,"height":37},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d364bf86642643adaf85912336f6a863","type":"text","conversion_output":false,"parent_id":"798ec94e8ecb4df0891d7cc888e3a465","text":"comparator product(s)","text_display":" comparator product(s)","confidence":1,"confidence_rate":1},{"cnt":[[265,2502],[596,2502],[596,2546],[265,2546]],"region":{"top_left_x":264,"top_left_y":2501,"width":333,"height":45},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03993d16e796417994063bccd80a4462","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Description of change","text_display":"Description of change","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2502],[1725,2502],[1725,2546],[939,2546]],"region":{"top_left_x":939,"top_left_y":2501,"width":786,"height":45},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"628b5bd54faf43c1ad38bdc4700c187f","type":"simple_cell","conversion_output":false,"parent_id":"0578e0fc1c704c779baa2b4ca2f1a115","text":"Film-coated added to tablets under pharmaceutical form","text_display":"Film-coated added to tablets under pharmaceutical form","cell_row":12,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":84,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8a017043a04643f2be9043a76a8da3bb","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2620],[1798,2620],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2620,"width":1506,"height":42},"line":85,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b1731787a8bb448f8f69e9aada4b4c78","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":86,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"25315b8beabe44cea5732fd7d891b91e","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-108","page":108,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fe0ad6b607e41c4ae3052c41de0861c","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51e9fad7148e49a2b68016e9e65d43c8","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"689eae3dbac94d06b6d537b72342fc2b","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"709587f0792f43eab2130abc8237b837","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5895b9d9dd42480f81830b1231faa729","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,210],[1816,210],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":210,"width":264,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66e4dd4ce3734d61898e18570cac6de2","type":"page_info","conversion_output":false,"text":"Page 108 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2565],[244,2565]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2233},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1eea5647d21249f8a2a1d222f8c9f579","type":"table","conversion_output":true,"children_ids":["6795bd37c96e4272ac37cda34e11db59","530fe4d9d27b40d0b10b5330a316a9e6","3dc6a1108e5346b98f1949ed3b205423","24634f1a040a4d3a9a2014176c942510","426b2b2ac2a647578dc35110029c50f0","1caa35e61aca477fa270dc3eae097381","071dd86dbcfc4bf0bc84f8e804491c96","cd346bae65da4f498c0f66b460fbedab","3b878455eff74bebbee24dc303d555e5","53017ba670704c0d9a16671e5f0614c8","00c0706b37494edca13a884fef0e5009","50cf563038374ca4920782ed86945716","4de6bff5189f4a0eb39f6284ac1d5131","c74df4570dce418e86e114353af8382c","d88ac520efcd4fd3a469b66f4437d44b","5668b11af78a4f839eba1fc61a8e943e","156fa2a6efa341a1b2d163922856c71f","5a1a8d26b9aa4e33adfd7e4dffd8b534","edab0f464ad947728f7d8781a6326720","4ee49c7720164c5992b18c82c9aa0dfe","d172eeebfff140999bd176a80b971d82","dd3c466fc2a84be49df9b458bc253bfd","e7306123ea6d4216a559425e5a4971d9","0c4d37a670114e089d54c144e376f340","dd43d0d714e34a6aa0d949cd1b9eebc1","a343799a3fbd4e6594d8cb4a0a8399d2","d5809dcd26a1460e81836b0a246ad49c","6a164bbb109a4b769933ae585e0a41f9","41e3bd178137462eae0acf02f6945edd","f3882fde8b2049a3b96fa06045220758","c7956af72b34457f9d9507f78ee48d55","c5b924459d7840a8a3b9952f268989ba","ad16744382ab4cefa4786706f6d89986","beda481f536444c196eb78fca9e45f07","a9f72d106f794bfdbeb3787c9c3bc7a1","068d581101ad4bb480af54421820e2f7","eccfbec6b1f249a89207194362b03a69","59ec7c7e91524d54924e8ae9d3aa9414","b3e071e6fa47477386443f8028593c7a","13f4577549e04129841fd96158e80a37","e60d80528d914ec48fd862e73d03bcd7","97cd0d53ec5646d999a57a0cc4acac44","f2f899f49cbb4760af117b5cb1407b35","f1c4a2c354324e57bf989e78f0f80c34","f23edec847dc45db9bb27efbae50ba8a","8a9dfd293e2c4881a0843d524a4ed987","9e7be2b5ffdc4da693b0f715208ef8af","52493490ca4f4674a61c3b8f6fb37051","b30d5933d50e442ca71b43e8a9f7cbf7"],"text":"\\begin{tabular}{|l|l|}\n\\hline & and sponsor entity omitted. \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 4.1.5.1. \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nText related to code breaking in case of SUSARs added. Change 2: \\\\\nText related to code breaking added for Japan\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1 and change 2: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 4.1.7 storage condition \\\\\n\\hline Description of change & \\begin{tabular}{l}\nAll trial medication should be stored according to the storage conditions as specified on the label and in the original package. \\\\\nWas changed into: \\\\\nThe study medication must be kept in its original packaging under the recommended storage conditions indicated on the label.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 4.2.2. \\\\\n\\hline Description of change & DDP4 was changed to DPP4. \\\\\n\\hline Rational for change & Correction of typographical error \\\\\n\\hline Section to be changed & 4.3 treatment compliance \\\\\n\\hline Description of change & Capsules were changed into tablets \\\\\n\\hline Rationale for change & Correction of error \\\\\n\\hline Section to be changed & 5.1.1 endpoints of efficacy \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nIn addition: \\\\\nThe primary endpoint in this trial is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint... \\\\\nWas changed into \\\\\nThe primary endpoint in this trial is time to the first occurrence of any of the following by adjudication confirmed components of the primary composite endpoint..... \\\\\nChange 2: \\\\\nAt the final analysis the primary endpoint (4-point MACE) will be tested for non-inferiority. Thereafter the\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & and sponsor entity omitted. \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 4.1.5.1. \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nText related to code breaking in case of SUSARs added. Change 2: \\\\\nText related to code breaking added for Japan\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1 and change 2: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 4.1.7 storage condition \\\\\n\\hline Description of change & \\begin{tabular}{l}\nAll trial medication should be stored according to the storage conditions as specified on the label and in the original package. \\\\\nWas changed into: \\\\\nThe study medication must be kept in its original packaging under the recommended storage conditions indicated on the label.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 4.2.2. \\\\\n\\hline Description of change & DDP4 was changed to DPP4. \\\\\n\\hline Rational for change & Correction of typographical error \\\\\n\\hline Section to be changed & 4.3 treatment compliance \\\\\n\\hline Description of change & Capsules were changed into tablets \\\\\n\\hline Rationale for change & Correction of error \\\\\n\\hline Section to be changed & 5.1.1 endpoints of efficacy \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nIn addition: \\\\\nThe primary endpoint in this trial is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint... \\\\\nWas changed into \\\\\nThe primary endpoint in this trial is time to the first occurrence of any of the following by adjudication confirmed components of the primary composite endpoint..... \\\\\nChange 2: \\\\\nAt the final analysis the primary endpoint (4-point MACE) will be tested for non-inferiority. Thereafter the\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.81494140625,"confidence_rate":0.9999916166049786},{"cnt":[[251,333],[601,333],[601,2566],[251,2566]],"region":{"top_left_x":250,"top_left_y":333,"width":351,"height":2234},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6795bd37c96e4272ac37cda34e11db59","type":"table_column","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[928,2566],[931,332],[1748,333],[1745,2567]],"region":{"top_left_x":928,"top_left_y":332,"width":820,"height":2236},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"530fe4d9d27b40d0b10b5330a316a9e6","type":"table_column","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,338],[1775,338],[1775,384],[244,384]],"region":{"top_left_x":244,"top_left_y":337,"width":1532,"height":47},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3dc6a1108e5346b98f1949ed3b205423","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,388],[1775,388],[1775,437],[244,437]],"region":{"top_left_x":244,"top_left_y":388,"width":1532,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24634f1a040a4d3a9a2014176c942510","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,439],[1775,439],[1775,490],[244,490]],"region":{"top_left_x":244,"top_left_y":438,"width":1532,"height":52},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"426b2b2ac2a647578dc35110029c50f0","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,490],[1775,490],[1775,660],[244,660]],"region":{"top_left_x":244,"top_left_y":489,"width":1532,"height":171},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1caa35e61aca477fa270dc3eae097381","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,653],[1775,653],[1775,736],[244,736]],"region":{"top_left_x":244,"top_left_y":653,"width":1532,"height":83},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"071dd86dbcfc4bf0bc84f8e804491c96","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,734],[1775,734],[1775,782],[244,782]],"region":{"top_left_x":244,"top_left_y":733,"width":1532,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd346bae65da4f498c0f66b460fbedab","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,784],[1775,784],[1775,1150],[244,1150]],"region":{"top_left_x":244,"top_left_y":784,"width":1532,"height":367},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b878455eff74bebbee24dc303d555e5","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,1148],[1775,1148],[1775,1196],[244,1196]],"region":{"top_left_x":244,"top_left_y":1148,"width":1532,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"53017ba670704c0d9a16671e5f0614c8","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,1199],[1775,1199],[1775,1247],[244,1247]],"region":{"top_left_x":244,"top_left_y":1198,"width":1532,"height":50},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00c0706b37494edca13a884fef0e5009","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,1249],[1775,1249],[1775,1298],[244,1298]],"region":{"top_left_x":244,"top_left_y":1249,"width":1532,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50cf563038374ca4920782ed86945716","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,1300],[1775,1300],[1775,1351],[244,1351]],"region":{"top_left_x":244,"top_left_y":1300,"width":1532,"height":51},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4de6bff5189f4a0eb39f6284ac1d5131","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,1353],[1775,1353],[1775,1404],[244,1404]],"region":{"top_left_x":244,"top_left_y":1353,"width":1532,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c74df4570dce418e86e114353af8382c","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,1406],[1775,1406],[1775,1454],[244,1454]],"region":{"top_left_x":244,"top_left_y":1405,"width":1532,"height":50},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d88ac520efcd4fd3a469b66f4437d44b","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,1457],[1775,1457],[1775,1507],[244,1507]],"region":{"top_left_x":244,"top_left_y":1456,"width":1532,"height":52},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5668b11af78a4f839eba1fc61a8e943e","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,1507],[1775,1507],[1775,1558],[244,1558]],"region":{"top_left_x":244,"top_left_y":1507,"width":1532,"height":51},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"156fa2a6efa341a1b2d163922856c71f","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[244,1556],[1775,1556],[1775,2564],[244,2564]],"region":{"top_left_x":244,"top_left_y":1555,"width":1532,"height":1010},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a1a8d26b9aa4e33adfd7e4dffd8b534","type":"table_row","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"","text_display":""},{"cnt":[[939,342],[1324,342],[1324,381],[939,381]],"region":{"top_left_x":939,"top_left_y":342,"width":385,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"edab0f464ad947728f7d8781a6326720","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"and sponsor entity omitted.","text_display":"and sponsor entity omitted.","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,393],[582,393],[582,432],[265,432]],"region":{"top_left_x":264,"top_left_y":392,"width":319,"height":41},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ee49c7720164c5992b18c82c9aa0dfe","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,393],[1172,393],[1172,427],[939,427]],"region":{"top_left_x":939,"top_left_y":392,"width":233,"height":36},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d172eeebfff140999bd176a80b971d82","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"For clarification","text_display":"For clarification","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,446],[592,446],[592,487],[267,487]],"region":{"top_left_x":267,"top_left_y":445,"width":325,"height":43},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd3c466fc2a84be49df9b458bc253bfd","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,446],[1050,446],[1050,478],[939,478]],"region":{"top_left_x":939,"top_left_y":445,"width":111,"height":34},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7306123ea6d4216a559425e5a4971d9","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"4.1.5.1.","text_display":"4.1.5.1.","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,499],[596,499],[596,538],[267,538]],"region":{"top_left_x":267,"top_left_y":498,"width":330,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c4d37a670114e089d54c144e376f340","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,494],[1731,494],[1731,658],[937,658]],"region":{"top_left_x":937,"top_left_y":494,"width":795,"height":164},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd43d0d714e34a6aa0d949cd1b9eebc1","type":"complex_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","children_ids":["e296f00be7634b6c81fdfd3f7a2b8c63","6a5d108cf312412c8bdd6e87568947fd","5a779c7d985940e5911e4bd5c6190586","9a25a73b38aa4f23b7723e85a94d2999"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nText related to code breaking in case of SUSARs added. Change 2: \\\\\nText related to code breaking added for Japan\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nText related to code breaking in case of SUSARs added. Change 2: \\\\\nText related to code breaking added for Japan\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,494],[1087,494],[1087,538],[939,538]],"region":{"top_left_x":939,"top_left_y":494,"width":148,"height":44},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e296f00be7634b6c81fdfd3f7a2b8c63","type":"text","conversion_output":false,"parent_id":"dd43d0d714e34a6aa0d949cd1b9eebc1","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,536],[1729,536],[1729,575],[939,575]],"region":{"top_left_x":939,"top_left_y":535,"width":791,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a5d108cf312412c8bdd6e87568947fd","type":"text","conversion_output":false,"parent_id":"dd43d0d714e34a6aa0d949cd1b9eebc1","text":"Text related to code breaking in case of SUSARs added.","text_display":"\nText related to code breaking in case of SUSARs added.","confidence":1,"confidence_rate":1},{"cnt":[[939,577],[1087,577],[1087,616],[939,616]],"region":{"top_left_x":939,"top_left_y":577,"width":148,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a779c7d985940e5911e4bd5c6190586","type":"text","conversion_output":false,"parent_id":"dd43d0d714e34a6aa0d949cd1b9eebc1","text":"Change 2:","text_display":" Change 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,614],[1582,614],[1582,655],[939,655]],"region":{"top_left_x":939,"top_left_y":613,"width":643,"height":43},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a25a73b38aa4f23b7723e85a94d2999","type":"text","conversion_output":false,"parent_id":"dd43d0d714e34a6aa0d949cd1b9eebc1","text":"Text related to code breaking added for Japan","text_display":"\nText related to code breaking added for Japan","confidence":1,"confidence_rate":1},{"cnt":[[267,660],[589,660],[589,699],[267,699]],"region":{"top_left_x":267,"top_left_y":659,"width":323,"height":41},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a343799a3fbd4e6594d8cb4a0a8399d2","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Rationale for change","text_display":"Rationale for change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,655],[1282,655],[1282,734],[937,734]],"region":{"top_left_x":937,"top_left_y":655,"width":346,"height":79},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d5809dcd26a1460e81836b0a246ad49c","type":"complex_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","children_ids":["56e3183afb594bf58e4b2fa4268b5089","c80708800fe74b1a8f5878099aa83cf5"],"text":"\\begin{tabular}{l}\nChange 1 and change 2: \\\\\nFor clarification\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1 and change 2: \\\\\nFor clarification\n\\end{tabular}","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,658],[1278,658],[1278,697],[939,697]],"region":{"top_left_x":939,"top_left_y":657,"width":339,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56e3183afb594bf58e4b2fa4268b5089","type":"text","conversion_output":false,"parent_id":"d5809dcd26a1460e81836b0a246ad49c","text":"Change 1 and change 2:","text_display":"Change 1 and change 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,697],[1172,697],[1172,731],[939,731]],"region":{"top_left_x":939,"top_left_y":696,"width":233,"height":36},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c80708800fe74b1a8f5878099aa83cf5","type":"text","conversion_output":false,"parent_id":"d5809dcd26a1460e81836b0a246ad49c","text":"For clarification","text_display":"\nFor clarification","confidence":1,"confidence_rate":1},{"cnt":[[267,741],[592,741],[592,780],[267,780]],"region":{"top_left_x":267,"top_left_y":740,"width":325,"height":40},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a164bbb109a4b769933ae585e0a41f9","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Section to be changed","text_display":"Section to be changed","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,741],[1278,741],[1278,777],[939,777]],"region":{"top_left_x":939,"top_left_y":740,"width":339,"height":38},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41e3bd178137462eae0acf02f6945edd","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"4.1.7 storage condition","text_display":"4.1.7 storage condition","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,789],[596,789],[596,833],[267,833]],"region":{"top_left_x":267,"top_left_y":788,"width":330,"height":45},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3882fde8b2049a3b96fa06045220758","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Description of change","text_display":"Description of change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,787],[1692,787],[1692,1148],[935,1148]],"region":{"top_left_x":934,"top_left_y":786,"width":759,"height":363},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7956af72b34457f9d9507f78ee48d55","type":"complex_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","children_ids":["05429c6cd5cd4d15bca9ef459179ef47","9d34667e3a73435e8853c55cab0aaccb","19f021294f9c4e18a42b52b6acef9d40","539f2cc2f5bd4d7781be944e9b1c13c8","cabab112ebe846ba8053af2d4f6fa7c9","38044dacf58b4e118a646649b86d88c8","b5d49bae3b114ca7b83822e1c502dc90"],"text":"\\begin{tabular}{l}\nAll trial medication should be stored according to the storage conditions as specified on the label and in the original package. \\\\\nWas changed into: \\\\\nThe study medication must be kept in its original packaging under the recommended storage conditions indicated on the label.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAll trial medication should be stored according to the storage conditions as specified on the label and in the original package. \\\\\nWas changed into: \\\\\nThe study medication must be kept in its original packaging under the recommended storage conditions indicated on the label.\n\\end{tabular}","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9931640625,"confidence_rate":0.9999554593715029},{"cnt":[[939,789],[1688,789],[1688,833],[939,833]],"region":{"top_left_x":939,"top_left_y":788,"width":749,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"05429c6cd5cd4d15bca9ef459179ef47","type":"text","conversion_output":false,"parent_id":"c7956af72b34457f9d9507f78ee48d55","text":"All trial medication should be stored according to the","text_display":"All trial medication should be stored according to the","confidence":1,"confidence_rate":1},{"cnt":[[939,830],[1688,830],[1688,869],[939,869]],"region":{"top_left_x":939,"top_left_y":830,"width":749,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d34667e3a73435e8853c55cab0aaccb","type":"text","conversion_output":false,"parent_id":"c7956af72b34457f9d9507f78ee48d55","text":"storage conditions as specified on the label and in the","text_display":" storage conditions as specified on the label and in the","confidence":1,"confidence_rate":1},{"cnt":[[939,872],[1186,872],[1186,911],[939,911]],"region":{"top_left_x":939,"top_left_y":871,"width":247,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19f021294f9c4e18a42b52b6acef9d40","type":"text","conversion_output":false,"parent_id":"c7956af72b34457f9d9507f78ee48d55","text":"original package.","text_display":" original package.","confidence":1,"confidence_rate":1},{"cnt":[[939,950],[1204,950],[1204,989],[939,989]],"region":{"top_left_x":939,"top_left_y":950,"width":266,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"539f2cc2f5bd4d7781be944e9b1c13c8","type":"text","conversion_output":false,"parent_id":"c7956af72b34457f9d9507f78ee48d55","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9931640625,"confidence_rate":0.9996882572586471},{"cnt":[[939,1028],[1628,1028],[1628,1072],[939,1072]],"region":{"top_left_x":939,"top_left_y":1028,"width":689,"height":45},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cabab112ebe846ba8053af2d4f6fa7c9","type":"text","conversion_output":false,"parent_id":"c7956af72b34457f9d9507f78ee48d55","text":"The study medication must be kept in its original","text_display":"\nThe study medication must be kept in its original","confidence":1,"confidence_rate":1},{"cnt":[[939,1070],[1543,1070],[1543,1109],[939,1109]],"region":{"top_left_x":939,"top_left_y":1069,"width":604,"height":40},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38044dacf58b4e118a646649b86d88c8","type":"text","conversion_output":false,"parent_id":"c7956af72b34457f9d9507f78ee48d55","text":"packaging under the recommended storage","text_display":" packaging under the recommended storage","confidence":1,"confidence_rate":1},{"cnt":[[939,1109],[1407,1109],[1407,1146],[939,1146]],"region":{"top_left_x":939,"top_left_y":1108,"width":468,"height":38},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5d49bae3b114ca7b83822e1c502dc90","type":"text","conversion_output":false,"parent_id":"c7956af72b34457f9d9507f78ee48d55","text":"conditions indicated on the label.","text_display":" conditions indicated on the label.","confidence":1,"confidence_rate":1},{"cnt":[[267,1153],[582,1153],[582,1192],[267,1192]],"region":{"top_left_x":267,"top_left_y":1152,"width":316,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5b924459d7840a8a3b9952f268989ba","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Rationale for change","text_display":"Rationale for change","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1153],[1172,1153],[1172,1187],[939,1187]],"region":{"top_left_x":939,"top_left_y":1152,"width":233,"height":36},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad16744382ab4cefa4786706f6d89986","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"For clarification","text_display":"For clarification","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1203],[592,1203],[592,1242],[267,1242]],"region":{"top_left_x":267,"top_left_y":1203,"width":325,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"beda481f536444c196eb78fca9e45f07","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Section to be changed","text_display":"Section to be changed","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1203],[1027,1203],[1027,1240],[939,1240]],"region":{"top_left_x":939,"top_left_y":1203,"width":88,"height":38},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9f72d106f794bfdbeb3787c9c3bc7a1","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"4.2.2.","text_display":"4.2.2.","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1254],[596,1254],[596,1295],[267,1295]],"region":{"top_left_x":267,"top_left_y":1254,"width":330,"height":42},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"068d581101ad4bb480af54421820e2f7","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Description of change","text_display":"Description of change","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1254],[1352,1254],[1352,1293],[939,1293]],"region":{"top_left_x":939,"top_left_y":1254,"width":413,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eccfbec6b1f249a89207194362b03a69","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"DDP4 was changed to DPP4.","text_display":"DDP4 was changed to DPP4.","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1305],[564,1305],[564,1348],[267,1348]],"region":{"top_left_x":267,"top_left_y":1304,"width":298,"height":45},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"59ec7c7e91524d54924e8ae9d3aa9414","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Rational for change","text_display":"Rational for change","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1305],[1409,1305],[1409,1348],[939,1348]],"region":{"top_left_x":939,"top_left_y":1304,"width":471,"height":45},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3e071e6fa47477386443f8028593c7a","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Correction of typographical error","text_display":"Correction of typographical error","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1360],[592,1360],[592,1399],[267,1399]],"region":{"top_left_x":267,"top_left_y":1359,"width":325,"height":41},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13f4577549e04129841fd96158e80a37","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Section to be changed","text_display":"Section to be changed","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1360],[1319,1360],[1319,1399],[939,1399]],"region":{"top_left_x":939,"top_left_y":1359,"width":381,"height":41},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e60d80528d914ec48fd862e73d03bcd7","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"4.3 treatment compliance","text_display":"4.3 treatment compliance","cell_row":11,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1411],[592,1411],[592,1450],[267,1450]],"region":{"top_left_x":267,"top_left_y":1410,"width":325,"height":40},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97cd0d53ec5646d999a57a0cc4acac44","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Description of change","text_display":"Description of change","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1411],[1434,1411],[1434,1450],[939,1450]],"region":{"top_left_x":939,"top_left_y":1410,"width":496,"height":40},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2f899f49cbb4760af117b5cb1407b35","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Capsules were changed into tablets","text_display":"Capsules were changed into tablets","cell_row":12,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1461],[582,1461],[582,1500],[267,1500]],"region":{"top_left_x":267,"top_left_y":1461,"width":316,"height":40},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1c4a2c354324e57bf989e78f0f80c34","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Rationale for change","text_display":"Rationale for change","cell_row":13,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1461],[1209,1461],[1209,1496],[939,1496]],"region":{"top_left_x":939,"top_left_y":1461,"width":270,"height":35},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f23edec847dc45db9bb27efbae50ba8a","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Correction of error","text_display":"Correction of error","cell_row":13,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1514],[592,1512],[592,1555],[267,1557]],"region":{"top_left_x":266,"top_left_y":1511,"width":326,"height":47},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a9dfd293e2c4881a0843d524a4ed987","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Section to be changed","text_display":"Section to be changed","cell_row":14,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1514],[1328,1514],[1328,1556],[939,1556]],"region":{"top_left_x":939,"top_left_y":1514,"width":390,"height":42},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e7be2b5ffdc4da693b0f715208ef8af","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"5.1.1 endpoints of efficacy","text_display":"5.1.1 endpoints of efficacy","cell_row":14,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1563],[596,1563],[596,1606],[267,1606]],"region":{"top_left_x":267,"top_left_y":1562,"width":330,"height":45},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52493490ca4f4674a61c3b8f6fb37051","type":"simple_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","text":"Description of change","text_display":"Description of change","cell_row":15,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1560],[1743,1560],[1743,2564],[935,2564]],"region":{"top_left_x":934,"top_left_y":1560,"width":809,"height":1005},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b30d5933d50e442ca71b43e8a9f7cbf7","type":"complex_cell","conversion_output":false,"parent_id":"1eea5647d21249f8a2a1d222f8c9f579","children_ids":["1de84509e1404866bdb7a1c9887cd245","8d1f2502f52f49169d8e44d5690aec43","6650cd41cfee404f8fb5193c506f3255","258a1ca3c9fa4bb7be550cd5f583a20b","9c48bd5aaa2e4903b3b477337ca90129","7d89504f388541f7a94fc56076dc65e0","b5e0c987b9d6447abf7ef56923c9b22d","4608285eaf424448a47f711f6a64789e","b88738d03a364f219985a0041e7c8ad8","e2a98689abcf4a89aaf7de68953748d7","b8b273ccf81f4b11815fab201fe8eaae","83c096d88802470980ec34f5617c79ec","54441a04c1b64adeabbc62a6a406bafc","e6c723c75aa044cbb0607c3752a2e303","cb7a1fc43ea54910bc6add49a6554601","b1a340b716f24e1b8ff7864ae43e024b","08721e193ba84d6a976a7b155bb1a072","155dceb294544cf3a27dd854ab8c266f","19bf21a3a23145c9806c716954a9db2a","d15d6d6ca6764cf1a43608634a3ea5fd","44cc090befc24f36a17d7f3a6b1c4f69"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nIn addition: \\\\\nThe primary endpoint in this trial is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint... \\\\\nWas changed into \\\\\nThe primary endpoint in this trial is time to the first occurrence of any of the following by adjudication confirmed components of the primary composite endpoint..... \\\\\nChange 2: \\\\\nAt the final analysis the primary endpoint (4-point MACE) will be tested for non-inferiority. Thereafter the\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nThe primary endpoint changed from 4-point MACE to 3point MACE. \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of 40\\% or more in eGFR). \\\\\nIn addition: \\\\\nThe primary endpoint in this trial is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint... \\\\\nWas changed into \\\\\nThe primary endpoint in this trial is time to the first occurrence of any of the following by adjudication confirmed components of the primary composite endpoint..... \\\\\nChange 2: \\\\\nAt the final analysis the primary endpoint (4-point MACE) will be tested for non-inferiority. Thereafter the\n\\end{tabular}","cell_row":15,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.81494140625,"confidence_rate":0.9997846784704381},{"cnt":[[939,1563],[1089,1563],[1089,1606],[939,1606]],"region":{"top_left_x":939,"top_left_y":1562,"width":151,"height":45},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1de84509e1404866bdb7a1c9887cd245","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,1604],[1743,1604],[1743,1643],[939,1643]],"region":{"top_left_x":939,"top_left_y":1603,"width":804,"height":41},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d1f2502f52f49169d8e44d5690aec43","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"The primary endpoint changed from 4-point MACE to 3-","text_display":"\nThe primary endpoint changed from 4-point MACE to 3","confidence":1,"confidence_rate":1},{"cnt":[[939,1645],[1135,1645],[1135,1685],[939,1685]],"region":{"top_left_x":939,"top_left_y":1645,"width":197,"height":40},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6650cd41cfee404f8fb5193c506f3255","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"point MACE.","text_display":"point MACE.","confidence":1,"confidence_rate":1},{"cnt":[[939,1685],[1738,1685],[1738,1724],[939,1724]],"region":{"top_left_x":939,"top_left_y":1684,"width":800,"height":40},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"258a1ca3c9fa4bb7be550cd5f583a20b","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"The key secondary endpoints were changed from 3-point","text_display":"\nThe key secondary endpoints were changed from 3-point","confidence":1,"confidence_rate":1},{"cnt":[[939,1724],[1646,1724],[1646,1763],[939,1763]],"region":{"top_left_x":939,"top_left_y":1723,"width":708,"height":40},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c48bd5aaa2e4903b3b477337ca90129","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"MACE and composite renal endpoint (renal death,","text_display":" MACE and composite renal endpoint (renal death,","confidence":1,"confidence_rate":1},{"cnt":[[939,1765],[1711,1765],[1711,1804],[939,1804]],"region":{"top_left_x":939,"top_left_y":1765,"width":772,"height":40},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d89504f388541f7a94fc56076dc65e0","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"sustained ESRD, sustained decrease of 50\\% or more in","text_display":" sustained ESRD, sustained decrease of 50\\% or more in","confidence":0.81494140625,"confidence_rate":0.9964162779241185},{"cnt":[[939,1802],[1619,1802],[1619,1846],[939,1846]],"region":{"top_left_x":939,"top_left_y":1801,"width":680,"height":45},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5e0c987b9d6447abf7ef56923c9b22d","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"eGFR) to composite renal endpoint (renal death,","text_display":" eGFR) to composite renal endpoint (renal death,","confidence":1,"confidence_rate":1},{"cnt":[[939,1843],[1711,1843],[1711,1883],[939,1883]],"region":{"top_left_x":939,"top_left_y":1843,"width":772,"height":40},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4608285eaf424448a47f711f6a64789e","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"sustained ESRD, sustained decrease of 40\\% or more in","text_display":" sustained ESRD, sustained decrease of 40\\% or more in","confidence":0.96337890625,"confidence_rate":0.9993456794218928},{"cnt":[[939,1885],[1048,1885],[1048,1924],[939,1924]],"region":{"top_left_x":939,"top_left_y":1884,"width":109,"height":41},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b88738d03a364f219985a0041e7c8ad8","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"eGFR).","text_display":" eGFR).","confidence":0.9990234375,"confidence_rate":0.9999111821583719},{"cnt":[[939,1963],[1107,1963],[1107,1998],[939,1998]],"region":{"top_left_x":939,"top_left_y":1963,"width":169,"height":35},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2a98689abcf4a89aaf7de68953748d7","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"In addition:","text_display":"\nIn addition:","confidence":1,"confidence_rate":1},{"cnt":[[939,2005],[1665,2005],[1665,2044],[939,2044]],"region":{"top_left_x":939,"top_left_y":2004,"width":726,"height":40},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8b273ccf81f4b11815fab201fe8eaae","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"The primary endpoint in this trial is time to the first","text_display":"\nThe primary endpoint in this trial is time to the first","confidence":1,"confidence_rate":1},{"cnt":[[939,2041],[1596,2041],[1596,2085],[939,2085]],"region":{"top_left_x":939,"top_left_y":2041,"width":657,"height":45},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83c096d88802470980ec34f5617c79ec","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"occurrence of any of the following adjudicated","text_display":" occurrence of any of the following adjudicated","confidence":1,"confidence_rate":1},{"cnt":[[939,2083],[1637,2083],[1637,2124],[939,2124]],"region":{"top_left_x":939,"top_left_y":2082,"width":699,"height":43},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54441a04c1b64adeabbc62a6a406bafc","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"components of the primary composite endpoint...","text_display":" components of the primary composite endpoint...","confidence":0.990234375,"confidence_rate":0.9998112943177666},{"cnt":[[939,2161],[1195,2161],[1195,2205],[939,2205]],"region":{"top_left_x":939,"top_left_y":2161,"width":256,"height":44},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e6c723c75aa044cbb0607c3752a2e303","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"Was changed into","text_display":"\nWas changed into","confidence":1,"confidence_rate":1},{"cnt":[[939,2239],[1665,2239],[1665,2283],[939,2283]],"region":{"top_left_x":939,"top_left_y":2239,"width":726,"height":45},"line":84,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb7a1fc43ea54910bc6add49a6554601","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"The primary endpoint in this trial is time to the first","text_display":"\nThe primary endpoint in this trial is time to the first","confidence":1,"confidence_rate":1},{"cnt":[[939,2281],[1651,2281],[1651,2325],[939,2325]],"region":{"top_left_x":939,"top_left_y":2280,"width":712,"height":45},"line":85,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1a340b716f24e1b8ff7864ae43e024b","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"occurrence of any of the following by adjudication","text_display":" occurrence of any of the following by adjudication","confidence":1,"confidence_rate":1},{"cnt":[[939,2322],[1628,2322],[1628,2364],[939,2364]],"region":{"top_left_x":939,"top_left_y":2322,"width":689,"height":42},"line":86,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08721e193ba84d6a976a7b155bb1a072","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"confirmed components of the primary composite","text_display":" confirmed components of the primary composite","confidence":1,"confidence_rate":1},{"cnt":[[939,2364],[1121,2364],[1121,2403],[939,2403]],"region":{"top_left_x":939,"top_left_y":2363,"width":183,"height":40},"line":87,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"155dceb294544cf3a27dd854ab8c266f","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"endpoint.....","text_display":" endpoint.....","confidence":1,"confidence_rate":1},{"cnt":[[939,2442],[1089,2442],[1089,2481],[939,2481]],"region":{"top_left_x":939,"top_left_y":2442,"width":151,"height":40},"line":88,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19bf21a3a23145c9806c716954a9db2a","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2484],[1646,2484],[1646,2523],[939,2523]],"region":{"top_left_x":939,"top_left_y":2483,"width":708,"height":40},"line":89,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d15d6d6ca6764cf1a43608634a3ea5fd","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"At the final analysis the primary endpoint (4-point","text_display":"\nAt the final analysis the primary endpoint (4-point","confidence":1,"confidence_rate":1},{"cnt":[[939,2520],[1729,2520],[1729,2564],[939,2564]],"region":{"top_left_x":939,"top_left_y":2520,"width":791,"height":45},"line":90,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44cc090befc24f36a17d7f3a6b1c4f69","type":"text","conversion_output":false,"parent_id":"b30d5933d50e442ca71b43e8a9f7cbf7","text":"MACE) will be tested for non-inferiority. Thereafter the","text_display":" MACE) will be tested for non-inferiority. Thereafter the","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":91,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d57ef9ca2e1a4cd9a08c159e690382b1","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":92,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f78e4ab2b7424288882fdae233111fe8","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":93,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7233fd745fe14e0c9d4ee7787fd68735","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-109","page":109,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b5dc46d954245a08d6a4882b70a3c2b","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fced7265f473492b89c2bbd723523dcb","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63de594559b5481fafe5c352fe6fa38c","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,210],[637,210],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":210,"width":396,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd3d7afebd46483db3145d26236aba66","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3671097ddb6e4189b6ff0ea7af276a78","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,206],[1816,206],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":205,"width":264,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e5d3f2b331449c6aa05406b09b61c98","type":"page_info","conversion_output":false,"text":"Page 109 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1777,331],[1777,2570],[242,2570]],"region":{"top_left_x":242,"top_left_y":331,"width":1536,"height":2239},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d399608373164fc08e8b4158d21ad0f2","type":"table","conversion_output":true,"children_ids":["070d978c43b549fca389a08bbe24a259","ea10e3ecf41b4f74a42c0e0d4058c79c","6bdf065ca57e40f89ce6b66f863f36e4","8192912d29d5486884cd221e13520225"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\n4-point MACE and the combined composite renal endpoint will be tested separately (= in parallel) for superiority. In case the 4-point MACE and/or composite renal endpoint is significantly superior, the 3-point MACE will then be tested for superiority. \\\\\nWas changed into: \\\\\nThe primary endpoint (3-point MACE) will be tested for non-inferiority. Thereafter, if non-inferiority has been demonstrated, the 3-point MACE and the combined composite renal endpoint will be tested separately for superiority.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\n4-point MACE and the combined composite renal endpoint will be tested separately (= in parallel) for superiority. In case the 4-point MACE and/or composite renal endpoint is significantly superior, the 3-point MACE will then be tested for superiority. \\\\\nWas changed into: \\\\\nThe primary endpoint (3-point MACE) will be tested for non-inferiority. Thereafter, if non-inferiority has been demonstrated, the 3-point MACE and the combined composite renal endpoint will be tested separately for superiority.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.99658203125,"confidence_rate":0.9999812344794522},{"cnt":[[242,331],[841,331],[841,2567],[242,2567]],"region":{"top_left_x":242,"top_left_y":331,"width":599,"height":2236},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"070d978c43b549fca389a08bbe24a259","type":"table_column","conversion_output":false,"parent_id":"d399608373164fc08e8b4158d21ad0f2","text":"","text_display":""},{"cnt":[[928,331],[1748,331],[1748,2564],[928,2564]],"region":{"top_left_x":928,"top_left_y":331,"width":820,"height":2234},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea10e3ecf41b4f74a42c0e0d4058c79c","type":"table_column","conversion_output":false,"parent_id":"d399608373164fc08e8b4158d21ad0f2","text":"","text_display":""},{"cnt":[[242,331],[1778,331],[1778,833],[242,833]],"region":{"top_left_x":242,"top_left_y":331,"width":1536,"height":502},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6bdf065ca57e40f89ce6b66f863f36e4","type":"table_row","conversion_output":false,"parent_id":"d399608373164fc08e8b4158d21ad0f2","text":"","text_display":""},{"cnt":[[933,336],[1746,336],[1746,826],[933,826]],"region":{"top_left_x":932,"top_left_y":335,"width":814,"height":492},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8192912d29d5486884cd221e13520225","type":"complex_cell","conversion_output":false,"parent_id":"d399608373164fc08e8b4158d21ad0f2","children_ids":["3cfadcf80c68438b8a5945432cbdb03d","fdb68af3645749a9b40a53339b7e44d9","b444f7b57a2347cfa0aa774d6d9370a0","7115c687cbb142639f2263c5e5ee93e3","70e37f0e80e542b38dc94672fffd7194","cde0cc29c2cf4b1ebcbf3bb112666fe2","974f6a9df770430bb711d901c6ac3f9c","73d80a19e67f4b888c88663fad5d8343","9488af46ffcf4ccca5b1f365cb18c7ed","ce89c76680fd41e8887ef8fe397b934c","3d693e17395149b18dd576310adef6e9"],"text":"\\begin{tabular}{l}\n4-point MACE and the combined composite renal endpoint will be tested separately (= in parallel) for superiority. In case the 4-point MACE and/or composite renal endpoint is significantly superior, the 3-point MACE will then be tested for superiority. \\\\\nWas changed into: \\\\\nThe primary endpoint (3-point MACE) will be tested for non-inferiority. Thereafter, if non-inferiority has been demonstrated, the 3-point MACE and the combined composite renal endpoint will be tested separately for superiority.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n4-point MACE and the combined composite renal endpoint will be tested separately (= in parallel) for superiority. In case the 4-point MACE and/or composite renal endpoint is significantly superior, the 3-point MACE will then be tested for superiority. \\\\\nWas changed into: \\\\\nThe primary endpoint (3-point MACE) will be tested for non-inferiority. Thereafter, if non-inferiority has been demonstrated, the 3-point MACE and the combined composite renal endpoint will be tested separately for superiority.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99658203125,"confidence_rate":0.9999812344794522},{"cnt":[[937,340],[1640,340],[1640,379],[937,379]],"region":{"top_left_x":937,"top_left_y":340,"width":703,"height":40},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3cfadcf80c68438b8a5945432cbdb03d","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"4-point MACE and the combined composite renal","text_display":"4-point MACE and the combined composite renal","confidence":1,"confidence_rate":1},{"cnt":[[937,382],[1663,382],[1663,421],[937,421]],"region":{"top_left_x":937,"top_left_y":381,"width":726,"height":40},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fdb68af3645749a9b40a53339b7e44d9","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"endpoint will be tested separately (= in parallel) for","text_display":" endpoint will be tested separately (= in parallel) for","confidence":0.99951171875,"confidence_rate":0.9999917220597181},{"cnt":[[937,418],[1729,418],[1729,462],[937,462]],"region":{"top_left_x":937,"top_left_y":418,"width":793,"height":45},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b444f7b57a2347cfa0aa774d6d9370a0","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"superiority. In case the 4-point MACE and/or composite","text_display":" superiority. In case the 4-point MACE and/or composite","confidence":0.99853515625,"confidence_rate":0.9999751542462456},{"cnt":[[937,460],[1653,460],[1653,504],[937,504]],"region":{"top_left_x":937,"top_left_y":459,"width":717,"height":45},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7115c687cbb142639f2263c5e5ee93e3","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"renal endpoint is significantly superior, the 3-point","text_display":" renal endpoint is significantly superior, the 3-point","confidence":1,"confidence_rate":1},{"cnt":[[937,501],[1524,501],[1524,541],[937,541]],"region":{"top_left_x":937,"top_left_y":501,"width":588,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70e37f0e80e542b38dc94672fffd7194","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"MACE will then be tested for superiority.","text_display":" MACE will then be tested for superiority.","confidence":1,"confidence_rate":1},{"cnt":[[937,561],[1207,561],[1207,600],[937,600]],"region":{"top_left_x":937,"top_left_y":561,"width":270,"height":40},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cde0cc29c2cf4b1ebcbf3bb112666fe2","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99658203125,"confidence_rate":0.9998443837753903},{"cnt":[[937,621],[1736,621],[1736,665],[937,665]],"region":{"top_left_x":937,"top_left_y":621,"width":800,"height":44},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"974f6a9df770430bb711d901c6ac3f9c","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"The primary endpoint (3-point MACE) will be tested for","text_display":"\nThe primary endpoint (3-point MACE) will be tested for","confidence":0.99951171875,"confidence_rate":0.9999917220597181},{"cnt":[[937,663],[1695,663],[1695,702],[937,702]],"region":{"top_left_x":937,"top_left_y":662,"width":758,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73d80a19e67f4b888c88663fad5d8343","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"non-inferiority. Thereafter, if non-inferiority has been","text_display":" non-inferiority. Thereafter, if non-inferiority has been","confidence":1,"confidence_rate":1},{"cnt":[[937,704],[1667,704],[1667,743],[937,743]],"region":{"top_left_x":937,"top_left_y":704,"width":731,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9488af46ffcf4ccca5b1f365cb18c7ed","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"demonstrated, the 3-point MACE and the combined","text_display":" demonstrated, the 3-point MACE and the combined","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[937,741],[1690,741],[1690,785],[937,785]],"region":{"top_left_x":937,"top_left_y":740,"width":754,"height":45},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce89c76680fd41e8887ef8fe397b934c","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"composite renal endpoint will be tested separately for","text_display":" composite renal endpoint will be tested separately for","confidence":1,"confidence_rate":1},{"cnt":[[937,782],[1105,782],[1105,821],[937,821]],"region":{"top_left_x":937,"top_left_y":782,"width":169,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d693e17395149b18dd576310adef6e9","type":"text","conversion_output":false,"parent_id":"8192912d29d5486884cd221e13520225","text":"superiority.","text_display":" superiority.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":23,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"958c9cad6d6e4b8aa63b01e1624a68ce","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[288,2618],[1800,2618],[1800,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2617,"width":1514,"height":45},"line":24,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"daa26cc62322454f9b73f986d1ad88d2","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99267578125,"confidence_rate":0.9999382273489243},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":25,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"27542910bb57437084b8f9578b8daf92","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-110","page":110,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3941d1e4a86e4e8daa36341749f9960c","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,117],[1816,160],[1503,162]],"region":{"top_left_x":1502,"top_left_y":116,"width":315,"height":47},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e6795b0774dc4a8c94f186c952129582","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04ec1ec438664bc78cc55386380ed326","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,210],[637,210],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":210,"width":396,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9427d931afd4f87a3b71010262ab734","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a8708a8230b435d94294738a7725fd3","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ef1e06d6c53489c99cd741817016fa6","type":"page_info","conversion_output":false,"text":"Page 110 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1777,331],[1777,2554],[242,2554]],"region":{"top_left_x":242,"top_left_y":331,"width":1536,"height":2223},"line":7,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1bc854ac83244b55833f340a3b503856","type":"page_info","conversion_output":false,"text":"\\begin{tabular}{|l|l|l|}\n\\hline & & \\\\\n\\hline\n\\end{tabular}","text_display":"","confidence":0.4739586766032198,"confidence_rate":0.9693691328748633},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":8,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b8b180ff921e4fd8bd5c1cceb78d63c5","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2620],[1798,2620],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2620,"width":1506,"height":42},"line":9,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e0b8cd3e80fb4c969299e541879ebad4","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"26f949301709443fa3e5e03f08adbe2d","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-111","page":111,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1da4a8b8f3b2456eab87282974d305cd","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,121],[1816,121],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":121,"width":314,"height":39},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3939ca9be4af4e96b4c0f2ca84d36d44","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9b6ca1d8d59436b9c16ed45da647577","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[637,208],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":396,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"809a3d2deec940a495d76564ab899adb","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6dbf0f3878d84821b42d7536684b2360","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b236f78fb454423792efbbe9147ed86a","type":"page_info","conversion_output":false,"text":"Page 111 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,329],[1777,329],[1777,2568],[242,2568]],"region":{"top_left_x":242,"top_left_y":328,"width":1536,"height":2240},"line":7,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"76aed8b5be1e4bcfad2bf5e4bbdd2db6","type":"text","conversion_output":true,"text":"\\(\\left.\\begin{array}{|l|l|l|}\\hline & & \\\\ \\text { In addition: } \\\\ \\text { Definition of MI added. }\\end{array}\\right]\\)","text_display":"\n\\(\\left.\\begin{array}{|l|l|l|}\\hline & & \\\\ \\text { In addition: } \\\\ \\text { Definition of MI added. }\\end{array}\\right]\\)","confidence":0.465130784968111,"confidence_rate":0.9894252453939089},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":8,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2736d90c5ad74e85aabcf024e57aed22","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[292,2620],[1798,2620],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2620,"width":1506,"height":42},"line":9,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4bf1fd4f02ff448eb73c6d005e0e9b7d","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999876814398867},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0a544f2722374d0ba2a5e1e516ad82cc","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-112","page":112,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a9450d851774b2c86bd26615880cb48","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8906072db9ae42c6b308c2aba6ce9e05","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,164],[599,164],[599,203],[244,203]],"region":{"top_left_x":244,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c91d9f34981e4e73b3b8550ae5fcf21c","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3ca790968b449a5b6c12344a2d502d4","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fdfff371508c443a954e490898c01e61","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2755e86c952404ea7517a6baca97e5f","type":"page_info","conversion_output":false,"text":"Page 112 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2547],[244,2547]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2217},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1886e870dbb14737914c10729fae2ea8","type":"table","conversion_output":true,"children_ids":["286c5915ea00437faafe177b9886c3c5","71dca000f9254b54a7e6a78540138b93","4cdc01835c5c4f1fb8f6d7f88f3c605b","7cccb657c15b4890a794a6c5a96554c8","f5956b401a9b4cd0bf94a57486b80668","e1aaa7a9c0694836b67d769e824b7369","6b28e73e233d48f88871e3419f49860e","614e69d2cd1846d191bba81cb55c3f96","05ce87cd52214470b86f1c794b78ed05","2f583e811dab40daa84012a49eb734ef","3e74d8059ca944078f2014e349d94a07","d05a3ac2ecd5483f887faba89149ca5d","c16ffe03d8e04171ac8a2a4431338bde","748c26da4ac44842a37595306fef7e08","6b3a31689d0b48de9b60a7ff25b50c9e","893d5b9285da46618ed9dc59791b1564","3e988985f5814149afe7256856913947","4d5ad4e93a694d61bae4e54e95d5b93e","f4359ba7dd3043b19472beaac57a5514","e85606a56acf40ea91b3aade82d5830e","487e6e16218f4a568774519b2af46163","949c9ef0131748f996323c9ef4646142"],"text":"\\begin{tabular}{|l|l|}\n\\hline & Change 5: Definition of albuminuria progression updated. \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: Based on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and \\\\\nHospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 4: \\\\\nFor clarification \\\\\nChange 5: \\\\\nFor clarification/correction of error.\n\\end{tabular} \\\\\n\\hline Section to be changed & 5.2.1.1 reporting waiver for cardiovascular-outcome events \\\\\n\\hline Description of change & ..... secondary was changed into key secondary... \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 5.2.2.1 definition of adverse events \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe definition of AEs was updated and AESI language was revised reflecting the newly released process by drug safety for reporting of AESIs.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & Change 5: Definition of albuminuria progression updated. \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: Based on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and \\\\\nHospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 4: \\\\\nFor clarification \\\\\nChange 5: \\\\\nFor clarification/correction of error.\n\\end{tabular} \\\\\n\\hline Section to be changed & 5.2.1.1 reporting waiver for cardiovascular-outcome events \\\\\n\\hline Description of change & ..... secondary was changed into key secondary... \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 5.2.2.1 definition of adverse events \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe definition of AEs was updated and AESI language was revised reflecting the newly released process by drug safety for reporting of AESIs.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.98193359375,"confidence_rate":0.9999693157800139},{"cnt":[[251,331],[601,331],[601,2548],[251,2548]],"region":{"top_left_x":250,"top_left_y":331,"width":351,"height":2218},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"286c5915ea00437faafe177b9886c3c5","type":"table_column","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"","text_display":""},{"cnt":[[921,331],[1768,331],[1768,2548],[921,2548]],"region":{"top_left_x":920,"top_left_y":331,"width":849,"height":2218},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71dca000f9254b54a7e6a78540138b93","type":"table_column","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"","text_display":""},{"cnt":[[244,796],[1775,796],[1775,893],[244,893]],"region":{"top_left_x":244,"top_left_y":796,"width":1532,"height":97},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cdc01835c5c4f1fb8f6d7f88f3c605b","type":"table_row","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"","text_display":""},{"cnt":[[244,897],[1775,897],[1775,2148],[244,2148]],"region":{"top_left_x":244,"top_left_y":897,"width":1532,"height":1251},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7cccb657c15b4890a794a6c5a96554c8","type":"table_row","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"","text_display":""},{"cnt":[[244,2143],[1775,2143],[1775,2231],[244,2231]],"region":{"top_left_x":244,"top_left_y":2143,"width":1532,"height":88},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5956b401a9b4cd0bf94a57486b80668","type":"table_row","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"","text_display":""},{"cnt":[[244,2224],[1775,2224],[1775,2277],[244,2277]],"region":{"top_left_x":244,"top_left_y":2223,"width":1532,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1aaa7a9c0694836b67d769e824b7369","type":"table_row","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"","text_display":""},{"cnt":[[244,2274],[1775,2274],[1775,2327],[244,2327]],"region":{"top_left_x":244,"top_left_y":2274,"width":1532,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b28e73e233d48f88871e3419f49860e","type":"table_row","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"","text_display":""},{"cnt":[[244,2327],[1775,2327],[1775,2378],[244,2378]],"region":{"top_left_x":244,"top_left_y":2327,"width":1532,"height":51},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"614e69d2cd1846d191bba81cb55c3f96","type":"table_row","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"","text_display":""},{"cnt":[[244,2378],[1775,2378],[1775,2548],[244,2548]],"region":{"top_left_x":244,"top_left_y":2377,"width":1532,"height":172},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"05ce87cd52214470b86f1c794b78ed05","type":"table_row","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"","text_display":""},{"cnt":[[935,801],[1605,801],[1605,891],[935,891]],"region":{"top_left_x":934,"top_left_y":800,"width":671,"height":91},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f583e811dab40daa84012a49eb734ef","type":"complex_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","children_ids":["d6356bbee6ff440d8d3a80c2faea8fbb","bf767170d748473fa9bbdc2def8112d5"],"text":"Change 5: Definition of albuminuria progression updated.","text_display":"Change 5: Definition of albuminuria progression updated.","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,805],[1089,805],[1089,844],[939,844]],"region":{"top_left_x":939,"top_left_y":805,"width":151,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6356bbee6ff440d8d3a80c2faea8fbb","type":"text","conversion_output":false,"parent_id":"2f583e811dab40daa84012a49eb734ef","text":"Change 5:","text_display":"Change 5:","confidence":1,"confidence_rate":1},{"cnt":[[939,842],[1600,842],[1600,886],[939,886]],"region":{"top_left_x":939,"top_left_y":842,"width":662,"height":44},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf767170d748473fa9bbdc2def8112d5","type":"text","conversion_output":false,"parent_id":"2f583e811dab40daa84012a49eb734ef","text":"Definition of albuminuria progression updated.","text_display":" Definition of albuminuria progression updated.","confidence":1,"confidence_rate":1},{"cnt":[[265,907],[582,907],[582,950],[265,950]],"region":{"top_left_x":264,"top_left_y":906,"width":319,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e74d8059ca944078f2014e349d94a07","type":"simple_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[932,904],[1761,904],[1761,2145],[932,2145]],"region":{"top_left_x":932,"top_left_y":904,"width":830,"height":1242},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d05a3ac2ecd5483f887faba89149ca5d","type":"complex_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","children_ids":["78313c93b58f4cd98e993ed868aa9007","5e9021f706864ffab91844164f0f8133","36dbbec410374db89f27cceb8e0dc32c","70c6e37c82694608863d24dd5c8060aa","d1ef3a683310498b92c6b7cfec9301a7","75379b0528074b7e8720e4e4706d609f","4383838005d446c8ab932333535a41b0","a6ea7ef7124645fc9dabb59a13c3b47b","853e8e53f9a44b629e73cfc945b351b3","58d0f8d6aa2b497eb99ffc421d41c72e","be21e88210594b9eba4cb6deb37f9699","4207fbcb2deb47e7a9104149d4036087","83b4ace7d80c460ca6e0f928c85879cd","0d74397ac71a406bafdf1ab9092c2356","443ab1f7e25f458da054ddbdf6690881","ec3475f5712240458edce4fdf542f225","5ea799481084454d96fa3fc8d5ba618b","8320a2b397874c8485f6a40945c6d74a"],"text":"\\begin{tabular}{l}\nChange 1: Based on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and \\\\\nHospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 4: \\\\\nFor clarification \\\\\nChange 5: \\\\\nFor clarification/correction of error.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: Based on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and \\\\\nHospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 4: \\\\\nFor clarification \\\\\nChange 5: \\\\\nFor clarification/correction of error.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990236759185791,"confidence_rate":0.9999955301995775},{"cnt":[[939,907],[1630,907],[1630,950],[939,950]],"region":{"top_left_x":939,"top_left_y":906,"width":692,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78313c93b58f4cd98e993ed868aa9007","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"Change 1: Based on review of recently published","text_display":"Change 1: Based on review of recently published","confidence":1,"confidence_rate":1},{"cnt":[[939,948],[1676,948],[1676,987],[939,987]],"region":{"top_left_x":939,"top_left_y":948,"width":738,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e9021f706864ffab91844164f0f8133","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"cardiovascular outcome trials, changing the protocol","text_display":" cardiovascular outcome trials, changing the protocol","confidence":1,"confidence_rate":1},{"cnt":[[939,987],[1665,987],[1665,1029],[939,1029]],"region":{"top_left_x":939,"top_left_y":987,"width":726,"height":42},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36dbbec410374db89f27cceb8e0dc32c","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"definitions of the primary and secondary endpoints,","text_display":" definitions of the primary and secondary endpoints,","confidence":1,"confidence_rate":1},{"cnt":[[939,1026],[1715,1026],[1715,1070],[939,1070]],"region":{"top_left_x":939,"top_left_y":1026,"width":777,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70c6e37c82694608863d24dd5c8060aa","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"essentially substituting 4-Point MACE (Cardiovascular","text_display":" essentially substituting 4-Point MACE (Cardiovascular","confidence":0.9990236759185791,"confidence_rate":0.999983158745329},{"cnt":[[939,1068],[1674,1068],[1674,1109],[939,1109]],"region":{"top_left_x":939,"top_left_y":1067,"width":735,"height":43},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1ef3a683310498b92c6b7cfec9301a7","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"(CV) Death, Non-Fatal Stoke, Non-fatal Myocardial","text_display":" (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial","confidence":1,"confidence_rate":1},{"cnt":[[939,1109],[1144,1109],[1144,1144],[939,1144]],"region":{"top_left_x":939,"top_left_y":1109,"width":206,"height":35},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"75379b0528074b7e8720e4e4706d609f","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"Infarction and","text_display":" Infarction and","confidence":1,"confidence_rate":1},{"cnt":[[939,1146],[1752,1146],[1752,1190],[939,1190]],"region":{"top_left_x":939,"top_left_y":1146,"width":814,"height":44},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4383838005d446c8ab932333535a41b0","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"Hospitalization for Unstable Angina) with 3-Point MACE","text_display":"\nHospitalization for Unstable Angina) with 3-Point MACE","confidence":1,"confidence_rate":1},{"cnt":[[939,1188],[1665,1188],[1665,1229],[939,1229]],"region":{"top_left_x":939,"top_left_y":1187,"width":726,"height":42},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6ea7ef7124645fc9dabb59a13c3b47b","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"(CV Death, Non-Fatal Stoke, Non-fatal Myocardial","text_display":" (CV Death, Non-Fatal Stoke, Non-fatal Myocardial","confidence":1,"confidence_rate":1},{"cnt":[[939,1229],[1103,1229],[1103,1268],[939,1268]],"region":{"top_left_x":939,"top_left_y":1228,"width":164,"height":41},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"853e8e53f9a44b629e73cfc945b351b3","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"Infarction).","text_display":" Infarction).","confidence":0.99951171875,"confidence_rate":0.9999712709716212},{"cnt":[[939,1266],[1655,1266],[1655,1310],[939,1310]],"region":{"top_left_x":939,"top_left_y":1265,"width":717,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58d0f8d6aa2b497eb99ffc421d41c72e","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"eGFR cut off changed in response to the NIH/FDA","text_display":"\neGFR cut off changed in response to the NIH/FDA","confidence":1,"confidence_rate":1},{"cnt":[[939,1307],[1708,1307],[1708,1346],[939,1346]],"region":{"top_left_x":939,"top_left_y":1307,"width":770,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be21e88210594b9eba4cb6deb37f9699","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"scientific workshop on GFR decline as an endpoint for","text_display":" scientific workshop on GFR decline as an endpoint for","confidence":1,"confidence_rate":1},{"cnt":[[939,1349],[1720,1349],[1720,1388],[939,1388]],"region":{"top_left_x":939,"top_left_y":1348,"width":781,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4207fbcb2deb47e7a9104149d4036087","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"clinical trials in CKD and the current clinical landscape","text_display":" clinical trials in CKD and the current clinical landscape","confidence":1,"confidence_rate":1},{"cnt":[[939,1386],[1678,1386],[1678,1429],[939,1429]],"region":{"top_left_x":939,"top_left_y":1385,"width":740,"height":45},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83b4ace7d80c460ca6e0f928c85879cd","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"on decline in estimated glomerular filtration rate and","text_display":" on decline in estimated glomerular filtration rate and","confidence":1,"confidence_rate":1},{"cnt":[[939,1427],[1725,1427],[1725,1468],[939,1468]],"region":{"top_left_x":939,"top_left_y":1426,"width":786,"height":43},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d74397ac71a406bafdf1ab9092c2356","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"subsequent risk of end stage renal disease and mortality.","text_display":" subsequent risk of end stage renal disease and mortality.","confidence":1,"confidence_rate":1},{"cnt":[[939,1943],[1089,1943],[1089,1987],[939,1987]],"region":{"top_left_x":939,"top_left_y":1942,"width":151,"height":45},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"443ab1f7e25f458da054ddbdf6690881","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"Change 4:","text_display":"\nChange 4:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1984],[1172,1984],[1172,2023],[939,2023]],"region":{"top_left_x":939,"top_left_y":1984,"width":233,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec3475f5712240458edce4fdf542f225","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"For clarification","text_display":"\nFor clarification","confidence":1,"confidence_rate":1},{"cnt":[[939,2065],[1089,2065],[1089,2106],[939,2106]],"region":{"top_left_x":939,"top_left_y":2064,"width":151,"height":43},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ea799481084454d96fa3fc8d5ba618b","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"Change 5:","text_display":"\nChange 5:","confidence":1,"confidence_rate":1},{"cnt":[[939,2104],[1444,2104],[1444,2143],[939,2143]],"region":{"top_left_x":939,"top_left_y":2103,"width":505,"height":41},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8320a2b397874c8485f6a40945c6d74a","type":"text","conversion_output":false,"parent_id":"d05a3ac2ecd5483f887faba89149ca5d","text":"For clarification/correction of error.","text_display":"\nFor clarification/correction of error.","confidence":1,"confidence_rate":1},{"cnt":[[265,2145],[596,2145],[596,2189],[265,2189]],"region":{"top_left_x":264,"top_left_y":2145,"width":333,"height":45},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c16ffe03d8e04171ac8a2a4431338bde","type":"simple_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2145],[1725,2145],[1725,2226],[935,2226]],"region":{"top_left_x":934,"top_left_y":2145,"width":791,"height":81},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"748c26da4ac44842a37595306fef7e08","type":"complex_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","children_ids":["9e98bddcf40541c2b50e2956701d8217","6f9f8bbe1dd74d8c90c2581ee586a06c"],"text":"5.2.1.1 reporting waiver for cardiovascular-outcome events","text_display":"5.2.1.1 reporting waiver for cardiovascular-outcome events","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9936575889587402,"confidence_rate":0.9999431925994906},{"cnt":[[939,2148],[1720,2148],[1720,2189],[939,2189]],"region":{"top_left_x":939,"top_left_y":2147,"width":781,"height":43},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e98bddcf40541c2b50e2956701d8217","type":"text","conversion_output":false,"parent_id":"748c26da4ac44842a37595306fef7e08","text":"5.2.1.1 reporting waiver for cardiovascular-outcome","text_display":"5.2.1.1 reporting waiver for cardiovascular-outcome","confidence":0.9936575889587402,"confidence_rate":0.9998863884260619},{"cnt":[[939,2191],[1041,2191],[1041,2224],[939,2224]],"region":{"top_left_x":939,"top_left_y":2191,"width":102,"height":33},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f9f8bbe1dd74d8c90c2581ee586a06c","type":"text","conversion_output":false,"parent_id":"748c26da4ac44842a37595306fef7e08","text":"events","text_display":" events","confidence":1,"confidence_rate":1},{"cnt":[[262,2228],[596,2228],[596,2272],[262,2272]],"region":{"top_left_x":262,"top_left_y":2228,"width":335,"height":45},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b3a31689d0b48de9b60a7ff25b50c9e","type":"simple_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2228],[1642,2228],[1642,2272],[939,2272]],"region":{"top_left_x":939,"top_left_y":2228,"width":703,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"893d5b9285da46618ed9dc59791b1564","type":"simple_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"..... secondary was changed into key secondary...","text_display":"..... secondary was changed into key secondary...","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.98193359375,"confidence_rate":0.9996624348326361},{"cnt":[[262,2279],[582,2279],[582,2323],[262,2323]],"region":{"top_left_x":262,"top_left_y":2278,"width":321,"height":45},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e988985f5814149afe7256856913947","type":"simple_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"Rationale for change","text_display":"Rationale for change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2279],[1172,2279],[1172,2318],[939,2318]],"region":{"top_left_x":939,"top_left_y":2278,"width":233,"height":41},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d5ad4e93a694d61bae4e54e95d5b93e","type":"simple_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"For clarification","text_display":"For clarification","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,2332],[596,2332],[596,2378],[262,2378]],"region":{"top_left_x":262,"top_left_y":2331,"width":335,"height":47},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4359ba7dd3043b19472beaac57a5514","type":"simple_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"Section to be changed","text_display":"Section to be changed","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2334],[1455,2334],[1455,2369],[939,2369]],"region":{"top_left_x":939,"top_left_y":2334,"width":517,"height":35},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e85606a56acf40ea91b3aade82d5830e","type":"simple_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"5.2.2.1 definition of adverse events","text_display":"5.2.2.1 definition of adverse events","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,2385],[596,2385],[596,2429],[262,2429]],"region":{"top_left_x":262,"top_left_y":2384,"width":335,"height":45},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"487e6e16218f4a568774519b2af46163","type":"simple_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","text":"Description of change","text_display":"Description of change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2380],[1752,2380],[1752,2546],[935,2546]],"region":{"top_left_x":934,"top_left_y":2380,"width":819,"height":167},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"949c9ef0131748f996323c9ef4646142","type":"complex_cell","conversion_output":false,"parent_id":"1886e870dbb14737914c10729fae2ea8","children_ids":["96980b8603904dfcb7ada44698cdb6a9","38a5eb0e72d0412ab96dabdd117da323","7502af75f36b4b43aff7db6b4a535be4","f74b050c25774ebebf44bd9d9604ad24"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nThe definition of AEs was updated and AESI language was revised reflecting the newly released process by drug safety for reporting of AESIs.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nThe definition of AEs was updated and AESI language was revised reflecting the newly released process by drug safety for reporting of AESIs.\n\\end{tabular}","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2385],[1089,2385],[1089,2424],[939,2424]],"region":{"top_left_x":939,"top_left_y":2384,"width":151,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96980b8603904dfcb7ada44698cdb6a9","type":"text","conversion_output":false,"parent_id":"949c9ef0131748f996323c9ef4646142","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2424],[1711,2424],[1711,2465],[939,2465]],"region":{"top_left_x":939,"top_left_y":2423,"width":772,"height":43},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38a5eb0e72d0412ab96dabdd117da323","type":"text","conversion_output":false,"parent_id":"949c9ef0131748f996323c9ef4646142","text":"The definition of AEs was updated and AESI language","text_display":"\nThe definition of AEs was updated and AESI language","confidence":1,"confidence_rate":1},{"cnt":[[939,2463],[1748,2463],[1748,2507],[939,2507]],"region":{"top_left_x":939,"top_left_y":2463,"width":809,"height":44},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7502af75f36b4b43aff7db6b4a535be4","type":"text","conversion_output":false,"parent_id":"949c9ef0131748f996323c9ef4646142","text":"was revised reflecting the newly released process by drug","text_display":" was revised reflecting the newly released process by drug","confidence":1,"confidence_rate":1},{"cnt":[[939,2500],[1361,2500],[1361,2544],[939,2544]],"region":{"top_left_x":939,"top_left_y":2499,"width":422,"height":45},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f74b050c25774ebebf44bd9d9604ad24","type":"text","conversion_output":false,"parent_id":"949c9ef0131748f996323c9ef4646142","text":"safety for reporting of AESIs.","text_display":" safety for reporting of AESIs.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":56,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"da350c757c3f4f2fa61f3e3c53eecc82","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[288,2620],[1798,2620],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2620,"width":1511,"height":42},"line":57,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a3488dc11d1546e38d5faea2b94c6d77","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.978515625,"confidence_rate":0.9998175080490214},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":58,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c12a5844001f49b18f30d264fc9f4889","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-113","page":113,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b98a1b15dc7d4dc092cd5319d785b12c","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7cbff4ca213f4591b86d8e1f20685ed9","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0433936d185441c3b5a54005ef574d77","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4beaddfbd3354f3aa7818ebc67c22690","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8789c3a263c54c47b75644b25ddbeab9","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,210],[1816,210],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":210,"width":264,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6ccc9bfb10a466586c629d9732cb7c6","type":"page_info","conversion_output":false,"text":"Page 113 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2540],[244,2540]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2208},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5477d49ee6494162aee97404c8bbacc2","type":"table","conversion_output":true,"children_ids":["ca7faa063d704ab99f394e9de7e190c4","7e365c904a754957b12ceb834387cd86","8ff896bd4f554d199af7cd98b6995193","35c7a4a4c18a42019fc8f9e1f14a3371","8715530002174ec38f5fd8ef8d21822d","f050728cad0c4fb0bca6e74c574f7495","b03a8df3e1fd4b5ea964e418a416f854","b5b8755562d841d784b270e5271bc40b","3216e2b769f44b4f9d39fa1ebe9d413e","688ba28a81424015a725a22f2145a3b7","87af012c73014292a3496bc39b39c8a4","6e7e9a3aeb824f99936a32965d54906f","1fb6b1541c914152922435c13be3f9d7","293eb25b9b0b4175b6fd065ab1cb84ad","58f24ece63954d6b8495f4cb1acda1bd","9a28ed320a5c4967be51876562997995","3c78498e8a5a4adaa0cae79d70a7b130","9a700cc56830489ead819fe3fd55657e","c3b32402b0e6413b9dc92d722202d4a5","66244958d42a49cb9d490d5e8fde5d8a","f36d9e14c5d04cf49178eeec5e76a870","4d1a7a252fae4924872130d08fecee26","a2eef345815948008da8c804a281350d","30068162105648b3a9608e041108cb97","c896d5c7f4254a04a9b49f98bcedc4a8","0a521280a87641d9b7347f9934d68cb5","59bb5f7bebc04db1808bafb1a8fc050f","0ec00bf4621548639fe20b805f7148e1","6f871dc4514e4b6895fc386f435dc2b5","01e4b176fde64b98aa2fd62f016076d6","44b07b8941a6429b83063bd4c7ae0de5","a3c7146485cd4cc8b374d9f77fd518bc","dd73b11f707f4722ac74f84656dcbfa3","8cc4b426a23745de89a501686973d742","18ef964c7c0f463cadf1bb90c8fbe264","162e42908f3c45b5961739ab24052895","50558aa698e0405d98a7b67f8801a318","f026f0c4822b46c2851d8801cc5cfae7","2aa488ff5ff141c4ab864204dd256f8d","3f63af19b86d4515aa3d37967bae26a4","7b4e9af40df241a1aa1dbc1edff119fe","eee0ab504936463898edb9a3d963d600","e3aa6dd385844d3f9027a5ad654382e6","f108f88a55d945a89cf0c4bcd76f54de","3d6f3b4b17604f56b56820c681fe9e84","63160afed1714be68ccb31adc3d9684b","95897526fbc54bbb81f385f515c59856","2747f9a4db234140805b6fd3f2450c65","60d612f89de446808a6d3c7d83ac28a7"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 2: \\\\\nEstimated creatinine clearance \\\\\nWas changed into: \\\\\nEstimated glomerular filtration rate\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo reflect the current standard AEs text and revised AESI process \\\\\nChange 2: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 5.2.2.2 Adverse event and serious adverse event reporting \\\\\n\\hline Description of change & Section was updated \\\\\n\\hline Rationale of change & For clarification per current standard text. \\\\\n\\hline Section to be changed & 5.2.2.3 Oncological adverse events \\\\\n\\hline Description of change & Added a reference to the oncology committee assessment charter \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 5.2.3.1 \\\\\n\\hline Description of change & \\begin{tabular}{l}\nNo renal impairment with evidence of kidney damage (UACR \\(\\geq 30 mg / g\\) creatinine) \\\\\nWas changed into: \\\\\nNo renal impairment with evidence of kidney damage ( \\(eGFR \\geq 90 mL / min / 1.73 m^{2}\\) and UACR \\(\\geq 30 mg / g\\) creatinine) \\\\\nIn addition definition of prevalent kidney disease added.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 6.2.2 treatment period \\& 6.2.3 end of treatment and follow-up \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nPatient retention language revised \\\\\nChange 2: \\\\\nChange in follow-up period from 7 to 30 days\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo optimize retention language \\\\\nChange 2: \\\\\nTo allow for outcome event data collection up to 30 days after EOT\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.1 Statistical design - model \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 2: \\\\\nEstimated creatinine clearance \\\\\nWas changed into: \\\\\nEstimated glomerular filtration rate\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo reflect the current standard AEs text and revised AESI process \\\\\nChange 2: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 5.2.2.2 Adverse event and serious adverse event reporting \\\\\n\\hline Description of change & Section was updated \\\\\n\\hline Rationale of change & For clarification per current standard text. \\\\\n\\hline Section to be changed & 5.2.2.3 Oncological adverse events \\\\\n\\hline Description of change & Added a reference to the oncology committee assessment charter \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 5.2.3.1 \\\\\n\\hline Description of change & \\begin{tabular}{l}\nNo renal impairment with evidence of kidney damage (UACR \\(\\geq 30 mg / g\\) creatinine) \\\\\nWas changed into: \\\\\nNo renal impairment with evidence of kidney damage ( \\(eGFR \\geq 90 mL / min / 1.73 m^{2}\\) and UACR \\(\\geq 30 mg / g\\) creatinine) \\\\\nIn addition definition of prevalent kidney disease added.\n\\end{tabular} \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 6.2.2 treatment period \\& 6.2.3 end of treatment and follow-up \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nPatient retention language revised \\\\\nChange 2: \\\\\nChange in follow-up period from 7 to 30 days\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nTo optimize retention language \\\\\nChange 2: \\\\\nTo allow for outcome event data collection up to 30 days after EOT\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.1 Statistical design - model \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.99072265625,"confidence_rate":0.9999938992360078},{"cnt":[[251,333],[603,333],[606,2541],[253,2541]],"region":{"top_left_x":250,"top_left_y":332,"width":356,"height":2210},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca7faa063d704ab99f394e9de7e190c4","type":"table_column","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[914,333],[1766,333],[1766,2541],[914,2541]],"region":{"top_left_x":914,"top_left_y":333,"width":852,"height":2209},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e365c904a754957b12ceb834387cd86","type":"table_column","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,374],[1775,374],[1775,623],[244,623]],"region":{"top_left_x":244,"top_left_y":374,"width":1532,"height":250},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ff896bd4f554d199af7cd98b6995193","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,619],[1775,619],[1775,860],[244,860]],"region":{"top_left_x":244,"top_left_y":618,"width":1532,"height":243},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35c7a4a4c18a42019fc8f9e1f14a3371","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,860],[1775,860],[1775,948],[244,948]],"region":{"top_left_x":244,"top_left_y":860,"width":1532,"height":88},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8715530002174ec38f5fd8ef8d21822d","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,943],[1775,943],[1775,989],[244,989]],"region":{"top_left_x":244,"top_left_y":943,"width":1532,"height":47},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f050728cad0c4fb0bca6e74c574f7495","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,992],[1775,992],[1775,1040],[244,1040]],"region":{"top_left_x":244,"top_left_y":991,"width":1532,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b03a8df3e1fd4b5ea964e418a416f854","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,1044],[1775,1044],[1775,1093],[244,1093]],"region":{"top_left_x":244,"top_left_y":1044,"width":1532,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5b8755562d841d784b270e5271bc40b","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,1093],[1775,1093],[1775,1178],[244,1178]],"region":{"top_left_x":244,"top_left_y":1092,"width":1532,"height":87},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3216e2b769f44b4f9d39fa1ebe9d413e","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,1176],[1775,1176],[1775,1226],[244,1226]],"region":{"top_left_x":244,"top_left_y":1175,"width":1532,"height":52},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"688ba28a81424015a725a22f2145a3b7","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,1229],[1775,1229],[1775,1277],[244,1277]],"region":{"top_left_x":244,"top_left_y":1228,"width":1532,"height":50},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87af012c73014292a3496bc39b39c8a4","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,1282],[1775,1282],[1775,1708],[244,1708]],"region":{"top_left_x":244,"top_left_y":1281,"width":1532,"height":427},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e7e9a3aeb824f99936a32965d54906f","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,1743],[1775,1741],[1775,1790],[244,1793]],"region":{"top_left_x":243,"top_left_y":1740,"width":1533,"height":53},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fb6b1541c914152922435c13be3f9d7","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,1795],[1775,1795],[1775,1885],[244,1885]],"region":{"top_left_x":244,"top_left_y":1795,"width":1532,"height":90},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"293eb25b9b0b4175b6fd065ab1cb84ad","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,1876],[1775,1876],[1775,2088],[244,2088]],"region":{"top_left_x":244,"top_left_y":1875,"width":1532,"height":213},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58f24ece63954d6b8495f4cb1acda1bd","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,2078],[1775,2078],[1775,2327],[244,2327]],"region":{"top_left_x":244,"top_left_y":2078,"width":1532,"height":249},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a28ed320a5c4967be51876562997995","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,2318],[1775,2318],[1775,2371],[244,2371]],"region":{"top_left_x":244,"top_left_y":2317,"width":1532,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c78498e8a5a4adaa0cae79d70a7b130","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[244,2368],[1775,2368],[1775,2539],[244,2539]],"region":{"top_left_x":244,"top_left_y":2368,"width":1532,"height":171},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a700cc56830489ead819fe3fd55657e","type":"table_row","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"","text_display":""},{"cnt":[[935,377],[1439,377],[1439,623],[935,623]],"region":{"top_left_x":934,"top_left_y":376,"width":506,"height":248},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3b32402b0e6413b9dc92d722202d4a5","type":"complex_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","children_ids":["01896ed7086a49c69e8a0708fa5dcdcb","1a94ab16e1d84feebd3f3fc3d67eb601","5bf1418f78aa441cb3ccae20a3d98299","1eee1b6f323844b79f42e41ab5492432"],"text":"\\begin{tabular}{l}\nChange 2: \\\\\nEstimated creatinine clearance \\\\\nWas changed into: \\\\\nEstimated glomerular filtration rate\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 2: \\\\\nEstimated creatinine clearance \\\\\nWas changed into: \\\\\nEstimated glomerular filtration rate\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99072265625,"confidence_rate":0.9998940891733388},{"cnt":[[939,379],[1089,379],[1089,418],[939,418]],"region":{"top_left_x":939,"top_left_y":379,"width":151,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01896ed7086a49c69e8a0708fa5dcdcb","type":"text","conversion_output":false,"parent_id":"c3b32402b0e6413b9dc92d722202d4a5","text":"Change 2:","text_display":"Change 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,420],[1370,420],[1370,455],[939,455]],"region":{"top_left_x":939,"top_left_y":420,"width":431,"height":36},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1a94ab16e1d84feebd3f3fc3d67eb601","type":"text","conversion_output":false,"parent_id":"c3b32402b0e6413b9dc92d722202d4a5","text":"Estimated creatinine clearance","text_display":"\nEstimated creatinine clearance","confidence":1,"confidence_rate":1},{"cnt":[[939,501],[1204,501],[1204,543],[939,543]],"region":{"top_left_x":939,"top_left_y":501,"width":266,"height":42},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bf1418f78aa441cb3ccae20a3d98299","type":"text","conversion_output":false,"parent_id":"c3b32402b0e6413b9dc92d722202d4a5","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99072265625,"confidence_rate":0.9995764239912223},{"cnt":[[939,582],[1437,582],[1437,621],[939,621]],"region":{"top_left_x":939,"top_left_y":581,"width":498,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1eee1b6f323844b79f42e41ab5492432","type":"text","conversion_output":false,"parent_id":"c3b32402b0e6413b9dc92d722202d4a5","text":"Estimated glomerular filtration rate","text_display":"\nEstimated glomerular filtration rate","confidence":1,"confidence_rate":1},{"cnt":[[267,623],[582,623],[582,662],[267,662]],"region":{"top_left_x":267,"top_left_y":623,"width":316,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66244958d42a49cb9d490d5e8fde5d8a","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,619],[1676,619],[1676,858],[935,858]],"region":{"top_left_x":934,"top_left_y":618,"width":743,"height":240},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f36d9e14c5d04cf49178eeec5e76a870","type":"complex_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","children_ids":["6b783f1b32c045b9b4eb49ad05c945b8","03f7adec046b4197b8c92f108d1098a6","acddfa390b7c474383b2faf878a4b998","c4433f71111840ddb10a5dd6a5edfb83","7152c1b5a26d4e51949344addea44dcc"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nTo reflect the current standard AEs text and revised AESI process \\\\\nChange 2: \\\\\nFor clarification\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nTo reflect the current standard AEs text and revised AESI process \\\\\nChange 2: \\\\\nFor clarification\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,623],[1089,623],[1089,662],[939,662]],"region":{"top_left_x":939,"top_left_y":623,"width":151,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b783f1b32c045b9b4eb49ad05c945b8","type":"text","conversion_output":false,"parent_id":"f36d9e14c5d04cf49178eeec5e76a870","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,660],[1674,660],[1674,697],[939,697]],"region":{"top_left_x":939,"top_left_y":659,"width":735,"height":38},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03f7adec046b4197b8c92f108d1098a6","type":"text","conversion_output":false,"parent_id":"f36d9e14c5d04cf49178eeec5e76a870","text":"To reflect the current standard AEs text and revised","text_display":"\nTo reflect the current standard AEs text and revised","confidence":1,"confidence_rate":1},{"cnt":[[939,704],[1135,701],[1136,742],[939,745]],"region":{"top_left_x":938,"top_left_y":700,"width":198,"height":45},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"acddfa390b7c474383b2faf878a4b998","type":"text","conversion_output":false,"parent_id":"f36d9e14c5d04cf49178eeec5e76a870","text":"AESI process","text_display":" AESI process","confidence":1,"confidence_rate":1},{"cnt":[[939,780],[1089,780],[1089,821],[939,821]],"region":{"top_left_x":939,"top_left_y":779,"width":151,"height":43},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c4433f71111840ddb10a5dd6a5edfb83","type":"text","conversion_output":false,"parent_id":"f36d9e14c5d04cf49178eeec5e76a870","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,821],[1172,821],[1172,856],[939,856]],"region":{"top_left_x":939,"top_left_y":821,"width":233,"height":35},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7152c1b5a26d4e51949344addea44dcc","type":"text","conversion_output":false,"parent_id":"f36d9e14c5d04cf49178eeec5e76a870","text":"For clarification","text_display":"\nFor clarification","confidence":1,"confidence_rate":1},{"cnt":[[265,863],[592,863],[592,906],[265,906]],"region":{"top_left_x":264,"top_left_y":862,"width":328,"height":45},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d1a7a252fae4924872130d08fecee26","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,863],[1651,863],[1651,948],[937,948]],"region":{"top_left_x":937,"top_left_y":862,"width":714,"height":86},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2eef345815948008da8c804a281350d","type":"complex_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","children_ids":["a1dfb2a92e904952a765aaf58f026a1f","755a258b0c9e47738377bb8213ccf7f8"],"text":"5.2.2.2 Adverse event and serious adverse event reporting","text_display":"5.2.2.2 Adverse event and serious adverse event reporting","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,863],[1646,863],[1646,897],[939,897]],"region":{"top_left_x":939,"top_left_y":862,"width":708,"height":36},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a1dfb2a92e904952a765aaf58f026a1f","type":"text","conversion_output":false,"parent_id":"a2eef345815948008da8c804a281350d","text":"5.2.2.2 Adverse event and serious adverse event","text_display":"5.2.2.2 Adverse event and serious adverse event","confidence":1,"confidence_rate":1},{"cnt":[[939,904],[1089,904],[1089,943],[939,943]],"region":{"top_left_x":939,"top_left_y":904,"width":151,"height":40},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"755a258b0c9e47738377bb8213ccf7f8","type":"text","conversion_output":false,"parent_id":"a2eef345815948008da8c804a281350d","text":"reporting","text_display":" reporting","confidence":1,"confidence_rate":1},{"cnt":[[267,945],[596,945],[596,985],[267,985]],"region":{"top_left_x":267,"top_left_y":945,"width":330,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30068162105648b3a9608e041108cb97","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,945],[1232,945],[1232,985],[939,985]],"region":{"top_left_x":939,"top_left_y":945,"width":293,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c896d5c7f4254a04a9b49f98bcedc4a8","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Section was updated","text_display":"Section was updated","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,996],[566,996],[566,1038],[267,1038]],"region":{"top_left_x":267,"top_left_y":996,"width":300,"height":42},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a521280a87641d9b7347f9934d68cb5","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Rationale of change","text_display":"Rationale of change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,996],[1526,996],[1526,1035],[939,1035]],"region":{"top_left_x":939,"top_left_y":996,"width":588,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"59bb5f7bebc04db1808bafb1a8fc050f","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"For clarification per current standard text.","text_display":"For clarification per current standard text.","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1047],[592,1047],[592,1091],[267,1091]],"region":{"top_left_x":267,"top_left_y":1046,"width":325,"height":45},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ec00bf4621548639fe20b805f7148e1","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Section to be changed","text_display":"Section to be changed","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1047],[1451,1047],[1451,1091],[939,1091]],"region":{"top_left_x":939,"top_left_y":1046,"width":512,"height":45},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f871dc4514e4b6895fc386f435dc2b5","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"5.2.2.3 Oncological adverse events","text_display":"5.2.2.3 Oncological adverse events","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1102],[596,1102],[596,1141],[267,1141]],"region":{"top_left_x":267,"top_left_y":1102,"width":330,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01e4b176fde64b98aa2fd62f016076d6","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Description of change","text_display":"Description of change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1097],[1748,1097],[1748,1176],[935,1176]],"region":{"top_left_x":934,"top_left_y":1097,"width":814,"height":79},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44b07b8941a6429b83063bd4c7ae0de5","type":"complex_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","children_ids":["27b98189db304e14a58f88ab24014c74","7142d8a373cf4d7eb8860382fe78e46c"],"text":"Added a reference to the oncology committee assessment charter","text_display":"Added a reference to the oncology committee assessment charter","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1102],[1743,1102],[1743,1139],[939,1139]],"region":{"top_left_x":939,"top_left_y":1102,"width":804,"height":37},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27b98189db304e14a58f88ab24014c74","type":"text","conversion_output":false,"parent_id":"44b07b8941a6429b83063bd4c7ae0de5","text":"Added a reference to the oncology committee assessment","text_display":"Added a reference to the oncology committee assessment","confidence":1,"confidence_rate":1},{"cnt":[[939,1139],[1043,1139],[1043,1173],[939,1173]],"region":{"top_left_x":939,"top_left_y":1138,"width":104,"height":36},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7142d8a373cf4d7eb8860382fe78e46c","type":"text","conversion_output":false,"parent_id":"44b07b8941a6429b83063bd4c7ae0de5","text":"charter","text_display":" charter","confidence":1,"confidence_rate":1},{"cnt":[[267,1183],[582,1183],[582,1224],[267,1224]],"region":{"top_left_x":267,"top_left_y":1182,"width":316,"height":43},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3c7146485cd4cc8b374d9f77fd518bc","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Rationale for change","text_display":"Rationale for change","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1180],[1172,1180],[1172,1219],[939,1219]],"region":{"top_left_x":939,"top_left_y":1180,"width":233,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd73b11f707f4722ac74f84656dcbfa3","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"For clarification","text_display":"For clarification","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1231],[592,1231],[592,1275],[267,1275]],"region":{"top_left_x":267,"top_left_y":1230,"width":325,"height":45},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8cc4b426a23745de89a501686973d742","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Section to be changed","text_display":"Section to be changed","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1231],[1038,1231],[1038,1268],[939,1268]],"region":{"top_left_x":939,"top_left_y":1230,"width":100,"height":38},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18ef964c7c0f463cadf1bb90c8fbe264","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"5.2.3.1","text_display":"5.2.3.1","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1286],[596,1286],[596,1325],[267,1325]],"region":{"top_left_x":267,"top_left_y":1286,"width":330,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"162e42908f3c45b5961739ab24052895","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Description of change","text_display":"Description of change","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1291],[1743,1291],[1743,1701],[935,1701]],"region":{"top_left_x":934,"top_left_y":1290,"width":809,"height":411},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50558aa698e0405d98a7b67f8801a318","type":"complex_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","children_ids":["b6196b76bb5043c1900fb72ed9c1fd62","730e35c4181c40c896d46af09eb082e7","9ede5fb731d64067ad00d28c39f74bbc","e8fae8dd76ad4056a33af27c82172287","9477321135d2474ca870e800f4c53ea3","dae9cd6e98664cdbb2da727f14a34609","b79a2de4b07f4f11a51fa486d21940a4"],"text":"\\begin{tabular}{l}\nNo renal impairment with evidence of kidney damage (UACR \\(\\geq 30 mg / g\\) creatinine) \\\\\nWas changed into: \\\\\nNo renal impairment with evidence of kidney damage ( \\(eGFR \\geq 90 mL / min / 1.73 m^{2}\\) and UACR \\(\\geq 30 mg / g\\) creatinine) \\\\\nIn addition definition of prevalent kidney disease added.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nNo renal impairment with evidence of kidney damage (UACR \\(\\geq 30 mg / g\\) creatinine) \\\\\nWas changed into: \\\\\nNo renal impairment with evidence of kidney damage ( \\(eGFR \\geq 90 mL / min / 1.73 m^{2}\\) and UACR \\(\\geq 30 mg / g\\) creatinine) \\\\\nIn addition definition of prevalent kidney disease added.\n\\end{tabular}","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9912109375,"confidence_rate":0.9999298767898971},{"cnt":[[939,1295],[1697,1295],[1697,1335],[939,1335]],"region":{"top_left_x":939,"top_left_y":1295,"width":758,"height":40},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6196b76bb5043c1900fb72ed9c1fd62","type":"text","conversion_output":false,"parent_id":"50558aa698e0405d98a7b67f8801a318","text":"No renal impairment with evidence of kidney damage","text_display":"No renal impairment with evidence of kidney damage","confidence":1,"confidence_rate":1},{"cnt":[[939,1332],[1354,1332],[1354,1376],[939,1376]],"region":{"top_left_x":939,"top_left_y":1332,"width":415,"height":45},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"730e35c4181c40c896d46af09eb082e7","type":"text","conversion_output":false,"parent_id":"50558aa698e0405d98a7b67f8801a318","text":"(UACR \\(\\geq 30 mg / g\\) creatinine)","text_display":" (UACR \\(\\geq 30 mg / g\\) creatinine)","confidence":1,"confidence_rate":1},{"cnt":[[939,1415],[1204,1415],[1204,1454],[939,1454]],"region":{"top_left_x":939,"top_left_y":1415,"width":266,"height":40},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ede5fb731d64067ad00d28c39f74bbc","type":"text","conversion_output":false,"parent_id":"50558aa698e0405d98a7b67f8801a318","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9912109375,"confidence_rate":0.9995988116737686},{"cnt":[[939,1493],[1697,1493],[1697,1533],[939,1533]],"region":{"top_left_x":939,"top_left_y":1493,"width":758,"height":40},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e8fae8dd76ad4056a33af27c82172287","type":"text","conversion_output":false,"parent_id":"50558aa698e0405d98a7b67f8801a318","text":"No renal impairment with evidence of kidney damage","text_display":"\nNo renal impairment with evidence of kidney damage","confidence":1,"confidence_rate":1},{"cnt":[[939,1533],[1646,1533],[1646,1579],[939,1579]],"region":{"top_left_x":939,"top_left_y":1532,"width":708,"height":47},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9477321135d2474ca870e800f4c53ea3","type":"text","conversion_output":false,"parent_id":"50558aa698e0405d98a7b67f8801a318","text":"( \\(eGFR \\geq 90 mL / min / 1.73 m^{2}\\) and UACR \\(\\geq 30 mg / g\\)","text_display":" ( \\(eGFR \\geq 90 mL / min / 1.73 m^{2}\\) and UACR \\(\\geq 30 mg / g\\)","confidence":0.9936578260967508,"confidence_rate":0.9999103931567808},{"cnt":[[939,1576],[1094,1576],[1094,1615],[939,1615]],"region":{"top_left_x":939,"top_left_y":1576,"width":155,"height":40},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dae9cd6e98664cdbb2da727f14a34609","type":"text","conversion_output":false,"parent_id":"50558aa698e0405d98a7b67f8801a318","text":"creatinine)","text_display":" creatinine)","confidence":1,"confidence_rate":1},{"cnt":[[939,1655],[1729,1655],[1729,1698],[939,1698]],"region":{"top_left_x":939,"top_left_y":1654,"width":791,"height":45},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b79a2de4b07f4f11a51fa486d21940a4","type":"text","conversion_output":false,"parent_id":"50558aa698e0405d98a7b67f8801a318","text":"In addition definition of prevalent kidney disease added.","text_display":"\nIn addition definition of prevalent kidney disease added.","confidence":1,"confidence_rate":1},{"cnt":[[267,1747],[582,1747],[582,1790],[267,1790]],"region":{"top_left_x":267,"top_left_y":1746,"width":316,"height":45},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f026f0c4822b46c2851d8801cc5cfae7","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Rationale for change","text_display":"Rationale for change","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1747],[1172,1747],[1172,1781],[939,1781]],"region":{"top_left_x":939,"top_left_y":1746,"width":233,"height":36},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2aa488ff5ff141c4ab864204dd256f8d","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"For clarification","text_display":"For clarification","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,1802],[596,1802],[596,1841],[267,1841]],"region":{"top_left_x":267,"top_left_y":1801,"width":330,"height":41},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f63af19b86d4515aa3d37967bae26a4","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Section to be changed","text_display":"Section to be changed","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,1797],[1715,1797],[1715,1883],[937,1883]],"region":{"top_left_x":937,"top_left_y":1797,"width":779,"height":86},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b4e9af40df241a1aa1dbc1edff119fe","type":"complex_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","children_ids":["15927dd598c448eeb2fb535216dbd3ec","42eb24572c30457e90cb19e3ee6ce125"],"text":"6.2.2 treatment period \\& 6.2.3 end of treatment and follow-up","text_display":"6.2.2 treatment period \\& 6.2.3 end of treatment and follow-up","cell_row":11,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999956392907747},{"cnt":[[939,1802],[1711,1802],[1711,1841],[939,1841]],"region":{"top_left_x":939,"top_left_y":1801,"width":772,"height":41},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15927dd598c448eeb2fb535216dbd3ec","type":"text","conversion_output":false,"parent_id":"7b4e9af40df241a1aa1dbc1edff119fe","text":"6.2.2 treatment period \\& 6.2.3 end of treatment and","text_display":"6.2.2 treatment period \\& 6.2.3 end of treatment and","confidence":0.99951171875,"confidence_rate":0.9999912786005654},{"cnt":[[939,1839],[1089,1839],[1089,1883],[939,1883]],"region":{"top_left_x":939,"top_left_y":1838,"width":151,"height":45},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42eb24572c30457e90cb19e3ee6ce125","type":"text","conversion_output":false,"parent_id":"7b4e9af40df241a1aa1dbc1edff119fe","text":"follow-up","text_display":" follow-up","confidence":1,"confidence_rate":1},{"cnt":[[265,1883],[596,1883],[596,1924],[265,1924]],"region":{"top_left_x":264,"top_left_y":1882,"width":333,"height":43},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eee0ab504936463898edb9a3d963d600","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Description of change","text_display":"Description of change","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1880],[1591,1880],[1591,2085],[935,2085]],"region":{"top_left_x":934,"top_left_y":1880,"width":657,"height":206},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3aa6dd385844d3f9027a5ad654382e6","type":"complex_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","children_ids":["c734f4d361a4469288fecd6626e8b5a2","4eede3dca33f453abb24279a19fc95fc","08703dd3c2f44400ac79e0d0e793cada","dd4f3d5324504eb6965c4327abf6ff17"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nPatient retention language revised \\\\\nChange 2: \\\\\nChange in follow-up period from 7 to 30 days\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nPatient retention language revised \\\\\nChange 2: \\\\\nChange in follow-up period from 7 to 30 days\n\\end{tabular}","cell_row":12,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999912786005654},{"cnt":[[939,1885],[1089,1885],[1089,1919],[939,1919]],"region":{"top_left_x":939,"top_left_y":1884,"width":151,"height":36},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c734f4d361a4469288fecd6626e8b5a2","type":"text","conversion_output":false,"parent_id":"e3aa6dd385844d3f9027a5ad654382e6","text":"Change 1:","text_display":"Change 1:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1922],[1421,1922],[1421,1961],[939,1961]],"region":{"top_left_x":939,"top_left_y":1921,"width":482,"height":40},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4eede3dca33f453abb24279a19fc95fc","type":"text","conversion_output":false,"parent_id":"e3aa6dd385844d3f9027a5ad654382e6","text":"Patient retention language revised","text_display":"\nPatient retention language revised","confidence":1,"confidence_rate":1},{"cnt":[[939,2000],[1089,2000],[1089,2039],[939,2039]],"region":{"top_left_x":939,"top_left_y":2000,"width":151,"height":40},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08703dd3c2f44400ac79e0d0e793cada","type":"text","conversion_output":false,"parent_id":"e3aa6dd385844d3f9027a5ad654382e6","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2041],[1584,2041],[1584,2081],[939,2081]],"region":{"top_left_x":939,"top_left_y":2041,"width":646,"height":40},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd4f3d5324504eb6965c4327abf6ff17","type":"text","conversion_output":false,"parent_id":"e3aa6dd385844d3f9027a5ad654382e6","text":"Change in follow-up period from 7 to 30 days","text_display":"\nChange in follow-up period from 7 to 30 days","confidence":1,"confidence_rate":1},{"cnt":[[265,2083],[582,2083],[582,2127],[265,2127]],"region":{"top_left_x":264,"top_left_y":2082,"width":319,"height":45},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f108f88a55d945a89cf0c4bcd76f54de","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Rationale for change","text_display":"Rationale for change","cell_row":13,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2078],[1743,2078],[1743,2320],[935,2320]],"region":{"top_left_x":934,"top_left_y":2078,"width":809,"height":243},"line":78,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d6f3b4b17604f56b56820c681fe9e84","type":"complex_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","children_ids":["eb69f346f85f4b39ba0a7968d0f6370b","2a42774f3aef419ea85abf4df07fc608","6e6ee9f5d8234963944132da34e3834c","3eba1a729ee94bb4b642ec35682620f7","6a2009e34c174d7abb119ffadfd94342"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nTo optimize retention language \\\\\nChange 2: \\\\\nTo allow for outcome event data collection up to 30 days after EOT\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nTo optimize retention language \\\\\nChange 2: \\\\\nTo allow for outcome event data collection up to 30 days after EOT\n\\end{tabular}","cell_row":13,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2083],[1089,2083],[1089,2122],[939,2122]],"region":{"top_left_x":939,"top_left_y":2082,"width":151,"height":41},"line":79,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb69f346f85f4b39ba0a7968d0f6370b","type":"text","conversion_output":false,"parent_id":"3d6f3b4b17604f56b56820c681fe9e84","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2124],[1381,2124],[1381,2163],[939,2163]],"region":{"top_left_x":939,"top_left_y":2124,"width":443,"height":40},"line":80,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a42774f3aef419ea85abf4df07fc608","type":"text","conversion_output":false,"parent_id":"3d6f3b4b17604f56b56820c681fe9e84","text":"To optimize retention language","text_display":"\nTo optimize retention language","confidence":1,"confidence_rate":1},{"cnt":[[939,2203],[1089,2203],[1089,2242],[939,2242]],"region":{"top_left_x":939,"top_left_y":2202,"width":151,"height":40},"line":81,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e6ee9f5d8234963944132da34e3834c","type":"text","conversion_output":false,"parent_id":"3d6f3b4b17604f56b56820c681fe9e84","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2244],[1738,2244],[1738,2283],[939,2283]],"region":{"top_left_x":939,"top_left_y":2244,"width":800,"height":40},"line":82,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3eba1a729ee94bb4b642ec35682620f7","type":"text","conversion_output":false,"parent_id":"3d6f3b4b17604f56b56820c681fe9e84","text":"To allow for outcome event data collection up to 30 days","text_display":"\nTo allow for outcome event data collection up to 30 days","confidence":1,"confidence_rate":1},{"cnt":[[939,2281],[1089,2281],[1089,2318],[939,2318]],"region":{"top_left_x":939,"top_left_y":2280,"width":151,"height":38},"line":83,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a2009e34c174d7abb119ffadfd94342","type":"text","conversion_output":false,"parent_id":"3d6f3b4b17604f56b56820c681fe9e84","text":"after EOT","text_display":" after EOT","confidence":1,"confidence_rate":1},{"cnt":[[265,2325],[592,2325],[592,2366],[265,2366]],"region":{"top_left_x":264,"top_left_y":2324,"width":328,"height":43},"line":84,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63160afed1714be68ccb31adc3d9684b","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Section to be changed","text_display":"Section to be changed","cell_row":14,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2325],[1370,2325],[1370,2366],[939,2366]],"region":{"top_left_x":939,"top_left_y":2324,"width":431,"height":43},"line":85,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95897526fbc54bbb81f385f515c59856","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"7.1 Statistical design - model","text_display":"7.1 Statistical design - model","cell_row":14,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2378],[596,2378],[596,2417],[267,2417]],"region":{"top_left_x":267,"top_left_y":2377,"width":330,"height":40},"line":86,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2747f9a4db234140805b6fd3f2450c65","type":"simple_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","text":"Description of change","text_display":"Description of change","cell_row":15,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2373],[1729,2373],[1729,2536],[935,2536]],"region":{"top_left_x":934,"top_left_y":2373,"width":796,"height":164},"line":87,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60d612f89de446808a6d3c7d83ac28a7","type":"complex_cell","conversion_output":false,"parent_id":"5477d49ee6494162aee97404c8bbacc2","children_ids":["124e50af81c343f6b78f5f745f653fd3","24d9b5c722dd4c0fb8d1e6ec839a0381","f1d8d17541734ee88be981404264152a","feb908ac21d242bfba303876042132d3"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nNumber of randomized patients decreased from 8300 to 7000 and number of patients per treatment group decreased from 4150 to 3500.\n\\end{tabular}","cell_row":15,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2378],[1089,2378],[1089,2417],[939,2417]],"region":{"top_left_x":939,"top_left_y":2377,"width":151,"height":40},"line":88,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"124e50af81c343f6b78f5f745f653fd3","type":"text","conversion_output":false,"parent_id":"60d612f89de446808a6d3c7d83ac28a7","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2414],[1725,2414],[1725,2456],[939,2456]],"region":{"top_left_x":939,"top_left_y":2414,"width":786,"height":42},"line":89,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24d9b5c722dd4c0fb8d1e6ec839a0381","type":"text","conversion_output":false,"parent_id":"60d612f89de446808a6d3c7d83ac28a7","text":"Number of randomized patients decreased from 8300 to","text_display":"\nNumber of randomized patients decreased from 8300 to","confidence":1,"confidence_rate":1},{"cnt":[[939,2456],[1628,2456],[1628,2495],[939,2495]],"region":{"top_left_x":939,"top_left_y":2455,"width":689,"height":41},"line":90,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1d8d17541734ee88be981404264152a","type":"text","conversion_output":false,"parent_id":"60d612f89de446808a6d3c7d83ac28a7","text":"7000 and number of patients per treatment group","text_display":" 7000 and number of patients per treatment group","confidence":1,"confidence_rate":1},{"cnt":[[939,2495],[1361,2495],[1361,2530],[939,2530]],"region":{"top_left_x":939,"top_left_y":2495,"width":422,"height":35},"line":91,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"feb908ac21d242bfba303876042132d3","type":"text","conversion_output":false,"parent_id":"60d612f89de446808a6d3c7d83ac28a7","text":"decreased from 4150 to 3500.","text_display":" decreased from 4150 to 3500.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":92,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"45773eeeaaa44b3bbb750ab34c724d4b","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":93,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c4326b5a6bc54c9fb92cdf8972d1dea0","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":94,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9746ab01dbef4a7e826118bbbfaff636","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-114","page":114,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"779ffa35be9f442ba8f67e0ef17d179a","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a4ada6f6f2d4f0195a70dde60e60fbd","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3e206a17632f4657bd69ec4c4d46439e","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"edb72fb6fe724b0cb0a7658cd7395fc6","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d35a665cf44d4f6c9ebc985f64ebafe4","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,210],[1816,210],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":210,"width":264,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e800b226281e402fb3831dc08acb6480","type":"page_info","conversion_output":false,"text":"Page 114 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2554],[244,2554]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2221},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a293bf589d54dc2b4b919aefa10b4cb","type":"table","conversion_output":true,"children_ids":["fb73221e1bdf457ba7b970fbfc43ede9","3807e8f561ee4c93a4b3d0848bc43480","bdc0a1320cf84200907d8f7fd5a0d5d9","9af0ab44aafc4fbe9d6b6eb6024473df","ae99821e08ce48d393688723a526c4cc","ba25bfb593e64c8e9aab0d646794cf3a","754dac387c7946d4b74a2c6fe215f6a5","56e3cd6071034f52bf1469585a6f92b4","100c34a68cb84d919d47016dfb1c8f91","995ce641df1a434fb59053716cf0d8b4","abfea8926e954d0d9e30ded5cd2678ab","311edaa74a7244a68cf8746302167cb6","f077655aeb924e4f9aabdbe17f5dbabd"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 2: \\\\\nNumber of endpoint events decreased from 625 to 611. \\\\\nChange 3: \\\\\nThe primary endpoint was changed from 4-point MACE to 3-point MACE\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. The required number of patients with event is not affected by the lower number of randomised patients in this event-driven study \\\\\nChange 2: \\\\\nSince the planned interim analysis for efficacy will not be performed, a slightly lower number of patients with event is required for the same power (90\\% for non-inferiority) \\\\\nChange 3: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction).\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.2 Null and alternative hypothesis \\\\\n\\hline Description of change & \\begin{tabular}{l}\nRelevant changes are summarised as follows: \\\\\nChange 1: \\\\\nAn interim analysis will be performed at the one-sided alpha-level of \\(1.0 \\%\\), the final analysis at the one-sided alpha-level of 2.12\\%. At the interim analysis MACE endpoints will be tested in a pre-specified order, at the final analysis also the composite renal endpoint will be tested for superiority \\\\\nWas changed into: \\\\\nNo confirmatory interim analysis for efficacy endpoints will be performed \\\\\nChange 2: \\\\\nThe experimentwise (multiple) level alpha is controlled with the following three step gatekeeping hierarchy within the interim and final analysis, respectively. For the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the one-sided alpha-level of \\(2.12 \\%\\). In case of significance, the null hypothesis is rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 2: \\\\\nNumber of endpoint events decreased from 625 to 611. \\\\\nChange 3: \\\\\nThe primary endpoint was changed from 4-point MACE to 3-point MACE\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. The required number of patients with event is not affected by the lower number of randomised patients in this event-driven study \\\\\nChange 2: \\\\\nSince the planned interim analysis for efficacy will not be performed, a slightly lower number of patients with event is required for the same power (90\\% for non-inferiority) \\\\\nChange 3: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction).\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.2 Null and alternative hypothesis \\\\\n\\hline Description of change & \\begin{tabular}{l}\nRelevant changes are summarised as follows: \\\\\nChange 1: \\\\\nAn interim analysis will be performed at the one-sided alpha-level of \\(1.0 \\%\\), the final analysis at the one-sided alpha-level of 2.12\\%. At the interim analysis MACE endpoints will be tested in a pre-specified order, at the final analysis also the composite renal endpoint will be tested for superiority \\\\\nWas changed into: \\\\\nNo confirmatory interim analysis for efficacy endpoints will be performed \\\\\nChange 2: \\\\\nThe experimentwise (multiple) level alpha is controlled with the following three step gatekeeping hierarchy within the interim and final analysis, respectively. For the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the one-sided alpha-level of \\(2.12 \\%\\). In case of significance, the null hypothesis is rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.56591796875,"confidence_rate":0.9999081511273826},{"cnt":[[253,333],[601,333],[601,2555],[253,2555]],"region":{"top_left_x":253,"top_left_y":333,"width":348,"height":2222},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb73221e1bdf457ba7b970fbfc43ede9","type":"table_column","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"","text_display":""},{"cnt":[[921,333],[1768,333],[1768,2555],[921,2555]],"region":{"top_left_x":920,"top_left_y":333,"width":849,"height":2222},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3807e8f561ee4c93a4b3d0848bc43480","type":"table_column","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"","text_display":""},{"cnt":[[244,372],[1775,372],[1775,625],[244,625]],"region":{"top_left_x":244,"top_left_y":372,"width":1532,"height":254},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bdc0a1320cf84200907d8f7fd5a0d5d9","type":"table_row","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"","text_display":""},{"cnt":[[244,658],[1775,658],[1775,1503],[244,1503]],"region":{"top_left_x":244,"top_left_y":657,"width":1532,"height":846},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9af0ab44aafc4fbe9d6b6eb6024473df","type":"table_row","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"","text_display":""},{"cnt":[[244,1503],[1775,1503],[1775,1546],[244,1546]],"region":{"top_left_x":244,"top_left_y":1502,"width":1532,"height":45},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae99821e08ce48d393688723a526c4cc","type":"table_row","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"","text_display":""},{"cnt":[[244,1549],[1775,1549],[1775,2555],[244,2555]],"region":{"top_left_x":244,"top_left_y":1548,"width":1532,"height":1007},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba25bfb593e64c8e9aab0d646794cf3a","type":"table_row","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"","text_display":""},{"cnt":[[932,377],[1738,377],[1738,623],[932,623]],"region":{"top_left_x":932,"top_left_y":376,"width":807,"height":248},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"754dac387c7946d4b74a2c6fe215f6a5","type":"complex_cell","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","children_ids":["3ca23b9abd7e48c4a8952591a7c7d1ff","faf320a570db44838e661494391f54b1","0376866888be4c148c48822be28371b9","d9d799acdbb44fb4999db95ab5b99f94","4eefb35c1bbc4c5aa89781f910efd759"],"text":"\\begin{tabular}{l}\nChange 2: \\\\\nNumber of endpoint events decreased from 625 to 611. \\\\\nChange 3: \\\\\nThe primary endpoint was changed from 4-point MACE to 3-point MACE\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 2: \\\\\nNumber of endpoint events decreased from 625 to 611. \\\\\nChange 3: \\\\\nThe primary endpoint was changed from 4-point MACE to 3-point MACE\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,379],[1089,379],[1089,418],[939,418]],"region":{"top_left_x":939,"top_left_y":379,"width":151,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ca23b9abd7e48c4a8952591a7c7d1ff","type":"text","conversion_output":false,"parent_id":"754dac387c7946d4b74a2c6fe215f6a5","text":"Change 2:","text_display":"Change 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,420],[1711,420],[1711,460],[939,460]],"region":{"top_left_x":939,"top_left_y":420,"width":772,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"faf320a570db44838e661494391f54b1","type":"text","conversion_output":false,"parent_id":"754dac387c7946d4b74a2c6fe215f6a5","text":"Number of endpoint events decreased from 625 to 611.","text_display":"\nNumber of endpoint events decreased from 625 to 611.","confidence":1,"confidence_rate":1},{"cnt":[[939,501],[1089,501],[1089,538],[939,538]],"region":{"top_left_x":939,"top_left_y":501,"width":151,"height":37},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0376866888be4c148c48822be28371b9","type":"text","conversion_output":false,"parent_id":"754dac387c7946d4b74a2c6fe215f6a5","text":"Change 3:","text_display":"\nChange 3:","confidence":1,"confidence_rate":1},{"cnt":[[939,540],[1729,540],[1729,579],[939,579]],"region":{"top_left_x":939,"top_left_y":540,"width":791,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9d799acdbb44fb4999db95ab5b99f94","type":"text","conversion_output":false,"parent_id":"754dac387c7946d4b74a2c6fe215f6a5","text":"The primary endpoint was changed from 4-point MACE","text_display":"\nThe primary endpoint was changed from 4-point MACE","confidence":1,"confidence_rate":1},{"cnt":[[939,582],[1190,582],[1190,621],[939,621]],"region":{"top_left_x":939,"top_left_y":581,"width":252,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4eefb35c1bbc4c5aa89781f910efd759","type":"text","conversion_output":false,"parent_id":"754dac387c7946d4b74a2c6fe215f6a5","text":"to 3-point MACE","text_display":" to 3-point MACE","confidence":1,"confidence_rate":1},{"cnt":[[267,665],[580,665],[580,704],[267,704]],"region":{"top_left_x":267,"top_left_y":664,"width":314,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56e3cd6071034f52bf1469585a6f92b4","type":"simple_cell","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,660],[1761,660],[1761,1500],[935,1500]],"region":{"top_left_x":934,"top_left_y":659,"width":828,"height":842},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"100c34a68cb84d919d47016dfb1c8f91","type":"complex_cell","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","children_ids":["d5e685b015e84765a6dd5c8b9c47c26c","e2cff539ac0547379aa3fa2c580d9ca2","b6784950966749f4b249359e03d9f043","f98373d9ca50471f92ac010940ba6233","a937e72b7fa84e978213ec64a3dca37e","61996dfa2a7c40aa824524c2a1aa6978","7351746394444da7b554a855149c30a3","3cae80627b7f41ccb8a6e557fdb2a23a","9a9454bbddf844e081d9e6c9f83c33dd","15abb96eb09a45388d2866e4a77ed23b","37b0abf05af140e5b38c13816fd3399c","0a13eca150c848668ce5d5b6f4957850","962aaa0f8bd9418b8207ce75b2f8203a","295b7119180145a1a5a63d986f7d4c97","9caf1e28e6d244419ae0a9531c410f16","25fee9141d144c089be27cb5d759ccdc","9ab9a2799ac042ff9ae83ff1bcd6fa5a","0b9b0e4863f04752b552d5edb34177cb","36832a852d3e4a9b8ea08f607f582d52"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. The required number of patients with event is not affected by the lower number of randomised patients in this event-driven study \\\\\nChange 2: \\\\\nSince the planned interim analysis for efficacy will not be performed, a slightly lower number of patients with event is required for the same power (90\\% for non-inferiority) \\\\\nChange 3: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nOverall MACE event rates are higher than initially expected and this allows reducing the sample size without major impact on study duration. The required number of patients with event is not affected by the lower number of randomised patients in this event-driven study \\\\\nChange 2: \\\\\nSince the planned interim analysis for efficacy will not be performed, a slightly lower number of patients with event is required for the same power (90\\% for non-inferiority) \\\\\nChange 3: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction).\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.900390625,"confidence_rate":0.9999037853356534},{"cnt":[[939,660],[1089,660],[1089,704],[939,704]],"region":{"top_left_x":939,"top_left_y":659,"width":151,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d5e685b015e84765a6dd5c8b9c47c26c","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,701],[1651,701],[1651,741],[939,741]],"region":{"top_left_x":939,"top_left_y":701,"width":712,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2cff539ac0547379aa3fa2c580d9ca2","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"Overall MACE event rates are higher than initially","text_display":"\nOverall MACE event rates are higher than initially","confidence":0.99755859375,"confidence_rate":0.9999555575086554},{"cnt":[[939,743],[1752,743],[1752,782],[939,782]],"region":{"top_left_x":939,"top_left_y":742,"width":814,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6784950966749f4b249359e03d9f043","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"expected and this allows reducing the sample size without","text_display":" expected and this allows reducing the sample size without","confidence":1,"confidence_rate":1},{"cnt":[[939,782],[1734,782],[1734,823],[939,823]],"region":{"top_left_x":939,"top_left_y":781,"width":795,"height":43},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f98373d9ca50471f92ac010940ba6233","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"major impact on study duration. The required number of","text_display":" major impact on study duration. The required number of","confidence":1,"confidence_rate":1},{"cnt":[[939,821],[1752,821],[1752,860],[939,860]],"region":{"top_left_x":939,"top_left_y":821,"width":814,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a937e72b7fa84e978213ec64a3dca37e","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"patients with event is not affected by the lower number of","text_display":" patients with event is not affected by the lower number of","confidence":1,"confidence_rate":1},{"cnt":[[939,863],[1586,863],[1586,902],[939,902]],"region":{"top_left_x":939,"top_left_y":862,"width":648,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61996dfa2a7c40aa824524c2a1aa6978","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"randomised patients in this event-driven study","text_display":" randomised patients in this event-driven study","confidence":1,"confidence_rate":1},{"cnt":[[939,941],[1087,941],[1087,980],[939,980]],"region":{"top_left_x":939,"top_left_y":940,"width":148,"height":41},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7351746394444da7b554a855149c30a3","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,982],[1748,982],[1748,1021],[939,1021]],"region":{"top_left_x":939,"top_left_y":982,"width":809,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3cae80627b7f41ccb8a6e557fdb2a23a","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"Since the planned interim analysis for efficacy will not be","text_display":"\nSince the planned interim analysis for efficacy will not be","confidence":1,"confidence_rate":1},{"cnt":[[939,1024],[1748,1024],[1748,1063],[939,1063]],"region":{"top_left_x":939,"top_left_y":1023,"width":809,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a9454bbddf844e081d9e6c9f83c33dd","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"performed, a slightly lower number of patients with event","text_display":" performed, a slightly lower number of patients with event","confidence":1,"confidence_rate":1},{"cnt":[[939,1061],[1725,1061],[1725,1100],[939,1100]],"region":{"top_left_x":939,"top_left_y":1060,"width":786,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15abb96eb09a45388d2866e4a77ed23b","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"is required for the same power (90\\% for non-inferiority)","text_display":" is required for the same power (90\\% for non-inferiority)","confidence":0.900390625,"confidence_rate":0.9982813706353862},{"cnt":[[939,1143],[1089,1143],[1089,1183],[939,1183]],"region":{"top_left_x":939,"top_left_y":1143,"width":151,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37b0abf05af140e5b38c13816fd3399c","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1183],[1692,1183],[1692,1219],[939,1219]],"region":{"top_left_x":939,"top_left_y":1182,"width":754,"height":38},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a13eca150c848668ce5d5b6f4957850","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"Based on review of recently published cardiovascular","text_display":"\nBased on review of recently published cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[939,1222],[1711,1222],[1711,1261],[939,1261]],"region":{"top_left_x":939,"top_left_y":1221,"width":772,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"962aaa0f8bd9418b8207ce75b2f8203a","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"outcome trials, changing the protocol definitions of the","text_display":" outcome trials, changing the protocol definitions of the","confidence":1,"confidence_rate":1},{"cnt":[[939,1263],[1743,1263],[1743,1302],[939,1302]],"region":{"top_left_x":939,"top_left_y":1263,"width":804,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"295b7119180145a1a5a63d986f7d4c97","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"primary and secondary endpoints, essentially substituting","text_display":" primary and secondary endpoints, essentially substituting","confidence":1,"confidence_rate":1},{"cnt":[[939,1300],[1720,1300],[1720,1339],[939,1339]],"region":{"top_left_x":939,"top_left_y":1300,"width":781,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9caf1e28e6d244419ae0a9531c410f16","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"4-Point MACE (Cardiovascular (CV) Death, Non-Fatal","text_display":" 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal","confidence":1,"confidence_rate":1},{"cnt":[[939,1341],[1550,1341],[1550,1381],[939,1381]],"region":{"top_left_x":939,"top_left_y":1341,"width":611,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25fee9141d144c089be27cb5d759ccdc","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"Stoke, Non-fatal Myocardial Infarction and","text_display":" Stoke, Non-fatal Myocardial Infarction and","confidence":1,"confidence_rate":1},{"cnt":[[939,1383],[1752,1383],[1752,1422],[939,1422]],"region":{"top_left_x":939,"top_left_y":1382,"width":814,"height":41},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ab9a2799ac042ff9ae83ff1bcd6fa5a","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"Hospitalization for Unstable Angina) with 3-Point MACE","text_display":" Hospitalization for Unstable Angina) with 3-Point MACE","confidence":1,"confidence_rate":1},{"cnt":[[939,1422],[1665,1422],[1665,1459],[939,1459]],"region":{"top_left_x":939,"top_left_y":1422,"width":726,"height":37},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b9b0e4863f04752b552d5edb34177cb","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"(CV Death, Non-Fatal Stoke, Non-fatal Myocardial","text_display":" (CV Death, Non-Fatal Stoke, Non-fatal Myocardial","confidence":1,"confidence_rate":1},{"cnt":[[939,1461],[1103,1461],[1103,1500],[939,1500]],"region":{"top_left_x":939,"top_left_y":1461,"width":164,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36832a852d3e4a9b8ea08f607f582d52","type":"text","conversion_output":false,"parent_id":"100c34a68cb84d919d47016dfb1c8f91","text":"Infarction).","text_display":" Infarction).","confidence":0.99951171875,"confidence_rate":0.9999712709716212},{"cnt":[[267,1505],[592,1505],[592,1542],[267,1542]],"region":{"top_left_x":267,"top_left_y":1504,"width":325,"height":38},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"995ce641df1a434fb59053716cf0d8b4","type":"simple_cell","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1505],[1462,1505],[1462,1544],[939,1544]],"region":{"top_left_x":939,"top_left_y":1504,"width":524,"height":41},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abfea8926e954d0d9e30ded5cd2678ab","type":"simple_cell","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"7.2 Null and alternative hypothesis","text_display":"7.2 Null and alternative hypothesis","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99560546875,"confidence_rate":0.9998899006717523},{"cnt":[[267,1556],[596,1556],[596,1597],[267,1597]],"region":{"top_left_x":267,"top_left_y":1555,"width":330,"height":43},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"311edaa74a7244a68cf8746302167cb6","type":"simple_cell","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1551],[1752,1551],[1752,2555],[935,2555]],"region":{"top_left_x":934,"top_left_y":1551,"width":819,"height":1004},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f077655aeb924e4f9aabdbe17f5dbabd","type":"complex_cell","conversion_output":false,"parent_id":"8a293bf589d54dc2b4b919aefa10b4cb","children_ids":["ad884d27ae154cc2b3b6c4e3973bc76f","329a9594307546b880991d574b500102","ab77aff9986a4025a4f26ef3369e4887","50ce5aca557d4ffa991e9581e576a454","80b502c4ca724b9c9ae951184daf933f","dd83b5263e754fb0b82074b41ad0608e","18faa396d78f439c92527e4f7951041f","8f8669b42097445fabe6d08be556546b","1675cb91889f43cd94e563b777cddf8f","91c7af67daf24b72ae40cd52690747d5","ff5301de9b5946868ff805f83f5d231f","3bb3da3391174106af2bc0abfa774415","5f62a4f230a6439a8169df80e86dcaa7","c09a5bbab54b411aa973488e681f6a03","17c226e83ba2460ba67a533041db9667","3f2d3ba64636459c95b966279e7fb681","dd33ca0216d048d6a934292080cacae2","2ed49d68319e43e190d0df7f7eee8141","90fe703051bd4663ab260a1b88123a18","957bd523efbf45ba8a7abc5a5d357d0c","06ab0b3cd60b4dc399f4a4173a3a07c4","8336e799c2af46978569b3c6a9b632c7"],"text":"\\begin{tabular}{l}\nRelevant changes are summarised as follows: \\\\\nChange 1: \\\\\nAn interim analysis will be performed at the one-sided alpha-level of \\(1.0 \\%\\), the final analysis at the one-sided alpha-level of 2.12\\%. At the interim analysis MACE endpoints will be tested in a pre-specified order, at the final analysis also the composite renal endpoint will be tested for superiority \\\\\nWas changed into: \\\\\nNo confirmatory interim analysis for efficacy endpoints will be performed \\\\\nChange 2: \\\\\nThe experimentwise (multiple) level alpha is controlled with the following three step gatekeeping hierarchy within the interim and final analysis, respectively. For the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the one-sided alpha-level of \\(2.12 \\%\\). In case of significance, the null hypothesis is rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nRelevant changes are summarised as follows: \\\\\nChange 1: \\\\\nAn interim analysis will be performed at the one-sided alpha-level of \\(1.0 \\%\\), the final analysis at the one-sided alpha-level of 2.12\\%. At the interim analysis MACE endpoints will be tested in a pre-specified order, at the final analysis also the composite renal endpoint will be tested for superiority \\\\\nWas changed into: \\\\\nNo confirmatory interim analysis for efficacy endpoints will be performed \\\\\nChange 2: \\\\\nThe experimentwise (multiple) level alpha is controlled with the following three step gatekeeping hierarchy within the interim and final analysis, respectively. For the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the one-sided alpha-level of \\(2.12 \\%\\). In case of significance, the null hypothesis is rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.56591796875,"confidence_rate":0.9995634483624216},{"cnt":[[939,1553],[1577,1553],[1577,1592],[939,1592]],"region":{"top_left_x":939,"top_left_y":1553,"width":639,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad884d27ae154cc2b3b6c4e3973bc76f","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"Relevant changes are summarised as follows:","text_display":"Relevant changes are summarised as follows:","confidence":1,"confidence_rate":1},{"cnt":[[939,1634],[1089,1634],[1089,1671],[939,1671]],"region":{"top_left_x":939,"top_left_y":1633,"width":151,"height":38},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"329a9594307546b880991d574b500102","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"Change 1:","text_display":"\nChange 1:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1673],[1706,1673],[1706,1715],[939,1715]],"region":{"top_left_x":939,"top_left_y":1673,"width":768,"height":42},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab77aff9986a4025a4f26ef3369e4887","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"An interim analysis will be performed at the one-sided","text_display":"\nAn interim analysis will be performed at the one-sided","confidence":0.9960966110229492,"confidence_rate":0.9999337136024198},{"cnt":[[939,1715],[1701,1715],[1701,1754],[939,1754]],"region":{"top_left_x":939,"top_left_y":1714,"width":763,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50ce5aca557d4ffa991e9581e576a454","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"alpha-level of \\(1.0 \\%\\), the final analysis at the one-sided","text_display":" alpha-level of \\(1.0 \\%\\), the final analysis at the one-sided","confidence":0.56591796875,"confidence_rate":0.9912796883718712},{"cnt":[[939,1756],[1678,1756],[1678,1795],[939,1795]],"region":{"top_left_x":939,"top_left_y":1755,"width":740,"height":41},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80b502c4ca724b9c9ae951184daf933f","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"alpha-level of 2.12\\%. At the interim analysis MACE","text_display":" alpha-level of 2.12\\%. At the interim analysis MACE","confidence":0.9794921875,"confidence_rate":0.9996233251845504},{"cnt":[[939,1795],[1701,1795],[1701,1834],[939,1834]],"region":{"top_left_x":939,"top_left_y":1795,"width":763,"height":40},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd83b5263e754fb0b82074b41ad0608e","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"endpoints will be tested in a pre-specified order, at the","text_display":" endpoints will be tested in a pre-specified order, at the","confidence":1,"confidence_rate":1},{"cnt":[[939,1834],[1711,1834],[1711,1873],[939,1873]],"region":{"top_left_x":939,"top_left_y":1834,"width":772,"height":40},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18faa396d78f439c92527e4f7951041f","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"final analysis also the composite renal endpoint will be","text_display":" final analysis also the composite renal endpoint will be","confidence":1,"confidence_rate":1},{"cnt":[[939,1876],[1236,1876],[1236,1915],[939,1915]],"region":{"top_left_x":939,"top_left_y":1875,"width":298,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f8669b42097445fabe6d08be556546b","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"tested for superiority","text_display":" tested for superiority","confidence":1,"confidence_rate":1},{"cnt":[[939,1954],[1204,1954],[1204,1993],[939,1993]],"region":{"top_left_x":939,"top_left_y":1953,"width":266,"height":41},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1675cb91889f43cd94e563b777cddf8f","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99462890625,"confidence_rate":0.9997552313274409},{"cnt":[[939,2035],[1720,2035],[1720,2076],[939,2076]],"region":{"top_left_x":939,"top_left_y":2034,"width":781,"height":42},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91c7af67daf24b72ae40cd52690747d5","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"No confirmatory interim analysis for efficacy endpoints","text_display":"\nNo confirmatory interim analysis for efficacy endpoints","confidence":1,"confidence_rate":1},{"cnt":[[939,2074],[1195,2074],[1195,2113],[939,2113]],"region":{"top_left_x":939,"top_left_y":2073,"width":256,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff5301de9b5946868ff805f83f5d231f","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"will be performed","text_display":" will be performed","confidence":1,"confidence_rate":1},{"cnt":[[939,2115],[1089,2115],[1089,2154],[939,2154]],"region":{"top_left_x":939,"top_left_y":2115,"width":151,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3bb3da3391174106af2bc0abfa774415","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,2152],[1720,2152],[1720,2196],[939,2196]],"region":{"top_left_x":939,"top_left_y":2151,"width":781,"height":45},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f62a4f230a6439a8169df80e86dcaa7","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"The experimentwise (multiple) level alpha is controlled","text_display":"\nThe experimentwise (multiple) level alpha is controlled","confidence":1,"confidence_rate":1},{"cnt":[[939,2193],[1665,2193],[1665,2233],[939,2233]],"region":{"top_left_x":939,"top_left_y":2193,"width":726,"height":40},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c09a5bbab54b411aa973488e681f6a03","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"with the following three step gatekeeping hierarchy","text_display":" with the following three step gatekeeping hierarchy","confidence":1,"confidence_rate":1},{"cnt":[[939,2235],[1637,2235],[1637,2274],[939,2274]],"region":{"top_left_x":939,"top_left_y":2234,"width":699,"height":41},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17c226e83ba2460ba67a533041db9667","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"within the interim and final analysis, respectively.","text_display":" within the interim and final analysis, respectively.","confidence":1,"confidence_rate":1},{"cnt":[[939,2274],[1745,2274],[1745,2313],[939,2313]],"region":{"top_left_x":939,"top_left_y":2274,"width":807,"height":40},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f2d3ba64636459c95b966279e7fb681","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"For the final analysis, the first hypothesis (non-inferiority","text_display":" For the final analysis, the first hypothesis (non-inferiority","confidence":1,"confidence_rate":1},{"cnt":[[939,2313],[1711,2313],[1711,2352],[939,2352]],"region":{"top_left_x":939,"top_left_y":2313,"width":772,"height":40},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd33ca0216d048d6a934292080cacae2","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"of the primary endpoint) will be tested at the one-sided","text_display":" of the primary endpoint) will be tested at the one-sided","confidence":1,"confidence_rate":1},{"cnt":[[939,2355],[1688,2355],[1688,2394],[939,2394]],"region":{"top_left_x":939,"top_left_y":2354,"width":749,"height":40},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ed49d68319e43e190d0df7f7eee8141","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"alpha-level of \\(2.12 \\%\\). In case of significance, the null","text_display":" alpha-level of \\(2.12 \\%\\). In case of significance, the null","confidence":0.994140625,"confidence_rate":0.9999081822078711},{"cnt":[[939,2391],[1688,2391],[1688,2435],[939,2435]],"region":{"top_left_x":939,"top_left_y":2391,"width":749,"height":45},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90fe703051bd4663ab260a1b88123a18","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"hypothesis is rejected in a confirmatory sense and the","text_display":" hypothesis is rejected in a confirmatory sense and the","confidence":0.998046875,"confidence_rate":0.9999668643653395},{"cnt":[[939,2433],[1688,2433],[1688,2474],[939,2474]],"region":{"top_left_x":939,"top_left_y":2432,"width":749,"height":43},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"957bd523efbf45ba8a7abc5a5d357d0c","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"next set of hypotheses (two separate hypothesis tests)","text_display":" next set of hypotheses (two separate hypothesis tests)","confidence":1,"confidence_rate":1},{"cnt":[[939,2474],[1621,2474],[1621,2513],[939,2513]],"region":{"top_left_x":939,"top_left_y":2474,"width":682,"height":40},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06ab0b3cd60b4dc399f4a4173a3a07c4","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"will be tested: a) test of the primary endpoint for","text_display":" will be tested: a) test of the primary endpoint for","confidence":1,"confidence_rate":1},{"cnt":[[939,2551],[939,2513],[1568,2516],[1568,2553]],"region":{"top_left_x":939,"top_left_y":2513,"width":630,"height":41},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8336e799c2af46978569b3c6a9b632c7","type":"text","conversion_output":false,"parent_id":"f077655aeb924e4f9aabdbe17f5dbabd","text":"superiority and b) test of the composite renal","text_display":" superiority and b) test of the composite renal","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":67,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d3bc2784c28641c0b2181a2e102c11e4","type":"section_header","conversion_output":false,"children_ids":["fa63c04b707e419c9df3062deec10ba7"],"text":"","text_display":""},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":68,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fa63c04b707e419c9df3062deec10ba7","type":"text","conversion_output":true,"parent_id":"d3bc2784c28641c0b2181a2e102c11e4","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":69,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c2b2cdbd3d0e42109c39ecf36e0b73c9","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":70,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a8a598ff2eb54ed18522bfc71afd0add","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-115","page":115,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9ef3007538b45e1a6a88b6e4088a47e","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"989ca451fcf1476da7598c3447582901","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"933229d6a132412c82ffcba46ca9c8a9","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43b67578b2dc4cbdb1f000e41f4e9d8a","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4921ec1f2e6f4cbc936a2c8b219e2102","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4263c9894f3f4a18bd65877d6ca2b0b8","type":"page_info","conversion_output":false,"text":"Page 115 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2556],[244,2556]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2224},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"760039e21710476b944d6e6e78e0533b","type":"table","conversion_output":true,"children_ids":["c0c944bb90a441f48e56b5874f50f1b2","c233b56af78546ba9ce6c77bef7183b2","d62fbd8268904574816135f318cdf852","06f43d6a0e5b4e80b22002f4387b3408","f149333dfbc4430fae98d00cb8e62617","6e8bd082447042429db3d812ce858e0f","77ac8a290ecf44c7b35e44657041ec1b","bb46f0fcc2714f64ac60282229e95696","13a3ceb9eb114baba0b8a170f2de0d5b","dbb17bc687564e8da8984f61f450ceba","18dc5d21e88e481cb6f73e83ac3adf72","2c6bab37213043958105240c5a62b97e","b006e73eec2c4759b2c74d806e0071cd"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nendpoint for superiority. To adjust for multiplicity the truncated Hochberg multiple test procedure will be applied with a selected gamma of 0.5. Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately. If both tests are significant at the one-sided alpha-level of 1.59\\% each, superiority of both endpoints (4-point MACE and composite renal endpoint) has been demonstrated. If not, superiority can only be claimed for the endpoint significant at the alpha-level of 1.06\\%. If superiority of both, the 4-point MACE and the composite renal endpoint has been demonstrated at the one-sided alpha-level of \\(1.59 \\%\\) each, then superiority of the 3-point MACE can be tested at the alpha-level of 2.12\\%. If superiority of only one of these endpoints (4-point MACE or composite renal endpoint) has been demonstrated at the one-sided alpha-level of 1.06\\%, then superiority of the 3-point MACE can be tested at the alpha-level of 0.53\\%. \\\\\nWas changed into: \\\\\nFor the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the one-sided alpha-level of \\(2.5 \\%\\). In case of significance, the null hypothesis is rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal endpoint for superiority. To adjust for multiplicity a sequentially rejective multiple test procedure will be applied. Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately, at the initial alpha-levels of 0.2*alpha for 3-point MACE and 0.8*alpha for the composite renal endpoint, respectively. If both null hypotheses cannot be rejected at these initial alpha-levels, the procedure stops and for none of these endpoints superiority can be declared. After having shown superiority for one of these endpoints, the used alpha can be shuffled to the other test: If H0(Sup2) is rejected at the alpha-level of 0.8*alpha, then H0(Sup1) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided). If H0(Sup1) is rejected at the alphalevel of 0.2*alpha, then H 0 (Sup1) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided).\n\\end{tabular} \\\\\n\\hline Rationale for change & A higher alpha-level will be assigned to the composite renal endpoint, the endpoint with the expected higher power for superiority. Nevertheless, this strategy allows testing both, 3-point MACE and the renal endpoint for superiority, independently of each other. \\\\\n\\hline Section to be changed & 7.3 planned analysis \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nHospitalisation for unstable angina pectoris deleted from Important protocol violations.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nendpoint for superiority. To adjust for multiplicity the truncated Hochberg multiple test procedure will be applied with a selected gamma of 0.5. Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately. If both tests are significant at the one-sided alpha-level of 1.59\\% each, superiority of both endpoints (4-point MACE and composite renal endpoint) has been demonstrated. If not, superiority can only be claimed for the endpoint significant at the alpha-level of 1.06\\%. If superiority of both, the 4-point MACE and the composite renal endpoint has been demonstrated at the one-sided alpha-level of \\(1.59 \\%\\) each, then superiority of the 3-point MACE can be tested at the alpha-level of 2.12\\%. If superiority of only one of these endpoints (4-point MACE or composite renal endpoint) has been demonstrated at the one-sided alpha-level of 1.06\\%, then superiority of the 3-point MACE can be tested at the alpha-level of 0.53\\%. \\\\\nWas changed into: \\\\\nFor the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the one-sided alpha-level of \\(2.5 \\%\\). In case of significance, the null hypothesis is rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal endpoint for superiority. To adjust for multiplicity a sequentially rejective multiple test procedure will be applied. Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately, at the initial alpha-levels of 0.2*alpha for 3-point MACE and 0.8*alpha for the composite renal endpoint, respectively. If both null hypotheses cannot be rejected at these initial alpha-levels, the procedure stops and for none of these endpoints superiority can be declared. After having shown superiority for one of these endpoints, the used alpha can be shuffled to the other test: If H0(Sup2) is rejected at the alpha-level of 0.8*alpha, then H0(Sup1) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided). If H0(Sup1) is rejected at the alphalevel of 0.2*alpha, then H 0 (Sup1) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided).\n\\end{tabular} \\\\\n\\hline Rationale for change & A higher alpha-level will be assigned to the composite renal endpoint, the endpoint with the expected higher power for superiority. Nevertheless, this strategy allows testing both, 3-point MACE and the renal endpoint for superiority, independently of each other. \\\\\n\\hline Section to be changed & 7.3 planned analysis \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nHospitalisation for unstable angina pectoris deleted from Important protocol violations.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.45717999525368214,"confidence_rate":0.9997630540243695},{"cnt":[[250,2557],[253,332],[605,333],[602,2558]],"region":{"top_left_x":249,"top_left_y":332,"width":357,"height":2226},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0c944bb90a441f48e56b5874f50f1b2","type":"table_column","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"","text_display":""},{"cnt":[[927,2557],[930,332],[1761,333],[1759,2558]],"region":{"top_left_x":927,"top_left_y":332,"width":835,"height":2227},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c233b56af78546ba9ce6c77bef7183b2","type":"table_column","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"","text_display":""},{"cnt":[[244,333],[1775,333],[1775,2071],[244,2071]],"region":{"top_left_x":244,"top_left_y":333,"width":1532,"height":1739},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d62fbd8268904574816135f318cdf852","type":"table_row","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"","text_display":""},{"cnt":[[244,2134],[1775,2134],[1775,2350],[244,2350]],"region":{"top_left_x":244,"top_left_y":2133,"width":1532,"height":217},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06f43d6a0e5b4e80b22002f4387b3408","type":"table_row","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"","text_display":""},{"cnt":[[244,2378],[1775,2378],[1775,2428],[244,2428]],"region":{"top_left_x":244,"top_left_y":2377,"width":1532,"height":52},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f149333dfbc4430fae98d00cb8e62617","type":"table_row","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"","text_display":""},{"cnt":[[244,2557],[244,2426],[1775,2428],[1775,2559]],"region":{"top_left_x":243,"top_left_y":2425,"width":1533,"height":134},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e8bd082447042429db3d812ce858e0f","type":"table_row","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"","text_display":""},{"cnt":[[932,338],[1757,338],[1757,2062],[932,2062]],"region":{"top_left_x":932,"top_left_y":337,"width":825,"height":1726},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77ac8a290ecf44c7b35e44657041ec1b","type":"complex_cell","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","children_ids":["9b1f8abf061843b282f9e5ddf22a2c02","351afd0b2e4c419298ca096b35e16c58","d7e55a1093f145b59c30298531c45c10","0191bda27f0b4d869aa843b263e6bfc2","ddfa754c8ceb46f5ab1c56c3e6995399","02822fd05c8e468c962ede7d531e3b50","8a2926be6c864f51b439081e22453b00","44fc6f77b57847c8a79cc1250f2b1ff0","4065b16925eb442eb94b5567f33cb158","52fefd064532423fa6cf58ae87015db5","abfb805e5e2f4160baf6cba0cb55bab6","fd7620696db14f62ac3a3c8c68fbde32","d9c5450102fe4ccf9d936099a852b172","c40b8c3364b54c509f6ac0389010316b","138eccd51acf4e38a9bf33aac1053b4c","f26b7672616344e0816403dde113775b","769826a865544c3e8e410d32a1543339","c856daf5f17f46c7a0f83a07231d8409","35b8e60df3854dccad2a0e2d28d8ff8b","78ca7daeb7e44c9dbb30f4b5ec16e653","a2971c8e14dc4b21932cc1cdb5a5ef7b","51a1c7e14fea41a284801c8e3c8d4ac7","16a187dd6f134bd597c675cc3528c68b","420bf9b12a054e05955f091e8b6b0518","43e797c6df41413fa287d4dacc315a12","a19797d9697144db8b4d3e4ae15a91d6","03578de6419a49eb9c28f1fead01fcd5","dd781df51b324454a57b22059ac4caca","10343265ad45485cbd258f53050e7d27","ed7fbc15db09406188724c35ba775f0c","40978da099c84de8a41990db1e22cd12","d03a116442944e3ab6a0c84fcc193c2e","ef4a53b3250b4305b3b8e12071da0222","fbb4f8dc24cd47d49aafada140147128","5d135802cba14bff9ff5254289dabec7","23940b696dc543e7be06a674e4c0efe3","f0fe7afaecbe4b96aa0b31e36e2688d6","1f67745e8bd84f96b37db4d93f5443f5","46352b0b31314b5985af1271d5a538ee","239150907fe44135b1c3dc2c565db2a5","c13eb98dddc740d1aac9b7053c5b3c4b"],"text":"\\begin{tabular}{l}\nendpoint for superiority. To adjust for multiplicity the truncated Hochberg multiple test procedure will be applied with a selected gamma of 0.5. Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately. If both tests are significant at the one-sided alpha-level of 1.59\\% each, superiority of both endpoints (4-point MACE and composite renal endpoint) has been demonstrated. If not, superiority can only be claimed for the endpoint significant at the alpha-level of 1.06\\%. If superiority of both, the 4-point MACE and the composite renal endpoint has been demonstrated at the one-sided alpha-level of \\(1.59 \\%\\) each, then superiority of the 3-point MACE can be tested at the alpha-level of 2.12\\%. If superiority of only one of these endpoints (4-point MACE or composite renal endpoint) has been demonstrated at the one-sided alpha-level of 1.06\\%, then superiority of the 3-point MACE can be tested at the alpha-level of 0.53\\%. \\\\\nWas changed into: \\\\\nFor the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the one-sided alpha-level of \\(2.5 \\%\\). In case of significance, the null hypothesis is rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal endpoint for superiority. To adjust for multiplicity a sequentially rejective multiple test procedure will be applied. Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately, at the initial alpha-levels of 0.2*alpha for 3-point MACE and 0.8*alpha for the composite renal endpoint, respectively. If both null hypotheses cannot be rejected at these initial alpha-levels, the procedure stops and for none of these endpoints superiority can be declared. After having shown superiority for one of these endpoints, the used alpha can be shuffled to the other test: If H0(Sup2) is rejected at the alpha-level of 0.8*alpha, then H0(Sup1) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided). If H0(Sup1) is rejected at the alphalevel of 0.2*alpha, then H 0 (Sup1) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nendpoint for superiority. To adjust for multiplicity the truncated Hochberg multiple test procedure will be applied with a selected gamma of 0.5. Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately. If both tests are significant at the one-sided alpha-level of 1.59\\% each, superiority of both endpoints (4-point MACE and composite renal endpoint) has been demonstrated. If not, superiority can only be claimed for the endpoint significant at the alpha-level of 1.06\\%. If superiority of both, the 4-point MACE and the composite renal endpoint has been demonstrated at the one-sided alpha-level of \\(1.59 \\%\\) each, then superiority of the 3-point MACE can be tested at the alpha-level of 2.12\\%. If superiority of only one of these endpoints (4-point MACE or composite renal endpoint) has been demonstrated at the one-sided alpha-level of 1.06\\%, then superiority of the 3-point MACE can be tested at the alpha-level of 0.53\\%. \\\\\nWas changed into: \\\\\nFor the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be tested at the one-sided alpha-level of \\(2.5 \\%\\). In case of significance, the null hypothesis is rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests) will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal endpoint for superiority. To adjust for multiplicity a sequentially rejective multiple test procedure will be applied. Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately, at the initial alpha-levels of 0.2*alpha for 3-point MACE and 0.8*alpha for the composite renal endpoint, respectively. If both null hypotheses cannot be rejected at these initial alpha-levels, the procedure stops and for none of these endpoints superiority can be declared. After having shown superiority for one of these endpoints, the used alpha can be shuffled to the other test: If H0(Sup2) is rejected at the alpha-level of 0.8*alpha, then H0(Sup1) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided). If H0(Sup1) is rejected at the alphalevel of 0.2*alpha, then H 0 (Sup1) can be tested at the full alpha-level of \\(2.5 \\%\\) (one-sided).\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.45717999525368214,"confidence_rate":0.9983695576947602},{"cnt":[[939,342],[1695,342],[1695,381],[939,381]],"region":{"top_left_x":939,"top_left_y":342,"width":756,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b1f8abf061843b282f9e5ddf22a2c02","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"endpoint for superiority. To adjust for multiplicity the","text_display":"endpoint for superiority. To adjust for multiplicity the","confidence":1,"confidence_rate":1},{"cnt":[[939,379],[1655,379],[1655,418],[939,418]],"region":{"top_left_x":939,"top_left_y":379,"width":717,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"351afd0b2e4c419298ca096b35e16c58","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"truncated Hochberg multiple test procedure will be","text_display":" truncated Hochberg multiple test procedure will be","confidence":1,"confidence_rate":1},{"cnt":[[939,420],[1692,420],[1692,460],[939,460]],"region":{"top_left_x":939,"top_left_y":420,"width":754,"height":40},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7e55a1093f145b59c30298531c45c10","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"applied with a selected gamma of 0.5. Both one-sided","text_display":" applied with a selected gamma of 0.5. Both one-sided","confidence":0.54638671875,"confidence_rate":0.989452019383139},{"cnt":[[939,462],[1646,462],[1646,501],[939,501]],"region":{"top_left_x":939,"top_left_y":461,"width":708,"height":41},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0191bda27f0b4d869aa843b263e6bfc2","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"hypotheses H0(Sup1) and H0(Sup2) will be tested","text_display":" hypotheses H0(Sup1) and H0(Sup2) will be tested","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[939,501],[1704,501],[1704,540],[939,540]],"region":{"top_left_x":939,"top_left_y":501,"width":765,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ddfa754c8ceb46f5ab1c56c3e6995399","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"separately. If both tests are significant at the one-sided","text_display":" separately. If both tests are significant at the one-sided","confidence":0.99853515625,"confidence_rate":0.9999767317360675},{"cnt":[[939,540],[1729,540],[1729,579],[939,579]],"region":{"top_left_x":939,"top_left_y":540,"width":791,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02822fd05c8e468c962ede7d531e3b50","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"alpha-level of 1.59\\% each, superiority of both endpoints","text_display":" alpha-level of 1.59\\% each, superiority of both endpoints","confidence":0.880859375,"confidence_rate":0.9979225332955578},{"cnt":[[939,582],[1725,582],[1725,621],[939,621]],"region":{"top_left_x":939,"top_left_y":581,"width":786,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a2926be6c864f51b439081e22453b00","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"(4-point MACE and composite renal endpoint) has been","text_display":" (4-point MACE and composite renal endpoint) has been","confidence":1,"confidence_rate":1},{"cnt":[[939,621],[1729,621],[1729,660],[939,660]],"region":{"top_left_x":939,"top_left_y":620,"width":791,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44fc6f77b57847c8a79cc1250f2b1ff0","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"demonstrated. If not, superiority can only be claimed for","text_display":" demonstrated. If not, superiority can only be claimed for","confidence":1,"confidence_rate":1},{"cnt":[[939,660],[1701,660],[1701,699],[939,699]],"region":{"top_left_x":939,"top_left_y":659,"width":763,"height":41},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4065b16925eb442eb94b5567f33cb158","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"the endpoint significant at the alpha-level of 1.06\\%. If","text_display":" the endpoint significant at the alpha-level of 1.06\\%. If","confidence":0.8056640625,"confidence_rate":0.9964638339110993},{"cnt":[[939,701],[1743,701],[1743,741],[939,741]],"region":{"top_left_x":939,"top_left_y":701,"width":804,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52fefd064532423fa6cf58ae87015db5","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"superiority of both, the 4-point MACE and the composite","text_display":" superiority of both, the 4-point MACE and the composite","confidence":0.99462890625,"confidence_rate":0.9999102445293867},{"cnt":[[939,743],[1701,743],[1701,782],[939,782]],"region":{"top_left_x":939,"top_left_y":742,"width":763,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abfb805e5e2f4160baf6cba0cb55bab6","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"renal endpoint has been demonstrated at the one-sided","text_display":" renal endpoint has been demonstrated at the one-sided","confidence":1,"confidence_rate":1},{"cnt":[[939,780],[1743,780],[1743,819],[939,819]],"region":{"top_left_x":939,"top_left_y":779,"width":804,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd7620696db14f62ac3a3c8c68fbde32","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"alpha-level of \\(1.59 \\%\\) each, then superiority of the 3-point","text_display":" alpha-level of \\(1.59 \\%\\) each, then superiority of the 3-point","confidence":0.8254492282867432,"confidence_rate":0.9970977421152157},{"cnt":[[939,821],[1628,821],[1628,860],[939,860]],"region":{"top_left_x":939,"top_left_y":821,"width":689,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9c5450102fe4ccf9d936099a852b172","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"MACE can be tested at the alpha-level of 2.12\\%.","text_display":" MACE can be tested at the alpha-level of 2.12\\%.","confidence":0.80322265625,"confidence_rate":0.9957949560040957},{"cnt":[[939,863],[1678,863],[1678,902],[939,902]],"region":{"top_left_x":939,"top_left_y":862,"width":740,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c40b8c3364b54c509f6ac0389010316b","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"If superiority of only one of these endpoints (4-point","text_display":" If superiority of only one of these endpoints (4-point","confidence":0.98876953125,"confidence_rate":0.9998085944793785},{"cnt":[[939,899],[1586,899],[1586,943],[939,943]],"region":{"top_left_x":939,"top_left_y":899,"width":648,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"138eccd51acf4e38a9bf33aac1053b4c","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"MACE or composite renal endpoint) has been","text_display":" MACE or composite renal endpoint) has been","confidence":1,"confidence_rate":1},{"cnt":[[939,941],[1738,941],[1738,980],[939,980]],"region":{"top_left_x":939,"top_left_y":940,"width":800,"height":41},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f26b7672616344e0816403dde113775b","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"demonstrated at the one-sided alpha-level of 1.06\\%, then","text_display":" demonstrated at the one-sided alpha-level of 1.06\\%, then","confidence":0.67236328125,"confidence_rate":0.9935136444151212},{"cnt":[[939,980],[1676,980],[1676,1021],[939,1021]],"region":{"top_left_x":939,"top_left_y":980,"width":738,"height":42},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"769826a865544c3e8e410d32a1543339","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"superiority of the 3-point MACE can be tested at the","text_display":" superiority of the 3-point MACE can be tested at the","confidence":0.91845703125,"confidence_rate":0.9985088294476405},{"cnt":[[939,1019],[1246,1019],[1246,1058],[939,1058]],"region":{"top_left_x":939,"top_left_y":1019,"width":307,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c856daf5f17f46c7a0f83a07231d8409","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"alpha-level of 0.53\\%.","text_display":" alpha-level of 0.53\\%.","confidence":0.99951171875,"confidence_rate":0.9999812155418875},{"cnt":[[939,1097],[1204,1097],[1204,1141],[939,1141]],"region":{"top_left_x":939,"top_left_y":1097,"width":266,"height":45},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35b8e60df3854dccad2a0e2d28d8ff8b","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.98779296875,"confidence_rate":0.999441876309383},{"cnt":[[939,1180],[1748,1180],[1748,1219],[939,1219]],"region":{"top_left_x":939,"top_left_y":1180,"width":809,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78ca7daeb7e44c9dbb30f4b5ec16e653","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"For the final analysis, the first hypothesis (non-inferiority","text_display":"\nFor the final analysis, the first hypothesis (non-inferiority","confidence":1,"confidence_rate":1},{"cnt":[[939,1222],[1711,1222],[1711,1261],[939,1261]],"region":{"top_left_x":939,"top_left_y":1221,"width":772,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2971c8e14dc4b21932cc1cdb5a5ef7b","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"of the primary endpoint) will be tested at the one-sided","text_display":" of the primary endpoint) will be tested at the one-sided","confidence":1,"confidence_rate":1},{"cnt":[[939,1261],[1669,1261],[1669,1300],[939,1300]],"region":{"top_left_x":939,"top_left_y":1260,"width":731,"height":41},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51a1c7e14fea41a284801c8e3c8d4ac7","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"alpha-level of \\(2.5 \\%\\). In case of significance, the null","text_display":" alpha-level of \\(2.5 \\%\\). In case of significance, the null","confidence":0.9990234375,"confidence_rate":0.9999844915544187},{"cnt":[[939,1300],[1688,1300],[1688,1339],[939,1339]],"region":{"top_left_x":939,"top_left_y":1300,"width":749,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16a187dd6f134bd597c675cc3528c68b","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"hypothesis is rejected in a confirmatory sense and the","text_display":" hypothesis is rejected in a confirmatory sense and the","confidence":0.99658203125,"confidence_rate":0.9999419707795306},{"cnt":[[939,1341],[1750,1341],[1750,1381],[939,1381]],"region":{"top_left_x":939,"top_left_y":1341,"width":811,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"420bf9b12a054e05955f091e8b6b0518","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"next set of hypotheses (two separate hypothesis tests) will","text_display":" next set of hypotheses (two separate hypothesis tests) will","confidence":1,"confidence_rate":1},{"cnt":[[939,1378],[1715,1378],[1715,1422],[939,1422]],"region":{"top_left_x":939,"top_left_y":1378,"width":777,"height":45},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43e797c6df41413fa287d4dacc315a12","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"be tested: a) test of the primary endpoint for superiority","text_display":" be tested: a) test of the primary endpoint for superiority","confidence":0.98828125,"confidence_rate":0.9998129070952982},{"cnt":[[939,1420],[1591,1420],[1591,1459],[939,1459]],"region":{"top_left_x":939,"top_left_y":1419,"width":652,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a19797d9697144db8b4d3e4ae15a91d6","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"and b) test of the composite renal endpoint for","text_display":" and b) test of the composite renal endpoint for","confidence":1,"confidence_rate":1},{"cnt":[[939,1459],[1665,1459],[1665,1500],[939,1500]],"region":{"top_left_x":939,"top_left_y":1458,"width":726,"height":43},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03578de6419a49eb9c28f1fead01fcd5","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"superiority. To adjust for multiplicity a sequentially","text_display":" superiority. To adjust for multiplicity a sequentially","confidence":1,"confidence_rate":1},{"cnt":[[939,1498],[1697,1498],[1697,1540],[939,1540]],"region":{"top_left_x":939,"top_left_y":1498,"width":758,"height":42},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd781df51b324454a57b22059ac4caca","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"rejective multiple test procedure will be applied. Both","text_display":" rejective multiple test procedure will be applied. Both","confidence":1,"confidence_rate":1},{"cnt":[[939,1540],[1701,1540],[1701,1579],[939,1579]],"region":{"top_left_x":939,"top_left_y":1539,"width":763,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10343265ad45485cbd258f53050e7d27","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"one-sided hypotheses H0(Sup1) and H0(Sup2) will be","text_display":" one-sided hypotheses H0(Sup1) and H0(Sup2) will be","confidence":1,"confidence_rate":1},{"cnt":[[939,1581],[1720,1581],[1720,1620],[939,1620]],"region":{"top_left_x":939,"top_left_y":1580,"width":781,"height":41},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed7fbc15db09406188724c35ba775f0c","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"tested separately, at the initial alpha-levels of 0.2*alpha","text_display":" tested separately, at the initial alpha-levels of 0.2*alpha","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[939,1618],[1738,1618],[1738,1662],[939,1662]],"region":{"top_left_x":939,"top_left_y":1617,"width":800,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40978da099c84de8a41990db1e22cd12","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"for 3-point MACE and 0.8*alpha for the composite renal","text_display":" for 3-point MACE and 0.8*alpha for the composite renal","confidence":0.9887747764587402,"confidence_rate":0.999808684373527},{"cnt":[[939,1659],[1731,1659],[1731,1698],[939,1698]],"region":{"top_left_x":939,"top_left_y":1659,"width":793,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d03a116442944e3ab6a0c84fcc193c2e","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"endpoint, respectively. If both null hypotheses cannot be","text_display":" endpoint, respectively. If both null hypotheses cannot be","confidence":1,"confidence_rate":1},{"cnt":[[939,1701],[1725,1701],[1725,1740],[939,1740]],"region":{"top_left_x":939,"top_left_y":1700,"width":786,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef4a53b3250b4305b3b8e12071da0222","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"rejected at these initial alpha-levels, the procedure stops","text_display":" rejected at these initial alpha-levels, the procedure stops","confidence":1,"confidence_rate":1},{"cnt":[[939,1740],[1642,1740],[1642,1779],[939,1779]],"region":{"top_left_x":939,"top_left_y":1739,"width":703,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fbb4f8dc24cd47d49aafada140147128","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"and for none of these endpoints superiority can be","text_display":" and for none of these endpoints superiority can be","confidence":1,"confidence_rate":1},{"cnt":[[939,1779],[1743,1779],[1743,1818],[939,1818]],"region":{"top_left_x":939,"top_left_y":1778,"width":804,"height":41},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d135802cba14bff9ff5254289dabec7","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"declared. After having shown superiority for one of these","text_display":" declared. After having shown superiority for one of these","confidence":1,"confidence_rate":1},{"cnt":[[939,1820],[1748,1820],[1748,1860],[939,1860]],"region":{"top_left_x":939,"top_left_y":1820,"width":809,"height":40},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23940b696dc543e7be06a674e4c0efe3","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"endpoints, the used alpha can be shuffled to the other test:","text_display":" endpoints, the used alpha can be shuffled to the other test:","confidence":1,"confidence_rate":1},{"cnt":[[939,1857],[1701,1857],[1701,1901],[939,1901]],"region":{"top_left_x":939,"top_left_y":1857,"width":763,"height":45},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0fe7afaecbe4b96aa0b31e36e2688d6","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"If H0(Sup2) is rejected at the alpha-level of 0.8*alpha,","text_display":" If H0(Sup2) is rejected at the alpha-level of 0.8*alpha,","confidence":0.663252592086792,"confidence_rate":0.9932914660198883},{"cnt":[[939,1899],[1688,1899],[1688,1938],[939,1938]],"region":{"top_left_x":939,"top_left_y":1898,"width":749,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f67745e8bd84f96b37db4d93f5443f5","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"then H0(Sup1) can be tested at the full alpha-level of","text_display":" then H0(Sup1) can be tested at the full alpha-level of","confidence":0.8186233043670654,"confidence_rate":0.9966136914894191},{"cnt":[[939,1940],[1701,1940],[1701,1979],[939,1979]],"region":{"top_left_x":939,"top_left_y":1940,"width":763,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"46352b0b31314b5985af1271d5a538ee","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"\\(2.5 \\%\\) (one-sided). If H0(Sup1) is rejected at the alpha-","text_display":" \\(2.5 \\%\\) (one-sided). If H0(Sup1) is rejected at the alpha","confidence":0.5905506518902257,"confidence_rate":0.9911126119712649},{"cnt":[[939,1977],[1748,1977],[1748,2021],[939,2021]],"region":{"top_left_x":939,"top_left_y":1976,"width":809,"height":45},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"239150907fe44135b1c3dc2c565db2a5","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"level of 0.2*alpha, then H 0 (Sup1) can be tested at the full","text_display":"level of 0.2*alpha, then H 0 (Sup1) can be tested at the full","confidence":0.45717999525368214,"confidence_rate":0.9890369023621348},{"cnt":[[939,2018],[1393,2018],[1393,2060],[939,2060]],"region":{"top_left_x":939,"top_left_y":2018,"width":454,"height":42},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c13eb98dddc740d1aac9b7053c5b3c4b","type":"text","conversion_output":false,"parent_id":"77ac8a290ecf44c7b35e44657041ec1b","text":"alpha-level of \\(2.5 \\%\\) (one-sided).","text_display":" alpha-level of \\(2.5 \\%\\) (one-sided).","confidence":0.84765625,"confidence_rate":0.9958765227021349},{"cnt":[[265,2143],[582,2143],[582,2182],[265,2182]],"region":{"top_left_x":264,"top_left_y":2142,"width":319,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb46f0fcc2714f64ac60282229e95696","type":"simple_cell","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2140],[1729,2140],[1729,2343],[935,2343]],"region":{"top_left_x":934,"top_left_y":2140,"width":796,"height":204},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13a3ceb9eb114baba0b8a170f2de0d5b","type":"complex_cell","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","children_ids":["afe803c5ae3c4f7da8b4baccc3428fba","cea0e9b91c024cd68b867f3546b0fedd","a934fa9c4790412988c649ea3191eae7","21cad4f3f20b48f2b975f1e4bd2d46f0","6a8bbae761914488a6d82bf059044f58"],"text":"A higher alpha-level will be assigned to the composite renal endpoint, the endpoint with the expected higher power for superiority. Nevertheless, this strategy allows testing both, 3-point MACE and the renal endpoint for superiority, independently of each other.","text_display":"A higher alpha-level will be assigned to the composite renal endpoint, the endpoint with the expected higher power for superiority. Nevertheless, this strategy allows testing both, 3-point MACE and the renal endpoint for superiority, independently of each other.","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9921875,"confidence_rate":0.9999729549262039},{"cnt":[[939,2143],[1701,2143],[1701,2182],[939,2182]],"region":{"top_left_x":939,"top_left_y":2142,"width":763,"height":40},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"afe803c5ae3c4f7da8b4baccc3428fba","type":"text","conversion_output":false,"parent_id":"13a3ceb9eb114baba0b8a170f2de0d5b","text":"A higher alpha-level will be assigned to the composite","text_display":"A higher alpha-level will be assigned to the composite","confidence":1,"confidence_rate":1},{"cnt":[[939,2182],[1688,2182],[1688,2221],[939,2221]],"region":{"top_left_x":939,"top_left_y":2181,"width":749,"height":41},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cea0e9b91c024cd68b867f3546b0fedd","type":"text","conversion_output":false,"parent_id":"13a3ceb9eb114baba0b8a170f2de0d5b","text":"renal endpoint, the endpoint with the expected higher","text_display":" renal endpoint, the endpoint with the expected higher","confidence":1,"confidence_rate":1},{"cnt":[[939,2221],[1722,2221],[1722,2260],[939,2260]],"region":{"top_left_x":939,"top_left_y":2221,"width":784,"height":40},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a934fa9c4790412988c649ea3191eae7","type":"text","conversion_output":false,"parent_id":"13a3ceb9eb114baba0b8a170f2de0d5b","text":"power for superiority. Nevertheless, this strategy allows","text_display":" power for superiority. Nevertheless, this strategy allows","confidence":1,"confidence_rate":1},{"cnt":[[939,2262],[1706,2262],[1706,2302],[939,2302]],"region":{"top_left_x":939,"top_left_y":2262,"width":768,"height":40},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"21cad4f3f20b48f2b975f1e4bd2d46f0","type":"text","conversion_output":false,"parent_id":"13a3ceb9eb114baba0b8a170f2de0d5b","text":"testing both, 3-point MACE and the renal endpoint for","text_display":" testing both, 3-point MACE and the renal endpoint for","confidence":0.9921875,"confidence_rate":0.9998647819451815},{"cnt":[[939,2299],[1508,2299],[1508,2343],[939,2343]],"region":{"top_left_x":939,"top_left_y":2299,"width":570,"height":45},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a8bbae761914488a6d82bf059044f58","type":"text","conversion_output":false,"parent_id":"13a3ceb9eb114baba0b8a170f2de0d5b","text":"superiority, independently of each other.","text_display":" superiority, independently of each other.","confidence":1,"confidence_rate":1},{"cnt":[[265,2385],[592,2385],[592,2424],[265,2424]],"region":{"top_left_x":264,"top_left_y":2384,"width":328,"height":40},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dbb17bc687564e8da8984f61f450ceba","type":"simple_cell","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2385],[1246,2385],[1246,2426],[939,2426]],"region":{"top_left_x":939,"top_left_y":2384,"width":307,"height":42},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18dc5d21e88e481cb6f73e83ac3adf72","type":"simple_cell","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"7.3 planned analysis","text_display":"7.3 planned analysis","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2435],[596,2435],[596,2477],[267,2477]],"region":{"top_left_x":267,"top_left_y":2435,"width":330,"height":42},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c6bab37213043958105240c5a62b97e","type":"simple_cell","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2433],[1741,2433],[1741,2555],[935,2555]],"region":{"top_left_x":934,"top_left_y":2432,"width":807,"height":123},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b006e73eec2c4759b2c74d806e0071cd","type":"complex_cell","conversion_output":false,"parent_id":"760039e21710476b944d6e6e78e0533b","children_ids":["08fed808081b413dae67be6b214be08a","a214800e36764f67b466b5427a1859b6","7c4b1cb08179496ebe98aef2391aef17"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nHospitalisation for unstable angina pectoris deleted from Important protocol violations.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nHospitalisation for unstable angina pectoris deleted from Important protocol violations.\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2433],[1089,2433],[1089,2472],[939,2472]],"region":{"top_left_x":939,"top_left_y":2432,"width":151,"height":41},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08fed808081b413dae67be6b214be08a","type":"text","conversion_output":false,"parent_id":"b006e73eec2c4759b2c74d806e0071cd","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2474],[1738,2474],[1738,2513],[939,2513]],"region":{"top_left_x":939,"top_left_y":2474,"width":800,"height":40},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a214800e36764f67b466b5427a1859b6","type":"text","conversion_output":false,"parent_id":"b006e73eec2c4759b2c74d806e0071cd","text":"Hospitalisation for unstable angina pectoris deleted from","text_display":"\nHospitalisation for unstable angina pectoris deleted from","confidence":1,"confidence_rate":1},{"cnt":[[939,2516],[1361,2516],[1361,2553],[939,2553]],"region":{"top_left_x":939,"top_left_y":2515,"width":422,"height":38},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c4b1cb08179496ebe98aef2391aef17","type":"text","conversion_output":false,"parent_id":"b006e73eec2c4759b2c74d806e0071cd","text":"Important protocol violations.","text_display":" Important protocol violations.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":70,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7763040f3eaf42caad3129de5ad37479","type":"section_header","conversion_output":false,"children_ids":["185b91d84234462186f8e1a2d86f3f0e"],"text":"","text_display":""},{"cnt":[[793,2586],[1300,2586],[1300,2620],[793,2620]],"region":{"top_left_x":792,"top_left_y":2585,"width":508,"height":36},"line":71,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"185b91d84234462186f8e1a2d86f3f0e","type":"text","conversion_output":true,"parent_id":"7763040f3eaf42caad3129de5ad37479","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":72,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1cb5763834b64965906e82058c622e0a","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":73,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8fd28804341d4070afb958c0d6bc2d0f","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-116","page":116,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb6795e032c04679bd05673b7b44dedf","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,121],[1816,121],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":121,"width":314,"height":42},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"88d4fddc6df74955bc3ef09750114ce7","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40190b1786a646cda7769cfdbdbbdf1d","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed4811de048b4219b534843227ff85f4","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ce84cc2b8ef498e97bd57afa47885f9","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8af46d71ed5f4b9e9602371dec2dac03","type":"page_info","conversion_output":false,"text":"Page 116 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2545],[244,2545]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2214},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08f50a69e3504a51bd82bf1eb2e7414b","type":"table","conversion_output":true,"children_ids":["f8201bd308aa475186d991d9e442b0d6","b6509df5d834423cb06a8ba828f26fec","0a097b53bde54757ad492f5097bd5784","aa2f6a903df4438a859f23b4f26d82b9"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 2: \\\\\nSystolic and diastolic blood pressure ( \\(\\leq 160\\) and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) ) \\\\\nWas changed into: \\\\\nSystolic and diastolic blood pressure (<140 and < 90 \\(mmHg , \\geq 140\\) or \\(\\geq 90 mmHg\\) ) \\\\\nChange 3: \\\\\nPrior anti-diabetic treatment (none, monotherapy, combination therapy ) \\\\\nWas changed into: \\\\\nPrior anti-diabetic treatment (insulin, no insulin) \\\\\nChange 4: \\\\\nThe following subgroup has been added: \\\\\nPrevalent kidney disease defined as eGFR \\(<60 mL / min / 1.73 m^{2}\\) at baseline and/or UACR \\(>300 mg / g\\) creatinine at baseline \\\\\nChange 5: \\\\\n'In case only randomized patients take study drug, this set is identical to the FAS...' was deleted \\\\\nChange 6: \\\\\nAnalysis sets have been redefined in 7.3 and 7.3.1 as follows: \\\\\nThe full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug \\\\\nWas changed into: \\\\\nThe Treated Set consisting of all patients who were treated with at least one dose of study drug \\\\\nIn addition: \\\\\nThe '30-day treatment' set of patients including all patients with minimum treatment duration of 30-days \\\\\nWas changed into: \\\\\nThe 'on-treatment' set (OS) including all patients with minimum treatment duration of 30-days \\\\\nIn addition:\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nChange 2: \\\\\nSystolic and diastolic blood pressure ( \\(\\leq 160\\) and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) ) \\\\\nWas changed into: \\\\\nSystolic and diastolic blood pressure (<140 and < 90 \\(mmHg , \\geq 140\\) or \\(\\geq 90 mmHg\\) ) \\\\\nChange 3: \\\\\nPrior anti-diabetic treatment (none, monotherapy, combination therapy ) \\\\\nWas changed into: \\\\\nPrior anti-diabetic treatment (insulin, no insulin) \\\\\nChange 4: \\\\\nThe following subgroup has been added: \\\\\nPrevalent kidney disease defined as eGFR \\(<60 mL / min / 1.73 m^{2}\\) at baseline and/or UACR \\(>300 mg / g\\) creatinine at baseline \\\\\nChange 5: \\\\\n'In case only randomized patients take study drug, this set is identical to the FAS...' was deleted \\\\\nChange 6: \\\\\nAnalysis sets have been redefined in 7.3 and 7.3.1 as follows: \\\\\nThe full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug \\\\\nWas changed into: \\\\\nThe Treated Set consisting of all patients who were treated with at least one dose of study drug \\\\\nIn addition: \\\\\nThe '30-day treatment' set of patients including all patients with minimum treatment duration of 30-days \\\\\nWas changed into: \\\\\nThe 'on-treatment' set (OS) including all patients with minimum treatment duration of 30-days \\\\\nIn addition:\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.5733576114289463,"confidence_rate":0.9992326620826273},{"cnt":[[244,331],[840,331],[840,2544],[244,2544]],"region":{"top_left_x":244,"top_left_y":331,"width":597,"height":2213},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8201bd308aa475186d991d9e442b0d6","type":"table_column","conversion_output":false,"parent_id":"08f50a69e3504a51bd82bf1eb2e7414b","text":"","text_display":""},{"cnt":[[921,331],[1766,331],[1766,2544],[921,2544]],"region":{"top_left_x":920,"top_left_y":331,"width":846,"height":2213},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6509df5d834423cb06a8ba828f26fec","type":"table_column","conversion_output":false,"parent_id":"08f50a69e3504a51bd82bf1eb2e7414b","text":"","text_display":""},{"cnt":[[244,372],[1773,372],[1773,2509],[244,2509]],"region":{"top_left_x":244,"top_left_y":372,"width":1529,"height":2138},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a097b53bde54757ad492f5097bd5784","type":"table_row","conversion_output":false,"parent_id":"08f50a69e3504a51bd82bf1eb2e7414b","text":"","text_display":""},{"cnt":[[930,377],[1759,377],[1759,2507],[930,2507]],"region":{"top_left_x":930,"top_left_y":377,"width":830,"height":2130},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa2f6a903df4438a859f23b4f26d82b9","type":"complex_cell","conversion_output":false,"parent_id":"08f50a69e3504a51bd82bf1eb2e7414b","children_ids":["eb3d372b9bac41a2bcd15a56a7e6e7d6","33b9379688524d829e001bd594161d35","aa2957734ee0498d94a9d7c7851b380a","a0c3f1ad1b9c43419307ae0d96792958","d4e5e46f5e7b46c6ae3983c262bce0fa","6beb8e47c502497da8892e64bce17ff2","af51dfb0df2f441095676408b8fb7e37","0467ff257e98443cb7c525c2285a9b15","1fff5bbd98334b9c9c5a482824612255","b0949cd09f8845a3802713006aa15812","2165ae7e8c8449fbb5f6a82121383e95","db329d1f51f4457e8250dd4f57de0a0a","c620a01576ea45cbbd3b5c7b0dabbb39","0816a45f6dd94171aded3dc68eeed307","6e6a0d843f0c406c9ee88c96bd851975","79c6dd669c0141a78f8c78a55b6252f2","ffb31ab6792142828e9cf12d49602706","0ba33cc9d5a4475f9e5a3fbf5dc9c67e","2e0d75b0e4dd40d197e15fd05e97339e","010150476eba453bbfac235ce801428b","fa95d3049ace43b18a367692d52a4b50","e08b89e7ffaa452fa36664055f6de2db","5e70966c283a456396f31ba32cad82c8","c75600e3527a49c19bb5767fd22d4d0b","43ff40760af44a1abe3b13ea94b26383","4b32be93b7fe496bab28fb857c3d64a0","ccf34c3f632848b2ae86cd112c4721e7","a33748ef8b18422b9598fb5cfa17aec1","738aee69f2874530a759808b8412a0c7","de5fbdace10f4a6e9f8f3666f370ca87","18afa103c2d843239afdd85f8a33b136","a51ff9e1b58241b38716339e1c99c9b5","7f679ac9cb5c46389f0103f95bd21184","29192d2cdd5d4796a3cf40c274a932ad","89aaf1bb5a0b47168e0a4476dd46af7f"],"text":"\\begin{tabular}{l}\nChange 2: \\\\\nSystolic and diastolic blood pressure ( \\(\\leq 160\\) and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) ) \\\\\nWas changed into: \\\\\nSystolic and diastolic blood pressure (<140 and < 90 \\(mmHg , \\geq 140\\) or \\(\\geq 90 mmHg\\) ) \\\\\nChange 3: \\\\\nPrior anti-diabetic treatment (none, monotherapy, combination therapy ) \\\\\nWas changed into: \\\\\nPrior anti-diabetic treatment (insulin, no insulin) \\\\\nChange 4: \\\\\nThe following subgroup has been added: \\\\\nPrevalent kidney disease defined as eGFR \\(<60 mL / min / 1.73 m^{2}\\) at baseline and/or UACR \\(>300 mg / g\\) creatinine at baseline \\\\\nChange 5: \\\\\n'In case only randomized patients take study drug, this set is identical to the FAS...' was deleted \\\\\nChange 6: \\\\\nAnalysis sets have been redefined in 7.3 and 7.3.1 as follows: \\\\\nThe full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug \\\\\nWas changed into: \\\\\nThe Treated Set consisting of all patients who were treated with at least one dose of study drug \\\\\nIn addition: \\\\\nThe '30-day treatment' set of patients including all patients with minimum treatment duration of 30-days \\\\\nWas changed into: \\\\\nThe 'on-treatment' set (OS) including all patients with minimum treatment duration of 30-days \\\\\nIn addition:\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 2: \\\\\nSystolic and diastolic blood pressure ( \\(\\leq 160\\) and \\(\\leq 100 mmHg ,>160\\) or \\(>100 mmHg\\) ) \\\\\nWas changed into: \\\\\nSystolic and diastolic blood pressure (<140 and < 90 \\(mmHg , \\geq 140\\) or \\(\\geq 90 mmHg\\) ) \\\\\nChange 3: \\\\\nPrior anti-diabetic treatment (none, monotherapy, combination therapy ) \\\\\nWas changed into: \\\\\nPrior anti-diabetic treatment (insulin, no insulin) \\\\\nChange 4: \\\\\nThe following subgroup has been added: \\\\\nPrevalent kidney disease defined as eGFR \\(<60 mL / min / 1.73 m^{2}\\) at baseline and/or UACR \\(>300 mg / g\\) creatinine at baseline \\\\\nChange 5: \\\\\n'In case only randomized patients take study drug, this set is identical to the FAS...' was deleted \\\\\nChange 6: \\\\\nAnalysis sets have been redefined in 7.3 and 7.3.1 as follows: \\\\\nThe full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug \\\\\nWas changed into: \\\\\nThe Treated Set consisting of all patients who were treated with at least one dose of study drug \\\\\nIn addition: \\\\\nThe '30-day treatment' set of patients including all patients with minimum treatment duration of 30-days \\\\\nWas changed into: \\\\\nThe 'on-treatment' set (OS) including all patients with minimum treatment duration of 30-days \\\\\nIn addition:\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.5733576114289463,"confidence_rate":0.9992326620826273},{"cnt":[[939,379],[1089,379],[1089,421],[939,421]],"region":{"top_left_x":939,"top_left_y":379,"width":151,"height":42},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb3d372b9bac41a2bcd15a56a7e6e7d6","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Change 2:","text_display":"Change 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,418],[1695,418],[1695,462],[939,462]],"region":{"top_left_x":939,"top_left_y":418,"width":756,"height":45},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"33b9379688524d829e001bd594161d35","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Systolic and diastolic blood pressure ( \\(\\leq 160\\) and \\(\\leq 100\\)","text_display":"\nSystolic and diastolic blood pressure ( \\(\\leq 160\\) and \\(\\leq 100","confidence":1,"confidence_rate":1},{"cnt":[[939,460],[1393,460],[1393,501],[939,501]],"region":{"top_left_x":939,"top_left_y":459,"width":454,"height":43},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa2957734ee0498d94a9d7c7851b380a","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"\\(mmHg ,>160\\) or \\(>100 mmHg\\) )","text_display":" mmHg ,>160\\) or \\(>100 mmHg\\) )","confidence":0.9503344595432281,"confidence_rate":0.9985859647560111},{"cnt":[[939,538],[1204,538],[1204,582],[939,582]],"region":{"top_left_x":939,"top_left_y":538,"width":266,"height":44},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0c3f1ad1b9c43419307ae0d96792958","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9921875,"confidence_rate":0.9996435554750392},{"cnt":[[939,619],[1678,619],[1678,660],[939,660]],"region":{"top_left_x":939,"top_left_y":618,"width":740,"height":43},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d4e5e46f5e7b46c6ae3983c262bce0fa","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Systolic and diastolic blood pressure (<140 and < 90","text_display":"\nSystolic and diastolic blood pressure (<140 and < 90","confidence":0.9990234375,"confidence_rate":0.9999825530156321},{"cnt":[[939,658],[1375,658],[1375,702],[939,702]],"region":{"top_left_x":939,"top_left_y":657,"width":436,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6beb8e47c502497da8892e64bce17ff2","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"\\(mmHg , \\geq 140\\) or \\(\\geq 90 mmHg\\) )","text_display":" \\(mmHg , \\geq 140\\) or \\(\\geq 90 mmHg\\) )","confidence":0.9859067115138487,"confidence_rate":0.9995945524468051},{"cnt":[[939,741],[1089,741],[1089,780],[939,780]],"region":{"top_left_x":939,"top_left_y":740,"width":151,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af51dfb0df2f441095676408b8fb7e37","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,782],[1632,782],[1632,821],[939,821]],"region":{"top_left_x":939,"top_left_y":782,"width":694,"height":40},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0467ff257e98443cb7c525c2285a9b15","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Prior anti-diabetic treatment (none, monotherapy,","text_display":"\nPrior anti-diabetic treatment (none, monotherapy,","confidence":1,"confidence_rate":1},{"cnt":[[939,819],[1250,819],[1250,863],[939,863]],"region":{"top_left_x":939,"top_left_y":819,"width":312,"height":44},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1fff5bbd98334b9c9c5a482824612255","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"combination therapy )","text_display":" combination therapy )","confidence":0.99951171875,"confidence_rate":0.9999812155418875},{"cnt":[[939,902],[1204,902],[1204,941],[939,941]],"region":{"top_left_x":939,"top_left_y":902,"width":266,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0949cd09f8845a3802713006aa15812","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9970703125,"confidence_rate":0.9998666458272406},{"cnt":[[939,980],[1619,980],[1619,1019],[939,1019]],"region":{"top_left_x":939,"top_left_y":980,"width":680,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2165ae7e8c8449fbb5f6a82121383e95","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Prior anti-diabetic treatment (insulin, no insulin)","text_display":"\nPrior anti-diabetic treatment (insulin, no insulin)","confidence":1,"confidence_rate":1},{"cnt":[[939,1082],[1089,1082],[1089,1121],[939,1121]],"region":{"top_left_x":939,"top_left_y":1081,"width":151,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"db329d1f51f4457e8250dd4f57de0a0a","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Change 4:","text_display":"\nChange 4:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1118],[1510,1118],[1510,1162],[939,1162]],"region":{"top_left_x":939,"top_left_y":1118,"width":572,"height":45},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c620a01576ea45cbbd3b5c7b0dabbb39","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"The following subgroup has been added:","text_display":"\nThe following subgroup has been added:","confidence":1,"confidence_rate":1},{"cnt":[[939,1201],[1602,1201],[1602,1240],[939,1240]],"region":{"top_left_x":939,"top_left_y":1201,"width":664,"height":40},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0816a45f6dd94171aded3dc68eeed307","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Prevalent kidney disease defined as eGFR \\(<60\\)","text_display":"\nPrevalent kidney disease defined as eGFR \\(<60","confidence":0.5733576114289463,"confidence_rate":0.9884784363673216},{"cnt":[[939,1234],[1701,1234],[1701,1282],[939,1282]],"region":{"top_left_x":939,"top_left_y":1233,"width":763,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e6a0d843f0c406c9ee88c96bd851975","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"\\(mL / min / 1.73 m^{2}\\) at baseline and/or UACR \\(>300 mg / g\\)","text_display":" mL / min / 1.73 m^{2}\\) at baseline and/or UACR \\(>300 mg / g\\)","confidence":0.9990234375,"confidence_rate":0.9999862389728834},{"cnt":[[939,1280],[1241,1280],[1241,1319],[939,1319]],"region":{"top_left_x":939,"top_left_y":1279,"width":302,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79c6dd669c0141a78f8c78a55b6252f2","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"creatinine at baseline","text_display":" creatinine at baseline","confidence":1,"confidence_rate":1},{"cnt":[[939,1381],[1089,1381],[1089,1420],[939,1420]],"region":{"top_left_x":939,"top_left_y":1380,"width":151,"height":41},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ffb31ab6792142828e9cf12d49602706","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Change 5:","text_display":"\nChange 5:","confidence":1,"confidence_rate":1},{"cnt":[[939,1422],[1752,1422],[1752,1462],[939,1462]],"region":{"top_left_x":939,"top_left_y":1422,"width":814,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ba33cc9d5a4475f9e5a3fbf5dc9c67e","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"'In case only randomized patients take study drug, this set","text_display":"\n'In case only randomized patients take study drug, this set","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[939,1462],[1476,1462],[1476,1498],[939,1498]],"region":{"top_left_x":939,"top_left_y":1461,"width":537,"height":38},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e0d75b0e4dd40d197e15fd05e97339e","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"is identical to the FAS...' was deleted","text_display":" is identical to the FAS...' was deleted","confidence":0.6089382851496339,"confidence_rate":0.9887897099230161},{"cnt":[[939,1561],[1089,1561],[1089,1604],[939,1604]],"region":{"top_left_x":939,"top_left_y":1560,"width":151,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"010150476eba453bbfac235ce801428b","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Change 6:","text_display":"\nChange 6:","confidence":1,"confidence_rate":1},{"cnt":[[939,1602],[1678,1602],[1678,1641],[939,1641]],"region":{"top_left_x":939,"top_left_y":1601,"width":740,"height":41},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa95d3049ace43b18a367692d52a4b50","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Analysis sets have been redefined in 7.3 and 7.3.1 as","text_display":"\nAnalysis sets have been redefined in 7.3 and 7.3.1 as","confidence":1,"confidence_rate":1},{"cnt":[[939,1643],[1057,1643],[1057,1678],[939,1678]],"region":{"top_left_x":939,"top_left_y":1643,"width":118,"height":35},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e08b89e7ffaa452fa36664055f6de2db","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"follows:","text_display":" follows:","confidence":1,"confidence_rate":1},{"cnt":[[939,1722],[1725,1722],[1725,1761],[939,1761]],"region":{"top_left_x":939,"top_left_y":1721,"width":786,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e70966c283a456396f31ba32cad82c8","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"The full analysis set (FAS) consisting of all randomized","text_display":"\nThe full analysis set (FAS) consisting of all randomized","confidence":1,"confidence_rate":1},{"cnt":[[939,1763],[1729,1763],[1729,1802],[939,1802]],"region":{"top_left_x":939,"top_left_y":1763,"width":791,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c75600e3527a49c19bb5767fd22d4d0b","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"patients who were treated with at least one dose of study","text_display":" patients who were treated with at least one dose of study","confidence":1,"confidence_rate":1},{"cnt":[[939,1800],[1013,1800],[1013,1846],[939,1846]],"region":{"top_left_x":939,"top_left_y":1799,"width":75,"height":48},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43ff40760af44a1abe3b13ea94b26383","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"drug","text_display":" drug","confidence":1,"confidence_rate":1},{"cnt":[[939,1883],[1204,1883],[1204,1922],[939,1922]],"region":{"top_left_x":939,"top_left_y":1882,"width":266,"height":41},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b32be93b7fe496bab28fb857c3d64a0","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.974609375,"confidence_rate":0.9988316589838895},{"cnt":[[939,1961],[1660,1961],[1660,2000],[939,2000]],"region":{"top_left_x":939,"top_left_y":1961,"width":722,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ccf34c3f632848b2ae86cd112c4721e7","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"The Treated Set consisting of all patients who were","text_display":"\nThe Treated Set consisting of all patients who were","confidence":0.99951171875,"confidence_rate":0.9999912786005654},{"cnt":[[939,2003],[1540,2003],[1540,2042],[939,2042]],"region":{"top_left_x":939,"top_left_y":2002,"width":602,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a33748ef8b18422b9598fb5cfa17aec1","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"treated with at least one dose of study drug","text_display":" treated with at least one dose of study drug","confidence":1,"confidence_rate":1},{"cnt":[[939,2062],[1105,2062],[1105,2097],[939,2097]],"region":{"top_left_x":939,"top_left_y":2062,"width":167,"height":36},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"738aee69f2874530a759808b8412a0c7","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"In addition:","text_display":"\nIn addition:","confidence":1,"confidence_rate":1},{"cnt":[[939,2143],[1651,2141],[1651,2184],[939,2187]],"region":{"top_left_x":939,"top_left_y":2140,"width":712,"height":47},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de5fbdace10f4a6e9f8f3666f370ca87","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"The '30-day treatment' set of patients including all","text_display":"\nThe '30-day treatment' set of patients including all","confidence":0.99951171875,"confidence_rate":0.9999914316069175},{"cnt":[[939,2182],[1688,2182],[1688,2221],[939,2221]],"region":{"top_left_x":939,"top_left_y":2182,"width":749,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18afa103c2d843239afdd85f8a33b136","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"patients with minimum treatment duration of 30-days","text_display":" patients with minimum treatment duration of 30-days","confidence":1,"confidence_rate":1},{"cnt":[[939,2260],[1204,2260],[1204,2304],[939,2304]],"region":{"top_left_x":939,"top_left_y":2260,"width":266,"height":45},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a51ff9e1b58241b38716339e1c99c9b5","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9921875,"confidence_rate":0.9996435554750392},{"cnt":[[939,2341],[1701,2341],[1701,2383],[939,2383]],"region":{"top_left_x":939,"top_left_y":2341,"width":763,"height":42},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f679ac9cb5c46389f0103f95bd21184","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"The 'on-treatment' set (OS) including all patients with","text_display":"\nThe 'on-treatment' set (OS) including all patients with","confidence":0.99853515625,"confidence_rate":0.999975568337083},{"cnt":[[939,2383],[1499,2383],[1499,2424],[939,2424]],"region":{"top_left_x":939,"top_left_y":2382,"width":560,"height":42},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29192d2cdd5d4796a3cf40c274a932ad","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"minimum treatment duration of 30-days","text_display":" minimum treatment duration of 30-days","confidence":1,"confidence_rate":1},{"cnt":[[939,2463],[1107,2463],[1107,2498],[939,2498]],"region":{"top_left_x":939,"top_left_y":2463,"width":169,"height":35},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89aaf1bb5a0b47168e0a4476dd46af7f","type":"text","conversion_output":false,"parent_id":"aa2f6a903df4438a859f23b4f26d82b9","text":"In addition:","text_display":"\nIn addition:","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1c4d13abaaea42dd8915b85cff337c7b","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9bdb071ee699467190fd5aec27a59eec","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c91e166520904291be32f77bb0126b00","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-117","page":117,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63d4248ebda34109ab5cca40b549e6b4","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac61d76d061540d1b6ec0ea770bc46d8","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"939e7c410ba1446f90e5c6da07ffb826","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9025922b452f4a308e60456f334b7ec0","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5afdfdac36c14a66af1490f495bb159c","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe678e9e49b5482db51a5cc0d9be8d10","type":"page_info","conversion_output":false,"text":"Page 117 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2538],[244,2538]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2207},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ab8b6d12b994fcfae31fe0a5018538f","type":"table","conversion_output":true,"children_ids":["b7240370424e473fa6696578740ed632","9c53b8b7f68144c289b76909ee9cf1e0","75ec990d45bd4337bc36bcd0e796e418","d78d2ec56f4d4d579df622b57de8c545","c56eb5997bd1445a83dc75a468c233cc","a86a65eff8004cf99473d63710120e2e","63d42e9a761a4edf9261295a3f114f10","42d10082fc93420786809b981c22b5ac","76c7546e1148453a85d9c8eb5eb7fd5b","656691f4a95c42d881492193a7c0bbf8","369e133628e94918963236b64c0c3a7b","887bcee8625c4d20b56d8aa1527d46e1","59278363af15475d9f220f3b8cc226da"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nThe 'on-treatment analysis' on the FAS (consisting of all randomized patients who were treated with at least one dose of study drug) with censoring at the time patients are on treatment +30 days after permanent treatment discontinuation or end of observation \\\\\nWas changed into: \\\\\nThe 'TS+30 analysis' on the TS (consisting of all patients who were treated with at least one dose of study drug) with censoring at the time patients are on treatment +30 days after permanent treatment discontinuation or end of observation\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nDeleted due to the change of the primary endpoint. \\\\\nChange 2: \\\\\nBP limit changed to \\(140 / 90 mmHg\\), to reflect BP treatment standards for the CARMELINA population. \\\\\nChange 3: \\\\\nInsulin treatment (with or without oral anti-diabetics) is considered the most important differentiator of antidiabetic treatment, while e.g. combination therapy of anti-diabetic drugs per se is not associated with a different risk for outcome events as compared to monotherapy (including insulin). \\\\\nChange 4: \\\\\nTo investigate the potential impact of impaired renal function on outcome events and renal endpoints \\\\\nChange 5: \\\\\nOnly randomized patients took study drug and therefore this statement is no longer required \\\\\nChange 6: \\\\\nSince only randomized patients took study drug, the TS is identical to the FAS and thus there is no impact on derived analysis sets. Labels were changed in order to align with recently published outcome studies and notations used by FDA.\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.3.2 Secondary analyses \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of \\(40 \\%\\) or more in eGFR). \\\\\nIn addition: \\\\\nAfter non-inferiority has been established for the primary\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nThe 'on-treatment analysis' on the FAS (consisting of all randomized patients who were treated with at least one dose of study drug) with censoring at the time patients are on treatment +30 days after permanent treatment discontinuation or end of observation \\\\\nWas changed into: \\\\\nThe 'TS+30 analysis' on the TS (consisting of all patients who were treated with at least one dose of study drug) with censoring at the time patients are on treatment +30 days after permanent treatment discontinuation or end of observation\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nDeleted due to the change of the primary endpoint. \\\\\nChange 2: \\\\\nBP limit changed to \\(140 / 90 mmHg\\), to reflect BP treatment standards for the CARMELINA population. \\\\\nChange 3: \\\\\nInsulin treatment (with or without oral anti-diabetics) is considered the most important differentiator of antidiabetic treatment, while e.g. combination therapy of anti-diabetic drugs per se is not associated with a different risk for outcome events as compared to monotherapy (including insulin). \\\\\nChange 4: \\\\\nTo investigate the potential impact of impaired renal function on outcome events and renal endpoints \\\\\nChange 5: \\\\\nOnly randomized patients took study drug and therefore this statement is no longer required \\\\\nChange 6: \\\\\nSince only randomized patients took study drug, the TS is identical to the FAS and thus there is no impact on derived analysis sets. Labels were changed in order to align with recently published outcome studies and notations used by FDA.\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.3.2 Secondary analyses \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of \\(40 \\%\\) or more in eGFR). \\\\\nIn addition: \\\\\nAfter non-inferiority has been established for the primary\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.7021484375,"confidence_rate":0.9998275864119973},{"cnt":[[250,331],[601,331],[603,2539],[253,2539]],"region":{"top_left_x":250,"top_left_y":330,"width":354,"height":2210},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7240370424e473fa6696578740ed632","type":"table_column","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"","text_display":""},{"cnt":[[912,331],[1768,331],[1768,2539],[912,2539]],"region":{"top_left_x":911,"top_left_y":331,"width":858,"height":2209},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c53b8b7f68144c289b76909ee9cf1e0","type":"table_column","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"","text_display":""},{"cnt":[[244,331],[1775,331],[1775,888],[244,888]],"region":{"top_left_x":244,"top_left_y":331,"width":1532,"height":558},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"75ec990d45bd4337bc36bcd0e796e418","type":"table_row","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"","text_display":""},{"cnt":[[244,895],[1775,895],[1775,2069],[244,2069]],"region":{"top_left_x":244,"top_left_y":895,"width":1532,"height":1175},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d78d2ec56f4d4d579df622b57de8c545","type":"table_row","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"","text_display":""},{"cnt":[[244,2058],[1775,2058],[1775,2111],[244,2111]],"region":{"top_left_x":244,"top_left_y":2057,"width":1532,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c56eb5997bd1445a83dc75a468c233cc","type":"table_row","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"","text_display":""},{"cnt":[[244,2106],[1775,2106],[1775,2539],[244,2539]],"region":{"top_left_x":244,"top_left_y":2106,"width":1532,"height":434},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a86a65eff8004cf99473d63710120e2e","type":"table_row","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"","text_display":""},{"cnt":[[930,336],[1759,333],[1760,879],[932,881]],"region":{"top_left_x":930,"top_left_y":333,"width":831,"height":549},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63d42e9a761a4edf9261295a3f114f10","type":"complex_cell","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","children_ids":["e5139425c18a4c00b1be4eab9b3da2a3","496266d3776c4e7896de17eee185b8e4","d833cbe4b3c64939b65e8af016501a19","31f3da11c3b842bd97e6eaf696904fbd","99b0450f63de482f951cc70654cdda06","f321c58b4cdf4dc6aaa5c0dcbb31e978","94c6c4c2b4d5426d829ca7a439f98eac","b3e5b32db25e48729b33860e22450a5b","c5e83211871a443fabba34a20c8024d3","619e415e8050461b89a7ae5358677fe1","be5eb726517a4d8893098f66fb9a8894"],"text":"\\begin{tabular}{l}\nThe 'on-treatment analysis' on the FAS (consisting of all randomized patients who were treated with at least one dose of study drug) with censoring at the time patients are on treatment +30 days after permanent treatment discontinuation or end of observation \\\\\nWas changed into: \\\\\nThe 'TS+30 analysis' on the TS (consisting of all patients who were treated with at least one dose of study drug) with censoring at the time patients are on treatment +30 days after permanent treatment discontinuation or end of observation\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe 'on-treatment analysis' on the FAS (consisting of all randomized patients who were treated with at least one dose of study drug) with censoring at the time patients are on treatment +30 days after permanent treatment discontinuation or end of observation \\\\\nWas changed into: \\\\\nThe 'TS+30 analysis' on the TS (consisting of all patients who were treated with at least one dose of study drug) with censoring at the time patients are on treatment +30 days after permanent treatment discontinuation or end of observation\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.91259765625,"confidence_rate":0.9996925644238847},{"cnt":[[939,340],[1741,340],[1741,379],[939,379]],"region":{"top_left_x":939,"top_left_y":340,"width":802,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5139425c18a4c00b1be4eab9b3da2a3","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"The 'on-treatment analysis' on the FAS (consisting of all","text_display":"The 'on-treatment analysis' on the FAS (consisting of all","confidence":1,"confidence_rate":1},{"cnt":[[939,382],[1711,382],[1711,421],[939,421]],"region":{"top_left_x":939,"top_left_y":381,"width":772,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"496266d3776c4e7896de17eee185b8e4","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"randomized patients who were treated with at least one","text_display":" randomized patients who were treated with at least one","confidence":1,"confidence_rate":1},{"cnt":[[939,418],[1752,418],[1752,462],[939,462]],"region":{"top_left_x":939,"top_left_y":418,"width":814,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d833cbe4b3c64939b65e8af016501a19","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"dose of study drug) with censoring at the time patients are","text_display":" dose of study drug) with censoring at the time patients are","confidence":1,"confidence_rate":1},{"cnt":[[939,460],[1635,460],[1635,501],[939,501]],"region":{"top_left_x":939,"top_left_y":459,"width":696,"height":43},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31f3da11c3b842bd97e6eaf696904fbd","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"on treatment +30 days after permanent treatment","text_display":" on treatment +30 days after permanent treatment","confidence":0.91259765625,"confidence_rate":0.9983384695325718},{"cnt":[[939,501],[1467,501],[1467,536],[939,536]],"region":{"top_left_x":939,"top_left_y":501,"width":528,"height":35},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99b0450f63de482f951cc70654cdda06","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"discontinuation or end of observation","text_display":" discontinuation or end of observation","confidence":0.982421875,"confidence_rate":0.9995778402073948},{"cnt":[[939,603],[1204,603],[1204,642],[939,642]],"region":{"top_left_x":939,"top_left_y":602,"width":266,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f321c58b4cdf4dc6aaa5c0dcbb31e978","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9921875,"confidence_rate":0.9996435554750392},{"cnt":[[939,681],[1748,681],[1748,722],[939,722]],"region":{"top_left_x":939,"top_left_y":680,"width":809,"height":43},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94c6c4c2b4d5426d829ca7a439f98eac","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"The 'TS+30 analysis' on the TS (consisting of all patients","text_display":"\nThe 'TS+30 analysis' on the TS (consisting of all patients","confidence":1,"confidence_rate":1},{"cnt":[[939,722],[1697,722],[1697,762],[939,762]],"region":{"top_left_x":939,"top_left_y":722,"width":758,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3e5b32db25e48729b33860e22450a5b","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"who were treated with at least one dose of study drug)","text_display":" who were treated with at least one dose of study drug)","confidence":0.99951171875,"confidence_rate":0.9999917220597181},{"cnt":[[939,759],[1731,759],[1731,801],[939,801]],"region":{"top_left_x":939,"top_left_y":759,"width":793,"height":42},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5e83211871a443fabba34a20c8024d3","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"with censoring at the time patients are on treatment +30","text_display":" with censoring at the time patients are on treatment +30","confidence":0.9460484981536865,"confidence_rate":0.99907606967509},{"cnt":[[939,801],[1738,801],[1738,840],[939,840]],"region":{"top_left_x":939,"top_left_y":800,"width":800,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"619e415e8050461b89a7ae5358677fe1","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"days after permanent treatment discontinuation or end of","text_display":" days after permanent treatment discontinuation or end of","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[939,842],[1112,842],[1112,877],[939,877]],"region":{"top_left_x":939,"top_left_y":842,"width":174,"height":35},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be5eb726517a4d8893098f66fb9a8894","type":"text","conversion_output":false,"parent_id":"63d42e9a761a4edf9261295a3f114f10","text":"observation","text_display":" observation","confidence":1,"confidence_rate":1},{"cnt":[[265,902],[582,902],[582,946],[265,946]],"region":{"top_left_x":264,"top_left_y":902,"width":319,"height":44},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42d10082fc93420786809b981c22b5ac","type":"simple_cell","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,897],[1752,897],[1752,2065],[935,2065]],"region":{"top_left_x":934,"top_left_y":897,"width":819,"height":1168},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76c7546e1148453a85d9c8eb5eb7fd5b","type":"complex_cell","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","children_ids":["620eff1fa4914699a2b1364d0ef3893e","d20d2e2ed26d4b75a96d8306bf14c4d9","a48c926e25fe4bbea27e4b0b51982694","2753d30d61d24cfb8e0171de535921be","8f595090e87949658cb267327edb934e","808929a18aba47048ce0d2e44d5abf9c","ec10dc2dd95c4985a195c7873281eac3","7bf74eea64f748cebde536b2058555f2","3c6983c1f534472fa1e1de0a5054db78","93d8044228444790b7d5575dec2be386","5d1b2822f39f450cad31ed06c2a2901b","fac79a2a11e04f3fbc471c65b0d9443e","5ac8da61d3c24dabbb58f5989012ab29","fa9fd39520c84002aa0978e9e5c48feb","26da455c7c59488981a3475c94b3acc4","9881b24be30d492b92528ade58c0d1e1","cd6da775e22d41c8aea51d988a72f31c","b6c6c83f999b47769fb35fe120dbe4dc","edde878aa0f3499dba781ae6dfa19428","3c15471b7ad342ed829087c41910def2","92cbd5d531e74b9e8f25cee9410a79bc","6ddb965ab4cc4332a1153b10a64b6d68","5b05be7b8ef94ede9fa5331661aa9498","9854e214f7234ab8b51953127ff3e6ca"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nDeleted due to the change of the primary endpoint. \\\\\nChange 2: \\\\\nBP limit changed to \\(140 / 90 mmHg\\), to reflect BP treatment standards for the CARMELINA population. \\\\\nChange 3: \\\\\nInsulin treatment (with or without oral anti-diabetics) is considered the most important differentiator of antidiabetic treatment, while e.g. combination therapy of anti-diabetic drugs per se is not associated with a different risk for outcome events as compared to monotherapy (including insulin). \\\\\nChange 4: \\\\\nTo investigate the potential impact of impaired renal function on outcome events and renal endpoints \\\\\nChange 5: \\\\\nOnly randomized patients took study drug and therefore this statement is no longer required \\\\\nChange 6: \\\\\nSince only randomized patients took study drug, the TS is identical to the FAS and thus there is no impact on derived analysis sets. Labels were changed in order to align with recently published outcome studies and notations used by FDA.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nDeleted due to the change of the primary endpoint. \\\\\nChange 2: \\\\\nBP limit changed to \\(140 / 90 mmHg\\), to reflect BP treatment standards for the CARMELINA population. \\\\\nChange 3: \\\\\nInsulin treatment (with or without oral anti-diabetics) is considered the most important differentiator of antidiabetic treatment, while e.g. combination therapy of anti-diabetic drugs per se is not associated with a different risk for outcome events as compared to monotherapy (including insulin). \\\\\nChange 4: \\\\\nTo investigate the potential impact of impaired renal function on outcome events and renal endpoints \\\\\nChange 5: \\\\\nOnly randomized patients took study drug and therefore this statement is no longer required \\\\\nChange 6: \\\\\nSince only randomized patients took study drug, the TS is identical to the FAS and thus there is no impact on derived analysis sets. Labels were changed in order to align with recently published outcome studies and notations used by FDA.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9975600242614746,"confidence_rate":0.9999967606448135},{"cnt":[[939,902],[1089,902],[1089,946],[939,946]],"region":{"top_left_x":939,"top_left_y":902,"width":151,"height":44},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"620eff1fa4914699a2b1364d0ef3893e","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,943],[1651,943],[1651,987],[939,987]],"region":{"top_left_x":939,"top_left_y":943,"width":712,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d20d2e2ed26d4b75a96d8306bf14c4d9","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Deleted due to the change of the primary endpoint.","text_display":"\nDeleted due to the change of the primary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[939,1022],[1089,1022],[1089,1065],[939,1065]],"region":{"top_left_x":939,"top_left_y":1021,"width":151,"height":45},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a48c926e25fe4bbea27e4b0b51982694","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Change 2:","text_display":"\nChange 2:","confidence":1,"confidence_rate":1},{"cnt":[[939,1063],[1628,1063],[1628,1107],[939,1107]],"region":{"top_left_x":939,"top_left_y":1063,"width":689,"height":44},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2753d30d61d24cfb8e0171de535921be","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"BP limit changed to \\(140 / 90 mmHg\\), to reflect BP","text_display":"\nBP limit changed to \\(140 / 90 mmHg\\), to reflect BP","confidence":0.9975600242614746,"confidence_rate":0.9999571420178975},{"cnt":[[939,1105],[1697,1105],[1697,1146],[939,1146]],"region":{"top_left_x":939,"top_left_y":1104,"width":758,"height":43},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f595090e87949658cb267327edb934e","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"treatment standards for the CARMELINA population.","text_display":" treatment standards for the CARMELINA population.","confidence":1,"confidence_rate":1},{"cnt":[[939,1183],[1089,1183],[1089,1224],[939,1224]],"region":{"top_left_x":939,"top_left_y":1182,"width":151,"height":43},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"808929a18aba47048ce0d2e44d5abf9c","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Change 3:","text_display":"\nChange 3:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,1224],[1720,1224],[1720,1264],[939,1264]],"region":{"top_left_x":939,"top_left_y":1224,"width":781,"height":40},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec10dc2dd95c4985a195c7873281eac3","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Insulin treatment (with or without oral anti-diabetics) is","text_display":"\nInsulin treatment (with or without oral anti-diabetics) is","confidence":1,"confidence_rate":1},{"cnt":[[939,1261],[1669,1261],[1669,1305],[939,1305]],"region":{"top_left_x":939,"top_left_y":1261,"width":731,"height":44},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7bf74eea64f748cebde536b2058555f2","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"considered the most important differentiator of anti-","text_display":" considered the most important differentiator of anti","confidence":1,"confidence_rate":1},{"cnt":[[939,1303],[1688,1303],[1688,1346],[939,1346]],"region":{"top_left_x":939,"top_left_y":1302,"width":749,"height":45},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c6983c1f534472fa1e1de0a5054db78","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"diabetic treatment, while e.g. combination therapy of","text_display":"diabetic treatment, while e.g. combination therapy of","confidence":1,"confidence_rate":1},{"cnt":[[939,1344],[1628,1344],[1628,1383],[939,1383]],"region":{"top_left_x":939,"top_left_y":1344,"width":689,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"93d8044228444790b7d5575dec2be386","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"anti-diabetic drugs per se is not associated with a","text_display":" anti-diabetic drugs per se is not associated with a","confidence":1,"confidence_rate":1},{"cnt":[[939,1383],[1621,1383],[1621,1425],[939,1425]],"region":{"top_left_x":939,"top_left_y":1383,"width":682,"height":42},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d1b2822f39f450cad31ed06c2a2901b","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"different risk for outcome events as compared to","text_display":" different risk for outcome events as compared to","confidence":1,"confidence_rate":1},{"cnt":[[939,1422],[1402,1422],[1402,1466],[939,1466]],"region":{"top_left_x":939,"top_left_y":1422,"width":464,"height":45},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fac79a2a11e04f3fbc471c65b0d9443e","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"monotherapy (including insulin).","text_display":" monotherapy (including insulin).","confidence":1,"confidence_rate":1},{"cnt":[[939,1501],[1089,1501],[1089,1544],[939,1544]],"region":{"top_left_x":939,"top_left_y":1500,"width":151,"height":45},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ac8da61d3c24dabbb58f5989012ab29","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Change 4:","text_display":"\nChange 4:","confidence":1,"confidence_rate":1},{"cnt":[[939,1542],[1676,1542],[1676,1586],[939,1586]],"region":{"top_left_x":939,"top_left_y":1542,"width":738,"height":44},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa9fd39520c84002aa0978e9e5c48feb","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"To investigate the potential impact of impaired renal","text_display":"\nTo investigate the potential impact of impaired renal","confidence":1,"confidence_rate":1},{"cnt":[[939,1584],[1614,1584],[1614,1627],[939,1627]],"region":{"top_left_x":939,"top_left_y":1583,"width":675,"height":45},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"26da455c7c59488981a3475c94b3acc4","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"function on outcome events and renal endpoints","text_display":" function on outcome events and renal endpoints","confidence":1,"confidence_rate":1},{"cnt":[[939,1662],[1089,1662],[1089,1706],[939,1706]],"region":{"top_left_x":939,"top_left_y":1661,"width":151,"height":45},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9881b24be30d492b92528ade58c0d1e1","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Change 5:","text_display":"\nChange 5:","confidence":1,"confidence_rate":1},{"cnt":[[939,1703],[1725,1703],[1725,1742],[939,1742]],"region":{"top_left_x":939,"top_left_y":1703,"width":786,"height":40},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd6da775e22d41c8aea51d988a72f31c","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Only randomized patients took study drug and therefore","text_display":"\nOnly randomized patients took study drug and therefore","confidence":1,"confidence_rate":1},{"cnt":[[939,1740],[1437,1740],[1437,1784],[939,1784]],"region":{"top_left_x":939,"top_left_y":1740,"width":498,"height":44},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6c6c83f999b47769fb35fe120dbe4dc","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"this statement is no longer required","text_display":" this statement is no longer required","confidence":1,"confidence_rate":1},{"cnt":[[939,1818],[1089,1818],[1089,1862],[939,1862]],"region":{"top_left_x":939,"top_left_y":1818,"width":151,"height":45},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"edde878aa0f3499dba781ae6dfa19428","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Change 6:","text_display":"\nChange 6:","confidence":1,"confidence_rate":1},{"cnt":[[939,1860],[1750,1860],[1750,1904],[939,1904]],"region":{"top_left_x":939,"top_left_y":1859,"width":811,"height":45},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c15471b7ad342ed829087c41910def2","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"Since only randomized patients took study drug, the TS is","text_display":"\nSince only randomized patients took study drug, the TS is","confidence":1,"confidence_rate":1},{"cnt":[[939,1901],[1651,1901],[1651,1945],[939,1945]],"region":{"top_left_x":939,"top_left_y":1901,"width":712,"height":45},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92cbd5d531e74b9e8f25cee9410a79bc","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"identical to the FAS and thus there is no impact on","text_display":" identical to the FAS and thus there is no impact on","confidence":1,"confidence_rate":1},{"cnt":[[939,1943],[1697,1943],[1697,1982],[939,1982]],"region":{"top_left_x":939,"top_left_y":1942,"width":758,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ddb965ab4cc4332a1153b10a64b6d68","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"derived analysis sets. Labels were changed in order to","text_display":" derived analysis sets. Labels were changed in order to","confidence":1,"confidence_rate":1},{"cnt":[[939,1980],[1646,1980],[1646,2023],[939,2023]],"region":{"top_left_x":939,"top_left_y":1979,"width":708,"height":45},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b05be7b8ef94ede9fa5331661aa9498","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"align with recently published outcome studies and","text_display":" align with recently published outcome studies and","confidence":1,"confidence_rate":1},{"cnt":[[939,2021],[1278,2021],[1278,2065],[939,2065]],"region":{"top_left_x":939,"top_left_y":2021,"width":339,"height":44},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9854e214f7234ab8b51953127ff3e6ca","type":"text","conversion_output":false,"parent_id":"76c7546e1148453a85d9c8eb5eb7fd5b","text":"notations used by FDA.","text_display":" notations used by FDA.","confidence":1,"confidence_rate":1},{"cnt":[[265,2062],[596,2062],[596,2106],[265,2106]],"region":{"top_left_x":264,"top_left_y":2062,"width":333,"height":45},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"656691f4a95c42d881492193a7c0bbf8","type":"simple_cell","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2062],[1315,2062],[1315,2106],[939,2106]],"region":{"top_left_x":939,"top_left_y":2062,"width":376,"height":45},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"369e133628e94918963236b64c0c3a7b","type":"simple_cell","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"7.3.2 Secondary analyses","text_display":"7.3.2 Secondary analyses","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,2113],[596,2113],[596,2159],[262,2159]],"region":{"top_left_x":262,"top_left_y":2113,"width":335,"height":47},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"887bcee8625c4d20b56d8aa1527d46e1","type":"simple_cell","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[930,2132],[1750,2132],[1750,2539],[930,2539]],"region":{"top_left_x":930,"top_left_y":2131,"width":820,"height":409},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"59278363af15475d9f220f3b8cc226da","type":"complex_cell","conversion_output":false,"parent_id":"3ab8b6d12b994fcfae31fe0a5018538f","children_ids":["0b79fc3a330541528d22b124f3907b68","e26a601280474d89b83b4d81066278c4","1e79b180c61a46a2a3c18958031cb172","77bf2611884f4033af8841d644c75749","adb48e713e9942c4a2bfaec0b30e9417","4d1aee95cf11423490c9a7461ea6f065","4c617ec5a4cc4f66a78a3a74c3fd676d","0222e066e1da47c29fbe758be70cf78b","6c3b619d7a844f9cb5d27e405da546a9"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of \\(40 \\%\\) or more in eGFR). \\\\\nIn addition: \\\\\nAfter non-inferiority has been established for the primary\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nThe key secondary endpoints were changed from 3-point MACE and composite renal endpoint (renal death, sustained ESRD, sustained decrease of 50\\% or more in eGFR) to composite renal endpoint (renal death, sustained ESRD, sustained decrease of \\(40 \\%\\) or more in eGFR). \\\\\nIn addition: \\\\\nAfter non-inferiority has been established for the primary\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.7021484375,"confidence_rate":0.9991041245702441},{"cnt":[[939,2136],[1089,2136],[1089,2175],[939,2175]],"region":{"top_left_x":939,"top_left_y":2136,"width":151,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b79fc3a330541528d22b124f3907b68","type":"text","conversion_output":false,"parent_id":"59278363af15475d9f220f3b8cc226da","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,2175],[1738,2175],[1738,2217],[939,2217]],"region":{"top_left_x":939,"top_left_y":2175,"width":800,"height":42},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e26a601280474d89b83b4d81066278c4","type":"text","conversion_output":false,"parent_id":"59278363af15475d9f220f3b8cc226da","text":"The key secondary endpoints were changed from 3-point","text_display":"\nThe key secondary endpoints were changed from 3-point","confidence":1,"confidence_rate":1},{"cnt":[[939,2214],[1646,2214],[1646,2258],[939,2258]],"region":{"top_left_x":939,"top_left_y":2214,"width":708,"height":45},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e79b180c61a46a2a3c18958031cb172","type":"text","conversion_output":false,"parent_id":"59278363af15475d9f220f3b8cc226da","text":"MACE and composite renal endpoint (renal death,","text_display":" MACE and composite renal endpoint (renal death,","confidence":1,"confidence_rate":1},{"cnt":[[939,2256],[1711,2256],[1711,2295],[939,2295]],"region":{"top_left_x":939,"top_left_y":2255,"width":772,"height":41},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77bf2611884f4033af8841d644c75749","type":"text","conversion_output":false,"parent_id":"59278363af15475d9f220f3b8cc226da","text":"sustained ESRD, sustained decrease of 50\\% or more in","text_display":" sustained ESRD, sustained decrease of 50\\% or more in","confidence":0.8857421875,"confidence_rate":0.9978736786469701},{"cnt":[[939,2295],[1619,2295],[1619,2336],[939,2336]],"region":{"top_left_x":939,"top_left_y":2295,"width":680,"height":42},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"adb48e713e9942c4a2bfaec0b30e9417","type":"text","conversion_output":false,"parent_id":"59278363af15475d9f220f3b8cc226da","text":"eGFR) to composite renal endpoint (renal death,","text_display":" eGFR) to composite renal endpoint (renal death,","confidence":1,"confidence_rate":1},{"cnt":[[939,2334],[1711,2334],[1711,2378],[939,2378]],"region":{"top_left_x":939,"top_left_y":2334,"width":772,"height":44},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d1aee95cf11423490c9a7461ea6f065","type":"text","conversion_output":false,"parent_id":"59278363af15475d9f220f3b8cc226da","text":"sustained ESRD, sustained decrease of \\(40 \\%\\) or more in","text_display":" sustained ESRD, sustained decrease of \\(40 \\%\\) or more in","confidence":0.7021484375,"confidence_rate":0.9941238251837307},{"cnt":[[939,2376],[1048,2376],[1048,2417],[939,2417]],"region":{"top_left_x":939,"top_left_y":2375,"width":109,"height":43},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c617ec5a4cc4f66a78a3a74c3fd676d","type":"text","conversion_output":false,"parent_id":"59278363af15475d9f220f3b8cc226da","text":"eGFR).","text_display":" eGFR).","confidence":0.99951171875,"confidence_rate":0.9999556009403848},{"cnt":[[939,2454],[1107,2454],[1107,2493],[939,2493]],"region":{"top_left_x":939,"top_left_y":2453,"width":169,"height":41},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0222e066e1da47c29fbe758be70cf78b","type":"text","conversion_output":false,"parent_id":"59278363af15475d9f220f3b8cc226da","text":"In addition:","text_display":"\nIn addition:","confidence":1,"confidence_rate":1},{"cnt":[[937,2495],[1743,2495],[1743,2537],[937,2537]],"region":{"top_left_x":937,"top_left_y":2495,"width":806,"height":42},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c3b619d7a844f9cb5d27e405da546a9","type":"text","conversion_output":false,"parent_id":"59278363af15475d9f220f3b8cc226da","text":"After non-inferiority has been established for the primary","text_display":"\nAfter non-inferiority has been established for the primary","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":65,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"03f4b587de5c403f92e77dbae3936598","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":66,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"8f2cde16d5b44e71a2501f0a7b0b48c5","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1766,2664],[1766,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1470,"height":40},"line":67,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e9c662ca3b7847e1af349a04244c29e0","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-118","page":118,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b661b9c2bd7422a95d12ef66ad214fe","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,121],[1816,121],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":121,"width":314,"height":39},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec40e587b06643e28b8aa77c7a2a92b6","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd456a56f11444d5baa6a4e31616cb9a","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50008c4847504cb5801a4d865ba8aba5","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff04966986074f6fafaea89d4ac0e5c4","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,206],[1816,206],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":205,"width":264,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d66275c2b2844aa7ac7faef244c1abab","type":"page_info","conversion_output":false,"text":"Page 118 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2570],[244,2570]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2239},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e64f5c7e434d4e7792e03b0b52f53362","type":"table","conversion_output":true,"children_ids":["9b125f3a1a704327a2969a807e971eed","69493f0886c24542a69aaf0378090a09","859a550afc064203ad7025cb95978041","6d292037320c43299d2b23e3f8a680c4"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nendpoint (4-point MACE), the same endpoint and the composite renal endpoint (at the final analysis) will be tested for superiority. In case of significant superiority of the 4-point MACE and/or the composite renal endpoint, the 3-point MACE will then be tested for superiority. \\\\\nWas changed into: \\\\\nAfter non-inferiority has been established for the primary endpoint (3-point MACE), the same endpoint and the composite renal endpoint will be tested for superiority.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nendpoint (4-point MACE), the same endpoint and the composite renal endpoint (at the final analysis) will be tested for superiority. In case of significant superiority of the 4-point MACE and/or the composite renal endpoint, the 3-point MACE will then be tested for superiority. \\\\\nWas changed into: \\\\\nAfter non-inferiority has been established for the primary endpoint (3-point MACE), the same endpoint and the composite renal endpoint will be tested for superiority.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.951171875,"confidence_rate":0.999887022696707},{"cnt":[[244,331],[833,331],[833,2567],[244,2567]],"region":{"top_left_x":244,"top_left_y":331,"width":590,"height":2236},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b125f3a1a704327a2969a807e971eed","type":"table_column","conversion_output":false,"parent_id":"e64f5c7e434d4e7792e03b0b52f53362","text":"","text_display":""},{"cnt":[[928,2567],[930,330],[1766,331],[1764,2568]],"region":{"top_left_x":927,"top_left_y":330,"width":840,"height":2238},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69493f0886c24542a69aaf0378090a09","type":"table_column","conversion_output":false,"parent_id":"e64f5c7e434d4e7792e03b0b52f53362","text":"","text_display":""},{"cnt":[[242,333],[1775,328],[1777,798],[244,803]],"region":{"top_left_x":242,"top_left_y":328,"width":1535,"height":476},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"859a550afc064203ad7025cb95978041","type":"table_row","conversion_output":false,"parent_id":"e64f5c7e434d4e7792e03b0b52f53362","text":"","text_display":""},{"cnt":[[932,336],[1752,336],[1752,789],[932,789]],"region":{"top_left_x":932,"top_left_y":335,"width":821,"height":455},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d292037320c43299d2b23e3f8a680c4","type":"complex_cell","conversion_output":false,"parent_id":"e64f5c7e434d4e7792e03b0b52f53362","children_ids":["788434538c2943bdb4ab6a0df9159a5d","637cf1a28a0746a3bab8256841817c64","ea7fc33dd6f040099d297051d4571fb8","ae572f405c73486f90fee01183d52f32","d44c0909513c43db9a56d83878a27bc1","ad22a942cf8e4a609fafd4909dc64080","a80af2c2780e4f1aba3f15d87b1d32d6","22388c6c66244ae5a3390cd1c0c9c1f3","4414d52b37cc4c2e8ca927e66718f56e"],"text":"\\begin{tabular}{l}\nendpoint (4-point MACE), the same endpoint and the composite renal endpoint (at the final analysis) will be tested for superiority. In case of significant superiority of the 4-point MACE and/or the composite renal endpoint, the 3-point MACE will then be tested for superiority. \\\\\nWas changed into: \\\\\nAfter non-inferiority has been established for the primary endpoint (3-point MACE), the same endpoint and the composite renal endpoint will be tested for superiority.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nendpoint (4-point MACE), the same endpoint and the composite renal endpoint (at the final analysis) will be tested for superiority. In case of significant superiority of the 4-point MACE and/or the composite renal endpoint, the 3-point MACE will then be tested for superiority. \\\\\nWas changed into: \\\\\nAfter non-inferiority has been established for the primary endpoint (3-point MACE), the same endpoint and the composite renal endpoint will be tested for superiority.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.951171875,"confidence_rate":0.999887022696707},{"cnt":[[939,340],[1690,340],[1690,379],[939,379]],"region":{"top_left_x":939,"top_left_y":340,"width":751,"height":40},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"788434538c2943bdb4ab6a0df9159a5d","type":"text","conversion_output":false,"parent_id":"6d292037320c43299d2b23e3f8a680c4","text":"endpoint (4-point MACE), the same endpoint and the","text_display":"endpoint (4-point MACE), the same endpoint and the","confidence":0.99658203125,"confidence_rate":0.9999377506039459},{"cnt":[[939,379],[1701,379],[1701,421],[939,421]],"region":{"top_left_x":939,"top_left_y":379,"width":763,"height":42},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"637cf1a28a0746a3bab8256841817c64","type":"text","conversion_output":false,"parent_id":"6d292037320c43299d2b23e3f8a680c4","text":"composite renal endpoint (at the final analysis) will be","text_display":" composite renal endpoint (at the final analysis) will be","confidence":1,"confidence_rate":1},{"cnt":[[939,418],[1743,418],[1743,462],[939,462]],"region":{"top_left_x":939,"top_left_y":418,"width":804,"height":45},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea7fc33dd6f040099d297051d4571fb8","type":"text","conversion_output":false,"parent_id":"6d292037320c43299d2b23e3f8a680c4","text":"tested for superiority. In case of significant superiority of","text_display":" tested for superiority. In case of significant superiority of","confidence":1,"confidence_rate":1},{"cnt":[[939,460],[1722,460],[1722,501],[939,501]],"region":{"top_left_x":939,"top_left_y":459,"width":784,"height":43},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae572f405c73486f90fee01183d52f32","type":"text","conversion_output":false,"parent_id":"6d292037320c43299d2b23e3f8a680c4","text":"the 4-point MACE and/or the composite renal endpoint,","text_display":" the 4-point MACE and/or the composite renal endpoint,","confidence":1,"confidence_rate":1},{"cnt":[[939,501],[1683,501],[1683,541],[939,541]],"region":{"top_left_x":939,"top_left_y":501,"width":745,"height":40},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d44c0909513c43db9a56d83878a27bc1","type":"text","conversion_output":false,"parent_id":"6d292037320c43299d2b23e3f8a680c4","text":"the 3-point MACE will then be tested for superiority.","text_display":" the 3-point MACE will then be tested for superiority.","confidence":1,"confidence_rate":1},{"cnt":[[939,580],[1213,580],[1213,623],[939,623]],"region":{"top_left_x":939,"top_left_y":579,"width":275,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad22a942cf8e4a609fafd4909dc64080","type":"text","conversion_output":false,"parent_id":"6d292037320c43299d2b23e3f8a680c4","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.9990234375,"confidence_rate":0.9999555900930661},{"cnt":[[939,663],[1743,663],[1743,702],[939,702]],"region":{"top_left_x":939,"top_left_y":662,"width":804,"height":40},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a80af2c2780e4f1aba3f15d87b1d32d6","type":"text","conversion_output":false,"parent_id":"6d292037320c43299d2b23e3f8a680c4","text":"After non-inferiority has been established for the primary","text_display":"\nAfter non-inferiority has been established for the primary","confidence":1,"confidence_rate":1},{"cnt":[[939,702],[1688,702],[1688,743],[939,743]],"region":{"top_left_x":939,"top_left_y":701,"width":749,"height":43},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22388c6c66244ae5a3390cd1c0c9c1f3","type":"text","conversion_output":false,"parent_id":"6d292037320c43299d2b23e3f8a680c4","text":"endpoint (3-point MACE), the same endpoint and the","text_display":" endpoint (3-point MACE), the same endpoint and the","confidence":0.951171875,"confidence_rate":0.999090223153461},{"cnt":[[939,741],[1706,741],[1706,782],[939,782]],"region":{"top_left_x":939,"top_left_y":740,"width":768,"height":43},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4414d52b37cc4c2e8ca927e66718f56e","type":"text","conversion_output":false,"parent_id":"6d292037320c43299d2b23e3f8a680c4","text":"composite renal endpoint will be tested for superiority.","text_display":" composite renal endpoint will be tested for superiority.","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":21,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d841153b1400429cbdc8be70a215139b","type":"section_header","conversion_output":false,"children_ids":["dfdccd650b0f4f6397a9ecb56f415422"],"text":"","text_display":""},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":22,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"dfdccd650b0f4f6397a9ecb56f415422","type":"text","conversion_output":true,"parent_id":"d841153b1400429cbdc8be70a215139b","text":"Proprietary confidential information.","text_display":"\n\n\\section*{Proprietary confidential information.}","confidence":0.9970703125,"confidence_rate":0.999930145596247},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":23,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"502f568ad7174ad5a4538cd165dfa54e","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":24,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"309a0e7d3c454b50b4d37a381d617198","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-119","page":119,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"954ee1c0bb1944d1bb9deed4a457d9c2","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,117],[1816,160],[1503,162]],"region":{"top_left_x":1502,"top_left_y":116,"width":315,"height":47},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3623f609f04848b5806ab9946300d0ad","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4823e8efb35a4453aa785512c2b21190","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[637,208],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":396,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e2386956fe0482b846e2eb79f10a32c","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd1c7f7c53d94a18b6fce81a79343ecc","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1901a6f0b69e4c0fae106c0690c863ed","type":"page_info","conversion_output":false,"text":"Page 119 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1777,331],[1777,2554],[242,2554]],"region":{"top_left_x":242,"top_left_y":331,"width":1536,"height":2223},"line":7,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3ab08d6677564155918ae0cc04c26688","type":"page_info","conversion_output":false,"text":"\\begin{tabular}{|l|l|l|}\n\\hline & & \\\\\n& & \\\\\n\\hline\n\\end{tabular}","text_display":"","confidence":0.5839135751549642,"confidence_rate":0.9838290764191377},{"cnt":[[790,2584],[1300,2584],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2583,"width":510,"height":38},"line":8,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2e1c9d9958bf4a3395526e0ccf3a1de7","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99609375,"confidence_rate":0.9999068162627995},{"cnt":[[292,2620],[1798,2620],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2620,"width":1506,"height":42},"line":9,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3b49920721b1439a94231235bc432fde","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999876814398867},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1e99385841794786b5ac67a2bdb6fce4","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-120","page":120,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c4310bf9ee31452cafc65f2160457e1f","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,121],[1816,121],[1816,160],[1503,160]],"region":{"top_left_x":1503,"top_left_y":121,"width":314,"height":39},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7c1dc61ca3844589c7fa509ed1c77df","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef0d77dd20a9469e927f87a416cfb80f","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,208],[637,208],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":207,"width":396,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4bbd4b16bcd4fc8b0ac581d0d80a44b","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae0f1a90a5be4a5a9d590af8c73464b3","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc2e0ebfbac048449e8448a221ad1d3d","type":"page_info","conversion_output":false,"text":"Page 120 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,331],[1012,331],[1012,2549],[242,2549]],"region":{"top_left_x":242,"top_left_y":331,"width":770,"height":2219},"line":7,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"60e7529ec66248fbb8b296f819608956","type":"diagram","conversion_output":true,"text":"","text_display":"\n![](https://cdn.mathpix.com/cropped/eb2f265e-249c-4fb0-ae0a-f82484d8e575-120.jpg?height=2219&width=770&top_left_y=331&top_left_x=242)"},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":8,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"aa8b0c322dd442d2823885fceeae52d3","type":"page_info","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2620],[1798,2620],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2620,"width":1506,"height":42},"line":9,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2c71cc84fd224029b1d2f340125e8fcd","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999876814398867},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":10,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c5d651d707544f52bb56d75b0611a7ef","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-121","page":121,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"420dafef5e5040c99a9344a769fffe84","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9dcc574f87704b7dbbc53236370390d0","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,164],[599,164],[599,203],[244,203]],"region":{"top_left_x":244,"top_left_y":164,"width":355,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72a528d8adb44af9ba4ab2878c763759","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,210],[637,210],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":210,"width":396,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f310248ee6c240ed88e65ac6ba40ae96","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12b1e26ec09247d5bcc6e6ee09d605d5","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,206],[1816,206],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":205,"width":264,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b4bf073b7e24c62a3959a590e5f709d","type":"page_info","conversion_output":false,"text":"Page 121 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,331],[1775,331],[1775,2570],[244,2570]],"region":{"top_left_x":244,"top_left_y":331,"width":1531,"height":2239},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5efae66f0a564d79aee311712e286669","type":"table","conversion_output":true,"children_ids":["caa443829edb45a6be6d99bf8f7af342","5cd7277f26db412d8c33a326e62350da","5cdb9e9e79a34020b68daac9abf0b1a4","ff5a352b94c446caa94127fe000fe27c","34d683e1ba00474db7edeb2244576130","68202ea76d0740a5a49f308213c07a25","858a2696defb46d885f5fdf0edb2d68e","1b0abc273df84af88cd6c8cc2d7145e0","a045614663a14d10874c005f4560b37a","2a333bc98ff0453faf1f18456eb08a45","8fa56265ba094add81326e7b13fdfe24","31e5feb75ec44f2db99825bcc2fcf197","85f901b2e4224e03a7d4b955478f8119","b3888c5a64b64d1d8c6202c615cc972b","6de1d75388a94c8d82eb90777d124525","fe320a56b817492582fe080c7f6f20c0","732f2371bef54cf8b4c0e2803bea072d","85e8f183ca504a72beb9e5c37ea8520a","bc362550b37f4232ab54ec13b03b955a","03d27e5f8934401ba4f0b271bc62800e","c3bfbe2cb75b4e3286a105433f014881"],"selected_labels":["97fd03b57da34d86988b3cba79a2d662"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 3: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.3.4 Interim analyses \\\\\n\\hline Description of the change & Interim analyses removed \\\\\n\\hline Rationale for change & Based on observed event rates, the time interval between interim and final analyses is estimated to be around nine months. This time interval is too short to make meaningful differences to trial conduct, especially as the overall objective is to ensure adequate exposure to study drugs to characterise cardiovascular, renal and overall safety profile \\\\\n\\hline Section to be changed & 7.6 Determination of sample size \\\\\n\\hline Description of change & Assuming the hazard over time in patients on linagliptin is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\) linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 625 patients with events will deliver an overall power of \\(90 \\%\\) in a test to demonstrate \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\begin{tabular}{|l|l|}\n\\hline & \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 3: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 7.3.4 Interim analyses \\\\\n\\hline Description of the change & Interim analyses removed \\\\\n\\hline Rationale for change & Based on observed event rates, the time interval between interim and final analyses is estimated to be around nine months. This time interval is too short to make meaningful differences to trial conduct, especially as the overall objective is to ensure adequate exposure to study drugs to characterise cardiovascular, renal and overall safety profile \\\\\n\\hline Section to be changed & 7.6 Determination of sample size \\\\\n\\hline Description of change & Assuming the hazard over time in patients on linagliptin is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\) linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 625 patients with events will deliver an overall power of \\(90 \\%\\) in a test to demonstrate \\\\\n\\hline\n\\end{tabular}\n\\captionsetup{labelformat=empty}\n\\caption{Proprietary confidential information.}\n\\end{table}","confidence":0.9176730439030507,"confidence_rate":0.9999672081678593},{"cnt":[[249,331],[656,331],[656,2569],[249,2569]],"region":{"top_left_x":248,"top_left_y":331,"width":409,"height":2239},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"caa443829edb45a6be6d99bf8f7af342","type":"table_column","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"","text_display":""},{"cnt":[[930,331],[1768,331],[1768,2569],[930,2569]],"region":{"top_left_x":930,"top_left_y":331,"width":839,"height":2239},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cd7277f26db412d8c33a326e62350da","type":"table_column","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"","text_display":""},{"cnt":[[244,331],[1771,331],[1771,891],[244,891]],"region":{"top_left_x":244,"top_left_y":331,"width":1527,"height":560},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cdb9e9e79a34020b68daac9abf0b1a4","type":"table_row","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"","text_display":""},{"cnt":[[244,886],[1775,886],[1775,1966],[244,1966]],"region":{"top_left_x":244,"top_left_y":885,"width":1532,"height":1081},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff5a352b94c446caa94127fe000fe27c","type":"table_row","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"","text_display":""},{"cnt":[[244,1966],[1775,1966],[1775,2014],[244,2014]],"region":{"top_left_x":244,"top_left_y":1965,"width":1532,"height":50},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34d683e1ba00474db7edeb2244576130","type":"table_row","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"","text_display":""},{"cnt":[[244,2019],[1775,2019],[1775,2065],[244,2065]],"region":{"top_left_x":244,"top_left_y":2018,"width":1532,"height":47},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68202ea76d0740a5a49f308213c07a25","type":"table_row","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"","text_display":""},{"cnt":[[244,2067],[1775,2067],[1775,2355],[244,2355]],"region":{"top_left_x":244,"top_left_y":2067,"width":1532,"height":288},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"858a2696defb46d885f5fdf0edb2d68e","type":"table_row","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"","text_display":""},{"cnt":[[244,2353],[1775,2353],[1775,2396],[244,2396]],"region":{"top_left_x":244,"top_left_y":2352,"width":1532,"height":45},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b0abc273df84af88cd6c8cc2d7145e0","type":"table_row","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"","text_display":""},{"cnt":[[244,2401],[1775,2401],[1775,2567],[244,2567]],"region":{"top_left_x":244,"top_left_y":2400,"width":1532,"height":167},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a045614663a14d10874c005f4560b37a","type":"table_row","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"","text_display":""},{"cnt":[[264,930],[265,888],[583,891],[582,932]],"region":{"top_left_x":264,"top_left_y":888,"width":319,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a333bc98ff0453faf1f18456eb08a45","type":"simple_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,888],[1761,888],[1761,1963],[935,1963]],"region":{"top_left_x":934,"top_left_y":888,"width":828,"height":1076},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fa56265ba094add81326e7b13fdfe24","type":"complex_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","children_ids":["3d2a82d9ed4943629a295b20745b3dfa","38eb696c2cd04dd39d93676122731cdc","2201d34dadbe416e95aa0a4982fd5e3e","9d7510618415493392cd1645f9456649","8546f4950911460f832322894414a080","0cfaf6c0b812429b8ae6a36d41166a14","f8255b1859a54b949dd14a99c3f04488","70f78660ddeb4390a246ba762af15b44","4ebee6bce72d484b8e4086bb72ba3b64","59b16a704ec84c21ae39ff1cd8d430f6","bdf2adbd5dac4527ba92f5e6352cdefb","1b81e7dca9604ceb8ea2aba85e80e335","28efe7a041a14d63981788fba5541570","cd020edf9bb540479833d0095e03edf5","bc5ea03a037542d3bc8a91232af9f3e0","1d65282acc1a43c89a60e3397685454d"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 3: \\\\\nFor clarification\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nBased on review of recently published cardiovascular outcome trials, changing the protocol definitions of the primary and secondary endpoints, essentially substituting 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction and Hospitalization for Unstable Angina) with 3-Point MACE (CV Death, Non-Fatal Stoke, Non-fatal Myocardial Infarction). \\\\\neGFR cut off changed in response to the NIH/FDA scientific workshop on GFR decline as an endpoint for clinical trials in CKD and the current clinical landscape on decline in estimated glomerular filtration rate and subsequent risk of end stage renal disease and mortality. \\\\\nChange 3: \\\\\nFor clarification\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999915538547862},{"cnt":[[939,893],[1089,893],[1089,930],[939,930]],"region":{"top_left_x":939,"top_left_y":892,"width":151,"height":38},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d2a82d9ed4943629a295b20745b3dfa","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,930],[1690,930],[1690,969],[939,969]],"region":{"top_left_x":939,"top_left_y":929,"width":751,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38eb696c2cd04dd39d93676122731cdc","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"Based on review of recently published cardiovascular","text_display":"\nBased on review of recently published cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[939,971],[1711,971],[1711,1010],[939,1010]],"region":{"top_left_x":939,"top_left_y":971,"width":772,"height":40},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2201d34dadbe416e95aa0a4982fd5e3e","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"outcome trials, changing the protocol definitions of the","text_display":" outcome trials, changing the protocol definitions of the","confidence":1,"confidence_rate":1},{"cnt":[[939,1008],[1743,1008],[1743,1049],[939,1049]],"region":{"top_left_x":939,"top_left_y":1007,"width":804,"height":43},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d7510618415493392cd1645f9456649","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"primary and secondary endpoints, essentially substituting","text_display":" primary and secondary endpoints, essentially substituting","confidence":0.99951171875,"confidence_rate":0.999992122603638},{"cnt":[[939,1049],[1720,1049],[1720,1089],[939,1089]],"region":{"top_left_x":939,"top_left_y":1049,"width":781,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8546f4950911460f832322894414a080","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"4-Point MACE (Cardiovascular (CV) Death, Non-Fatal","text_display":" 4-Point MACE (Cardiovascular (CV) Death, Non-Fatal","confidence":1,"confidence_rate":1},{"cnt":[[939,1091],[1547,1091],[1547,1130],[939,1130]],"region":{"top_left_x":939,"top_left_y":1090,"width":609,"height":40},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0cfaf6c0b812429b8ae6a36d41166a14","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"Stoke, Non-fatal Myocardial Infarction and","text_display":" Stoke, Non-fatal Myocardial Infarction and","confidence":1,"confidence_rate":1},{"cnt":[[939,1130],[1752,1128],[1752,1168],[939,1170]],"region":{"top_left_x":939,"top_left_y":1127,"width":814,"height":44},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8255b1859a54b949dd14a99c3f04488","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"Hospitalization for Unstable Angina) with 3-Point MACE","text_display":" Hospitalization for Unstable Angina) with 3-Point MACE","confidence":1,"confidence_rate":1},{"cnt":[[939,1169],[1665,1169],[1665,1208],[939,1208]],"region":{"top_left_x":939,"top_left_y":1169,"width":726,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70f78660ddeb4390a246ba762af15b44","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"(CV Death, Non-Fatal Stoke, Non-fatal Myocardial","text_display":" (CV Death, Non-Fatal Stoke, Non-fatal Myocardial","confidence":1,"confidence_rate":1},{"cnt":[[939,1211],[1103,1211],[1103,1247],[939,1247]],"region":{"top_left_x":939,"top_left_y":1210,"width":164,"height":38},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ebee6bce72d484b8e4086bb72ba3b64","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"Infarction).","text_display":" Infarction).","confidence":0.9990234375,"confidence_rate":0.9999425287310763},{"cnt":[[939,1247],[1655,1247],[1655,1289],[939,1289]],"region":{"top_left_x":939,"top_left_y":1247,"width":717,"height":42},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"59b16a704ec84c21ae39ff1cd8d430f6","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"eGFR cut off changed in response to the NIH/FDA","text_display":"\neGFR cut off changed in response to the NIH/FDA","confidence":1,"confidence_rate":1},{"cnt":[[939,1289],[1708,1289],[1708,1328],[939,1328]],"region":{"top_left_x":939,"top_left_y":1288,"width":770,"height":40},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bdf2adbd5dac4527ba92f5e6352cdefb","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"scientific workshop on GFR decline as an endpoint for","text_display":" scientific workshop on GFR decline as an endpoint for","confidence":1,"confidence_rate":1},{"cnt":[[939,1330],[1720,1330],[1720,1369],[939,1369]],"region":{"top_left_x":939,"top_left_y":1330,"width":781,"height":40},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b81e7dca9604ceb8ea2aba85e80e335","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"clinical trials in CKD and the current clinical landscape","text_display":" clinical trials in CKD and the current clinical landscape","confidence":1,"confidence_rate":1},{"cnt":[[939,1372],[1678,1372],[1678,1411],[939,1411]],"region":{"top_left_x":939,"top_left_y":1371,"width":740,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"28efe7a041a14d63981788fba5541570","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"on decline in estimated glomerular filtration rate and","text_display":" on decline in estimated glomerular filtration rate and","confidence":1,"confidence_rate":1},{"cnt":[[939,1409],[1725,1409],[1725,1448],[939,1448]],"region":{"top_left_x":939,"top_left_y":1408,"width":786,"height":40},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd020edf9bb540479833d0095e03edf5","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"subsequent risk of end stage renal disease and mortality.","text_display":" subsequent risk of end stage renal disease and mortality.","confidence":1,"confidence_rate":1},{"cnt":[[939,1887],[1087,1887],[1087,1927],[939,1927]],"region":{"top_left_x":939,"top_left_y":1887,"width":148,"height":40},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc5ea03a037542d3bc8a91232af9f3e0","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"Change 3:","text_display":"\nChange 3:","confidence":0.9990234375,"confidence_rate":0.9999302138888906},{"cnt":[[939,1929],[1172,1929],[1172,1963],[939,1963]],"region":{"top_left_x":939,"top_left_y":1928,"width":233,"height":36},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d65282acc1a43c89a60e3397685454d","type":"text","conversion_output":false,"parent_id":"8fa56265ba094add81326e7b13fdfe24","text":"For clarification","text_display":"\nFor clarification","confidence":1,"confidence_rate":1},{"cnt":[[267,1970],[592,1970],[592,2010],[267,2010]],"region":{"top_left_x":267,"top_left_y":1970,"width":325,"height":40},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31e5feb75ec44f2db99825bcc2fcf197","type":"simple_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1970],[1269,1970],[1269,2010],[939,2010]],"region":{"top_left_x":939,"top_left_y":1970,"width":330,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85f901b2e4224e03a7d4b955478f8119","type":"simple_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"7.3.4 Interim analyses","text_display":"7.3.4 Interim analyses","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2021],[647,2021],[647,2065],[267,2065]],"region":{"top_left_x":267,"top_left_y":2021,"width":380,"height":44},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3888c5a64b64d1d8c6202c615cc972b","type":"simple_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"Description of the change","text_display":"Description of the change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2021],[1305,2021],[1305,2065],[939,2065]],"region":{"top_left_x":939,"top_left_y":2021,"width":367,"height":44},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6de1d75388a94c8d82eb90777d124525","type":"simple_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"Interim analyses removed","text_display":"Interim analyses removed","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2074],[582,2074],[582,2113],[267,2113]],"region":{"top_left_x":267,"top_left_y":2073,"width":316,"height":41},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fe320a56b817492582fe080c7f6f20c0","type":"simple_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"Rationale for change","text_display":"Rationale for change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,2072],[1750,2072],[1750,2353],[937,2353]],"region":{"top_left_x":937,"top_left_y":2071,"width":813,"height":282},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"732f2371bef54cf8b4c0e2803bea072d","type":"complex_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","children_ids":["ac4a925e2c5e4d208c4ecdcea0068420","38cd90b6030845e5a8abf0f41c5401fc","c1b86cbadab346938af60336f0a96e70","8022269200ca4df4b381557a5aa31a8b","1df980a914b743d8b52a7cd38b1fb2dd","44e534ba2e7642599126402c61867570","f922ea492d4a4bf981fefb2ccac4cfba"],"text":"Based on observed event rates, the time interval between interim and final analyses is estimated to be around nine months. This time interval is too short to make meaningful differences to trial conduct, especially as the overall objective is to ensure adequate exposure to study drugs to characterise cardiovascular, renal and overall safety profile","text_display":"Based on observed event rates, the time interval between interim and final analyses is estimated to be around nine months. This time interval is too short to make meaningful differences to trial conduct, especially as the overall objective is to ensure adequate exposure to study drugs to characterise cardiovascular, renal and overall safety profile","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2074],[1738,2074],[1738,2111],[939,2111]],"region":{"top_left_x":939,"top_left_y":2073,"width":800,"height":38},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac4a925e2c5e4d208c4ecdcea0068420","type":"text","conversion_output":false,"parent_id":"732f2371bef54cf8b4c0e2803bea072d","text":"Based on observed event rates, the time interval between","text_display":"Based on observed event rates, the time interval between","confidence":1,"confidence_rate":1},{"cnt":[[939,2113],[1729,2113],[1729,2152],[939,2152]],"region":{"top_left_x":939,"top_left_y":2113,"width":791,"height":40},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38cd90b6030845e5a8abf0f41c5401fc","type":"text","conversion_output":false,"parent_id":"732f2371bef54cf8b4c0e2803bea072d","text":"interim and final analyses is estimated to be around nine","text_display":" interim and final analyses is estimated to be around nine","confidence":1,"confidence_rate":1},{"cnt":[[939,2150],[1596,2150],[1596,2189],[939,2189]],"region":{"top_left_x":939,"top_left_y":2149,"width":657,"height":41},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1b86cbadab346938af60336f0a96e70","type":"text","conversion_output":false,"parent_id":"732f2371bef54cf8b4c0e2803bea072d","text":"months. This time interval is too short to make","text_display":" months. This time interval is too short to make","confidence":1,"confidence_rate":1},{"cnt":[[939,2191],[1729,2191],[1729,2233],[939,2233]],"region":{"top_left_x":939,"top_left_y":2191,"width":791,"height":42},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8022269200ca4df4b381557a5aa31a8b","type":"text","conversion_output":false,"parent_id":"732f2371bef54cf8b4c0e2803bea072d","text":"meaningful differences to trial conduct, especially as the","text_display":" meaningful differences to trial conduct, especially as the","confidence":1,"confidence_rate":1},{"cnt":[[939,2233],[1731,2233],[1731,2272],[939,2272]],"region":{"top_left_x":939,"top_left_y":2232,"width":793,"height":41},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1df980a914b743d8b52a7cd38b1fb2dd","type":"text","conversion_output":false,"parent_id":"732f2371bef54cf8b4c0e2803bea072d","text":"overall objective is to ensure adequate exposure to study","text_display":" overall objective is to ensure adequate exposure to study","confidence":1,"confidence_rate":1},{"cnt":[[939,2274],[1697,2274],[1697,2313],[939,2313]],"region":{"top_left_x":939,"top_left_y":2274,"width":758,"height":40},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44e534ba2e7642599126402c61867570","type":"text","conversion_output":false,"parent_id":"732f2371bef54cf8b4c0e2803bea072d","text":"drugs to characterise cardiovascular, renal and overall","text_display":" drugs to characterise cardiovascular, renal and overall","confidence":1,"confidence_rate":1},{"cnt":[[939,2311],[1130,2311],[1130,2350],[939,2350]],"region":{"top_left_x":939,"top_left_y":2311,"width":192,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f922ea492d4a4bf981fefb2ccac4cfba","type":"text","conversion_output":false,"parent_id":"732f2371bef54cf8b4c0e2803bea072d","text":"safety profile","text_display":" safety profile","confidence":1,"confidence_rate":1},{"cnt":[[265,2353],[592,2353],[592,2396],[265,2396]],"region":{"top_left_x":264,"top_left_y":2352,"width":328,"height":45},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"85e8f183ca504a72beb9e5c37ea8520a","type":"simple_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"Section to be changed","text_display":"Section to be changed","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2353],[1427,2353],[1427,2396],[939,2396]],"region":{"top_left_x":939,"top_left_y":2352,"width":489,"height":45},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc362550b37f4232ab54ec13b03b955a","type":"simple_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"7.6 Determination of sample size","text_display":"7.6 Determination of sample size","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,2406],[596,2406],[596,2447],[267,2447]],"region":{"top_left_x":267,"top_left_y":2405,"width":330,"height":43},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03d27e5f8934401ba4f0b271bc62800e","type":"simple_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","text":"Description of change","text_display":"Description of change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2403],[1757,2403],[1757,2567],[935,2567]],"region":{"top_left_x":934,"top_left_y":2403,"width":823,"height":164},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3bfbe2cb75b4e3286a105433f014881","type":"complex_cell","conversion_output":false,"parent_id":"5efae66f0a564d79aee311712e286669","children_ids":["f0794e3c7199498ba1f99584af383600","6e8d3dabb44c4e6784f33f849a644226","5c2409ee802e4632b6d12b0775ae00be","706e8d93e4f2436fbbbf3073f44976e3"],"text":"Assuming the hazard over time in patients on linagliptin is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\) linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 625 patients with events will deliver an overall power of \\(90 \\%\\) in a test to demonstrate","text_display":"Assuming the hazard over time in patients on linagliptin is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\) linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 625 patients with events will deliver an overall power of \\(90 \\%\\) in a test to demonstrate","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9176730439030507,"confidence_rate":0.9996150118701846},{"cnt":[[939,2403],[1729,2403],[1729,2447],[939,2447]],"region":{"top_left_x":939,"top_left_y":2403,"width":791,"height":45},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0794e3c7199498ba1f99584af383600","type":"text","conversion_output":false,"parent_id":"c3bfbe2cb75b4e3286a105433f014881","text":"Assuming the hazard over time in patients on linagliptin","text_display":"Assuming the hazard over time in patients on linagliptin","confidence":1,"confidence_rate":1},{"cnt":[[939,2445],[1752,2445],[1752,2484],[939,2484]],"region":{"top_left_x":939,"top_left_y":2444,"width":814,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e8d3dabb44c4e6784f33f849a644226","type":"text","conversion_output":false,"parent_id":"c3bfbe2cb75b4e3286a105433f014881","text":"is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\)","text_display":" is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\)","confidence":0.9951193332672119,"confidence_rate":0.9999223424427574},{"cnt":[[939,2482],[1706,2482],[1706,2525],[939,2525]],"region":{"top_left_x":939,"top_left_y":2481,"width":768,"height":45},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c2409ee802e4632b6d12b0775ae00be","type":"text","conversion_output":false,"parent_id":"c3bfbe2cb75b4e3286a105433f014881","text":"linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 625 patients with events will","text_display":" linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 625 patients with events will","confidence":0.9176730439030507,"confidence_rate":0.9988074600703526},{"cnt":[[939,2523],[1725,2523],[1725,2564],[939,2564]],"region":{"top_left_x":939,"top_left_y":2522,"width":786,"height":43},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"706e8d93e4f2436fbbbf3073f44976e3","type":"text","conversion_output":false,"parent_id":"c3bfbe2cb75b4e3286a105433f014881","text":"deliver an overall power of \\(90 \\%\\) in a test to demonstrate","text_display":" deliver an overall power of \\(90 \\%\\) in a test to demonstrate","confidence":0.98291015625,"confidence_rate":0.9997306993848033},{"cnt":[[790,2581],[1300,2581],[1300,2625],[790,2625]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":44},"line":56,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"97fd03b57da34d86988b3cba79a2d662","type":"figure_label","conversion_output":false,"text":"Proprietary confidential information.","text_display":"","confidence":0.9970703125,"confidence_rate":0.999930145596247},{"cnt":[[288,2618],[1798,2618],[1798,2661],[288,2661]],"region":{"top_left_x":287,"top_left_y":2617,"width":1511,"height":45},"line":57,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"33387b7f7f724c87a8fdd415cb42d034","type":"page_info","conversion_output":false,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"","confidence":0.986328125,"confidence_rate":0.9998843243735954},{"cnt":[[295,2664],[1768,2664],[1768,2702],[295,2702]],"region":{"top_left_x":294,"top_left_y":2663,"width":1475,"height":40},"line":58,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b8ff01e65f07431692f14d4b92a13b5c","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-122","page":122,"lines":[{"cnt":[[247,123],[610,123],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":123,"width":364,"height":44},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"75875c5aae6c4176a301011025459850","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03d257f5d5804c2e806057d5e475b25b","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84afbce743c246d394601d08a4a66e94","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,210],[637,210],[637,249],[244,249]],"region":{"top_left_x":244,"top_left_y":210,"width":394,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a221f454760e4d7995dc36308e941184","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ffb39293cdc4db3b826d9c05c619e74","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,210],[1816,210],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":210,"width":264,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7dddfaa8d7b49a284e8465e242dfaab","type":"page_info","conversion_output":false,"text":"Page 122 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,2547],[244,2547]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":2215},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ebf176f11914d71a451c26951e471aa","type":"table","conversion_output":true,"children_ids":["b72790f18f7045ce9a1f6218a354b05f","6bdcff86e12641e886762923247912c9","41d4c16d97114f8f836211d0a70e50f1","c3cf447183d449fea8ba0c306b435866","efb4f0ea12cf46588a24443461de037c","6211802607d9469ea46ffbbc2dbf7897","71d11bf016034261b3351198715ec700","9ec51b3f358c4c438910ab79fdd0fa2e","d87ee9956bf748d596655c56178dff84","cb043a6d6a0b4f878d790294d763bfb4","a6ac77c596b9481e8fee48b9610285cf","f4aefef64577451e8262653aeaec178e","21d4871bef854a0b87f267496f029d0d","f3e9fb70dca54e51872c87283bec708f","479093995bcb407eb88cd959782dfb54","5bca8d20c9974e3da249b9efcaa07e9c","0da2eb5d0d324970b362cfe25464155d","78079f13d03c4339ae71a59a64e10a51","c17875515a0245959f2a0dfc8afd8405","90f100a4e9cf463aa4ca0842efbd7189","fccd554a4a2246de978ebf568731eff8","cfacd118014a44ddb5809da0d6f9f964","a7a4681b3462459892f89fce4d119a90","e1f3865c7216449cb6d4a94b273c31e3","30ded986eba3439ba22599eeacd1b881","23649ce6c05945b885929ddbab3c1d64","524ac8fcaf4f443cbe8348f8f1dac802","226f7a0ff2d4455d8b46e416dca210d9","dd58750e111443f29945b7408acb58ce","c7ffc0433ead48479e88fbadb298e701","4750ab4aa86248318c6d2ba840d887f5"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nnon-inferiority of linagliptin vs. placebo within the pre-specified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) and with one interim analysis at \\(\\alpha=1.0 \\%\\) after 70\\% of the events (calculated with East, version 5.4). Assuming a study duration of 3.8 years, recruitment within 3 years and a cumulative lost to follow-up rate of \\(2.0 \\%, 4150\\) patients per group are required to achieve 625 patients with a primary endpoint \\\\\nWas changed into: \\\\\nAssuming the hazard over time in patients on linagliptin is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\) linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 611patients with events will deliver an overall power of \\(90 \\%\\) in a test to demonstrate non-inferiority of linagliptin vs. placebo within the prespecified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) (calculated with East, version 5.4)\n\\end{tabular} \\\\\n\\hline Rationale for change & The change of the primary variable does not affect the required number of patients with event; the slight reduction from 625 to 611 patients is due to the elimination of the interim analysis. Since the event rate is higher than initially assumed the same power can be achieved within the originally planned timelines with a sample size of approximately 7000 patients. \\\\\n\\hline Section to be changed & 8. Informed consent, data protection, trial records \\\\\n\\hline Description of change & \\begin{tabular}{l}\nInsurance Cover: The terms and conditions of the insurance cover are made available to the investigator and the patients via documentation in the ISF (Investigator Site File). \\\\\nWas changed into: \\\\\nThe certificate of insurance cover is made available to the Investigator and the patients, and is stored in the ISF.\n\\end{tabular} \\\\\n\\hline Section to be changed & 9.2.Unpublished references \\\\\n\\hline Decsription of change & Author of IB omitted \\\\\n\\hline Rationale for change & Change in authorship \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 10.3 Blood pressure measurement procedure \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\n.....If an electronic blood pressure device is used the pulse rate at time of the second blood pressure reading may be used. \\\\\nWas changed into: \\\\\n.....If an electronic blood pressure device is used the pulse rate at time of the second blood pressure reading\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nnon-inferiority of linagliptin vs. placebo within the pre-specified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) and with one interim analysis at \\(\\alpha=1.0 \\%\\) after 70\\% of the events (calculated with East, version 5.4). Assuming a study duration of 3.8 years, recruitment within 3 years and a cumulative lost to follow-up rate of \\(2.0 \\%, 4150\\) patients per group are required to achieve 625 patients with a primary endpoint \\\\\nWas changed into: \\\\\nAssuming the hazard over time in patients on linagliptin is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\) linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 611patients with events will deliver an overall power of \\(90 \\%\\) in a test to demonstrate non-inferiority of linagliptin vs. placebo within the prespecified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) (calculated with East, version 5.4)\n\\end{tabular} \\\\\n\\hline Rationale for change & The change of the primary variable does not affect the required number of patients with event; the slight reduction from 625 to 611 patients is due to the elimination of the interim analysis. Since the event rate is higher than initially assumed the same power can be achieved within the originally planned timelines with a sample size of approximately 7000 patients. \\\\\n\\hline Section to be changed & 8. Informed consent, data protection, trial records \\\\\n\\hline Description of change & \\begin{tabular}{l}\nInsurance Cover: The terms and conditions of the insurance cover are made available to the investigator and the patients via documentation in the ISF (Investigator Site File). \\\\\nWas changed into: \\\\\nThe certificate of insurance cover is made available to the Investigator and the patients, and is stored in the ISF.\n\\end{tabular} \\\\\n\\hline Section to be changed & 9.2.Unpublished references \\\\\n\\hline Decsription of change & Author of IB omitted \\\\\n\\hline Rationale for change & Change in authorship \\\\\n\\hline Rationale for change & For clarification \\\\\n\\hline Section to be changed & 10.3 Blood pressure measurement procedure \\\\\n\\hline Description of change & \\begin{tabular}{l}\nChange 1: \\\\\n.....If an electronic blood pressure device is used the pulse rate at time of the second blood pressure reading may be used. \\\\\nWas changed into: \\\\\n.....If an electronic blood pressure device is used the pulse rate at time of the second blood pressure reading\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.4775657653808594,"confidence_rate":0.9995637307539267},{"cnt":[[251,333],[603,333],[603,2548],[251,2548]],"region":{"top_left_x":250,"top_left_y":333,"width":354,"height":2216},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b72790f18f7045ce9a1f6218a354b05f","type":"table_column","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[930,333],[1764,333],[1764,2548],[930,2548]],"region":{"top_left_x":930,"top_left_y":333,"width":834,"height":2216},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6bdcff86e12641e886762923247912c9","type":"table_column","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,333],[1775,333],[1775,1150],[244,1150]],"region":{"top_left_x":244,"top_left_y":333,"width":1532,"height":818},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41d4c16d97114f8f836211d0a70e50f1","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,1176],[1775,1176],[1775,1468],[244,1468]],"region":{"top_left_x":244,"top_left_y":1175,"width":1532,"height":294},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3cf447183d449fea8ba0c306b435866","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,1461],[1775,1461],[1775,1510],[244,1510]],"region":{"top_left_x":244,"top_left_y":1461,"width":1532,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"efb4f0ea12cf46588a24443461de037c","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,1507],[1775,1507],[1775,1892],[244,1892]],"region":{"top_left_x":244,"top_left_y":1507,"width":1532,"height":385},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6211802607d9469ea46ffbbc2dbf7897","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,1913],[1775,1913],[1775,1968],[244,1968]],"region":{"top_left_x":244,"top_left_y":1912,"width":1532,"height":56},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71d11bf016034261b3351198715ec700","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,1968],[1775,1968],[1775,2021],[244,2021]],"region":{"top_left_x":244,"top_left_y":1967,"width":1532,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ec51b3f358c4c438910ab79fdd0fa2e","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,2018],[1775,2018],[1775,2071],[244,2071]],"region":{"top_left_x":244,"top_left_y":2018,"width":1532,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d87ee9956bf748d596655c56178dff84","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,2069],[1775,2069],[1775,2122],[244,2122]],"region":{"top_left_x":244,"top_left_y":2069,"width":1532,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb043a6d6a0b4f878d790294d763bfb4","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,2122],[1775,2122],[1775,2173],[244,2173]],"region":{"top_left_x":244,"top_left_y":2122,"width":1532,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6ac77c596b9481e8fee48b9610285cf","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[244,2168],[1775,2168],[1775,2546],[244,2546]],"region":{"top_left_x":244,"top_left_y":2168,"width":1532,"height":378},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4aefef64577451e8262653aeaec178e","type":"table_row","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"","text_display":""},{"cnt":[[932,335],[1759,335],[1759,1141],[932,1141]],"region":{"top_left_x":932,"top_left_y":335,"width":828,"height":807},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"21d4871bef854a0b87f267496f029d0d","type":"complex_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","children_ids":["a492b31d7b3c440e8bda2d9d965b83dd","9fd05e76863c4706913316ce6aaf3b32","37e156e22b27499882c736b1f2b4f653","807dfe4935b642c0ac53287c78f164eb","f3108a045d164858aa1c01ee906904a2","19708846bb3d44648fe79992eba3e15a","cf307beab2b148038c3aa895c0c213ce","14c98844a0d34adaaa83905388fb0826","52254a934a2b405b9528f74e5f23ab11","41aa61e0622e446999a4c203b4f32b5b","96cfee0948e748d9a5d813a518703d28","718924b1c0d04a5097a5c3c000ef66b5","4f6f6c65df3f48beae827632c10d8425","04b641caf86441809e6ab010fc0cdddf","acc3011afdef4a74bbd2afb8bf591156","3493f098a0e0459dafbacd93ef0f61dd","a99e3c6defb341a9b75a68381f1e6117","b1a35f4b75c94f13bd986cf726d3b01c"],"text":"\\begin{tabular}{l}\nnon-inferiority of linagliptin vs. placebo within the pre-specified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) and with one interim analysis at \\(\\alpha=1.0 \\%\\) after 70\\% of the events (calculated with East, version 5.4). Assuming a study duration of 3.8 years, recruitment within 3 years and a cumulative lost to follow-up rate of \\(2.0 \\%, 4150\\) patients per group are required to achieve 625 patients with a primary endpoint \\\\\nWas changed into: \\\\\nAssuming the hazard over time in patients on linagliptin is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\) linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 611patients with events will deliver an overall power of \\(90 \\%\\) in a test to demonstrate non-inferiority of linagliptin vs. placebo within the prespecified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) (calculated with East, version 5.4)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nnon-inferiority of linagliptin vs. placebo within the pre-specified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) and with one interim analysis at \\(\\alpha=1.0 \\%\\) after 70\\% of the events (calculated with East, version 5.4). Assuming a study duration of 3.8 years, recruitment within 3 years and a cumulative lost to follow-up rate of \\(2.0 \\%, 4150\\) patients per group are required to achieve 625 patients with a primary endpoint \\\\\nWas changed into: \\\\\nAssuming the hazard over time in patients on linagliptin is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\) linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 611patients with events will deliver an overall power of \\(90 \\%\\) in a test to demonstrate non-inferiority of linagliptin vs. placebo within the prespecified non-inferiority (NI) margin of 1.3 for the HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) (calculated with East, version 5.4)\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.4775657653808594,"confidence_rate":0.9989176833598794},{"cnt":[[939,340],[1653,340],[1653,381],[939,381]],"region":{"top_left_x":939,"top_left_y":339,"width":715,"height":43},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a492b31d7b3c440e8bda2d9d965b83dd","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"non-inferiority of linagliptin vs. placebo within the","text_display":"non-inferiority of linagliptin vs. placebo within the","confidence":1,"confidence_rate":1},{"cnt":[[939,379],[1706,379],[1706,423],[939,423]],"region":{"top_left_x":939,"top_left_y":379,"width":768,"height":44},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9fd05e76863c4706913316ce6aaf3b32","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"pre-specified non-inferiority (NI) margin of 1.3 for the","text_display":" pre-specified non-inferiority (NI) margin of 1.3 for the","confidence":1,"confidence_rate":1},{"cnt":[[939,420],[1720,420],[1720,460],[939,460]],"region":{"top_left_x":939,"top_left_y":420,"width":781,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37e156e22b27499882c736b1f2b4f653","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) and with one","text_display":" HR; at the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) and with one","confidence":0.9814627128653228,"confidence_rate":0.9997364959073036},{"cnt":[[939,457],[1651,457],[1651,501],[939,501]],"region":{"top_left_x":939,"top_left_y":457,"width":712,"height":45},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"807dfe4935b642c0ac53287c78f164eb","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"interim analysis at \\(\\alpha=1.0 \\%\\) after 70\\% of the events","text_display":" interim analysis at \\(\\alpha=1.0 \\%\\) after 70\\% of the events","confidence":0.9848771095275879,"confidence_rate":0.9997373033471134},{"cnt":[[939,499],[1688,499],[1688,543],[939,543]],"region":{"top_left_x":939,"top_left_y":498,"width":749,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3108a045d164858aa1c01ee906904a2","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"(calculated with East, version 5.4). Assuming a study","text_display":" (calculated with East, version 5.4). Assuming a study","confidence":1,"confidence_rate":1},{"cnt":[[939,540],[1701,540],[1701,582],[939,582]],"region":{"top_left_x":939,"top_left_y":540,"width":763,"height":42},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19708846bb3d44648fe79992eba3e15a","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"duration of 3.8 years, recruitment within 3 years and a","text_display":" duration of 3.8 years, recruitment within 3 years and a","confidence":1,"confidence_rate":1},{"cnt":[[939,582],[1725,582],[1725,621],[939,621]],"region":{"top_left_x":939,"top_left_y":581,"width":786,"height":40},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf307beab2b148038c3aa895c0c213ce","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"cumulative lost to follow-up rate of \\(2.0 \\%, 4150\\) patients","text_display":" cumulative lost to follow-up rate of \\(2.0 \\%, 4150\\) patients","confidence":0.9545421600341797,"confidence_rate":0.9992618048694961},{"cnt":[[939,619],[1678,619],[1678,662],[939,662]],"region":{"top_left_x":939,"top_left_y":618,"width":740,"height":45},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14c98844a0d34adaaa83905388fb0826","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"per group are required to achieve 625 patients with a","text_display":" per group are required to achieve 625 patients with a","confidence":1,"confidence_rate":1},{"cnt":[[939,660],[1186,660],[1186,704],[939,704]],"region":{"top_left_x":939,"top_left_y":659,"width":247,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52254a934a2b405b9528f74e5f23ab11","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"primary endpoint","text_display":" primary endpoint","confidence":1,"confidence_rate":1},{"cnt":[[939,738],[1204,738],[1204,782],[939,782]],"region":{"top_left_x":939,"top_left_y":738,"width":266,"height":44},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41aa61e0622e446999a4c203b4f32b5b","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99560546875,"confidence_rate":0.9997998284195073},{"cnt":[[939,819],[1729,819],[1729,860],[939,860]],"region":{"top_left_x":939,"top_left_y":818,"width":791,"height":43},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96cfee0948e748d9a5d813a518703d28","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"Assuming the hazard over time in patients on linagliptin","text_display":"\nAssuming the hazard over time in patients on linagliptin","confidence":1,"confidence_rate":1},{"cnt":[[939,858],[1752,858],[1752,902],[939,902]],"region":{"top_left_x":939,"top_left_y":857,"width":814,"height":45},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"718924b1c0d04a5097a5c3c000ef66b5","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\)","text_display":" is the same as in patients on placebo (hazard ratio (HR): \\(\\lambda\\)","confidence":0.9951193332672119,"confidence_rate":0.9999223424427574},{"cnt":[[939,899],[1697,899],[1697,943],[939,943]],"region":{"top_left_x":939,"top_left_y":899,"width":758,"height":45},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f6f6c65df3f48beae827632c10d8425","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 611patients with events will","text_display":" linagliptin/ \\(\\lambda\\) placebo \\(=1\\) ), 611patients with events will","confidence":0.5822078306955518,"confidence_rate":0.9920767353032072},{"cnt":[[939,941],[1725,941],[1725,980],[939,980]],"region":{"top_left_x":939,"top_left_y":940,"width":786,"height":41},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04b641caf86441809e6ab010fc0cdddf","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"deliver an overall power of \\(90 \\%\\) in a test to demonstrate","text_display":" deliver an overall power of \\(90 \\%\\) in a test to demonstrate","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[939,978],[1720,978],[1720,1021],[939,1021]],"region":{"top_left_x":939,"top_left_y":977,"width":781,"height":45},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"acc3011afdef4a74bbd2afb8bf591156","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"non-inferiority of linagliptin vs. placebo within the pre-","text_display":" non-inferiority of linagliptin vs. placebo within the pre","confidence":1,"confidence_rate":1},{"cnt":[[939,1019],[1752,1019],[1752,1061],[939,1061]],"region":{"top_left_x":939,"top_left_y":1019,"width":814,"height":42},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3493f098a0e0459dafbacd93ef0f61dd","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"specified non-inferiority (NI) margin of 1.3 for the HR; at","text_display":"specified non-inferiority (NI) margin of 1.3 for the HR; at","confidence":1,"confidence_rate":1},{"cnt":[[939,1061],[1748,1061],[1748,1100],[939,1100]],"region":{"top_left_x":939,"top_left_y":1060,"width":809,"height":40},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a99e3c6defb341a9b75a68381f1e6117","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) (calculated with East,","text_display":" the overall 1 -sided \\(\\alpha\\)-level of \\(2.5 \\%\\) (calculated with East,","confidence":0.4775657653808594,"confidence_rate":0.9900624984406281},{"cnt":[[939,1100],[1112,1100],[1112,1139],[939,1139]],"region":{"top_left_x":939,"top_left_y":1099,"width":174,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1a35f4b75c94f13bd986cf726d3b01c","type":"text","conversion_output":false,"parent_id":"21d4871bef854a0b87f267496f029d0d","text":"version 5.4)","text_display":" version 5.4)","confidence":1,"confidence_rate":1},{"cnt":[[265,1183],[582,1183],[582,1224],[265,1224]],"region":{"top_left_x":264,"top_left_y":1182,"width":319,"height":43},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3e9fb70dca54e51872c87283bec708f","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1180],[1750,1180],[1750,1466],[935,1466]],"region":{"top_left_x":934,"top_left_y":1180,"width":816,"height":286},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"479093995bcb407eb88cd959782dfb54","type":"complex_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","children_ids":["f10719e03b864a53b733c40fdbe344e0","fa80ca4451f8453da954ff8d3356d6e3","886945930a56465bac985a482fe841fa","4d954160c43743b5b783f1dbc228f172","4d15639d0b454c449b3c04ae1537be4c","9c1620aa0fc34ce58084ca3179fdb505","a184e85255b04288b345cac2d451a0c7"],"text":"The change of the primary variable does not affect the required number of patients with event; the slight reduction from 625 to 611 patients is due to the elimination of the interim analysis. Since the event rate is higher than initially assumed the same power can be achieved within the originally planned timelines with a sample size of approximately 7000 patients.","text_display":"The change of the primary variable does not affect the required number of patients with event; the slight reduction from 625 to 611 patients is due to the elimination of the interim analysis. Since the event rate is higher than initially assumed the same power can be achieved within the originally planned timelines with a sample size of approximately 7000 patients.","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1185],[1701,1185],[1701,1224],[939,1224]],"region":{"top_left_x":939,"top_left_y":1184,"width":763,"height":41},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f10719e03b864a53b733c40fdbe344e0","type":"text","conversion_output":false,"parent_id":"479093995bcb407eb88cd959782dfb54","text":"The change of the primary variable does not affect the","text_display":"The change of the primary variable does not affect the","confidence":1,"confidence_rate":1},{"cnt":[[939,1222],[1632,1222],[1632,1266],[939,1266]],"region":{"top_left_x":939,"top_left_y":1221,"width":694,"height":45},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa80ca4451f8453da954ff8d3356d6e3","type":"text","conversion_output":false,"parent_id":"479093995bcb407eb88cd959782dfb54","text":"required number of patients with event; the slight","text_display":" required number of patients with event; the slight","confidence":1,"confidence_rate":1},{"cnt":[[939,1263],[1605,1263],[1605,1302],[939,1302]],"region":{"top_left_x":939,"top_left_y":1263,"width":666,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"886945930a56465bac985a482fe841fa","type":"text","conversion_output":false,"parent_id":"479093995bcb407eb88cd959782dfb54","text":"reduction from 625 to 611 patients is due to the","text_display":" reduction from 625 to 611 patients is due to the","confidence":1,"confidence_rate":1},{"cnt":[[939,1300],[1745,1300],[1745,1344],[939,1344]],"region":{"top_left_x":939,"top_left_y":1300,"width":807,"height":44},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d954160c43743b5b783f1dbc228f172","type":"text","conversion_output":false,"parent_id":"479093995bcb407eb88cd959782dfb54","text":"elimination of the interim analysis. Since the event rate is","text_display":" elimination of the interim analysis. Since the event rate is","confidence":1,"confidence_rate":1},{"cnt":[[939,1341],[1674,1341],[1674,1385],[939,1385]],"region":{"top_left_x":939,"top_left_y":1341,"width":735,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d15639d0b454c449b3c04ae1537be4c","type":"text","conversion_output":false,"parent_id":"479093995bcb407eb88cd959782dfb54","text":"higher than initially assumed the same power can be","text_display":" higher than initially assumed the same power can be","confidence":1,"confidence_rate":1},{"cnt":[[939,1383],[1711,1383],[1711,1422],[939,1422]],"region":{"top_left_x":939,"top_left_y":1382,"width":772,"height":41},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c1620aa0fc34ce58084ca3179fdb505","type":"text","conversion_output":false,"parent_id":"479093995bcb407eb88cd959782dfb54","text":"achieved within the originally planned timelines with a","text_display":" achieved within the originally planned timelines with a","confidence":1,"confidence_rate":1},{"cnt":[[939,1422],[1554,1422],[1554,1464],[939,1464]],"region":{"top_left_x":939,"top_left_y":1422,"width":616,"height":42},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a184e85255b04288b345cac2d451a0c7","type":"text","conversion_output":false,"parent_id":"479093995bcb407eb88cd959782dfb54","text":"sample size of approximately 7000 patients.","text_display":" sample size of approximately 7000 patients.","confidence":1,"confidence_rate":1},{"cnt":[[265,1466],[596,1466],[596,1507],[265,1507]],"region":{"top_left_x":264,"top_left_y":1465,"width":333,"height":43},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bca8d20c9974e3da249b9efcaa07e9c","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1466],[1690,1466],[1690,1505],[939,1505]],"region":{"top_left_x":939,"top_left_y":1465,"width":751,"height":40},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0da2eb5d0d324970b362cfe25464155d","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"8. Informed consent, data protection, trial records","text_display":"8. Informed consent, data protection, trial records","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[265,1516],[596,1516],[596,1560],[265,1560]],"region":{"top_left_x":264,"top_left_y":1516,"width":333,"height":45},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78079f13d03c4339ae71a59a64e10a51","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,1512],[1757,1512],[1757,1883],[935,1883]],"region":{"top_left_x":934,"top_left_y":1511,"width":823,"height":372},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c17875515a0245959f2a0dfc8afd8405","type":"complex_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","children_ids":["f964ab1f482147ee967e9e0a5baee1d3","7fdedc8962aa425cb86bbc843d3bb5b2","e1235827baf543a8b66a30ce8fd9c234","d343c44e0846445a8eb411dd51371eaf","9a0bbf3c3f844637b6c73f752cd85f12","b640460fba93486eb4f40755d5edb9d3","71c7ba665f264ef682918aa71cb9422c"],"text":"\\begin{tabular}{l}\nInsurance Cover: The terms and conditions of the insurance cover are made available to the investigator and the patients via documentation in the ISF (Investigator Site File). \\\\\nWas changed into: \\\\\nThe certificate of insurance cover is made available to the Investigator and the patients, and is stored in the ISF.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nInsurance Cover: The terms and conditions of the insurance cover are made available to the investigator and the patients via documentation in the ISF (Investigator Site File). \\\\\nWas changed into: \\\\\nThe certificate of insurance cover is made available to the Investigator and the patients, and is stored in the ISF.\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99072265625,"confidence_rate":0.99993947815403},{"cnt":[[939,1516],[1635,1516],[1635,1556],[939,1556]],"region":{"top_left_x":939,"top_left_y":1516,"width":696,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f964ab1f482147ee967e9e0a5baee1d3","type":"text","conversion_output":false,"parent_id":"c17875515a0245959f2a0dfc8afd8405","text":"Insurance Cover: The terms and conditions of the","text_display":"Insurance Cover: The terms and conditions of the","confidence":1,"confidence_rate":1},{"cnt":[[939,1553],[1752,1553],[1752,1597],[939,1597]],"region":{"top_left_x":939,"top_left_y":1553,"width":814,"height":45},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fdedc8962aa425cb86bbc843d3bb5b2","type":"text","conversion_output":false,"parent_id":"c17875515a0245959f2a0dfc8afd8405","text":"insurance cover are made available to the investigator and","text_display":" insurance cover are made available to the investigator and","confidence":1,"confidence_rate":1},{"cnt":[[939,1595],[1706,1595],[1706,1636],[939,1636]],"region":{"top_left_x":939,"top_left_y":1594,"width":768,"height":43},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1235827baf543a8b66a30ce8fd9c234","type":"text","conversion_output":false,"parent_id":"c17875515a0245959f2a0dfc8afd8405","text":"the patients via documentation in the ISF (Investigator","text_display":" the patients via documentation in the ISF (Investigator","confidence":1,"confidence_rate":1},{"cnt":[[939,1636],[1084,1636],[1084,1680],[939,1680]],"region":{"top_left_x":939,"top_left_y":1636,"width":146,"height":44},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d343c44e0846445a8eb411dd51371eaf","type":"text","conversion_output":false,"parent_id":"c17875515a0245959f2a0dfc8afd8405","text":"Site File).","text_display":" Site File).","confidence":1,"confidence_rate":1},{"cnt":[[939,1717],[1204,1717],[1204,1758],[939,1758]],"region":{"top_left_x":939,"top_left_y":1716,"width":266,"height":43},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a0bbf3c3f844637b6c73f752cd85f12","type":"text","conversion_output":false,"parent_id":"c17875515a0245959f2a0dfc8afd8405","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.99072265625,"confidence_rate":0.9995764239912223},{"cnt":[[939,1797],[1750,1797],[1750,1837],[939,1837]],"region":{"top_left_x":939,"top_left_y":1797,"width":811,"height":40},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b640460fba93486eb4f40755d5edb9d3","type":"text","conversion_output":false,"parent_id":"c17875515a0245959f2a0dfc8afd8405","text":"The certificate of insurance cover is made available to the","text_display":"\nThe certificate of insurance cover is made available to the","confidence":1,"confidence_rate":1},{"cnt":[[939,1839],[1688,1839],[1688,1883],[939,1883]],"region":{"top_left_x":939,"top_left_y":1838,"width":749,"height":45},"line":58,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71c7ba665f264ef682918aa71cb9422c","type":"text","conversion_output":false,"parent_id":"c17875515a0245959f2a0dfc8afd8405","text":"Investigator and the patients, and is stored in the ISF.","text_display":" Investigator and the patients, and is stored in the ISF.","confidence":1,"confidence_rate":1},{"cnt":[[265,1922],[596,1922],[596,1965],[265,1965]],"region":{"top_left_x":264,"top_left_y":1921,"width":333,"height":45},"line":59,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90f100a4e9cf463aa4ca0842efbd7189","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Section to be changed","text_display":"Section to be changed","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,1922],[1352,1922],[1352,1965],[937,1965]],"region":{"top_left_x":937,"top_left_y":1921,"width":415,"height":45},"line":60,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fccd554a4a2246de978ebf568731eff8","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"9.2.Unpublished references","text_display":"9.2.Unpublished references","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.94970703125,"confidence_rate":0.9983368126925598},{"cnt":[[262,1972],[596,1972],[596,2016],[262,2016]],"region":{"top_left_x":262,"top_left_y":1972,"width":335,"height":45},"line":61,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfacd118014a44ddb5809da0d6f9f964","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Decsription of change","text_display":"Decsription of change","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,1972],[1241,1972],[1241,2014],[939,2014]],"region":{"top_left_x":939,"top_left_y":1972,"width":302,"height":42},"line":62,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7a4681b3462459892f89fce4d119a90","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Author of IB omitted","text_display":"Author of IB omitted","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,2023],[582,2023],[582,2067],[262,2067]],"region":{"top_left_x":262,"top_left_y":2023,"width":321,"height":44},"line":63,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1f3865c7216449cb6d4a94b273c31e3","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Rationale for change","text_display":"Rationale for change","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2023],[1246,2023],[1246,2067],[939,2067]],"region":{"top_left_x":939,"top_left_y":2023,"width":307,"height":44},"line":64,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30ded986eba3439ba22599eeacd1b881","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Change in authorship","text_display":"Change in authorship","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,2078],[582,2078],[582,2122],[262,2122]],"region":{"top_left_x":262,"top_left_y":2078,"width":321,"height":45},"line":65,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"23649ce6c05945b885929ddbab3c1d64","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Rationale for change","text_display":"Rationale for change","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2078],[1172,2078],[1172,2113],[939,2113]],"region":{"top_left_x":939,"top_left_y":2078,"width":233,"height":35},"line":66,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"524ac8fcaf4f443cbe8348f8f1dac802","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"For clarification","text_display":"For clarification","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[262,2129],[596,2129],[596,2173],[262,2173]],"region":{"top_left_x":262,"top_left_y":2128,"width":335,"height":45},"line":67,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"226f7a0ff2d4455d8b46e416dca210d9","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Section to be changed","text_display":"Section to be changed","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,2129],[1609,2129],[1609,2170],[939,2170]],"region":{"top_left_x":939,"top_left_y":2128,"width":671,"height":43},"line":68,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd58750e111443f29945b7408acb58ce","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"10.3 Blood pressure measurement procedure","text_display":"10.3 Blood pressure measurement procedure","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.779296875,"confidence_rate":0.99459372746935},{"cnt":[[262,2180],[596,2180],[596,2223],[262,2223]],"region":{"top_left_x":262,"top_left_y":2179,"width":335,"height":45},"line":69,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7ffc0433ead48479e88fbadb298e701","type":"simple_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","text":"Description of change","text_display":"Description of change","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[935,2177],[1711,2177],[1711,2546],[935,2546]],"region":{"top_left_x":934,"top_left_y":2177,"width":777,"height":369},"line":70,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4750ab4aa86248318c6d2ba840d887f5","type":"complex_cell","conversion_output":false,"parent_id":"2ebf176f11914d71a451c26951e471aa","children_ids":["530bdad0f1b9461f8b46f2b35a5fe8fa","86fff390a7064699afeecc2957ea7cb5","d6ba1201d216445f9fc839a518621e49","18fa1e45080947308e28c3cd5ffdd9e4","13dc7dcd16c544bb939c4a2af1301e2d","6f732bef302441a987c1aaf04d65ba15","a6ab7bb380ca4302a3eed483261f9888"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\n.....If an electronic blood pressure device is used the pulse rate at time of the second blood pressure reading may be used. \\\\\nWas changed into: \\\\\n.....If an electronic blood pressure device is used the pulse rate at time of the second blood pressure reading\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\n.....If an electronic blood pressure device is used the pulse rate at time of the second blood pressure reading may be used. \\\\\nWas changed into: \\\\\n.....If an electronic blood pressure device is used the pulse rate at time of the second blood pressure reading\n\\end{tabular}","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9878220381215215,"confidence_rate":0.9999380152683064},{"cnt":[[939,2180],[1089,2180],[1089,2219],[939,2219]],"region":{"top_left_x":939,"top_left_y":2179,"width":151,"height":40},"line":71,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"530bdad0f1b9461f8b46f2b35a5fe8fa","type":"text","conversion_output":false,"parent_id":"4750ab4aa86248318c6d2ba840d887f5","text":"Change 1:","text_display":"Change 1:","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[939,2219],[1676,2219],[1676,2260],[939,2260]],"region":{"top_left_x":939,"top_left_y":2218,"width":738,"height":43},"line":72,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"86fff390a7064699afeecc2957ea7cb5","type":"text","conversion_output":false,"parent_id":"4750ab4aa86248318c6d2ba840d887f5","text":".....If an electronic blood pressure device is used the","text_display":"\n.....If an electronic blood pressure device is used the","confidence":0.9878220381215215,"confidence_rate":0.9997958088362338},{"cnt":[[939,2258],[1706,2258],[1706,2302],[939,2302]],"region":{"top_left_x":939,"top_left_y":2257,"width":768,"height":45},"line":73,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6ba1201d216445f9fc839a518621e49","type":"text","conversion_output":false,"parent_id":"4750ab4aa86248318c6d2ba840d887f5","text":"pulse rate at time of the second blood pressure reading","text_display":" pulse rate at time of the second blood pressure reading","confidence":1,"confidence_rate":1},{"cnt":[[939,2299],[1130,2299],[1130,2343],[939,2343]],"region":{"top_left_x":939,"top_left_y":2299,"width":192,"height":45},"line":74,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18fa1e45080947308e28c3cd5ffdd9e4","type":"text","conversion_output":false,"parent_id":"4750ab4aa86248318c6d2ba840d887f5","text":"may be used.","text_display":" may be used.","confidence":1,"confidence_rate":1},{"cnt":[[939,2380],[1206,2380],[1206,2421],[939,2421]],"region":{"top_left_x":939,"top_left_y":2379,"width":268,"height":43},"line":75,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13dc7dcd16c544bb939c4a2af1301e2d","type":"text","conversion_output":false,"parent_id":"4750ab4aa86248318c6d2ba840d887f5","text":"Was changed into:","text_display":"\nWas changed into:","confidence":0.998046875,"confidence_rate":0.9999111387285874},{"cnt":[[939,2461],[1676,2461],[1676,2504],[939,2504]],"region":{"top_left_x":939,"top_left_y":2460,"width":738,"height":45},"line":76,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f732bef302441a987c1aaf04d65ba15","type":"text","conversion_output":false,"parent_id":"4750ab4aa86248318c6d2ba840d887f5","text":".....If an electronic blood pressure device is used the","text_display":"\n.....If an electronic blood pressure device is used the","confidence":0.9936635453486815,"confidence_rate":0.9998940620253329},{"cnt":[[939,2502],[1706,2502],[1706,2546],[939,2546]],"region":{"top_left_x":939,"top_left_y":2501,"width":768,"height":45},"line":77,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6ab7bb380ca4302a3eed483261f9888","type":"text","conversion_output":false,"parent_id":"4750ab4aa86248318c6d2ba840d887f5","text":"pulse rate at time of the second blood pressure reading","text_display":" pulse rate at time of the second blood pressure reading","confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":78,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b156a797e364421a936f83bac1bbe40c","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2622],[1798,2622],[1798,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2622,"width":1506,"height":40},"line":79,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"de5ca3ce572442e6aa3e15e5d4e3604a","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":80,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b9d0203fc047478bbc9bb9d52471577b","type":"text","conversion_output":true,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"\nThis document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-123","page":123,"lines":[{"cnt":[[247,121],[610,121],[610,167],[247,167]],"region":{"top_left_x":246,"top_left_y":121,"width":364,"height":46},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"84498ecf8b62415a9fce06527e3dd48a","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1503,119],[1816,119],[1816,162],[1503,162]],"region":{"top_left_x":1503,"top_left_y":118,"width":314,"height":45},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb2f5a7e085245b8a8547c160a233bf8","type":"page_info","conversion_output":false,"text":"22 November 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,164],[599,164],[599,203],[247,203]],"region":{"top_left_x":246,"top_left_y":164,"width":353,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"140cbe6640df44e3891399c081af7e67","type":"page_info","conversion_output":false,"text":"BI Trial No.: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,210],[637,210],[637,249],[242,249]],"region":{"top_left_x":242,"top_left_y":210,"width":396,"height":39},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ac33ebc262a49ff84d53c16f3315bde","type":"page_info","conversion_output":false,"text":"Doc. No.: c02155180-06","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[868,210],[1108,210],[1108,249],[868,249]],"region":{"top_left_x":868,"top_left_y":210,"width":240,"height":39},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7af88300a8e24579a47c3feb9c885e82","type":"page_info","conversion_output":false,"text":"Trial Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1553,208],[1816,208],[1816,254],[1553,254]],"region":{"top_left_x":1553,"top_left_y":207,"width":264,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b7b816ba25d408497b9d599cc390f97","type":"page_info","conversion_output":false,"text":"Page 123 of 123","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[244,334],[1775,334],[1775,930],[244,930]],"region":{"top_left_x":244,"top_left_y":333,"width":1531,"height":597},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab6631ac036144f8ae1f60d4f9770e32","type":"table","conversion_output":true,"children_ids":["b500c467b3f645af9c6a7f2fb02ad242","2c8d5885bf674c9f8f7540b477363870","ec5c325a144f470f9ff9225bbf26cfca","a1ac914ff1554ecea315560d7e224923","7cdc687f93cd4cfda184b2b6aca34785","40ec93cfead34822896e2a6dafd9028f","a31225ee71254dec9d6c9bf72a8a6ed8","dee708fdd6f24e73b87e18ab004d6d6b","e0d4b615fe9e414a8b71f982d0247e9d","b7845fb3fdb8481bba02aeb4d4885a3a","c68f0e7acb874478ba50e33e64b80ea3","881d1e6fd19442e685acfa408b3dfda4","8149a4f797aa4cd2ada7b874f26c826c","0599186dae104da68c3e15e7ac1ff618","75e3a024b3f64c82bdd0ba3d13a021c1","fa352de21fc84339955f6b0a254d481a"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nshould be used. \\\\\nIn addition the following wording was added in the last paragraph: the mean value should be recorded in the eCRF.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 10.4 silent myocardial infarction \\\\\n\\hline Description of change & Definition of silent MI requires no preceding clinical history of MI (including stent thrombosis and other coronary events) and investigator reporting of silent MI \\\\\n\\hline Rationale for change & Clarification added \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nshould be used. \\\\\nIn addition the following wording was added in the last paragraph: the mean value should be recorded in the eCRF.\n\\end{tabular} \\\\\n\\hline Rationale for change & \\begin{tabular}{l}\nChange 1: \\\\\nFor clarification\n\\end{tabular} \\\\\n\\hline Section to be changed & 10.4 silent myocardial infarction \\\\\n\\hline Description of change & Definition of silent MI requires no preceding clinical history of MI (including stent thrombosis and other coronary events) and investigator reporting of silent MI \\\\\n\\hline Rationale for change & Clarification added \\\\\n\\hline\n\\end{tabular}","confidence":0.99609375,"confidence_rate":0.9999980585835705},{"cnt":[[253,333],[601,333],[601,929],[253,929]],"region":{"top_left_x":253,"top_left_y":333,"width":348,"height":597},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b500c467b3f645af9c6a7f2fb02ad242","type":"table_column","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"","text_display":""},{"cnt":[[930,333],[1727,333],[1727,929],[930,929]],"region":{"top_left_x":930,"top_left_y":333,"width":797,"height":597},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c8d5885bf674c9f8f7540b477363870","type":"table_column","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"","text_display":""},{"cnt":[[244,335],[1775,335],[1775,547],[244,547]],"region":{"top_left_x":244,"top_left_y":335,"width":1532,"height":213},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec5c325a144f470f9ff9225bbf26cfca","type":"table_row","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"","text_display":""},{"cnt":[[244,579],[1775,579],[1775,667],[244,667]],"region":{"top_left_x":244,"top_left_y":579,"width":1532,"height":88},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a1ac914ff1554ecea315560d7e224923","type":"table_row","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"","text_display":""},{"cnt":[[244,750],[244,703],[1775,706],[1775,752]],"region":{"top_left_x":243,"top_left_y":703,"width":1533,"height":50},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7cdc687f93cd4cfda184b2b6aca34785","type":"table_row","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"","text_display":""},{"cnt":[[244,750],[1775,750],[1775,881],[244,881]],"region":{"top_left_x":244,"top_left_y":749,"width":1532,"height":132},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40ec93cfead34822896e2a6dafd9028f","type":"table_row","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"","text_display":""},{"cnt":[[244,875],[1775,872],[1775,925],[244,928]],"region":{"top_left_x":243,"top_left_y":871,"width":1533,"height":58},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a31225ee71254dec9d6c9bf72a8a6ed8","type":"table_row","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"","text_display":""},{"cnt":[[935,338],[1720,338],[1720,543],[935,543]],"region":{"top_left_x":934,"top_left_y":337,"width":786,"height":206},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dee708fdd6f24e73b87e18ab004d6d6b","type":"complex_cell","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","children_ids":["ced47c28af8541cbadff8f6837639939","67d2d5c3225443df803bb3e9cb33522a","4d1856e2dcaf42a2a4c8828dd5e83a24","e1ec45aee9ad42a1a0e1c9b1babe2e40"],"text":"\\begin{tabular}{l}\nshould be used. \\\\\nIn addition the following wording was added in the last paragraph: the mean value should be recorded in the eCRF.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nshould be used. \\\\\nIn addition the following wording was added in the last paragraph: the mean value should be recorded in the eCRF.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99609375,"confidence_rate":0.9999825273878213},{"cnt":[[939,342],[1158,342],[1158,377],[939,377]],"region":{"top_left_x":939,"top_left_y":342,"width":220,"height":35},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ced47c28af8541cbadff8f6837639939","type":"text","conversion_output":false,"parent_id":"dee708fdd6f24e73b87e18ab004d6d6b","text":"should be used.","text_display":"should be used.","confidence":1,"confidence_rate":1},{"cnt":[[939,420],[1715,420],[1715,464],[939,464]],"region":{"top_left_x":939,"top_left_y":420,"width":777,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67d2d5c3225443df803bb3e9cb33522a","type":"text","conversion_output":false,"parent_id":"dee708fdd6f24e73b87e18ab004d6d6b","text":"In addition the following wording was added in the last","text_display":"\nIn addition the following wording was added in the last","confidence":1,"confidence_rate":1},{"cnt":[[939,462],[1674,462],[1674,503],[939,503]],"region":{"top_left_x":939,"top_left_y":461,"width":735,"height":43},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d1856e2dcaf42a2a4c8828dd5e83a24","type":"text","conversion_output":false,"parent_id":"dee708fdd6f24e73b87e18ab004d6d6b","text":"paragraph: the mean value should be recorded in the","text_display":" paragraph: the mean value should be recorded in the","confidence":0.99609375,"confidence_rate":0.9999301113830171},{"cnt":[[939,503],[1034,503],[1034,538],[939,538]],"region":{"top_left_x":939,"top_left_y":503,"width":95,"height":35},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1ec45aee9ad42a1a0e1c9b1babe2e40","type":"text","conversion_output":false,"parent_id":"dee708fdd6f24e73b87e18ab004d6d6b","text":"eCRF.","text_display":" eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[267,586],[582,586],[582,625],[267,625]],"region":{"top_left_x":267,"top_left_y":586,"width":316,"height":40},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0d4b615fe9e414a8b71f982d0247e9d","type":"simple_cell","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"Rationale for change","text_display":"Rationale for change","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,582],[1172,582],[1172,662],[937,662]],"region":{"top_left_x":937,"top_left_y":581,"width":235,"height":82},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7845fb3fdb8481bba02aeb4d4885a3a","type":"complex_cell","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","children_ids":["053b062676bd49918e9d396583097e88","779133391c574c36a5b28a7973447d17"],"text":"\\begin{tabular}{l}\nChange 1: \\\\\nFor clarification\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nChange 1: \\\\\nFor clarification\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,586],[1087,586],[1087,625],[939,625]],"region":{"top_left_x":939,"top_left_y":586,"width":148,"height":40},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"053b062676bd49918e9d396583097e88","type":"text","conversion_output":false,"parent_id":"b7845fb3fdb8481bba02aeb4d4885a3a","text":"Change 1:","text_display":"Change 1:","confidence":1,"confidence_rate":1},{"cnt":[[939,623],[1170,623],[1170,658],[939,658]],"region":{"top_left_x":939,"top_left_y":623,"width":231,"height":35},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"779133391c574c36a5b28a7973447d17","type":"text","conversion_output":false,"parent_id":"b7845fb3fdb8481bba02aeb4d4885a3a","text":"For clarification","text_display":"\nFor clarification","confidence":1,"confidence_rate":1},{"cnt":[[267,708],[592,708],[592,745],[267,745]],"region":{"top_left_x":267,"top_left_y":708,"width":325,"height":38},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c68f0e7acb874478ba50e33e64b80ea3","type":"simple_cell","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"Section to be changed","text_display":"Section to be changed","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,708],[1425,708],[1425,745],[939,745]],"region":{"top_left_x":939,"top_left_y":708,"width":487,"height":38},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"881d1e6fd19442e685acfa408b3dfda4","type":"simple_cell","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"10.4 silent myocardial infarction","text_display":"10.4 silent myocardial infarction","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[267,757],[592,757],[592,796],[267,796]],"region":{"top_left_x":267,"top_left_y":756,"width":325,"height":40},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8149a4f797aa4cd2ada7b874f26c826c","type":"simple_cell","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"Description of change","text_display":"Description of change","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[937,752],[1720,752],[1720,879],[937,879]],"region":{"top_left_x":937,"top_left_y":752,"width":783,"height":127},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0599186dae104da68c3e15e7ac1ff618","type":"complex_cell","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","children_ids":["f837ad5cb75f412d8553b2a864032b96","747f48ecee1a44538f7a321631d0d2ea","a674782f357649b4885928a2bbeb8ce0"],"text":"Definition of silent MI requires no preceding clinical history of MI (including stent thrombosis and other coronary events) and investigator reporting of silent MI","text_display":"Definition of silent MI requires no preceding clinical history of MI (including stent thrombosis and other coronary events) and investigator reporting of silent MI","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,757],[1683,757],[1683,796],[939,796]],"region":{"top_left_x":939,"top_left_y":756,"width":745,"height":40},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f837ad5cb75f412d8553b2a864032b96","type":"text","conversion_output":false,"parent_id":"0599186dae104da68c3e15e7ac1ff618","text":"Definition of silent MI requires no preceding clinical","text_display":"Definition of silent MI requires no preceding clinical","confidence":1,"confidence_rate":1},{"cnt":[[939,798],[1660,798],[1660,835],[939,835]],"region":{"top_left_x":939,"top_left_y":798,"width":722,"height":37},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"747f48ecee1a44538f7a321631d0d2ea","type":"text","conversion_output":false,"parent_id":"0599186dae104da68c3e15e7ac1ff618","text":"history of MI (including stent thrombosis and other","text_display":" history of MI (including stent thrombosis and other","confidence":1,"confidence_rate":1},{"cnt":[[939,874],[939,834],[1720,837],[1720,877]],"region":{"top_left_x":939,"top_left_y":834,"width":782,"height":43},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a674782f357649b4885928a2bbeb8ce0","type":"text","conversion_output":false,"parent_id":"0599186dae104da68c3e15e7ac1ff618","text":"coronary events) and investigator reporting of silent MI","text_display":" coronary events) and investigator reporting of silent MI","confidence":1,"confidence_rate":1},{"cnt":[[267,881],[580,881],[580,918],[267,918]],"region":{"top_left_x":267,"top_left_y":880,"width":314,"height":38},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"75e3a024b3f64c82bdd0ba3d13a021c1","type":"simple_cell","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"Rationale for change","text_display":"Rationale for change","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[939,876],[1213,876],[1213,911],[939,911]],"region":{"top_left_x":939,"top_left_y":876,"width":275,"height":35},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa352de21fc84339955f6b0a254d481a","type":"simple_cell","conversion_output":false,"parent_id":"ab6631ac036144f8ae1f60d4f9770e32","text":"Clarification added","text_display":"Clarification added","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[790,2581],[1300,2581],[1300,2620],[790,2620]],"region":{"top_left_x":790,"top_left_y":2581,"width":510,"height":40},"line":33,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d3b8c3e77b5044bf8e77343d11eb5a29","type":"text","conversion_output":true,"text":"Proprietary confidential information.","text_display":"\n\nProprietary confidential information.","confidence":0.99853515625,"confidence_rate":0.9999650978071315},{"cnt":[[292,2618],[1800,2618],[1800,2661],[292,2661]],"region":{"top_left_x":292,"top_left_y":2617,"width":1509,"height":45},"line":34,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d113f6cb7cdc430b8c79776df58c9984","type":"text","conversion_output":true,"text":"© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","text_display":"\n© 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.","confidence":0.994140625,"confidence_rate":0.9999506179547201},{"cnt":[[297,2664],[1768,2664],[1768,2702],[297,2702]],"region":{"top_left_x":296,"top_left_y":2663,"width":1473,"height":40},"line":35,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"39dddfa356324ee4929c7450416eb76b","type":"page_info","conversion_output":false,"text":"This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-124","page":124,"lines":[{"cnt":[[1435,236],[1846,236],[1846,372],[1435,372]],"region":{"top_left_x":1435,"top_left_y":236,"width":411,"height":136},"line":1,"column":0,"font_size":56,"is_printed":true,"is_handwritten":false,"id":"c44f2128afc741d9834ca8e598c34edb","type":"page_info","conversion_output":false,"children_ids":["cc949e8fd5f34530b864130d6d8675cb","045e702fe4d343cbb1a50e97076d909f"],"text":"","text_display":""},{"cnt":[[1568,245],[1837,245],[1837,312],[1568,312]],"region":{"top_left_x":1568,"top_left_y":244,"width":269,"height":68},"line":2,"column":0,"font_size":56,"is_printed":true,"is_handwritten":false,"id":"cc949e8fd5f34530b864130d6d8675cb","type":"text","conversion_output":false,"parent_id":"c44f2128afc741d9834ca8e598c34edb","text":"Boehringer","text_display":"\nBoehringer","confidence":1,"confidence_rate":1},{"cnt":[[1571,305],[1815,305],[1815,370],[1571,370]],"region":{"top_left_x":1570,"top_left_y":305,"width":246,"height":65},"line":3,"column":0,"font_size":56,"is_printed":true,"is_handwritten":false,"id":"045e702fe4d343cbb1a50e97076d909f","type":"text","conversion_output":false,"parent_id":"c44f2128afc741d9834ca8e598c34edb","text":"Ingelheim","text_display":" Ingelheim","confidence":1,"confidence_rate":1},{"cnt":[[318,374],[932,374],[932,421],[318,421]],"region":{"top_left_x":317,"top_left_y":373,"width":616,"height":49},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"008eac3f3886422bae647ea4b4777145","type":"section_header","conversion_output":false,"children_ids":["cfd3b6bbc0b647fc8c17966a02086664"],"text":"","text_display":""},{"cnt":[[322,378],[930,378],[930,417],[322,417]],"region":{"top_left_x":322,"top_left_y":378,"width":609,"height":39},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfd3b6bbc0b647fc8c17966a02086664","type":"text","conversion_output":true,"parent_id":"008eac3f3886422bae647ea4b4777145","text":"APPROVAL / SIGNATURE PAGE","text_display":"\n\n\\section*{APPROVAL / SIGNATURE PAGE}","confidence":1,"confidence_rate":1},{"cnt":[[318,468],[1601,468],[1601,509],[318,509]],"region":{"top_left_x":317,"top_left_y":468,"width":1284,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a99f773e34448f9840706a907c82453","type":"text","conversion_output":true,"text":"Document Number: c02155180 Technical Version Number:6.0","text_display":"\n\nDocument Number: c02155180 Technical Version Number:6.0","confidence":0.9970724578015506,"confidence_rate":0.9999511372632887},{"cnt":[[322,533],[1149,533],[1149,578],[322,578]],"region":{"top_left_x":322,"top_left_y":532,"width":828,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f5a4bccac864983b39c7f55b8ad83b1","type":"text","conversion_output":true,"text":"Document Name: 1218-0022--protocol-revision-02","text_display":"\nDocument Name: 1218-0022--protocol-revision-02","confidence":1,"confidence_rate":1},{"cnt":[[320,730],[1532,730],[1532,778],[320,778]],"region":{"top_left_x":320,"top_left_y":730,"width":1212,"height":48},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ebdbf87eb9c4042afb49b53a2248fa6","type":"text","conversion_output":true,"text":"Title: A multicenter, international, randomized, parallel group, double blind,","text_display":"\n\nTitle: A multicenter, international, randomized, parallel group, double blind,","confidence":1,"confidence_rate":1},{"cnt":[[421,778],[1717,778],[1717,823],[421,823]],"region":{"top_left_x":421,"top_left_y":777,"width":1296,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"598cc59edee346888254847ed2f1871f","type":"text","conversion_output":true,"text":"placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study","text_display":" placebo-controlled CArdiovascular Safety \\& Renal Microvascular outcomE study","confidence":1,"confidence_rate":1},{"cnt":[[421,825],[1727,825],[1727,870],[421,870]],"region":{"top_left_x":421,"top_left_y":825,"width":1307,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4d8bee98927479d8d839c61c6a44e9b","type":"text","conversion_output":true,"text":"with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high","text_display":" with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high","confidence":0.99658203125,"confidence_rate":0.9999643358094245},{"cnt":[[421,872],[883,872],[883,909],[421,909]],"region":{"top_left_x":421,"top_left_y":872,"width":463,"height":37},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b935627369ca408eb3b5fecc1d7d7ff1","type":"text","conversion_output":true,"text":"vascular risk. CARMELINA","text_display":" vascular risk. CARMELINA","confidence":1,"confidence_rate":1},{"cnt":[[316,993],[926,993],[926,1051],[316,1051]],"region":{"top_left_x":315,"top_left_y":992,"width":611,"height":59},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c449f1051ea464eafe0a48a660b7804","type":"section_header","conversion_output":false,"children_ids":["9b9ed3d98e1f49a69fd5ca21387b6216"],"text":"","text_display":""},{"cnt":[[322,997],[922,997],[922,1044],[322,1044]],"region":{"top_left_x":322,"top_left_y":996,"width":600,"height":49},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b9ed3d98e1f49a69fd5ca21387b6216","type":"text","conversion_output":true,"parent_id":"2c449f1051ea464eafe0a48a660b7804","text":"Signatures (obtained electronically)","text_display":"\n\n\\section*{Signatures (obtained electronically)}","confidence":1,"confidence_rate":1},{"cnt":[[318,1079],[1815,1079],[1815,1921],[318,1921]],"region":{"top_left_x":317,"top_left_y":1078,"width":1499,"height":843},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"298ef8987b974fb984cccb8812db3338","type":"table","conversion_output":true,"children_ids":["2f49bbccef164f82bc61df20befbab88","933eec1de58c447aa5162a3070a8fbaf","5ff8f715e41a4005b7a1b5119db00776","c2a217b3b62b49fab3daa47cc14507a9","b10cde0a52074f3f9b8335afff8e2223","cc761ab09ecb494b97edf0755b50aba4","acf7791048274bd5896e1e9b107c41e2","b08ae5d5d3c448758e26e1434c9c6021","6297e6f854aa42aeb10b30743a6a4871","ff31c7cdc21d46c3a6bf2d9eef0790c9","aec5d5b37da847f0aed6e85c9313ccdb","6116356e2a794119979b42fd5bbf8c0a","9982637225dc4ce9b84864c68ad969fe","4bc7d349ce2c4d33b0f428645847e8d6","b5431e0f1dfb4a8e9d46c82513f99e37","23a7ad9d0be1425ba08cce7c38d75c5e","c5707bd518c44b2f8fe9ba6f6cb44491","77d0bc8c6cda4e648fa80dad6fa9203e","e44ae831605843e7bd6c58180b596d45","1294f9123649438c975af40f12768530","824c3ed4cdef474e89c6861b2e16b050","a9b8a4452ee84d1ea68c9dd9426d8db1","eca349dd267d4be089b48bcdeb23d033","bfda94f6caca412994a077a1c0e31364","3106ea76d3a146468ee4012ffe400a53"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Meaning of Signature & Signed by & Date Signed \\\\\n\\hline \\multicolumn{2}{|l|}{Author-Trial Clinical Monitor} & 23 Nov 2016 13:09 CET \\\\\n\\hline Approval-Therapeutic Area & & 23 Nov 2016 13:24 CET \\\\\n\\hline Approval-Team Member Medicine & & 23 Nov 2016 13:51 CET \\\\\n\\hline Author-Trial Statistician & & 23 Nov 2016 14:14 CET \\\\\n\\hline Approval-Team Member Medicine & & 24 Nov 2016 15:38 CET \\\\\n\\hline Verification-Paper Signature Completion & & 30 Nov 2016 10:40 CET \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Meaning of Signature & Signed by & Date Signed \\\\\n\\hline \\multicolumn{2}{|l|}{Author-Trial Clinical Monitor} & 23 Nov 2016 13:09 CET \\\\\n\\hline Approval-Therapeutic Area & & 23 Nov 2016 13:24 CET \\\\\n\\hline Approval-Team Member Medicine & & 23 Nov 2016 13:51 CET \\\\\n\\hline Author-Trial Statistician & & 23 Nov 2016 14:14 CET \\\\\n\\hline Approval-Team Member Medicine & & 24 Nov 2016 15:38 CET \\\\\n\\hline Verification-Paper Signature Completion & & 30 Nov 2016 10:40 CET \\\\\n\\hline\n\\end{tabular}","confidence":1,"confidence_rate":1},{"cnt":[[321,1078],[798,1078],[798,1920],[321,1920]],"region":{"top_left_x":321,"top_left_y":1078,"width":477,"height":843},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f49bbccef164f82bc61df20befbab88","type":"table_column","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[863,1078],[1042,1078],[1042,1920],[863,1920]],"region":{"top_left_x":862,"top_left_y":1078,"width":181,"height":843},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"933eec1de58c447aa5162a3070a8fbaf","type":"table_column","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[1382,1078],[1718,1078],[1718,1920],[1382,1920]],"region":{"top_left_x":1382,"top_left_y":1078,"width":337,"height":843},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ff8f715e41a4005b7a1b5119db00776","type":"table_column","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[317,1104],[1816,1104],[1816,1158],[317,1158]],"region":{"top_left_x":317,"top_left_y":1103,"width":1499,"height":56},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2a217b3b62b49fab3daa47cc14507a9","type":"table_row","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[317,1195],[1818,1195],[1818,1236],[317,1236]],"region":{"top_left_x":317,"top_left_y":1194,"width":1501,"height":43},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b10cde0a52074f3f9b8335afff8e2223","type":"table_row","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[317,1325],[1816,1325],[1816,1368],[317,1368]],"region":{"top_left_x":317,"top_left_y":1324,"width":1499,"height":45},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc761ab09ecb494b97edf0755b50aba4","type":"table_row","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[317,1455],[1816,1455],[1816,1498],[317,1498]],"region":{"top_left_x":317,"top_left_y":1454,"width":1499,"height":45},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"acf7791048274bd5896e1e9b107c41e2","type":"table_row","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[317,1583],[1816,1583],[1816,1622],[317,1622]],"region":{"top_left_x":317,"top_left_y":1582,"width":1499,"height":40},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b08ae5d5d3c448758e26e1434c9c6021","type":"table_row","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[317,1712],[1816,1712],[1816,1756],[317,1756]],"region":{"top_left_x":317,"top_left_y":1712,"width":1499,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6297e6f854aa42aeb10b30743a6a4871","type":"table_row","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[317,1840],[1816,1840],[1816,1920],[317,1920]],"region":{"top_left_x":317,"top_left_y":1840,"width":1499,"height":81},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff31c7cdc21d46c3a6bf2d9eef0790c9","type":"table_row","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"","text_display":""},{"cnt":[[339,1108],[709,1108],[709,1154],[339,1154]],"region":{"top_left_x":338,"top_left_y":1108,"width":371,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aec5d5b37da847f0aed6e85c9313ccdb","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"Meaning of Signature","text_display":"Meaning of Signature","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[867,1108],[1038,1108],[1038,1154],[867,1154]],"region":{"top_left_x":867,"top_left_y":1108,"width":172,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6116356e2a794119979b42fd5bbf8c0a","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"Signed by","text_display":"Signed by","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1398,1108],[1605,1108],[1605,1154],[1398,1154]],"region":{"top_left_x":1397,"top_left_y":1108,"width":209,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9982637225dc4ce9b84864c68ad969fe","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"Date Signed","text_display":"Date Signed","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[323,1195],[1047,1195],[1047,1232],[323,1232]],"region":{"top_left_x":323,"top_left_y":1194,"width":724,"height":38},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4bc7d349ce2c4d33b0f428645847e8d6","type":"table_spanning_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","children_ids":["15b35cc512464bd8a5ffd9d4abdb89ad"],"text":"","text_display":"Author-Trial Clinical Monitor","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[326,1199],[728,1199],[728,1232],[326,1232]],"region":{"top_left_x":325,"top_left_y":1199,"width":404,"height":33},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15b35cc512464bd8a5ffd9d4abdb89ad","type":"simple_cell","conversion_output":false,"parent_id":"4bc7d349ce2c4d33b0f428645847e8d6","text":"Author-Trial Clinical Monitor","text_display":"Author-Trial Clinical Monitor","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[1385,1199],[1714,1199],[1714,1232],[1385,1232]],"region":{"top_left_x":1384,"top_left_y":1199,"width":330,"height":33},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5431e0f1dfb4a8e9d46c82513f99e37","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"23 Nov 2016 13:09 CET","text_display":"23 Nov 2016 13:09 CET","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[326,1329],[696,1329],[696,1366],[326,1366]],"region":{"top_left_x":325,"top_left_y":1329,"width":371,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23a7ad9d0be1425ba08cce7c38d75c5e","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"Approval-Therapeutic Area","text_display":"Approval-Therapeutic Area","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1385,1329],[1714,1329],[1714,1362],[1385,1362]],"region":{"top_left_x":1384,"top_left_y":1329,"width":330,"height":33},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5707bd518c44b2f8fe9ba6f6cb44491","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"23 Nov 2016 13:24 CET","text_display":"23 Nov 2016 13:24 CET","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[326,1457],[791,1457],[791,1492],[326,1492]],"region":{"top_left_x":325,"top_left_y":1456,"width":467,"height":36},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77d0bc8c6cda4e648fa80dad6fa9203e","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"Approval-Team Member Medicine","text_display":"Approval-Team Member Medicine","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1387,1459],[1714,1459],[1714,1489],[1387,1489]],"region":{"top_left_x":1386,"top_left_y":1459,"width":328,"height":31},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e44ae831605843e7bd6c58180b596d45","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"23 Nov 2016 13:51 CET","text_display":"23 Nov 2016 13:51 CET","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[326,1587],[653,1587],[653,1617],[326,1617]],"region":{"top_left_x":325,"top_left_y":1586,"width":328,"height":32},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1294f9123649438c975af40f12768530","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"Author-Trial Statistician","text_display":"Author-Trial Statistician","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1387,1589],[1714,1589],[1714,1617],[1387,1617]],"region":{"top_left_x":1386,"top_left_y":1589,"width":328,"height":29},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"824c3ed4cdef474e89c6861b2e16b050","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"23 Nov 2016 14:14 CET","text_display":"23 Nov 2016 14:14 CET","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[326,1715],[791,1715],[791,1751],[326,1751]],"region":{"top_left_x":325,"top_left_y":1714,"width":467,"height":38},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9b8a4452ee84d1ea68c9dd9426d8db1","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"Approval-Team Member Medicine","text_display":"Approval-Team Member Medicine","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1385,1715],[1714,1715],[1714,1747],[1385,1747]],"region":{"top_left_x":1384,"top_left_y":1714,"width":330,"height":34},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eca349dd267d4be089b48bcdeb23d033","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"24 Nov 2016 15:38 CET","text_display":"24 Nov 2016 15:38 CET","cell_row":5,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[326,1842],[711,1842],[711,1920],[326,1920]],"region":{"top_left_x":325,"top_left_y":1842,"width":387,"height":79},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bfda94f6caca412994a077a1c0e31364","type":"complex_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","children_ids":["8ebfa325b0354152ace9cebb171a08b2","0dffaff8aee0479484478c15fffec4b4"],"text":"Verification-Paper Signature Completion","text_display":"Verification-Paper Signature Completion","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[328,1845],[709,1845],[709,1881],[328,1881]],"region":{"top_left_x":327,"top_left_y":1844,"width":382,"height":38},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ebfa325b0354152ace9cebb171a08b2","type":"text","conversion_output":false,"parent_id":"bfda94f6caca412994a077a1c0e31364","text":"Verification-Paper Signature","text_display":"Verification-Paper Signature","confidence":1,"confidence_rate":1},{"cnt":[[328,1884],[488,1884],[488,1916],[328,1916]],"region":{"top_left_x":327,"top_left_y":1883,"width":162,"height":34},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0dffaff8aee0479484478c15fffec4b4","type":"text","conversion_output":false,"parent_id":"bfda94f6caca412994a077a1c0e31364","text":"Completion","text_display":" Completion","confidence":1,"confidence_rate":1},{"cnt":[[1387,1845],[1714,1845],[1714,1877],[1387,1877]],"region":{"top_left_x":1386,"top_left_y":1844,"width":328,"height":34},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3106ea76d3a146468ee4012ffe400a53","type":"simple_cell","conversion_output":false,"parent_id":"298ef8987b974fb984cccb8812db3338","text":"30 Nov 2016 10:40 CET","text_display":"30 Nov 2016 10:40 CET","cell_row":6,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"eb2f265e-249c-4fb0-ae0a-f82484d8e575-125","page":125,"lines":[{"cnt":[[322,236],[694,236],[694,286],[322,286]],"region":{"top_left_x":322,"top_left_y":236,"width":372,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba826e0abc8a4189ad8e9480b260ad08","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,236],[1807,236],[1807,286],[1611,286]],"region":{"top_left_x":1611,"top_left_y":236,"width":196,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c806d982704d49dbae837dc201d064f1","type":"page_info","conversion_output":false,"text":"Page 2 of 2","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,284],[849,284],[849,324],[318,324]],"region":{"top_left_x":317,"top_left_y":283,"width":532,"height":42},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcab69d9aa9c4f29b8e53f32c96b14af","type":"page_info","conversion_output":false,"text":"Document Number: c02155180","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[1042,284],[1515,284],[1515,322],[1042,322]],"region":{"top_left_x":1041,"top_left_y":283,"width":474,"height":40},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4659635624b455787464300cf8d8061","type":"page_info","conversion_output":false,"text":"Technical Version Number:","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1667,277],[1729,277],[1729,322],[1667,322]],"region":{"top_left_x":1667,"top_left_y":277,"width":63,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc40d697676d4956b6e94d7a9d78f5ae","type":"page_info","conversion_output":false,"text":"6.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,374],[1137,374],[1137,423],[322,423]],"region":{"top_left_x":322,"top_left_y":373,"width":815,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fd0142bafc04206b77b5a94ab194277","type":"text","conversion_output":true,"text":"(Continued) Signatures (obtained electronically)","text_display":"\n(Continued) Signatures (obtained electronically)","confidence":1,"confidence_rate":1},{"cnt":[[318,458],[1815,458],[1815,556],[318,556]],"region":{"top_left_x":317,"top_left_y":457,"width":1499,"height":100},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dfce019b586471cab90f5e9de4e7c8e","type":"table","conversion_output":true,"text":"\\begin{tabular}{|l|l|l|}\n\\hline Meaning of Signature & Signed by & Date Signed \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Meaning of Signature & Signed by & Date Signed \\\\\n\\hline\n\\end{tabular}","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]}]}