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The trial will include subjects with T2D","confidence":1,"confidence_rate":1},{"cnt":[[318,748],[1188,748],[1188,784],[318,784]],"region":{"top_left_x":317,"top_left_y":747,"width":872,"height":38},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e55ab33fe9c745848f94f157f4759049","type":"text","conversion_output":true,"text":"who have failed on diet and exercise and/or metformin.","text_display":" who have failed on diet and exercise and/or metformin.","confidence":0.99853515625,"confidence_rate":0.9999751542462456},{"cnt":[[318,838],[1712,838],[1712,879],[318,879]],"region":{"top_left_x":317,"top_left_y":837,"width":1396,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a7e29782c47482ca8d4352d7f034fb7","type":"text","conversion_output":true,"text":"The primary objective of the trial is to compare the efficacy on glycaemic control of oral","text_display":"\n\nThe primary objective of the trial is to compare the efficacy on glycaemic control of oral","confidence":1,"confidence_rate":1},{"cnt":[[318,885],[1489,885],[1489,930],[318,930]],"region":{"top_left_x":317,"top_left_y":885,"width":1172,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"11369ba3f7be46fc95d0ade1421ea064","type":"text","conversion_output":true,"text":"semaglutide in a SNAC formulation against placebo in subjects with T2D.","text_display":" semaglutide in a SNAC formulation against placebo in subjects with 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consolidated version 3 which includes protocol amendments one","text_display":"protocol-version-3 \\(0^{\\prime \\prime}\\), that is, the consolidated version 3 which includes protocol amendments one","confidence":0.6595452807387119,"confidence_rate":0.9964490150116857},{"cnt":[[318,1143],[458,1143],[458,1179],[318,1179]],"region":{"top_left_x":317,"top_left_y":1142,"width":141,"height":38},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ed7fccd825846cab735957b421ec9ef","type":"text","conversion_output":true,"text":"and two.","text_display":" and two.","confidence":1,"confidence_rate":1},{"cnt":[[318,1233],[1863,1233],[1863,1274],[318,1274]],"region":{"top_left_x":317,"top_left_y":1233,"width":1546,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a9ad7244ce5426595fa042daefdb14b","type":"text","conversion_output":true,"text":"This SAP contains a more technical and detailed elaboration of the statistical analyses specified in","text_display":"\n\nThis SAP contains a more technical and detailed elaboration of the statistical analyses specified in","confidence":1,"confidence_rate":1},{"cnt":[[318,1280],[917,1280],[917,1326],[318,1326]],"region":{"top_left_x":317,"top_left_y":1280,"width":601,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c122a9887ee41878bc090cbff04258c","type":"text","conversion_output":true,"text":"the statistical section of the protocol. .","text_display":" the statistical section of the protocol. .","confidence":1,"confidence_rate":1},{"cnt":[[314,1371],[973,1371],[973,1420],[314,1420]],"region":{"top_left_x":313,"top_left_y":1370,"width":661,"height":51},"line":25,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"380dd0eeb73b49bc811be3f78cc1897f","type":"section_header","conversion_output":false,"children_ids":["79120e8345fb43b2b06e63f3b4a173ba"],"text":"","text_display":""},{"cnt":[[318,1375],[971,1375],[971,1420],[318,1420]],"region":{"top_left_x":317,"top_left_y":1375,"width":655,"height":46},"line":26,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"79120e8345fb43b2b06e63f3b4a173ba","type":"text","conversion_output":true,"parent_id":"380dd0eeb73b49bc811be3f78cc1897f","text":"2 Statistical considerations","text_display":"\n\n\\section*{2 Statistical 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difference between treatments.","text_display":" with a confidence level of \\(95 \\%\\) including a p-value for test of no difference between treatments.","confidence":0.6625846299575642,"confidence_rate":0.9960500621276985},{"cnt":[[318,1594],[1884,1594],[1884,1637],[318,1637]],"region":{"top_left_x":317,"top_left_y":1594,"width":1568,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3eea7c79016b4d5a9a412519b8c5bffa","type":"text","conversion_output":true,"text":"The stratification variable referred to in the following is defined as the two level factor of treatment","text_display":"\n\nThe stratification variable referred to in the following is defined as the two level factor of 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The","text_display":" MMRM\") will be used in the analysis of the primary and continuous secondary endpoints. The","confidence":0.6495850086212158,"confidence_rate":0.9954690163529852},{"cnt":[[318,2069],[1768,2069],[1768,2112],[318,2112]],"region":{"top_left_x":317,"top_left_y":2068,"width":1452,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"64a0a390555b45eb83da4551bb8d3591","type":"text","conversion_output":true,"text":"model will include treatment, country and the stratification variable as fixed factors, and the","text_display":" model will include treatment, country and the stratification variable as fixed factors, and the","confidence":1,"confidence_rate":1},{"cnt":[[318,2118],[1863,2118],[1863,2163],[318,2163]],"region":{"top_left_x":317,"top_left_y":2118,"width":1546,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab8d071701bf46859d3550d6878e193a","type":"text","conversion_output":true,"text":"corresponding baseline value as covariate. All factors and the covariate will be nested within visit.","text_display":" corresponding baseline value as covariate. All factors and the covariate will be nested within visit.","confidence":1,"confidence_rate":1},{"cnt":[[318,2170],[1472,2170],[1472,2213],[318,2213]],"region":{"top_left_x":317,"top_left_y":2169,"width":1155,"height":44},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3374fddf03a4e34bfba34cfecbd5889","type":"text","conversion_output":true,"text":"The model will assume an unstructured covariance matrix within subject.","text_display":" The model will assume an unstructured covariance matrix within subject.","confidence":1,"confidence_rate":1},{"cnt":[[318,2256],[1871,2256],[1871,2301],[318,2301]],"region":{"top_left_x":317,"top_left_y":2255,"width":1555,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e12387f2c2f8457eb08bbb213b78d9cf","type":"text","conversion_output":true,"text":"Unless otherwise stated, the estimated differences with corresponding two sided p -values and \\(95 \\%\\)","text_display":"\n\nUnless otherwise stated, the estimated differences with corresponding two sided p -values and \\(95 \\%\\)","confidence":0.6019394397735596,"confidence_rate":0.9952673239444741},{"cnt":[[318,2307],[1867,2307],[1867,2350],[318,2350]],"region":{"top_left_x":317,"top_left_y":2307,"width":1550,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e402d7f62fc485fa29fb8bd73ab95f5","type":"text","conversion_output":true,"text":"confidence intervals at 26 weeks will be presented for the planned comparisons between treatment","text_display":" confidence intervals at 26 weeks will be presented for the planned comparisons between 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2012-004994-16","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[318,423],[1772,423],[1772,466],[318,466]],"region":{"top_left_x":317,"top_left_y":423,"width":1456,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13c2bfb18cb04de2b5d4621a980d4e62","type":"text","conversion_output":true,"text":"The patient years observation time (PYO) used in e.g. the calculation of AE rates will for an","text_display":"\n\nThe patient years observation time (PYO) used in e.g. the calculation of AE rates will for an","confidence":0.822265625,"confidence_rate":0.998005137374734},{"cnt":[[318,473],[1858,473],[1858,518],[318,518]],"region":{"top_left_x":317,"top_left_y":472,"width":1542,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9e303611a8d4bdcb021c27ba99c03ca","type":"text","conversion_output":true,"text":"observation period be calculated as the difference between start-date and end-date, both inclusive.","text_display":" observation period be calculated as the difference between start-date and end-date, both inclusive.","confidence":1,"confidence_rate":1},{"cnt":[[318,563],[1815,563],[1815,608],[318,608]],"region":{"top_left_x":317,"top_left_y":562,"width":1499,"height":47},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6fa7ad0270784b7b8b6e36c45ba80221","type":"text","conversion_output":true,"text":"Values of laboratory parameters below the blower limit of quantification (LLOQ) will be set to","text_display":"\n\nValues of laboratory parameters below the blower limit of quantification (LLOQ) will be set to","confidence":1,"confidence_rate":1},{"cnt":[[318,610],[466,610],[466,655],[318,655]],"region":{"top_left_x":317,"top_left_y":610,"width":150,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21c04cb1713b479ab7cb61fe44d0f44a","type":"text","conversion_output":true,"text":"LLOQ/2.","text_display":" LLOQ/2.","confidence":0.99951171875,"confidence_rate":0.9999593007867263},{"cnt":[[318,700],[1803,700],[1803,746],[318,746]],"region":{"top_left_x":317,"top_left_y":700,"width":1486,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d13177a0c47b4a3badf88028c9bfe61e","type":"text","conversion_output":true,"text":"The stratification variable \"Treatment with metformin at screening (yes/no)\" will based on the","text_display":"\n\nThe stratification variable \"Treatment with metformin at screening (yes/no)\" will based on the","confidence":1,"confidence_rate":1},{"cnt":[[318,752],[1493,752],[1493,793],[318,793]],"region":{"top_left_x":317,"top_left_y":751,"width":1177,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd5a8507384e4dce90770f3e2f0c8584","type":"text","conversion_output":true,"text":"actual information on concomitant medication recorded through the eCRF.","text_display":" actual information on concomitant medication recorded through the 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Subjects in the SAS will contribute to","confidence":1,"confidence_rate":1},{"cnt":[[318,1354],[1044,1354],[1044,1390],[318,1390]],"region":{"top_left_x":317,"top_left_y":1353,"width":728,"height":38},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5598373ee8c459a940d900fb0a2bdcd","type":"text","conversion_output":true,"text":"the evaluation based on their actual treatment.","text_display":" the evaluation based on their actual treatment.","confidence":1,"confidence_rate":1},{"cnt":[[318,1439],[1854,1439],[1854,1485],[318,1485]],"region":{"top_left_x":317,"top_left_y":1439,"width":1538,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a0b222910154a868a56b49307ee24be","type":"text","conversion_output":true,"text":"Before data are locked for statistical analysis, a review of all data will take place. 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Any decision to","confidence":1,"confidence_rate":1},{"cnt":[[318,1491],[1884,1491],[1884,1536],[318,1536]],"region":{"top_left_x":317,"top_left_y":1491,"width":1568,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7e89bb0d62b42a8ae9b698171effb65","type":"text","conversion_output":true,"text":"exclude a subject or single observations from the statistical analysis is the joint responsibility of the","text_display":" exclude a subject or single observations from the statistical analysis is the joint responsibility of the","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[318,1543],[1749,1543],[1749,1586],[318,1586]],"region":{"top_left_x":317,"top_left_y":1542,"width":1432,"height":44},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d6101bd2b9a34459aa252515a8c2568a","type":"text","conversion_output":true,"text":"members of the study group. 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The subjects or observations to be excluded,","confidence":1,"confidence_rate":1},{"cnt":[[318,1641],[1824,1641],[1824,1684],[318,1684]],"region":{"top_left_x":317,"top_left_y":1641,"width":1508,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7cd6e901e2041c58a05a5b724c4e2b0","type":"text","conversion_output":true,"text":"and the reasons for their exclusion, must be documented and signed by those responsible before","text_display":" and the reasons for their exclusion, must be documented and signed by those responsible before","confidence":1,"confidence_rate":1},{"cnt":[[318,1689],[1846,1689],[1846,1734],[318,1734]],"region":{"top_left_x":317,"top_left_y":1688,"width":1529,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29db1d48a3254f82a13f2215faa25e63","type":"text","conversion_output":true,"text":"database lock. 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This observation period will be used for","text_display":" participant and where data are collected systematically. This observation period will be used for","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[318,1334],[1699,1334],[1699,1377],[318,1377]],"region":{"top_left_x":317,"top_left_y":1334,"width":1383,"height":44},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"769bd025eb494b48b6cccd0c7f41b488","type":"text","conversion_output":true,"text":"supportive analyses of both efficacy and safety. The in-trial observation period includes","text_display":" supportive analyses of both efficacy and safety. 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at a follow-up","text_display":" which is scheduled to take place 5 weeks after planned last dose of trial treatment at a follow-up","confidence":0.9990236759185791,"confidence_rate":0.9999907849387211},{"cnt":[[318,1482],[552,1482],[552,1525],[318,1525]],"region":{"top_left_x":317,"top_left_y":1482,"width":236,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41f9a0bd16d4488db3011c4b66c510b1","type":"text","conversion_output":true,"text":"visit (visit 12).","text_display":" visit (visit 12).","confidence":1,"confidence_rate":1},{"cnt":[[318,1573],[1858,1573],[1858,1616],[318,1616]],"region":{"top_left_x":317,"top_left_y":1572,"width":1542,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc726dfb60c14cedb18f4653efd23011","type":"text","conversion_output":true,"text":"For subjects that prematurely discontinue treatment, their in-trial observation period will end with","text_display":"\n\nFor 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considered to be exposed to trial treatment.","confidence":1,"confidence_rate":1},{"cnt":[[318,2194],[1850,2194],[1850,2237],[318,2237]],"region":{"top_left_x":317,"top_left_y":2193,"width":1533,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8519ee2642b84f3398e36ab569580d1d","type":"text","conversion_output":true,"text":"For adverse events and hypoglycaemic episodes, this period includes those observations from the","text_display":"\n\nFor adverse events and hypoglycaemic episodes, this period includes those observations from the","confidence":1,"confidence_rate":1},{"cnt":[[318,2243],[1850,2243],[1850,2288],[318,2288]],"region":{"top_left_x":317,"top_left_y":2242,"width":1533,"height":47},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8bab9372bd38478f932860d0c8445049","type":"text","conversion_output":true,"text":"in-trial observation period that are recorded on or after the date of first dose of 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2015 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 8 \\text { of } 551\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 21 January 2015 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 8 \\text { of } 551\\end{array}\\right|\\)","confidence":0.4124956906895019,"confidence_rate":0.993557125771791},{"cnt":[[1792,232],[1970,232],[1970,260],[1792,260]],"region":{"top_left_x":1791,"top_left_y":232,"width":180,"height":28},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"3ea2673234b745c38c2f5d8e46ee8371","type":"page_info","conversion_output":false,"text":"Novo 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To avoid potential confounding of initiation of anti-diabetic rescue therapies on efficacy","text_display":" period. To avoid potential confounding of initiation of anti-diabetic rescue therapies on efficacy","confidence":1,"confidence_rate":1},{"cnt":[[318,1392],[1888,1392],[1888,1437],[318,1437]],"region":{"top_left_x":317,"top_left_y":1392,"width":1572,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"503313251069490ab3fd3e40eaf9d636","type":"text","conversion_output":true,"text":"endpoints, information that is collected after initiation of anti-diabetic rescue therapies are excluded","text_display":" endpoints, information that is collected after initiation of anti-diabetic rescue therapies are excluded","confidence":1,"confidence_rate":1},{"cnt":[[318,1444],[1867,1444],[1867,1489],[318,1489]],"region":{"top_left_x":317,"top_left_y":1443,"width":1550,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5356e96ff48a435ba1c9504f5d8aa9e3","type":"text","conversion_output":true,"text":"from this observation period. Specifically, it includes observations recorded at or after date of first","text_display":" from this observation period. Specifically, it includes observations recorded at or after date of first","confidence":1,"confidence_rate":1},{"cnt":[[318,1491],[1450,1491],[1450,1536],[318,1536]],"region":{"top_left_x":317,"top_left_y":1491,"width":1134,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e39f3cde242414daf00ca8a65e4ee5c","type":"text","conversion_output":true,"text":"dose of trial treatment and not after the first occurrence of the following","text_display":" dose of trial treatment and not after the first occurrence of the following","confidence":1,"confidence_rate":1},{"cnt":[[378,1581],[1248,1581],[1248,1626],[378,1626]],"region":{"top_left_x":378,"top_left_y":1581,"width":871,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2bc57403a91440f3a8645989f18658ee","type":"text","conversion_output":true,"text":"- the end-date of the on-treatment observation period","text_display":"\n- the end-date of the on-treatment observation period","confidence":1,"confidence_rate":1},{"cnt":[[378,1633],[922,1633],[922,1669],[378,1669]],"region":{"top_left_x":378,"top_left_y":1632,"width":544,"height":38},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"412557204dd54299905a725624186db1","type":"text","conversion_output":true,"text":"- initiation of rescue medication","text_display":"\n- initiation of rescue medication","confidence":1,"confidence_rate":1},{"cnt":[[318,1721],[1833,1721],[1833,1764],[318,1764]],"region":{"top_left_x":317,"top_left_y":1720,"width":1516,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5da0ef61a29d49d4a2fb728959ab50cc","type":"text","conversion_output":true,"text":"This observation period is the primary observation period for examination of efficacy endpoints.","text_display":"\n\nThis observation period is the primary observation period for examination of efficacy 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the last post-","text_display":" last observation carried forward (LOCF), where missing observations are imputed as the last post","confidence":1,"confidence_rate":1},{"cnt":[[318,2067],[1781,2067],[1781,2110],[318,2110]],"region":{"top_left_x":317,"top_left_y":2066,"width":1465,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e309391e2e984ae9b29efb71e4f17ff2","type":"text","conversion_output":true,"text":"baseline available value obtained prior to the missing assessment, and by prediction from the","text_display":"baseline available value obtained prior to the missing assessment, and by prediction from the","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[318,2116],[1835,2116],[1835,2159],[318,2159]],"region":{"top_left_x":317,"top_left_y":2116,"width":1518,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"246071477a9d4bfea176208898c4e74b","type":"text","conversion_output":true,"text":"standard MMRM for the specific endpoint, where missing observations are imputed as the value","text_display":" standard MMRM for the specific endpoint, where missing observations are imputed as the value","confidence":1,"confidence_rate":1},{"cnt":[[318,2166],[1863,2166],[1863,2209],[318,2209]],"region":{"top_left_x":317,"top_left_y":2165,"width":1546,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7a72a492890473681f81316476c5372","type":"text","conversion_output":true,"text":"that is predicted by the MMRM model. The MMRM imputations will be based on the randomised","text_display":" that is predicted by the MMRM model. The MMRM imputations will be based on the randomised","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[318,2213],[1815,2213],[1815,2258],[318,2258]],"region":{"top_left_x":317,"top_left_y":2212,"width":1499,"height":47},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d17b0dad39d4b4986d27264caef833d","type":"text","conversion_output":true,"text":"treatment and carried out for those endpoints where the standard MMRM analysis is part of the","text_display":" treatment and carried out for those endpoints where the standard MMRM analysis is part of the","confidence":1,"confidence_rate":1},{"cnt":[[318,2264],[526,2264],[526,2301],[318,2301]],"region":{"top_left_x":317,"top_left_y":2264,"width":210,"height":37},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ccbed01f48840ac91f3c338badb22a6","type":"text","conversion_output":true,"text":"examination.","text_display":" 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\\\\ \\text { Page: } & 9 \\text { of } 551\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 21 January } 2015 \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 9 \\text { of } 551\\end{array}\\right|\\)","confidence":0.3804034327621886,"confidence_rate":0.9929184072803573},{"cnt":[[1792,232],[1970,232],[1970,260],[1792,260]],"region":{"top_left_x":1791,"top_left_y":232,"width":180,"height":28},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5d709fdadd7d4629aff63c920b7af3f6","type":"page_info","conversion_output":false,"text":"Novo 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U111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[924,305],[1147,305],[1147,337],[924,337]],"region":{"top_left_x":923,"top_left_y":305,"width":225,"height":33},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8c08efcbd75949e58a60afd03c44a062","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":0.99560546875,"confidence_rate":0.9997409620511278},{"cnt":[[318,335],[694,335],[694,363],[318,363]],"region":{"top_left_x":317,"top_left_y":335,"width":377,"height":29},"line":7,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b413c7fa755a40ddb7c0109427d00b12","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[318,425],[1828,425],[1828,466],[318,466]],"region":{"top_left_x":317,"top_left_y":425,"width":1512,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bfe567710b39405fa9976c6db739f244","type":"text","conversion_output":true,"text":"Note that the LOCF and MMRM imputations depend on the considered observation period, and","text_display":"\n\nNote that the LOCF and MMRM imputations depend on the considered observation period, and","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[318,473],[1454,473],[1454,518],[318,518]],"region":{"top_left_x":317,"top_left_y":472,"width":1138,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d299c18aa5d40e1b34ad738ff1e89db","type":"text","conversion_output":true,"text":"separate imputation for the three observation periods will be carried out.","text_display":" separate imputation for the three observation periods will be carried out.","confidence":1,"confidence_rate":1},{"cnt":[[314,559],[758,559],[758,608],[314,608]],"region":{"top_left_x":313,"top_left_y":558,"width":446,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"304205c8c16a4f60a00bd26e3e30206b","type":"section_header","conversion_output":false,"children_ids":["6815e83985cb498db168732d4ca73d77"],"text":"","text_display":""},{"cnt":[[318,563],[754,563],[754,608],[318,608]],"region":{"top_left_x":317,"top_left_y":562,"width":438,"height":47},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6815e83985cb498db168732d4ca73d77","type":"text","conversion_output":true,"parent_id":"304205c8c16a4f60a00bd26e3e30206b","text":"2.6 Primary endpoint","text_display":"\n\n\\subsection*{2.6 Primary 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will be made between a) the pool of the two treatment arms","text_display":" comparison of the primary endpoint will be made between a) the pool of the two treatment arms","confidence":0.97998046875,"confidence_rate":0.999793667846927},{"cnt":[[318,868],[1712,868],[1712,913],[318,913]],"region":{"top_left_x":317,"top_left_y":867,"width":1396,"height":47},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"622b5e0a9c754613b0804a155a7e78bc","type":"text","conversion_output":true,"text":"using standard and fast escalation regimens to an end dose of 40 mg and b) placebo. 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Both absolute ( kg ) and relative change","text_display":"\n\nThese endpoints will be analysed by the standard MMRM. 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Missing response","text_display":" weeks will be presented for the planned comparisons between treatment arms. 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Fasting HOMA-B (\\%) = 20 x fasting insulin [ \\(\\mu U / ml ] /( FPG [ mmol / L ]-3.5)\\)","text_display":"\n1. Fasting HOMA-B (\\%) = 20 x fasting insulin [ \\(\\mu U / ml ] /( FPG [ mmol / L ]-3.5)\\)","confidence":0.6946318303399688,"confidence_rate":0.9961718375963512},{"cnt":[[318,791],[1485,791],[1485,831],[318,831]],"region":{"top_left_x":317,"top_left_y":790,"width":1168,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0d0d116b7694cfa91ad5df4ea05d314","type":"text","conversion_output":true,"text":"2. Fasting HOMA-IR (\\%) = fasting insulin [ \\(\\mu U / ml\\) ] x FPG \\([ mmol / L ] / 22.5\\)","text_display":"\n2. Fasting HOMA-IR (\\%) = fasting insulin [ \\(\\mu U / ml\\) ] x FPG \\([ mmol / L ] / 22.5\\)","confidence":0.40814828808094733,"confidence_rate":0.9899817037624932},{"cnt":[[316,877],[574,877],[574,917],[316,917]],"region":{"top_left_x":315,"top_left_y":876,"width":259,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8daa3a87fb11499fb536c6ee40c6debd","type":"section_header","conversion_output":false,"children_ids":["545b502a882f404b82f8dc35aa38c11a"],"text":"","text_display":""},{"cnt":[[318,881],[574,881],[574,913],[318,913]],"region":{"top_left_x":317,"top_left_y":880,"width":257,"height":34},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"545b502a882f404b82f8dc35aa38c11a","type":"text","conversion_output":true,"parent_id":"8daa3a87fb11499fb536c6ee40c6debd","text":"PRO outcomes","text_display":"\n\n\\section*{PRO outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[318,967],[1888,967],[1888,1012],[318,1012]],"region":{"top_left_x":317,"top_left_y":966,"width":1572,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ddba7e9c0e6b4ad087fd61111cf1f9f8","type":"text","conversion_output":true,"text":"The outcomes from the SF-36 questionnaire in terms of total scores overall and within each domain","text_display":"\n\nThe outcomes from the SF-36 questionnaire in terms of total scores overall and within each domain","confidence":1,"confidence_rate":1},{"cnt":[[318,1018],[1601,1018],[1601,1059],[318,1059]],"region":{"top_left_x":317,"top_left_y":1018,"width":1284,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab39def659454598b150b0548671e09a","type":"text","conversion_output":true,"text":"will be calculated. Each of these scores will be analysed by the standard MMRM.","text_display":" will be calculated. 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The on-","text_display":"\n\nAll safety endpoints will be summarised and analysed using the safety analysis set. The on","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[318,1225],[1841,1225],[1841,1270],[318,1270]],"region":{"top_left_x":317,"top_left_y":1224,"width":1525,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3463cebe3fab4ca495ad4c08d76be727","type":"text","conversion_output":true,"text":"treatment observation period will be the primary observation period for examination of all safety","text_display":"treatment observation period will be the primary observation period for examination of all safety","confidence":1,"confidence_rate":1},{"cnt":[[318,1276],[483,1276],[483,1317],[318,1317]],"region":{"top_left_x":317,"top_left_y":1276,"width":167,"height":41},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d58fe102dc614577a07406bf11f2b97a","type":"text","conversion_output":true,"text":"endpoints.","text_display":" endpoints.","confidence":1,"confidence_rate":1},{"cnt":[[314,1362],[578,1362],[578,1403],[314,1403]],"region":{"top_left_x":313,"top_left_y":1362,"width":265,"height":41},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ec5efdeafd54f7abba207800154ea7e","type":"section_header","conversion_output":false,"children_ids":["9aaa0505a0414655adf61afdfcb19fa3"],"text":"","text_display":""},{"cnt":[[318,1366],[574,1366],[574,1399],[318,1399]],"region":{"top_left_x":317,"top_left_y":1366,"width":257,"height":33},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9aaa0505a0414655adf61afdfcb19fa3","type":"text","conversion_output":true,"parent_id":"8ec5efdeafd54f7abba207800154ea7e","text":"Adverse events","text_display":"\n\n\\section*{Adverse events}","confidence":1,"confidence_rate":1},{"cnt":[[318,1452],[1783,1452],[1783,1497],[318,1497]],"region":{"top_left_x":317,"top_left_y":1452,"width":1467,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c6fd3312309b4af8aa5b7a0fc536c26c","type":"text","conversion_output":true,"text":"All AEs will be coded using the most recent version of the Medical Dictionary for regulatory","text_display":"\n\nAll AEs will be coded using the most recent version of the Medical Dictionary for regulatory","confidence":1,"confidence_rate":1},{"cnt":[[318,1500],[1803,1500],[1803,1545],[318,1545]],"region":{"top_left_x":317,"top_left_y":1499,"width":1486,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"351332c2684e41ea916d15d3ea855074","type":"text","conversion_output":true,"text":"Activities (MedDRA) coding. This is version 17.1. A TEAE is an event that has onset date (or","text_display":" Activities (MedDRA) coding. This is version 17.1. A TEAE is an event that has onset date (or","confidence":1,"confidence_rate":1},{"cnt":[[318,1551],[1886,1551],[1886,1594],[318,1594]],"region":{"top_left_x":317,"top_left_y":1551,"width":1570,"height":44},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fdcbc0fb13304004a1f36284c3ca295a","type":"text","conversion_output":true,"text":"increase in severity) during the on-treatment observation period. On-treatment AEs are summarised","text_display":" increase in severity) during the on-treatment observation period. On-treatment AEs are summarised","confidence":1,"confidence_rate":1},{"cnt":[[318,1601],[1824,1601],[1824,1644],[318,1644]],"region":{"top_left_x":317,"top_left_y":1600,"width":1508,"height":44},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5fcb0cb0dc8c4823818530c968601373","type":"text","conversion_output":true,"text":"descriptively. These are supported by outputs including all in-trial adverse events, i.e. AEs with","text_display":" descriptively. These are supported by outputs including all in-trial adverse events, i.e. AEs with","confidence":1,"confidence_rate":1},{"cnt":[[318,1650],[1884,1650],[1884,1695],[318,1695]],"region":{"top_left_x":317,"top_left_y":1650,"width":1568,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15c2c3a4a9984c4995849a9f01705e8c","type":"text","conversion_output":true,"text":"onset date (or increase in severity) during the in-trial observation period. Adverse events with onset","text_display":" onset date (or increase in severity) during the in-trial observation period. Adverse events with onset","confidence":1,"confidence_rate":1},{"cnt":[[318,1697],[1480,1697],[1480,1742],[318,1742]],"region":{"top_left_x":317,"top_left_y":1697,"width":1164,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd55cabd0dcb4235aeed1126f17d2459","type":"text","conversion_output":true,"text":"after the end of the in-trial observation period will be reported in a listing.","text_display":" after the end of the in-trial observation period will be reported in a listing.","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[318,1788],[1880,1788],[1880,1833],[318,1833]],"region":{"top_left_x":317,"top_left_y":1787,"width":1563,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8455ec26f4884a638363d6d1c07af67c","type":"text","conversion_output":true,"text":"Most frequent adverse events will be defined as preferred terms that are experienced by at least \\(5 \\%\\)","text_display":"\n\nMost frequent adverse events will be defined as preferred terms that are experienced by at least \\(5 \\%\\)","confidence":0.9990234375,"confidence_rate":0.9999905142231666},{"cnt":[[318,1835],[1008,1835],[1008,1880],[318,1880]],"region":{"top_left_x":317,"top_left_y":1834,"width":691,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d905991ff4754777a691c2fe9d49f7bf","type":"text","conversion_output":true,"text":"of the subjects in any of the treatment arms.","text_display":" of the subjects in any of the treatment arms.","confidence":1,"confidence_rate":1},{"cnt":[[318,1925],[1871,1925],[1871,1970],[318,1970]],"region":{"top_left_x":317,"top_left_y":1925,"width":1555,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"512283a101654ae6a881bc21d70d2fd2","type":"text","conversion_output":true,"text":"Based on MedDRA searches, 19 pre-defined groups of adverse events will be evaluated. These are","text_display":"\n\nBased on MedDRA searches, 19 pre-defined groups of adverse events will be evaluated. These are","confidence":1,"confidence_rate":1},{"cnt":[[318,1977],[1893,1977],[1893,2022],[318,2022]],"region":{"top_left_x":317,"top_left_y":1976,"width":1576,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70861ca7d1af4eaa94e4f6f7e457197f","type":"text","conversion_output":true,"text":"defined by Global Safety and consist of pre-specified preferred terms. The groups are the following:","text_display":" defined by Global Safety and consist of pre-specified preferred terms. The groups are the following:","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[318,2067],[870,2067],[870,2103],[318,2103]],"region":{"top_left_x":317,"top_left_y":2066,"width":554,"height":38},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0734e6adbf114e76b9757ddc1f200034","type":"text","conversion_output":true,"text":"- Gastrointestinal adverse events","text_display":"\n- Gastrointestinal adverse events","confidence":1,"confidence_rate":1},{"cnt":[[318,2114],[662,2114],[662,2159],[318,2159]],"region":{"top_left_x":317,"top_left_y":2114,"width":345,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ebc1aa067d694b8bb950492e2d8c00f7","type":"text","conversion_output":true,"text":"- Allergic reactions","text_display":"\n- Allergic 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2012-004994-16","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[318,425],[1240,425],[1240,466],[318,466]],"region":{"top_left_x":317,"top_left_y":425,"width":923,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"084f412fa442400889d7e20aa7787f66","type":"text","conversion_output":true,"text":"These endpoints will be analysed by the standard MMRM.","text_display":"\n\nThese endpoints will be analysed by the standard 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The estimated differences and corresponding 95\\% confidence","text_display":" analysed by the standard MMRM. 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Standard errors of the means will be calculated using the Delta-method.","text_display":" p-values. 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2012-004994-16","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[318,423],[1850,423],[1850,466],[318,466]],"region":{"top_left_x":317,"top_left_y":423,"width":1533,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6008e71c56aa47b8a2ce17f8eb872cf9","type":"text","conversion_output":true,"text":"- Cumulative distribution functions presenting the distribution of the maximum value observed","text_display":"\n- Cumulative distribution functions presenting the distribution of the maximum value observed","confidence":1,"confidence_rate":1},{"cnt":[[374,473],[597,473],[597,518],[374,518]],"region":{"top_left_x":373,"top_left_y":472,"width":225,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"292663d0f2c5485f9362d3a6134428b0","type":"text","conversion_output":true,"text":"post-baseline.","text_display":" 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These will be done on log-scale and reported with the following statistical outputs:","text_display":" analyses. 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tests}","confidence":0.9985356330871582,"confidence_rate":0.999955593708839},{"cnt":[[348,1111],[1785,1111],[1785,1149],[348,1149]],"region":{"top_left_x":348,"top_left_y":1110,"width":1438,"height":40},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e569ed1e8f544b258044d76287d30227","type":"text","conversion_output":true,"text":"Results of pregnancy tests (based on human chorionic gonadotropin samples) for male","text_display":"\n\nResults of pregnancy tests (based on human chorionic gonadotropin samples) for male","confidence":0.994140625,"confidence_rate":0.9999332225877904},{"cnt":[[348,1147],[889,1147],[889,1188],[348,1188]],"region":{"top_left_x":348,"top_left_y":1147,"width":542,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33f9ecfc93b342c4a2c0d5bcc996c0bb","type":"text","conversion_output":true,"text":"subjects will not be summarised.","text_display":" subjects will not be summarised.","confidence":0.9990234375,"confidence_rate":0.9999735938716796},{"cnt":[[344,1229],[917,1229],[917,1278],[344,1278]],"region":{"top_left_x":343,"top_left_y":1228,"width":575,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94f81c840dc340d28218de1f254f5ea3","type":"section_header","conversion_output":false,"children_ids":["60c64d44ba83405baf7299f8ad49cc4a"],"text":"","text_display":""},{"cnt":[[348,1229],[917,1229],[917,1274],[348,1274]],"region":{"top_left_x":348,"top_left_y":1228,"width":570,"height":47},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60c64d44ba83405baf7299f8ad49cc4a","type":"text","conversion_output":true,"parent_id":"94f81c840dc340d28218de1f254f5ea3","text":"Subjects lost to follow-up","text_display":"\n\n\\section*{Subjects lost to follow-up}","confidence":0.99853515625,"confidence_rate":0.9999527134508668},{"cnt":[[408,1326],[1755,1326],[1755,1364],[408,1364]],"region":{"top_left_x":408,"top_left_y":1325,"width":1348,"height":40},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e774184effb6445cbd1edfea8d07329d","type":"text","conversion_output":true,"text":"1. Lost to follow-up (Yes/No) will be defined based on comments to reasons for","text_display":"\n1. Lost to follow-up (Yes/No) will be defined based on comments to reasons for","confidence":1,"confidence_rate":1},{"cnt":[[466,1366],[1747,1366],[1747,1403],[466,1403]],"region":{"top_left_x":466,"top_left_y":1366,"width":1281,"height":37},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a46b4d2cdb640f4986bd242911c5847","type":"text","conversion_output":true,"text":"premature treatment discontinuation given on the end-of-trial electronic case","text_display":" premature treatment discontinuation given on the end-of-trial electronic case","confidence":1,"confidence_rate":1},{"cnt":[[466,1405],[1781,1405],[1781,1446],[466,1446]],"region":{"top_left_x":466,"top_left_y":1405,"width":1316,"height":41},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82b66ed76a7a436bb6a5c14fe04746de","type":"text","conversion_output":true,"text":"report form. For the following subjects status is thus \"Yes\" for lost to follow-up:","text_display":" report form. For the following subjects status is thus \"Yes\" for lost to follow-up:","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[546,1463],[752,1463],[752,1897],[546,1897]],"region":{"top_left_x":545,"top_left_y":1463,"width":207,"height":435},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f7bf3726dae48c0a7f859fb19e44b1b","type":"diagram","conversion_output":true,"text":"","text_display":"\n![](https://cdn.mathpix.com/cropped/5199561c-e755-4cb9-9600-eb1169e648ec-30.jpg?height=435&width=207&top_left_y=1463&top_left_x=545)"},{"cnt":[[466,1921],[1699,1921],[1699,1962],[466,1962]],"region":{"top_left_x":466,"top_left_y":1920,"width":1234,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f3a851f1d5343a6b9c11ac4d8dcd2bd","type":"text","conversion_output":true,"text":"For these subjects, the on-treatment and the on-treatment without rescue","text_display":"\n\nFor these subjects, the on-treatment and the on-treatment without rescue","confidence":1,"confidence_rate":1},{"cnt":[[464,1959],[1785,1959],[1785,2000],[464,2000]],"region":{"top_left_x":464,"top_left_y":1959,"width":1322,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98a57ec7970b48ec990d3b4cdb586441","type":"text","conversion_output":true,"text":"observation periods will use the date of last drug from the IVRS system as end-","text_display":" observation periods will use the date of last drug from the IVRS system as end","confidence":1,"confidence_rate":1},{"cnt":[[464,2002],[552,2002],[552,2035],[464,2035]],"region":{"top_left_x":464,"top_left_y":2002,"width":89,"height":33},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"45a782d9443c46b99449c11b53df3567","type":"text","conversion_output":true,"text":"date.","text_display":"date.","confidence":1,"confidence_rate":1},{"cnt":[[1646,2501],[1796,2501],[1796,2533],[1646,2533]],"region":{"top_left_x":1645,"top_left_y":2500,"width":152,"height":34},"line":32,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1eea6c7e960043a2bcd4eee8f57dec0a","type":"page_info","conversion_output":false,"text":"Page 2 of 2","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]}]}
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