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The Investigator must confirm the","text_display":" safety risk and the subject is at least 18 years of age. 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run-in period into the following groups: 1 to \\(<2\\) attacks per 4 weeks,","text_display":" rate observed during the run-in period into the following groups: 1 to \\(<2\\) attacks per 4 weeks,","confidence":0.9731698036193848,"confidence_rate":0.9997482104405792},{"cnt":[[305,1650],[1274,1650],[1274,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1650,"width":970,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2421cb737904919aeb3732d883f1f34","type":"text","conversion_output":true,"text":"2 to \\(<3\\) attacks per 4 weeks, and \\(\\geq 3\\) attacks per 4 weeks.","text_display":" 2 to \\(<3\\) attacks per 4 weeks, and \\(\\geq 3\\) attacks per 4 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Subjects randomized to one of the 4","text_display":" on Day 0 through two weeks after the final dose. 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\\multicolumn{6}{|l|}{Table 1. Treatment Period Dosing Schedule} \\\\\n\\hline \\multicolumn{2}{|c|}{Treatment Period} & \\multicolumn{4}{|c|}{Treatment Arms: DX-2930 or Placebo} \\\\\n\\hline Dose Number & Dose Day/ Week & 300 mg every 2 weeks & 300 mg every 4 weeks & 150 mg every 4 weeks & Placebo \\\\\n\\hline \\multicolumn{6}{|r|}{\\begin{tabular}{l}\n1 Day 0/ Week 0 \\\\\nDX-2930 \\\\\nDX-2930 \\\\\nDX-2930 \\\\\nPlacebo\n\\end{tabular}} \\\\\n\\hline 2 & Day 14/ Week 2 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 3 & Day 28/ Week 4 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 4 & Day 42/ Week 6 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 5 & Day 56/ Week 8 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 6 & Day 70/ Week 10 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 7 & Day 84/ Week 12 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 8 & Day 98/ Week 14 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 9 & Day 112/ Week 16 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 10 & Day 126/ Week 18 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 11 & Day 140/ Week 20 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 12 & Day 154/ Week 22 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 13 & Day 168/ Week 24 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline -- & Day 182/ Week 26 & No Dose & No Dose & No Dose & No Dose \\\\\n\\hline \\multicolumn{6}{|c|}{\\begin{tabular}{l}\nOpen-Label Extension (OLE) Study: \\\\\nSubjects who complete the treatment period will be offered the option of enrolling in an open-label extension (OLE) study that will be described in a separate protocol (DX-293004). \\\\\nFollow-up Period: \\\\\nSubjects who do not participate in the OLE will undergo safety and additional evaluations (i.e., PK and PD) during an 8 week follow-up period. Subjects (or caregivers) will be instructed to inform the site of any HAE attack they experience after the final follow-up visit.\n\\end{tabular}} \\\\\n\\hline \\multicolumn{6}{|c|}{\\begin{tabular}{l}\nStudy Population: \\\\\nThe study will enroll approximately 120 subjects to provide 108 completed. Subjects will be 12 years of age and older with a confirmed diagnosis of HAE (Type I or II) who experience at least 1 Investigator-confirmed attack per 4 weeks during the run-in period. HAE diagnosis will be confirmed through documented clinical history consistent with HAE and diagnostic testing conducted either during the screening visit or during participation in study DX-2930-02.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline \\multicolumn{6}{|l|}{Table 1. Treatment Period Dosing Schedule} \\\\\n\\hline \\multicolumn{2}{|c|}{Treatment Period} & \\multicolumn{4}{|c|}{Treatment Arms: DX-2930 or Placebo} \\\\\n\\hline Dose Number & Dose Day/ Week & 300 mg every 2 weeks & 300 mg every 4 weeks & 150 mg every 4 weeks & Placebo \\\\\n\\hline \\multicolumn{6}{|r|}{\\begin{tabular}{l}\n1 Day 0/ Week 0 \\\\\nDX-2930 \\\\\nDX-2930 \\\\\nDX-2930 \\\\\nPlacebo\n\\end{tabular}} \\\\\n\\hline 2 & Day 14/ Week 2 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 3 & Day 28/ Week 4 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 4 & Day 42/ Week 6 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 5 & Day 56/ Week 8 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 6 & Day 70/ Week 10 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 7 & Day 84/ Week 12 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 8 & Day 98/ Week 14 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 9 & Day 112/ Week 16 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 10 & Day 126/ Week 18 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 11 & Day 140/ Week 20 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline 12 & Day 154/ Week 22 & DX-2930 & Placebo & Placebo & Placebo \\\\\n\\hline 13 & Day 168/ Week 24 & DX-2930 & DX-2930 & DX-2930 & Placebo \\\\\n\\hline -- & Day 182/ Week 26 & No Dose & No Dose & No Dose & No Dose \\\\\n\\hline \\multicolumn{6}{|c|}{\\begin{tabular}{l}\nOpen-Label Extension (OLE) Study: \\\\\nSubjects who complete the treatment period will be offered the option of enrolling in an open-label extension (OLE) study that will be described in a separate protocol (DX-293004). \\\\\nFollow-up Period: \\\\\nSubjects who do not participate in the OLE will undergo safety and additional evaluations (i.e., PK and PD) during an 8 week follow-up period. Subjects (or caregivers) will be instructed to inform the site of any HAE attack they experience after the final follow-up visit.\n\\end{tabular}} \\\\\n\\hline \\multicolumn{6}{|c|}{\\begin{tabular}{l}\nStudy Population: \\\\\nThe study will enroll approximately 120 subjects to provide 108 completed. Subjects will be 12 years of age and older with a confirmed diagnosis of HAE (Type I or II) who experience at least 1 Investigator-confirmed attack per 4 weeks during the run-in period. 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DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e51530b83c634af199094b8b364b4c6f","type":"page_info","conversion_output":false,"text":"Final: 14 September 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Males and females 12 years of age or older at the time of screening.","text_display":"\n1. Males and females 12 years of age or older at the time of screening.","confidence":1,"confidence_rate":1},{"cnt":[[301,455],[1671,455],[1671,511],[301,511]],"region":{"top_left_x":300,"top_left_y":455,"width":1372,"height":57},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2510748e81b426d9c411f0f04452037","type":"text","conversion_output":true,"text":"2. Documented diagnosis of HAE (Type I or II) based upon all of the following:","text_display":"\n2. 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Subjects with functional C1-INH level 40-50\\% of the normal level may","text_display":" normal level. Subjects with functional C1-INH level 40-50\\% of the normal level may","confidence":0.9464836120605469,"confidence_rate":0.9993679972377644},{"cnt":[[430,752],[1848,752],[1848,806],[430,806]],"region":{"top_left_x":429,"top_left_y":751,"width":1419,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37f413cae43d4720852be9d63981c259","type":"text","conversion_output":true,"text":"be enrolled if they also have a C4 level below the normal range. Subjects may begin","text_display":" be enrolled if they also have a C4 level below the normal range. Subjects may begin","confidence":0.9863345623016357,"confidence_rate":0.9998436523456835},{"cnt":[[430,801],[1734,801],[1734,853],[430,853]],"region":{"top_left_x":429,"top_left_y":801,"width":1305,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9dd68e490b34c13b0906daa0483200c","type":"text","conversion_output":true,"text":"participating in the run-in period before these diagnostic results are available.","text_display":" participating in the run-in period before these diagnostic results are available.","confidence":1,"confidence_rate":1},{"cnt":[[430,846],[1876,846],[1876,900],[430,900]],"region":{"top_left_x":429,"top_left_y":846,"width":1447,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b0e180d51364fc1ae3d68e573deefd6","type":"text","conversion_output":true,"text":"Subjects may be retested if results are incongruent with clinical history or believed by","text_display":" Subjects may be retested if results are incongruent with clinical history or believed by","confidence":1,"confidence_rate":1},{"cnt":[[430,898],[1326,898],[1326,947],[430,947]],"region":{"top_left_x":429,"top_left_y":898,"width":897,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70d9d3c10e9d4f379399ab7c3c683ad3","type":"text","conversion_output":true,"text":"the Investigator to be confounded by recent LTP use.","text_display":" the Investigator to be confounded by recent LTP use.","confidence":1,"confidence_rate":1},{"cnt":[[370,945],[1818,945],[1818,999],[370,999]],"region":{"top_left_x":369,"top_left_y":945,"width":1449,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"219877ec008241b7ab11066d31c7a477","type":"text","conversion_output":true,"text":"- At least one of the following: Age at reported onset of first angioedema symptoms","text_display":"\n- At least one of the following: Age at reported onset of first angioedema symptoms","confidence":1,"confidence_rate":1},{"cnt":[[430,993],[1846,993],[1846,1046],[430,1046]],"region":{"top_left_x":429,"top_left_y":992,"width":1417,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"564970c3a6154d2cb6c76168c02213ed","type":"text","conversion_output":true,"text":"\\(\\leq 30\\) years, a family history consistent with HAE Type I or II, or C1q within normal","text_display":" \\(\\leq 30\\) years, a family history consistent with HAE Type I or II, or C1q within normal","confidence":0.9990234375,"confidence_rate":0.9999886391383975},{"cnt":[[430,1044],[544,1044],[544,1089],[430,1089]],"region":{"top_left_x":429,"top_left_y":1044,"width":115,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57b300421c9c465f8a2c43dd6599fcbb","type":"text","conversion_output":true,"text":"range.","text_display":" range.","confidence":1,"confidence_rate":1},{"cnt":[[301,1087],[1863,1087],[1863,1141],[301,1141]],"region":{"top_left_x":300,"top_left_y":1087,"width":1563,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"786013bd33c147998f395774227f4bf9","type":"text","conversion_output":true,"text":"3. 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The test product will be administered subcutaneously into the upper arm in a","text_display":" solution. The test product will be administered subcutaneously into the upper arm in a","confidence":1,"confidence_rate":1},{"cnt":[[305,1594],[587,1594],[587,1644],[305,1644]],"region":{"top_left_x":305,"top_left_y":1594,"width":282,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0aad2a3636b54b008683a9b7f89e2bd7","type":"text","conversion_output":true,"text":"blinded manner.","text_display":" blinded manner.","confidence":1,"confidence_rate":1},{"cnt":[[305,1706],[1809,1706],[1809,1760],[305,1760]],"region":{"top_left_x":305,"top_left_y":1705,"width":1504,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02df81b4465f4c5b993b08526fb866a1","type":"text","conversion_output":true,"text":"For each 300 mg dose of DX-2930, each subject will receive a total of 3 mL , divided into","text_display":"\n\nFor each 300 mg dose of DX-2930, each subject will receive a total of 3 mL , divided into","confidence":1,"confidence_rate":1},{"cnt":[[305,1755],[1781,1755],[1781,1807],[305,1807]],"region":{"top_left_x":305,"top_left_y":1755,"width":1477,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d127cac9b9f4c4b9c69919f99828f6e","type":"text","conversion_output":true,"text":"2 separate 1.5 mL SC injections of DX-2930. The 2 injections will be given in the same","text_display":" 2 separate 1.5 mL SC injections of DX-2930. The 2 injections will be given in the same","confidence":0.9892899582857761,"confidence_rate":0.999890130454191},{"cnt":[[305,1805],[1454,1805],[1454,1858],[305,1858]],"region":{"top_left_x":305,"top_left_y":1804,"width":1150,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e64c26bea01421b897c558764ef5038","type":"text","conversion_output":true,"text":"upper arm, with at least 2 cm separation between each injection site.","text_display":" upper arm, with at least 2 cm separation between each injection site.","confidence":1,"confidence_rate":1},{"cnt":[[305,1912],[1811,1912],[1811,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1912,"width":1507,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48f0506d4f3b4825becaf283b300cf31","type":"text","conversion_output":true,"text":"For each 150 mg dose of DX-2930, each subject will receive a total of 3 mL , divided into","text_display":"\n\nFor each 150 mg dose of DX-2930, each subject will receive a total of 3 mL , divided into","confidence":1,"confidence_rate":1},{"cnt":[[305,1959],[1820,1959],[1820,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1959,"width":1515,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3be4b1eccea442c4829502c834969b4a","type":"text","conversion_output":true,"text":"2 separate 1.5 mL SC injections, where one injection is DX-2930 and the other is placebo.","text_display":" 2 separate 1.5 mL SC injections, where one injection is DX-2930 and the other is placebo.","confidence":0.7595836844675432,"confidence_rate":0.9971979659096745},{"cnt":[[305,2007],[1841,2007],[1841,2060],[305,2060]],"region":{"top_left_x":305,"top_left_y":2006,"width":1537,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13114273422e47bc8473ed341dd94cea","type":"text","conversion_output":true,"text":"The 2 injections will be given in the same upper arm, with at least 2 cm separation between","text_display":" The 2 injections will be given in the same upper arm, with at least 2 cm separation between","confidence":1,"confidence_rate":1},{"cnt":[[305,2058],[629,2058],[629,2108],[305,2108]],"region":{"top_left_x":305,"top_left_y":2058,"width":325,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"225a7a0230c34158855a2989f037f2b5","type":"text","conversion_output":true,"text":"each injection site.","text_display":" each injection 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Administration:}","confidence":0.9990234375,"confidence_rate":0.9999792121384572},{"cnt":[[305,2174],[1828,2174],[1828,2228],[305,2228]],"region":{"top_left_x":305,"top_left_y":2174,"width":1524,"height":54},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f8ae1ef9cc841508dbda2a536cabec4","type":"text","conversion_output":true,"text":"Placebo consists of the inactive formulation of the test product: 30 mM sodium phosphate,","text_display":"\n\nPlacebo consists of the inactive formulation of the test product: 30 mM sodium phosphate,","confidence":1,"confidence_rate":1},{"cnt":[[309,2221],[1858,2221],[1858,2275],[309,2275]],"region":{"top_left_x":309,"top_left_y":2221,"width":1550,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95648909c8eb451889bd065dfb2fbeb8","type":"text","conversion_output":true,"text":"19 mM citric acid, 50 mM histidine, 90 mM sodium chloride, pH 6.0 with \\(0.01 \\%\\) Tween 80 .","text_display":" 19 mM citric acid, 50 mM histidine, 90 mM sodium chloride, pH 6.0 with \\(0.01 \\%\\) Tween 80 .","confidence":0.88720703125,"confidence_rate":0.9989507533204068},{"cnt":[[305,2329],[1858,2329],[1858,2383],[305,2383]],"region":{"top_left_x":305,"top_left_y":2328,"width":1554,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"396fabd52e784123b51552c1e61b87e8","type":"text","conversion_output":true,"text":"Placebo doses will be administered to subjects randomized to the placebo treatment arm and","text_display":"\n\nPlacebo doses will be administered to subjects randomized to the placebo treatment arm and","confidence":1,"confidence_rate":1},{"cnt":[[305,2380],[1820,2380],[1820,2432],[305,2432]],"region":{"top_left_x":305,"top_left_y":2380,"width":1515,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c290069c6dfa4d9f8c0360ed0fffa850","type":"text","conversion_output":true,"text":"in between doses of DX-2930 for subjects randomized to the 300 mg or 150 mg DX-2930","text_display":" in between doses of DX-2930 for subjects randomized to the 300 mg or 150 mg DX-2930","confidence":1,"confidence_rate":1},{"cnt":[[305,2428],[1573,2428],[1573,2481],[305,2481]],"region":{"top_left_x":305,"top_left_y":2427,"width":1268,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3a50c17edf1432cb2286e850d2006ed","type":"text","conversion_output":true,"text":"every 4 weeks treatment arms, according to the dosing schedule in Table 1.","text_display":" every 4 weeks treatment arms, according to the dosing schedule in Table 1.","confidence":0.9990234375,"confidence_rate":0.9999879378548738},{"cnt":[[305,2587],[492,2587],[492,2625],[305,2625]],"region":{"top_left_x":305,"top_left_y":2586,"width":187,"height":40},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"07b3dc0ef7cd452c91004a418b95c85e","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[993,2587],[1197,2587],[1197,2628],[993,2628]],"region":{"top_left_x":992,"top_left_y":2586,"width":205,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e6a57eaa72f4544b079e6aedd63bc02","type":"page_info","conversion_output":false,"text":"Page 7 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,2587],[1880,2587],[1880,2632],[1706,2632]],"region":{"top_left_x":1705,"top_left_y":2586,"width":175,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61a5d8ebb1c24a9685f6f6320da71ef6","type":"page_info","conversion_output":false,"text":"Dyax 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DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f9b21511aba47778595e37d096c3f78","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,339],[1781,339],[1781,393],[305,393]],"region":{"top_left_x":305,"top_left_y":339,"width":1477,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2126013569364230b321e0e95ebf74b2","type":"text","conversion_output":true,"text":"For each placebo dose, each subject will receive a total of 3 mL , divided into 2 separate","text_display":"\n\nFor each placebo dose, each subject will receive a total of 3 mL , divided into 2 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The 2 injections will be given in the same upper arm, with","text_display":" 1.5 mL SC injections of placebo. The 2 injections will be given in the same upper arm, with","confidence":0.8378087907991016,"confidence_rate":0.9982319111359294},{"cnt":[[305,438],[1179,438],[1179,488],[305,488]],"region":{"top_left_x":305,"top_left_y":438,"width":875,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d22da2db6da241b38f86f989eb76e4f1","type":"text","conversion_output":true,"text":"at least 2 cm separation between each injection site.","text_display":" at least 2 cm separation between each injection site.","confidence":1,"confidence_rate":1},{"cnt":[[301,498],[741,498],[741,552],[301,552]],"region":{"top_left_x":300,"top_left_y":498,"width":442,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4580e6ee0ef548c9907552152ba04a30","type":"section_header","conversion_output":false,"children_ids":["de972454f50f41b7bd14c4d76267e1f5"],"text":"","text_display":""},{"cnt":[[305,503],[737,503],[737,548],[305,548]],"region":{"top_left_x":305,"top_left_y":502,"width":432,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de972454f50f41b7bd14c4d76267e1f5","type":"text","conversion_output":true,"parent_id":"4580e6ee0ef548c9907552152ba04a30","text":"Duration of Treatment:","text_display":"\n\n\\section*{Duration of Treatment:}","confidence":1,"confidence_rate":1},{"cnt":[[305,554],[1798,554],[1798,608],[305,608]],"region":{"top_left_x":305,"top_left_y":554,"width":1494,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8b2d8950ec948d3a4df2d3a020981bf","type":"text","conversion_output":true,"text":"Subjects will receive a dose of blinded IMP every 2 weeks during the 26-week treatment","text_display":"\n\nSubjects will receive a dose of blinded IMP every 2 weeks during the 26-week treatment","confidence":0.99072265625,"confidence_rate":0.9999008491037157},{"cnt":[[305,604],[1824,604],[1824,655],[305,655]],"region":{"top_left_x":305,"top_left_y":603,"width":1520,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3025a492bf4406aa817d3808d992b1a","type":"text","conversion_output":true,"text":"period for a total of 13 doses. 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An additional QOL assessment will be conducted on Day","text_display":" and on Days \\(98 \\pm 3\\), and \\(182 \\pm 3\\). An additional QOL assessment will be conducted on Day","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[305,1783],[958,1783],[958,1833],[305,1833]],"region":{"top_left_x":305,"top_left_y":1783,"width":654,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"181120b3edd9437b99073c77bd7c1dd8","type":"text","conversion_output":true,"text":"\\(238 \\pm 3\\) for subjects not entering OLE.","text_display":" \\(238 \\pm 3\\) for subjects not entering OLE.","confidence":1,"confidence_rate":1},{"cnt":[[305,1846],[887,1846],[887,1897],[305,1897]],"region":{"top_left_x":305,"top_left_y":1845,"width":583,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dffd917efd524e649158b5ad1ec903e6","type":"section_header","conversion_output":false,"children_ids":["9b207e2250ae4087aa38d72f6342bebd"],"text":"","text_display":""},{"cnt":[[305,1848],[883,1848],[883,1893],[305,1893]],"region":{"top_left_x":305,"top_left_y":1847,"width":579,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b207e2250ae4087aa38d72f6342bebd","type":"text","conversion_output":true,"parent_id":"dffd917efd524e649158b5ad1ec903e6","text":"Collection of HAE Attack Data:","text_display":"\n\n\\section*{Collection of HAE Attack Data:}","confidence":1,"confidence_rate":1},{"cnt":[[305,1904],[1841,1904],[1841,1953],[305,1953]],"region":{"top_left_x":305,"top_left_y":1903,"width":1537,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ce13a7500cb4e03bc48ed50aa0d4f54","type":"text","conversion_output":true,"text":"The collection, reporting and assessment of attacks in this study will be done in accordance","text_display":"\n\nThe collection, reporting and assessment of attacks in this study will be done in accordance","confidence":1,"confidence_rate":1},{"cnt":[[305,1951],[1846,1951],[1846,2000],[305,2000]],"region":{"top_left_x":305,"top_left_y":1950,"width":1541,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7798f5be6d004ddaa420b4f9b1f22a66","type":"text","conversion_output":true,"text":"with the HAE Attack Assessment and Reporting Procedures (HAARP). 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attack","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[370,1216],[1882,1216],[1882,1270],[370,1270]],"region":{"top_left_x":369,"top_left_y":1216,"width":1514,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea944d49c7b54d14b541c0c2bbf6e7dd","type":"text","conversion_output":true,"text":"- If the attack resolved, date and time the subject was no longer experiencing symptoms","text_display":"\n- If the attack resolved, date and time the subject was no longer experiencing symptoms","confidence":1,"confidence_rate":1},{"cnt":[[305,1306],[1794,1306],[1794,1360],[305,1360]],"region":{"top_left_x":305,"top_left_y":1306,"width":1489,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ca65297a7a74b7c8ce8cd5b2eeb1e57","type":"text","conversion_output":true,"text":"Site personnel will review the information provided and solicit additional information as","text_display":"\n\nSite personnel will review the information provided and solicit additional information as","confidence":1,"confidence_rate":1},{"cnt":[[305,1354],[1360,1354],[1360,1405],[305,1405]],"region":{"top_left_x":305,"top_left_y":1353,"width":1055,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"962cf1f709cb4453a7bebb783bcc9e18","type":"text","conversion_output":true,"text":"necessary to document the attack, as described in the HAARP.","text_display":" necessary to document the attack, as described in the HAARP.","confidence":1,"confidence_rate":1},{"cnt":[[305,1444],[1766,1444],[1766,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1443,"width":1462,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edad6ed1c2df4658a64bb93e1074f056","type":"text","conversion_output":true,"text":"Site personnel will contact the subject or caregiver on a weekly basis or approximately","text_display":"\n\nSite personnel will contact the subject or caregiver on a weekly basis or approximately","confidence":0.99609375,"confidence_rate":0.9999574585209889},{"cnt":[[305,1491],[1712,1491],[1712,1545],[305,1545]],"region":{"top_left_x":305,"top_left_y":1491,"width":1408,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb50e91c2d0649a79f91fe8bf6a7cb8f","type":"text","conversion_output":true,"text":"7 days after last contact with the subject throughout the run-in period. If the subject","text_display":" 7 days after last contact with the subject throughout the run-in period. If the subject","confidence":1,"confidence_rate":1},{"cnt":[[305,1538],[1880,1538],[1880,1592],[305,1592]],"region":{"top_left_x":305,"top_left_y":1538,"width":1575,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e53abdfaf8dd4dbb9aa47cb7ac062982","type":"text","conversion_output":true,"text":"experiences 1 or more Investigator-confirmed HAE attacks by end of week 4, the subject will","text_display":" experiences 1 or more Investigator-confirmed HAE attacks by end of week 4, the subject will","confidence":0.9912109375,"confidence_rate":0.999910833125869},{"cnt":[[305,1588],[1790,1588],[1790,1639],[305,1639]],"region":{"top_left_x":305,"top_left_y":1587,"width":1485,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1c635562b6d41248afcf825f755d412","type":"text","conversion_output":true,"text":"have fulfilled the run-in requirement and may proceed to enrollment and randomization.","text_display":" have fulfilled the run-in requirement and may proceed to enrollment and randomization.","confidence":1,"confidence_rate":1},{"cnt":[[305,1635],[1858,1635],[1858,1687],[305,1687]],"region":{"top_left_x":305,"top_left_y":1634,"width":1554,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c896584707342b98e0c9c8514e51734","type":"text","conversion_output":true,"text":"Subjects who experience 3 or more Investigator-confirmed attacks can exit the run-in period","text_display":" Subjects who experience 3 or more Investigator-confirmed attacks can exit the run-in period","confidence":1,"confidence_rate":1},{"cnt":[[305,1684],[1678,1684],[1678,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1684,"width":1373,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebdcffcdc75b42b79a40ec4c2237a8f2","type":"text","conversion_output":true,"text":"early and proceed to enrollment and randomization. If the subject experiences no","text_display":" early and proceed to enrollment and randomization. If the subject experiences no","confidence":1,"confidence_rate":1},{"cnt":[[305,1732],[1869,1732],[1869,1783],[305,1783]],"region":{"top_left_x":305,"top_left_y":1731,"width":1565,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9299266827ee456689b0792f73277255","type":"text","conversion_output":true,"text":"Investigator-confirmed HAE attacks by the end of week 4, the subject will remain in the run-","text_display":" Investigator-confirmed HAE attacks by the end of week 4, the subject will remain in the run","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,1779],[1854,1779],[1854,1830],[305,1830]],"region":{"top_left_x":305,"top_left_y":1778,"width":1550,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4e6355eabb04b8c9553b759d0fc8b0b","type":"text","conversion_output":true,"text":"in period for an additional 4 weeks. The maximum duration of the run-in period is 8 weeks.","text_display":"in period for an additional 4 weeks. The maximum duration of the run-in period is 8 weeks.","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[305,1826],[1764,1826],[1764,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1826,"width":1459,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31c5abf627584f068e18bbdb5fef291b","type":"text","conversion_output":true,"text":"If run-in has been extended and the subject has 2 or more Investigator-confirmed HAE","text_display":" If run-in has been extended and the subject has 2 or more Investigator-confirmed HAE","confidence":1,"confidence_rate":1},{"cnt":[[305,1876],[1843,1876],[1843,1927],[305,1927]],"region":{"top_left_x":305,"top_left_y":1875,"width":1539,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0aa5730fe26e4ff6b93a14a05c43f8ea","type":"text","conversion_output":true,"text":"attacks by the end of week 8, the subject will have fulfilled the run-in requirement and may","text_display":" attacks by the end of week 8, the subject will have fulfilled the run-in requirement and may","confidence":0.85205078125,"confidence_rate":0.9983507516976488},{"cnt":[[305,1925],[1850,1925],[1850,1979],[305,1979]],"region":{"top_left_x":305,"top_left_y":1925,"width":1545,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dadd0f4a2a84fb8878616127e963f34","type":"text","conversion_output":true,"text":"proceed to the double-blind treatment period. Subjects who have their run-in extended may","text_display":" proceed to the double-blind treatment period. Subjects who have their run-in extended may","confidence":1,"confidence_rate":1},{"cnt":[[305,1972],[1828,1972],[1828,2022],[305,2022]],"region":{"top_left_x":305,"top_left_y":1972,"width":1524,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00e39c2b124948b48c70c952e4782852","type":"text","conversion_output":true,"text":"not exit the run-in period early. Subjects who do not meet the minimum attack rate during","text_display":" not exit the run-in period early. Subjects who do not meet the minimum attack rate during","confidence":1,"confidence_rate":1},{"cnt":[[305,2020],[956,2020],[956,2069],[305,2069]],"region":{"top_left_x":305,"top_left_y":2019,"width":652,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"850a2a0aedce4dd1a0fe3066a9d40f2d","type":"text","conversion_output":true,"text":"run-in will be considered a screen fail.","text_display":" run-in will be considered a screen fail.","confidence":1,"confidence_rate":1},{"cnt":[[305,2108],[1869,2108],[1869,2159],[305,2159]],"region":{"top_left_x":305,"top_left_y":2107,"width":1565,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab44eb72bec9453f9751767bec8684f6","type":"text","conversion_output":true,"text":"During the treatment period site personnel will contact the subject or caregiver once between","text_display":"\n\nDuring the treatment period site personnel will contact the subject or caregiver once between","confidence":1,"confidence_rate":1},{"cnt":[[305,2157],[1876,2157],[1876,2211],[305,2211]],"region":{"top_left_x":305,"top_left_y":2157,"width":1571,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f84e8ca45744e79be8837a050df9441","type":"text","conversion_output":true,"text":"scheduled study visits or approximately 7 days after last contact to solicit for any HAE attack","text_display":" scheduled study visits or approximately 7 days after last contact to solicit for any HAE attack","confidence":1,"confidence_rate":1},{"cnt":[[305,2204],[870,2204],[870,2258],[305,2258]],"region":{"top_left_x":305,"top_left_y":2204,"width":566,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f81086497f594f10ab827d35c55782c0","type":"text","conversion_output":true,"text":"information not already reported.","text_display":" information not already 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personnel will solicit for any new HAE attack information that was not already","confidence":1,"confidence_rate":1},{"cnt":[[305,2391],[647,2391],[647,2443],[305,2443]],"region":{"top_left_x":305,"top_left_y":2391,"width":342,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc0b0c8ab73b4218b49581c545e05806","type":"text","conversion_output":true,"text":"provided to the site.","text_display":" provided to the 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124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,2587],[1880,2587],[1880,2632],[1706,2632]],"region":{"top_left_x":1705,"top_left_y":2586,"width":175,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0bd1be87328d4d769c8abb6ca0020cdc","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-11","page":11,"lines":[{"cnt":[[305,125],[449,125],[449,165],[305,165]],"region":{"top_left_x":305,"top_left_y":124,"width":145,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c94dd58f7e34692b63c4dcf23f40718","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,163],[827,163],[827,208],[305,208]],"region":{"top_left_x":305,"top_left_y":163,"width":523,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"211de491d1c94c82b66c2d394b910312","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5e9c7aaa3ad4734adc0046dcaa3b3d6","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,284],[1764,284],[1764,337],[305,337]],"region":{"top_left_x":305,"top_left_y":283,"width":1459,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"813f092506314a5e8ac9562cae6c5ec9","type":"text","conversion_output":true,"text":"In this study HAE attacks will be captured as AEs. All AEs, regardless of seriousness,","text_display":"\n\nIn this study HAE attacks will be captured as AEs. All AEs, regardless of seriousness,","confidence":1,"confidence_rate":1},{"cnt":[[305,335],[1833,335],[1833,387],[305,387]],"region":{"top_left_x":305,"top_left_y":335,"width":1528,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddabaa929de94386b60866ec272e3717","type":"text","conversion_output":true,"text":"severity, or causal relationship to IMP, will be recorded on the AE page of the eCRF. Any","text_display":" severity, or causal relationship to IMP, will be recorded on the AE page of the eCRF. Any","confidence":0.9975595474243164,"confidence_rate":0.999974006344927},{"cnt":[[305,382],[1858,382],[1858,434],[305,434]],"region":{"top_left_x":305,"top_left_y":382,"width":1554,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42976b3053b347d08e1ed568b0fa6130","type":"text","conversion_output":true,"text":"AE reported to the site meeting criteria for a serious adverse event must be reported to Dyax","text_display":" AE reported to the site meeting criteria for a serious adverse event must be reported to Dyax","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,430],[1869,430],[1869,483],[305,483]],"region":{"top_left_x":305,"top_left_y":429,"width":1565,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c727a43e98b4f6db0c221635f9184bb","type":"text","conversion_output":true,"text":"using the SAE Reporting Form in the EDC system within 24 hours of becoming aware of the","text_display":" using the SAE Reporting Form in the EDC system within 24 hours of becoming aware of the","confidence":1,"confidence_rate":1},{"cnt":[[305,477],[1717,477],[1717,531],[305,531]],"region":{"top_left_x":305,"top_left_y":476,"width":1412,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"536e3dbb0d1b44c69f6c8ee659768bea","type":"text","conversion_output":true,"text":"event. For all serious adverse events that are reported as HAE attacks, the Principal","text_display":" event. 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For all","text_display":" and, in accordance with HAARP, evaluate if it represented a confirmed HAE attack. For all","confidence":1,"confidence_rate":1},{"cnt":[[305,623],[1807,623],[1807,672],[305,672]],"region":{"top_left_x":305,"top_left_y":623,"width":1502,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87ca53ec072344e3a140b53b1c55c5a1","type":"text","conversion_output":true,"text":"non-serious AEs that are reported as HAE attacks, the Principal Investigator or physician","text_display":" non-serious AEs that are reported as HAE attacks, the Principal Investigator or physician","confidence":1,"confidence_rate":1},{"cnt":[[305,670],[1824,670],[1824,724],[305,724]],"region":{"top_left_x":305,"top_left_y":670,"width":1520,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b1f2b9a271944ec93654a045819000c","type":"text","conversion_output":true,"text":"designee will review the event within 3 days of initial notification and, in accordance with","text_display":" designee will review the event within 3 days of initial notification and, in accordance with","confidence":1,"confidence_rate":1},{"cnt":[[305,718],[1841,718],[1841,769],[305,769]],"region":{"top_left_x":305,"top_left_y":717,"width":1537,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0be6cea87fc4f879e1fd63ea113020c","type":"text","conversion_output":true,"text":"HAARP, evaluate if it represented a confirmed HAE attack. If necessary for the evaluation,","text_display":" HAARP, evaluate if it represented a confirmed HAE attack. If necessary for the evaluation,","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[305,765],[1871,765],[1871,819],[305,819]],"region":{"top_left_x":305,"top_left_y":764,"width":1567,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e230c3f41c3041a2a288fe927e9322c3","type":"text","conversion_output":true,"text":"the Investigator or designee may contact the subject for additional information. Any subject-","text_display":" the Investigator or designee may contact the subject for additional information. Any subject","confidence":1,"confidence_rate":1},{"cnt":[[305,814],[1755,814],[1755,866],[305,866]],"region":{"top_left_x":305,"top_left_y":814,"width":1451,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75b1339b71504ea180ba93f98bf6b09e","type":"text","conversion_output":true,"text":"reported attack not confirmed by the Investigator must have an alternate AE diagnosis","text_display":"reported attack not confirmed by the Investigator must have an alternate AE diagnosis","confidence":0.8173828125,"confidence_rate":0.9977619777245849},{"cnt":[[305,862],[1841,862],[1841,913],[305,913]],"region":{"top_left_x":305,"top_left_y":861,"width":1537,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"662305f732664ed3b77f20a6007979f1","type":"text","conversion_output":true,"text":"recorded. All subject-reported and Investigator-confirmed HAE attacks will be recorded in","text_display":" recorded. 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These sample sizes will also provide adequately sized","text_display":" reductions of attacks of near \\(100 \\%\\). These sample sizes will also provide adequately sized","confidence":1,"confidence_rate":1},{"cnt":[[305,1886],[1861,1886],[1861,1938],[305,1938]],"region":{"top_left_x":305,"top_left_y":1886,"width":1556,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c1bde0770bf4d018b9d2bff1d6bd567","type":"text","conversion_output":true,"text":"safety population for evaluation. Up to 120 subjects may be enrolled to account for potential","text_display":" safety population for evaluation. 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For the","text_display":" placebo arm during the efficacy assessment period (Day 14 through Day 182). 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The baseline attack rate for each subject as determined","text_display":" ANOVA for counts using the GEE. The baseline attack rate for each subject as determined","confidence":1,"confidence_rate":1},{"cnt":[[305,2432],[1848,2432],[1848,2486],[305,2486]],"region":{"top_left_x":305,"top_left_y":2432,"width":1543,"height":54},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d0b014c9ab548998f1fb696f62e9028","type":"text","conversion_output":true,"text":"by the run-in period will be used as a continuous covariate in an analysis of covariance. For","text_display":" by the run-in period will be used as a continuous covariate in an analysis of covariance. For","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,2587],[492,2587],[492,2628],[305,2628]],"region":{"top_left_x":305,"top_left_y":2586,"width":187,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b4f586fa5114bc0b1c5434bbe47de90","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[984,2587],[1205,2587],[1205,2632],[984,2632]],"region":{"top_left_x":983,"top_left_y":2586,"width":223,"height":46},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cde3f1844efd461b98ee4c5f0f989547","type":"page_info","conversion_output":false,"text":"Page 13 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,2587],[1880,2587],[1880,2632],[1706,2632]],"region":{"top_left_x":1705,"top_left_y":2586,"width":175,"height":46},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"627bd9af3d45465fbcd83ba71403a014","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-14","page":14,"lines":[{"cnt":[[305,125],[449,125],[449,165],[305,165]],"region":{"top_left_x":305,"top_left_y":124,"width":145,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"935bf15c495e46fa811691e116a2e242","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,163],[827,163],[827,208],[305,208]],"region":{"top_left_x":305,"top_left_y":163,"width":523,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"530525fa489e4ceda0c5e83f9e4486b5","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c246cf054c544b09545d460d503f753","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,284],[1846,284],[1846,337],[305,337]],"region":{"top_left_x":305,"top_left_y":283,"width":1541,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f948b63ee994b468b44079b1b9419a2","type":"text","conversion_output":true,"text":"each subject, the least squares mean will be calculated and adjusted for their baseline attack","text_display":"\neach subject, the least squares mean will be calculated and adjusted for their baseline attack","confidence":1,"confidence_rate":1},{"cnt":[[305,335],[1815,335],[1815,387],[305,387]],"region":{"top_left_x":305,"top_left_y":335,"width":1511,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96589eca0e224bb98323f1472a6fe550","type":"text","conversion_output":true,"text":"rate. A Poisson distribution will be assumed rather than a Gaussian distribution. Repeated","text_display":" rate. A Poisson distribution will be assumed rather than a Gaussian distribution. 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There will be no Last Observation Carried Forward","text_display":" the discrete unit of measurement. 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Subject weeks for which","text_display":" the total duration of observation during the specified time period. Subject weeks for which","confidence":1,"confidence_rate":1},{"cnt":[[305,574],[1708,574],[1708,625],[305,625]],"region":{"top_left_x":305,"top_left_y":573,"width":1404,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2a46848824d4b1280c11e302c4cfa84","type":"text","conversion_output":true,"text":"completed observation is less than the full 168 hours within a week will be handled","text_display":" completed observation is less than the full 168 hours within a week will be handled","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[305,623],[1588,623],[1588,672],[305,672]],"region":{"top_left_x":305,"top_left_y":623,"width":1283,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5edfa1dbadc24304a626d55736683116","type":"text","conversion_output":true,"text":"according to an a priori plan to be described in the Statistical Analysis Plan.","text_display":" according to an a priori plan to be described in the Statistical Analysis Plan.","confidence":1,"confidence_rate":1},{"cnt":[[305,709],[1783,709],[1783,763],[305,763]],"region":{"top_left_x":305,"top_left_y":708,"width":1479,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13742d3750ac451fba1f99c0414c60be","type":"text","conversion_output":true,"text":"There are three active treatment arms ordered by highest total monthly dose; 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If statistical significance is found for both the primary and secondary treatment","text_display":" level alpha. 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The a priori order of testing the secondary","text_display":" tested in a closed sequential methodology. The a priori order of testing the secondary","confidence":0.92529296875,"confidence_rate":0.9991471235912533},{"cnt":[[305,1280],[1734,1280],[1734,1332],[305,1332]],"region":{"top_left_x":305,"top_left_y":1280,"width":1429,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbd22ea4babe475bb2f2b412332f3044","type":"text","conversion_output":true,"text":"hypotheses has been pre-specified above. In order to preserve the overall level alpha,","text_display":" hypotheses has been pre-specified above. 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The descriptive analysis will use life table","text_display":" comparing each active treatment group vs placebo. The descriptive analysis will use life table","confidence":1,"confidence_rate":1},{"cnt":[[305,1560],[1880,1560],[1880,1613],[305,1613]],"region":{"top_left_x":305,"top_left_y":1559,"width":1575,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a54701f06334ef6bf8c5656f0d73712","type":"text","conversion_output":true,"text":"summaries based on Kaplan Meier (KM) estimates. Subjects without any HAE attacks during","text_display":" summaries based on Kaplan Meier (KM) estimates. 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Summaries in terms of severity and relationship to study","text_display":" Regulatory Activities (MedDRA \\({ }^{\\text {® }}\\) ). Summaries in terms of severity and relationship to study","confidence":0.9926843643188477,"confidence_rate":0.9999338533033615},{"cnt":[[305,2445],[1811,2445],[1811,2499],[305,2499]],"region":{"top_left_x":305,"top_left_y":2444,"width":1507,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a90ab78cbb074d0faf183c7eb3c793cc","type":"text","conversion_output":true,"text":"medication will also be provided. Serious AEs will be summarized separately in a similar","text_display":" medication will also be provided. 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Patient listings of AEs causing discontinuation of study medication, AEs leading to","text_display":"\nfashion. 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system Organ Classes (SOCs) and Preferred","confidence":1,"confidence_rate":1},{"cnt":[[305,473],[1841,473],[1841,522],[305,522]],"region":{"top_left_x":305,"top_left_y":472,"width":1537,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8548cfd7222c499190cdcff8932d4f5f","type":"text","conversion_output":true,"text":"Terms (PTs) determined by the search of relevant Standardized MedDRA Queries (SMQs).","text_display":" Terms (PTs) determined by the search of relevant Standardized MedDRA Queries (SMQs).","confidence":1,"confidence_rate":1},{"cnt":[[305,520],[1652,520],[1652,569],[305,569]],"region":{"top_left_x":305,"top_left_y":519,"width":1348,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8d483057b744f878951bc745f513030","type":"text","conversion_output":true,"text":"Summary tables with SOCs and PTs, from the SMQ searches, will be generated","text_display":" Summary tables with SOCs and PTs, from the SMQ searches, will be generated","confidence":1,"confidence_rate":1},{"cnt":[[305,567],[1706,567],[1706,621],[305,621]],"region":{"top_left_x":305,"top_left_y":567,"width":1401,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdd4656790274da79cdbffbef3aa1a4a","type":"text","conversion_output":true,"text":"presenting the number and percentage of subjects by AE, severity, seriousness, and","text_display":" presenting the number and percentage of subjects by AE, severity, seriousness, and","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[305,619],[862,619],[862,668],[305,668]],"region":{"top_left_x":305,"top_left_y":618,"width":557,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4080631956df4fffad877b71ae6f07c5","type":"text","conversion_output":true,"text":"relationship to study medication.","text_display":" relationship to study 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summarized for each treatment group with descriptive statistics at each assessment obtained.","confidence":1,"confidence_rate":1},{"cnt":[[305,939],[1835,939],[1835,990],[305,990]],"region":{"top_left_x":305,"top_left_y":938,"width":1530,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bb14e3d980647958bb1192dd98a577f","type":"text","conversion_output":true,"text":"For all laboratory tests, a shift table will be produced summarizing changes from normal to","text_display":" For all laboratory tests, a shift table will be produced summarizing changes from normal to","confidence":1,"confidence_rate":1},{"cnt":[[305,988],[737,988],[737,1033],[305,1033]],"region":{"top_left_x":305,"top_left_y":988,"width":432,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6adbb645e5344e69b2148e3089fd1e3a","type":"text","conversion_output":true,"text":"abnormal and vice-versa.","text_display":" abnormal and 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The incidence of","confidence":1,"confidence_rate":1},{"cnt":[[305,1489],[1858,1489],[1858,1540],[305,1540]],"region":{"top_left_x":305,"top_left_y":1488,"width":1554,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6230ae6029904b7b86af7e093ab4b360","type":"text","conversion_output":true,"text":"AEs by month from the start of study medication will be examined and the incidence among","text_display":" AEs by month from the start of study medication will be examined and the incidence among","confidence":1,"confidence_rate":1},{"cnt":[[305,1538],[1858,1538],[1858,1588],[305,1588]],"region":{"top_left_x":305,"top_left_y":1538,"width":1554,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c0b6f7fa3f54d0a988753b34a94f568","type":"text","conversion_output":true,"text":"the four treatment arms will be compared. The rate of study discontinuation among the four","text_display":" the four treatment arms will be compared. 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Follow-up visits have a \\(\\pm 3\\) day window.","confidence":0.5195350735448301,"confidence_rate":0.9941180787338001},{"cnt":[[245,1461],[2479,1461],[2479,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1460,"width":2236,"height":42},"line":183,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"987ce9e11e104637883866c2867497b2","type":"text","conversion_output":true,"text":"\\({ }^{\\text {4. }}\\) Site personnel contact the subject to solicit for any attacks not already reported by the subject once between scheduled site visits or approximately 7 days after last contact with","text_display":"\n\\({ }^{\\text {4. }}\\) Site personnel contact the subject to solicit for any attacks not already reported by the subject once between scheduled site visits or approximately 7 days after last contact with","confidence":0.6011934280395508,"confidence_rate":0.9974841672895812},{"cnt":[[277,1500],[380,1500],[380,1536],[277,1536]],"region":{"top_left_x":277,"top_left_y":1499,"width":104,"height":38},"line":184,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73cf215f51fe49b1b4081bcf7d40b175","type":"text","conversion_output":true,"text":"subject.","text_display":" subject.","confidence":1,"confidence_rate":1},{"cnt":[[245,1534],[2486,1534],[2486,1579],[245,1579]],"region":{"top_left_x":244,"top_left_y":1533,"width":2242,"height":47},"line":185,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8603d988d86942888e6b24c8cc96bb73","type":"text","conversion_output":true,"text":"\\({ }^{5 .}\\) Subjects who are on long-term prophylactic (LTP) therapy for HAE are required to undergo a minimum 2 week washout period prior to the start of the run-in period. This LTP","text_display":"\n\\({ }^{5 .}\\) Subjects who are on long-term prophylactic (LTP) therapy for HAE are required to undergo a minimum 2 week washout period prior to the start of the run-in period. This LTP","confidence":0.9931719303131104,"confidence_rate":0.9999633616999952},{"cnt":[[275,1577],[2436,1577],[2436,1613],[275,1613]],"region":{"top_left_x":275,"top_left_y":1576,"width":2162,"height":38},"line":186,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10ccc0cba87a4734ab3a2df77153ca52","type":"text","conversion_output":true,"text":"washout is permitted as long as the investigator determines that doing so would not place the subject at any undue safety risk and the subject is at least 18 years of age. The","text_display":" washout is permitted as long as the investigator determines that doing so would not place the subject at any undue safety risk and the subject is at least 18 years of age. The","confidence":1,"confidence_rate":1},{"cnt":[[275,1611],[1992,1611],[1992,1652],[275,1652]],"region":{"top_left_x":275,"top_left_y":1611,"width":1717,"height":42},"line":187,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17e0d70873ac4d27a312a897a7615c5f","type":"text","conversion_output":true,"text":"Investigator must confirm that the subject has successfully completed the 2 week washout period before they can enter the run-in period.","text_display":" Investigator must confirm that the subject has successfully completed the 2 week washout period before they can enter the run-in period.","confidence":1,"confidence_rate":1},{"cnt":[[245,1689],[245,1644],[2211,1646],[2211,1691]],"region":{"top_left_x":244,"top_left_y":1643,"width":1967,"height":48},"line":188,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53abf1e3cd7446be820f58244e2cd875","type":"text","conversion_output":true,"text":"\\({ }^{6 .}\\) Samples for C1-INH, C4, and C1q assays will be obtained at screening for eligibility assessment unless already collected as part of protocol DX-2930-02.","text_display":"\n\\({ }^{6 .}\\) Samples for C1-INH, C4, and C1q assays will be obtained at screening for eligibility assessment unless already collected as part of protocol DX-2930-02.","confidence":0.5616485672478575,"confidence_rate":0.9965308570329721},{"cnt":[[245,1684],[2438,1684],[2438,1729],[245,1729]],"region":{"top_left_x":244,"top_left_y":1684,"width":2195,"height":46},"line":189,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c7eb1c2aa5e44508a5d2b1dfd65eb54","type":"text","conversion_output":true,"text":"7. The pregnancy test will only be conducted in females of childbearing potential. Tests performed on Day 0 and Day 182 must be urine-based. Tests performed at screening,","text_display":"\n7. The pregnancy test will only be conducted in females of childbearing potential. Tests performed on Day 0 and Day 182 must be urine-based. Tests performed at screening,","confidence":0.9951171875,"confidence_rate":0.9999729574243491},{"cnt":[[275,1727],[917,1727],[917,1764],[275,1764]],"region":{"top_left_x":275,"top_left_y":1727,"width":643,"height":37},"line":190,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8aecabbe1854757a846d11de980e6aa","type":"text","conversion_output":true,"text":"Day 98, and Day 238 can be serum or urine-based.","text_display":" Day 98, and Day 238 can be serum or urine-based.","confidence":1,"confidence_rate":1},{"cnt":[[245,1757],[2499,1757],[2499,1803],[245,1803]],"region":{"top_left_x":244,"top_left_y":1757,"width":2255,"height":46},"line":191,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c18b305a97c498c802ecec487ee0003","type":"text","conversion_output":true,"text":"\\({ }^{\\text {8. }}\\) There is a \\(\\pm 15\\) minute window for all vital signs. At study visits in which IMP is administered, vital signs including sitting or supine BP, HR, body temperature, and RR, will be","text_display":"\n\\({ }^{\\text {8. }}\\) There is a \\(\\pm 15\\) minute window for all vital signs. At study visits in which IMP is administered, vital signs including sitting or supine BP, HR, body temperature, and RR, will be","confidence":0.954946882997433,"confidence_rate":0.9997683707500661},{"cnt":[[277,1800],[2434,1800],[2434,1841],[277,1841]],"region":{"top_left_x":277,"top_left_y":1800,"width":2158,"height":42},"line":192,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34977bccbe6746c89459bea2e7f44f08","type":"text","conversion_output":true,"text":"obtained prior to dosing, 1 hour after dosing, and 2 hours after dosing for the first 4 doses with the ability to eliminate the 2 hour vitals for the remaining doses based on the","text_display":" obtained prior to dosing, 1 hour after dosing, and 2 hours after dosing for the first 4 doses with the ability to eliminate the 2 hour vitals for the remaining doses based on the","confidence":0.99951171875,"confidence_rate":0.9999974953851976},{"cnt":[[275,1835],[1068,1835],[1068,1876],[275,1876]],"region":{"top_left_x":275,"top_left_y":1834,"width":793,"height":42},"line":193,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e76cb496185a4514a3f433c69994abb0","type":"text","conversion_output":true,"text":"discretion of the Investigator and the absence of safety signals.","text_display":" discretion of the Investigator and the absence of safety signals.","confidence":1,"confidence_rate":1},{"cnt":[[245,1959],[428,1959],[428,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1959,"width":184,"height":37},"line":194,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"66c934a57286416392efadc17f5e29f9","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1268,1962],[1485,1962],[1485,2002],[1268,2002]],"region":{"top_left_x":1267,"top_left_y":1961,"width":218,"height":42},"line":195,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5fcbafead704444bf96b9357061d84a","type":"page_info","conversion_output":false,"text":"Page 17 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2333,1964],[2503,1964],[2503,2004],[2333,2004]],"region":{"top_left_x":2333,"top_left_y":1963,"width":170,"height":42},"line":196,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f39d5b232d07495eb0071c6ad4c6e377","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-18","page":18,"lines":[{"cnt":[[245,125],[385,125],[385,161],[245,161]],"region":{"top_left_x":244,"top_left_y":124,"width":141,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b6da20edee943ca89c0ac322fd84fa2","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,163],[758,163],[758,204],[245,204]],"region":{"top_left_x":244,"top_left_y":163,"width":515,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cc5de9f7137494ab4befbeeb8375089","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2136,163],[2503,163],[2503,208],[2136,208]],"region":{"top_left_x":2135,"top_left_y":163,"width":368,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eabac632039d438293a5be7aa3419e08","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,305],[1072,305],[1072,354],[245,354]],"region":{"top_left_x":244,"top_left_y":305,"width":829,"height":50},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"172674d974494d0fb57f4f921c7ecac6","type":"text","conversion_output":true,"text":"\\({ }^{9 .}\\) Height and weight will be collected at the Screening visit only.","text_display":"\n\\({ }^{9 .}\\) Height and weight will be collected at the Screening visit only.","confidence":0.9417675237637013,"confidence_rate":0.999231105687724},{"cnt":[[245,346],[2473,346],[2473,393],[245,393]],"region":{"top_left_x":244,"top_left_y":345,"width":2229,"height":49},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"62f8824dabd444b4b9f776563cb4aeeb","type":"text","conversion_output":true,"text":"\\({ }^{10}\\) ECGs (single recordings) are collected at screening, baseline prior to Dose 1, Day 56, Day \\(144 \\pm 1\\) day to capture the estimated \\(C _{\\max }\\) and Day 182. The ECG assessment at \\(C _{\\max }\\)","text_display":"\n\\({ }^{10}\\) ECGs (single recordings) are collected at screening, baseline prior to Dose 1, Day 56, Day \\(144 \\pm 1\\) day to capture the estimated \\(C _{\\max }\\) and Day 182. The ECG assessment at \\(C _{\\max }\\)","confidence":0.503864684084325,"confidence_rate":0.9968169486329771},{"cnt":[[277,391],[1669,391],[1669,428],[277,428]],"region":{"top_left_x":277,"top_left_y":391,"width":1393,"height":37},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10b719cdffec4be0962f75adcc790567","type":"text","conversion_output":true,"text":"on Day \\(144 \\pm 1\\) day may be performed via at-home nurse or technician in lieu of a subject visit to the study site.","text_display":" on Day \\(144 \\pm 1\\) day may be performed via at-home nurse or technician in lieu of a subject visit to the study site.","confidence":0.99658203125,"confidence_rate":0.999971228789113},{"cnt":[[245,421],[1540,421],[1540,466],[245,466]],"region":{"top_left_x":244,"top_left_y":421,"width":1297,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6594741d7fd7491ea16851c73b5060dd","type":"text","conversion_output":true,"text":"\\({ }^{11}\\). Clinical laboratory testing will include Hematology, Coagulation, Serum Chemistry, and Urinalysis.","text_display":"\n\\({ }^{11}\\). Clinical laboratory testing will include Hematology, Coagulation, Serum Chemistry, and Urinalysis.","confidence":0.91943359375,"confidence_rate":0.9992634515824015},{"cnt":[[245,460],[2479,460],[2479,507],[245,507]],"region":{"top_left_x":244,"top_left_y":459,"width":2236,"height":49},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ef99799f52664fe19d2f1097cb3d2b24","type":"text","conversion_output":true,"text":"\\({ }^{12 .}\\) Historical attack information will be collected at screening. During the study subjects (or caregivers, in the event the subject is \\(<18\\) years old or is incapacitated) are instructed","text_display":"\n\\({ }^{12 .}\\) Historical attack information will be collected at screening. During the study subjects (or caregivers, in the event the subject is \\(<18\\) years old or is incapacitated) are instructed","confidence":0.99169921875,"confidence_rate":0.9999581143215561},{"cnt":[[275,505],[2488,505],[2488,544],[275,544]],"region":{"top_left_x":275,"top_left_y":504,"width":2213,"height":40},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58ea7d21a51c486aa165cbea023757e3","type":"text","conversion_output":true,"text":"to report details of the attack to the study site within 72 hours of the onset of the attack. Site personnel will also contact the subject once a week or at approximately 7 days after","text_display":" to report details of the attack to the study site within 72 hours of the onset of the attack. Site personnel will also contact the subject once a week or at approximately 7 days after","confidence":1,"confidence_rate":1},{"cnt":[[275,541],[2436,541],[2436,580],[275,580]],"region":{"top_left_x":275,"top_left_y":541,"width":2162,"height":40},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0e89ce63abf4fbaa725e153e36b6079","type":"text","conversion_output":true,"text":"last contact with the subject during the run-in period and once between study visits or approximately 7 days after last contact with the subject during the treatment period in","text_display":" last contact with the subject during the run-in period and once between study visits or approximately 7 days after last contact with the subject during the treatment period in","confidence":1,"confidence_rate":1},{"cnt":[[275,576],[2486,576],[2486,617],[275,617]],"region":{"top_left_x":275,"top_left_y":575,"width":2211,"height":42},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2bdb2786df34f9583c86d5d3450f37e","type":"text","conversion_output":true,"text":"order to solicit for any attack that may have occurred. In addition, during study visits, site personnel will solicit for any new HAE attack information that was not given through","text_display":" order to solicit for any attack that may have occurred. In addition, during study visits, site personnel will solicit for any new HAE attack information that was not given through","confidence":0.99951171875,"confidence_rate":0.9999973456529896},{"cnt":[[275,614],[711,614],[711,651],[275,651]],"region":{"top_left_x":275,"top_left_y":614,"width":437,"height":37},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50bcff25517b4c05982a76441ae21f89","type":"text","conversion_output":true,"text":"prior subject contact with the site.","text_display":" prior subject contact with the site.","confidence":1,"confidence_rate":1},{"cnt":[[245,645],[1687,645],[1687,690],[245,690]],"region":{"top_left_x":244,"top_left_y":644,"width":1443,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfa0357f49994739b8f95bb84e38750b","type":"text","conversion_output":true,"text":"\\({ }^{13 .}\\) Quality of life data will be obtained using the EQ5D and Angioedema Quality of Life Questionnaire (AE-QoL).","text_display":"\n\\({ }^{13 .}\\) Quality of life data will be obtained using the EQ5D and Angioedema Quality of Life Questionnaire (AE-QoL).","confidence":0.9960978019516915,"confidence_rate":0.9999679527144456},{"cnt":[[245,683],[2477,683],[2477,728],[245,728]],"region":{"top_left_x":244,"top_left_y":683,"width":2234,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9d78ff51634487792efd820fc859555","type":"text","conversion_output":true,"text":"\\({ }^{14 .}\\) Subjects who rollover into the Open-Label Extension protocol (DX-2930-04) will provide consent by Day 182 and receive their first open-label dose following the completion","text_display":"\n\\({ }^{14 .}\\) Subjects who rollover into the Open-Label Extension protocol (DX-2930-04) will provide consent by Day 182 and receive their first open-label dose following the completion","confidence":0.86572265625,"confidence_rate":0.9992333223450353},{"cnt":[[275,726],[2471,726],[2471,765],[275,765]],"region":{"top_left_x":275,"top_left_y":726,"width":2196,"height":39},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0b3012878fd4ee9bf39077effeba35f","type":"text","conversion_output":true,"text":"of all DX-2930-03 assessments scheduled on Day 182. At the completion of these assessments, the subject will be discharged from DX-2930-03 and roll into the DX-2930-04","text_display":" of all DX-2930-03 assessments scheduled on Day 182. At the completion of these assessments, the subject will be discharged from DX-2930-03 and roll into the DX-2930-04","confidence":1,"confidence_rate":1},{"cnt":[[275,765],[363,765],[363,801],[275,801]],"region":{"top_left_x":275,"top_left_y":764,"width":89,"height":38},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc3d5a6974384bea936d9cfdac69e04b","type":"text","conversion_output":true,"text":"study.","text_display":" study.","confidence":1,"confidence_rate":1},{"cnt":[[245,795],[2095,795],[2095,840],[245,840]],"region":{"top_left_x":244,"top_left_y":794,"width":1851,"height":47},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ca1ba03552a4a19899d0ad4f4f0e4c0","type":"text","conversion_output":true,"text":"\\({ }^{15}\\). Subjects who terminate from the study early will undergo (if possible) all of the assessments and procedures as Day 182 at their final study visit.","text_display":"\n\\({ }^{15}\\). Subjects who terminate from the study early will undergo (if possible) all of the assessments and procedures as Day 182 at their final study visit.","confidence":0.996584415435791,"confidence_rate":0.999979389182348},{"cnt":[[245,1959],[432,1959],[432,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1959,"width":188,"height":37},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b4319ad62464b81b6e6e990abd7e2c4","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1268,1959],[1485,1959],[1485,2002],[1268,2002]],"region":{"top_left_x":1267,"top_left_y":1959,"width":218,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f63bb2593aa045bc8cdf04089eab88dd","type":"page_info","conversion_output":false,"text":"Page 18 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2333,1959],[2503,1959],[2503,2004],[2333,2004]],"region":{"top_left_x":2333,"top_left_y":1959,"width":170,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"45835e2c538c49a59ca51ff6556903d4","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-19","page":19,"lines":[{"cnt":[[305,125],[449,125],[449,161],[305,161]],"region":{"top_left_x":305,"top_left_y":124,"width":145,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e39d6403206483a84076eff5427f1f0","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,163],[827,163],[827,204],[305,204]],"region":{"top_left_x":305,"top_left_y":163,"width":523,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fceec370330f45e088df6a8057982c00","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: 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DX-2930 is being developed for prophylactic treatment of","text_display":" active plasma kallikrein. DX-2930 is being developed for prophylactic treatment of","confidence":1,"confidence_rate":1},{"cnt":[[305,571],[1669,571],[1669,623],[305,623]],"region":{"top_left_x":305,"top_left_y":571,"width":1365,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ddb4a0ee6af431090d7b4988ea05cfa","type":"text","conversion_output":true,"text":"angioedema attacks in patients with hereditary angioedema (HAE), a serious and","text_display":" angioedema attacks in patients with hereditary angioedema (HAE), a serious and","confidence":1,"confidence_rate":1},{"cnt":[[305,619],[715,619],[715,672],[305,672]],"region":{"top_left_x":305,"top_left_y":618,"width":411,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b2fee056e564f2fbfe8df36a41fee16","type":"text","conversion_output":true,"text":"life-threatening disease.","text_display":" life-threatening disease.","confidence":1,"confidence_rate":1},{"cnt":[[301,700],[958,700],[958,776],[301,776]],"region":{"top_left_x":300,"top_left_y":700,"width":659,"height":76},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0539eb319b314aecaf11cf426d170a14","type":"section_header","conversion_output":false,"children_ids":["5f8579d6fc5a477c8926b888e663b7c2"],"text":"","text_display":""},{"cnt":[[309,709],[952,709],[952,767],[309,767]],"region":{"top_left_x":309,"top_left_y":708,"width":643,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f8579d6fc5a477c8926b888e663b7c2","type":"text","conversion_output":true,"parent_id":"0539eb319b314aecaf11cf426d170a14","text":"1.2 Hereditary Angioedema","text_display":"\n\n\\subsection*{1.2 Hereditary Angioedema}","confidence":1,"confidence_rate":1},{"cnt":[[305,804],[1792,804],[1792,855],[305,855]],"region":{"top_left_x":305,"top_left_y":803,"width":1487,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc783952c20d40a4a2295f627145de73","type":"text","conversion_output":true,"text":"HAE is a long-term, debilitating, and life-threatening disease caused by mutations in the","text_display":"\n\nHAE is a long-term, debilitating, and life-threatening disease caused by mutations in the","confidence":1,"confidence_rate":1},{"cnt":[[305,851],[1863,851],[1863,904],[305,904]],"region":{"top_left_x":305,"top_left_y":850,"width":1558,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f34130991dbf4a1089e1312c65517e94","type":"text","conversion_output":true,"text":"C1-inhibitor (C1-INH) gene, resulting in deficiency or dysfunction of C1-INH protein. HAE","text_display":" C1-inhibitor (C1-INH) gene, resulting in deficiency or dysfunction of C1-INH protein. HAE","confidence":0.9606832273666069,"confidence_rate":0.9995733830217894},{"cnt":[[305,900],[1803,900],[1803,952],[305,952]],"region":{"top_left_x":305,"top_left_y":900,"width":1498,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9741b5662f0549efb9d9cb82c4658787","type":"text","conversion_output":true,"text":"manifests clinically as unpredictable, intermittent attacks of subcutaneous or submucosal","text_display":" manifests clinically as unpredictable, intermittent attacks of subcutaneous or submucosal","confidence":1,"confidence_rate":1},{"cnt":[[305,947],[1747,947],[1747,999],[305,999]],"region":{"top_left_x":305,"top_left_y":947,"width":1442,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd9027eac61646a4882d3a14660e6e2b","type":"text","conversion_output":true,"text":"edema of the face, larynx, gastrointestinal tract, limbs and/or genitalia (Zuraw, 2008).","text_display":" edema of the face, larynx, gastrointestinal tract, limbs and/or genitalia (Zuraw, 2008).","confidence":1,"confidence_rate":1},{"cnt":[[305,993],[1798,993],[1798,1046],[305,1046]],"region":{"top_left_x":305,"top_left_y":992,"width":1494,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"086d5502437744ba8a8c3f81e9f40ab9","type":"text","conversion_output":true,"text":"Swelling may last up to five or more days; most patients suffer multiple attacks per year.","text_display":" Swelling may last up to five or more days; most patients suffer multiple attacks per year.","confidence":1,"confidence_rate":1},{"cnt":[[305,1044],[1854,1044],[1854,1094],[305,1094]],"region":{"top_left_x":305,"top_left_y":1044,"width":1550,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f7ab2bce2e24908aa79cc6c3681f811","type":"text","conversion_output":true,"text":"HAE is an orphan disorder. The exact prevalence of HAE is unknown, but current estimates","text_display":" HAE is an orphan disorder. The exact prevalence of HAE is unknown, but current estimates","confidence":1,"confidence_rate":1},{"cnt":[[305,1091],[1704,1091],[1704,1143],[305,1143]],"region":{"top_left_x":305,"top_left_y":1091,"width":1399,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74bbdfbfd4dd4b329817bc2ad74bcd16","type":"text","conversion_output":true,"text":"range from 1 per 10,000 to 1 per 150,000 persons, with many authors agreeing that","text_display":" range from 1 per 10,000 to 1 per 150,000 persons, with many authors agreeing that","confidence":0.4359126049093902,"confidence_rate":0.9910154576180903},{"cnt":[[305,1139],[1876,1139],[1876,1192],[305,1192]],"region":{"top_left_x":305,"top_left_y":1138,"width":1571,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1e257937fe44cbdab4c178eff357b63","type":"text","conversion_output":true,"text":"1 per 50,000 is likely the closest estimate (Bygum, 2009; Goring et al., 1998; Lei et al., 2011;","text_display":" 1 per 50,000 is likely the closest estimate (Bygum, 2009; Goring et al., 1998; Lei et al., 2011;","confidence":0.7620660129468888,"confidence_rate":0.9973653980706217},{"cnt":[[305,1186],[1042,1186],[1042,1240],[305,1240]],"region":{"top_left_x":305,"top_left_y":1185,"width":737,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cd7298607324d11885bde6a8033e9f0","type":"text","conversion_output":true,"text":"Nordenfelt et al., 2014; Roche et al., 2005).","text_display":" Nordenfelt et al., 2014; Roche et al., 2005).","confidence":1,"confidence_rate":1},{"cnt":[[305,1276],[1843,1276],[1843,1330],[305,1330]],"region":{"top_left_x":305,"top_left_y":1276,"width":1539,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71ff84a7c55044fba8bd55448bfcd9dd","type":"text","conversion_output":true,"text":"Swelling in the larynx can obstruct the airways and cause death from asphyxiation (Bork et","text_display":"\n\nSwelling in the larynx can obstruct the airways and cause death from asphyxiation (Bork et","confidence":1,"confidence_rate":1},{"cnt":[[305,1323],[1768,1323],[1768,1377],[305,1377]],"region":{"top_left_x":305,"top_left_y":1323,"width":1464,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ce64c06a1894ea5896f07d873ee5a76","type":"text","conversion_output":true,"text":"al., 2012; Bork et al., 2000). Approximately \\(50 \\%\\) of all HAE patients will experience a","text_display":" al., 2012; Bork et al., 2000). Approximately \\(50 \\%\\) of all HAE patients will experience a","confidence":0.96728515625,"confidence_rate":0.99964621217788},{"cnt":[[305,1371],[1871,1371],[1871,1424],[305,1424]],"region":{"top_left_x":305,"top_left_y":1370,"width":1567,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b77fc013aef94a4096f367014f43b4b7","type":"text","conversion_output":true,"text":"laryngeal attack in their lifetime, and there is no way to predict which patients are at risk of a","text_display":" laryngeal attack in their lifetime, and there is no way to predict which patients are at risk of a","confidence":1,"confidence_rate":1},{"cnt":[[305,1418],[1212,1418],[1212,1472],[305,1472]],"region":{"top_left_x":305,"top_left_y":1417,"width":907,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b40a040ae1ec4adb957bdaf9e2751493","type":"text","conversion_output":true,"text":"laryngeal attack (Bork et al., 2003; Bork et al., 2006).","text_display":" laryngeal attack (Bork et al., 2003; Bork et al., 2006).","confidence":1,"confidence_rate":1},{"cnt":[[305,1508],[1807,1508],[1807,1562],[305,1562]],"region":{"top_left_x":305,"top_left_y":1508,"width":1502,"height":54},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1b8109577254331baa803a9788493d6","type":"text","conversion_output":true,"text":"Abdominal attacks are often associated with nausea, vomiting, and severe pain; intestinal","text_display":"\n\nAbdominal attacks are often associated with nausea, vomiting, and severe pain; intestinal","confidence":0.69921875,"confidence_rate":0.9962009407269292},{"cnt":[[305,1555],[1790,1555],[1790,1609],[305,1609]],"region":{"top_left_x":305,"top_left_y":1555,"width":1485,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b6fdf9cc65c494db1b93e3e2746a54d","type":"text","conversion_output":true,"text":"symptoms resembling abdominal emergencies may lead to unnecessary surgery (Zuraw,","text_display":" symptoms resembling abdominal emergencies may lead to unnecessary surgery (Zuraw,","confidence":1,"confidence_rate":1},{"cnt":[[305,1607],[423,1607],[423,1656],[305,1656]],"region":{"top_left_x":305,"top_left_y":1607,"width":119,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04e1803d68f34e62b6336287f87dd9c3","type":"text","conversion_output":true,"text":"2008).","text_display":" 2008).","confidence":1,"confidence_rate":1},{"cnt":[[305,1693],[1843,1693],[1843,1747],[305,1747]],"region":{"top_left_x":305,"top_left_y":1692,"width":1539,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70e89ef126be444c81d9093c69af5ecb","type":"text","conversion_output":true,"text":"Approximately \\(85 \\%\\) of patients have Type I HAE, characterized by very low production of","text_display":"\n\nApproximately \\(85 \\%\\) of patients have Type I HAE, characterized by very low production of","confidence":0.99462890625,"confidence_rate":0.9999427083440744},{"cnt":[[305,1745],[1803,1745],[1803,1796],[305,1796]],"region":{"top_left_x":305,"top_left_y":1744,"width":1498,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06a8ae04365a46eda5103af7236369d3","type":"text","conversion_output":true,"text":"functionally normal C1-INH protein, while the remaining approximately \\(15 \\%\\) of patients","text_display":" functionally normal C1-INH protein, while the remaining approximately \\(15 \\%\\) of patients","confidence":0.9878137038322166,"confidence_rate":0.9998681682831667},{"cnt":[[305,1790],[1867,1790],[1867,1841],[305,1841]],"region":{"top_left_x":305,"top_left_y":1789,"width":1562,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a24bf4263024ee7ba67a52654829427","type":"text","conversion_output":true,"text":"have Type II HAE and produce normal or elevated levels of a functionally impaired C1-INH","text_display":" have Type II HAE and produce normal or elevated levels of a functionally impaired C1-INH","confidence":1,"confidence_rate":1},{"cnt":[[305,1839],[1714,1839],[1714,1893],[305,1893]],"region":{"top_left_x":305,"top_left_y":1839,"width":1410,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e2701f64be449ce8536ed900bee60cf","type":"text","conversion_output":true,"text":"(Zuraw, 2008). In patients with Types I and II HAE, uncontrolled plasma kallikrein","text_display":" (Zuraw, 2008). In patients with Types I and II HAE, uncontrolled plasma kallikrein","confidence":1,"confidence_rate":1},{"cnt":[[305,1886],[1755,1886],[1755,1940],[305,1940]],"region":{"top_left_x":305,"top_left_y":1886,"width":1451,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89ff39e2bd3842fe929e9eadb2b4ac14","type":"text","conversion_output":true,"text":"generation results in excess bradykinin release from high-molecular weight kininogen","text_display":" generation results in excess bradykinin release from high-molecular weight kininogen","confidence":1,"confidence_rate":1},{"cnt":[[305,1934],[1880,1934],[1880,1987],[305,1987]],"region":{"top_left_x":305,"top_left_y":1933,"width":1575,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9cf597c54d04d8e8e73c5d07c52fd06","type":"text","conversion_output":true,"text":"(HMWK) and vascular leak mediated by bradykinin binding to the B2 receptor (B2-R) on the","text_display":" (HMWK) and vascular leak mediated by bradykinin binding to the B2 receptor (B2-R) on the","confidence":0.99365234375,"confidence_rate":0.9999315304271299},{"cnt":[[305,1981],[1846,1981],[1846,2035],[305,2035]],"region":{"top_left_x":305,"top_left_y":1980,"width":1541,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30cc00a4b5b94d44a246f6180b7d81ef","type":"text","conversion_output":true,"text":"surface of endothelial cells (Zuraw, 2008). Clinical suspicion of Types I and II HAE can be","text_display":" surface of endothelial cells (Zuraw, 2008). Clinical suspicion of Types I and II HAE can be","confidence":1,"confidence_rate":1},{"cnt":[[305,2030],[1729,2030],[1729,2082],[305,2082]],"region":{"top_left_x":305,"top_left_y":2030,"width":1425,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2b5f61623e34f038560ce1f3c4111d7","type":"text","conversion_output":true,"text":"confirmed by available blood tests. In addition to abnormalities in C1-INH level and","text_display":" confirmed by available blood tests. In addition to abnormalities in C1-INH level and","confidence":0.97216796875,"confidence_rate":0.9996828965565214},{"cnt":[[305,2075],[1809,2075],[1809,2133],[305,2133]],"region":{"top_left_x":305,"top_left_y":2075,"width":1504,"height":59},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dcf20f707e44495afb093d70e9c8941","type":"text","conversion_output":true,"text":"function, plasma C4 levels are markedly reduced at all times in blood from most patients.","text_display":" function, plasma C4 levels are markedly reduced at all times in blood from most patients.","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[296,2159],[1188,2159],[1188,2232],[296,2232]],"region":{"top_left_x":296,"top_left_y":2159,"width":893,"height":74},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bc65a1aaaac4b0a94784d16d2545da9","type":"section_header","conversion_output":false,"children_ids":["f5a648ea709b4f8d89d2aa56925c8a09"],"text":"","text_display":""},{"cnt":[[305,2166],[1179,2166],[1179,2224],[305,2224]],"region":{"top_left_x":305,"top_left_y":2165,"width":875,"height":59},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5a648ea709b4f8d89d2aa56925c8a09","type":"text","conversion_output":true,"parent_id":"6bc65a1aaaac4b0a94784d16d2545da9","text":"1.3 Therapeutic Rationale for DX-2930","text_display":"\n\n\\subsection*{1.3 Therapeutic Rationale for DX-2930}","confidence":0.9980480668600649,"confidence_rate":0.9999534810667048},{"cnt":[[305,2260],[1772,2260],[1772,2314],[305,2314]],"region":{"top_left_x":305,"top_left_y":2260,"width":1468,"height":54},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a7d509c8fe34fbab1423eac0e29cb14","type":"text","conversion_output":true,"text":"Plasma kallikrein plays a critical role in the pathogenesis of HAE attacks (Davis, 2006;","text_display":"\n\nPlasma kallikrein plays a critical role in the pathogenesis of HAE attacks (Davis, 2006;","confidence":0.99853515625,"confidence_rate":0.9999842375685026},{"cnt":[[305,2312],[1824,2312],[1824,2361],[305,2361]],"region":{"top_left_x":305,"top_left_y":2311,"width":1520,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b46208106ec4740b148ef8f1a4b94ed","type":"text","conversion_output":true,"text":"Kaplan and Joseph, 2010). In normal physiology, C1-INH regulates the activity of plasma","text_display":" Kaplan and Joseph, 2010). 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Plasma kallikrein regulates the release of bradykinin from high molecular weight","text_display":" XIIa. Plasma kallikrein regulates the release of bradykinin from high molecular weight","confidence":1,"confidence_rate":1},{"cnt":[[305,2587],[492,2587],[492,2628],[305,2628]],"region":{"top_left_x":305,"top_left_y":2586,"width":187,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6c162c4359145d4b6cf3685f68338a1","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[984,2587],[1205,2587],[1205,2632],[984,2632]],"region":{"top_left_x":983,"top_left_y":2586,"width":223,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97548f0156db4d55a686cd86039c2585","type":"page_info","conversion_output":false,"text":"Page 28 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,2587],[1884,2587],[1884,2632],[1706,2632]],"region":{"top_left_x":1705,"top_left_y":2586,"width":180,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6512c2c492a14b6182d1a7fa680f8c66","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-29","page":29,"lines":[{"cnt":[[305,125],[449,125],[449,165],[305,165]],"region":{"top_left_x":305,"top_left_y":124,"width":145,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5fdb82fbc3a439bacb5c38f5c1e94c1","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,163],[827,163],[827,208],[305,208]],"region":{"top_left_x":305,"top_left_y":163,"width":523,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40ef9ef28ae9474c9b956f0aa6e9c9d9","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c4fc80ea667403f82e395b44dd8c0d3","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999684830886739},{"cnt":[[305,284],[1869,284],[1869,337],[305,337]],"region":{"top_left_x":305,"top_left_y":283,"width":1565,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"900e415c6c6b4359be6a790cde78d889","type":"text","conversion_output":true,"text":"kininogen (HMWK). Due to a deficiency of C1-INH in HAE, uncontrolled plasma kallikrein","text_display":"\nkininogen (HMWK). Due to a deficiency of C1-INH in HAE, uncontrolled plasma kallikrein","confidence":0.876953125,"confidence_rate":0.9985581642114061},{"cnt":[[305,333],[1704,333],[1704,385],[305,385]],"region":{"top_left_x":305,"top_left_y":333,"width":1399,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61bc1ac871f24852bc36ce42ef626db1","type":"text","conversion_output":true,"text":"activity occurs and leads to the excessive generation of bradykinin. Bradykinin is a","text_display":" activity occurs and leads to the excessive generation of bradykinin. Bradykinin is a","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[305,380],[1766,380],[1766,432],[305,432]],"region":{"top_left_x":305,"top_left_y":380,"width":1462,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45fc3cc874084e54b080a9f26002fac4","type":"text","conversion_output":true,"text":"vasodilator which is thought to be responsible for the characteristic HAE symptoms of","text_display":" vasodilator which is thought to be responsible for the characteristic HAE symptoms of","confidence":1,"confidence_rate":1},{"cnt":[[305,430],[1691,430],[1691,479],[305,479]],"region":{"top_left_x":305,"top_left_y":429,"width":1386,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"553c93ba81db4c0e937f00318dda00c8","type":"text","conversion_output":true,"text":"localized swelling, inflammation, and pain (Craig et al., 2012; Zuraw et al., 2013).","text_display":" localized swelling, inflammation, and pain (Craig et al., 2012; Zuraw et al., 2013).","confidence":1,"confidence_rate":1},{"cnt":[[305,477],[1858,477],[1858,526],[305,526]],"region":{"top_left_x":305,"top_left_y":476,"width":1554,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c53599fac27448aa422c2f6fc150b9b","type":"text","conversion_output":true,"text":"Intervening at the level of bradykinin production with a plasma kallikrein inhibitor therefore","text_display":" Intervening at the level of bradykinin production with a plasma kallikrein inhibitor therefore","confidence":1,"confidence_rate":1},{"cnt":[[305,524],[1858,524],[1858,578],[305,578]],"region":{"top_left_x":305,"top_left_y":524,"width":1554,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5b5bce98bd34df2b1188601742c4abe","type":"text","conversion_output":true,"text":"represents an attractive and rational therapeutic strategy for HAE. Indeed, the importance of","text_display":" represents an attractive and rational therapeutic strategy for HAE. Indeed, the importance of","confidence":0.9985356330871582,"confidence_rate":0.9999850466409257},{"cnt":[[305,574],[1695,574],[1695,623],[305,623]],"region":{"top_left_x":305,"top_left_y":573,"width":1391,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"086f6cafa1154ec6a5a5466f7870dc7a","type":"text","conversion_output":true,"text":"plasma kallikrein as a drug target in HAE has been validated through the observed","text_display":" plasma kallikrein as a drug target in HAE has been validated through the observed","confidence":1,"confidence_rate":1},{"cnt":[[305,614],[1850,614],[1850,672],[305,672]],"region":{"top_left_x":305,"top_left_y":614,"width":1545,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1807d214906429a8fe05cf79d40a2a2","type":"text","conversion_output":true,"text":"effectiveness of Kalbitor \\({ }^{®}\\) (ecallantide), a peptide that specifically targets plasma kallikrein,","text_display":" effectiveness of Kalbitor \\({ }^{®}\\) (ecallantide), a peptide that specifically targets plasma kallikrein,","confidence":0.5533338114619255,"confidence_rate":0.9947300616919317},{"cnt":[[305,666],[1854,666],[1854,720],[305,720]],"region":{"top_left_x":305,"top_left_y":666,"width":1550,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f063bcda4ed04aa186b6fff50828be30","type":"text","conversion_output":true,"text":"which was approved by the FDA for the treatment of acute HAE attacks (Kalbitor \\({ }^{®}\\) package","text_display":" which was approved by the FDA for the treatment of acute HAE attacks (Kalbitor \\({ }^{®}\\) package","confidence":0.8299188613891602,"confidence_rate":0.9981916628374761},{"cnt":[[305,718],[537,718],[537,767],[305,767]],"region":{"top_left_x":305,"top_left_y":717,"width":233,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ff25872de30431b87a286e4b7e8156c","type":"text","conversion_output":true,"text":"insert, 2015).","text_display":" insert, 2015).","confidence":1,"confidence_rate":1},{"cnt":[[305,804],[1850,804],[1850,857],[305,857]],"region":{"top_left_x":305,"top_left_y":803,"width":1545,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e83d0872086497cbd8f9e0f5427959d","type":"text","conversion_output":true,"text":"DX-2930 is a highly potent and specific inhibitor of plasma kallikrein ( \\(K _{ i }=125 pM\\) ). X-ray","text_display":"\n\nDX-2930 is a highly potent and specific inhibitor of plasma kallikrein ( \\(K _{ i }=125 pM\\) ). X-ray","confidence":0.9985356330871582,"confidence_rate":0.9999871453444995},{"cnt":[[305,855],[1747,855],[1747,904],[305,904]],"region":{"top_left_x":305,"top_left_y":855,"width":1442,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba588f0d958341bc8797f07142f611db","type":"text","conversion_output":true,"text":"crystallography of DX-2930 combined with plasma kallikrein demonstrates DX-2930","text_display":" crystallography of DX-2930 combined with plasma kallikrein demonstrates DX-2930","confidence":1,"confidence_rate":1},{"cnt":[[305,902],[1360,902],[1360,954],[305,954]],"region":{"top_left_x":305,"top_left_y":902,"width":1055,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1825e057dce143b5bccb63bcc03ea3b1","type":"text","conversion_output":true,"text":"binding to the active site of kallikrein (Kenniston et al., 2014).","text_display":" binding to the active site of kallikrein (Kenniston et al., 2014).","confidence":1,"confidence_rate":1},{"cnt":[[301,984],[1063,984],[1063,1053],[301,1053]],"region":{"top_left_x":300,"top_left_y":983,"width":764,"height":70},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9cbf0d01c1143649c891dd15e855ca5","type":"section_header","conversion_output":false,"children_ids":["98275bd3923d43c0a961b865faa01376"],"text":"","text_display":""},{"cnt":[[305,988],[1057,988],[1057,1046],[305,1046]],"region":{"top_left_x":305,"top_left_y":988,"width":753,"height":59},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98275bd3923d43c0a961b865faa01376","type":"text","conversion_output":true,"parent_id":"d9cbf0d01c1143649c891dd15e855ca5","text":"1.4 Safety Rationale for DX-2930","text_display":"\n\n\\subsection*{1.4 Safety Rationale for DX-2930}","confidence":0.9990236759185791,"confidence_rate":0.9999736003215528},{"cnt":[[305,1083],[1869,1083],[1869,1137],[305,1137]],"region":{"top_left_x":305,"top_left_y":1082,"width":1565,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"523c7536d35145c6962fdb0fc068d749","type":"text","conversion_output":true,"text":"Safety data from the Phase 1a clinical study, a first-in-human study with DX-2930 in healthy","text_display":"\n\nSafety data from the Phase 1a clinical study, a first-in-human study with DX-2930 in healthy","confidence":0.998046875,"confidence_rate":0.9999798452048033},{"cnt":[[305,1134],[1841,1134],[1841,1184],[305,1184]],"region":{"top_left_x":305,"top_left_y":1134,"width":1537,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9664ae552578488c97c504171c9fa2b2","type":"text","conversion_output":true,"text":"subjects did not identify any safety concerns. Single doses up to \\(3 mg / kg\\) of DX-2930 were","text_display":" subjects did not identify any safety concerns. Single doses up to \\(3 mg / kg\\) of DX-2930 were","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,1182],[1826,1182],[1826,1231],[305,1231]],"region":{"top_left_x":305,"top_left_y":1181,"width":1522,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"888f7da0d0c746af945f679e13b7a9fc","type":"text","conversion_output":true,"text":"well-tolerated. There were no dose-limiting toxicities, serious adverse events, or any other","text_display":" well-tolerated. There were no dose-limiting toxicities, serious adverse events, or any other","confidence":1,"confidence_rate":1},{"cnt":[[305,1229],[758,1229],[758,1278],[305,1278]],"region":{"top_left_x":305,"top_left_y":1228,"width":454,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0807d085cb824f7c95f4f36d5761fc24","type":"text","conversion_output":true,"text":"safety concerns identified.","text_display":" safety concerns identified.","confidence":1,"confidence_rate":1},{"cnt":[[305,1317],[1882,1317],[1882,1369],[305,1369]],"region":{"top_left_x":305,"top_left_y":1316,"width":1578,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd541cad5e57444e824c5bf0c460c1c9","type":"text","conversion_output":true,"text":"Pharmacokinetic (PK) data from the Phase 1a clinical study in conjunction with data from the","text_display":"\n\nPharmacokinetic (PK) data from the Phase 1a clinical study in conjunction with data from the","confidence":0.99658203125,"confidence_rate":0.9999647034750034},{"cnt":[[305,1366],[1863,1366],[1863,1420],[305,1420]],"region":{"top_left_x":305,"top_left_y":1366,"width":1558,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a2c6c3d029346b38a42e6b0220cff8b","type":"text","conversion_output":true,"text":"nonclinical toxicity studies support a wide safety margin. The mean \\(C _{\\text {max }}\\) for human subjects","text_display":" nonclinical toxicity studies support a wide safety margin. The mean \\(C _{\\text {max }}\\) for human subjects","confidence":0.9980475902557373,"confidence_rate":0.9999828570050077},{"cnt":[[305,1418],[1792,1418],[1792,1470],[305,1470]],"region":{"top_left_x":305,"top_left_y":1417,"width":1487,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fa71bf2f9e24ed7b567efed35a05596","type":"text","conversion_output":true,"text":"treated at the highest dose of \\(3 mg / kg\\) was approximately \\(14.5 \\mu g / mL\\). As comparison, a","text_display":" treated at the highest dose of \\(3 mg / kg\\) was approximately \\(14.5 \\mu g / mL\\). 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No toxicologically significant findings were observed in","text_display":" DX-2930 SC weekly for 28 days. No toxicologically significant findings were observed in","confidence":1,"confidence_rate":1},{"cnt":[[305,1564],[1760,1564],[1760,1618],[305,1618]],"region":{"top_left_x":305,"top_left_y":1564,"width":1455,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f22914fbf6154930bd7434bac6f4138f","type":"text","conversion_output":true,"text":"these treated animals or in any other nonclinical toxicity study to date for systemically","text_display":" these treated animals or in any other nonclinical toxicity study to date for systemically","confidence":1,"confidence_rate":1},{"cnt":[[305,1611],[711,1611],[711,1661],[305,1661]],"region":{"top_left_x":305,"top_left_y":1611,"width":407,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb0a908ff68644628bfc04fba13a0f7b","type":"text","conversion_output":true,"text":"administered DX-2930.","text_display":" administered DX-2930.","confidence":1,"confidence_rate":1},{"cnt":[[305,1702],[1796,1702],[1796,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1701,"width":1492,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cc6f0358a304e06a118c09eaa64719f","type":"text","conversion_output":true,"text":"Safety data is also available from the Phase lb study, a multiple-ascending dose study in","text_display":"\n\nSafety data is also available from the Phase lb study, a multiple-ascending dose study in","confidence":0.68359375,"confidence_rate":0.9959614591568635},{"cnt":[[305,1749],[1863,1749],[1863,1803],[305,1803]],"region":{"top_left_x":305,"top_left_y":1748,"width":1558,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a20bed6370274da59350cc9cb68ebc75","type":"text","conversion_output":true,"text":"HAE patients. In this study, two doses of DX-2930 up to 400 mg administered 14 days apart","text_display":" HAE patients. In this study, two doses of DX-2930 up to 400 mg administered 14 days apart","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,1800],[1807,1800],[1807,1850],[305,1850]],"region":{"top_left_x":305,"top_left_y":1800,"width":1502,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdb445a75fbe41dda41e4c65689c58e8","type":"text","conversion_output":true,"text":"were well-tolerated. There were no dose-limiting toxicities, serious adverse events in any","text_display":" were well-tolerated. There were no dose-limiting toxicities, serious adverse events in any","confidence":1,"confidence_rate":1},{"cnt":[[305,1848],[1764,1848],[1764,1897],[305,1897]],"region":{"top_left_x":305,"top_left_y":1847,"width":1459,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf2ce96e8a2d4276acdd1b59b96c01cd","type":"text","conversion_output":true,"text":"DX-2930 treated subjects, or any other safety concerns identified in this study of HAE","text_display":" DX-2930 treated subjects, or any other safety concerns identified in this study of HAE","confidence":1,"confidence_rate":1},{"cnt":[[305,1895],[1869,1895],[1869,1944],[305,1944]],"region":{"top_left_x":305,"top_left_y":1894,"width":1565,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d0ada0b67414fb389fcdf21d4fe7434","type":"text","conversion_output":true,"text":"patients. Pharmacokinetic data from the 1 b study found that the drug exposure following two","text_display":" patients. 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DX-2930, please refer to the DX-2930","confidence":1,"confidence_rate":1},{"cnt":[[305,2127],[724,2127],[724,2179],[305,2179]],"region":{"top_left_x":305,"top_left_y":2126,"width":420,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f0bea495c89488cb6e40e86c7374b97","type":"text","conversion_output":true,"text":"Investigator's Brochure.","text_display":" Investigator's 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Toxicology}","confidence":1,"confidence_rate":1},{"cnt":[[305,2310],[1781,2310],[1781,2361],[305,2361]],"region":{"top_left_x":305,"top_left_y":2309,"width":1477,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63273e7587814d68880805ef1f5d3353","type":"text","conversion_output":true,"text":"For detail regarding the nonclinical findings, please refer to the DX-2930 Investigator's","text_display":"\n\nFor detail regarding the nonclinical findings, please refer to the DX-2930 Investigator's","confidence":1,"confidence_rate":1},{"cnt":[[305,2359],[483,2359],[483,2408],[305,2408]],"region":{"top_left_x":305,"top_left_y":2358,"width":179,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e352ec3bbc74e6e97ddf9ba11dd02ff","type":"text","conversion_output":true,"text":"Brochure.","text_display":" Brochure.","confidence":1,"confidence_rate":1},{"cnt":[[305,2587],[492,2587],[492,2628],[305,2628]],"region":{"top_left_x":305,"top_left_y":2586,"width":187,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e542ba66e30d4e89b065f1eeabf4c891","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[984,2587],[1205,2587],[1205,2632],[984,2632]],"region":{"top_left_x":983,"top_left_y":2586,"width":223,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c18f163b4d1d4e65a5120ca457fa304e","type":"page_info","conversion_output":false,"text":"Page 29 of 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DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0ac3404bd0e4a99ad4428176360d515","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[301,277],[913,277],[913,346],[301,346]],"region":{"top_left_x":300,"top_left_y":277,"width":614,"height":69},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e38edf98f51e4e3e8bccf93ea6ea9ded","type":"section_header","conversion_output":false,"children_ids":["60293694732d481499155ffd60047c2d"],"text":"","text_display":""},{"cnt":[[305,284],[907,284],[907,342],[305,342]],"region":{"top_left_x":305,"top_left_y":283,"width":602,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60293694732d481499155ffd60047c2d","type":"text","conversion_output":true,"parent_id":"e38edf98f51e4e3e8bccf93ea6ea9ded","text":"1.6 DX-2930 Clinical Data","text_display":"\n\n\\subsection*{1.6 DX-2930 Clinical Data}","confidence":1,"confidence_rate":1},{"cnt":[[305,378],[1843,378],[1843,432],[305,432]],"region":{"top_left_x":305,"top_left_y":378,"width":1539,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b003e91f2d1449a2b97ede52e8f0a928","type":"text","conversion_output":true,"text":"The clinical development program to date for DX-2930 consists of 2 studies to evaluate the","text_display":"\n\nThe clinical development program to date for DX-2930 consists of 2 studies to evaluate the","confidence":0.9965848922729492,"confidence_rate":0.9999650929305077},{"cnt":[[305,425],[1867,425],[1867,479],[305,479]],"region":{"top_left_x":305,"top_left_y":425,"width":1562,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"099524adcea8421a817ebe3fe3ff7fe8","type":"text","conversion_output":true,"text":"safety, tolerability, and PK of DX-2930, including a Phase 1a single-ascending dose study in","text_display":" safety, tolerability, and PK of DX-2930, including a Phase 1a single-ascending dose study in","confidence":0.99853515625,"confidence_rate":0.9999848875607663},{"cnt":[[305,473],[1764,473],[1764,526],[305,526]],"region":{"top_left_x":305,"top_left_y":472,"width":1459,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"178afdcb2b9b42b79a5a115547eca858","type":"text","conversion_output":true,"text":"healthy subjects and a Phase 1b multiple-ascending dose study in HAE patients. These","text_display":" healthy subjects and a Phase 1b multiple-ascending dose study in HAE patients. These","confidence":0.99853515625,"confidence_rate":0.9999835291504493},{"cnt":[[305,524],[1141,524],[1141,576],[305,576]],"region":{"top_left_x":305,"top_left_y":524,"width":836,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbf6593a56a84529860c0dde5c0662e9","type":"text","conversion_output":true,"text":"studies are summarized in the following sections.","text_display":" studies are summarized in the following sections.","confidence":1,"confidence_rate":1},{"cnt":[[301,604],[1678,604],[1678,675],[301,675]],"region":{"top_left_x":300,"top_left_y":603,"width":1378,"height":72},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"905893416d194534b4ac1189fb35dfd3","type":"section_header","conversion_output":false,"children_ids":["a799aec2296a4231872c7268a59fb495"],"text":"","text_display":""},{"cnt":[[309,608],[1671,608],[1671,668],[309,668]],"region":{"top_left_x":309,"top_left_y":608,"width":1363,"height":61},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a799aec2296a4231872c7268a59fb495","type":"text","conversion_output":true,"parent_id":"905893416d194534b4ac1189fb35dfd3","text":"1.6.1 Single-Ascending Dose Study in Healthy Subjects (DX-2930-01)","text_display":"\n\n\\subsection*{1.6.1 Single-Ascending Dose Study in Healthy Subjects (DX-2930-01)}","confidence":0.9970715045928955,"confidence_rate":0.9999586939257971},{"cnt":[[305,700],[1846,700],[1846,754],[305,754]],"region":{"top_left_x":305,"top_left_y":700,"width":1541,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8251856a054e48ca95b9b47ce85af0dc","type":"text","conversion_output":true,"text":"DX-2930-01 was a Phase 1a randomized, double-blind, placebo-controlled study in healthy","text_display":"\n\nDX-2930-01 was a Phase 1a randomized, double-blind, placebo-controlled study in healthy","confidence":0.6513671875,"confidence_rate":0.9953512546770952},{"cnt":[[305,750],[1858,750],[1858,801],[305,801]],"region":{"top_left_x":305,"top_left_y":749,"width":1554,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbf2777401ca483cae631cb7c4d968a4","type":"text","conversion_output":true,"text":"subjects to evaluate the safety, tolerability, and PK following a single, SC dose of DX-2930.","text_display":" subjects to evaluate the safety, tolerability, and PK following a single, SC dose of DX-2930.","confidence":1,"confidence_rate":1},{"cnt":[[305,799],[1869,799],[1869,849],[305,849]],"region":{"top_left_x":305,"top_left_y":799,"width":1565,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85c77e8ef4a04c9285a145b21e41dd49","type":"text","conversion_output":true,"text":"Participating subjects were randomized to receive placebo or active study drug within one of","text_display":" Participating subjects were randomized to receive placebo or active study drug within one of","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[305,846],[1876,846],[1876,896],[305,896]],"region":{"top_left_x":305,"top_left_y":846,"width":1571,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f3a32ee9b0e4b00b8cd446b6fd5f156","type":"text","conversion_output":true,"text":"the following sequential, ascending dose cohorts: \\(0.1,0.3,1.0\\), or \\(3.0 mg / kg\\). For each dosing","text_display":" the following sequential, ascending dose cohorts: \\(0.1,0.3,1.0\\), or \\(3.0 mg / kg\\). For each dosing","confidence":0.9990234375,"confidence_rate":0.9999911178608298},{"cnt":[[305,894],[1852,894],[1852,947],[305,947]],"region":{"top_left_x":305,"top_left_y":893,"width":1547,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"355afc8cee1b4ec792c66a5aab11c097","type":"text","conversion_output":true,"text":"cohort, 6 subjects were randomized to receive active drug and 2 subjects to receive placebo.","text_display":" cohort, 6 subjects were randomized to receive active drug and 2 subjects to receive placebo.","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[305,984],[1867,984],[1867,1036],[305,1036]],"region":{"top_left_x":305,"top_left_y":983,"width":1562,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72ee7902b82f45abb713cbb23edd6f44","type":"text","conversion_output":true,"text":"A total of 32 subjects enrolled in the study and were randomized. The treatment groups were","text_display":"\n\nA total of 32 subjects enrolled in the study and were randomized. The treatment groups were","confidence":1,"confidence_rate":1},{"cnt":[[305,1031],[1850,1031],[1850,1085],[305,1085]],"region":{"top_left_x":305,"top_left_y":1031,"width":1545,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1f28090bf1942e2acc10bd1ea6c4929","type":"text","conversion_output":true,"text":"well balanced for demographic characteristics. The actual dose of DX-2930 administered to","text_display":" well balanced for demographic characteristics. The actual dose of DX-2930 administered to","confidence":1,"confidence_rate":1},{"cnt":[[305,1079],[1813,1079],[1813,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1078,"width":1509,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbd1d4786232405d82cc752683fc440a","type":"text","conversion_output":true,"text":"subjects ranged from 6.2 mg (in the \\(0.1 mg / kg\\) group) to 300 mg (in the \\(3.0 mg / kg\\) group)","text_display":" subjects ranged from 6.2 mg (in the \\(0.1 mg / kg\\) group) to 300 mg (in the \\(3.0 mg / kg\\) group)","confidence":1,"confidence_rate":1},{"cnt":[[305,1126],[617,1126],[617,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1125,"width":312,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08e64df2702c48df802d5930426480a3","type":"text","conversion_output":true,"text":"across all cohorts.","text_display":" across all cohorts.","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1811,1216],[1811,1270],[305,1270]],"region":{"top_left_x":305,"top_left_y":1216,"width":1507,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a8ce13fbfae447ba93b9801c9f7eb28","type":"text","conversion_output":true,"text":"Based on the safety analysis, a single administration of DX-2930 was well tolerated up to","text_display":"\n\nBased on the safety analysis, a single administration of DX-2930 was well tolerated up to","confidence":0.99755859375,"confidence_rate":0.9999739961748949},{"cnt":[[305,1263],[1852,1263],[1852,1317],[305,1317]],"region":{"top_left_x":305,"top_left_y":1263,"width":1547,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6dcf3b1f86a246e48192d1c819e1a661","type":"text","conversion_output":true,"text":"doses of \\(3.0 mg / kg\\) without evidence of dose-limiting toxicity. There were no deaths, SAEs,","text_display":" doses of \\(3.0 mg / kg\\) without evidence of dose-limiting toxicity. There were no deaths, SAEs,","confidence":1,"confidence_rate":1},{"cnt":[[305,1313],[1858,1313],[1858,1364],[305,1364]],"region":{"top_left_x":305,"top_left_y":1312,"width":1554,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdc82b4d47304c63a192a4be985df63d","type":"text","conversion_output":true,"text":"or subject discontinuations due to adverse events (AEs) during the study. Furthermore, there","text_display":" or subject discontinuations due to adverse events (AEs) during the study. Furthermore, there","confidence":0.9980475902557373,"confidence_rate":0.9999798525928524},{"cnt":[[305,1362],[1815,1362],[1815,1412],[305,1412]],"region":{"top_left_x":305,"top_left_y":1362,"width":1511,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6045612c7e6443a4bece8d15fe1da3cf","type":"text","conversion_output":true,"text":"was no significant imbalance between placebo and DX-2930 for any particular treatment-","text_display":" was no significant imbalance between placebo and DX-2930 for any particular treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,1409],[1854,1409],[1854,1463],[305,1463]],"region":{"top_left_x":305,"top_left_y":1409,"width":1550,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5848b90033c843dfbf4f5f8a7a412bb3","type":"text","conversion_output":true,"text":"emergent adverse event (TEAE). The most commonly reported TEAE was headache, which","text_display":"emergent adverse event (TEAE). The most commonly reported TEAE was headache, which","confidence":1,"confidence_rate":1},{"cnt":[[305,1457],[1270,1457],[1270,1510],[305,1510]],"region":{"top_left_x":305,"top_left_y":1456,"width":965,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0617ef20ca8648d8a1e86f4525d023a9","type":"text","conversion_output":true,"text":"occurred at a rate of \\(25 \\%\\) for both DX-2930 and placebo.","text_display":" occurred at a rate of \\(25 \\%\\) for both DX-2930 and placebo.","confidence":0.9990236759185791,"confidence_rate":0.9999844953424807},{"cnt":[[305,1543],[1850,1543],[1850,1596],[305,1596]],"region":{"top_left_x":305,"top_left_y":1542,"width":1545,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"174b4f73ad3442dbb030b9565bb23203","type":"text","conversion_output":true,"text":"The PK profile demonstrated linear, dose-dependent drug exposure with a mean half-life of","text_display":"\n\nThe PK profile demonstrated linear, dose-dependent drug exposure with a mean half-life of","confidence":1,"confidence_rate":1},{"cnt":[[305,1594],[1815,1594],[1815,1646],[305,1646]],"region":{"top_left_x":305,"top_left_y":1594,"width":1511,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bec0ebf6503a44a899bd32f715b248a1","type":"text","conversion_output":true,"text":"approximately 17 to 21 days across dose groups. Results from two exploratory biomarker","text_display":" approximately 17 to 21 days across dose groups. Results from two exploratory biomarker","confidence":1,"confidence_rate":1},{"cnt":[[305,1641],[1833,1641],[1833,1695],[305,1695]],"region":{"top_left_x":305,"top_left_y":1641,"width":1528,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1512841a9344f5c9702fcba24452cd2","type":"text","conversion_output":true,"text":"assays provide evidence for an important pharmacodynamic effect of DX-2930 in humans.","text_display":" assays provide evidence for an important pharmacodynamic effect of DX-2930 in humans.","confidence":1,"confidence_rate":1},{"cnt":[[305,1732],[1867,1732],[1867,1785],[305,1785]],"region":{"top_left_x":305,"top_left_y":1731,"width":1562,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a0544fecc41422a922afb8d91ae4c23","type":"text","conversion_output":true,"text":"For additional detail regarding the single dose, clinical study in healthy subjects, please refer","text_display":"\n\nFor additional detail regarding the single dose, clinical study in healthy subjects, please refer","confidence":1,"confidence_rate":1},{"cnt":[[305,1779],[995,1779],[995,1833],[305,1833]],"region":{"top_left_x":305,"top_left_y":1778,"width":690,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4a2c8164d9e4152af5e2c379c7d9839","type":"text","conversion_output":true,"text":"to the DX-2930 Investigator's Brochure.","text_display":" to the DX-2930 Investigator's Brochure.","confidence":0.97412109375,"confidence_rate":0.9994042762221983},{"cnt":[[301,1861],[1644,1861],[1644,1931],[301,1931]],"region":{"top_left_x":300,"top_left_y":1860,"width":1344,"height":72},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73e1d00b14344ba99edb00fd791c3e84","type":"section_header","conversion_output":false,"children_ids":["576c7d031aa0420db13998cdcd6c454a"],"text":"","text_display":""},{"cnt":[[309,1869],[1635,1869],[1635,1923],[309,1923]],"region":{"top_left_x":309,"top_left_y":1869,"width":1326,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"576c7d031aa0420db13998cdcd6c454a","type":"text","conversion_output":true,"parent_id":"73e1d00b14344ba99edb00fd791c3e84","text":"1.6.2 Multiple-Ascending Dose Study in HAE Patients (DX-2930-02)","text_display":"\n\n\\subsection*{1.6.2 Multiple-Ascending Dose Study in HAE Patients (DX-2930-02)}","confidence":1,"confidence_rate":1},{"cnt":[[305,1955],[1732,1955],[1732,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1955,"width":1427,"height":59},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f2cfa993b0f43afbe09d68b1eb37bd1","type":"text","conversion_output":true,"text":"DX-2930-02 was a Phase 1b randomized, double-blind, placebo-controlled, multiple","text_display":"\n\nDX-2930-02 was a Phase 1b randomized, double-blind, placebo-controlled, multiple","confidence":0.99560546875,"confidence_rate":0.9999481870413384},{"cnt":[[305,2007],[1798,2007],[1798,2060],[305,2060]],"region":{"top_left_x":305,"top_left_y":2006,"width":1494,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e369184d07164817873dad7227b6e2c3","type":"text","conversion_output":true,"text":"ascending-dose study in patients with HAE to evaluate safety, tolerability, and PK of SC","text_display":" ascending-dose study in patients with HAE to evaluate safety, tolerability, and PK of SC","confidence":1,"confidence_rate":1},{"cnt":[[305,2054],[1841,2054],[1841,2105],[305,2105]],"region":{"top_left_x":305,"top_left_y":2053,"width":1537,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3918708358d7473ebecf6da7e11ec5b9","type":"text","conversion_output":true,"text":"DX-2930. Participating subjects were randomized 2:1 to receive either active study drug or","text_display":" DX-2930. Participating subjects were randomized 2:1 to receive either active study drug or","confidence":0.99169921875,"confidence_rate":0.9999122625377982},{"cnt":[[305,2101],[1792,2101],[1792,2155],[305,2155]],"region":{"top_left_x":305,"top_left_y":2101,"width":1487,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"229cf3bbe2d84eb09e434a2c3a14e271","type":"text","conversion_output":true,"text":"placebo within one of the following sequential, ascending dose cohorts: \\(30,100,300\\), or","text_display":" placebo within one of the following sequential, ascending dose cohorts: \\(30,100,300\\), or","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[305,2151],[1729,2151],[1729,2204],[305,2204]],"region":{"top_left_x":305,"top_left_y":2150,"width":1425,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adc7e7e058c1468a9c6e6cf76756f1e9","type":"text","conversion_output":true,"text":"400 mg (nominal 6 subjects per cohort). Each subject received 2 doses of study drug","text_display":" 400 mg (nominal 6 subjects per cohort). Each subject received 2 doses of study drug","confidence":1,"confidence_rate":1},{"cnt":[[305,2200],[1583,2200],[1583,2254],[305,2254]],"region":{"top_left_x":305,"top_left_y":2200,"width":1279,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"670a44fd7aad4e91889faca517cdb408","type":"text","conversion_output":true,"text":"separated by 14 days and were followed for 15 weeks after the second dose.","text_display":" separated by 14 days and were followed for 15 weeks after the second dose.","confidence":1,"confidence_rate":1},{"cnt":[[314,2286],[1880,2286],[1880,2340],[314,2340]],"region":{"top_left_x":313,"top_left_y":2285,"width":1567,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f65d11bc367448d87199ec28b2cadac","type":"text","conversion_output":true,"text":"A total of 37 subjects were randomized and treated with DX-2930 or placebo. One subject in","text_display":"\n\nA total of 37 subjects were randomized and treated with DX-2930 or placebo. One subject in","confidence":0.99755859375,"confidence_rate":0.9999750575422747},{"cnt":[[305,2333],[1676,2333],[1676,2387],[305,2387]],"region":{"top_left_x":305,"top_left_y":2333,"width":1371,"height":54},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44fccb9ca1e44912a6938e84dc4c679d","type":"text","conversion_output":true,"text":"the 400 mg dose group received a single dose of DX-2930 and, following several","text_display":" the 400 mg dose group received a single dose of DX-2930 and, following several","confidence":1,"confidence_rate":1},{"cnt":[[305,2385],[1882,2385],[1882,2436],[305,2436]],"region":{"top_left_x":305,"top_left_y":2384,"width":1578,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d5236444e214b16847cbb9d72843ca3","type":"text","conversion_output":true,"text":"unsuccessful attempts to schedule their second dose, was replaced. This subject returned for a","text_display":" unsuccessful attempts to schedule their second dose, was replaced. This subject returned for a","confidence":1,"confidence_rate":1},{"cnt":[[305,2432],[1781,2432],[1781,2486],[305,2486]],"region":{"top_left_x":305,"top_left_y":2432,"width":1477,"height":54},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8258ce34f3d84e2988dc04d288baca39","type":"text","conversion_output":true,"text":"single follow-up visit before being lost to follow-up for reasons not related to the study.","text_display":" single follow-up visit before being lost to follow-up for reasons not related to the study.","confidence":1,"confidence_rate":1},{"cnt":[[305,2587],[492,2587],[492,2628],[305,2628]],"region":{"top_left_x":305,"top_left_y":2586,"width":187,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93ea4c02d6df4191943f56629fa17c9d","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[984,2587],[1205,2587],[1205,2632],[984,2632]],"region":{"top_left_x":983,"top_left_y":2586,"width":223,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b860e567ab1046209ac7833cb4f5f821","type":"page_info","conversion_output":false,"text":"Page 30 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,2587],[1882,2587],[1882,2632],[1706,2632]],"region":{"top_left_x":1705,"top_left_y":2586,"width":178,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"415b2bae094045b087bbb9722b36d214","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-31","page":31,"lines":[{"cnt":[[305,125],[449,125],[449,165],[305,165]],"region":{"top_left_x":305,"top_left_y":124,"width":145,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3dc8cb4a69643f6995e331f6c795655","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,163],[827,163],[827,208],[305,208]],"region":{"top_left_x":305,"top_left_y":163,"width":523,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2deb85ac96074653865fdaf2281ad41a","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8916c36cd6a341c2bd89d5f72d254e5f","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,284],[1764,284],[1764,337],[305,337]],"region":{"top_left_x":305,"top_left_y":283,"width":1459,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e863978ee5c34ee1ae298db0eac83877","type":"text","conversion_output":true,"text":"Routine Cl-INH testing revealed that one other subject did not have HAE Type I or II,","text_display":"\n\nRoutine Cl-INH testing revealed that one other subject did not have HAE Type I or II,","confidence":0.71240234375,"confidence_rate":0.9962391737144075},{"cnt":[[305,331],[1119,331],[1119,385],[305,385]],"region":{"top_left_x":305,"top_left_y":330,"width":815,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b05d59e5cd264545966ad241e64239a4","type":"text","conversion_output":true,"text":"despite a historical lab test indicating otherwise.","text_display":" despite a historical lab test indicating otherwise.","confidence":1,"confidence_rate":1},{"cnt":[[305,421],[1824,421],[1824,475],[305,475]],"region":{"top_left_x":305,"top_left_y":421,"width":1520,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26cfa6e9d5114b7cbefaa46641510d7b","type":"text","conversion_output":true,"text":"Subject demographics were balanced in terms of age, race, ethnicity and BMI. There were","text_display":"\n\nSubject demographics were balanced in terms of age, race, ethnicity and BMI. There were","confidence":1,"confidence_rate":1},{"cnt":[[305,468],[1742,468],[1742,522],[305,522]],"region":{"top_left_x":305,"top_left_y":468,"width":1438,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19f8fc11c214427b873939d7821ccb40","type":"text","conversion_output":true,"text":"slightly more females in the DX-2930 group than in the placebo group ( \\(66.7 \\%\\) versus","text_display":" slightly more females in the DX-2930 group than in the placebo group ( \\(66.7 \\%\\) versus","confidence":0.9970724578015506,"confidence_rate":0.9999677825428174},{"cnt":[[305,520],[449,520],[449,569],[305,569]],"region":{"top_left_x":305,"top_left_y":519,"width":145,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"254c034a4b794fd2adca5b21bb327b01","type":"text","conversion_output":true,"text":"\\(53.8 \\%\\) ).","text_display":" \\(53.8 \\%\\) ).","confidence":0.965364933013916,"confidence_rate":0.9970668866564437},{"cnt":[[305,606],[1824,606],[1824,660],[305,660]],"region":{"top_left_x":305,"top_left_y":605,"width":1520,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"727a1fc05dab424aa020850b3747bc5f","type":"text","conversion_output":true,"text":"The most common AEs reported were HAE attacks, injection site pain, and headache. The","text_display":"\n\nThe most common AEs reported were HAE attacks, injection site pain, and headache. The","confidence":1,"confidence_rate":1},{"cnt":[[305,657],[1747,657],[1747,707],[305,707]],"region":{"top_left_x":305,"top_left_y":657,"width":1442,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7ab1e463146442db3c8294e670cfcc2","type":"text","conversion_output":true,"text":"rates were not appreciably higher in the DX-2930 subjects compared to placebo. Two","text_display":" rates were not appreciably higher in the DX-2930 subjects compared to placebo. Two","confidence":1,"confidence_rate":1},{"cnt":[[305,705],[1863,705],[1863,758],[305,758]],"region":{"top_left_x":305,"top_left_y":704,"width":1558,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a34a9995eee842ea97a73488a8ac5d7a","type":"text","conversion_output":true,"text":"subjects were reported to have 3 related severe TEAEs. One of these was a DX-2930 subject","text_display":" subjects were reported to have 3 related severe TEAEs. One of these was a DX-2930 subject","confidence":0.9975595474243164,"confidence_rate":0.999974810262278},{"cnt":[[305,752],[1828,752],[1828,806],[305,806]],"region":{"top_left_x":305,"top_left_y":751,"width":1524,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a67b1f97a0248dcb7c31713f65aa991","type":"text","conversion_output":true,"text":"\\((30 mg )\\) with injection site pain lasting 1 minute and one was a DX-2930 subject ( 400 mg )","text_display":" \\((30 mg )\\) with injection site pain lasting 1 minute and one was a DX-2930 subject ( 400 mg )","confidence":0.7967805862426758,"confidence_rate":0.9978180000145708},{"cnt":[[305,799],[1317,799],[1317,853],[305,853]],"region":{"top_left_x":305,"top_left_y":799,"width":1012,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b3085cf28f64e00b1a6d45738a35c91","type":"text","conversion_output":true,"text":"with worsening headache lasting 1 minute and night sweats.","text_display":" with worsening headache lasting 1 minute and night sweats.","confidence":1,"confidence_rate":1},{"cnt":[[305,889],[1826,889],[1826,943],[305,943]],"region":{"top_left_x":305,"top_left_y":889,"width":1522,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"631e8b9e68794ce3ac1d9191d08c4914","type":"text","conversion_output":true,"text":"No safety signals were identified for vital signs, physical examinations, clinical laboratory","text_display":"\n\nNo safety signals were identified for vital signs, physical examinations, clinical laboratory","confidence":1,"confidence_rate":1},{"cnt":[[305,937],[1876,937],[1876,990],[305,990]],"region":{"top_left_x":305,"top_left_y":936,"width":1571,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cf2a3cd87fb42e38f91f8367dae2834","type":"text","conversion_output":true,"text":"tests, or electrocardiograms (ECG). Results suggest DX-2930 was well tolerated in this study","text_display":" tests, or electrocardiograms (ECG). Results suggest DX-2930 was well tolerated in this study","confidence":1,"confidence_rate":1},{"cnt":[[305,984],[1403,984],[1403,1038],[305,1038]],"region":{"top_left_x":305,"top_left_y":983,"width":1098,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d5c5b56995e4a1ab904f6bfc801c15f","type":"text","conversion_output":true,"text":"with no evidence of dose-limiting toxicity at doses up to 400 mg .","text_display":" with no evidence of dose-limiting toxicity at doses up to 400 mg .","confidence":1,"confidence_rate":1},{"cnt":[[305,1074],[1837,1074],[1837,1128],[305,1128]],"region":{"top_left_x":305,"top_left_y":1074,"width":1532,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4cec0ccec424dcb914a2b9b1a9c9c10","type":"text","conversion_output":true,"text":"A total of 3 out of 92 post-dose samples ( \\(3.3 \\%\\) ), obtained from 2 out of 23 subjects ( \\(8.7 \\%\\) ),","text_display":"\n\nA total of 3 out of 92 post-dose samples ( \\(3.3 \\%\\) ), obtained from 2 out of 23 subjects ( \\(8.7 \\%\\) ),","confidence":0.9926934077005275,"confidence_rate":0.9999378543363281},{"cnt":[[305,1124],[1147,1124],[1147,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1123,"width":843,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bd22f9a0f9c47c79d03c8cc31ec6c46","type":"text","conversion_output":true,"text":"were confirmed to be anti-drug antibody-positive.","text_display":" were confirmed to be anti-drug antibody-positive.","confidence":1,"confidence_rate":1},{"cnt":[[305,1212],[1854,1212],[1854,1263],[305,1263]],"region":{"top_left_x":305,"top_left_y":1211,"width":1550,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f6e6be90d484ffb8c88afc959fc22ea","type":"text","conversion_output":true,"text":"The pharmacokinetic analysis for all subjects in the \\(30,100,300\\), and 400 mg doses showed","text_display":"\n\nThe pharmacokinetic analysis for all subjects in the \\(30,100,300\\), and 400 mg doses showed","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,1259],[1790,1259],[1790,1313],[305,1313]],"region":{"top_left_x":305,"top_left_y":1258,"width":1485,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4240f4b1661642a3bc717d72fd712f93","type":"text","conversion_output":true,"text":"drug levels in HAE subjects were dose-dependent and exhibited a prolonged half-life of","text_display":" drug levels in HAE subjects were dose-dependent and exhibited a prolonged half-life of","confidence":1,"confidence_rate":1},{"cnt":[[305,1308],[1861,1308],[1861,1360],[305,1360]],"region":{"top_left_x":305,"top_left_y":1308,"width":1556,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e1878f492294d129e1e4a0907ed36f8","type":"text","conversion_output":true,"text":"approximately 2 weeks, typical of a human monoclonal antibody. \\(C _{\\text {max }}\\) drug levels increased","text_display":" approximately 2 weeks, typical of a human monoclonal antibody. \\(C _{\\text {max }}\\) drug levels increased","confidence":0.9970724578015506,"confidence_rate":0.9999745061003487},{"cnt":[[305,1354],[1815,1354],[1815,1407],[305,1407]],"region":{"top_left_x":305,"top_left_y":1353,"width":1511,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f739be6bb444b11a77995933dbeab16","type":"text","conversion_output":true,"text":"with increasing dose, as expected. These parameters are consisted with values obtained in","text_display":" with increasing dose, as expected. These parameters are consisted with values obtained in","confidence":1,"confidence_rate":1},{"cnt":[[305,1405],[960,1405],[960,1454],[305,1454]],"region":{"top_left_x":305,"top_left_y":1405,"width":656,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f371a5928b2f46c19dfbd12eb126bb86","type":"text","conversion_output":true,"text":"healthy subjects in study DX-2930-01.","text_display":" healthy subjects in study DX-2930-01.","confidence":1,"confidence_rate":1},{"cnt":[[305,1491],[1781,1491],[1781,1545],[305,1545]],"region":{"top_left_x":305,"top_left_y":1491,"width":1477,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8bc0a93d0aa4e6d83225fb983a790e9","type":"text","conversion_output":true,"text":"A Western blot assay showed pre-dose baseline levels of mean 2-chain high-molecular-","text_display":"\n\nA Western blot assay showed pre-dose baseline levels of mean 2-chain high-molecular","confidence":1,"confidence_rate":1},{"cnt":[[305,1543],[1721,1543],[1721,1594],[305,1594]],"region":{"top_left_x":305,"top_left_y":1542,"width":1416,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80c143f7e87a4b2ea545c6109621721b","type":"text","conversion_output":true,"text":"weight kininogen (HMWK) in unactivated plasma collected from HAE patients was","text_display":"weight kininogen (HMWK) in unactivated plasma collected from HAE patients was","confidence":1,"confidence_rate":1},{"cnt":[[305,1590],[1760,1590],[1760,1641],[305,1641]],"region":{"top_left_x":305,"top_left_y":1589,"width":1455,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8cbdd702d6e4a30a8e99f6d436dd1fc","type":"text","conversion_output":true,"text":"approximately \\(50 \\%\\). A statistically significant reduction in 2-chain HMWK levels was","text_display":" approximately \\(50 \\%\\). A statistically significant reduction in 2-chain HMWK levels was","confidence":0.8052706718444824,"confidence_rate":0.9976486728436581},{"cnt":[[305,1637],[1830,1637],[1830,1689],[305,1689]],"region":{"top_left_x":305,"top_left_y":1637,"width":1526,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3fe50749745405893cb35c7a27f3a4f","type":"text","conversion_output":true,"text":"observed on study days 8 and 22 in the 300 and 400 mg dose groups compared to pre-dose","text_display":" observed on study days 8 and 22 in the 300 and 400 mg dose groups compared to pre-dose","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[305,1684],[1798,1684],[1798,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1684,"width":1494,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b85b313fd14347cd8e1327ba831b7466","type":"text","conversion_output":true,"text":"levels, levels similar to that observed in healthy subjects. This outcome demonstrates the","text_display":" levels, levels similar to that observed in healthy subjects. This outcome demonstrates the","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[305,1732],[1863,1732],[1863,1785],[305,1785]],"region":{"top_left_x":305,"top_left_y":1731,"width":1558,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"441009ff91ce4cabab5c30948fa3bfdc","type":"text","conversion_output":true,"text":"pharmacodynamic activity of DX-2930 and its ability to effectively normalize the instability","text_display":" pharmacodynamic activity of DX-2930 and its ability to effectively normalize the instability","confidence":1,"confidence_rate":1},{"cnt":[[305,1783],[801,1783],[801,1833],[305,1833]],"region":{"top_left_x":305,"top_left_y":1783,"width":497,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89e10b276d0841e9a95623f2d1c13d0a","type":"text","conversion_output":true,"text":"of HAE plasma in this assay.","text_display":" of HAE plasma in this assay.","confidence":1,"confidence_rate":1},{"cnt":[[305,1869],[1837,1869],[1837,1923],[305,1923]],"region":{"top_left_x":305,"top_left_y":1869,"width":1532,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09d4f983adae4f2b88d5a3a1df6ef43d","type":"text","conversion_output":true,"text":"Primary efficacy analyses were based on subjects in the \\(300 mg , 400 mg\\), and placebo dose","text_display":"\n\nPrimary efficacy analyses were based on subjects in the \\(300 mg , 400 mg\\), and placebo dose","confidence":1,"confidence_rate":1},{"cnt":[[305,1921],[1674,1921],[1674,1970],[305,1970]],"region":{"top_left_x":305,"top_left_y":1920,"width":1369,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64fb46b8b3ec48869277cf2367dfa2e4","type":"text","conversion_output":true,"text":"groups who reported having at least 2 attacks in the 3 months prior to study entry","text_display":" groups who reported having at least 2 attacks in the 3 months prior to study entry","confidence":1,"confidence_rate":1},{"cnt":[[305,1968],[1697,1968],[1697,2017],[305,2017]],"region":{"top_left_x":305,"top_left_y":1967,"width":1393,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bc9aff92fa34115b4b75fc19b40276b","type":"text","conversion_output":true,"text":"( 0.15 attacks/week). Of those subjects treated with 300 or 400 mg DX-2930, 15 of","text_display":" ( 0.15 attacks/week). Of those subjects treated with 300 or 400 mg DX-2930, 15 of","confidence":0.9423733507951617,"confidence_rate":0.9994066386634717},{"cnt":[[305,2015],[1811,2015],[1811,2069],[305,2069]],"region":{"top_left_x":305,"top_left_y":2015,"width":1507,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a1c2f7ffcf74b9b885171c7a1f9be47","type":"text","conversion_output":true,"text":"16 subjects met these criteria. Of the placebo treated subjects, 11 of 13 subjects met these","text_display":" 16 subjects met these criteria. Of the placebo treated subjects, 11 of 13 subjects met these","confidence":0.9970715045928955,"confidence_rate":0.9999712475521841},{"cnt":[[305,2062],[445,2062],[445,2108],[305,2108]],"region":{"top_left_x":305,"top_left_y":2062,"width":140,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"793c08fdc59d4e4b9a65e48a7edb0ddd","type":"text","conversion_output":true,"text":"criteria.","text_display":" criteria.","confidence":1,"confidence_rate":1},{"cnt":[[305,2151],[1785,2151],[1785,2204],[305,2204]],"region":{"top_left_x":305,"top_left_y":2150,"width":1481,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1906deaf00c4c16bf15a9b9f06428b0","type":"text","conversion_output":true,"text":"The baseline HAE attack rates (attacks/week) were 0.39 attacks per week in the placebo","text_display":"\n\nThe baseline HAE attack rates (attacks/week) were 0.39 attacks per week in the placebo","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[305,2200],[1876,2200],[1876,2254],[305,2254]],"region":{"top_left_x":305,"top_left_y":2200,"width":1571,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bb18197e6b649e8bde5dd6151ef3489","type":"text","conversion_output":true,"text":"group, 0.33 attacks per week in the 300 mg group, 0.55 attacks per week in the 400 mg group","text_display":" group, 0.33 attacks per week in the 300 mg group, 0.55 attacks per week in the 400 mg group","confidence":0.99951171875,"confidence_rate":0.9999956392907748},{"cnt":[[305,2247],[1854,2247],[1854,2301],[305,2301]],"region":{"top_left_x":305,"top_left_y":2247,"width":1550,"height":54},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c77eae1a5ccb42078fac577d5016d714","type":"text","conversion_output":true,"text":"and 0.49 attacks per week in the 300 and 400 mg combined group. During the pre-specified,","text_display":" and 0.49 attacks per week in the 300 and 400 mg combined group. 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A statistically significant finding of HAE attack prevention by","text_display":" acute attacks of HAE. A statistically significant finding of HAE attack prevention by","confidence":1,"confidence_rate":1},{"cnt":[[305,614],[1828,614],[1828,668],[305,668]],"region":{"top_left_x":305,"top_left_y":614,"width":1524,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49f57927890548b5933999feeaca57a2","type":"text","conversion_output":true,"text":"DX-2930 was observed. DX-2930 was well tolerated in HAE subjects up to 400 mg . Drug","text_display":" DX-2930 was observed. DX-2930 was well tolerated in HAE subjects up to 400 mg . 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Only subjects meeting a minimum baseline rate of at least 1","text_display":" baseline HAE attack rate. 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subcutaneous (SC) administrations of DX-2930 or placebo in a double-blind fashion.","confidence":1,"confidence_rate":1},{"cnt":[[305,657],[1807,657],[1807,707],[305,707]],"region":{"top_left_x":305,"top_left_y":657,"width":1502,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17c8887370d041cb9fa96e89b2ac4ce7","type":"text","conversion_output":true,"text":"Subjects who are randomized to DX-2930 will be assigned in a \\(1: 1: 1\\) ratio to one of three","text_display":" Subjects who are randomized to DX-2930 will be assigned in a \\(1: 1: 1\\) ratio to one of three","confidence":0.986376503482461,"confidence_rate":0.9998571232506496},{"cnt":[[305,705],[1790,705],[1790,754],[305,754]],"region":{"top_left_x":305,"top_left_y":704,"width":1485,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86a6d9a6ee3e423999d984aa8db14d3d","type":"text","conversion_output":true,"text":"dose regimens: 300 mg every 2 weeks, 300 mg every 4 weeks or 150 mg every 4 weeks.","text_display":" dose regimens: 300 mg every 2 weeks, 300 mg every 4 weeks or 150 mg every 4 weeks.","confidence":0.9892578125,"confidence_rate":0.9999027047213236},{"cnt":[[305,752],[1794,752],[1794,801],[305,801]],"region":{"top_left_x":305,"top_left_y":751,"width":1489,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"641dea5ff4274ad58fe64c9c54b3ac69","type":"text","conversion_output":true,"text":"Randomization into all treatment groups will be blocked by naïve vs. non-naïve subjects","text_display":" Randomization into all treatment groups will be blocked by naïve vs. non-naïve 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Day 0 through two weeks after the final dose. 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Based on these considerations, 300 mg every 2 weeks,","text_display":" prevent a majority of HAE attacks. 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Steady-state trough concentrations","text_display":" HAE attacks (DX-2930 Investigators Brochure). Steady-state trough concentrations","confidence":0.9990234375,"confidence_rate":0.9999885054819704},{"cnt":[[305,2447],[1820,2447],[1820,2501],[305,2501]],"region":{"top_left_x":305,"top_left_y":2447,"width":1515,"height":54},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78b2574b00634801962f1fd13ba8fa51","type":"text","conversion_output":true,"text":"following DX-2930 administration every 2 weeks would be approximately \\(27,000 ng / mL\\).","text_display":" following DX-2930 administration every 2 weeks would be approximately \\(27,000 ng / mL\\).","confidence":1,"confidence_rate":1},{"cnt":[[305,2587],[492,2587],[492,2628],[305,2628]],"region":{"top_left_x":305,"top_left_y":2586,"width":187,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ebca605b2db4f03a0d0ff037109cb38","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[984,2587],[1205,2587],[1205,2632],[984,2632]],"region":{"top_left_x":983,"top_left_y":2586,"width":223,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4549128e54ae43c9ac7449bfb9003c8f","type":"page_info","conversion_output":false,"text":"Page 37 of 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DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b58be5fcd134301843828cb6307f296","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,284],[1854,284],[1854,337],[305,337]],"region":{"top_left_x":305,"top_left_y":283,"width":1550,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fa545528ad34172b41285a113ded7f4","type":"text","conversion_output":true,"text":"The maximum plasma concentration ( \\(C _{\\text {max }}\\) ) obtained following ecallantide administration to","text_display":"\n\nThe maximum plasma concentration ( \\(C _{\\text {max }}\\) ) obtained following ecallantide administration 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Evaluation of the DX-2930 plasma concentrations at the time of attacks reported","text_display":"2930-02. Evaluation of the DX-2930 plasma concentrations at the time of attacks reported","confidence":0.99755859375,"confidence_rate":0.9999737165675469},{"cnt":[[305,1040],[1809,1040],[1809,1094],[305,1094]],"region":{"top_left_x":305,"top_left_y":1039,"width":1504,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0f19a56069d41aca6c970615bc719c7","type":"text","conversion_output":true,"text":"by DX-2930 treated subjects in DX-2930-02 suggests that the 3 planned dosing regimens","text_display":" by DX-2930 treated subjects in DX-2930-02 suggests that the 3 planned dosing regimens","confidence":0.998046875,"confidence_rate":0.9999789783410032},{"cnt":[[305,1087],[1197,1087],[1197,1141],[305,1141]],"region":{"top_left_x":305,"top_left_y":1087,"width":892,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52c059395c1a4595b88c47ec1a81bfc0","type":"text","conversion_output":true,"text":"will provide a meaningful range of clinical response.","text_display":" will provide a meaningful range of clinical response.","confidence":1,"confidence_rate":1},{"cnt":[[299,1169],[1328,1169],[1328,1242],[299,1242]],"region":{"top_left_x":298,"top_left_y":1168,"width":1030,"height":74},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"877faf3722594b2c964d6a388fa4d753","type":"section_header","conversion_output":false,"children_ids":["0d7efa833f814ed690ca4e13451abd9e"],"text":"","text_display":""},{"cnt":[[305,1177],[1319,1175],[1319,1235],[305,1237]],"region":{"top_left_x":304,"top_left_y":1174,"width":1016,"height":64},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d7efa833f814ed690ca4e13451abd9e","type":"text","conversion_output":true,"parent_id":"877faf3722594b2c964d6a388fa4d753","text":"3.3 Individual Subject Dosing and Follow-Up","text_display":"\n\n\\subsection*{3.3 Individual Subject Dosing and Follow-Up}","confidence":1,"confidence_rate":1},{"cnt":[[305,1268],[1811,1268],[1811,1321],[305,1321]],"region":{"top_left_x":305,"top_left_y":1267,"width":1507,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a0334b93f6a4ec8bfae5c11b184998d","type":"text","conversion_output":true,"text":"Subjects will receive a dose of blinded IMP every 2 weeks during the 26 week Treatment","text_display":"\n\nSubjects will receive a dose of blinded IMP every 2 weeks during the 26 week Treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,1319],[1828,1319],[1828,1369],[305,1369]],"region":{"top_left_x":305,"top_left_y":1319,"width":1524,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bea023cf32d49c29cd91b26d9d99245","type":"text","conversion_output":true,"text":"Period for a total of 13 doses. The first dose of IMP will be administered on Day 0 and the","text_display":" Period for a total of 13 doses. The first dose of IMP will be administered on Day 0 and the","confidence":1,"confidence_rate":1},{"cnt":[[305,1366],[1828,1366],[1828,1418],[305,1418]],"region":{"top_left_x":305,"top_left_y":1366,"width":1524,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b05a0b41d13445c7bf42d23f39f36485","type":"text","conversion_output":true,"text":"last dose of IMP will be administered on Day 168. There will be \\(\\pm 3\\) day window around","text_display":" last dose of IMP will be administered on Day 168. 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After each dose, subjects will be monitored at the study site through 2 hours post-dose","text_display":" doses. 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HAE diagnosis","confidence":1,"confidence_rate":1},{"cnt":[[305,619],[1841,619],[1841,672],[305,672]],"region":{"top_left_x":305,"top_left_y":618,"width":1537,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1ea2cc419744803aacfe1d0188447b0","type":"text","conversion_output":true,"text":"will be confirmed through documented clinical history consistent with HAE and diagnostic","text_display":" will be confirmed through documented clinical history consistent with HAE and diagnostic","confidence":1,"confidence_rate":1},{"cnt":[[305,666],[1863,666],[1863,720],[305,720]],"region":{"top_left_x":305,"top_left_y":666,"width":1558,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56584e4cb55d408db78091ba211d4706","type":"text","conversion_output":true,"text":"testing conducted either during the screening visit or during participation in study DX-2930-","text_display":" testing conducted either during the screening visit or during participation in study DX-2930","confidence":1,"confidence_rate":1},{"cnt":[[294,709],[367,709],[367,763],[294,763]],"region":{"top_left_x":294,"top_left_y":708,"width":74,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c5273a8714f4536b17710fcffe8beef","type":"text","conversion_output":true,"text":"02.","text_display":"02.","confidence":1,"confidence_rate":1},{"cnt":[[305,804],[1811,804],[1811,857],[305,857]],"region":{"top_left_x":305,"top_left_y":803,"width":1507,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fddf9392caca4dd8a333629e30a2b0d9","type":"text","conversion_output":true,"text":"The subject population includes subjects who are 12 to 17 years old. Like adults, children","text_display":"\n\nThe subject population includes subjects who are 12 to 17 years old. Like adults, children","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[305,853],[1813,853],[1813,904],[305,904]],"region":{"top_left_x":305,"top_left_y":852,"width":1509,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3b95f60a74b4a548f501e1ad3ea6f56","type":"text","conversion_output":true,"text":"with HAE can suffer from recurrent and debilitating attacks. Symptoms may present very","text_display":" with HAE can suffer from recurrent and debilitating attacks. Symptoms may present very","confidence":1,"confidence_rate":1},{"cnt":[[305,902],[1772,902],[1772,952],[305,952]],"region":{"top_left_x":305,"top_left_y":902,"width":1468,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eaa20144838e4e22903a295c0c8e1ae9","type":"text","conversion_output":true,"text":"early in childhood, and upper airway angioedema has been reported in HAE patients as","text_display":" early in childhood, and upper airway angioedema has been reported in HAE patients as","confidence":1,"confidence_rate":1},{"cnt":[[305,950],[1807,950],[1807,1003],[305,1003]],"region":{"top_left_x":305,"top_left_y":949,"width":1502,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f04d42162daf4fad9a5eeaff441a4cbb","type":"text","conversion_output":true,"text":"young as the age of 3 (Bork et al., 2003). In one case series of 49 pediatric HAE patients,","text_display":" young as the age of 3 (Bork et al., 2003). In one case series of 49 pediatric HAE patients,","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[1835,997],[1835,1051],[305,1051]],"region":{"top_left_x":305,"top_left_y":996,"width":1530,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2bb66cf8ed7454889aee3cdc8273daf","type":"text","conversion_output":true,"text":"23 had suffered at least one episode of airway angioedema by the age of 18 (Farkas, 2010).","text_display":" 23 had suffered at least one episode of airway angioedema by the age of 18 (Farkas, 2010).","confidence":1,"confidence_rate":1},{"cnt":[[305,1044],[1846,1044],[1846,1098],[305,1098]],"region":{"top_left_x":305,"top_left_y":1044,"width":1541,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"315ea41c6d364c07b5f68daaabb1a1d8","type":"text","conversion_output":true,"text":"An important unmet medical need exists among children with HAE, especially adolescents,","text_display":" An important unmet medical need exists among children with HAE, especially adolescents,","confidence":1,"confidence_rate":1},{"cnt":[[305,1091],[1846,1091],[1846,1147],[305,1147]],"region":{"top_left_x":305,"top_left_y":1091,"width":1541,"height":57},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9319528fd8c8461ea2ffe7b03a12d7b1","type":"text","conversion_output":true,"text":"since the disease commonly worsens after puberty (Bennett and Craig, 2015; Zuraw, 2008).","text_display":" since the disease commonly worsens after puberty (Bennett and Craig, 2015; Zuraw, 2008).","confidence":1,"confidence_rate":1},{"cnt":[[299,1175],[821,1175],[821,1242],[299,1242]],"region":{"top_left_x":298,"top_left_y":1175,"width":523,"height":67},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b50105b33404b87a60b6291c16c7afd","type":"section_header","conversion_output":false,"children_ids":["43219ca978154dea9b3490113cd6c640"],"text":"","text_display":""},{"cnt":[[305,1182],[814,1182],[814,1233],[305,1233]],"region":{"top_left_x":305,"top_left_y":1181,"width":510,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43219ca978154dea9b3490113cd6c640","type":"text","conversion_output":true,"parent_id":"0b50105b33404b87a60b6291c16c7afd","text":"4.2 Inclusion Criteria","text_display":"\n\n\\subsection*{4.2 Inclusion Criteria}","confidence":1,"confidence_rate":1},{"cnt":[[305,1276],[1540,1276],[1540,1330],[305,1330]],"region":{"top_left_x":305,"top_left_y":1276,"width":1236,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5748b158e72468cabeb88dd35c3c048","type":"text","conversion_output":true,"text":"Each subject must meet the following criteria to be enrolled in this study:","text_display":"\n\nEach subject must meet the following criteria to be enrolled in this study:","confidence":1,"confidence_rate":1},{"cnt":[[305,1362],[1510,1362],[1510,1416],[305,1416]],"region":{"top_left_x":305,"top_left_y":1362,"width":1206,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6934171328e4d299d6904b1a1d74f6f","type":"text","conversion_output":true,"text":"1. Males and females 12 years of age or older at the time of screening.","text_display":"\n1. Males and females 12 years of age or older at the time of screening.","confidence":0.9990236759185791,"confidence_rate":0.9999876355068686},{"cnt":[[305,1414],[1678,1414],[1678,1467],[305,1467]],"region":{"top_left_x":305,"top_left_y":1413,"width":1373,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6cc0e40b0834055ae2af6d956fada18","type":"text","conversion_output":true,"text":"2. Documented diagnosis of HAE (Type I or II) based upon all of the following:","text_display":"\n2. Documented diagnosis of HAE (Type I or II) based upon all of the following:","confidence":1,"confidence_rate":1},{"cnt":[[367,1463],[1729,1463],[1729,1515],[367,1515]],"region":{"top_left_x":367,"top_left_y":1463,"width":1363,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"807fd62f0d3946f4909c51ab6497becc","type":"text","conversion_output":true,"text":"- Documented clinical history consistent with HAE (subcutaneous or mucosal,","text_display":"\n- Documented clinical history consistent with HAE (subcutaneous or mucosal,","confidence":1,"confidence_rate":1},{"cnt":[[430,1508],[1502,1508],[1502,1562],[430,1562]],"region":{"top_left_x":429,"top_left_y":1508,"width":1073,"height":54},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"061adbaf822141838425accb4cbd90fd","type":"text","conversion_output":true,"text":"nonpruritic swelling episodes without accompanying urticaria).","text_display":" nonpruritic swelling episodes without accompanying urticaria).","confidence":1,"confidence_rate":1},{"cnt":[[370,1555],[1846,1555],[1846,1609],[370,1609]],"region":{"top_left_x":369,"top_left_y":1555,"width":1477,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aeac0d36a5aa4a46a9ee9ddb6f27959b","type":"text","conversion_output":true,"text":"- Diagnostic testing results obtained during screening (or a prior DX-2930 study) that","text_display":"\n- Diagnostic testing results obtained during screening (or a prior DX-2930 study) that","confidence":1,"confidence_rate":1},{"cnt":[[430,1607],[1777,1607],[1777,1656],[430,1656]],"region":{"top_left_x":429,"top_left_y":1607,"width":1348,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cc08ced20e64bf1a60a938813244759","type":"text","conversion_output":true,"text":"confirm HAE Type I or II: C1 inhibitor (C1-INH) functional level \\(<40 \\%\\) of the","text_display":" confirm HAE Type I or II: C1 inhibitor (C1-INH) functional level \\(<40 \\%\\) of the","confidence":0.7564663887023926,"confidence_rate":0.9966829282413168},{"cnt":[[430,1654],[1871,1654],[1871,1704],[430,1704]],"region":{"top_left_x":429,"top_left_y":1654,"width":1443,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3dc52b0005a4c319e07a9418300a309","type":"text","conversion_output":true,"text":"normal level. Subjects with functional C1-INH level 40-50\\% of the normal level may","text_display":" normal level. Subjects with functional C1-INH level 40-50\\% of the normal level may","confidence":0.9566044807434082,"confidence_rate":0.9994901844401777},{"cnt":[[430,1702],[1850,1702],[1850,1755],[430,1755]],"region":{"top_left_x":429,"top_left_y":1701,"width":1421,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6baaf9c3c0fa4a57bb8d5eff45310b0d","type":"text","conversion_output":true,"text":"be enrolled if they also have a C4 level below the normal range. Subjects may begin","text_display":" be enrolled if they also have a C4 level below the normal range. Subjects may begin","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[430,1749],[1738,1749],[1738,1800],[430,1800]],"region":{"top_left_x":429,"top_left_y":1748,"width":1310,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ac1895111894a4d8a777868cef3398f","type":"text","conversion_output":true,"text":"participating in the run-in period before these diagnostic results are available.","text_display":" participating in the run-in period before these diagnostic results are available.","confidence":1,"confidence_rate":1},{"cnt":[[432,1796],[1880,1796],[1880,1850],[432,1850]],"region":{"top_left_x":431,"top_left_y":1796,"width":1449,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8bc34968a7b49bfa907a674773fcd22","type":"text","conversion_output":true,"text":"Subjects may be retested if results are incongruent with clinical history or believed by","text_display":" Subjects may be retested if results are incongruent with clinical history or believed by","confidence":1,"confidence_rate":1},{"cnt":[[430,1848],[1330,1848],[1330,1897],[430,1897]],"region":{"top_left_x":429,"top_left_y":1847,"width":901,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dab0ae7cac9048989fb32bf682719b63","type":"text","conversion_output":true,"text":"the Investigator to be confounded by recent LTP use.","text_display":" the Investigator to be confounded by recent LTP use.","confidence":1,"confidence_rate":1},{"cnt":[[367,1893],[1807,1893],[1807,1944],[367,1944]],"region":{"top_left_x":367,"top_left_y":1892,"width":1440,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51950a4130eb4e9e8eba52c1bfc21ee2","type":"text","conversion_output":true,"text":"- At least one of the following: age at reported onset of first angioedema symptoms","text_display":"\n- At least one of the following: age at reported onset of first angioedema symptoms","confidence":1,"confidence_rate":1},{"cnt":[[430,1938],[1846,1938],[1846,1992],[430,1992]],"region":{"top_left_x":429,"top_left_y":1937,"width":1417,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8a8f25c4bb14dd2b65c67f9ae53987e","type":"text","conversion_output":true,"text":"\\(\\leq 30\\) years, a family history consistent with HAE Type I or II, or C1q within normal","text_display":" \\(\\leq 30\\) years, a family history consistent with HAE Type I or II, or C1q within normal","confidence":0.99267578125,"confidence_rate":0.9999145249028433},{"cnt":[[430,1994],[544,1994],[544,2039],[430,2039]],"region":{"top_left_x":429,"top_left_y":1993,"width":115,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6aba3786cce46d88a83c3bca18cef05","type":"text","conversion_output":true,"text":"range.","text_display":" range.","confidence":1,"confidence_rate":1},{"cnt":[[305,2037],[1867,2037],[1867,2090],[305,2090]],"region":{"top_left_x":305,"top_left_y":2036,"width":1562,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6df50cf1095e48ff92baeff4bd4769f9","type":"text","conversion_output":true,"text":"3. Experiencing a baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks","text_display":"\n3. Experiencing a baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks","confidence":1,"confidence_rate":1},{"cnt":[[370,2086],[1016,2086],[1016,2138],[370,2138]],"region":{"top_left_x":369,"top_left_y":2086,"width":648,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37f52c84d170455fb097979da24c620a","type":"text","conversion_output":true,"text":"as confirmed during the run-in period.","text_display":" as confirmed during the run-in period.","confidence":1,"confidence_rate":1},{"cnt":[[305,2131],[1869,2131],[1869,2185],[305,2185]],"region":{"top_left_x":305,"top_left_y":2131,"width":1565,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35f09b413373430ea0efec6160765d35","type":"text","conversion_output":true,"text":"4. Adult subjects and caregivers of subjects under the age of 18 are willing and able to read,","text_display":"\n4. Adult subjects and caregivers of subjects under the age of 18 are willing and able to read,","confidence":1,"confidence_rate":1},{"cnt":[[367,2179],[1850,2179],[1850,2232],[367,2232]],"region":{"top_left_x":367,"top_left_y":2178,"width":1483,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a2ae911853944b9bb4d9225d0c1dc51","type":"text","conversion_output":true,"text":"understand, and sign an informed consent form. Subjects age 12 to 17, whose caregiver","text_display":" understand, and sign an informed consent form. Subjects age 12 to 17, whose caregiver","confidence":1,"confidence_rate":1},{"cnt":[[370,2230],[1824,2230],[1824,2279],[370,2279]],"region":{"top_left_x":369,"top_left_y":2230,"width":1456,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fce4917546b41c5bbacc8671399b570","type":"text","conversion_output":true,"text":"provides informed consent, are willing and able to read, understand and sign an assent","text_display":" provides informed consent, are willing and able to read, understand and sign an assent","confidence":1,"confidence_rate":1},{"cnt":[[370,2277],[473,2277],[473,2322],[370,2322]],"region":{"top_left_x":369,"top_left_y":2277,"width":104,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a328895522f0459e9c4f085e595bcd2d","type":"text","conversion_output":true,"text":"form.","text_display":" form.","confidence":1,"confidence_rate":1},{"cnt":[[305,2322],[1772,2322],[1772,2376],[305,2376]],"region":{"top_left_x":305,"top_left_y":2322,"width":1468,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ce551968f4e4a87b5be48da4b163351","type":"text","conversion_output":true,"text":"5. Males and females who are fertile and sexually active must adhere to contraception","text_display":"\n5. Males and females who are fertile and sexually active must adhere to contraception","confidence":1,"confidence_rate":1},{"cnt":[[367,2372],[1268,2372],[1268,2426],[367,2426]],"region":{"top_left_x":367,"top_left_y":2371,"width":901,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db7bfa5bc4e449369afcf1304af8254d","type":"text","conversion_output":true,"text":"requirements for the duration of the study as follows:","text_display":" requirements for the duration of the study as 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124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,2587],[1882,2587],[1882,2632],[1706,2632]],"region":{"top_left_x":1705,"top_left_y":2586,"width":178,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5596ba018d1d4d7eb1d68fb9956229d7","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-40","page":40,"lines":[{"cnt":[[305,125],[449,125],[449,165],[305,165]],"region":{"top_left_x":305,"top_left_y":124,"width":145,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1160a3019d344b7481db964c271f311d","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,163],[827,163],[827,208],[305,208]],"region":{"top_left_x":305,"top_left_y":163,"width":523,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26f377ab9d504e95bbeb64a7cb3af73a","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f63f61762f644c88b22e94ea59afef91","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[370,284],[1828,284],[1828,337],[370,337]],"region":{"top_left_x":369,"top_left_y":283,"width":1460,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a644a4f9179c480eb60bdfb00cc1ca1f","type":"text","conversion_output":true,"text":"- Females of childbearing potential must agree to be abstinent or else use any two of","text_display":"\n- Females of childbearing potential must agree to be abstinent or else use any two 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contraceptive, condom with or","confidence":1,"confidence_rate":1},{"cnt":[[430,430],[1846,430],[1846,479],[430,479]],"region":{"top_left_x":429,"top_left_y":429,"width":1417,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81a204ad6c3c4d178a5295ac60bd235c","type":"text","conversion_output":true,"text":"without spermicidal jelly, diaphragm or cervical cap with spermicidal jelly, or intra-","text_display":" without spermicidal jelly, diaphragm or cervical cap with spermicidal jelly, or intra","confidence":1,"confidence_rate":1},{"cnt":[[430,477],[1818,477],[1818,526],[430,526]],"region":{"top_left_x":429,"top_left_y":476,"width":1389,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e48505f3c6a94570a6b30bd341e7af41","type":"text","conversion_output":true,"text":"uterine device (IUD, all types). 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The active ingredient,","confidence":0.7276718616485596,"confidence_rate":0.9969769114112799},{"cnt":[[305,705],[1749,705],[1749,754],[305,754]],"region":{"top_left_x":305,"top_left_y":704,"width":1444,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a181c3db0f5349d388feaa0b832be2bc","type":"text","conversion_output":true,"text":"DX-2930, is formulated using the following compendial components: 30 mM sodium","text_display":" DX-2930, is formulated using the following compendial components: 30 mM sodium","confidence":1,"confidence_rate":1},{"cnt":[[305,752],[1837,752],[1837,804],[305,804]],"region":{"top_left_x":305,"top_left_y":751,"width":1532,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8fcc5fdd47946d5864fd93536272838","type":"text","conversion_output":true,"text":"phosphate, 19 mM citric acid, 50 mM histidine, 90 mM sodium chloride, \\(0.01 \\%\\) Tween 80 .","text_display":" phosphate, 19 mM citric acid, 50 mM histidine, 90 mM sodium chloride, \\(0.01 \\%\\) Tween 80 .","confidence":1,"confidence_rate":1},{"cnt":[[305,799],[1820,799],[1820,851],[305,851]],"region":{"top_left_x":305,"top_left_y":799,"width":1515,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46c8ee0aa4954b9c8c59aaa1c9992a44","type":"text","conversion_output":true,"text":"Each vial contains a nominal concentration of 100 mg DX-2930 active ingredient in 1 mL","text_display":" Each vial contains a nominal concentration of 100 mg DX-2930 active ingredient in 1 mL","confidence":0.9965834617614746,"confidence_rate":0.9999647182725911},{"cnt":[[305,846],[1858,846],[1858,900],[305,900]],"region":{"top_left_x":305,"top_left_y":846,"width":1554,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a88af5bd62734c9e81a067d5f2782335","type":"text","conversion_output":true,"text":"solution. The test product will be administered by subcutaneous injection into the upper arm","text_display":" solution. The test product will be administered by subcutaneous injection into the upper arm","confidence":1,"confidence_rate":1},{"cnt":[[305,894],[660,894],[660,943],[305,943]],"region":{"top_left_x":305,"top_left_y":893,"width":355,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a36b6604dbf44bc9e4dca60fc4e1d8e","type":"text","conversion_output":true,"text":"in a blinded manner.","text_display":" in a blinded manner.","confidence":1,"confidence_rate":1},{"cnt":[[305,984],[1841,984],[1841,1038],[305,1038]],"region":{"top_left_x":305,"top_left_y":983,"width":1537,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0833db17ddb4363b73ac067f2b42974","type":"text","conversion_output":true,"text":"For each 300 mg dose of DX-2930, each subject will receive a total of 3 mL , divided into 2","text_display":"\n\nFor each 300 mg dose of DX-2930, each subject will receive a total of 3 mL , divided into 2","confidence":1,"confidence_rate":1},{"cnt":[[305,1036],[1858,1033],[1858,1087],[305,1089]],"region":{"top_left_x":305,"top_left_y":1033,"width":1554,"height":57},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"368e248f055b4f1391d85cdb1cf4085b","type":"text","conversion_output":true,"text":"separate 1.5 mL SC injections of DX-2930. The 2 injections will be given in the same upper","text_display":" separate 1.5 mL SC injections of DX-2930. The 2 injections will be given in the same upper","confidence":1,"confidence_rate":1},{"cnt":[[305,1079],[1349,1079],[1349,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1078,"width":1045,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57a7aac764614fda92dc31fc47b672f0","type":"text","conversion_output":true,"text":"arm, with at least 2 cm separation between each injection site.","text_display":" arm, with at least 2 cm separation between each injection site.","confidence":0.94873046875,"confidence_rate":0.9992792935764374},{"cnt":[[305,1169],[1843,1169],[1843,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1168,"width":1539,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d4d1ed067ba468ba703922cd4fa5907","type":"text","conversion_output":true,"text":"For each 150 mg dose of DX-2930, each subject will receive a total of 3 mL , divided into 2","text_display":"\n\nFor each 150 mg dose of DX-2930, each subject will receive a total of 3 mL , divided into 2","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1867,1216],[1867,1270],[305,1270]],"region":{"top_left_x":305,"top_left_y":1216,"width":1562,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5efa9d2b29da465e98a3ed7a12b68097","type":"text","conversion_output":true,"text":"separate 1.5 mL SC injections, where one injection is DX-2930 and the other is placebo. The","text_display":" separate 1.5 mL SC injections, where one injection is DX-2930 and the other is placebo. The","confidence":0.4875372920650989,"confidence_rate":0.9929124784157674},{"cnt":[[305,1268],[1854,1268],[1854,1319],[305,1319]],"region":{"top_left_x":305,"top_left_y":1267,"width":1550,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95a345a915ab42bda6236f0b1485965d","type":"text","conversion_output":true,"text":"2 injections will be given in the same upper arm, with at least 2 cm separation between each","text_display":" 2 injections will be given in the same upper arm, with at least 2 cm separation between each","confidence":1,"confidence_rate":1},{"cnt":[[305,1315],[544,1315],[544,1366],[305,1366]],"region":{"top_left_x":305,"top_left_y":1314,"width":239,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cad1ecf37495434190f92ab2a4795555","type":"text","conversion_output":true,"text":"injection site.","text_display":" injection 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DX-2930 for subjects randomized to the 300 mg or 150 mg DX-2930","text_display":" in between doses of DX-2930 for subjects randomized to the 300 mg or 150 mg DX-2930","confidence":1,"confidence_rate":1},{"cnt":[[305,1727],[1575,1727],[1575,1781],[305,1781]],"region":{"top_left_x":305,"top_left_y":1727,"width":1270,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faa0345b749745db9c231fdd647032de","type":"text","conversion_output":true,"text":"every 4 weeks treatment arms, according to the dosing schedule in Table 1.","text_display":" every 4 weeks treatment arms, according to the dosing schedule in Table 1.","confidence":1,"confidence_rate":1},{"cnt":[[305,1835],[1841,1835],[1841,1888],[305,1888]],"region":{"top_left_x":305,"top_left_y":1834,"width":1537,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c80e4966747d46efb62f5de6d06a34f6","type":"text","conversion_output":true,"text":"For each placebo dose, each subject will receive a total of 3 mL , divided into 2 separate 1.5","text_display":"\n\nFor each placebo dose, each subject will receive a total of 3 mL , divided into 2 separate 1.5","confidence":1,"confidence_rate":1},{"cnt":[[305,1884],[1833,1884],[1833,1936],[305,1936]],"region":{"top_left_x":305,"top_left_y":1884,"width":1528,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5da55e28cfb749f1b14172e143324778","type":"text","conversion_output":true,"text":"mL SC injections of placebo. The 2 injections will be given in the same upper arm, with at","text_display":" mL SC injections of placebo. 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Subjects will be assigned to one of the DX-2930 or placebo","text_display":" an identification number. 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contacted by the site at the end of the 2 week washout","confidence":0.9985356330871582,"confidence_rate":0.9999850466409257},{"cnt":[[305,2286],[1811,2286],[1811,2340],[305,2340]],"region":{"top_left_x":305,"top_left_y":2285,"width":1507,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"238fe8c4f5cb4a409af847e21fdca152","type":"text","conversion_output":true,"text":"period. The Investigator must confirm the subject has successfully completed the 2 week","text_display":" period. The Investigator must confirm the subject has successfully completed the 2 week","confidence":1,"confidence_rate":1},{"cnt":[[305,2333],[1803,2333],[1803,2387],[305,2387]],"region":{"top_left_x":305,"top_left_y":2333,"width":1498,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3392fead5d204631aeb36f5e3e6275e7","type":"text","conversion_output":true,"text":"washout period before they can enter the run-in period. Confirmation of washout will be","text_display":" washout period before they can enter the run-in period. Confirmation of washout will be","confidence":1,"confidence_rate":1},{"cnt":[[305,2383],[683,2383],[683,2434],[305,2434]],"region":{"top_left_x":305,"top_left_y":2382,"width":379,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16f8e2ed33704c1ba07260b8bbbceb51","type":"text","conversion_output":true,"text":"captured in the eCRF.","text_display":" captured in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[305,2587],[492,2587],[492,2628],[305,2628]],"region":{"top_left_x":305,"top_left_y":2586,"width":187,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd2f9ebe31954cae9a4d22d70d2f4f43","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[984,2587],[1205,2587],[1205,2632],[984,2632]],"region":{"top_left_x":983,"top_left_y":2586,"width":223,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"812734a4055749fab2d356c34f2a12b6","type":"page_info","conversion_output":false,"text":"Page 46 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,2587],[1880,2587],[1880,2632],[1706,2632]],"region":{"top_left_x":1705,"top_left_y":2586,"width":175,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bbc91deb4686448e91b3b916a2fd5585","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-47","page":47,"lines":[{"cnt":[[305,125],[449,125],[449,165],[305,165]],"region":{"top_left_x":305,"top_left_y":124,"width":145,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81917fc886e34d0da32d0050f6f3f418","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,163],[827,163],[827,208],[305,208]],"region":{"top_left_x":305,"top_left_y":163,"width":523,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2529e63408664705bf6730642d34f7b1","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a8ab0752d89494dbf4745b9510f79bd","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,284],[1807,284],[1807,337],[305,337]],"region":{"top_left_x":305,"top_left_y":283,"width":1502,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bac64ca95ba4d948040d244a32de41c","type":"text","conversion_output":true,"text":"Site personnel will contact the subject or caregiver weekly, or approximately 7 days after","text_display":"\n\nSite personnel will contact the subject or caregiver weekly, or approximately 7 days after","confidence":1,"confidence_rate":1},{"cnt":[[305,331],[1837,331],[1837,385],[305,385]],"region":{"top_left_x":305,"top_left_y":330,"width":1532,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a5b91f3580647fe88e0bac9f3c202cb","type":"text","conversion_output":true,"text":"their last contact with the subject, throughout the run-in period. If the subject experiences 1","text_display":" their last contact with the subject, throughout the run-in period. If the subject experiences 1","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[1785,382],[1785,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1481,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49dec26db8f4408292880d2f6be95ceb","type":"text","conversion_output":true,"text":"or more Investigator confirmed HAE attacks by the end of week 4, the subject will have","text_display":" or more Investigator confirmed HAE attacks by the end of week 4, the subject will have","confidence":0.9775390625,"confidence_rate":0.9997503935054107},{"cnt":[[305,430],[1850,430],[1850,479],[305,479]],"region":{"top_left_x":305,"top_left_y":429,"width":1545,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6163932764e24935939681bd0e38c744","type":"text","conversion_output":true,"text":"fulfilled the run-in requirement and may proceed to enrollment and randomization. Subjects","text_display":" fulfilled the run-in requirement and may proceed to enrollment and randomization. Subjects","confidence":1,"confidence_rate":1},{"cnt":[[305,477],[1871,477],[1871,529],[305,529]],"region":{"top_left_x":305,"top_left_y":476,"width":1567,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcb4d2b0fcbe42a59af57097d1f337f5","type":"text","conversion_output":true,"text":"who experience 3 or more Investigator-confirmed attacks can exit the run-in period early and","text_display":" who experience 3 or more Investigator-confirmed attacks can exit the run-in period early and","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[305,524],[1738,524],[1738,578],[305,578]],"region":{"top_left_x":305,"top_left_y":524,"width":1434,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d820cd6726c94b2ba987e2605043a864","type":"text","conversion_output":true,"text":"proceed to enrollment and randomization. If the subject experiences no Investigator-","text_display":" proceed to enrollment and randomization. If the subject experiences no Investigator","confidence":1,"confidence_rate":1},{"cnt":[[305,574],[1725,574],[1725,625],[305,625]],"region":{"top_left_x":305,"top_left_y":573,"width":1421,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c5f1a2e7017431fa37968fce3e8d618","type":"text","conversion_output":true,"text":"confirmed HAE attacks the end of the subject will remain in the run-in period for an","text_display":"confirmed HAE attacks the end of the subject will remain in the run-in period for an","confidence":1,"confidence_rate":1},{"cnt":[[305,619],[1803,619],[1803,672],[305,672]],"region":{"top_left_x":305,"top_left_y":618,"width":1498,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e81e260800fe4f53ac10ace13a6eb7f2","type":"text","conversion_output":true,"text":"additional 4 weeks. The maximum duration of the run-in period is 8 weeks. If run-in has","text_display":" additional 4 weeks. The maximum duration of the run-in period is 8 weeks. If run-in has","confidence":1,"confidence_rate":1},{"cnt":[[305,666],[1858,666],[1858,720],[305,720]],"region":{"top_left_x":305,"top_left_y":666,"width":1554,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ca4f3631d6242c5a0d1b93563e5ba39","type":"text","conversion_output":true,"text":"been extended and the subject has 2 or more Investigator-confirmed HAE attacks by the end","text_display":" been extended and the subject has 2 or more Investigator-confirmed HAE attacks by the end","confidence":0.99560546875,"confidence_rate":0.9999545967463781},{"cnt":[[305,718],[1777,718],[1777,767],[305,767]],"region":{"top_left_x":305,"top_left_y":717,"width":1472,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa8d44680a2745658971c2066e14e70a","type":"text","conversion_output":true,"text":"of week 8 , the subject will have fulfilled the run-in requirement and may proceed to the","text_display":" of week 8 , the subject will have fulfilled the run-in requirement and may proceed to the","confidence":0.70263671875,"confidence_rate":0.9963683087524536},{"cnt":[[305,765],[1880,765],[1880,816],[305,816]],"region":{"top_left_x":305,"top_left_y":764,"width":1575,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66633bd73ef2411984dae95637aaf81b","type":"text","conversion_output":true,"text":"double-blind treatment period. 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All AEs, regardless of seriousness,","text_display":"\n\nIn this study HAE attacks will be captured as AEs. All AEs, regardless of seriousness,","confidence":1,"confidence_rate":1},{"cnt":[[305,1369],[1725,1369],[1725,1420],[305,1420]],"region":{"top_left_x":305,"top_left_y":1368,"width":1421,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a75b34d3d6c24e43bfcb855c4bf14137","type":"text","conversion_output":true,"text":"severity, or causal relationship to study drug, will be recorded on the AE page of the","text_display":" severity, or causal relationship to study drug, will be recorded on the AE page of the","confidence":1,"confidence_rate":1},{"cnt":[[305,1418],[1777,1418],[1777,1467],[305,1467]],"region":{"top_left_x":305,"top_left_y":1417,"width":1472,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"989ca9d8463245c0b3a791c9d6b145d4","type":"text","conversion_output":true,"text":"eCRF. Any AE reported to the site meeting criteria for a serious adverse event must be","text_display":" eCRF. Any AE reported to the site meeting criteria for a serious adverse event must be","confidence":0.99658203125,"confidence_rate":0.9999623762753774},{"cnt":[[305,1465],[1777,1465],[1777,1515],[305,1515]],"region":{"top_left_x":305,"top_left_y":1465,"width":1472,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"751b4d1ed0c8463ca598484fdceb2df1","type":"text","conversion_output":true,"text":"reported to Dyax using the SAE Reporting Form in the EDC system within 24 hours of","text_display":" reported to Dyax using the SAE Reporting Form in the EDC system within 24 hours of","confidence":1,"confidence_rate":1},{"cnt":[[305,1512],[1749,1512],[1749,1562],[305,1562]],"region":{"top_left_x":305,"top_left_y":1512,"width":1444,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37e854e18bf64c28a8a86e7f2af4ca3b","type":"text","conversion_output":true,"text":"becoming aware of the event. 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For all non-serious AEs that are reported as HAE attacks, the Principal","text_display":" HAE attack. For all non-serious AEs that are reported as HAE attacks, the Principal","confidence":1,"confidence_rate":1},{"cnt":[[305,1704],[1841,1704],[1841,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1703,"width":1537,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d375be508014a84966656002d9fca9f","type":"text","conversion_output":true,"text":"Investigator or physician designee will review the event within 3 days of initial notification","text_display":" Investigator or physician designee will review the event within 3 days of initial notification","confidence":1,"confidence_rate":1},{"cnt":[[305,1749],[1768,1749],[1768,1803],[305,1803]],"region":{"top_left_x":305,"top_left_y":1748,"width":1464,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5316f5bedd854f409956708412d8066e","type":"text","conversion_output":true,"text":"and, in accordance with HAARP, evaluate if it represented a confirmed HAE attack. If","text_display":" and, in accordance with HAARP, evaluate if it represented a confirmed HAE attack. If","confidence":1,"confidence_rate":1},{"cnt":[[305,1800],[1729,1800],[1729,1850],[305,1850]],"region":{"top_left_x":305,"top_left_y":1800,"width":1425,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfb13952b08043d99f6f12d990bb29ed","type":"text","conversion_output":true,"text":"necessary for the evaluation, the Investigator or designee may contact the subject for","text_display":" necessary for the evaluation, the Investigator or designee may contact the subject for","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[305,1848],[1846,1848],[1846,1899],[305,1899]],"region":{"top_left_x":305,"top_left_y":1847,"width":1541,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"105df22f65324a1fa142089a83ba5bef","type":"text","conversion_output":true,"text":"additional information. Any subject-reported attack not confirmed by the Investigator must","text_display":" additional information. Any subject-reported attack not confirmed by the Investigator must","confidence":1,"confidence_rate":1},{"cnt":[[305,1895],[1824,1895],[1824,1949],[305,1949]],"region":{"top_left_x":305,"top_left_y":1894,"width":1520,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b32d6b64de1d4077ae343c6d83ea95a8","type":"text","conversion_output":true,"text":"have an alternate AE diagnosis recorded. All subject-reported and Investigator-confirmed","text_display":" have an alternate AE diagnosis recorded. 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neck, torso,","confidence":1,"confidence_rate":1},{"cnt":[[367,2368],[849,2368],[849,2421],[367,2421]],"region":{"top_left_x":367,"top_left_y":2367,"width":482,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3d2858c797841ba93410a3e8ced3e38","type":"text","conversion_output":true,"text":"and/or genitourinary region.","text_display":" and/or genitourinary 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nausea,","confidence":0.99755859375,"confidence_rate":0.9999728404650293},{"cnt":[[367,348],[741,348],[741,397],[367,397]],"region":{"top_left_x":367,"top_left_y":348,"width":375,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67badea298b84cd6bd45062247f820fc","type":"text","conversion_output":true,"text":"vomiting, or diarrhea.","text_display":" vomiting, or diarrhea.","confidence":1,"confidence_rate":1},{"cnt":[[305,404],[1882,404],[1882,458],[305,458]],"region":{"top_left_x":305,"top_left_y":403,"width":1578,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a503d012b55491bb278b73433e67776","type":"text","conversion_output":true,"text":"- Laryngeal angioedema: stridor, dyspnea, difficulty speaking, difficulty swallowing, throat","text_display":"\n- Laryngeal angioedema: stridor, dyspnea, difficulty speaking, difficulty swallowing, 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Routine vital sign assessments will be taken with","text_display":" Study Activities Schedule (Appendix 1). 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The findings of each examination will be recorded on the","text_display":" Activities Schedule (Appendix 1). The findings of each examination will be recorded on the","confidence":0.9990236759185791,"confidence_rate":0.9999897179371111},{"cnt":[[305,1727],[1858,1727],[1858,1777],[305,1777]],"region":{"top_left_x":305,"top_left_y":1727,"width":1554,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"947b1dae9c3f483c9378804ece0ec189","type":"text","conversion_output":true,"text":"source documents and eCRF. The physical examination will include the body systems listed","text_display":" source documents and eCRF. 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Pre-planned hospitalizations for an elective","text_display":" the study does not meet this criterion. 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intervention to prevent one of the outcomes listed in the definition","confidence":1,"confidence_rate":1},{"cnt":[[370,1422],[488,1422],[488,1472],[370,1472]],"region":{"top_left_x":369,"top_left_y":1422,"width":119,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d53b79c3fe7a469c89c248aaa6d13c23","type":"text","conversion_output":true,"text":"above.","text_display":" 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Overdose}","confidence":1,"confidence_rate":1},{"cnt":[[305,1603],[1828,1603],[1828,1656],[305,1656]],"region":{"top_left_x":305,"top_left_y":1602,"width":1524,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11b4135166f6466984f9d8b5d0134699","type":"text","conversion_output":true,"text":"An overdose is defined as a significant variation from the recommended/scheduled dosage","text_display":"\n\nAn overdose is defined as a significant variation from the recommended/scheduled dosage","confidence":1,"confidence_rate":1},{"cnt":[[305,1652],[1854,1652],[1854,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1652,"width":1550,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"660cf93237414cef8a6cf96f3fad77a0","type":"text","conversion_output":true,"text":"for a product. The dosing for this study will be conducted in a controlled clinical setting and","text_display":" for a product. The dosing for this study will be conducted in a controlled clinical setting and","confidence":0.93505859375,"confidence_rate":0.9993287645339397},{"cnt":[[305,1697],[1749,1697],[1749,1751],[305,1751]],"region":{"top_left_x":305,"top_left_y":1697,"width":1444,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d390505a06f408497ce9df927f7ce33","type":"text","conversion_output":true,"text":"an overdose is not anticipated. However, in the event of an accident, for this study, an","text_display":" an overdose is not anticipated. 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Investigators will report all diagnoses, or signs and","text_display":" events are considered AESI for this study. 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administration.","text_display":" reactions, regardless of causality, within 24 hours from the time of study drug administration.","confidence":1,"confidence_rate":1},{"cnt":[[305,881],[1768,881],[1768,935],[305,935]],"region":{"top_left_x":305,"top_left_y":880,"width":1464,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96f50f3a534c46dd8f56d51fb17d7bf4","type":"text","conversion_output":true,"text":"Investigators will report hypersensitivity reactions that occur after 24 hours, only if the","text_display":" Investigators will report hypersensitivity reactions that occur after 24 hours, only if the","confidence":1,"confidence_rate":1},{"cnt":[[305,932],[1158,932],[1158,982],[305,982]],"region":{"top_left_x":305,"top_left_y":932,"width":854,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a115afe81dfc4169b5e6515ce8664ef8","type":"text","conversion_output":true,"text":"reactions are suspected 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Investigators will report all diagnoses, or signs","confidence":1,"confidence_rate":1},{"cnt":[[305,1336],[1876,1336],[1876,1388],[305,1388]],"region":{"top_left_x":305,"top_left_y":1336,"width":1571,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a8ee7b416704c438a299b5f2018efad","type":"text","conversion_output":true,"text":"and symptoms when diagnoses cannot be determined, that are consistent with a clinical event","text_display":" and symptoms when diagnoses cannot be determined, that are consistent with a clinical event","confidence":0.9975595474243164,"confidence_rate":0.9999745478725159},{"cnt":[[305,1386],[1833,1386],[1833,1437],[305,1437]],"region":{"top_left_x":305,"top_left_y":1385,"width":1528,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a00771ca9d02469bb9aa1b3cd12e3cc1","type":"text","conversion_output":true,"text":"of bleeding. Coagulation testing (aPTT, PT, INR) should be performed when possible, and","text_display":" of bleeding. Coagulation testing (aPTT, PT, INR) should be performed when possible, and","confidence":1,"confidence_rate":1},{"cnt":[[305,1433],[1852,1433],[1852,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1433,"width":1547,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41689bbcbf374150bab55d3e1f11e23b","type":"text","conversion_output":true,"text":"when temporally reasonable, with any reports of bleeding or for clinical conditions possibly","text_display":" when temporally reasonable, with any reports of bleeding or for clinical conditions possibly","confidence":1,"confidence_rate":1},{"cnt":[[305,1482],[690,1482],[690,1534],[305,1534]],"region":{"top_left_x":305,"top_left_y":1482,"width":385,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e3e128874ab4869b8170c792fda245c","type":"text","conversion_output":true,"text":"indicative of bleeding.","text_display":" indicative of 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The questioning of subjects with regard to the possible occurrence","text_display":" for evidence of AEs. The questioning of subjects with regard to the possible occurrence","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[370,2200],[1826,2200],[1826,2249],[370,2249]],"region":{"top_left_x":369,"top_left_y":2200,"width":1458,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3307e3efc52d46749a53a484c897701c","type":"text","conversion_output":true,"text":"of AEs will be generalized such as, \"How have you been feeling since your last visit?\"","text_display":" of AEs will be generalized such as, \"How have you been feeling since your last visit?\"","confidence":1,"confidence_rate":1},{"cnt":[[370,2247],[1669,2247],[1669,2299],[370,2299]],"region":{"top_left_x":369,"top_left_y":2247,"width":1301,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff81255312f84dbeb27f6dabf85162dd","type":"text","conversion_output":true,"text":"The presence or absence of specific AEs should not be elicited from subjects.","text_display":" The presence or absence of specific AEs should not be elicited from subjects.","confidence":1,"confidence_rate":1},{"cnt":[[305,2307],[1712,2307],[1712,2361],[305,2361]],"region":{"top_left_x":305,"top_left_y":2307,"width":1408,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1348340ce37f4ed8847f30a7d72f6263","type":"text","conversion_output":true,"text":"- Subjects having TEAEs will be monitored until resolution with relevant clinical","text_display":"\n- Subjects having TEAEs will be monitored until resolution with relevant clinical","confidence":1,"confidence_rate":1},{"cnt":[[370,2357],[1504,2357],[1504,2408],[370,2408]],"region":{"top_left_x":369,"top_left_y":2356,"width":1135,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3625f729f03e4dc080c888e2c825fa55","type":"text","conversion_output":true,"text":"assessments and laboratory tests, as determined by the Investigator.","text_display":" assessments and laboratory tests, as determined by the Investigator.","confidence":1,"confidence_rate":1},{"cnt":[[305,2587],[492,2587],[492,2625],[305,2625]],"region":{"top_left_x":305,"top_left_y":2586,"width":187,"height":40},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4eecc5644e24e8c972641fe0565475d","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[984,2587],[1205,2587],[1205,2632],[984,2632]],"region":{"top_left_x":983,"top_left_y":2586,"width":223,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"281d09e32d1641d1b606a2dce8bf48e0","type":"page_info","conversion_output":false,"text":"Page 55 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,2587],[1880,2587],[1880,2632],[1706,2632]],"region":{"top_left_x":1705,"top_left_y":2586,"width":175,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fb9096ab7d6a43d9905618519473ea62","type":"page_info","conversion_output":false,"text":"Dyax 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DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5f38584090144188e8e4b191df24b31","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,296],[1880,296],[1880,350],[305,350]],"region":{"top_left_x":305,"top_left_y":296,"width":1575,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bafa7f55eda84f41a9e4f75276a88642","type":"text","conversion_output":true,"text":"- AEs, actions taken as a result of AEs, and follow-up results must be recorded in the eCRF","text_display":"\n- AEs, actions taken as a result of AEs, and follow-up results must be recorded in the eCRF","confidence":1,"confidence_rate":1},{"cnt":[[367,348],[1843,348],[1843,397],[367,397]],"region":{"top_left_x":367,"top_left_y":348,"width":1477,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea3d79d9a2494c6292a6a7b0cea16ed2","type":"text","conversion_output":true,"text":"as well as in the subject's source documentation. Follow-up laboratory results should be","text_display":" as well as in the subject's source documentation. Follow-up laboratory results should be","confidence":1,"confidence_rate":1},{"cnt":[[370,395],[1141,395],[1141,445],[370,445]],"region":{"top_left_x":369,"top_left_y":395,"width":772,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a68e45e236b4ab29d1c5fcae6ecb288","type":"text","conversion_output":true,"text":"filed with the subject's source documentation.","text_display":" filed with the subject's source documentation.","confidence":1,"confidence_rate":1},{"cnt":[[305,490],[1755,490],[1755,541],[305,541]],"region":{"top_left_x":305,"top_left_y":489,"width":1451,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46322cff50ad471886f5c82de5386eb3","type":"text","conversion_output":true,"text":"For any SAEs or AEs that require the subject to be discontinued from dosing, relevant","text_display":"\n\nFor any SAEs or AEs that require the subject to be discontinued from dosing, relevant","confidence":1,"confidence_rate":1},{"cnt":[[305,537],[1861,537],[1861,591],[305,591]],"region":{"top_left_x":305,"top_left_y":537,"width":1556,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8865f5a13fd43e89aa9a561547a5618","type":"text","conversion_output":true,"text":"clinical assessments and laboratory tests will be repeated as clinically appropriate, until final","text_display":" clinical assessments and laboratory tests will be repeated as clinically appropriate, until final","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,587],[1779,587],[1779,638],[305,638]],"region":{"top_left_x":305,"top_left_y":586,"width":1474,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cde56142476443f09eaa21236d384313","type":"text","conversion_output":true,"text":"resolution or stabilization of the event(s). Subjects will continue to be followed through","text_display":" resolution or stabilization of the event(s). Subjects will continue to be followed through","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[305,632],[887,632],[887,685],[305,685]],"region":{"top_left_x":305,"top_left_y":631,"width":583,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4be7836aabdd4e20b7e572a0a328ac8b","type":"text","conversion_output":true,"text":"completion of all scheduled visits.","text_display":" completion of all scheduled visits.","confidence":1,"confidence_rate":1},{"cnt":[[301,718],[1302,718],[1302,780],[301,780]],"region":{"top_left_x":300,"top_left_y":717,"width":1002,"height":63},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95f663e059ee49559f98bdb4bfec5cd6","type":"section_header","conversion_output":false,"children_ids":["48ed4680f12548319369b37c6ca902f9"],"text":"","text_display":""},{"cnt":[[305,722],[1296,722],[1296,776],[305,776]],"region":{"top_left_x":305,"top_left_y":721,"width":991,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48ed4680f12548319369b37c6ca902f9","type":"text","conversion_output":true,"parent_id":"95f663e059ee49559f98bdb4bfec5cd6","text":"6.16.2.2 Monitoring of Safety Laboratory Assessments","text_display":"\n\n\\subsection*{6.16.2.2 Monitoring of Safety Laboratory Assessments}","confidence":1,"confidence_rate":1},{"cnt":[[305,808],[1777,808],[1777,862],[305,862]],"region":{"top_left_x":305,"top_left_y":807,"width":1472,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d72212bcf5ff4860b9b2ced65c0cf0ef","type":"text","conversion_output":true,"text":"All safety laboratory assessments will be performed at a central laboratory. The clinical","text_display":"\n\nAll safety laboratory assessments will be performed at a central laboratory. The clinical","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[305,855],[1762,855],[1762,909],[305,909]],"region":{"top_left_x":305,"top_left_y":855,"width":1457,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8feb8f6e8634f5fbf8af4177820025c","type":"text","conversion_output":true,"text":"laboratory values will be reported to the Investigator who will review them for clinical","text_display":" laboratory values will be reported to the Investigator who will review them for clinical","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[305,904],[1446,904],[1446,956],[305,956]],"region":{"top_left_x":305,"top_left_y":904,"width":1141,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"662f0923568144ffadcabd09762843c6","type":"text","conversion_output":true,"text":"significance and consideration of abnormal values as potential AEs.","text_display":" significance and consideration of abnormal values as potential AEs.","confidence":1,"confidence_rate":1},{"cnt":[[301,986],[1068,986],[1068,1051],[301,1051]],"region":{"top_left_x":300,"top_left_y":986,"width":768,"height":65},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f5228628408431f877688f1b70c9ff2","type":"section_header","conversion_output":false,"children_ids":["cf0f31fc208e493484a4583b7ac118ba"],"text":"","text_display":""},{"cnt":[[305,993],[1061,993],[1061,1042],[305,1042]],"region":{"top_left_x":305,"top_left_y":992,"width":757,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf0f31fc208e493484a4583b7ac118ba","type":"text","conversion_output":true,"parent_id":"0f5228628408431f877688f1b70c9ff2","text":"6.16.3 Assessment of Adverse Events","text_display":"\n\n\\subsection*{6.16.3 Assessment of Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[301,1079],[930,1079],[930,1139],[301,1139]],"region":{"top_left_x":300,"top_left_y":1078,"width":631,"height":61},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7803738a5e7d42ed9612055ef6346970","type":"section_header","conversion_output":false,"children_ids":["ff9e636353f04a35b9ba24e60f0a7702"],"text":"","text_display":""},{"cnt":[[305,1083],[926,1083],[926,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1082,"width":621,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff9e636353f04a35b9ba24e60f0a7702","type":"text","conversion_output":true,"parent_id":"7803738a5e7d42ed9612055ef6346970","text":"6.16.3.1 Assessment of Severity","text_display":"\n\n\\subsection*{6.16.3.1 Assessment of Severity}","confidence":1,"confidence_rate":1},{"cnt":[[305,1171],[1841,1171],[1841,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1170,"width":1537,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce376dd8020c4600a65239407dba7547","type":"text","conversion_output":true,"text":"The term \"severe\" is often used to describe the intensity (severity) of a specific event (as in","text_display":"\n\nThe term \"severe\" is often used to describe the intensity (severity) of a specific event (as in","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1751,1216],[1751,1268],[305,1268]],"region":{"top_left_x":305,"top_left_y":1216,"width":1446,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ccd44dd9e8243d9855931a5a61abed7","type":"text","conversion_output":true,"text":"mild, moderate, or severe myocardial infarction); the event itself, however, may be of","text_display":" mild, moderate, or severe myocardial infarction); the event itself, however, may be of","confidence":1,"confidence_rate":1},{"cnt":[[305,1265],[1740,1265],[1740,1317],[305,1317]],"region":{"top_left_x":305,"top_left_y":1265,"width":1436,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f62c7145c0b745398f3f91d526ad49bd","type":"text","conversion_output":true,"text":"relatively minor medical significance (such as severe nausea). This is not the same as","text_display":" relatively minor medical significance (such as severe nausea). This is not the same as","confidence":1,"confidence_rate":1},{"cnt":[[305,1315],[1858,1315],[1858,1364],[305,1364]],"region":{"top_left_x":305,"top_left_y":1314,"width":1554,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbebb50aa46144e48fe55a6e005abeb9","type":"text","conversion_output":true,"text":"\"serious,\" which is based on subject/event outcome or action criteria usually associated with","text_display":" \"serious,\" which is based on subject/event outcome or action criteria usually associated with","confidence":1,"confidence_rate":1},{"cnt":[[305,1362],[1270,1362],[1270,1416],[305,1416]],"region":{"top_left_x":305,"top_left_y":1362,"width":965,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c88d4031d0a48f0ae9b5a90fd00d139","type":"text","conversion_output":true,"text":"events that pose a threat to a subject's life or functioning.","text_display":" events that pose a threat to a subject's life or functioning.","confidence":0.99951171875,"confidence_rate":0.9999926000198329},{"cnt":[[305,1448],[1871,1448],[1871,1502],[305,1502]],"region":{"top_left_x":305,"top_left_y":1448,"width":1567,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d59900e4d62a4b3783e541ee42c4ecd3","type":"text","conversion_output":true,"text":"In this study, the severity of AEs will be assessed according to Division of Microbiology and","text_display":"\n\nIn this study, the severity of AEs will be assessed according to Division of Microbiology and","confidence":1,"confidence_rate":1},{"cnt":[[305,1500],[1783,1500],[1783,1549],[305,1549]],"region":{"top_left_x":305,"top_left_y":1499,"width":1479,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ac0ff7946e04eefa000db3aa472915f","type":"text","conversion_output":true,"text":"Infectious Diseases (DMID) Adult Toxicity Table, Draft, November 2007 (US National","text_display":" Infectious Diseases (DMID) Adult Toxicity Table, Draft, November 2007 (US National","confidence":1,"confidence_rate":1},{"cnt":[[305,1547],[1858,1547],[1858,1601],[305,1601]],"region":{"top_left_x":305,"top_left_y":1546,"width":1554,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c8fb96c93784e82a1cb40cceffea982","type":"text","conversion_output":true,"text":"Institutes of Health: National Institute of Allergy and Infectious Diseases) (Appendix 2) and","text_display":" Institutes of Health: National Institute of Allergy and Infectious Diseases) (Appendix 2) and","confidence":0.9776411549551912,"confidence_rate":0.9997692858685827},{"cnt":[[305,1594],[1785,1594],[1785,1646],[305,1646]],"region":{"top_left_x":305,"top_left_y":1594,"width":1481,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88e10fe9c12c4cebbf7e0049adafe639","type":"text","conversion_output":true,"text":"the Division of Microbiology and Infectious Diseases (DMID) Pediatric Toxicity Table,","text_display":" the Division of Microbiology and Infectious Diseases (DMID) Pediatric Toxicity Table,","confidence":0.9970703125,"confidence_rate":0.9999674006709831},{"cnt":[[305,1641],[1824,1641],[1824,1693],[305,1693]],"region":{"top_left_x":305,"top_left_y":1641,"width":1520,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd861db0ec5a498da685c99643d79932","type":"text","conversion_output":true,"text":"Draft, November 2007 (US National Institutes of Health: National Institute of Allergy and","text_display":" Draft, November 2007 (US National Institutes of Health: National Institute of Allergy and","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,1691],[1835,1691],[1835,1742],[305,1742]],"region":{"top_left_x":305,"top_left_y":1690,"width":1530,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7afabefa12584e41a5461cc8bea6966e","type":"text","conversion_output":true,"text":"Infectious Diseases) (Appendix 3). For abnormalities not specifically found in the Toxicity","text_display":" Infectious Diseases) (Appendix 3). For abnormalities not specifically found in the Toxicity","confidence":0.9980475902557373,"confidence_rate":0.9999796427261641},{"cnt":[[305,1740],[1605,1740],[1605,1792],[305,1792]],"region":{"top_left_x":305,"top_left_y":1740,"width":1300,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23e34fdc1d3b45f8aef8be12c6ff07c3","type":"text","conversion_output":true,"text":"Tables, the following general scale will be used to estimate grade of severity:","text_display":" Tables, the following general scale will be used to estimate grade of severity:","confidence":1,"confidence_rate":1},{"cnt":[[305,1841],[1880,1841],[1880,1895],[305,1895]],"region":{"top_left_x":305,"top_left_y":1841,"width":1575,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d44b6fd518d4fc3a621fe439f18c7bf","type":"text","conversion_output":true,"text":"- GRADE 1 (Mild): Transient or mild discomfort; no medical intervention/therapy required","text_display":"\n- GRADE 1 (Mild): Transient or mild discomfort; no medical intervention/therapy required","confidence":1,"confidence_rate":1},{"cnt":[[305,1899],[1848,1899],[1848,1953],[305,1953]],"region":{"top_left_x":305,"top_left_y":1899,"width":1543,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"932650be57f14d08b6b6fca5557fefca","type":"text","conversion_output":true,"text":"- GRADE 2 (Moderate): Mild to moderate limitation in activity - some assistance may be","text_display":"\n- GRADE 2 (Moderate): Mild to moderate limitation in activity - some assistance may be","confidence":1,"confidence_rate":1},{"cnt":[[365,1951],[1399,1951],[1399,2004],[365,2004]],"region":{"top_left_x":365,"top_left_y":1950,"width":1034,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13f97142507c478ba65516c9c91d798d","type":"text","conversion_output":true,"text":"needed; no or minimal medical intervention/therapy required","text_display":" needed; no or minimal medical intervention/therapy required","confidence":1,"confidence_rate":1},{"cnt":[[305,2007],[1785,2007],[1785,2065],[305,2065]],"region":{"top_left_x":305,"top_left_y":2006,"width":1481,"height":59},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7db9923097449deabbe95beb443081d","type":"text","conversion_output":true,"text":"- GRADE 3 (Severe): Marked limitation in activity, some assistance usually required;","text_display":"\n- GRADE 3 (Severe): Marked limitation in activity, some assistance usually required;","confidence":1,"confidence_rate":1},{"cnt":[[365,2058],[1442,2058],[1442,2112],[365,2112]],"region":{"top_left_x":365,"top_left_y":2058,"width":1077,"height":54},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94f5f1b35e4f4e2d8e8be33d3ce2fe3f","type":"text","conversion_output":true,"text":"medical intervention/therapy required, hospitalizations possible","text_display":" medical intervention/therapy required, hospitalizations possible","confidence":1,"confidence_rate":1},{"cnt":[[305,2118],[1755,2118],[1755,2172],[305,2172]],"region":{"top_left_x":305,"top_left_y":2118,"width":1451,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36a065f2a0004ccf95cf6d8d6bd16111","type":"text","conversion_output":true,"text":"- GRADE 4 (Life-threatening): Extreme limitation in activity, significant assistance","text_display":"\n- GRADE 4 (Life-threatening): Extreme limitation in activity, significant assistance","confidence":1,"confidence_rate":1},{"cnt":[[367,2168],[1807,2168],[1807,2219],[367,2219]],"region":{"top_left_x":367,"top_left_y":2167,"width":1440,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77b8269fdfe643c5b52f4b4b4105823b","type":"text","conversion_output":true,"text":"required; significant medical 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Clinical significance of individual laboratory AEs will be","confidence":1,"confidence_rate":1},{"cnt":[[305,709],[1639,709],[1639,761],[305,761]],"region":{"top_left_x":305,"top_left_y":708,"width":1335,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ce3ad1452a849a18fc136942b4bb7a4","type":"text","conversion_output":true,"text":"determined by the Investigator with input from the Medical Monitor as needed.","text_display":" determined by the Investigator with input from the Medical Monitor as needed.","confidence":1,"confidence_rate":1},{"cnt":[[305,799],[1815,799],[1815,853],[305,853]],"region":{"top_left_x":305,"top_left_y":799,"width":1511,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c52926af8d04d4eb3b68e9b745164ba","type":"text","conversion_output":true,"text":"Following is an exception to defining clinically significant, abnormal laboratory values as","text_display":"\n\nFollowing is an exception to defining clinically significant, abnormal laboratory values as","confidence":1,"confidence_rate":1},{"cnt":[[305,851],[400,851],[400,896],[305,896]],"region":{"top_left_x":305,"top_left_y":850,"width":95,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9a2775ca0b64ddc89bb9a3d0b8e3738","type":"text","conversion_output":true,"text":"AEs:","text_display":" AEs:","confidence":1,"confidence_rate":1},{"cnt":[[305,937],[1760,937],[1760,990],[305,990]],"region":{"top_left_x":305,"top_left_y":936,"width":1455,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73f7675d9ebd42d69c216587be8168c7","type":"text","conversion_output":true,"text":"- APTT prolongation in the absence of any associated bleeding or other evidence of","text_display":"\n- APTT prolongation in the absence of any associated bleeding or other evidence of","confidence":1,"confidence_rate":1},{"cnt":[[370,988],[1876,988],[1876,1040],[370,1040]],"region":{"top_left_x":369,"top_left_y":988,"width":1507,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91cd7f80823c48609f10a056ed4301b7","type":"text","conversion_output":true,"text":"clinical relevance will not be considered a clinically significant laboratory abnormality or","text_display":" clinical relevance will not be considered a clinically significant laboratory abnormality or","confidence":1,"confidence_rate":1},{"cnt":[[370,1038],[1867,1038],[1867,1089],[370,1089]],"region":{"top_left_x":369,"top_left_y":1037,"width":1498,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"633e3fadb0294d278f2d6472e9af8c68","type":"text","conversion_output":true,"text":"AE. 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In this study all HAE attacks reported by the subject,","text_display":" on the AE page of the eCRF. In this study all HAE attacks reported by the subject,","confidence":0.9975595474243164,"confidence_rate":0.9999719149307847},{"cnt":[[305,1830],[1858,1830],[1858,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1830,"width":1554,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e76902eadac84f1bbbeb627e4965b140","type":"text","conversion_output":true,"text":"regardless of whether or not they are confirmed by the Investigator, will be captured as AEs.","text_display":" regardless of whether or not they are confirmed by the Investigator, will be captured as AEs.","confidence":1,"confidence_rate":1},{"cnt":[[301,1908],[922,1908],[922,1974],[301,1974]],"region":{"top_left_x":300,"top_left_y":1907,"width":622,"height":68},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be33fdb4806b4239a7e0e1f7b5f8c1a4","type":"section_header","conversion_output":false,"children_ids":["b3d071f0263b4ec5bbcb9450781b8093"],"text":"","text_display":""},{"cnt":[[305,1914],[917,1914],[917,1968],[305,1968]],"region":{"top_left_x":305,"top_left_y":1914,"width":613,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3d071f0263b4ec5bbcb9450781b8093","type":"text","conversion_output":true,"parent_id":"be33fdb4806b4239a7e0e1f7b5f8c1a4","text":"6.16.5.2 Reporting Pregnancies","text_display":"\n\n\\subsection*{6.16.5.2 Reporting Pregnancies}","confidence":1,"confidence_rate":1},{"cnt":[[305,2002],[1775,2002],[1775,2056],[305,2056]],"region":{"top_left_x":305,"top_left_y":2002,"width":1470,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ffa1b02435a4908bfe5c64e695d92d3","type":"text","conversion_output":true,"text":"If a female subject or the female partner of a male subject becomes pregnant during the","text_display":"\n\nIf a female subject or the female partner of a male subject becomes pregnant during the","confidence":1,"confidence_rate":1},{"cnt":[[305,2054],[1568,2054],[1568,2103],[305,2103]],"region":{"top_left_x":305,"top_left_y":2053,"width":1264,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa0b382141bb41388aae64ad863f4578","type":"text","conversion_output":true,"text":"course of the study, the Investigator must report the pregnancy to the Dyax","text_display":" course of the study, the Investigator must report the pregnancy to the Dyax","confidence":1,"confidence_rate":1},{"cnt":[[305,2099],[1841,2099],[1841,2151],[305,2151]],"region":{"top_left_x":305,"top_left_y":2099,"width":1537,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2a9edd8564743ddb09b438af795e5c9","type":"text","conversion_output":true,"text":"Pharmacovigilance Department using the Pregnancy Reporting Form within 24 hours of","text_display":" Pharmacovigilance Department using the Pregnancy Reporting Form within 24 hours of","confidence":0.947265625,"confidence_rate":0.9993982285359863},{"cnt":[[305,2148],[1790,2148],[1790,2202],[305,2202]],"region":{"top_left_x":305,"top_left_y":2148,"width":1485,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"431c46c20c3c4a81b51faf16904f49b3","type":"text","conversion_output":true,"text":"becoming aware of the event. The Investigator must obtain consent to collect pregnancy","text_display":" becoming aware of the event. The Investigator must obtain consent to collect pregnancy","confidence":1,"confidence_rate":1},{"cnt":[[305,2196],[1377,2196],[1377,2249],[305,2249]],"region":{"top_left_x":305,"top_left_y":2195,"width":1073,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e0d9cb4367d4e8e87ee25a52c77a9c4","type":"text","conversion_output":true,"text":"information (including the status of the newborn, if applicable).","text_display":" information (including the status of the newborn, if applicable).","confidence":1,"confidence_rate":1},{"cnt":[[305,2286],[1772,2286],[1772,2340],[305,2340]],"region":{"top_left_x":305,"top_left_y":2285,"width":1468,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d25813efcb9541199fbdffa14b45be50","type":"text","conversion_output":true,"text":"If some of the information required for completion of the Pregnancy Reporting Form is","text_display":"\n\nIf some of the information required for completion of the Pregnancy Reporting Form is","confidence":1,"confidence_rate":1},{"cnt":[[305,2333],[1714,2333],[1714,2385],[305,2385]],"region":{"top_left_x":305,"top_left_y":2333,"width":1410,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f033f7633a1a4d6aa3921ef102d8b275","type":"text","conversion_output":true,"text":"unavailable at the time of the initial report, follow-up reports will be completed and","text_display":" unavailable at the time of the initial report, follow-up reports will be completed and","confidence":1,"confidence_rate":1},{"cnt":[[305,2380],[1811,2380],[1811,2432],[305,2432]],"region":{"top_left_x":305,"top_left_y":2380,"width":1507,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1a9bd8c28a04a1fae97623ef6393fbd","type":"text","conversion_output":true,"text":"submitted within 24 hours of becoming aware of the new information. 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Active treatment dose in each active treatment arm to","text_display":" observed for 24 weeks of efficacy. Active treatment dose in each active treatment arm to","confidence":1,"confidence_rate":1},{"cnt":[[305,859],[1818,859],[1818,913],[305,913]],"region":{"top_left_x":305,"top_left_y":859,"width":1513,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"782a064b1128404f9cf55c3bdedf7778","type":"text","conversion_output":true,"text":"placebo ratio was set at \\(1: 1.5\\). A \\(10 \\%\\) missing data / dropout rate for both active treatment","text_display":" placebo ratio was set at \\(1: 1.5\\). 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These sample sizes will also provide adequately sized","text_display":" reductions of attacks of near \\(100 \\%\\). These sample sizes will also provide adequately sized","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,1238],[1858,1238],[1858,1291],[305,1291]],"region":{"top_left_x":305,"top_left_y":1237,"width":1554,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cf744c3216447db9334ae46c01b25a9","type":"text","conversion_output":true,"text":"safety population for evaluation. Up to 120 subjects may be enrolled to account for potential","text_display":" safety population for evaluation. 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The primary efficacy analyses will be","text_display":" administered at least 1 dose of active IMP or placebo. 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All safety analyses will use the Safety Population.","text_display":" IMP or placebo. 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Sample concentrations below the","text_display":" will use either missing or zero for samples below LLOQ. Sample concentrations below the","confidence":1,"confidence_rate":1},{"cnt":[[305,984],[1858,984],[1858,1036],[305,1036]],"region":{"top_left_x":305,"top_left_y":983,"width":1554,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dad2788d0e0d4d5db94a473da7544518","type":"text","conversion_output":true,"text":"LLOQ will be assigned zero when they precede the first concentration not below the LLOQ.","text_display":" LLOQ will be assigned zero when they precede the first concentration not below the LLOQ.","confidence":1,"confidence_rate":1},{"cnt":[[305,1031],[1876,1031],[1876,1085],[305,1085]],"region":{"top_left_x":305,"top_left_y":1031,"width":1571,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1bab41e35e84c8eab7f9ea744c58358","type":"text","conversion_output":true,"text":"Sample concentrations following the last concentration not below the LLOQ will be assigned","text_display":" Sample concentrations following the last concentration not below the LLOQ will be assigned","confidence":1,"confidence_rate":1},{"cnt":[[305,1079],[1843,1079],[1843,1130],[305,1130]],"region":{"top_left_x":305,"top_left_y":1078,"width":1539,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23ae568c9c3a4a178704f5310b1b1f0c","type":"text","conversion_output":true,"text":"missing when below the LLOQ. If a sample concentration is below the LLOQ and between","text_display":" missing when below the LLOQ. If a sample concentration is below the LLOQ and between","confidence":1,"confidence_rate":1},{"cnt":[[305,1126],[1863,1126],[1863,1179],[305,1179]],"region":{"top_left_x":305,"top_left_y":1125,"width":1558,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb8615b466e24d0a902b0b7cc3089c7c","type":"text","conversion_output":true,"text":"the first and last concentrations not below the LLOQ, then the assignment of missing or zero","text_display":" the first and last concentrations not below the LLOQ, then the assignment of missing or zero","confidence":1,"confidence_rate":1},{"cnt":[[305,1175],[1566,1175],[1566,1229],[305,1229]],"region":{"top_left_x":305,"top_left_y":1175,"width":1262,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3ba3148ac5d4871841a89541783d7ae","type":"text","conversion_output":true,"text":"will be at the discretion of the PK specialists using physiological rationale.","text_display":" will be at the discretion of the PK specialists using physiological rationale.","confidence":1,"confidence_rate":1},{"cnt":[[305,1263],[1790,1263],[1790,1317],[305,1317]],"region":{"top_left_x":305,"top_left_y":1263,"width":1485,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fb96d5c4892448fa0dee68fbe9e0e79","type":"text","conversion_output":true,"text":"Full details of the planned PK parameters will be included in the statistical analysis plan","text_display":"\n\nFull details of the planned PK parameters will be included in the statistical analysis plan","confidence":1,"confidence_rate":1},{"cnt":[[305,1313],[432,1313],[432,1364],[305,1364]],"region":{"top_left_x":305,"top_left_y":1312,"width":127,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d83cd151eb6d414c85f58cb8af9ee584","type":"text","conversion_output":true,"text":"(SAP).","text_display":" (SAP).","confidence":1,"confidence_rate":1},{"cnt":[[296,1392],[1111,1392],[1111,1465],[296,1465]],"region":{"top_left_x":296,"top_left_y":1392,"width":815,"height":74},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2367e0a668df49c9b52ae0eff229796b","type":"section_header","conversion_output":false,"children_ids":["3c5c8c5198e849b8803018dbedc6207b"],"text":"","text_display":""},{"cnt":[[305,1401],[1104,1401],[1104,1457],[305,1457]],"region":{"top_left_x":305,"top_left_y":1400,"width":800,"height":57},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c5c8c5198e849b8803018dbedc6207b","type":"text","conversion_output":true,"parent_id":"2367e0a668df49c9b52ae0eff229796b","text":"9.5.2 Pharmacodynamic Assessments:","text_display":"\n\n\\subsection*{9.5.2 Pharmacodynamic Assessments:}","confidence":1,"confidence_rate":1},{"cnt":[[305,1491],[1760,1491],[1760,1545],[305,1545]],"region":{"top_left_x":305,"top_left_y":1491,"width":1455,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89ec12452fb14822893dd97fd2f1cf9b","type":"text","conversion_output":true,"text":"Blood samples will be collected to evaluate the pharmacodynamic effects of DX-2930","text_display":"\n\nBlood samples will be collected to evaluate the pharmacodynamic effects of DX-2930","confidence":0.9990236759185791,"confidence_rate":0.9999887724653715},{"cnt":[[305,1540],[1852,1540],[1852,1592],[305,1592]],"region":{"top_left_x":305,"top_left_y":1540,"width":1547,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5ab2b4a6ba54c769af03ff0cfcb83c1","type":"text","conversion_output":true,"text":"through biomarker assays prior to IMP administration on Day 0 and on Days \\(56 \\pm 3,98 \\pm 3\\),","text_display":" through biomarker assays prior to IMP administration on Day 0 and on Days \\(56 \\pm 3,98 \\pm 3\\),","confidence":1,"confidence_rate":1},{"cnt":[[305,1588],[1766,1588],[1766,1639],[305,1639]],"region":{"top_left_x":305,"top_left_y":1587,"width":1462,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47113cf4a1d04fd197a0c37e048976f9","type":"text","conversion_output":true,"text":"\\(140 \\pm 3\\), and \\(182 \\pm 3\\). 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Additional samples will be collected on Days \\(210 \\pm 3\\), and \\(238 \\pm 3\\)","confidence":0.9838943481445312,"confidence_rate":0.9998215900107328},{"cnt":[[305,1635],[1369,1635],[1369,1689],[305,1689]],"region":{"top_left_x":305,"top_left_y":1634,"width":1064,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f507b03ab634278a2dd3960a3ddf611","type":"text","conversion_output":true,"text":"during the follow-up period for any subjects not entering OLE.","text_display":" during the follow-up period for any subjects not entering OLE.","confidence":1,"confidence_rate":1},{"cnt":[[299,1714],[1059,1714],[1059,1785],[299,1785]],"region":{"top_left_x":298,"top_left_y":1714,"width":762,"height":72},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4450b3a3abed429ba73c8c89e50797d1","type":"section_header","conversion_output":false,"children_ids":["f347d9dfa2184c8e911d9f88ebc8fcbc"],"text":"","text_display":""},{"cnt":[[305,1723],[1051,1723],[1051,1779],[305,1779]],"region":{"top_left_x":305,"top_left_y":1723,"width":746,"height":56},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f347d9dfa2184c8e911d9f88ebc8fcbc","type":"text","conversion_output":true,"parent_id":"4450b3a3abed429ba73c8c89e50797d1","text":"9.5.3 Immunogenicity Assessments:","text_display":"\n\n\\subsection*{9.5.3 Immunogenicity Assessments:}","confidence":1,"confidence_rate":1},{"cnt":[[305,1813],[1841,1813],[1841,1867],[305,1867]],"region":{"top_left_x":305,"top_left_y":1813,"width":1537,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"750286ac2c98484aa499ec03c99b5bf3","type":"text","conversion_output":true,"text":"Blood samples will be collected to assay for the presence of anti-drug antibodies, including","text_display":"\n\nBlood samples will be collected to assay for the presence of anti-drug antibodies, including","confidence":1,"confidence_rate":1},{"cnt":[[305,1865],[1781,1865],[1781,1914],[305,1914]],"region":{"top_left_x":305,"top_left_y":1864,"width":1477,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5e344a8fcb243ad9a740508edc8a42a","type":"text","conversion_output":true,"text":"evaluation of neutralizing antibodies (if any confirmed positive anti-drug antibodies are","text_display":" evaluation of neutralizing antibodies (if any confirmed positive anti-drug antibodies are","confidence":0.998046875,"confidence_rate":0.9999792019733479},{"cnt":[[305,1910],[1869,1910],[1869,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1909,"width":1565,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e878d6e7993415b97fce6b6ac3b823d","type":"text","conversion_output":true,"text":"detected) prior to IMP administration on Day 0 and on Days \\(56 \\pm 3,98 \\pm 3,140 \\pm 3\\), and 182","text_display":" detected) prior to IMP administration on Day 0 and on Days \\(56 \\pm 3,98 \\pm 3,140 \\pm 3\\), and 182","confidence":1,"confidence_rate":1},{"cnt":[[305,1959],[1867,1959],[1867,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1959,"width":1562,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"104ef8d080a344b1bdbea677d66fe885","type":"text","conversion_output":true,"text":"\\(\\pm 3\\). Additional samples will be collected on Day \\(238 \\pm 3\\) during the follow-up period for any","text_display":" \\(\\pm 3\\). Additional samples will be collected on Day \\(238 \\pm 3\\) during the follow-up period for any","confidence":0.9703203445894815,"confidence_rate":0.9996894398847911},{"cnt":[[305,2007],[758,2007],[758,2060],[305,2060]],"region":{"top_left_x":305,"top_left_y":2006,"width":454,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c324636f11841518d95184c6bdac10f","type":"text","conversion_output":true,"text":"subjects not entering OLE","text_display":" subjects not entering 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assessment.","confidence":1,"confidence_rate":1},{"cnt":[[305,2587],[492,2587],[492,2628],[305,2628]],"region":{"top_left_x":305,"top_left_y":2586,"width":187,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"300869ec172f45cb9a4b58d26f0245e3","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[984,2587],[1207,2587],[1207,2632],[984,2632]],"region":{"top_left_x":983,"top_left_y":2586,"width":225,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c69b8f79f0224723b263576af6961166","type":"page_info","conversion_output":false,"text":"Page 74 of 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DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f416526d697e438bae0c18ab5df56e4c","type":"page_info","conversion_output":false,"text":"Final: 14 September 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Endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[305,378],[1738,378],[1738,428],[305,428]],"region":{"top_left_x":305,"top_left_y":378,"width":1434,"height":50},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"192fe406132c4acaacf3cd498d84b44a","type":"text","conversion_output":true,"text":"The primary analysis will be to compare the primary endpoint, which is mean rate of","text_display":"\n\nThe primary analysis will be to compare the primary endpoint, which is mean rate of","confidence":1,"confidence_rate":1},{"cnt":[[305,425],[1846,425],[1846,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1541,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41e666dde6b44b8a9733b29b7e5cc6cf","type":"text","conversion_output":true,"text":"Investigator-confirmed HAE attacks observed in each DX-2930 treatment arm to that in the","text_display":" Investigator-confirmed HAE attacks observed in each DX-2930 treatment arm to that in the","confidence":1,"confidence_rate":1},{"cnt":[[305,475],[1755,475],[1755,526],[305,526]],"region":{"top_left_x":305,"top_left_y":474,"width":1451,"height":53},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c3c5433e4f245989c10b30ae1951881","type":"text","conversion_output":true,"text":"placebo arm during the efficacy assessment period (Day 14 through Day 182). For the","text_display":" placebo arm during the efficacy assessment period (Day 14 through Day 182). For the","confidence":1,"confidence_rate":1},{"cnt":[[305,524],[1880,524],[1880,574],[305,574]],"region":{"top_left_x":305,"top_left_y":524,"width":1575,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ae04e0c8532443cba7373007c9916f5","type":"text","conversion_output":true,"text":"primary endpoint, an analysis of all randomized subjects who have received at least 1 dose of","text_display":" primary endpoint, an analysis of all randomized subjects who have received at least 1 dose of","confidence":1,"confidence_rate":1},{"cnt":[[305,571],[707,571],[707,614],[305,614]],"region":{"top_left_x":305,"top_left_y":571,"width":402,"height":44},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a627a3a90c1d4604852c4f1e972cd19e","type":"text","conversion_output":true,"text":"IMP will be conducted.","text_display":" IMP will be conducted.","confidence":1,"confidence_rate":1},{"cnt":[[305,662],[1794,662],[1794,711],[305,711]],"region":{"top_left_x":305,"top_left_y":661,"width":1489,"height":51},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8fe8310daade4c068aef83427d98d744","type":"text","conversion_output":true,"text":"The HAE attack rates of the treated and placebo groups will be compared using MMRM","text_display":"\n\nThe HAE attack rates of the treated and placebo groups will be compared using MMRM","confidence":1,"confidence_rate":1},{"cnt":[[305,709],[1833,709],[1833,758],[305,758]],"region":{"top_left_x":305,"top_left_y":708,"width":1528,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4273528569f450fbd371e90070355b4","type":"text","conversion_output":true,"text":"ANOVA for counts using the GEE. The baseline attack rate for each subject as determined","text_display":" ANOVA for counts using the GEE. The baseline attack rate for each subject as determined","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[305,756],[1852,756],[1852,806],[305,806]],"region":{"top_left_x":305,"top_left_y":756,"width":1547,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6beaa51b5f1240cda13448449b60d6a4","type":"text","conversion_output":true,"text":"by the run-in period will be used as a continuous covariate in an analysis of covariance. The","text_display":" by the run-in period will be used as a continuous covariate in an analysis of covariance. The","confidence":0.99658203125,"confidence_rate":0.9999650636373343},{"cnt":[[305,804],[1811,804],[1811,853],[305,853]],"region":{"top_left_x":305,"top_left_y":803,"width":1507,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc82ba3185fa4a168a5ae2860ac3edb6","type":"text","conversion_output":true,"text":"model will be based on two fixed effects (treatment group and prior use of DX-2930), the","text_display":" model will be based on two fixed effects (treatment group and prior use of DX-2930), the","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[305,851],[1846,851],[1846,900],[305,900]],"region":{"top_left_x":305,"top_left_y":850,"width":1541,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ca3d79d542440899ff2f1520746da72","type":"text","conversion_output":true,"text":"random effect will be the subject and the baseline attack rate will be continuous covariate.","text_display":" random effect will be the subject and the baseline attack rate will be continuous covariate.","confidence":0.6259765625,"confidence_rate":0.9951823397689382},{"cnt":[[305,900],[1803,900],[1803,952],[305,952]],"region":{"top_left_x":305,"top_left_y":900,"width":1498,"height":52},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e5cf97a631644dc908b2eae6b49fa33","type":"text","conversion_output":true,"text":"For each subject, the least squares mean will be calculated and adjusted for their baseline","text_display":" For each subject, the least squares mean will be calculated and adjusted for their baseline","confidence":1,"confidence_rate":1},{"cnt":[[305,950],[1757,950],[1757,995],[305,995]],"region":{"top_left_x":305,"top_left_y":949,"width":1453,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2cf54bc44ff645a79ed05d408b6a2d59","type":"text","conversion_output":true,"text":"attack rate. A Poisson distribution will be assumed rather than a Gaussian distribution.","text_display":" attack rate. A Poisson distribution will be assumed rather than a Gaussian distribution.","confidence":0.99853515625,"confidence_rate":0.9999842375685026},{"cnt":[[305,993],[1854,993],[1854,1046],[305,1046]],"region":{"top_left_x":305,"top_left_y":992,"width":1550,"height":55},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5faef15e3a74b97acd2c44c0f34911e","type":"text","conversion_output":true,"text":"Repeated measurement analysis will be employed, with a 7-day time period (i.e., 168 hours)","text_display":" Repeated measurement analysis will be employed, with a 7-day time period (i.e., 168 hours)","confidence":0.63720703125,"confidence_rate":0.9954119790432512},{"cnt":[[305,1044],[1768,1044],[1768,1094],[305,1094]],"region":{"top_left_x":305,"top_left_y":1044,"width":1464,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6385ca76941745aba0ba74c6f7500f4a","type":"text","conversion_output":true,"text":"serving as the discrete unit of measurement. There will be no Last Observation Carried","text_display":" serving as the discrete unit of measurement. 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The rate of the mean","confidence":1,"confidence_rate":1},{"cnt":[[305,1470],[1858,1470],[1858,1519],[305,1519]],"region":{"top_left_x":305,"top_left_y":1469,"width":1554,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e71fc26b81ce4720bcd958c1f1063cce","type":"text","conversion_output":true,"text":"event rate per week, for each dose level vs placebo and its \\(95 \\%\\) Confidence interval can also","text_display":" event rate per week, for each dose level vs placebo and its \\(95 \\%\\) Confidence interval can also","confidence":0.97314453125,"confidence_rate":0.9997278103908489},{"cnt":[[305,1517],[1876,1517],[1876,1566],[305,1566]],"region":{"top_left_x":305,"top_left_y":1516,"width":1571,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81bea7fa7c37425e88a5632ab39d0d90","type":"text","conversion_output":true,"text":"be estimated by transforming the above lsmean difference and its \\(95 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Trta (REF = 'Placebo') usubjid;","confidence":0.99658203125,"confidence_rate":0.9999144080794586},{"cnt":[[408,2075],[1253,2075],[1253,2125],[408,2125]],"region":{"top_left_x":408,"top_left_y":2075,"width":845,"height":50},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"373890d69a6d4adf82f864c3061b4003","type":"code","conversion_output":true,"parent_id":"520a4b3acb9a4b428b55c8296d2c6bc0","text":"MODEL attack=trta priordx base/ DIST=poisson;","text_display":"\n    MODEL attack=trta priordx base/ DIST=poisson;","confidence":0.99560546875,"confidence_rate":0.9999082497179616},{"cnt":[[408,2123],[1210,2123],[1210,2172],[408,2172]],"region":{"top_left_x":408,"top_left_y":2122,"width":802,"height":51},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d05905d8dd994909970a085efc1f427b","type":"code","conversion_output":true,"parent_id":"520a4b3acb9a4b428b55c8296d2c6bc0","text":"REPEATED SUBJECT=usubjid / CORR=ind;","text_display":"\n    REPEATED SUBJECT=usubjid / CORR=ind;","confidence":0.91943359375,"confidence_rate":0.9978485367603654},{"cnt":[[408,2170],[982,2170],[982,2219],[408,2219]],"region":{"top_left_x":408,"top_left_y":2169,"width":574,"height":51},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5d169adaf28400da50afd2422909cd6","type":"code","conversion_output":true,"parent_id":"520a4b3acb9a4b428b55c8296d2c6bc0","text":"LSMEANS trta/DIFF CL ILINK;","text_display":"\n    LSMEANS trta/DIFF CL ILINK;","confidence":1,"confidence_rate":1},{"cnt":[[408,2217],[1274,2217],[1274,2267],[408,2267]],"region":{"top_left_x":408,"top_left_y":2217,"width":867,"height":50},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3bccc4a9dbc8417790d0abe728de2fce","type":"code","conversion_output":true,"parent_id":"520a4b3acb9a4b428b55c8296d2c6bc0","text":"ODS OUTPUT diffs - meandiff lsmeans = means;","text_display":"\n    ODS OUTPUT diffs - meandiff lsmeans = means;","confidence":0.9990234375,"confidence_rate":0.9999792121384572},{"cnt":[[305,2264],[415,2264],[415,2314],[305,2314]],"region":{"top_left_x":305,"top_left_y":2264,"width":110,"height":50},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9cf1a702c61b47c48e6435b64fb90ca7","type":"code","conversion_output":true,"parent_id":"520a4b3acb9a4b428b55c8296d2c6bc0","text":"RUN;","text_display":"\nRUN;\n```\n","confidence":1,"confidence_rate":1},{"cnt":[[305,2355],[1785,2355],[1785,2404],[305,2404]],"region":{"top_left_x":305,"top_left_y":2354,"width":1481,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5312c25c410540c8b862f2cfb5717efe","type":"text","conversion_output":true,"text":"There are three active treatment arms ordered by highest total monthly dose; 1) Primary","text_display":"\n\nThere are three active treatment arms ordered by highest total monthly dose; 1) Primary","confidence":1,"confidence_rate":1},{"cnt":[[305,2402],[1811,2402],[1811,2454],[305,2454]],"region":{"top_left_x":305,"top_left_y":2401,"width":1507,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3124c4bba9c8472595121b49a01cb47b","type":"text","conversion_output":true,"text":"Treatment Arm: 300 mg DX-2930 every 2 weeks, 2) Secondary Treatment Arm: 300 mg","text_display":" Treatment Arm: 300 mg DX-2930 every 2 weeks, 2) Secondary Treatment Arm: 300 mg","confidence":0.9960966110229492,"confidence_rate":0.9999579468296076},{"cnt":[[305,2449],[1848,2449],[1848,2503],[305,2503]],"region":{"top_left_x":305,"top_left_y":2449,"width":1543,"height":54},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6c62121e38042f58b4b7b18275c1356","type":"text","conversion_output":true,"text":"DX-2930 every 4 weeks, and 3) Tertiary Treatment Arm: 150 mg DX-2930 every 4 weeks.","text_display":" DX-2930 every 4 weeks, 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DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8e3d5f3c0194a8aadb0d569a502be7c","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,284],[1833,284],[1833,337],[305,337]],"region":{"top_left_x":305,"top_left_y":283,"width":1528,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d0551752d6444108af13da23774a591","type":"text","conversion_output":true,"text":"For the primary endpoint, each of the three active treatment arms will be compared against","text_display":"\n\nFor the primary endpoint, each of the three active treatment arms will be compared 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If statistical significance is found for both the primary and secondary treatment","text_display":" level alpha. 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The same SAS code used for the","text_display":" MMRM model as described for the primary endpoint. 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The same SAS code used for","text_display":" using the MMRM model as described for the primary endpoint. The same SAS code used for","confidence":1,"confidence_rate":1},{"cnt":[[305,1549],[1377,1549],[1377,1601],[305,1601]],"region":{"top_left_x":305,"top_left_y":1549,"width":1073,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54fe102230504e27be2f517c966f92c2","type":"text","conversion_output":true,"text":"the primary endpoint will be used but with a different endpoint.","text_display":" the primary endpoint will be used but with a different endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[305,1635],[1884,1635],[1884,1691],[305,1691]],"region":{"top_left_x":305,"top_left_y":1634,"width":1580,"height":57},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"171c255fa3ad484fa9614a4393b3751e","type":"text","conversion_output":true,"text":"The fourth secondary endpoint, reduction in high-morbidity HAE attacks, will be tested using","text_display":"\n\nThe fourth secondary endpoint, reduction in high-morbidity HAE attacks, will be tested using","confidence":1,"confidence_rate":1},{"cnt":[[305,1684],[1833,1684],[1833,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1684,"width":1528,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20ba16e316d5467f8c36e3bf8c84c40c","type":"text","conversion_output":true,"text":"the MMRM model as described for the primary endpoint. The same SAS code used for the","text_display":" the MMRM model as described for the primary endpoint. The same SAS code used for the","confidence":1,"confidence_rate":1},{"cnt":[[305,1732],[1317,1732],[1317,1785],[305,1785]],"region":{"top_left_x":305,"top_left_y":1731,"width":1012,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"280179626b1646ff84182ad145b93d2e","type":"text","conversion_output":true,"text":"primary endpoint will be used but with a different endpoint.","text_display":" primary endpoint will be used but with a different endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[301,1815],[784,1815],[784,1886],[301,1886]],"region":{"top_left_x":300,"top_left_y":1815,"width":485,"height":72},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"402ba3483bfc473a9f81cea39a817eac","type":"section_header","conversion_output":false,"children_ids":["6ea7d0a40b21499bb5a48772927a6e49"],"text":"","text_display":""},{"cnt":[[305,1822],[778,1822],[778,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1821,"width":473,"height":59},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ea7d0a40b21499bb5a48772927a6e49","type":"text","conversion_output":true,"parent_id":"402ba3483bfc473a9f81cea39a817eac","text":"9.7 Safety Analysis","text_display":"\n\n\\subsection*{9.7 Safety Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[305,1916],[1841,1916],[1841,1970],[305,1970]],"region":{"top_left_x":305,"top_left_y":1916,"width":1537,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4338a61a9db24eb9ae74bef27dbaae34","type":"text","conversion_output":true,"text":"Treatment-emergent AEs are defined as AEs with onset at the time of or following the start","text_display":"\n\nTreatment-emergent AEs are defined as AEs with onset at the time of or following the start","confidence":1,"confidence_rate":1},{"cnt":[[305,1968],[1745,1968],[1745,2017],[305,2017]],"region":{"top_left_x":305,"top_left_y":1967,"width":1440,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18795ea8f63045a6bfdfcf0185c76012","type":"text","conversion_output":true,"text":"of treatment with study medication, or medical conditions present prior to the start of","text_display":" of treatment with study medication, or medical conditions present prior to the start of","confidence":1,"confidence_rate":1},{"cnt":[[305,2013],[1803,2013],[1803,2065],[305,2065]],"region":{"top_left_x":305,"top_left_y":2013,"width":1498,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ea4ac910a9d43e18959926626b73faa","type":"text","conversion_output":true,"text":"treatment but increasing in severity or relationship at the time of or following the start of","text_display":" treatment but increasing in severity or relationship at the time of or following the start of","confidence":1,"confidence_rate":1},{"cnt":[[305,2058],[1811,2058],[1811,2112],[305,2112]],"region":{"top_left_x":305,"top_left_y":2058,"width":1507,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08c4b443da55432982425cf4b3f4265b","type":"text","conversion_output":true,"text":"treatment. The number and percentage of subjects with TEAEs will be displayed for each","text_display":" treatment. The number and percentage of subjects with TEAEs will be displayed for each","confidence":1,"confidence_rate":1},{"cnt":[[305,2110],[1734,2110],[1734,2159],[305,2159]],"region":{"top_left_x":305,"top_left_y":2109,"width":1429,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30b7b8ad1a074203a9816917b89ccc1d","type":"text","conversion_output":true,"text":"treatment group by body system and preferred term using the Medical Dictionary for","text_display":" treatment group by body system and preferred term using the Medical Dictionary for","confidence":1,"confidence_rate":1},{"cnt":[[305,2153],[1865,2153],[1865,2209],[305,2209]],"region":{"top_left_x":305,"top_left_y":2152,"width":1560,"height":57},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aa32f99e75f4d339e4114aceb29f9d5","type":"text","conversion_output":true,"text":"Regulatory Activities (MedDRA \\({ }^{\\text {® }}\\) ). Summaries in terms of severity and relationship to study","text_display":" Regulatory Activities (MedDRA \\({ }^{\\text {® }}\\) ). Summaries in terms of severity and relationship to study","confidence":0.998046875,"confidence_rate":0.999982387228658},{"cnt":[[305,2204],[1811,2204],[1811,2254],[305,2254]],"region":{"top_left_x":305,"top_left_y":2204,"width":1507,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e7a1f363a714733a567111b1d50fb0b","type":"text","conversion_output":true,"text":"medication will also be provided. Serious AEs will be summarized separately in a similar","text_display":" medication will also be provided. Serious AEs will be summarized separately in a similar","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[305,2252],[1850,2252],[1850,2305],[305,2305]],"region":{"top_left_x":305,"top_left_y":2251,"width":1545,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecde473ecebd4ca49906b2127d4a09c2","type":"text","conversion_output":true,"text":"fashion. Patient listings of AEs causing discontinuation of study medication, AEs leading to","text_display":" fashion. Patient listings of AEs causing discontinuation of study medication, AEs leading to","confidence":0.85595703125,"confidence_rate":0.9983978301946478},{"cnt":[[305,2299],[999,2299],[999,2353],[305,2353]],"region":{"top_left_x":305,"top_left_y":2298,"width":695,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f52508ff7cc491eb326a00fffb202c7","type":"text","conversion_output":true,"text":"death, SAEs and AESI will be produced.","text_display":" death, SAEs and AESI will be produced.","confidence":1,"confidence_rate":1},{"cnt":[[305,2389],[1807,2389],[1807,2443],[305,2443]],"region":{"top_left_x":305,"top_left_y":2389,"width":1502,"height":54},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75e072685cc0474ab7842a0504b1ff68","type":"text","conversion_output":true,"text":"AESI will be analyzed according to primary system Organ Classes (SOCs) and Preferred","text_display":"\n\nAESI will be analyzed according to primary system Organ Classes (SOCs) and Preferred","confidence":1,"confidence_rate":1},{"cnt":[[305,2436],[1841,2436],[1841,2490],[305,2490]],"region":{"top_left_x":305,"top_left_y":2436,"width":1537,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"beb779244f8c48459588a92542ecea06","type":"text","conversion_output":true,"text":"Terms (PTs) determined by the search of relevant Standardized MedDRA Queries (SMQs).","text_display":" Terms (PTs) determined by the search of relevant Standardized MedDRA Queries 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DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4448400c71de4832a83904fa074777d1","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,284],[1652,284],[1652,337],[305,337]],"region":{"top_left_x":305,"top_left_y":283,"width":1348,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db1a685cbd344c22a4a2df55678ab7ff","type":"text","conversion_output":true,"text":"Summary tables with SOCs and PTs, from the SMQ searches, will be generated","text_display":"\n\nSummary tables with SOCs and PTs, from the SMQ searches, will be generated","confidence":1,"confidence_rate":1},{"cnt":[[305,333],[1708,333],[1708,385],[305,385]],"region":{"top_left_x":305,"top_left_y":333,"width":1404,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44cf2ed2efe848cea98c76ddf19ec8aa","type":"text","conversion_output":true,"text":"presenting the number and percentage of subjects by AE, severity, seriousness, and","text_display":" presenting the number and percentage of subjects by AE, severity, seriousness, and","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[862,382],[862,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":557,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7febefed4474d7f8ec879fbc37ce231","type":"text","conversion_output":true,"text":"relationship to study medication.","text_display":" relationship to study medication.","confidence":1,"confidence_rate":1},{"cnt":[[305,468],[1755,468],[1755,522],[305,522]],"region":{"top_left_x":305,"top_left_y":468,"width":1451,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de5dc470d4384a98bc2876fbf9d646d1","type":"text","conversion_output":true,"text":"Usage of concomitant medications (other than rescue mediations) will be summarized","text_display":"\n\nUsage of concomitant medications (other than rescue mediations) will be summarized","confidence":1,"confidence_rate":1},{"cnt":[[305,518],[1777,518],[1777,574],[305,574]],"region":{"top_left_x":305,"top_left_y":517,"width":1472,"height":57},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f171293f0931484b8124ae9fdc7268a0","type":"text","conversion_output":true,"text":"descriptively for each of the treatment groups and the combined active treatment group.","text_display":" descriptively for each of the treatment groups and the combined active treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[305,606],[1826,606],[1826,660],[305,660]],"region":{"top_left_x":305,"top_left_y":605,"width":1522,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08d697a9a9e84759ba8912c9e313a802","type":"text","conversion_output":true,"text":"Actual values and change from screening in vital signs and clinical laboratory tests will be","text_display":"\n\nActual values and change from screening in vital signs and clinical laboratory tests will be","confidence":1,"confidence_rate":1},{"cnt":[[305,657],[1861,657],[1861,707],[305,707]],"region":{"top_left_x":305,"top_left_y":657,"width":1556,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abb85608118f4afcaed6e9f37c627217","type":"text","conversion_output":true,"text":"summarized for each treatment group with descriptive statistics at each assessment obtained.","text_display":" summarized for each treatment group with descriptive statistics at each assessment obtained.","confidence":1,"confidence_rate":1},{"cnt":[[305,705],[1837,705],[1837,754],[305,754]],"region":{"top_left_x":305,"top_left_y":704,"width":1532,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcac0984f7324ff088cf36a2e187a084","type":"text","conversion_output":true,"text":"For all laboratory tests, a shift table will be produced summarizing changes from normal to","text_display":" For all laboratory tests, a shift table will be produced summarizing changes from normal to","confidence":1,"confidence_rate":1},{"cnt":[[305,752],[737,752],[737,801],[305,801]],"region":{"top_left_x":305,"top_left_y":751,"width":432,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4ef2886befa46258885e7bb53357654","type":"text","conversion_output":true,"text":"abnormal and vice-versa.","text_display":" abnormal and vice-versa.","confidence":1,"confidence_rate":1},{"cnt":[[305,838],[1235,838],[1235,896],[305,896]],"region":{"top_left_x":305,"top_left_y":837,"width":931,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a038a8a5901b4ae486a38d72930d297b","type":"text","conversion_output":true,"text":"Abnormal physical examination findings will be listed.","text_display":"\n\nAbnormal physical examination findings will be listed.","confidence":0.994145393371582,"confidence_rate":0.9999004827144693},{"cnt":[[305,930],[1865,930],[1865,982],[305,982]],"region":{"top_left_x":305,"top_left_y":930,"width":1560,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7c57b90cebc4a3caf80312461f07630","type":"text","conversion_output":true,"text":"The number and percentage of subjects with normal, abnormal-not clinically significant, and","text_display":"\nThe number and percentage of subjects with normal, abnormal-not clinically significant, and","confidence":1,"confidence_rate":1},{"cnt":[[305,980],[1790,980],[1790,1029],[305,1029]],"region":{"top_left_x":305,"top_left_y":979,"width":1485,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05797ec86f104c92b5e704659563104a","type":"text","conversion_output":true,"text":"abnormal-clinically significant ECG findings will be displayed for each of the treatment","text_display":" abnormal-clinically significant ECG findings will be displayed for each of the treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,1031],[440,1031],[440,1079],[305,1079]],"region":{"top_left_x":305,"top_left_y":1031,"width":136,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d3b9610c06649009eea31ca96d61cf6","type":"text","conversion_output":true,"text":"groups.","text_display":" groups.","confidence":1,"confidence_rate":1},{"cnt":[[305,1113],[1841,1113],[1841,1167],[305,1167]],"region":{"top_left_x":305,"top_left_y":1112,"width":1537,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a745beb283d9400f9a730bd949591659","type":"text","conversion_output":true,"text":"Additional analyses of AEs, SAEs, severe AEs, AESI, and abnormal findings will be based","text_display":"\n\nAdditional analyses of AEs, SAEs, severe AEs, AESI, and abnormal findings will be based","confidence":1,"confidence_rate":1},{"cnt":[[305,1164],[1852,1164],[1852,1216],[305,1216]],"region":{"top_left_x":305,"top_left_y":1164,"width":1547,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dca860670fc64246aad95f1f812de009","type":"text","conversion_output":true,"text":"on the timing (Study Day) and number of prior doses of study medication. The incidence of","text_display":" on the timing (Study Day) and number of prior doses of study medication. The incidence of","confidence":1,"confidence_rate":1},{"cnt":[[305,1212],[1858,1212],[1858,1263],[305,1263]],"region":{"top_left_x":305,"top_left_y":1211,"width":1554,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"475a6cb07a3e4c76816fecf5acaac2b4","type":"text","conversion_output":true,"text":"AEs by month from the start of study medication will be examined and the incidence among","text_display":" AEs by month from the start of study medication will be examined and the incidence among","confidence":1,"confidence_rate":1},{"cnt":[[305,1259],[1858,1259],[1858,1313],[305,1313]],"region":{"top_left_x":305,"top_left_y":1258,"width":1554,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd94507f01734d1c95692fbe5ee1b2bd","type":"text","conversion_output":true,"text":"the four treatment arms will be compared. The rate of study discontinuation among the four","text_display":" the four treatment arms will be compared. The rate of study discontinuation among the four","confidence":0.60791015625,"confidence_rate":0.9947744569296334},{"cnt":[[305,1311],[952,1311],[952,1360],[305,1360]],"region":{"top_left_x":305,"top_left_y":1310,"width":647,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e27c58a026b4448ba3190f39b0a8578","type":"text","conversion_output":true,"text":"treatment arms will also be compared.","text_display":" treatment arms will also be compared.","confidence":1,"confidence_rate":1},{"cnt":[[296,1388],[1308,1388],[1308,1463],[296,1463]],"region":{"top_left_x":296,"top_left_y":1387,"width":1013,"height":77},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f501098a88c745299921e7286672f27e","type":"section_header","conversion_output":false,"children_ids":["fd4c55a33af148b08ab318bc73748b8e"],"text":"","text_display":""},{"cnt":[[305,1396],[1300,1396],[1300,1454],[305,1454]],"region":{"top_left_x":305,"top_left_y":1396,"width":995,"height":59},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd4c55a33af148b08ab318bc73748b8e","type":"text","conversion_output":true,"parent_id":"f501098a88c745299921e7286672f27e","text":"9.8 Analysis of Quality of Life Assessments","text_display":"\n\n\\subsection*{9.8 Analysis of Quality of Life Assessments}","confidence":0.99951171875,"confidence_rate":0.999989825041388},{"cnt":[[305,1491],[1747,1491],[1747,1543],[305,1543]],"region":{"top_left_x":305,"top_left_y":1491,"width":1442,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40e08002b9f544ac8d9c0cab888069e2","type":"text","conversion_output":true,"text":"Quality of life data will be obtained using the EQ5D and Angioedema Quality of Life","text_display":"\n\nQuality of life data will be obtained using the EQ5D and Angioedema Quality of Life","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[305,1540],[1835,1540],[1835,1592],[305,1592]],"region":{"top_left_x":305,"top_left_y":1540,"width":1530,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82bb93ca94074cdfb74f9506c3379f83","type":"text","conversion_output":true,"text":"Questionnaire at pre-dose on Days 0, \\(98 \\pm 3\\), and \\(182 \\pm 3\\). An additional QOL assessment","text_display":" Questionnaire at pre-dose on Days 0, \\(98 \\pm 3\\), and \\(182 \\pm 3\\). An additional QOL assessment","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[305,1590],[1379,1590],[1379,1639],[305,1639]],"region":{"top_left_x":305,"top_left_y":1589,"width":1075,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ac7881e14684d448d38b815fb6d9f55","type":"text","conversion_output":true,"text":"will be conducted on Day \\(238 \\pm 3\\) for subjects not entering OLE.","text_display":" will be conducted on Day \\(238 \\pm 3\\) for subjects not entering OLE.","confidence":1,"confidence_rate":1},{"cnt":[[305,2585],[492,2585],[492,2628],[305,2628]],"region":{"top_left_x":305,"top_left_y":2584,"width":187,"height":44},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e26a4d0279b43ea97717dd7530f3c76","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[984,2587],[1205,2587],[1205,2632],[984,2632]],"region":{"top_left_x":983,"top_left_y":2586,"width":223,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0ea2aad587548d4bb82b3a35a971820","type":"page_info","conversion_output":false,"text":"Page 77 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,2587],[1880,2587],[1880,2632],[1706,2632]],"region":{"top_left_x":1705,"top_left_y":2586,"width":175,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5918a375e7f4ecaabc60020b635871a","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-78","page":78,"lines":[{"cnt":[[305,127],[449,127],[449,161],[305,161]],"region":{"top_left_x":305,"top_left_y":126,"width":145,"height":36},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"861d1100c8a64adabc793a56051c7cfd","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,168],[827,168],[827,204],[305,204]],"region":{"top_left_x":305,"top_left_y":167,"width":523,"height":38},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eddafdce6bd04242996e6a0d9837440f","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1508,163],[1880,163],[1880,208],[1508,208]],"region":{"top_left_x":1508,"top_left_y":163,"width":372,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51b4908318984ae0956a12f7fa3ec789","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,284],[1308,284],[1308,342],[305,342]],"region":{"top_left_x":305,"top_left_y":283,"width":1004,"height":59},"line":4,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"2c22cb5b6ae64fb495521518884b1d3d","type":"section_header","conversion_output":false,"children_ids":["46d6f46a55af4c319b563a185cf4a52e"],"text":"","text_display":""},{"cnt":[[309,288],[1304,288],[1304,337],[309,337]],"region":{"top_left_x":309,"top_left_y":287,"width":996,"height":51},"line":5,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"46d6f46a55af4c319b563a185cf4a52e","type":"text","conversion_output":true,"parent_id":"2c22cb5b6ae64fb495521518884b1d3d","text":"10 STUDY ADMINISTRATIVE STRUCTURE","text_display":"\n\n\\section*{10 STUDY ADMINISTRATIVE STRUCTURE}","confidence":0.9965834617614746,"confidence_rate":0.9999075073065535},{"cnt":[[305,382],[1274,382],[1274,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":970,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"308c9c0854484c06aaa962b14599063e","type":"text","conversion_output":true,"text":"The study administration structure is provided in Table 2.","text_display":"\n\nThe study administration structure is provided in Table 2.","confidence":1,"confidence_rate":1},{"cnt":[[305,473],[1182,473],[1182,524],[305,524]],"region":{"top_left_x":305,"top_left_y":472,"width":877,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc90d27677874623827603d51fd5d027","type":"figure_label","conversion_output":false,"text":"Table 2. Study Administrative Structure","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999889000502842},{"cnt":[[286,535],[1901,535],[1901,2436],[286,2436]],"region":{"top_left_x":285,"top_left_y":534,"width":1617,"height":1903},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c786419fc7949988a53607acb4fad4e","type":"table","conversion_output":true,"children_ids":["654596c949dc45c2a8eba7bf1df4d338","540bba4bd4f14282b92e733df881c10b","bff7d741aee14e9ea2e9db313c2862fc","418343bedceb4a63b212b6f2bacf41dd","da4dcaf811d242439e614c56c616bea8","1e800be8951f47d8a9c9c37998321997","c24599ba8ad14862bb87e26aa376da54","20124b1f2c624ba1803b17e9fbbc33ce","813133d7aa8b4bb3995a3bfa8bf0d3c4","194c5caf7fe64b21b96fea7dd9c2c089","d7345efec13248f0a3f18ee96215c003","e025134053c8453eb8d55971df697841","df67ecd0948f4dd883c0d5efb41ae4c1","31d218dc78684469b7414c8836348ee7","6c02118574ea450fac57b16dc78170e4","413117eb1d9d44eeb045a3b84f6391ac","d4830b98841b497c8274e74d694bef40","9890420267d4454883e8360e3443f1a2","82c7bfb6103b48598753eb1a6d02231b","ad8fb5d06b9e4f038c4fd8b08ae2ab36","358c3ba65bd9431aad715fcedc6d0a3f","eb0e0e3de85d4c7999c0e3aa6c7aad40","c35ecc3f352740fdae722e42c81cd98a","bd9d8fbab3da4a0b93ad0fd22f4a31a3","4cfb79cd49d24d928e2474190cd99384","29ca5cec75a74d3d9074020137ac8528"],"selected_labels":["cc90d27677874623827603d51fd5d027"],"text":"\\begin{tabular}{|l|l|}\n\\hline Sponsor Contact: & \\begin{tabular}{l}\nRyan Iarrobino \\\\\nPPD , Clinical Development \\\\\n55 Network Drive, Burlington, MA 01803 \\\\\nPhone: PPD \\\\\nEmail: PPD\n\\end{tabular} \\\\\n\\hline Sponsor Medical Director: & \\begin{tabular}{ll} \nPPD & , MD \\\\\nPPD & , Medical Research \\\\\n55 Network Drive, Burlington, MA 01803 \\\\\nPhone: PPD \\\\\nEmail: PPD\n\\end{tabular} \\\\\n\\hline Medical Monitor (US, Canada): & \\begin{tabular}{l}\nPPD, MD \\\\\nRho, Inc. \\\\\nPPD ,PPD ,PPD \\\\\nPhone: PPD \\\\\nEmail: PPD\n\\end{tabular} \\\\\n\\hline Medical Monitor (Jordan, Europe) & \\begin{tabular}{l}\nPPD ,M.D. \\\\\nVoisin Consulting![](https://cdn.mathpix.com/cropped/4ca27806-c43b-45a0-93e6-3c3e76c29356-78.jpg?height=92\\&width=389\\&top_left_y=1393\\&top_left_x=1107)\nPhone: PPD\nEmail: PPD\n\\end{tabular} \\\\\n\\hline Study Monitoring (US): & \\begin{tabular}{l}\nRho, Inc.\nPPD ,PPD ,PPD \\\\\nPhone: PPD\n\\end{tabular} \\\\\n\\hline Study Monitoring (Jordan) & Triumpharma\n\\begin{tabular}{l} \nPPD \\\\\nPPD\n\\end{tabular}\\(\\quad\\), PPD\nPPD\nPhone: PPD , PRD \\\\\n\\hline Study Monitoring (Canada) & \\begin{tabular}{l}\nRed Maple Trials Incorporated![](https://cdn.mathpix.com/cropped/4ca27806-c43b-45a0-93e6-3c3e76c29356-78.jpg?height=107\\&width=503\\&top_left_y=2119\\&top_left_x=1103) \\\\\nPhone: PPD\n\\end{tabular} \\\\\n\\hline Study Monitoring (Europe) & \\begin{tabular}{l}\nDyax Corp \\\\\n55 Network Drive, Burlington, MA 01803 \\\\\nPhone: PPD\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 2. Study Administrative Structure}\n\\begin{tabular}{|l|l|}\n\\hline Sponsor Contact: & \\begin{tabular}{l}\nRyan Iarrobino \\\\\nPPD , Clinical Development \\\\\n55 Network Drive, Burlington, MA 01803 \\\\\nPhone: PPD \\\\\nEmail: PPD\n\\end{tabular} \\\\\n\\hline Sponsor Medical Director: & \\begin{tabular}{ll} \nPPD & , MD \\\\\nPPD & , Medical Research \\\\\n55 Network Drive, Burlington, MA 01803 \\\\\nPhone: PPD \\\\\nEmail: PPD\n\\end{tabular} \\\\\n\\hline Medical Monitor (US, Canada): & \\begin{tabular}{l}\nPPD, MD \\\\\nRho, Inc. \\\\\nPPD ,PPD ,PPD \\\\\nPhone: PPD \\\\\nEmail: PPD\n\\end{tabular} \\\\\n\\hline Medical Monitor (Jordan, Europe) & \\begin{tabular}{l}\nPPD ,M.D. \\\\\nVoisin Consulting![](https://cdn.mathpix.com/cropped/4ca27806-c43b-45a0-93e6-3c3e76c29356-78.jpg?height=92\\&width=389\\&top_left_y=1393\\&top_left_x=1107)\nPhone: PPD\nEmail: PPD\n\\end{tabular} \\\\\n\\hline Study Monitoring (US): & \\begin{tabular}{l}\nRho, Inc.\nPPD ,PPD ,PPD \\\\\nPhone: PPD\n\\end{tabular} \\\\\n\\hline Study Monitoring (Jordan) & Triumpharma\n\\begin{tabular}{l} \nPPD \\\\\nPPD\n\\end{tabular}\\(\\quad\\), PPD\nPPD\nPhone: PPD , PRD \\\\\n\\hline Study Monitoring (Canada) & \\begin{tabular}{l}\nRed Maple Trials Incorporated![](https://cdn.mathpix.com/cropped/4ca27806-c43b-45a0-93e6-3c3e76c29356-78.jpg?height=107\\&width=503\\&top_left_y=2119\\&top_left_x=1103) \\\\\nPhone: PPD\n\\end{tabular} \\\\\n\\hline Study Monitoring (Europe) & \\begin{tabular}{l}\nDyax Corp \\\\\n55 Network Drive, Burlington, MA 01803 \\\\\nPhone: PPD\n\\end{tabular} 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Only subjects with a baseline rate of at least 1 Investigator-confirmed HAE attack per 4","text_display":"\n\\({ }^{1 .}\\) Subjects will undergo a run-in period to determine their baseline HAE attack rate. Only subjects with a baseline rate of at least 1 Investigator-confirmed HAE attack per 4","confidence":0.9970703125,"confidence_rate":0.9999843103507052},{"cnt":[[339,1259],[2484,1259],[2484,1296],[339,1296]],"region":{"top_left_x":339,"top_left_y":1258,"width":2145,"height":38},"line":194,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b7f70ed399814f6bbfd2f41d574c7ef6","type":"text","conversion_output":true,"text":"weeks will be eligible for enrollment and randomization. Subjects who experience 3 or more Investigator-confirmed attacks before the end of the 4 weeks can exit the run-","text_display":" weeks will be eligible for enrollment and randomization. Subjects who experience 3 or more Investigator-confirmed attacks before the end of the 4 weeks can exit the run","confidence":0.99951171875,"confidence_rate":0.9999972866675805},{"cnt":[[339,1293],[2484,1293],[2484,1334],[339,1334]],"region":{"top_left_x":339,"top_left_y":1293,"width":2145,"height":42},"line":195,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"488275fe4f7c4486aa1a5a736e4b9450","type":"text","conversion_output":true,"text":"in period early and proceed to enrollment and randomization. Subjects without at least 1 Investigator-confirmed attack after 4 weeks of run-in will have their run-in period","text_display":"in period early and proceed to enrollment and randomization. Subjects without at least 1 Investigator-confirmed attack after 4 weeks of run-in will have their run-in period","confidence":0.99951171875,"confidence_rate":0.9999973311483804},{"cnt":[[339,1332],[2503,1332],[2503,1369],[339,1369]],"region":{"top_left_x":339,"top_left_y":1332,"width":2164,"height":37},"line":196,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20d04e671d7d46119f89e2f552347d50","type":"text","conversion_output":true,"text":"extended for another 4 weeks, during which time they need to have at least 2 Investigator-confirmed attacks to proceed to enrollment and randomization. Subjects who have","text_display":" extended for another 4 weeks, during which time they need to have at least 2 Investigator-confirmed attacks to proceed to enrollment and randomization. Subjects who have","confidence":1,"confidence_rate":1},{"cnt":[[339,1366],[2391,1366],[2391,1405],[339,1405]],"region":{"top_left_x":339,"top_left_y":1366,"width":2053,"height":40},"line":197,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d94255f5561b4e93b05128b34a635a52","type":"text","conversion_output":true,"text":"their run-in extended may not exit run-in early. Subjects who do not meet the minimum attack rate during run-in or are otherwise determined to be ineligible due to","text_display":" their run-in extended may not exit run-in early. Subjects who do not meet the minimum attack rate during run-in or are otherwise determined to be ineligible due to","confidence":0.99951171875,"confidence_rate":0.9999970928584037},{"cnt":[[339,1401],[1029,1401],[1029,1439],[339,1439]],"region":{"top_left_x":339,"top_left_y":1400,"width":691,"height":40},"line":198,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37cdaffcae994ffc80b682f21d36c1ff","type":"text","conversion_output":true,"text":"screening assessments will be considered a screen fail.","text_display":" screening assessments will be considered a screen fail.","confidence":0.9990234375,"confidence_rate":0.999983716138453},{"cnt":[[275,1435],[2460,1435],[2460,1480],[275,1480]],"region":{"top_left_x":275,"top_left_y":1435,"width":2185,"height":46},"line":199,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6f6979b2e0e4e45a8d5c7cd79ec1979","type":"text","conversion_output":true,"text":"2. Treatment Period visits have a \\(\\pm 3\\) day window, with a maximum of 17 days or a minimum of 11 days between any two doses, starting with Dose 2, Day 14 through Day","text_display":"\n2. Treatment Period visits have a \\(\\pm 3\\) day window, with a maximum of 17 days or a minimum of 11 days between any two doses, starting with Dose 2, Day 14 through Day","confidence":0.5036602020263672,"confidence_rate":0.9961757476825115},{"cnt":[[339,1478],[404,1478],[404,1517],[339,1517]],"region":{"top_left_x":339,"top_left_y":1478,"width":65,"height":39},"line":200,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13b6e2830128466196b0a766edc559da","type":"text","conversion_output":true,"text":"182.","text_display":" 182.","confidence":1,"confidence_rate":1},{"cnt":[[277,1512],[1588,1512],[1588,1555],[277,1555]],"region":{"top_left_x":277,"top_left_y":1512,"width":1311,"height":44},"line":201,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f34d092cab514a049fbd5aff9b8da1e8","type":"text","conversion_output":true,"text":"3. For subjects who do not rollover into OLE (DX-2930-04). Follow-up visits have a \\(\\pm 3\\) day window","text_display":"\n3. For subjects who do not rollover into OLE (DX-2930-04). Follow-up visits have a \\(\\pm 3\\) day window","confidence":1,"confidence_rate":1},{"cnt":[[275,1549],[2481,1549],[2481,1596],[275,1596]],"region":{"top_left_x":275,"top_left_y":1549,"width":2207,"height":48},"line":202,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bec582d2dd2943c4be625e027f255581","type":"text","conversion_output":true,"text":"4. Site personnel contact the subject to solicit for any attacks not already reported by the subject once between scheduled site visits or approximately 7 days after last contact","text_display":"\n4. Site personnel contact the subject to solicit for any attacks not already reported by the subject once between scheduled site visits or approximately 7 days after last contact","confidence":1,"confidence_rate":1},{"cnt":[[339,1594],[505,1594],[505,1631],[339,1631]],"region":{"top_left_x":339,"top_left_y":1594,"width":166,"height":37},"line":203,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4eac28a7cf5d4388ab5ee7be19ebf2a8","type":"text","conversion_output":true,"text":"with subject.","text_display":" with subject.","confidence":1,"confidence_rate":1},{"cnt":[[277,1624],[2486,1624],[2486,1669],[277,1669]],"region":{"top_left_x":277,"top_left_y":1624,"width":2209,"height":46},"line":204,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"62fbb0d947bc4f4b941a23521be4081c","type":"text","conversion_output":true,"text":"\\({ }^{5}\\). Subjects who are on long-term prophylactic (LTP) therapy for HAE are required to undergo a minimum 2 week washout period prior to the start of the run-in period. This","text_display":"\n\\({ }^{5}\\). Subjects who are on long-term prophylactic (LTP) therapy for HAE are required to undergo a minimum 2 week washout period prior to the start of the run-in period. This","confidence":0.5279175147592241,"confidence_rate":0.9965341979054707},{"cnt":[[339,1667],[2496,1667],[2496,1708],[339,1708]],"region":{"top_left_x":339,"top_left_y":1667,"width":2158,"height":42},"line":205,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"712b54b1c6484dbca1e07de681c8e7da","type":"text","conversion_output":true,"text":"LTP washout is permitted as long as the investigator determines that doing so would not place the subject at any undue safety risk and the subject is at least 18 years of age.","text_display":" LTP washout is permitted as long as the investigator determines that doing so would not place the subject at any undue safety risk and the subject is at least 18 years of age.","confidence":1,"confidence_rate":1},{"cnt":[[339,1702],[2112,1702],[2112,1742],[339,1742]],"region":{"top_left_x":339,"top_left_y":1701,"width":1773,"height":42},"line":206,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d2be55fe9ea4fc88dfd22ff9be5ee89","type":"text","conversion_output":true,"text":"The Investigator must confirm that the subject has successfully completed the 2 week washout period before they can enter the run-in period.","text_display":" The Investigator must confirm that the subject has successfully completed the 2 week washout period before they can enter the run-in period.","confidence":1,"confidence_rate":1},{"cnt":[[277,1736],[2275,1736],[2275,1781],[277,1781]],"region":{"top_left_x":277,"top_left_y":1735,"width":1999,"height":47},"line":207,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"585fc83fc83144cc9d938b15665a11c7","type":"text","conversion_output":true,"text":"6. Samples for C1-INH, C4, and C1q assays will be obtained at screening for eligibility assessment unless already collected as part of protocol DX-2930-02.","text_display":"\n6. Samples for C1-INH, C4, and C1q assays will be obtained at screening for eligibility assessment unless already collected as part of protocol DX-2930-02.","confidence":1,"confidence_rate":1},{"cnt":[[277,1775],[2503,1775],[2503,1822],[277,1822]],"region":{"top_left_x":277,"top_left_y":1774,"width":2226,"height":48},"line":208,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab00a06c57954c98a24343c96f52f3e6","type":"text","conversion_output":true,"text":"7. The pregnancy test will only be conducted in females of childbearing potential. Tests performed on Day 0 and Day 182 must be urine-based. Tests performed at screening,","text_display":"\n7. The pregnancy test will only be conducted in females of childbearing potential. Tests performed on Day 0 and Day 182 must be urine-based. Tests performed at screening,","confidence":1,"confidence_rate":1},{"cnt":[[339,1818],[982,1818],[982,1858],[339,1858]],"region":{"top_left_x":339,"top_left_y":1817,"width":643,"height":42},"line":209,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dea55565fa0647a685a9180be84e7916","type":"text","conversion_output":true,"text":"Day 98, and Day 238 can be serum or urine-based.","text_display":" Day 98, and Day 238 can be serum or urine-based.","confidence":1,"confidence_rate":1},{"cnt":[[245,1959],[428,1959],[428,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1959,"width":184,"height":37},"line":210,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42ae1a1587aa45479ffb1ed075dc7b28","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1268,1962],[1485,1962],[1485,2004],[1268,2004]],"region":{"top_left_x":1267,"top_left_y":1961,"width":218,"height":44},"line":211,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cf506af1f5a411da4d73bafa9a44c97","type":"page_info","conversion_output":false,"text":"Page 87 of 124","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2333,1964],[2503,1964],[2503,2004],[2333,2004]],"region":{"top_left_x":2333,"top_left_y":1963,"width":170,"height":42},"line":212,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1d5c24bfa444e2e8e3e1c3c1c93cd3b","type":"page_info","conversion_output":false,"text":"Dyax Corp.","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"4ca27806-c43b-45a0-93e6-3c3e76c29356-88","page":88,"lines":[{"cnt":[[245,125],[385,125],[385,161],[245,161]],"region":{"top_left_x":244,"top_left_y":124,"width":141,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7ba2e6431ea4779b420abcb30732bf7","type":"page_info","conversion_output":false,"text":"DX-2930","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,163],[758,163],[758,204],[245,204]],"region":{"top_left_x":244,"top_left_y":163,"width":515,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c085a8d5315b49ebafb9622b6020e4a0","type":"page_info","conversion_output":false,"text":"Clinical Trial Protocol: DX-2930-03","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2136,163],[2503,163],[2503,208],[2136,208]],"region":{"top_left_x":2135,"top_left_y":163,"width":368,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c61367a052734f6188c91aa2c52c1342","type":"page_info","conversion_output":false,"text":"Final: 14 September 2015","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[275,305],[2469,305],[2469,354],[275,354]],"region":{"top_left_x":275,"top_left_y":305,"width":2194,"height":50},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b1006dca04748e6aa760632410f2895","type":"text","conversion_output":true,"text":"8. There is a \\(\\pm 15\\) minute window for all vital signs. At study visits in which IMP is administered, vital signs including sitting or supine BP, HR, body temperature, and RR,","text_display":"\n8. There is a \\(\\pm 15\\) minute window for all vital signs. At study visits in which IMP is administered, vital signs including sitting or supine BP, HR, body temperature, and RR,","confidence":0.9951229095458984,"confidence_rate":0.9999728391340263},{"cnt":[[339,352],[2428,352],[2428,389],[339,389]],"region":{"top_left_x":339,"top_left_y":352,"width":2089,"height":37},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3bf418cae97474e8a13a5bec5dbd228","type":"text","conversion_output":true,"text":"will be obtained prior to dosing, 1 hour after dosing, and 2 hours after dosing for the first 4 doses with the ability to eliminate the 2 hour vitals for the remaining doses","text_display":" will be obtained prior to dosing, 1 hour after dosing, and 2 hours after dosing for the first 4 doses with the ability to eliminate the 2 hour vitals for the remaining doses","confidence":1,"confidence_rate":1},{"cnt":[[339,387],[1296,387],[1296,423],[339,423]],"region":{"top_left_x":339,"top_left_y":386,"width":957,"height":38},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b1be2038e7e42cb9534da6817637a96","type":"text","conversion_output":true,"text":"based on the discretion of the Investigator and the absence of safety signals.","text_display":" based on the discretion of the Investigator and the absence of safety signals.","confidence":1,"confidence_rate":1},{"cnt":[[275,417],[1137,417],[1137,466],[275,466]],"region":{"top_left_x":275,"top_left_y":416,"width":862,"height":51},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b97aac16a0204dccb8ef770282639e49","type":"text","conversion_output":true,"text":"9. Height and weight will be collected at the Screening visit only.","text_display":"\n9. Height and weight will be collected at the Screening visit only.","confidence":0.998046875,"confidence_rate":0.999972847107038},{"cnt":[[277,458],[2471,458],[2471,505],[277,505]],"region":{"top_left_x":277,"top_left_y":457,"width":2194,"height":48},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2ee5cb5823884e91a0936110b321c917","type":"text","conversion_output":true,"text":"\\({ }^{10}\\). ECGs (single recordings) are collected at screening, baseline prior to Dose 1 , Day 56 , Day \\(144 \\pm 1\\) day to capture the estimated \\(C _{\\text {max }}\\) and Day 182. The ECG assessment at","text_display":"\n\\({ }^{10}\\). ECGs (single recordings) are collected at screening, baseline prior to Dose 1 , Day 56 , Day \\(144 \\pm 1\\) day to capture the estimated \\(C _{\\text {max }}\\) and Day 182. The ECG assessment at","confidence":0.43156384051640667,"confidence_rate":0.996006377571064},{"cnt":[[339,503],[1794,503],[1794,539],[339,539]],"region":{"top_left_x":339,"top_left_y":502,"width":1455,"height":38},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"125d66d70f794e4c9c08188235e29616","type":"text","conversion_output":true,"text":"\\(C _{\\text {max }}\\) on Day \\(144 \\pm 1\\) day may be performed via at-home nurse or technician in lieu of a subject visit to the study site.","text_display":" \\(C _{\\text {max }}\\) on Day \\(144 \\pm 1\\) day may be performed via at-home nurse or technician in lieu of a subject visit to the study site.","confidence":0.9951231479644775,"confidence_rate":0.999964574666017},{"cnt":[[275,533],[1601,533],[1601,580],[275,580]],"region":{"top_left_x":275,"top_left_y":532,"width":1326,"height":49},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d87291f9fde2443eb76639d2d77906ef","type":"text","conversion_output":true,"text":"\\({ }^{11 .}\\) Clinical laboratory testing will include Hematology, Coagulation, Serum Chemistry, and Urinalysis.","text_display":"\n\\({ }^{11 .}\\) Clinical laboratory testing will include Hematology, Coagulation, Serum Chemistry, and Urinalysis.","confidence":0.9804952144622803,"confidence_rate":0.9998257009080534},{"cnt":[[277,571],[2408,571],[2408,621],[277,621]],"region":{"top_left_x":277,"top_left_y":571,"width":2132,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e540f8e3ece54d979a4b08ce4f2c1b0c","type":"text","conversion_output":true,"text":"12. Historical attack information will be collected at screening. During the study subjects (or caregivers, in the event the subject is \\(<18\\) years old or is incapacitated) are","text_display":"\n12. Historical attack information will be collected at screening. During the study subjects (or caregivers, in the event the subject is \\(<18\\) years old or is incapacitated) are","confidence":1,"confidence_rate":1},{"cnt":[[339,614],[2340,614],[2340,655],[339,655]],"region":{"top_left_x":339,"top_left_y":614,"width":2001,"height":42},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f1abd2fac2640f7b745e3bf7df6bd3d","type":"text","conversion_output":true,"text":"instructed to report details of the attack to the study site within 72 hours of the onset of the attack. Site personnel will also contact the subject once a week or at","text_display":" instructed to report details of the attack to the study site within 72 hours of the onset of the attack. Site personnel will also contact the subject once a week or at","confidence":1,"confidence_rate":1},{"cnt":[[339,649],[2460,649],[2460,690],[339,690]],"region":{"top_left_x":339,"top_left_y":648,"width":2121,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"866a35649f714518965fe2c41c06a702","type":"text","conversion_output":true,"text":"approximately 7 days after last contact with the subject during the run-in period and once between study visits or approximately 7 days after last contact with the subject","text_display":" approximately 7 days after last contact with the subject during the run-in period and once between study visits or approximately 7 days after last contact with the subject","confidence":1,"confidence_rate":1},{"cnt":[[339,688],[2434,688],[2434,728],[339,728]],"region":{"top_left_x":339,"top_left_y":687,"width":2096,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0206993e28c54fef844989e67365aebc","type":"text","conversion_output":true,"text":"during the treatment period in order to solicit for any attack that may have occurred. In addition, during study visits, site personnel will solicit for any new HAE attack","text_display":" during the treatment period in order to solicit for any attack that may have occurred. In addition, during study visits, site personnel will solicit for any new HAE attack","confidence":1,"confidence_rate":1},{"cnt":[[339,722],[1268,722],[1268,763],[339,763]],"region":{"top_left_x":339,"top_left_y":721,"width":929,"height":42},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5bb69709eac640bda613f69ad08a6a57","type":"text","conversion_output":true,"text":"information that was not given through prior subject contact with the site.","text_display":" information that was not given through prior subject contact with the site.","confidence":1,"confidence_rate":1},{"cnt":[[275,752],[1747,752],[1747,801],[275,801]],"region":{"top_left_x":275,"top_left_y":751,"width":1472,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d5f8cf7f3454c4e937e456623c7b10e","type":"text","conversion_output":true,"text":"13. Quality of life data will be obtained using the EQ5D and Angioedema Quality of Life Questionnaire (AE-QoL).","text_display":"\n13. Quality of life data will be obtained using the EQ5D and Angioedema Quality of Life Questionnaire (AE-QoL).","confidence":1,"confidence_rate":1},{"cnt":[[277,795],[2387,795],[2387,840],[277,840]],"region":{"top_left_x":277,"top_left_y":794,"width":2110,"height":47},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2637727e942b45f3ab0bec62a25dc4ec","type":"text","conversion_output":true,"text":"14. Subjects who rollover into the Open-Label Extension protocol (DX-2930-04) will provide consent by Day 182 and receive their first open-label dose following the","text_display":"\n14. 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