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Subjects who fail screening will not","text_display":" to screening assessments will be considered screen failures. Subjects who fail screening will not","confidence":1,"confidence_rate":1},{"cnt":[[245,1850],[872,1850],[872,1899],[245,1899]],"region":{"top_left_x":244,"top_left_y":1849,"width":629,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d6df362c1454048ac69eeb5f8f741cb","type":"text","conversion_output":true,"text":"be allowed to rescreen into the study.","text_display":" be allowed to rescreen into the study.","confidence":1,"confidence_rate":1},{"cnt":[[241,1938],[546,1938],[546,1987],[241,1987]],"region":{"top_left_x":240,"top_left_y":1937,"width":306,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0184a277be2484687c834257ec39a96","type":"section_header","conversion_output":false,"children_ids":["c5ca9632527d4b759841006e8ca44b1d"],"text":"","text_display":""},{"cnt":[[245,1940],[544,1940],[544,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1940,"width":300,"height":44},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5ca9632527d4b759841006e8ca44b1d","type":"text","conversion_output":true,"parent_id":"a0184a277be2484687c834257ec39a96","text":"Treatment Period:","text_display":"\n\n\\section*{Treatment Period:}","confidence":1,"confidence_rate":1},{"cnt":[[245,2028],[1876,2028],[1876,2075],[245,2075]],"region":{"top_left_x":244,"top_left_y":2028,"width":1632,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"978f5e594f5f40769b23834e48add79f","type":"text","conversion_output":true,"text":"After verification of eligibility, subjects will be randomized \\(2: 1\\) to receive repeated subcutaneous","text_display":"\n\nAfter verification of eligibility, subjects will be randomized \\(2: 1\\) to receive repeated subcutaneous","confidence":0.657560505438596,"confidence_rate":0.9960897352073442},{"cnt":[[245,2075],[1734,2075],[1734,2125],[245,2125]],"region":{"top_left_x":244,"top_left_y":2075,"width":1490,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4f90dfeb31e41b3b5e7f34358a36b05","type":"text","conversion_output":true,"text":"(SC) administrations of DX-2930 or placebo in a double-blind fashion. Subjects who are","text_display":" (SC) administrations of DX-2930 or placebo in a double-blind fashion. Subjects who are","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[245,2123],[1878,2123],[1878,2172],[245,2172]],"region":{"top_left_x":244,"top_left_y":2122,"width":1634,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7be1b75b0091465eb58fcc7d23f6071b","type":"text","conversion_output":true,"text":"randomized to DX-2930 will be assigned in a 1:1:1 ratio to 1 of 3 dose regimens: 300 mg every 2","text_display":" randomized to DX-2930 will be assigned in a 1:1:1 ratio to 1 of 3 dose regimens: 300 mg every 2","confidence":0.7921943664550781,"confidence_rate":0.997884527090973},{"cnt":[[245,2170],[1766,2170],[1766,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":1523,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5aa9afdc08dc496a972ac6641d670fd2","type":"text","conversion_output":true,"text":"weeks, 300 mg every 4 weeks, or 150 mg every 4 weeks. Randomization into all treatment","text_display":" weeks, 300 mg every 4 weeks, or 150 mg every 4 weeks. Randomization into all treatment","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[245,2217],[1803,2217],[1803,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2217,"width":1559,"height":54},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88d6aa8031314e0b826a3cecf6ddc835","type":"text","conversion_output":true,"text":"groups will be stratified by the baseline attack rate observed during the run-in period into the","text_display":" groups will be stratified by the baseline attack rate observed during the run-in period into the","confidence":1,"confidence_rate":1},{"cnt":[[245,2264],[1880,2264],[1880,2316],[245,2316]],"region":{"top_left_x":244,"top_left_y":2264,"width":1636,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c47548a63cf648ba8e9150ad152a4f0c","type":"text","conversion_output":true,"text":"following groups: 1 to < 2 attacks per 4 weeks, 2 to \\(<3\\) attacks per 4 weeks, and \\(\\geq 3\\) attacks per 4","text_display":" following groups: 1 to < 2 attacks per 4 weeks, 2 to \\(<3\\) attacks per 4 weeks, and \\(\\geq 3\\) attacks per 4","confidence":0.7857292400144615,"confidence_rate":0.9980253699861186},{"cnt":[[245,2316],[367,2316],[367,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2316,"width":124,"height":41},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e926bbe1702c4c16b323fa77e27a7d17","type":"text","conversion_output":true,"text":"weeks.","text_display":" weeks.","confidence":1,"confidence_rate":1},{"cnt":[[245,2402],[1820,2402],[1820,2454],[245,2454]],"region":{"top_left_x":244,"top_left_y":2401,"width":1576,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"315ed6bcb32343f0be610f722343c74d","type":"text","conversion_output":true,"text":"Each subject will undergo a treatment period consisting of 13 doses of blinded Investigational","text_display":"\n\nEach subject will undergo a treatment period consisting of 13 doses of blinded Investigational","confidence":1,"confidence_rate":1},{"cnt":[[245,2449],[1848,2449],[1848,2503],[245,2503]],"region":{"top_left_x":244,"top_left_y":2449,"width":1604,"height":54},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a746c65fa5a4f59ba8b9c985a179939","type":"text","conversion_output":true,"text":"Medicinal Product (IMP), for a period of 26 weeks from the date of first dose on Day 0 through","text_display":" Medicinal Product (IMP), for a period of 26 weeks from the date of first dose on Day 0 through","confidence":1,"confidence_rate":1},{"cnt":[[247,2587],[432,2587],[432,2628],[247,2628]],"region":{"top_left_x":247,"top_left_y":2586,"width":185,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23c697dad15c4c8f8879d7c42f1acaea","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1693,2587],[1880,2587],[1880,2628],[1693,2628]],"region":{"top_left_x":1692,"top_left_y":2586,"width":188,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdef5d3cba9a4037b5440fdd85910a56","type":"page_info","conversion_output":false,"text":"Page 9 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-10","page":10,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f67f81c0cdb84fc6a76c4aa221750fd1","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,168],[1880,168],[1880,208],[1676,208]],"region":{"top_left_x":1675,"top_left_y":167,"width":205,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c9831e4e5e344ef9afaa0aedd120506","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,262],[1813,262],[1813,312],[245,312]],"region":{"top_left_x":244,"top_left_y":262,"width":1570,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c21bcd0c5edc4b209aa264160aceba70","type":"text","conversion_output":true,"text":"two weeks after the final dose. Subjects randomized to one of the 4 treatment arms will either","text_display":"\ntwo weeks after the final dose. 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Subjects (or caregivers) will be instructed to","text_display":" PK and PD) during an 8 week follow-up period. 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assays, anti-drug antibodies and quality of life data as collected","confidence":1,"confidence_rate":1},{"cnt":[[245,2290],[1833,2290],[1833,2340],[245,2340]],"region":{"top_left_x":244,"top_left_y":2290,"width":1589,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15352f73b89a46d29a2bb32b8b94eae8","type":"text","conversion_output":true,"text":"with the EuroQoL Group 5-Dimension (EQ5D) Questionnaire and the Angioedema Quality of","text_display":" with the EuroQoL Group 5-Dimension (EQ5D) Questionnaire and the Angioedema Quality of","confidence":0.9970715045928955,"confidence_rate":0.9999674139549379},{"cnt":[[245,2338],[761,2338],[761,2387],[245,2387]],"region":{"top_left_x":244,"top_left_y":2337,"width":517,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18fa09f02e78469c802fcd80bb24a514","type":"text","conversion_output":true,"text":"Life (AE-QoL) Questionnaire.","text_display":" Life 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EFFICACY AND SAFETY VARIABLES","text_display":"\n\n\\section*{6. EFFICACY AND SAFETY VARIABLES}","confidence":1,"confidence_rate":1},{"cnt":[[243,348],[896,348],[896,406],[243,406]],"region":{"top_left_x":242,"top_left_y":348,"width":654,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f18b61172284459b40e650c28aaad73","type":"section_header","conversion_output":false,"children_ids":["309d355816c440238365917826d7ae2b"],"text":"","text_display":""},{"cnt":[[245,352],[892,352],[892,400],[245,400]],"region":{"top_left_x":244,"top_left_y":352,"width":648,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"309d355816c440238365917826d7ae2b","type":"text","conversion_output":true,"parent_id":"2f18b61172284459b40e650c28aaad73","text":"6.1 Study Activities Schedule","text_display":"\n\n\\subsection*{6.1 Study Activities Schedule}","confidence":0.99951171875,"confidence_rate":0.9999856353826395},{"cnt":[[245,440],[1588,440],[1588,488],[245,488]],"region":{"top_left_x":244,"top_left_y":440,"width":1344,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d04d6537351042b99b540f6a509e854b","type":"text","conversion_output":true,"text":"Please refer to Appendix 10.4 for details of assessments performed at each visit.","text_display":"\n\nPlease refer to Appendix 10.4 for details of assessments performed at each visit.","confidence":1,"confidence_rate":1},{"cnt":[[243,529],[819,529],[819,582],[243,582]],"region":{"top_left_x":242,"top_left_y":528,"width":577,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c89d61c044941a69ed8aaacee18b479","type":"section_header","conversion_output":false,"children_ids":["631e3f0394b44f5989bef6e1927fbe1c"],"text":"","text_display":""},{"cnt":[[245,529],[816,529],[816,578],[245,578]],"region":{"top_left_x":244,"top_left_y":528,"width":573,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"631e3f0394b44f5989bef6e1927fbe1c","type":"text","conversion_output":true,"parent_id":"9c89d61c044941a69ed8aaacee18b479","text":"6.2 Efficacy Assessments","text_display":"\n\n\\subsection*{6.2 Efficacy Assessments}","confidence":0.99951171875,"confidence_rate":0.999983158745329},{"cnt":[[245,619],[1858,619],[1858,668],[245,668]],"region":{"top_left_x":244,"top_left_y":618,"width":1615,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8e415040b6c4706b72553d04ff14879","type":"text","conversion_output":true,"text":"The collection, reporting and assessment of attacks in this study will be done in accordance with","text_display":"\n\nThe collection, reporting and assessment of attacks in this study will be done in accordance with","confidence":1,"confidence_rate":1},{"cnt":[[245,666],[1861,666],[1861,715],[245,715]],"region":{"top_left_x":244,"top_left_y":666,"width":1617,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db7b76447c954ce59be275c9064fed09","type":"text","conversion_output":true,"text":"the HAE Attack Assessment and Reporting Procedures (HAARP). 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In the event that a subject is incapacitated following an attack, this information","text_display":" an HAE attack. In the event that a subject is incapacitated following an attack, this information","confidence":1,"confidence_rate":1},{"cnt":[[245,947],[1833,947],[1833,999],[245,999]],"region":{"top_left_x":244,"top_left_y":947,"width":1589,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1594329bd4840b2b7ba5e8630946501","type":"text","conversion_output":true,"text":"can be provided to the site by a family member or other individual with detailed knowledge of","text_display":" can be provided to the site by a family member or other individual with detailed knowledge of","confidence":1,"confidence_rate":1},{"cnt":[[245,997],[1854,997],[1854,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":996,"width":1611,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca3f70240f3d4afaa26cdf480aa5bf32","type":"text","conversion_output":true,"text":"the event. If desired by the subject, memory aids may be provided to assist in tracking any HAE","text_display":" the event. If desired by the subject, memory aids may be provided to assist in tracking any HAE","confidence":1,"confidence_rate":1},{"cnt":[[245,1044],[1863,1044],[1863,1094],[245,1094]],"region":{"top_left_x":244,"top_left_y":1044,"width":1619,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e2c884aa91e46cb9a4795c9e4be5815","type":"text","conversion_output":true,"text":"attacks subjects experience. Weekly communication between the subjects and the site personnel,","text_display":" attacks subjects experience. 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the severity of the attack, if the attack required acute treatment, if","confidence":1,"confidence_rate":1},{"cnt":[[245,1876],[1717,1876],[1717,1927],[245,1927]],"region":{"top_left_x":244,"top_left_y":1875,"width":1473,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83982fb42ef14614914418de204e8614","type":"text","conversion_output":true,"text":"the attack resulted in an emergency department visit or hospitalization, if the attack was","text_display":" the attack resulted in an emergency department visit or hospitalization, if the attack was","confidence":1,"confidence_rate":1},{"cnt":[[245,1925],[1850,1925],[1850,1974],[245,1974]],"region":{"top_left_x":244,"top_left_y":1925,"width":1606,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"087978a91ba246ffbe71c642fe45bccf","type":"text","conversion_output":true,"text":"hemodynamically significant (systolic blood pressure \\(<90\\), requires IV hydration, or associated","text_display":" hemodynamically significant (systolic blood pressure \\(<90\\), requires IV hydration, or associated","confidence":0.9975600242614746,"confidence_rate":0.9999762822489371},{"cnt":[[245,1972],[1824,1972],[1824,2022],[245,2022]],"region":{"top_left_x":244,"top_left_y":1972,"width":1581,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1362cdc616484c8ab220e840d2c3174e","type":"text","conversion_output":true,"text":"with syncope or near-syncope) and whether the attack was peripheral, abdominal or laryngeal.","text_display":" with syncope or near-syncope) and whether the attack was peripheral, abdominal or laryngeal.","confidence":1,"confidence_rate":1},{"cnt":[[245,2062],[1852,2062],[1852,2112],[245,2112]],"region":{"top_left_x":244,"top_left_y":2062,"width":1608,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59893be9747148e6b0e5109db179bfa9","type":"text","conversion_output":true,"text":"In this study HAE attacks will be captured as AEs. All AEs, regardless of seriousness, severity,","text_display":"\n\nIn this study HAE attacks will be captured as AEs. All AEs, regardless of seriousness, severity,","confidence":1,"confidence_rate":1},{"cnt":[[245,2110],[1775,2110],[1775,2159],[245,2159]],"region":{"top_left_x":244,"top_left_y":2109,"width":1531,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"960b79f961444ae0afc6088eebc0666b","type":"text","conversion_output":true,"text":"or causal relationship to study drug, will be recorded on the AE page of the eCRF. Any AE","text_display":" or causal relationship to study drug, will be recorded on the AE page of the eCRF. Any AE","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[245,2157],[1837,2157],[1837,2206],[245,2206]],"region":{"top_left_x":244,"top_left_y":2157,"width":1593,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"877b9a3110ca43bc96da9372dcb9e2c1","type":"text","conversion_output":true,"text":"reported to the site meeting criteria for a serious adverse event must be reported to the Sponsor","text_display":" reported to the site meeting criteria for a serious adverse event must be reported to the Sponsor","confidence":1,"confidence_rate":1},{"cnt":[[245,2204],[1837,2204],[1837,2254],[245,2254]],"region":{"top_left_x":244,"top_left_y":2204,"width":1593,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"098c22592de846c998da3e05e6ed61fb","type":"text","conversion_output":true,"text":"using the SAE Reporting Form in the electronic data capture (EDC) system within 24 hours of","text_display":" using the SAE Reporting Form in the electronic data capture (EDC) system within 24 hours of","confidence":1,"confidence_rate":1},{"cnt":[[245,2303],[245,2252],[1871,2254],[1871,2305]],"region":{"top_left_x":244,"top_left_y":2251,"width":1628,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf2363ce5e9b4b46a54177fe7a5c9355","type":"text","conversion_output":true,"text":"becoming aware of the event. For all serious adverse events that are reported as HAE attacks, the","text_display":" becoming aware of the event. For all serious adverse events that are reported as HAE attacks, the","confidence":1,"confidence_rate":1},{"cnt":[[245,2299],[1772,2299],[1772,2350],[245,2350]],"region":{"top_left_x":244,"top_left_y":2298,"width":1529,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4eea63e5af234d5bb74deb86c31d6c4a","type":"text","conversion_output":true,"text":"Principal Investigator or physician designee will review the event within 24 hours of initial","text_display":" Principal Investigator or physician designee will review the event within 24 hours of initial","confidence":1,"confidence_rate":1},{"cnt":[[245,2350],[1863,2350],[1863,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2350,"width":1619,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97f378aa24814e969f6b14d19538d092","type":"text","conversion_output":true,"text":"notification and, in accordance with HAARP, evaluate if it represented a confirmed HAE attack.","text_display":" notification and, in accordance with HAARP, evaluate if it represented a confirmed HAE attack.","confidence":0.99755859375,"confidence_rate":0.9999753094831817},{"cnt":[[245,2398],[1861,2398],[1861,2447],[245,2447]],"region":{"top_left_x":244,"top_left_y":2397,"width":1617,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c222fde8f1bf41dba24c0fa61c32c05a","type":"text","conversion_output":true,"text":"For all non-serious AEs that are reported as HAE attacks, the Principal Investigator or physician","text_display":" For all non-serious AEs that are reported as HAE attacks, the Principal Investigator or physician","confidence":1,"confidence_rate":1},{"cnt":[[245,2445],[1760,2445],[1760,2494],[245,2494]],"region":{"top_left_x":244,"top_left_y":2444,"width":1516,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78979b2e70d94cb19d7ec525e1b7e980","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":[[247,2587],[432,2587],[432,2628],[247,2628]],"region":{"top_left_x":247,"top_left_y":2586,"width":185,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b00822ad36848d89caa05eb1866b448","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1880,2587],[1880,2628],[1676,2628]],"region":{"top_left_x":1675,"top_left_y":2586,"width":205,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4b02a8cad7447b1bd08a5b008e3caac","type":"page_info","conversion_output":false,"text":"Page 14 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-15","page":15,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c54457735f7b4d88a7dd05d19025a128","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,168],[1880,168],[1880,208],[1676,208]],"region":{"top_left_x":1675,"top_left_y":167,"width":205,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39b646d6651c4112abb7e92a58341c11","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,260],[1841,260],[1841,312],[245,312]],"region":{"top_left_x":244,"top_left_y":259,"width":1598,"height":53},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75946e5ba487417baf8ee40c93a1b424","type":"text","conversion_output":true,"text":"HAARP, evaluate if it represented a confirmed HAE attack. If necessary for the evaluation, the","text_display":"\n\nHAARP, evaluate if it represented a confirmed HAE attack. If necessary for the evaluation, the","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[245,309],[1876,309],[1876,359],[245,359]],"region":{"top_left_x":244,"top_left_y":309,"width":1632,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16b44f6e57e84102bf4e9df8bd26c8b8","type":"text","conversion_output":true,"text":"Investigator or designee may contact the subject for additional information. Any subject-reported","text_display":" Investigator or designee may contact the subject for additional information. Any subject-reported","confidence":1,"confidence_rate":1},{"cnt":[[245,357],[1772,357],[1772,406],[245,406]],"region":{"top_left_x":244,"top_left_y":356,"width":1529,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6ab9a3b9012412aac476e53895284bf","type":"text","conversion_output":true,"text":"attack not confirmed by the Investigator must have an alternate AE diagnosis recorded. All","text_display":" attack not confirmed by the Investigator must have an alternate AE diagnosis recorded. All","confidence":1,"confidence_rate":1},{"cnt":[[245,404],[1712,404],[1712,453],[245,453]],"region":{"top_left_x":244,"top_left_y":403,"width":1469,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6f2ecceddef46a2a651ffe10cff91d1","type":"text","conversion_output":true,"text":"subject-reported and investigator-confirmed HAE attacks will be recorded in the eCRF.","text_display":" subject-reported and investigator-confirmed HAE attacks will be recorded in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1850,494],[1850,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1606,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60e94a0c473547f88995caabe8eb7b61","type":"text","conversion_output":true,"text":"Emergency department visits for HAE attacks and HAE attacks resulting in hospital admissions","text_display":"\n\nEmergency department visits for HAE attacks and HAE attacks resulting in hospital admissions","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[531,541],[531,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":287,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e2c865c69954570bb3daaf6db819b84","type":"text","conversion_output":true,"text":"will be captured.","text_display":" will be captured.","confidence":1,"confidence_rate":1},{"cnt":[[245,632],[1820,632],[1820,681],[245,681]],"region":{"top_left_x":244,"top_left_y":631,"width":1576,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"747270db484d4424bd59c57e65fec06e","type":"text","conversion_output":true,"text":"To be confirmed as an HAE attack, the event must have symptoms or signs consistent with an","text_display":"\n\nTo be confirmed as an HAE attack, the event must have symptoms or signs consistent with an","confidence":1,"confidence_rate":1},{"cnt":[[245,679],[1044,679],[1044,728],[245,728]],"region":{"top_left_x":244,"top_left_y":678,"width":801,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db16daba4e184f48980a52d23db30942","type":"text","conversion_output":true,"text":"attack in at least one of the following locations:","text_display":" attack in at least one of the following locations:","confidence":1,"confidence_rate":1},{"cnt":[[245,769],[1794,769],[1794,823],[245,823]],"region":{"top_left_x":244,"top_left_y":769,"width":1550,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb019c79928443c08109bf2b5c77f362","type":"text","conversion_output":true,"text":"- Peripheral angioedema: cutaneous swelling involving an extremity, the face, neck, torso,","text_display":"\n- Peripheral angioedema: cutaneous swelling involving an extremity, the face, neck, 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For a detailed definition on AEs, Serious AEs (SAEs), severity of AEs, and relatedness of","text_display":" visit. 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Routine vital sign assessments will be taken with the","text_display":" Study Activities Schedule (Appendix 10.4). Routine vital sign assessments will be taken with the","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1863,447],[1863,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1619,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c7f642e8d8c45e19abf8eb86a0591ed","type":"text","conversion_output":true,"text":"subject in the sitting or supine position after 5 minutes at rest and will include body temperature,","text_display":" subject in the sitting or supine position after 5 minutes at rest and will include body temperature,","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1830,494],[1830,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1587,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8240445008824e8cb83b7539766d41d2","type":"text","conversion_output":true,"text":"heart rate (HR), blood pressure (BP) and respiratory rate (RR). BP should be determined using","text_display":" heart rate (HR), blood pressure (BP) and respiratory rate (RR). BP should be determined using","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1876,541],[1876,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":1632,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf88774ad74347019ce06a7475f671f1","type":"text","conversion_output":true,"text":"the same arm and the same equipment for each assessment. There is a \\(\\pm 15\\) minute window for all","text_display":" the same arm and the same equipment for each assessment. There is a \\(\\pm 15\\) minute window for all","confidence":0.9956109506310895,"confidence_rate":0.9999564493689267},{"cnt":[[245,589],[432,589],[432,638],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":188,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64b20af75e06442b9b1456ddaff22ea3","type":"text","conversion_output":true,"text":"vital signs.","text_display":" vital signs.","confidence":1,"confidence_rate":1},{"cnt":[[245,679],[1854,679],[1854,728],[245,728]],"region":{"top_left_x":244,"top_left_y":678,"width":1611,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0263479e4db34e19a88f50ca51777ca7","type":"text","conversion_output":true,"text":"At study visits in which IMP is administered, vital signs will be obtained prior to dosing, 1 hour","text_display":"\n\nAt study visits in which IMP is administered, vital signs will be obtained prior to dosing, 1 hour","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[1858,726],[1858,776],[245,776]],"region":{"top_left_x":244,"top_left_y":726,"width":1615,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8283913d20c74168998cf58cbd5f2196","type":"text","conversion_output":true,"text":"after dosing, and 2 hours after dosing for the first 4 doses with the ability to eliminate the 2 hour","text_display":" after dosing, and 2 hours after dosing for the first 4 doses with the ability to eliminate the 2 hour","confidence":1,"confidence_rate":1},{"cnt":[[245,773],[1781,773],[1781,823],[245,823]],"region":{"top_left_x":244,"top_left_y":773,"width":1538,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cc7fcc39a2442c581880dff0bcc2da9","type":"text","conversion_output":true,"text":"vitals for the remaining doses based on the discretion of the Investigator and the absence of","text_display":" vitals for the remaining doses based on the discretion of the Investigator and the absence of","confidence":1,"confidence_rate":1},{"cnt":[[245,821],[488,821],[488,872],[245,872]],"region":{"top_left_x":244,"top_left_y":820,"width":244,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e98a5e454c04c0493db34dfbe1790ac","type":"text","conversion_output":true,"text":"safety signals.","text_display":" safety signals.","confidence":1,"confidence_rate":1},{"cnt":[[243,911],[834,911],[834,969],[243,969]],"region":{"top_left_x":242,"top_left_y":910,"width":592,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b55bda0705ce4347a053f65a8e485ca2","type":"section_header","conversion_output":false,"children_ids":["70c14702f5784987b994a9436e16a071"],"text":"","text_display":""},{"cnt":[[245,915],[829,915],[829,965],[245,965]],"region":{"top_left_x":244,"top_left_y":915,"width":586,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70c14702f5784987b994a9436e16a071","type":"text","conversion_output":true,"parent_id":"b55bda0705ce4347a053f65a8e485ca2","text":"6.3.3 Physical Examination","text_display":"\n\n\\subsection*{6.3.3 Physical Examination}","confidence":1,"confidence_rate":1},{"cnt":[[245,1001],[1871,1001],[1871,1051],[245,1051]],"region":{"top_left_x":244,"top_left_y":1001,"width":1628,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"102b50d74ddb443d8946262c08f55cac","type":"text","conversion_output":true,"text":"A physical examination including height, weight and calculation of Body Mass Index (BMI) will","text_display":"\n\nA physical examination including height, weight and calculation of Body Mass Index (BMI) will","confidence":1,"confidence_rate":1},{"cnt":[[245,1048],[1841,1048],[1841,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1048,"width":1598,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcb70032e2264e7086014b80d686004c","type":"text","conversion_output":true,"text":"be performed by the Investigator or his/her qualified designee according to the Study Activities","text_display":" be performed by the Investigator or his/her qualified designee according to the Study Activities","confidence":1,"confidence_rate":1},{"cnt":[[245,1096],[1755,1096],[1755,1147],[245,1147]],"region":{"top_left_x":244,"top_left_y":1095,"width":1512,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02645ba0ed4b4cefbdc79fa664b6bdce","type":"text","conversion_output":true,"text":"Schedule (Appendix 10.4). Height and weight will be collected at the screening visit only.","text_display":" Schedule (Appendix 10.4). Height and weight will be collected at the screening visit only.","confidence":0.9970722198486328,"confidence_rate":0.9999691365343536},{"cnt":[[241,1182],[913,1182],[913,1244],[241,1244]],"region":{"top_left_x":240,"top_left_y":1181,"width":674,"height":63},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97274f8994e64e5a8fc9e30d550f22ba","type":"section_header","conversion_output":false,"children_ids":["145d3d76d78e4653ac0859ad19f2059c"],"text":"","text_display":""},{"cnt":[[245,1188],[907,1188],[907,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1188,"width":663,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"145d3d76d78e4653ac0859ad19f2059c","type":"text","conversion_output":true,"parent_id":"97274f8994e64e5a8fc9e30d550f22ba","text":"6.3.4 Electrocardiogram (ECG)","text_display":"\n\n\\subsection*{6.3.4 Electrocardiogram (ECG)}","confidence":1,"confidence_rate":1},{"cnt":[[245,1276],[1783,1276],[1783,1326],[245,1326]],"region":{"top_left_x":244,"top_left_y":1276,"width":1540,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a66ebfbd42d4edda1a30ac808130bac","type":"text","conversion_output":true,"text":"A standard 12-lead ECG (single recording) will be performed at screening, baseline prior to","text_display":"\n\nA standard 12-lead ECG (single recording) will be performed at screening, baseline prior to","confidence":1,"confidence_rate":1},{"cnt":[[245,1323],[1794,1323],[1794,1377],[245,1377]],"region":{"top_left_x":244,"top_left_y":1323,"width":1550,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c95b2eb2d254cb885d0b2c5a5dec6ba","type":"text","conversion_output":true,"text":"Dose 1, Day 56, and Day \\(144 \\pm 1\\) day (to capture the estimated \\(C _{\\max }\\) ), and Day 182. The ECG","text_display":" Dose 1, Day 56, and Day \\(144 \\pm 1\\) day (to capture the estimated \\(C _{\\max }\\) ), and Day 182. The ECG","confidence":0.9057737636999263,"confidence_rate":0.9991167678412903},{"cnt":[[245,1371],[1854,1371],[1854,1422],[245,1422]],"region":{"top_left_x":244,"top_left_y":1370,"width":1611,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f5441f2fb014c9a9740d97a329c0621","type":"text","conversion_output":true,"text":"assessment at \\(C _{\\text {max }}\\) on Day \\(144 \\pm 1\\) day may be performed via at-home nurse or technician in lieu","text_display":" assessment at \\(C _{\\text {max }}\\) on Day \\(144 \\pm 1\\) day may be performed via at-home nurse or technician in lieu","confidence":1,"confidence_rate":1},{"cnt":[[245,1420],[1837,1420],[1837,1472],[245,1472]],"region":{"top_left_x":244,"top_left_y":1420,"width":1593,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15348c26f3ed415c8ee81d5455079e57","type":"text","conversion_output":true,"text":"of a subject visit to the study site. For subjects that do not rollover into OLE (DX-2930-04), an","text_display":" of a subject visit to the study site. For subjects that do not rollover into OLE (DX-2930-04), an","confidence":1,"confidence_rate":1},{"cnt":[[245,1470],[1764,1470],[1764,1519],[245,1519]],"region":{"top_left_x":244,"top_left_y":1469,"width":1520,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26f3d5653d584bcbbed7e892a4885a14","type":"text","conversion_output":true,"text":"ECG will be performed on Day 238. The date and time of each ECG and its results will be","text_display":" ECG will be performed on Day 238. The date and time of each ECG and its results will be","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[245,1517],[1796,1517],[1796,1566],[245,1566]],"region":{"top_left_x":244,"top_left_y":1516,"width":1553,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dec2a4dd56b74160aac11e64e17d30fc","type":"text","conversion_output":true,"text":"documented in the source documents and eCRF. Electrocardiograms will be sent to a central","text_display":" documented in the source documents and eCRF. 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Details of how to compute scores for the domains and the total score are included","text_display":" 17 questions. Details of how to compute scores for the domains and the total score are included","confidence":1,"confidence_rate":1},{"cnt":[[245,864],[606,864],[606,913],[245,913]],"region":{"top_left_x":244,"top_left_y":863,"width":362,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63af2c0df7834ea5afb99df6cf679982","type":"text","conversion_output":true,"text":"in Appendix 10.2.14.","text_display":" in Appendix 10.2.14.","confidence":0.9921875,"confidence_rate":0.9996863221087591},{"cnt":[[245,2587],[432,2587],[432,2628],[245,2628]],"region":{"top_left_x":244,"top_left_y":2586,"width":188,"height":42},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3d15ea8c2a84b4ea1914012cfe7e93f","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1880,2587],[1880,2628],[1676,2628]],"region":{"top_left_x":1675,"top_left_y":2586,"width":205,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3fb5795358443fda535f1fa27d5b6c2","type":"page_info","conversion_output":false,"text":"Page 20 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-21","page":21,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f3f6716fbd74c509ec09d2a4d004e1c","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1678,168],[1880,168],[1880,208],[1678,208]],"region":{"top_left_x":1677,"top_left_y":167,"width":203,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffbde622c11a4ed1a3f5badaf8b775f2","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[243,258],[947,258],[947,307],[243,307]],"region":{"top_left_x":242,"top_left_y":257,"width":706,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"681a22029fb34e8dacf470a1a8ac0b56","type":"section_header","conversion_output":false,"children_ids":["84835bce9c7e4590b78d4f790c729e4a"],"text":"","text_display":""},{"cnt":[[247,262],[941,262],[941,303],[247,303]],"region":{"top_left_x":247,"top_left_y":262,"width":695,"height":41},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84835bce9c7e4590b78d4f790c729e4a","type":"text","conversion_output":true,"parent_id":"681a22029fb34e8dacf470a1a8ac0b56","text":"7. STATISTICAL ANALYSIS","text_display":"\n\n\\section*{7. STATISTICAL ANALYSIS}","confidence":1,"confidence_rate":1},{"cnt":[[243,348],[831,348],[831,406],[243,406]],"region":{"top_left_x":242,"top_left_y":348,"width":590,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e680cd9f3e584144b24764e6845aba75","type":"section_header","conversion_output":false,"children_ids":["2235bc43d4ca49eab120f00495931846"],"text":"","text_display":""},{"cnt":[[249,352],[827,352],[827,402],[249,402]],"region":{"top_left_x":249,"top_left_y":352,"width":579,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2235bc43d4ca49eab120f00495931846","type":"text","conversion_output":true,"parent_id":"e680cd9f3e584144b24764e6845aba75","text":"7.1 General Methodology","text_display":"\n\n\\subsection*{7.1 General Methodology}","confidence":1,"confidence_rate":1},{"cnt":[[245,440],[1777,440],[1777,488],[245,488]],"region":{"top_left_x":244,"top_left_y":440,"width":1533,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1cade322c394df79ebe727c82e8b149","type":"text","conversion_output":true,"text":"All statistical analyses will be performed using SAS® Version 9.3 or higher (SAS Institute,","text_display":"\n\nAll statistical analyses will be performed using SAS® Version 9.3 or higher (SAS Institute,","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[307,483],[305,486],[245,486],[245,529],[247,531],[296,531],[299,529],[322,529],[299,529],[296,526],[294,526],[290,522],[290,520],[286,520],[284,522],[281,522],[279,520],[279,518],[281,516],[296,516],[299,513],[421,513],[423,511],[423,486],[421,486],[419,483],[393,483],[391,486],[382,486],[380,483],[378,483],[376,486],[350,486],[348,483],[342,483],[339,486],[331,486],[329,483]],"region":{"top_left_x":244,"top_left_y":483,"width":180,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb4350f9192048738d68c128b4281864","type":"text","conversion_output":true,"text":"PPD PPD","text_display":" PPD PPD","confidence":1,"confidence_rate":1},{"cnt":[[602,490],[733,490],[733,535],[602,535]],"region":{"top_left_x":601,"top_left_y":489,"width":132,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ee16249b8bb4db5941ca43b3337d6e2","type":"text","conversion_output":true,"text":", USA).","text_display":" , USA).","confidence":1,"confidence_rate":1},{"cnt":[[245,576],[1871,576],[1871,625],[245,625]],"region":{"top_left_x":244,"top_left_y":575,"width":1628,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b91049f4c92a42e18b9bee863701b779","type":"text","conversion_output":true,"text":"Unless otherwise specified, summary tabulations will be presented by treatment group (DX-2930","text_display":"\n\nUnless otherwise specified, summary tabulations will be presented by treatment group (DX-2930","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,625],[1837,625],[1837,672],[245,672]],"region":{"top_left_x":244,"top_left_y":625,"width":1593,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1537bac7e98e4e28b4ca0ceb669359c2","type":"text","conversion_output":true,"text":"300 mg every 2 weeks, DX-2930 300 mg every 4 weeks, DX-2930 150 mg every 4 weeks, and","text_display":" 300 mg every 2 weeks, DX-2930 300 mg every 4 weeks, DX-2930 150 mg every 4 weeks, and","confidence":0.99853515625,"confidence_rate":0.9999866735644114},{"cnt":[[245,675],[1833,675],[1833,724],[245,724]],"region":{"top_left_x":244,"top_left_y":674,"width":1589,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0b2d441ff3148a082c5d833d600971c","type":"text","conversion_output":true,"text":"Placebo). All data listings will be sorted by treatment group, site, and subject number, and will","text_display":" Placebo). All data listings will be sorted by treatment group, site, and subject number, and will","confidence":0.99853515625,"confidence_rate":0.9999856283612877},{"cnt":[[245,722],[909,722],[909,771],[245,771]],"region":{"top_left_x":244,"top_left_y":721,"width":665,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7030710f502e4f84942d30f59592918a","type":"text","conversion_output":true,"text":"include the subject's age, sex, and race.","text_display":" include the subject's age, sex, and race.","confidence":1,"confidence_rate":1},{"cnt":[[245,812],[1811,812],[1811,862],[245,862]],"region":{"top_left_x":244,"top_left_y":812,"width":1568,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c93420b35b804ffc90fc7fc462ca7d4c","type":"text","conversion_output":true,"text":"For categorical variables, the number and percentage of subjects within each category (with a","text_display":"\n\nFor categorical variables, the number and percentage of subjects within each category (with a","confidence":1,"confidence_rate":1},{"cnt":[[245,859],[1714,859],[1714,909],[245,909]],"region":{"top_left_x":244,"top_left_y":859,"width":1471,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53fcf52f91cd44acbf4c79f424fa4347","type":"text","conversion_output":true,"text":"category for missing data as needed) of the parameter will be presented. For continuous","text_display":" category for missing data as needed) of the parameter will be presented. For continuous","confidence":1,"confidence_rate":1},{"cnt":[[245,907],[1742,907],[1742,956],[245,956]],"region":{"top_left_x":244,"top_left_y":906,"width":1499,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28acbbd7d93c44459b2a139735b1f0f3","type":"text","conversion_output":true,"text":"variables, the number of subjects, mean, median, standard deviation (SD), minimum, and","text_display":" variables, the number of subjects, mean, median, standard deviation (SD), minimum, and","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1830,954],[1830,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":953,"width":1587,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f90a55ec85f44175a07d1ae33911a9e9","type":"text","conversion_output":true,"text":"maximum values will be presented. Where applicable, estimates from statistical model of least","text_display":" maximum values will be presented. Where applicable, estimates from statistical model of least","confidence":1,"confidence_rate":1},{"cnt":[[245,1003],[1815,1003],[1815,1051],[245,1051]],"region":{"top_left_x":244,"top_left_y":1003,"width":1572,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84a113086e284bffb44268c997d65611","type":"text","conversion_output":true,"text":"squares means, treatment differences, standard errors, p-values, and \\(95 \\%\\) confidence intervals","text_display":" squares means, treatment differences, standard errors, p-values, and \\(95 \\%\\) confidence intervals","confidence":0.9990236759185791,"confidence_rate":0.9999903287497746},{"cnt":[[245,1048],[1815,1048],[1815,1098],[245,1098]],"region":{"top_left_x":244,"top_left_y":1048,"width":1572,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6ade34304de47e599284c1f996bfd5e","type":"text","conversion_output":true,"text":"(CI) for least squares mean treatment differences will be provided. Time-to-event data will be","text_display":" (CI) for least squares mean treatment differences will be provided. Time-to-event data will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1096],[1876,1096],[1876,1147],[245,1147]],"region":{"top_left_x":244,"top_left_y":1095,"width":1632,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46b35676bd294126a5f26e803f709405","type":"text","conversion_output":true,"text":"summarized using Kaplan-Meier (KM) estimates of the 25th, 50th (median), and 75th percentiles","text_display":" summarized using Kaplan-Meier (KM) estimates of the 25th, 50th (median), and 75th percentiles","confidence":0.8741541547456109,"confidence_rate":0.9986285072707165},{"cnt":[[245,1147],[1833,1147],[1833,1195],[245,1195]],"region":{"top_left_x":244,"top_left_y":1147,"width":1589,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcee811229694527897f1c552791c4ee","type":"text","conversion_output":true,"text":"with associated two-sided \\(95 \\% CI\\), as well as percentage of censored observations. Plots of the","text_display":" with associated two-sided \\(95 \\% CI\\), as well as percentage of censored observations. Plots of the","confidence":0.8670787811279297,"confidence_rate":0.9986425845992598},{"cnt":[[245,1195],[1850,1195],[1850,1244],[245,1244]],"region":{"top_left_x":244,"top_left_y":1194,"width":1606,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acbfb193ff9741bcbf9927c64843fdbd","type":"text","conversion_output":true,"text":"KM curves and supporting data listings detailing each subject's contribution to the analysis will","text_display":" KM curves and supporting data listings detailing each subject's contribution to the analysis will","confidence":1,"confidence_rate":1},{"cnt":[[245,1242],[458,1242],[458,1291],[245,1291]],"region":{"top_left_x":244,"top_left_y":1241,"width":214,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37a4b972c93d4bdc8785690ee909a26d","type":"text","conversion_output":true,"text":"be provided.","text_display":" be provided.","confidence":1,"confidence_rate":1},{"cnt":[[245,1332],[1712,1332],[1712,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1332,"width":1469,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f951e6b8619f42bdaba0c21bc33a5bea","type":"text","conversion_output":true,"text":"Formal statistical hypothesis testing will be performed on the primary and rank ordered","text_display":"\n\nFormal statistical hypothesis testing will be performed on the primary and rank ordered","confidence":1,"confidence_rate":1},{"cnt":[[245,1379],[1781,1379],[1781,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1379,"width":1538,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b345266de5fa435eb289b3830c673176","type":"text","conversion_output":true,"text":"secondary efficacy endpoints with the global family-wise type I error rate (FWER) strongly","text_display":" secondary efficacy endpoints with the global family-wise type I error rate (FWER) strongly","confidence":1,"confidence_rate":1},{"cnt":[[245,1427],[1721,1427],[1721,1476],[245,1476]],"region":{"top_left_x":244,"top_left_y":1426,"width":1477,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db654f4bd53d43fa86f1322354214321","type":"text","conversion_output":true,"text":"controlled at two-sided 0.05 using a Bonferroni-based general gatekeeping procedure as","text_display":" controlled at two-sided 0.05 using a Bonferroni-based general gatekeeping procedure as","confidence":1,"confidence_rate":1},{"cnt":[[245,1474],[664,1474],[664,1519],[245,1519]],"region":{"top_left_x":244,"top_left_y":1473,"width":420,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4169fb1b80f843aab653e12f085137a9","type":"text","conversion_output":true,"text":"described in Section 9.5.","text_display":" described in Section 9.5.","confidence":1,"confidence_rate":1},{"cnt":[[245,1566],[1828,1566],[1828,1613],[245,1613]],"region":{"top_left_x":244,"top_left_y":1566,"width":1585,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"489810b7000348f9baffca9c7d5bdad1","type":"text","conversion_output":true,"text":"For the summary statistics of all numerical variables unless otherwise specified, minimum and","text_display":"\n\nFor the summary statistics of all numerical variables unless otherwise specified, minimum and","confidence":1,"confidence_rate":1},{"cnt":[[245,1611],[1858,1611],[1858,1661],[245,1661]],"region":{"top_left_x":244,"top_left_y":1611,"width":1615,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db36bd6198044414a2d92030bf0befc0","type":"text","conversion_output":true,"text":"maximum will be displayed to the same level of precision as reported. Mean and median will be","text_display":" maximum will be displayed to the same level of precision as reported. Mean and median will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1661],[1798,1661],[1798,1708],[245,1708]],"region":{"top_left_x":244,"top_left_y":1660,"width":1555,"height":49},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ef5532f13294a7294fbe028b901662a","type":"text","conversion_output":true,"text":"displayed to one level of precision greater than the data collected. Standard deviation will be","text_display":" displayed to one level of precision greater than the data collected. Standard deviation will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1708],[1863,1708],[1863,1760],[245,1760]],"region":{"top_left_x":244,"top_left_y":1708,"width":1619,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d170a449615549379528d718dd06cfdb","type":"text","conversion_output":true,"text":"displayed to two levels of precision greater than the data collected. P -values will be rounded to 3","text_display":" displayed to two levels of precision greater than the data collected. P -values will be rounded to 3","confidence":0.8883752152323723,"confidence_rate":0.9989245688223264},{"cnt":[[245,1757],[1287,1757],[1287,1807],[245,1807]],"region":{"top_left_x":244,"top_left_y":1757,"width":1043,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90e8bee566154c68b7545f18cb0bee75","type":"text","conversion_output":true,"text":"decimal places, p -values \\(<0.0005\\) will be displayed as \\(<0.001\\).","text_display":" decimal places, p -values \\(<0.0005\\) will be displayed as \\(<0.001\\).","confidence":0.994140625,"confidence_rate":0.9999265450918315},{"cnt":[[245,1848],[1876,1848],[1876,1895],[245,1895]],"region":{"top_left_x":244,"top_left_y":1847,"width":1632,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ca3ef104b7440e78077ff1e4f29b128","type":"text","conversion_output":true,"text":"When count data are presented, the percentage will be suppressed when the count is zero in order","text_display":"\n\nWhen count data are presented, the percentage will be suppressed when the count is zero in order","confidence":1,"confidence_rate":1},{"cnt":[[245,1895],[1880,1895],[1880,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1894,"width":1636,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05150214e33442619d3396fd2f3f266e","type":"text","conversion_output":true,"text":"to draw attention to the non-zero counts. The denominator for all percentages will be the number","text_display":" to draw attention to the non-zero counts. The denominator for all percentages will be the number","confidence":1,"confidence_rate":1},{"cnt":[[245,1942],[1852,1942],[1852,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1942,"width":1608,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4216958c26d94f6ca551c1580f3af5b2","type":"text","conversion_output":true,"text":"of subjects for that treatment group within the population of interest, unless otherwise specified.","text_display":" of subjects for that treatment group within the population of interest, unless otherwise specified.","confidence":1,"confidence_rate":1},{"cnt":[[245,2032],[1852,2032],[1852,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2032,"width":1608,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cc03cf78efc471ba949edc5c59fb527","type":"text","conversion_output":true,"text":"See Section 10.2 for detailed descriptions of analysis definitions and programming conventions.","text_display":"\n\nSee Section 10.2 for detailed descriptions of analysis definitions and programming conventions.","confidence":1,"confidence_rate":1},{"cnt":[[249,2587],[432,2587],[432,2628],[249,2628]],"region":{"top_left_x":249,"top_left_y":2586,"width":183,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a82f36288db14aa28d71f89d6891de13","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1678,2587],[1880,2587],[1880,2628],[1678,2628]],"region":{"top_left_x":1677,"top_left_y":2586,"width":203,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d6df71f3c814447af0bbd4558fc04f5","type":"page_info","conversion_output":false,"text":"Page 21 of 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The","text_display":"\n\nThe ITT Population will include all randomized subjects who received any study drug. The","confidence":1,"confidence_rate":1},{"cnt":[[245,576],[1854,576],[1854,625],[245,625]],"region":{"top_left_x":244,"top_left_y":575,"width":1611,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aaa9f9350470499daafa98bc6aa87842","type":"text","conversion_output":true,"text":"primary efficacy analyses will be carried out with the ITT Population. Subjects will be analyzed","text_display":" primary efficacy analyses will be carried out with the ITT Population. Subjects will be analyzed","confidence":0.9985356330871582,"confidence_rate":0.9999854907968839},{"cnt":[[245,625],[1876,625],[1876,675],[245,675]],"region":{"top_left_x":244,"top_left_y":625,"width":1632,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75d402ea3e50428a957a2c6d77ae4517","type":"text","conversion_output":true,"text":"according to their randomized treatment assignment regardless of the treatment actually received.","text_display":" according to their randomized treatment assignment regardless of the treatment actually received.","confidence":1,"confidence_rate":1},{"cnt":[[241,711],[763,711],[763,769],[241,769]],"region":{"top_left_x":240,"top_left_y":711,"width":523,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f22d1622c2b4168bb8d7bec1b33deee","type":"section_header","conversion_output":false,"children_ids":["6eb425e4029c498186a3a7f2a9eb616c"],"text":"","text_display":""},{"cnt":[[245,718],[758,718],[758,765],[245,765]],"region":{"top_left_x":244,"top_left_y":717,"width":515,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6eb425e4029c498186a3a7f2a9eb616c","type":"text","conversion_output":true,"parent_id":"8f22d1622c2b4168bb8d7bec1b33deee","text":"7.2.2 Safety Population","text_display":"\n\n\\subsection*{7.2.2 Safety Population}","confidence":1,"confidence_rate":1},{"cnt":[[245,804],[1858,804],[1858,853],[245,853]],"region":{"top_left_x":244,"top_left_y":803,"width":1615,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a817e349120f4f1583593538a88fa158","type":"text","conversion_output":true,"text":"The Safety Population will include all subjects who received any study drug. All safety analyses","text_display":"\n\nThe Safety Population will include all subjects who received any study drug. All safety analyses","confidence":1,"confidence_rate":1},{"cnt":[[245,853],[1790,853],[1790,900],[245,900]],"region":{"top_left_x":244,"top_left_y":852,"width":1546,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20b9307545904412ad10f6fea9e339fb","type":"text","conversion_output":true,"text":"will use the Safety Population. Subjects will be analyzed according to the treatment actually","text_display":" will use the Safety Population. Subjects will be analyzed according to the treatment actually","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,902],[1021,902],[1021,947],[245,947]],"region":{"top_left_x":244,"top_left_y":902,"width":777,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29e4743cdf044480b3083c00ef160cf8","type":"text","conversion_output":true,"text":"received, regardless of the treatment assigned.","text_display":" received, regardless of the treatment assigned.","confidence":1,"confidence_rate":1},{"cnt":[[243,988],[788,988],[788,1044],[243,1044]],"region":{"top_left_x":242,"top_left_y":988,"width":547,"height":57},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24e55ca341e949f1a190e48292c3843e","type":"section_header","conversion_output":false,"children_ids":["b1248a41fdc94c1aadfc7847b943ee08"],"text":"","text_display":""},{"cnt":[[245,993],[784,993],[784,1040],[245,1040]],"region":{"top_left_x":244,"top_left_y":992,"width":541,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1248a41fdc94c1aadfc7847b943ee08","type":"text","conversion_output":true,"parent_id":"24e55ca341e949f1a190e48292c3843e","text":"7.3 Subject Disposition","text_display":"\n\n\\subsection*{7.3 Subject Disposition}","confidence":1,"confidence_rate":1},{"cnt":[[245,1079],[1852,1079],[1852,1128],[245,1128]],"region":{"top_left_x":244,"top_left_y":1078,"width":1608,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"191f332e928e4df8b192764652a879d4","type":"text","conversion_output":true,"text":"The number of subjects screened, randomized, treated with study drug, completed the study and","text_display":"\n\nThe number of subjects screened, randomized, treated with study drug, completed the study and","confidence":1,"confidence_rate":1},{"cnt":[[245,1128],[1813,1128],[1813,1175],[245,1175]],"region":{"top_left_x":244,"top_left_y":1127,"width":1570,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c72ccc487d047bfa792a4d8ee23c35a","type":"text","conversion_output":true,"text":"discontinued prematurely by reason will be summarized overall and by randomized treatment","text_display":" discontinued prematurely by reason will be summarized overall and by randomized treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1177],[1852,1177],[1852,1222],[245,1222]],"region":{"top_left_x":244,"top_left_y":1177,"width":1608,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14c71b1c1bfa4e75af403d7cc467b698","type":"text","conversion_output":true,"text":"assignment for all subjects. 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Listings of all disposition data","confidence":1,"confidence_rate":1},{"cnt":[[245,1319],[535,1319],[535,1369],[245,1369]],"region":{"top_left_x":244,"top_left_y":1319,"width":291,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70b9cc04ba034c089878a1377d0b7037","type":"text","conversion_output":true,"text":"will be provided.","text_display":" will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[243,1405],[793,1405],[793,1454],[243,1454]],"region":{"top_left_x":242,"top_left_y":1405,"width":551,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9524b965a514dd1800fcdc6bf41735a","type":"section_header","conversion_output":false,"children_ids":["09bf294e46a54b56906ffa9bd7be4af7"],"text":"","text_display":""},{"cnt":[[245,1409],[788,1409],[788,1452],[245,1452]],"region":{"top_left_x":244,"top_left_y":1409,"width":545,"height":44},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09bf294e46a54b56906ffa9bd7be4af7","type":"text","conversion_output":true,"parent_id":"c9524b965a514dd1800fcdc6bf41735a","text":"7.4 Protocol Deviations","text_display":"\n\n\\subsection*{7.4 Protocol Deviations}","confidence":0.9907341003417969,"confidence_rate":0.9996675875775588},{"cnt":[[245,1500],[1416,1500],[1416,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1499,"width":1172,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f67d236c048425dab9b8429bbaf6ac2","type":"text","conversion_output":true,"text":"Protocol deviations will be collected at both the site and subject level.","text_display":"\n\nProtocol deviations will be collected at both the site and subject level.","confidence":1,"confidence_rate":1},{"cnt":[[245,1590],[1798,1590],[1798,1637],[245,1637]],"region":{"top_left_x":244,"top_left_y":1589,"width":1555,"height":49},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54cce5838ded419daa8cb4a14f432cf7","type":"text","conversion_output":true,"text":"Deviations at the site level will be applied to all subjects who were enrolled at that site at the","text_display":"\nDeviations at the site level will be applied to all subjects who were enrolled at that site at the","confidence":1,"confidence_rate":1},{"cnt":[[245,1637],[1830,1637],[1830,1687],[245,1687]],"region":{"top_left_x":244,"top_left_y":1637,"width":1587,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb9f4ab869504cffbc665b56790f9e02","type":"text","conversion_output":true,"text":"time of the deviation. 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IRB/EC, temperature excursion for IP and other.","text_display":" approval/notification or IRB/EC, temperature excursion for IP and other.","confidence":1,"confidence_rate":1},{"cnt":[[245,1916],[1525,1916],[1525,1966],[245,1966]],"region":{"top_left_x":244,"top_left_y":1916,"width":1282,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89080a1f91174b1192d835e209ba41da","type":"text","conversion_output":true,"text":"Deviation types for subject level deviations are: eligibility criteria, informed","text_display":"\n\nDeviation types for subject level deviations are: eligibility criteria, informed","confidence":1,"confidence_rate":1},{"cnt":[[245,1964],[1858,1964],[1858,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1963,"width":1615,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7806fb4c89c4fe781c02f945a1efdb5","type":"text","conversion_output":true,"text":"consent/assent/HIPAA, 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Characteristics}","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1757,348],[1757,400],[245,400]],"region":{"top_left_x":244,"top_left_y":348,"width":1514,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e8c1016ea34452b865f249d709db5ba","type":"text","conversion_output":true,"text":"Baseline and demographic variables will be descriptively summarized by treatment group,","text_display":"\n\nBaseline and demographic variables will be descriptively summarized by treatment group,","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[245,400],[1231,400],[1231,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":988,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48ed2a6ebd84453a9c0860b9d47f673c","type":"text","conversion_output":true,"text":"overall DX-2930, and overall for each analysis population.","text_display":" overall DX-2930, and overall for each analysis population.","confidence":1,"confidence_rate":1},{"cnt":[[245,486],[1841,486],[1841,539],[245,539]],"region":{"top_left_x":244,"top_left_y":485,"width":1598,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d13e3cc3b08437cade55ff053270a04","type":"text","conversion_output":true,"text":"Demographic variables to be presented include age (years), age category ( \\(<18,18\\) to \\(<40,40\\) to","text_display":"\n\nDemographic variables to be presented include age (years), age category ( \\(<18,18\\) to \\(<40,40\\) to","confidence":0.6454764994714424,"confidence_rate":0.9957995536177916},{"cnt":[[245,535],[1850,535],[1850,587],[245,587]],"region":{"top_left_x":244,"top_left_y":534,"width":1606,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15f9a880f57d4339abab85f893d3b163","type":"text","conversion_output":true,"text":"\\(<65, \\geq 65\\) years), sex (male, female), ethnicity (Hispanic, Non-Hispanic), race (American Indian","text_display":" \\(<65, \\geq 65\\) years), sex (male, female), ethnicity (Hispanic, Non-Hispanic), race (American Indian","confidence":0.9610748291015625,"confidence_rate":0.9995907744033491},{"cnt":[[245,584],[1863,584],[1863,634],[245,634]],"region":{"top_left_x":244,"top_left_y":584,"width":1619,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d4bdcc8ab5f406cb172710ef978c422","type":"text","conversion_output":true,"text":"or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander,","text_display":" or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific 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(cm), weight (kg), weight group ( \\(<50,50\\) to \\(<75,75\\) to \\(<100, \\geq 100 kg\\) ), BMI","confidence":0.7698488588139298,"confidence_rate":0.9975120422940317},{"cnt":[[245,722],[1381,722],[1381,778],[245,778]],"region":{"top_left_x":244,"top_left_y":721,"width":1138,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6f29a87adfb41b5bf6645dcc09aba61","type":"text","conversion_output":true,"text":"( \\(kg / m ^{2}\\) ) and BMI group ( \\(<18.5,18.5\\) to \\(<25,25\\) to \\(<30, \\geq 30 kg / m ^{2}\\) ).","text_display":" ( \\(kg / m ^{2}\\) ) and BMI group ( \\(<18.5,18.5\\) to \\(<25,25\\) to \\(<30, \\geq 30 kg / m ^{2}\\) 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attacks,","text_display":" angioedema symptoms, HAE type (Type I, Type II, Unspecified), history of laryngeal attacks,","confidence":1,"confidence_rate":1},{"cnt":[[245,913],[1852,913],[1852,965],[245,965]],"region":{"top_left_x":244,"top_left_y":913,"width":1608,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03eb6270517f4284ab8baeaea32e152c","type":"text","conversion_output":true,"text":"primary attack locations, number of attacks in the last 1,3 , and 12 months, baseline HAE attack","text_display":" primary attack locations, number of attacks in the last 1,3 , and 12 months, baseline HAE attack","confidence":1,"confidence_rate":1},{"cnt":[[245,958],[1858,958],[1858,1012],[245,1012]],"region":{"top_left_x":244,"top_left_y":958,"width":1615,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d32317ea10d74b0a9265c5edceeae7ba","type":"text","conversion_output":true,"text":"rate (attacks/4 weeks) and baseline HAE attack rate strata (1 to \\(<2,2\\) to \\(<3, \\geq 3\\) attacks/4 weeks).","text_display":" rate (attacks/4 weeks) and baseline HAE attack rate strata (1 to \\(<2,2\\) to \\(<3, \\geq 3\\) attacks/4 weeks).","confidence":0.46467821874274273,"confidence_rate":0.9928628797189128},{"cnt":[[245,1008],[1439,1008],[1439,1059],[245,1059]],"region":{"top_left_x":244,"top_left_y":1007,"width":1196,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15ca40568ca74ed8bc9300a3cd0f9c83","type":"text","conversion_output":true,"text":"All baseline and demographic data will be presented in subject listings.","text_display":" All baseline and demographic data will be presented in subject 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summarized by system organ class (SOC) and preferred term (PT) by treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1285],[1846,1285],[1846,1334],[245,1334]],"region":{"top_left_x":244,"top_left_y":1284,"width":1602,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89d9e93b0e644567b521cf0390868043","type":"text","conversion_output":true,"text":"group, overall DX-2930 and overall for each analysis population. Tabulations will be presented","text_display":" group, overall DX-2930 and overall for each analysis population. Tabulations will be presented","confidence":1,"confidence_rate":1},{"cnt":[[245,1332],[1841,1332],[1841,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1332,"width":1598,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4dfed3027c644b6a366bd33e7d22466","type":"text","conversion_output":true,"text":"sorted by SOC in alphabetical order and by PT within each SOC by descending frequency. All","text_display":" sorted by SOC in alphabetical order and by PT within each SOC by descending frequency. All","confidence":1,"confidence_rate":1},{"cnt":[[245,1379],[1119,1379],[1119,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1379,"width":876,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3602fb0377d4ab5b5e881f1a3e446ca","type":"text","conversion_output":true,"text":"medical history will be presented in subject listings.","text_display":" medical history will be presented in subject listings.","confidence":1,"confidence_rate":1},{"cnt":[[241,1465],[1291,1465],[1291,1525],[241,1525]],"region":{"top_left_x":240,"top_left_y":1465,"width":1052,"height":61},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a9e22a77706457b903ec4af91d79b7e","type":"section_header","conversion_output":false,"children_ids":["7cd9da49159547f085df44ff0607a4d0"],"text":"","text_display":""},{"cnt":[[245,1470],[1285,1470],[1285,1519],[245,1519]],"region":{"top_left_x":244,"top_left_y":1469,"width":1041,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7cd9da49159547f085df44ff0607a4d0","type":"text","conversion_output":true,"parent_id":"8a9e22a77706457b903ec4af91d79b7e","text":"7.7 Treatment Compliance and Extent of Exposure","text_display":"\n\n\\subsection*{7.7 Treatment Compliance and Extent of Exposure}","confidence":1,"confidence_rate":1},{"cnt":[[245,1560],[1755,1560],[1755,1609],[245,1609]],"region":{"top_left_x":244,"top_left_y":1559,"width":1512,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfca37f3fef249cc88bbab4adcaace3a","type":"text","conversion_output":true,"text":"All planned study drug administrations will be recorded in the case report form, including","text_display":"\n\nAll planned study drug administrations will be recorded in the case report form, including","confidence":1,"confidence_rate":1},{"cnt":[[245,1607],[1863,1607],[1863,1656],[245,1656]],"region":{"top_left_x":244,"top_left_y":1607,"width":1619,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa95abfc2222464a9e119714b1674793","type":"text","conversion_output":true,"text":"whether a full, partial, or no dose was given; date and time of dose; and location of the injection.","text_display":" whether a full, partial, or no dose was given; date and time of dose; and location of the injection.","confidence":1,"confidence_rate":1},{"cnt":[[245,1654],[1818,1654],[1818,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1654,"width":1574,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f866de770184dbcb507a6a48251e3e7","type":"text","conversion_output":true,"text":"Regardless of treatment assignment, all subjects are to receive two injections of blinded study","text_display":" Regardless of treatment assignment, all subjects are to receive two injections of blinded study","confidence":1,"confidence_rate":1},{"cnt":[[245,1702],[1781,1702],[1781,1755],[245,1755]],"region":{"top_left_x":244,"top_left_y":1701,"width":1538,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59135eaa78634258846329bf1d9d7037","type":"text","conversion_output":true,"text":"drug given in the same upper arm, with at least 2 cm separation between each injection site.","text_display":" drug given in the same upper arm, with at least 2 cm separation between each injection site.","confidence":1,"confidence_rate":1},{"cnt":[[245,1792],[1852,1792],[1852,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1791,"width":1608,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c4a00f59752418598855989eef81117","type":"text","conversion_output":true,"text":"It is anticipated that all subjects will be compliant with treatment because the study drug will be","text_display":"\n\nIt is anticipated that all subjects will be compliant with treatment because the study drug will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1839],[1846,1839],[1846,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1839,"width":1602,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1a4694bf14542d98b8d3ec002861066","type":"text","conversion_output":true,"text":"administered by qualified site personnel. Treatment compliance and the extent of exposure will","text_display":" administered by qualified site personnel. Treatment compliance and the extent of exposure will","confidence":1,"confidence_rate":1},{"cnt":[[245,1886],[1835,1886],[1835,1938],[245,1938]],"region":{"top_left_x":244,"top_left_y":1886,"width":1591,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e33770cf3c240a185c2238acca6fca1","type":"text","conversion_output":true,"text":"be described by the percentage of planned doses received by the subject, total number of doses","text_display":" be described by the percentage of planned doses received by the subject, total number of doses","confidence":1,"confidence_rate":1},{"cnt":[[245,1936],[1858,1936],[1858,1987],[245,1987]],"region":{"top_left_x":244,"top_left_y":1935,"width":1615,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cb7b4fa58b04f85a936413568192823","type":"text","conversion_output":true,"text":"received by the subject, and the number and percentage of subjects that received at least \\(80 \\%\\) of","text_display":" received by the subject, and the number and percentage of subjects that received at least \\(80 \\%\\) of","confidence":0.9873046875,"confidence_rate":0.9998771557519439},{"cnt":[[245,1985],[1824,1985],[1824,2035],[245,2035]],"region":{"top_left_x":244,"top_left_y":1985,"width":1581,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9e40239ce2948a399137fd7c2de2a50","type":"text","conversion_output":true,"text":"planned doses, summarized by treatment group for each analysis population. Listings of study","text_display":" planned doses, summarized by treatment group for each analysis population. Listings of study","confidence":1,"confidence_rate":1},{"cnt":[[245,2032],[1061,2032],[1061,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2032,"width":818,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d97c90db87ed445fb24c1f5246a94be5","type":"text","conversion_output":true,"text":"administrations by subject will also be provided.","text_display":" administrations by subject will also be 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Population.","confidence":1,"confidence_rate":1},{"cnt":[[241,2295],[913,2295],[913,2357],[241,2357]],"region":{"top_left_x":240,"top_left_y":2294,"width":674,"height":63},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3d6a9aecac84efb87122b7e957b3451","type":"section_header","conversion_output":false,"children_ids":["9d1b6eef20144a4397effd7d2488db7b"],"text":"","text_display":""},{"cnt":[[245,2299],[909,2299],[909,2353],[245,2353]],"region":{"top_left_x":244,"top_left_y":2298,"width":665,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d1b6eef20144a4397effd7d2488db7b","type":"text","conversion_output":true,"parent_id":"a3d6a9aecac84efb87122b7e957b3451","text":"7.8.1 Primary Efficacy Analysis","text_display":"\n\n\\subsection*{7.8.1 Primary Efficacy Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[245,2389],[1751,2389],[1751,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2389,"width":1507,"height":54},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37e48d296a104275ab8c133ad97b0f5f","type":"text","conversion_output":true,"text":"The primary efficacy endpoint, number of investigator-confirmed HAE attacks during the","text_display":"\n\nThe primary efficacy endpoint, number of investigator-confirmed HAE attacks during the","confidence":1,"confidence_rate":1},{"cnt":[[245,2436],[1800,2436],[1800,2490],[245,2490]],"region":{"top_left_x":244,"top_left_y":2436,"width":1557,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3846e50f664d442c84bcd6ebc0f4bd50","type":"text","conversion_output":true,"text":"treatment period (Day 0 through Day 182), will be compared for each active treatment group","text_display":" treatment period (Day 0 through Day 182), will be compared for each active treatment group","confidence":1,"confidence_rate":1},{"cnt":[[245,2587],[432,2587],[432,2632],[245,2632]],"region":{"top_left_x":244,"top_left_y":2586,"width":188,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a38dab797cf44f08573562db2cc5d03","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1882,2587],[1882,2632],[1676,2632]],"region":{"top_left_x":1675,"top_left_y":2586,"width":208,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e1108fc45b9492aabbdac9d21d2b878","type":"page_info","conversion_output":false,"text":"Page 23 of 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2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,262],[1717,262],[1717,312],[245,312]],"region":{"top_left_x":244,"top_left_y":262,"width":1473,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"066ede248e7e4f05860e617b0248f28b","type":"text","conversion_output":true,"text":"(DX-2930) to the placebo group using a generalized linear model (GLM) for count data","text_display":"\n(DX-2930) to the placebo group using a generalized linear model (GLM) for count data","confidence":1,"confidence_rate":1},{"cnt":[[245,309],[1760,309],[1760,359],[245,359]],"region":{"top_left_x":244,"top_left_y":309,"width":1516,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bcf2c2764cb4f18a231489af22b8dcd","type":"text","conversion_output":true,"text":"assuming a Poisson distribution with a log link function and Pearson chi-square scaling of","text_display":" assuming a Poisson distribution with a log link function and Pearson chi-square scaling of","confidence":1,"confidence_rate":1},{"cnt":[[245,357],[1841,357],[1841,406],[245,406]],"region":{"top_left_x":244,"top_left_y":356,"width":1598,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a654caa068264198aeb5314824d7af53","type":"text","conversion_output":true,"text":"standard errors to account for potential overdispersion. The model will include fixed effects for","text_display":" standard errors to account for potential overdispersion. The model will include fixed effects for","confidence":1,"confidence_rate":1},{"cnt":[[245,404],[1764,404],[1764,453],[245,453]],"region":{"top_left_x":244,"top_left_y":403,"width":1520,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c3885d2f49040c1885a6d31529ece19","type":"text","conversion_output":true,"text":"treatment group (categorical) and the normalized baseline attack rate (continuous), and the","text_display":" treatment group (categorical) and the normalized baseline attack rate (continuous), and the","confidence":1,"confidence_rate":1},{"cnt":[[245,451],[1848,451],[1848,501],[245,501]],"region":{"top_left_x":244,"top_left_y":451,"width":1604,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fa294cbfeea43b9a0da2adf09e95d19","type":"text","conversion_output":true,"text":"logarithm of time in days each subject was observed during the treatment period will be used as","text_display":" logarithm of time in days each subject was observed during the treatment period will be used as","confidence":1,"confidence_rate":1},{"cnt":[[245,501],[1742,501],[1742,546],[245,546]],"region":{"top_left_x":244,"top_left_y":500,"width":1499,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbbd39debcd04850beee08dca5e7d4d5","type":"text","conversion_output":true,"text":"an offset variable in the model. See Section 10.2.9.1 for the calculation of the normalized","text_display":" an offset variable in the model. See Section 10.2.9.1 for the calculation of the normalized","confidence":1,"confidence_rate":1},{"cnt":[[245,546],[582,546],[582,591],[245,591]],"region":{"top_left_x":244,"top_left_y":545,"width":339,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"018cc458b53f4ddc91dc5565abc313b0","type":"text","conversion_output":true,"text":"baseline attack rate.","text_display":" baseline attack rate.","confidence":1,"confidence_rate":1},{"cnt":[[245,638],[1858,638],[1858,690],[245,690]],"region":{"top_left_x":244,"top_left_y":638,"width":1615,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bec076246c143ca9ff9245427837f99","type":"text","conversion_output":true,"text":"From this model, the least squares mean rate and standard error for each treatment group as well","text_display":"\n\nFrom this model, the least squares mean rate and standard error for each treatment group as well","confidence":1,"confidence_rate":1},{"cnt":[[245,685],[1878,683],[1878,735],[245,737]],"region":{"top_left_x":244,"top_left_y":683,"width":1634,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f94ce2ac22f44c0b8dbdc5dd7382238","type":"text","conversion_output":true,"text":"as, the mean rate ratios relative to the placebo group and corresponding \\(95 \\%\\) confidence intervals","text_display":" as, the mean rate ratios relative to the placebo group and corresponding \\(95 \\%\\) confidence intervals","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[245,733],[1878,733],[1878,784],[245,784]],"region":{"top_left_x":244,"top_left_y":732,"width":1634,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26cfb54622b046e094fb9a920db9ea53","type":"text","conversion_output":true,"text":"for each active treatment group will be estimated. These estimates will be reported as mean event","text_display":" for each active treatment group will be estimated. These estimates will be reported as mean event","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[1820,782],[1820,831],[245,831]],"region":{"top_left_x":244,"top_left_y":782,"width":1576,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"830f49e240fd4fd891a9da0a93c7c263","type":"text","conversion_output":true,"text":"rates per unit of time (week and monthly) by transforming the estimates using the exponential","text_display":" rates per unit of time (week and monthly) by transforming the estimates using the exponential","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[920,829],[920,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":676,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22747eb00e2344d5a2e75173d1805498","type":"text","conversion_output":true,"text":"function and scaling by the unit of time.","text_display":" function and scaling by the unit of time.","confidence":1,"confidence_rate":1},{"cnt":[[245,920],[1334,920],[1334,969],[245,969]],"region":{"top_left_x":244,"top_left_y":919,"width":1091,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82fdcd74721448a68e061a7c236dc38f","type":"text","conversion_output":true,"text":"The primary endpoint will be tested by the following hypothesis:","text_display":"\n\nThe primary endpoint will be tested by the following hypothesis:","confidence":0.9990234375,"confidence_rate":0.9999858401053562},{"cnt":[[595,1005],[1525,1005],[1525,1063],[595,1063]],"region":{"top_left_x":595,"top_left_y":1005,"width":931,"height":59},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f70184cd7b3f4aff96a22e5fe1ebd363","type":"math","conversion_output":true,"text":"\\[\nH_{0}: \\lambda_{DX-2930} / \\lambda_{\\text {placebo }}=1 \\text { versus } H_{1}: \\lambda_{DX-2930} / \\lambda_{\\text {placebo }} \\neq 1\n\\]","text_display":"\n\\[\nH_{0}: \\lambda_{DX-2930} / \\lambda_{\\text {placebo }}=1 \\text { versus } H_{1}: \\lambda_{DX-2930} / \\lambda_{\\text {placebo }} \\neq 1\n\\]","confidence":0.7733888626098633,"confidence_rate":0.9978608470851706},{"cnt":[[243,1096],[1811,1096],[1811,1147],[243,1147]],"region":{"top_left_x":242,"top_left_y":1095,"width":1570,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34b7d8e774b14850874cba1d2a703f6b","type":"text","conversion_output":true,"text":"\\(\\lambda_{\\text {DX-2930 }}\\) refers to the mean investigator-confirmed HAE attack rate in the DX-2930 group and","text_display":"\n\\(\\lambda_{\\text {DX-2930 }}\\) refers to the mean investigator-confirmed HAE attack rate in the DX-2930 group and","confidence":0.994140625,"confidence_rate":0.9999450799334987},{"cnt":[[245,1145],[1852,1145],[1852,1197],[245,1197]],"region":{"top_left_x":244,"top_left_y":1145,"width":1608,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc4376db968a4022bfa38479fe151dec","type":"text","conversion_output":true,"text":"\\(\\lambda_{\\text {Placebo }}\\) refers to the mean investigator-confirmed HAE attack rate in the placebo group. The null","text_display":" \\(\\lambda_{\\text {Placebo }}\\) refers to the mean investigator-confirmed HAE attack rate in the placebo group. The null","confidence":0.9990234375,"confidence_rate":0.9999913536688149},{"cnt":[[245,1195],[1779,1195],[1779,1244],[245,1244]],"region":{"top_left_x":244,"top_left_y":1194,"width":1535,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e193a6586bd347cab4ba82cc3f84c39d","type":"text","conversion_output":true,"text":"hypothesis is that the mean investigator-confirmed HAE attack rate ratio is 1 (no difference","text_display":" hypothesis is that the mean investigator-confirmed HAE attack rate ratio is 1 (no difference","confidence":1,"confidence_rate":1},{"cnt":[[245,1242],[1863,1242],[1863,1291],[245,1291]],"region":{"top_left_x":244,"top_left_y":1241,"width":1619,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a3df476915e49c7988dd8d719fe9290","type":"text","conversion_output":true,"text":"between treatment groups), versus the alternative hypothesis that the HAE attack rate ratio is not","text_display":" between treatment groups), versus the alternative hypothesis that the HAE attack rate ratio is not","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[247,1289],[1833,1289],[1833,1338],[247,1338]],"region":{"top_left_x":247,"top_left_y":1289,"width":1586,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21e1d607deaf4fc1906cc3c2d3ec994f","type":"text","conversion_output":true,"text":"1. Estimated attack rate ratios less than one would indicate that subjects treated with DX-2930,","text_display":" 1. Estimated attack rate ratios less than one would indicate that subjects treated with DX-2930,","confidence":1,"confidence_rate":1},{"cnt":[[245,1336],[1848,1336],[1848,1388],[245,1388]],"region":{"top_left_x":244,"top_left_y":1336,"width":1604,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c2f5fe3ca394ab6b605230893699add","type":"text","conversion_output":true,"text":"on average, have a lower incidence of investigator-confirmed HAE attacks during the treatment","text_display":" on average, have a lower incidence of investigator-confirmed HAE attacks during the treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1386],[1848,1386],[1848,1437],[245,1437]],"region":{"top_left_x":244,"top_left_y":1385,"width":1604,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b044fb8a0b8d4f59b1863b9fa27babb6","type":"text","conversion_output":true,"text":"period. The hypothesis will be tested using the model-based least squares means estimate of the","text_display":" period. The hypothesis will be tested using the model-based least squares means estimate of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1435],[1190,1435],[1190,1485],[245,1485]],"region":{"top_left_x":244,"top_left_y":1435,"width":947,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cfa817edaed4f62aba94602fc65dff0","type":"text","conversion_output":true,"text":"treatment difference using a Wald-based chi-square test.","text_display":" treatment difference using a Wald-based chi-square test.","confidence":1,"confidence_rate":1},{"cnt":[[245,1521],[1747,1521],[1747,1573],[245,1573]],"region":{"top_left_x":244,"top_left_y":1521,"width":1503,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf027c94f104413eac5aae67a94ba067","type":"text","conversion_output":true,"text":"The percentage difference in mean investigator-confirmed HAE attack rate of each active","text_display":"\n\nThe percentage difference in mean investigator-confirmed HAE attack rate of each active","confidence":1,"confidence_rate":1},{"cnt":[[245,1571],[1835,1571],[1835,1622],[245,1622]],"region":{"top_left_x":244,"top_left_y":1570,"width":1591,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d44e1a24b9a6447c96366c9de308bf1b","type":"text","conversion_output":true,"text":"treatment group from the attack rate of placebo will be calculated as \\(100 \\%^{*}\\) (mean rate ratio -","text_display":" treatment group from the attack rate of placebo will be calculated as \\(100 \\%^{*}\\) (mean rate ratio ","confidence":0.9273686434607953,"confidence_rate":0.9993084583185358},{"cnt":[[247,1620],[1785,1620],[1785,1669],[247,1669]],"region":{"top_left_x":247,"top_left_y":1619,"width":1539,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e63e312e25db4148b1739b2e39302fa4","type":"text","conversion_output":true,"text":"1). Similarly, the estimated upper and lower confidence limits for the mean rate ratio can be","text_display":"1). Similarly, the estimated upper and lower confidence limits for the mean rate ratio can be","confidence":0.99658203125,"confidence_rate":0.9999650636373343},{"cnt":[[245,1667],[1867,1667],[1867,1717],[245,1717]],"region":{"top_left_x":244,"top_left_y":1667,"width":1623,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2034dbaf9d814f5ebff8614158194afb","type":"text","conversion_output":true,"text":"transformed by subtracting 1 and multiplying by \\(100 \\%\\) to calculate \\(95 \\%\\) confidence intervals for","text_display":" transformed by subtracting 1 and multiplying by \\(100 \\%\\) to calculate \\(95 \\%\\) confidence intervals for","confidence":1,"confidence_rate":1},{"cnt":[[245,1714],[1876,1714],[1876,1764],[245,1764]],"region":{"top_left_x":244,"top_left_y":1714,"width":1632,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f18732b240c74ae89eb868b37eacdcd2","type":"text","conversion_output":true,"text":"the percentage change. The mean rate ratios and corresponding \\(95 \\%\\) confidence intervals will be","text_display":" the percentage change. The mean rate ratios and corresponding \\(95 \\%\\) confidence intervals will be","confidence":0.9980480668600649,"confidence_rate":0.9999808448830297},{"cnt":[[245,1762],[1399,1762],[1399,1813],[245,1813]],"region":{"top_left_x":244,"top_left_y":1761,"width":1155,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"107916c28b5c4b90931391ad2e128740","type":"text","conversion_output":true,"text":"estimated from the generalized linear model as described previously.","text_display":" estimated from the generalized linear model as described previously.","confidence":1,"confidence_rate":1},{"cnt":[[245,1852],[1850,1852],[1850,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1851,"width":1606,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d19b4f90efc498790b8714fc70a67de","type":"text","conversion_output":true,"text":"In order to maintain the overall Type I error at 0.05 , a conservative Bonferroni-based procedure","text_display":"\n\nIn order to maintain the overall Type I error at 0.05 , a conservative Bonferroni-based procedure","confidence":0.97705078125,"confidence_rate":0.999778913475841},{"cnt":[[245,1899],[1830,1899],[1830,1951],[245,1951]],"region":{"top_left_x":244,"top_left_y":1899,"width":1587,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcbeae3ed0554cd3adb701f4e4dab4e7","type":"text","conversion_output":true,"text":"will be used for the comparisons of each of the active treatment groups with the placebo group","text_display":" will be used for the comparisons of each of the active treatment groups with the placebo group","confidence":1,"confidence_rate":1},{"cnt":[[245,1946],[1828,1946],[1828,1998],[245,1998]],"region":{"top_left_x":244,"top_left_y":1946,"width":1585,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2368fd0608104097a403d9d75a95034c","type":"text","conversion_output":true,"text":"with equal weights for each test set at \\(1.67 \\%\\) significance level \\((\\alpha / 3)\\). See Section 9.5 for more","text_display":" with equal weights for each test set at \\(1.67 \\%\\) significance level \\((\\alpha / 3)\\). See Section 9.5 for more","confidence":0.513671875,"confidence_rate":0.9940164363761081},{"cnt":[[245,1994],[460,1994],[460,2039],[245,2039]],"region":{"top_left_x":244,"top_left_y":1993,"width":216,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9dbbdf46099479b9aad8aa61491740f","type":"text","conversion_output":true,"text":"information.","text_display":" information.","confidence":1,"confidence_rate":1},{"cnt":[[245,2084],[1706,2084],[1706,2136],[245,2136]],"region":{"top_left_x":244,"top_left_y":2083,"width":1462,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88249a2dc6044308b500eb6dddb72f3b","type":"text","conversion_output":true,"text":"Unadjusted monthly investigator-confirmed HAE attack rates will be calculated for the","text_display":"\n\nUnadjusted monthly investigator-confirmed HAE attack rates will be calculated for the","confidence":1,"confidence_rate":1},{"cnt":[[245,2133],[1798,2133],[1798,2185],[245,2185]],"region":{"top_left_x":244,"top_left_y":2133,"width":1555,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d24af6a523774d88b334d8e5af3cd830","type":"text","conversion_output":true,"text":"pretreatment, run-in and treatment periods. See Section 10.2.9 for details. The pretreatment","text_display":" pretreatment, run-in and treatment periods. See Section 10.2.9 for details. The pretreatment","confidence":1,"confidence_rate":1},{"cnt":[[245,2179],[1807,2179],[1807,2230],[245,2230]],"region":{"top_left_x":244,"top_left_y":2178,"width":1563,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65ad235eaa5c4e59a6e113cb0a236924","type":"text","conversion_output":true,"text":"period, run-in period, treatment period, treatment period change from baseline, and treatment","text_display":" period, run-in period, treatment period, treatment period change from baseline, and treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,2228],[1861,2228],[1861,2279],[245,2279]],"region":{"top_left_x":244,"top_left_y":2227,"width":1617,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"735beddb2a5f4f48b6b1a33801e2d0fc","type":"text","conversion_output":true,"text":"period change from run-in period in the monthly investigator-confirmed HAE attack rate will be","text_display":" period change from run-in period in the monthly investigator-confirmed HAE attack rate will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2277],[1803,2277],[1803,2327],[245,2327]],"region":{"top_left_x":244,"top_left_y":2277,"width":1559,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa6e18d780d84aa18842d42c8f3a24d6","type":"text","conversion_output":true,"text":"summarized by treatment group. This summary will include the total number of investigator-","text_display":" summarized by treatment group. This summary will include the total number of investigator","confidence":1,"confidence_rate":1},{"cnt":[[245,2325],[1841,2325],[1841,2374],[245,2374]],"region":{"top_left_x":244,"top_left_y":2324,"width":1598,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af3d14f8f356425b954705ac672d4171","type":"text","conversion_output":true,"text":"confirmed HAE attacks reported and the subject-time in months each subject contributed to the","text_display":"confirmed HAE attacks reported and the subject-time in months each subject contributed to the","confidence":1,"confidence_rate":1},{"cnt":[[245,2372],[1775,2372],[1775,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2371,"width":1531,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f84078c07cfd4ef2b4d6159d13cefa12","type":"text","conversion_output":true,"text":"pretreatment, run-in period, and treatment period. Figures by treatment group (one for each","text_display":" pretreatment, run-in period, and treatment period. Figures by treatment group (one for each","confidence":1,"confidence_rate":1},{"cnt":[[245,2587],[432,2587],[432,2628],[245,2628]],"region":{"top_left_x":244,"top_left_y":2586,"width":188,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"761af0fb629645b4bff91fb5dbb5af75","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1880,2587],[1880,2628],[1676,2628]],"region":{"top_left_x":1675,"top_left_y":2586,"width":205,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c05faeb4164485bb5bb9cd8b68ae711","type":"page_info","conversion_output":false,"text":"Page 24 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-25","page":25,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0cbae042dae14f7baea42673735e810b","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,168],[1880,168],[1880,208],[1676,208]],"region":{"top_left_x":1675,"top_left_y":167,"width":205,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94c91845e3a0459d9a0972177783d6a8","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,262],[1833,262],[1833,312],[245,312]],"region":{"top_left_x":244,"top_left_y":262,"width":1589,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c46db157c2984f4b9d46a2dbca3911e6","type":"text","conversion_output":true,"text":"treatment group) plotting the on-study investigator-confirmed HAE attacks reported during the","text_display":"\ntreatment group) plotting the on-study investigator-confirmed HAE attacks reported during the","confidence":1,"confidence_rate":1},{"cnt":[[245,309],[1497,309],[1497,359],[245,359]],"region":{"top_left_x":244,"top_left_y":309,"width":1254,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e386a7beb354c8fac6f3387f5dd2290","type":"text","conversion_output":true,"text":"treatment period relative to randomization for each subject will be created.","text_display":" treatment period relative to randomization for each subject will be created.","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1768,397],[1768,449],[245,449]],"region":{"top_left_x":244,"top_left_y":397,"width":1525,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"020c407bc41c45f7a369c9a19fc32fac","type":"text","conversion_output":true,"text":"In addition to the data summaries for the primary analysis of the primary efficacy endpoint","text_display":"\n\nIn addition to the data summaries for the primary analysis of the primary efficacy endpoint","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1818,447],[1818,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1574,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dde73bf13a334034bab66667da0abc7d","type":"text","conversion_output":true,"text":"described above, the number of investigator-confirmed HAE attacks per month (defined as 28","text_display":" described above, the number of investigator-confirmed HAE attacks per month (defined as 28","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1863,494],[1863,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1619,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94f7fad7fbb8423689e909a73ec0623a","type":"text","conversion_output":true,"text":"days) will be summarized descriptively by month (per 28 day interval) and treatment group. The","text_display":" days) will be summarized descriptively by month (per 28 day interval) and treatment group. The","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1704,541],[1704,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":1460,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0654702c7a174a50abc50125186a5ef7","type":"text","conversion_output":true,"text":"summary will include the number, change from pretreatment, and percent change from","text_display":" summary will include the number, change from pretreatment, and percent change from","confidence":1,"confidence_rate":1},{"cnt":[[245,589],[1876,589],[1876,640],[245,640]],"region":{"top_left_x":244,"top_left_y":588,"width":1632,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0eb838cc333b4a9b9e77eb64743e83ed","type":"text","conversion_output":true,"text":"pretreatment of investigator-confirmed HAE attacks. Investigator-confirmed HAE attacks will be","text_display":" pretreatment of investigator-confirmed HAE attacks. Investigator-confirmed HAE attacks will be","confidence":1,"confidence_rate":1},{"cnt":[[245,638],[1734,638],[1734,690],[245,690]],"region":{"top_left_x":244,"top_left_y":638,"width":1490,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bde3971ee4a8468db5d3d56c692c076e","type":"text","conversion_output":true,"text":"grouped into 28-day intervals using the start date of the HAE attack. The date of the first","text_display":" grouped into 28-day intervals using the start date of the HAE attack. The date of the first","confidence":0.9208984375,"confidence_rate":0.999141977447816},{"cnt":[[245,688],[1867,688],[1867,735],[245,735]],"region":{"top_left_x":244,"top_left_y":687,"width":1623,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f20c728d78b43ac8325b43e8252430b","type":"text","conversion_output":true,"text":"exposure to study drug will be used as the start of the first interval and end of the interval will be","text_display":" exposure to study drug will be used as the start of the first interval and end of the interval will be","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[245,735],[1835,735],[1835,784],[245,784]],"region":{"top_left_x":244,"top_left_y":734,"width":1591,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34eb72897fc14d8aa0de70faf2be6900","type":"text","conversion_output":true,"text":"the date of first exposure to study drug plus 28 days. Each successive interval will start the last","text_display":" the date of first exposure to study drug plus 28 days. Each successive interval will start the last","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[1852,782],[1852,831],[245,831]],"region":{"top_left_x":244,"top_left_y":782,"width":1608,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff7d0504007249a7a0e107393a8c9d4b","type":"text","conversion_output":true,"text":"day of the prior interval plus 1 day and end 28 days later. See Section 10.2.6.1 for the definition","text_display":" day of the prior interval plus 1 day and end 28 days later. See Section 10.2.6.1 for the definition","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[698,829],[698,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":455,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb853c66d305423994dcea1d9f5781bb","type":"text","conversion_output":true,"text":"of the pretreatment period.","text_display":" of the pretreatment period.","confidence":1,"confidence_rate":1},{"cnt":[[245,920],[1008,920],[1008,969],[245,969]],"region":{"top_left_x":244,"top_left_y":919,"width":764,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bdb9feb996b44488579a659354f8728","type":"text","conversion_output":true,"text":"All HAE attacks will be presented in listings.","text_display":"\n\nAll HAE attacks will be presented in listings.","confidence":1,"confidence_rate":1},{"cnt":[[241,1005],[956,1005],[956,1063],[241,1063]],"region":{"top_left_x":240,"top_left_y":1005,"width":717,"height":59},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"633382c2fbac4c59b4bec871a87215d3","type":"section_header","conversion_output":false,"children_ids":["5b249a019f764001858954def159df34"],"text":"","text_display":""},{"cnt":[[245,1010],[952,1010],[952,1059],[245,1059]],"region":{"top_left_x":244,"top_left_y":1009,"width":708,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b249a019f764001858954def159df34","type":"text","conversion_output":true,"parent_id":"633382c2fbac4c59b4bec871a87215d3","text":"7.8.2 Secondary Efficacy Analyses","text_display":"\n\n\\subsection*{7.8.2 Secondary Efficacy Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[245,1096],[1291,1096],[1291,1147],[245,1147]],"region":{"top_left_x":244,"top_left_y":1095,"width":1048,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a509767fd0f47a0ae7c10f2498dde89","type":"text","conversion_output":true,"text":"The rank ordered secondary efficacy endpoints are as follows:","text_display":"\n\nThe rank ordered secondary efficacy endpoints are as follows:","confidence":1,"confidence_rate":1},{"cnt":[[249,1188],[1721,1188],[1721,1240],[249,1240]],"region":{"top_left_x":249,"top_left_y":1188,"width":1472,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4a11b834fba4265965d5bac9984b7ed","type":"text","conversion_output":true,"text":"1. Number of investigator-confirmed HAE attacks requiring acute treatment during the","text_display":"\n1. Number of investigator-confirmed HAE attacks requiring acute treatment during the","confidence":1,"confidence_rate":1},{"cnt":[[305,1238],[599,1238],[599,1287],[305,1287]],"region":{"top_left_x":305,"top_left_y":1237,"width":295,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"961c1bcb192c4162815bb7a6c5e60fda","type":"text","conversion_output":true,"text":"treatment period.","text_display":" treatment period.","confidence":1,"confidence_rate":1},{"cnt":[[245,1289],[1790,1289],[1790,1338],[245,1338]],"region":{"top_left_x":244,"top_left_y":1289,"width":1546,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdb85bd7e1074b4290b4cf649f269924","type":"text","conversion_output":true,"text":"2. Number of moderate or severe investigator-confirmed HAE attacks during the treatment","text_display":"\n2. Number of moderate or severe investigator-confirmed HAE attacks during the treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,1336],[432,1336],[432,1388],[305,1388]],"region":{"top_left_x":305,"top_left_y":1336,"width":127,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae055dadccbd4720ab7dd87995d559a6","type":"text","conversion_output":true,"text":"period.","text_display":" period.","confidence":1,"confidence_rate":1},{"cnt":[[245,1429],[1828,1429],[1828,1478],[245,1478]],"region":{"top_left_x":244,"top_left_y":1428,"width":1585,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c30bac02abb34918962b76d1d632b676","type":"text","conversion_output":true,"text":"The secondary endpoints will be analyzed using the same method as described for the primary","text_display":"\n\nThe secondary endpoints will be analyzed using the same method as described for the primary","confidence":1,"confidence_rate":1},{"cnt":[[245,1474],[1828,1474],[1828,1525],[245,1525]],"region":{"top_left_x":244,"top_left_y":1473,"width":1585,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f39160e85dfe4b90b6bc836e05e42a4e","type":"text","conversion_output":true,"text":"efficacy endpoint. Data summaries will parallel those described for the primary analysis of the","text_display":" efficacy endpoint. 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Secondary endpoints will not be declared statistically significant","text_display":" rank ordering of the endpoints. Secondary endpoints will not be declared statistically significant","confidence":1,"confidence_rate":1},{"cnt":[[245,1805],[1878,1805],[1878,1854],[245,1854]],"region":{"top_left_x":244,"top_left_y":1804,"width":1634,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7592ebb7c8e348959e0233b6e4e06fcb","type":"text","conversion_output":true,"text":"unless the primary endpoint for that active treatment group to placebo group comparison is found","text_display":" unless the primary endpoint for that active treatment group to placebo group comparison is found","confidence":1,"confidence_rate":1},{"cnt":[[245,1852],[1373,1852],[1373,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1851,"width":1129,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52adaf4ef43a4d5683461ba646ab114c","type":"text","conversion_output":true,"text":"to be statistically significant. See Section 9.5 for more information.","text_display":" to be statistically significant. See Section 9.5 for more information.","confidence":0.994140625,"confidence_rate":0.9999246617035978},{"cnt":[[243,1938],[986,1938],[986,1996],[243,1996]],"region":{"top_left_x":242,"top_left_y":1937,"width":745,"height":59},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f59cf5f64474ebc93d6e6918f8437ad","type":"section_header","conversion_output":false,"children_ids":["d72e916ac8d24a25b2d44d5fffd310e4"],"text":"","text_display":""},{"cnt":[[245,1942],[982,1942],[982,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1942,"width":738,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d72e916ac8d24a25b2d44d5fffd310e4","type":"text","conversion_output":true,"parent_id":"3f59cf5f64474ebc93d6e6918f8437ad","text":"7.8.3 Exploratory Efficacy Analyses","text_display":"\n\n\\subsection*{7.8.3 Exploratory Efficacy 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a subject is attack free after Day 14","confidence":0.9985356330871582,"confidence_rate":0.9999856330429514},{"cnt":[[245,2179],[1850,2179],[1850,2232],[245,2232]],"region":{"top_left_x":244,"top_left_y":2178,"width":1606,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"185f6b913f75455dade3d19be06d3d04","type":"text","conversion_output":true,"text":"- Number of high-morbidity investigator-confirmed HAE attacks during the treatment period.","text_display":"\n- Number of high-morbidity investigator-confirmed HAE attacks during the treatment period.","confidence":1,"confidence_rate":1},{"cnt":[[245,2239],[1837,2239],[1837,2290],[245,2290]],"region":{"top_left_x":244,"top_left_y":2238,"width":1593,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a47dfea9541747b392616159c3e64c56","type":"text","conversion_output":true,"text":"- Number of investigator-confirmed HAE attacks resulting in an emergency department visit","text_display":"\n- Number of investigator-confirmed HAE attacks resulting in an emergency department visit","confidence":1,"confidence_rate":1},{"cnt":[[305,2288],[788,2288],[788,2340],[305,2340]],"region":{"top_left_x":305,"top_left_y":2288,"width":484,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dae0c432840146e69edc4bc876f45d19","type":"text","conversion_output":true,"text":"or admission to the hospital.","text_display":" or admission to the hospital.","confidence":1,"confidence_rate":1},{"cnt":[[245,2346],[1846,2346],[1846,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2346,"width":1602,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f89d4478933642fea7dfd2b866838dc4","type":"text","conversion_output":true,"text":"- Number of investigator-confirmed HAE attacks resulting in an emergency department visit.","text_display":"\n- Number of investigator-confirmed 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Data summaries will parallel those described for the primary analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,309],[801,309],[801,359],[245,359]],"region":{"top_left_x":244,"top_left_y":309,"width":558,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f6612b11464401397e7096adb5fe6fa","type":"text","conversion_output":true,"text":"of the primary efficacy endpoint.","text_display":" of the primary efficacy endpoint.","confidence":0.99951171875,"confidence_rate":0.9999871474379078},{"cnt":[[241,395],[1680,395],[1680,451],[241,451]],"region":{"top_left_x":240,"top_left_y":395,"width":1441,"height":57},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96b8199962a64861b0ef8fa05eadc4cf","type":"section_header","conversion_output":false,"children_ids":["7bd52a4dd8c440fca22870ef1aa27967"],"text":"","text_display":""},{"cnt":[[245,400],[1674,400],[1674,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1430,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bd52a4dd8c440fca22870ef1aa27967","type":"text","conversion_output":true,"parent_id":"96b8199962a64861b0ef8fa05eadc4cf","text":"Number of investigator-confirmed HAE attacks resulting in admission to the hospital","text_display":"\n\n\\section*{Number of investigator-confirmed HAE attacks resulting in admission to the hospital}","confidence":1,"confidence_rate":1},{"cnt":[[245,490],[1798,490],[1798,535],[245,535]],"region":{"top_left_x":244,"top_left_y":489,"width":1555,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1190942dfc85475784f73369c265983f","type":"text","conversion_output":true,"text":"For each HAE attack, the site records if the attack resulted in hospitalization. The number of","text_display":"\n\nFor each HAE attack, the site records if the attack resulted in hospitalization. The number of","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1830,537],[1830,587],[245,587]],"region":{"top_left_x":244,"top_left_y":537,"width":1587,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf50f9453ed840338bb9cc765204d688","type":"text","conversion_output":true,"text":"investigator-confirmed HAE attacks resulting in admission to the hospital during the treatment","text_display":" investigator-confirmed HAE attacks resulting in admission to the hospital during the treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,584],[1747,584],[1747,634],[245,634]],"region":{"top_left_x":244,"top_left_y":584,"width":1503,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe65bdf946d442dc86571195085b12e6","type":"text","conversion_output":true,"text":"period will be analyzed using the same method as for the primary efficacy endpoint. Data","text_display":" period will be analyzed using the same method as for the primary efficacy endpoint. Data","confidence":1,"confidence_rate":1},{"cnt":[[245,632],[1714,632],[1714,681],[245,681]],"region":{"top_left_x":244,"top_left_y":631,"width":1471,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab87cfc4c9cd451ea7f77283be35e183","type":"text","conversion_output":true,"text":"summaries will parallel those described for the primary analysis of the primary efficacy","text_display":" summaries will parallel those described for the primary analysis of the primary efficacy","confidence":1,"confidence_rate":1},{"cnt":[[245,679],[406,679],[406,728],[245,728]],"region":{"top_left_x":244,"top_left_y":678,"width":163,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41f3f04a43eb4c0eb527e433cc35e9fb","type":"text","conversion_output":true,"text":"endpoint.","text_display":" endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[236,765],[1863,765],[1863,872],[236,872]],"region":{"top_left_x":236,"top_left_y":764,"width":1627,"height":109},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19ab5da53aad44fd9a16ee9d66d411a2","type":"section_header","conversion_output":false,"children_ids":["2cdd26592d67461988c1bafdf7126408","a31188e926f5483e80913fa2076eab84"],"text":"","text_display":""},{"cnt":[[243,769],[1858,769],[1858,819],[243,819]],"region":{"top_left_x":242,"top_left_y":769,"width":1617,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cdd26592d67461988c1bafdf7126408","type":"text","conversion_output":true,"parent_id":"19ab5da53aad44fd9a16ee9d66d411a2","text":"Achievement of reduction from pretreatment in the investigator-confirmed HAE attack rate (i.e.,","text_display":"\n\n\\section*{Achievement of reduction from pretreatment in the investigator-confirmed HAE attack rate (i.e.,","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,821],[587,821],[587,866],[245,866]],"region":{"top_left_x":244,"top_left_y":820,"width":343,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a31188e926f5483e80913fa2076eab84","type":"text","conversion_output":true,"parent_id":"19ab5da53aad44fd9a16ee9d66d411a2","text":"responder analysis)","text_display":" responder analysis)}","confidence":1,"confidence_rate":1},{"cnt":[[245,907],[1867,907],[1867,956],[245,956]],"region":{"top_left_x":244,"top_left_y":906,"width":1623,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1a162b73fe94167ba352da74bff9dd6","type":"text","conversion_output":true,"text":"There will be five classes of responders based on percent reduction in the investigator-confirmed","text_display":"\n\nThere will be five classes of responders based on percent reduction in the investigator-confirmed","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1725,954],[1725,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":953,"width":1482,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ba61be756984c9f9bc232782d9f708b","type":"text","conversion_output":true,"text":"HAE attack rate from the pretreatment attack rate: 50\\% or more reduction, \\(60 \\%\\) or more","text_display":" HAE attack rate from the pretreatment attack rate: 50\\% or more reduction, \\(60 \\%\\) or more","confidence":0.7525885105133057,"confidence_rate":0.9969483575046472},{"cnt":[[245,1001],[1858,1001],[1858,1051],[245,1051]],"region":{"top_left_x":244,"top_left_y":1001,"width":1615,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7144ae0972f4c4d906861e10f994232","type":"text","conversion_output":true,"text":"reduction, \\(70 \\%\\) or more reduction, \\(80 \\%\\) or more reduction and \\(90 \\%\\) or more reduction. For each","text_display":" reduction, \\(70 \\%\\) or more reduction, \\(80 \\%\\) or more reduction and \\(90 \\%\\) or more reduction. For each","confidence":0.9673452377319336,"confidence_rate":0.9996838611455278},{"cnt":[[245,1048],[1858,1048],[1858,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1048,"width":1615,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cbaaefa8bd241c18ee1712b99c4ee5d","type":"text","conversion_output":true,"text":"subject, a treatment period HAE attack rate and pretreatment HAE attack rate will be calculated.","text_display":" subject, a treatment period HAE attack rate and pretreatment HAE attack rate will be calculated.","confidence":1,"confidence_rate":1},{"cnt":[[245,1096],[1820,1096],[1820,1147],[245,1147]],"region":{"top_left_x":244,"top_left_y":1095,"width":1576,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"896613dcd2134857a2e3af0f2492442f","type":"text","conversion_output":true,"text":"See Section 10.2.9 for details. The percentage reduction will be calculated as the pretreatment","text_display":" See Section 10.2.9 for details. The percentage reduction will be calculated as the pretreatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1145],[1824,1145],[1824,1197],[245,1197]],"region":{"top_left_x":244,"top_left_y":1145,"width":1581,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db899bdc3b964b57bec7b6b2a9236771","type":"text","conversion_output":true,"text":"HAE attack rate minus the treatment period HAE attack rate divided by the pretreatment HAE","text_display":" HAE attack rate minus the treatment period HAE attack rate divided by the pretreatment HAE","confidence":1,"confidence_rate":1},{"cnt":[[245,1195],[1800,1195],[1800,1244],[245,1244]],"region":{"top_left_x":244,"top_left_y":1194,"width":1557,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e783a1d0456343edbc292746200033a3","type":"text","conversion_output":true,"text":"attack rate. Summary statistics will be presented for each of the five classes of responders by","text_display":" attack rate. Summary statistics will be presented for each of the five classes of responders by","confidence":1,"confidence_rate":1},{"cnt":[[245,1242],[1583,1242],[1583,1291],[245,1291]],"region":{"top_left_x":244,"top_left_y":1241,"width":1340,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31e486f369044be88792829a242a27eb","type":"text","conversion_output":true,"text":"treatment. The five classes of responders are nested and not mutually exclusive.","text_display":" treatment. The five classes of responders are nested and not mutually exclusive.","confidence":1,"confidence_rate":1},{"cnt":[[241,1328],[1777,1328],[1777,1431],[241,1431]],"region":{"top_left_x":240,"top_left_y":1327,"width":1537,"height":104},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea70fd87982340dda9417c7c558aa8a5","type":"section_header","conversion_output":false,"children_ids":["79bcf4a64d764d8885e3b83e04ebffe4","79d33c0dfe59419c85cd6062b57a210b"],"text":"","text_display":""},{"cnt":[[245,1332],[1772,1332],[1772,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1332,"width":1529,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79bcf4a64d764d8885e3b83e04ebffe4","type":"text","conversion_output":true,"parent_id":"ea70fd87982340dda9417c7c558aa8a5","text":"Characteristics of investigator-confirmed HAE attacks, including attack duration, severity,","text_display":"\n\n\\section*{Characteristics of investigator-confirmed HAE attacks, including attack duration, severity,","confidence":1,"confidence_rate":1},{"cnt":[[245,1381],[707,1381],[707,1424],[245,1424]],"region":{"top_left_x":244,"top_left_y":1381,"width":463,"height":44},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79d33c0dfe59419c85cd6062b57a210b","type":"text","conversion_output":true,"parent_id":"ea70fd87982340dda9417c7c558aa8a5","text":"location and mediation use","text_display":" location and mediation use}","confidence":1,"confidence_rate":1},{"cnt":[[245,1448],[1824,1448],[1824,1497],[245,1497]],"region":{"top_left_x":244,"top_left_y":1448,"width":1581,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f79f28ae474c4180a9095c13c7893c2a","type":"text","conversion_output":true,"text":"Attack characteristics, as described below, will be summarized by treatment group and overall","text_display":"\n\nAttack characteristics, as described below, will be summarized by treatment group and overall","confidence":1,"confidence_rate":1},{"cnt":[[245,1495],[1233,1495],[1233,1545],[245,1545]],"region":{"top_left_x":244,"top_left_y":1495,"width":990,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cdc0a8fe39642d09fb030b089c987d2","type":"text","conversion_output":true,"text":"DX-2930 for the pretreatment period and treatment period.","text_display":" DX-2930 for the pretreatment period and treatment period.","confidence":1,"confidence_rate":1},{"cnt":[[245,1564],[621,1564],[621,1609],[245,1609]],"region":{"top_left_x":244,"top_left_y":1564,"width":377,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2baadacb54140579089ca47e6c83ac8","type":"text","conversion_output":true,"text":"HAE Attack Duration","text_display":"\n\nHAE Attack Duration","confidence":1,"confidence_rate":1},{"cnt":[[245,1635],[1867,1635],[1867,1682],[245,1682]],"region":{"top_left_x":244,"top_left_y":1634,"width":1623,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dc8af009e2a4a1e9ba132bc9b567862","type":"text","conversion_output":true,"text":"For each subject, the mean, minimum and maximum duration of all investigator-confirmed HAE","text_display":"\nFor each subject, the mean, minimum and maximum duration of all investigator-confirmed HAE","confidence":1,"confidence_rate":1},{"cnt":[[245,1680],[1871,1680],[1871,1732],[245,1732]],"region":{"top_left_x":244,"top_left_y":1680,"width":1628,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d325afca4e44585b04f732bc206fd3f","type":"text","conversion_output":true,"text":"attacks will be calculated in hours and summarized. See Section 10.2.7.1 for details. The subject-","text_display":" attacks will be calculated in hours and summarized. See Section 10.2.7.1 for details. The subject","confidence":1,"confidence_rate":1},{"cnt":[[245,1729],[1871,1729],[1871,1781],[245,1781]],"region":{"top_left_x":244,"top_left_y":1729,"width":1628,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99f1e2b53c1a41eea3532ad715604719","type":"text","conversion_output":true,"text":"level average attack duration will be categorized into 12 hour intervals and tabulated by category","text_display":"level average attack duration will be categorized into 12 hour intervals and tabulated by category","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,1779],[1184,1779],[1184,1828],[245,1828]],"region":{"top_left_x":244,"top_left_y":1778,"width":940,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c53b70824836474998ebfd309572db65","type":"text","conversion_output":true,"text":"(<12 hours, 12-24 hours, >24-48 hours, and >48 hours).","text_display":" (<12 hours, 12-24 hours, >24-48 hours, and >48 hours).","confidence":0.9936599708162248,"confidence_rate":0.9998922055979855},{"cnt":[[245,1843],[612,1843],[612,1897],[245,1897]],"region":{"top_left_x":244,"top_left_y":1843,"width":369,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb1ea8cd6526476d801f5df37e06613b","type":"text","conversion_output":true,"text":"HAE Attack Severity","text_display":"\nHAE Attack Severity","confidence":1,"confidence_rate":1},{"cnt":[[245,1916],[1880,1916],[1880,1966],[245,1966]],"region":{"top_left_x":244,"top_left_y":1916,"width":1636,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b8d1b6c872141449110ef62c8747f1b","type":"text","conversion_output":true,"text":"For each subject, the mean and maximum severity of all investigator-confirmed HAE attacks will","text_display":"\nFor each subject, the mean and maximum severity of all investigator-confirmed HAE attacks will","confidence":1,"confidence_rate":1},{"cnt":[[245,1964],[1798,1964],[1798,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1963,"width":1555,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0efd5b85b81e49d3aa74ead592652eef","type":"text","conversion_output":true,"text":"be calculated using a numerical rating and summarized. See Section 10.2.7.2 for details. The","text_display":" be calculated using a numerical rating and summarized. See Section 10.2.7.2 for details. The","confidence":1,"confidence_rate":1},{"cnt":[[245,2011],[1837,2011],[1837,2060],[245,2060]],"region":{"top_left_x":244,"top_left_y":2010,"width":1593,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fe7ebe5da3845049a5ed53bad5ff466","type":"text","conversion_output":true,"text":"number and percentage of subjects, as well as the number of events, will be tabulated by attack","text_display":" number and percentage of subjects, as well as the number of events, will be tabulated by attack","confidence":1,"confidence_rate":1},{"cnt":[[245,2058],[883,2058],[883,2108],[245,2108]],"region":{"top_left_x":244,"top_left_y":2058,"width":640,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32c5e33f17fc4b93bb784b22e928dd93","type":"text","conversion_output":true,"text":"severity (mild, moderate, and severe).","text_display":" severity (mild, moderate, and severe).","confidence":1,"confidence_rate":1},{"cnt":[[245,2127],[621,2127],[621,2172],[245,2172]],"region":{"top_left_x":244,"top_left_y":2126,"width":377,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"160b0d00ca04481286c92ea4e7490cfd","type":"text","conversion_output":true,"text":"HAE Attack Location","text_display":"\n\nHAE Attack Location","confidence":1,"confidence_rate":1},{"cnt":[[245,2196],[1798,2196],[1798,2245],[245,2245]],"region":{"top_left_x":244,"top_left_y":2195,"width":1555,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d85598573db24edebe03c9c5d71457b7","type":"text","conversion_output":true,"text":"The number and percentage of subjects with attacks, as well as the number of events, will be","text_display":"\nThe number and percentage of subjects with attacks, as well as the number of events, will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2243],[1373,2243],[1373,2292],[245,2292]],"region":{"top_left_x":244,"top_left_y":2242,"width":1129,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18955753cccb439dbf63621be765ee71","type":"text","conversion_output":true,"text":"tabulated by attack location (peripheral, abdominal, and laryngeal).","text_display":" tabulated by attack location (peripheral, abdominal, and laryngeal).","confidence":1,"confidence_rate":1},{"cnt":[[247,2587],[432,2587],[432,2628],[247,2628]],"region":{"top_left_x":247,"top_left_y":2586,"width":185,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9ca9246d4ae46a2b0f94568fc35924a","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1880,2587],[1880,2628],[1676,2628]],"region":{"top_left_x":1675,"top_left_y":2586,"width":205,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c342fa0f2328437189d60fc75c11ea02","type":"page_info","conversion_output":false,"text":"Page 27 of 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2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,262],[651,262],[651,303],[245,303]],"region":{"top_left_x":244,"top_left_y":262,"width":407,"height":41},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac6aa102f921410cb38363cf117b69c4","type":"text","conversion_output":true,"text":"Rescue Medication Use","text_display":"\n\nRescue Medication Use","confidence":1,"confidence_rate":1},{"cnt":[[245,329],[1867,329],[1867,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":1623,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcc5238e056649d7a067cba4c2f2dbfd","type":"text","conversion_output":true,"text":"The number and percentage of subjects with rescue medication use for an HAE attack, as well as","text_display":"\nThe number and percentage of subjects with rescue medication use for an HAE attack, as well as","confidence":1,"confidence_rate":1},{"cnt":[[245,378],[1781,378],[1781,425],[245,425]],"region":{"top_left_x":244,"top_left_y":378,"width":1538,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"378e7da9cf284be4bf6cbd480c96b27f","type":"text","conversion_output":true,"text":"the number of events, will be tabulated by rescue medication by type (ecallantide, icatibant,","text_display":" the number of events, will be tabulated by rescue medication by type (ecallantide, icatibant,","confidence":0.9990236759185791,"confidence_rate":0.9999900326925697},{"cnt":[[245,425],[1848,425],[1848,475],[245,475]],"region":{"top_left_x":244,"top_left_y":425,"width":1604,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"575748acaac84efab0f1b0fc064d3569","type":"text","conversion_output":true,"text":"nano-filtered C1-INH, plasma-derived C1-INH, recombinant C1-INH, fresh frozen plasma, and","text_display":" nano-filtered C1-INH, plasma-derived C1-INH, recombinant C1-INH, fresh frozen plasma, and","confidence":1,"confidence_rate":1},{"cnt":[[245,473],[363,473],[363,522],[245,522]],"region":{"top_left_x":244,"top_left_y":472,"width":120,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41ecd47a6e6146bf8118a990fbee3a1f","type":"text","conversion_output":true,"text":"other).","text_display":" other).","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[694,541],[694,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":450,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7654a72d654492d884e0b2fcc942709","type":"text","conversion_output":true,"text":"Supportive Treatment Use","text_display":"\n\nSupportive Treatment Use","confidence":1,"confidence_rate":1},{"cnt":[[245,632],[1867,632],[1867,681],[245,681]],"region":{"top_left_x":244,"top_left_y":631,"width":1623,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"123be61e01414a978ad32afdff6deff4","type":"text","conversion_output":true,"text":"The number and percentage of subjects with supportive treatment use for an HAE attack, as well","text_display":"\nThe number and percentage of subjects with supportive treatment use for an HAE attack, as well","confidence":1,"confidence_rate":1},{"cnt":[[245,679],[1755,679],[1755,728],[245,728]],"region":{"top_left_x":244,"top_left_y":678,"width":1512,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96f293ea3fdc466e93c9f0b14822bca6","type":"text","conversion_output":true,"text":"as the number of events, will be tabulated by supportive treatment by type (IV fluids, pain","text_display":" as the number of events, will be tabulated by supportive treatment by type (IV fluids, pain","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[990,726],[990,776],[245,776]],"region":{"top_left_x":244,"top_left_y":726,"width":747,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f26d76035b6470ba80c5706fb8d2ed3","type":"text","conversion_output":true,"text":"medication, oxygen, anti-emetic, and other).","text_display":" medication, oxygen, anti-emetic, and 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days}","confidence":0.9990234375,"confidence_rate":0.999974948015144},{"cnt":[[245,907],[1871,907],[1871,956],[245,956]],"region":{"top_left_x":244,"top_left_y":906,"width":1628,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b24f87f97fc24b21b66c704ad211b230","type":"text","conversion_output":true,"text":"The percentage of HAE attack free days will be calculated by counting the number of days in the","text_display":"\n\nThe percentage of HAE attack free days will be calculated by counting the number of days in the","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1833,954],[1833,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":953,"width":1589,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9780526cf3341b0bf25516bdf1a3734","type":"text","conversion_output":true,"text":"treatment period without an HAE attack and dividing by the number of days the subject was in","text_display":" treatment period without an HAE attack and dividing by the number of days the subject was in","confidence":1,"confidence_rate":1},{"cnt":[[245,1001],[1811,1001],[1811,1051],[245,1051]],"region":{"top_left_x":244,"top_left_y":1001,"width":1568,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddd470adb7b3493a94d3a62e13a7fa17","type":"text","conversion_output":true,"text":"the treatment period. If an HAE attack was 8 hours or less on a particular day that day will be","text_display":" the treatment period. If an HAE attack was 8 hours or less on a particular day that day will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1048],[1878,1048],[1878,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1048,"width":1634,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"213d465a212e41ea9a3da35f05011b57","type":"text","conversion_output":true,"text":"considered attack-free. Summaries of the percentage of HAE attack free days will be provided by","text_display":" considered attack-free. Summaries of the percentage of HAE attack free days will be provided by","confidence":1,"confidence_rate":1},{"cnt":[[245,1100],[526,1100],[526,1149],[245,1149]],"region":{"top_left_x":244,"top_left_y":1100,"width":283,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15113aae91d549d48cb77d0977e4ffac","type":"text","conversion_output":true,"text":"treatment group.","text_display":" treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[243,1186],[763,1186],[763,1244],[243,1244]],"region":{"top_left_x":242,"top_left_y":1185,"width":521,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a8e36b134324bb18afbc5c519e64848","type":"section_header","conversion_output":false,"children_ids":["3e251a87a414460ea86237dd01e59ea2"],"text":"","text_display":""},{"cnt":[[245,1190],[758,1190],[758,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1190,"width":515,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e251a87a414460ea86237dd01e59ea2","type":"text","conversion_output":true,"parent_id":"3a8e36b134324bb18afbc5c519e64848","text":"7.9 Analysis of Safety","text_display":"\n\n\\subsection*{7.9 Analysis of Safety}","confidence":1,"confidence_rate":1},{"cnt":[[245,1276],[1768,1276],[1768,1326],[245,1326]],"region":{"top_left_x":244,"top_left_y":1276,"width":1525,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea6eb153964b47799227d172fcc3d294","type":"text","conversion_output":true,"text":"All safety analyses will be performed on the Safety Population. No inferential statistics are","text_display":"\n\nAll safety analyses will be performed on the Safety Population. No inferential statistics are","confidence":1,"confidence_rate":1},{"cnt":[[245,1326],[393,1326],[393,1377],[245,1377]],"region":{"top_left_x":244,"top_left_y":1325,"width":150,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"983b6b3bcb2741ccb99e3e1a065a56e4","type":"text","conversion_output":true,"text":"planned.","text_display":" planned.","confidence":1,"confidence_rate":1},{"cnt":[[243,1414],[720,1414],[720,1463],[243,1463]],"region":{"top_left_x":242,"top_left_y":1413,"width":478,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7b1e656888343cdab9a1e6febff17c0","type":"section_header","conversion_output":false,"children_ids":["18b80c9fe2bb420399dad3b2db9423ce"],"text":"","text_display":""},{"cnt":[[245,1418],[715,1418],[715,1459],[245,1459]],"region":{"top_left_x":244,"top_left_y":1417,"width":472,"height":42},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18b80c9fe2bb420399dad3b2db9423ce","type":"text","conversion_output":true,"parent_id":"e7b1e656888343cdab9a1e6febff17c0","text":"7.9.1 Adverse Events","text_display":"\n\n\\subsection*{7.9.1 Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[245,1504],[1661,1504],[1661,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1503,"width":1417,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faeb4770ae244f6aaf0b51c73e3ea121","type":"text","conversion_output":true,"text":"Adverse events (AEs) will be coded using the MedDRA coding dictionary version 18.1.","text_display":"\n\nAdverse events (AEs) will be coded using the MedDRA coding dictionary version 18.1.","confidence":1,"confidence_rate":1},{"cnt":[[245,1592],[1854,1592],[1854,1641],[245,1641]],"region":{"top_left_x":244,"top_left_y":1591,"width":1611,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"665c909137964f2cb1e722998e7d459c","type":"text","conversion_output":true,"text":"Treatment-emergent AEs (TEAEs) are defined as AEs with onset at the time of or following the","text_display":"\nTreatment-emergent AEs (TEAEs) are defined as AEs with onset at the time of or following the","confidence":1,"confidence_rate":1},{"cnt":[[245,1641],[1760,1641],[1760,1691],[245,1691]],"region":{"top_left_x":244,"top_left_y":1641,"width":1516,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5558fffac8044bc5a5dd4d2c817638c7","type":"text","conversion_output":true,"text":"start of treatment with study medication, or medical conditions present prior to the start of","text_display":" start of treatment with study medication, or medical conditions present prior to the start of","confidence":1,"confidence_rate":1},{"cnt":[[245,1689],[1738,1689],[1738,1738],[245,1738]],"region":{"top_left_x":244,"top_left_y":1688,"width":1495,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be761279533343c6bba6072f0f226e6a","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":[[245,1736],[1843,1736],[1843,1785],[245,1785]],"region":{"top_left_x":244,"top_left_y":1735,"width":1600,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d018d10839f6415c8715daacfbfb172b","type":"text","conversion_output":true,"text":"treatment. For AEs with partial onset times, non-missing date parts will be used to determine if","text_display":" treatment. For AEs with partial onset times, non-missing date parts will be used to determine if","confidence":1,"confidence_rate":1},{"cnt":[[245,1783],[1826,1783],[1826,1833],[245,1833]],"region":{"top_left_x":244,"top_left_y":1783,"width":1583,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8602c61b2e104d5fb65f24df28294438","type":"text","conversion_output":true,"text":"the AE is treatment-emergent or not. If a determination cannot be made using the non-missing","text_display":" the AE is treatment-emergent or not. If a determination cannot be made using the non-missing","confidence":0.91845703125,"confidence_rate":0.99917451413546},{"cnt":[[245,1830],[1850,1830],[1850,1882],[245,1882]],"region":{"top_left_x":244,"top_left_y":1830,"width":1606,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c0848d33a75427098e75ecfc0796e28","type":"text","conversion_output":true,"text":"date parts as to when the AE occurred relative to study drug administration, then the AE will be","text_display":" date parts as to when the AE occurred relative to study drug administration, then the AE will be","confidence":0.97998046875,"confidence_rate":0.9997997959112063},{"cnt":[[245,1878],[801,1878],[801,1929],[245,1929]],"region":{"top_left_x":244,"top_left_y":1877,"width":558,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"549bf9eac27c40cbbc9b4f7accab8e28","type":"text","conversion_output":true,"text":"classified as treatment-emergent.","text_display":" classified as treatment-emergent.","confidence":1,"confidence_rate":1},{"cnt":[[245,1968],[1865,1968],[1865,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1967,"width":1621,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bafe2d34b1d149498797feb2ad304ff2","type":"text","conversion_output":true,"text":"The analyses described in this section will be based on treatment-emergent AEs; plainly referred","text_display":"\n\nThe analyses described in this section will be based on treatment-emergent AEs; plainly referred","confidence":1,"confidence_rate":1},{"cnt":[[245,2015],[853,2015],[853,2067],[245,2067]],"region":{"top_left_x":244,"top_left_y":2015,"width":609,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7705fcfd18d4b59aa09f1e86c827602","type":"text","conversion_output":true,"text":"to as AEs in this section for brevity.","text_display":" to as AEs in this section for brevity.","confidence":1,"confidence_rate":1},{"cnt":[[245,2105],[1865,2105],[1865,2155],[245,2155]],"region":{"top_left_x":244,"top_left_y":2105,"width":1621,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3dc3504dcb04866bce64451e2a23bb4","type":"text","conversion_output":true,"text":"Related AEs are AEs classified as related to study drug by the investigator. Severe AEs are AEs","text_display":"\n\nRelated AEs are AEs classified as related to study drug by the investigator. Severe AEs are AEs","confidence":1,"confidence_rate":1},{"cnt":[[245,2153],[1536,2153],[1536,2206],[245,2206]],"region":{"top_left_x":244,"top_left_y":2152,"width":1293,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19311783e52a4f259ee4449b3058d101","type":"text","conversion_output":true,"text":"classified as severe (grade 3) or life threatening (grade 4) by the investigator.","text_display":" classified as severe (grade 3) or life threatening (grade 4) by the investigator.","confidence":0.9228515625,"confidence_rate":0.9990668672892888},{"cnt":[[245,2243],[1452,2243],[1452,2292],[245,2292]],"region":{"top_left_x":244,"top_left_y":2242,"width":1209,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0993d8f62c8449148aae3b681c3ecb17","type":"text","conversion_output":true,"text":"For this analysis, AEs will be classified to one of three analysis periods:","text_display":"\n\nFor this analysis, AEs will be classified to one of three analysis periods:","confidence":1,"confidence_rate":1},{"cnt":[[245,2338],[1777,2338],[1777,2387],[245,2387]],"region":{"top_left_x":244,"top_left_y":2337,"width":1533,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c034856dac3d441e9ad1a3f346110cb8","type":"text","conversion_output":true,"text":"- Pretreatment Period AEs will include AEs starting at or after informed consent to those","text_display":"\n- Pretreatment Period AEs will include AEs starting at or after informed consent to those","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[305,2385],[1807,2385],[1807,2434],[305,2434]],"region":{"top_left_x":305,"top_left_y":2384,"width":1502,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6d54c9bba38407daa0ad3b361790aaa","type":"text","conversion_output":true,"text":"starting before the first exposure to study drug (AEs starting prior to treatment on Day 0 ).","text_display":" starting before the first exposure to study drug (AEs starting prior to treatment on Day 0 ).","confidence":0.91357421875,"confidence_rate":0.9991054433260318},{"cnt":[[245,2587],[432,2587],[432,2628],[245,2628]],"region":{"top_left_x":244,"top_left_y":2586,"width":188,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e06dd6af87104d159b6d0a2ae800dea5","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1880,2587],[1880,2628],[1676,2628]],"region":{"top_left_x":1675,"top_left_y":2586,"width":205,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b586cdb6954447e6990791c9b7b32923","type":"page_info","conversion_output":false,"text":"Page 28 of 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2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,262],[1869,262],[1869,316],[245,316]],"region":{"top_left_x":244,"top_left_y":262,"width":1626,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7994b802ac2e4cb0898aaa6149c0e348","type":"text","conversion_output":true,"text":"- Treatment Period AEs will include all AEs starting at or after the first exposure to study drug","text_display":"\n- Treatment Period AEs will include all AEs starting at or after the first exposure to study drug","confidence":1,"confidence_rate":1},{"cnt":[[305,312],[1798,312],[1798,363],[305,363]],"region":{"top_left_x":305,"top_left_y":311,"width":1494,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1d75de3955446c097655e6d4463a0ee","type":"text","conversion_output":true,"text":"to those starting before or at the subject's last visit date during the treatment period (AEs","text_display":" to those starting before or at the subject's last visit date during the treatment period (AEs","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,361],[1308,361],[1308,410],[305,410]],"region":{"top_left_x":305,"top_left_y":360,"width":1004,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b27f89c6bb07431ebaa4bf8fd945986f","type":"text","conversion_output":true,"text":"starting at or after treatment on Day 0 to the Day 182 visit).","text_display":" starting at or after treatment on Day 0 to the Day 182 visit).","confidence":1,"confidence_rate":1},{"cnt":[[245,451],[1846,451],[1846,501],[245,501]],"region":{"top_left_x":244,"top_left_y":451,"width":1602,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7545b56333b54497bedb780839ef240e","type":"text","conversion_output":true,"text":"- Follow-up Period AEs will include all AEs starting at or after the subject's last visit date of","text_display":"\n- Follow-up Period AEs will include all AEs starting at or after the subject's last visit date of","confidence":1,"confidence_rate":1},{"cnt":[[305,501],[1291,501],[1291,552],[305,552]],"region":{"top_left_x":305,"top_left_y":500,"width":987,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca9ce3dc984c484e8391f88abc984708","type":"text","conversion_output":true,"text":"the treatment period (AEs starting after the Day 182 visit).","text_display":" the treatment period (AEs starting after the Day 182 visit).","confidence":1,"confidence_rate":1},{"cnt":[[243,589],[1871,589],[1871,638],[243,638]],"region":{"top_left_x":242,"top_left_y":588,"width":1630,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9908931d7d3e44b092e1103b819b4153","type":"text","conversion_output":true,"text":"For AEs with partial onset times, non-missing date parts will be used to determine if the AE falls","text_display":"\n\nFor AEs with partial onset times, non-missing date parts will be used to determine if the AE falls","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[1867,636],[1867,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1623,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cedd38ac2144841a16703dbae7c8487","type":"text","conversion_output":true,"text":"within the period. If a determination cannot be made using the non-missing date parts as to if the","text_display":" within the period. If a determination cannot be made using the non-missing date parts as to if the","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1783,683],[1783,735],[245,735]],"region":{"top_left_x":244,"top_left_y":683,"width":1540,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8842de04f7254ffe8db3d5f51acee4bc","type":"text","conversion_output":true,"text":"AE falls within the period, the AE will be conservatively counted as a treatment-period AE.","text_display":" AE falls within the period, the AE will be conservatively counted as a treatment-period AE.","confidence":0.6220703125,"confidence_rate":0.9950673914040649},{"cnt":[[245,773],[1876,773],[1876,827],[245,827]],"region":{"top_left_x":244,"top_left_y":773,"width":1632,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85442e73191c456a9767623a0995275c","type":"text","conversion_output":true,"text":"The number and percentage of subjects with any AE, any related AE, any SAE, any related SAE,","text_display":"\n\nThe number and percentage of subjects with any AE, any related AE, any SAE, any related SAE,","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,821],[1796,821],[1796,872],[245,872]],"region":{"top_left_x":244,"top_left_y":820,"width":1553,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9aa1eaed61344fd2bc942cd80c09f5b0","type":"text","conversion_output":true,"text":"any severe AE, and any related severe AE will as well as the total number of events for each","text_display":" any severe AE, and any related severe AE will as well as the total number of events for each","confidence":0.97607421875,"confidence_rate":0.9997503749588464},{"cnt":[[245,870],[1691,870],[1691,922],[245,922]],"region":{"top_left_x":244,"top_left_y":870,"width":1447,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29254eb308684e68b1a349dd021dd4d7","type":"text","conversion_output":true,"text":"category will be summarized by treatment group. The number of deaths due to an AE,","text_display":" category will be summarized by treatment group. The number of deaths due to an AE,","confidence":0.931640625,"confidence_rate":0.9991864445164234},{"cnt":[[245,920],[1790,920],[1790,969],[245,969]],"region":{"top_left_x":244,"top_left_y":919,"width":1546,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"027d328491224d309579b90e22a59b96","type":"text","conversion_output":true,"text":"hospitalization due to an AE and study discontinuation due to an AE will be summarized by","text_display":" hospitalization due to an AE and study discontinuation due to an AE will be summarized by","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[245,967],[1830,967],[1830,1016],[245,1016]],"region":{"top_left_x":244,"top_left_y":966,"width":1587,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46604ab739d340cf84e595820163f002","type":"text","conversion_output":true,"text":"treatment group and overall DX-2930. This tabulation will be repeated for each of the analysis","text_display":" treatment group and overall DX-2930. This tabulation will be repeated for each of the analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,1014],[385,1014],[385,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1014,"width":141,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a7ceb2b26094f889eaaf13055990ef5","type":"text","conversion_output":true,"text":"periods.","text_display":" periods.","confidence":1,"confidence_rate":1},{"cnt":[[245,1104],[1841,1104],[1841,1154],[245,1154]],"region":{"top_left_x":244,"top_left_y":1104,"width":1598,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"747ce60a003f45a196041047180182d7","type":"text","conversion_output":true,"text":"The number and percentage of subjects with an AE, as well as the total number of AEs, will be","text_display":"\n\nThe number and percentage of subjects with an AE, as well as the total number of AEs, will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1152],[1820,1152],[1820,1201],[245,1201]],"region":{"top_left_x":244,"top_left_y":1151,"width":1576,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a79afef09a54a4a9c0e3846ddfaa841","type":"text","conversion_output":true,"text":"summarized for each treatment group and overall DX-2930 by SOC, and PT for each analysis","text_display":" summarized for each treatment group and overall DX-2930 by SOC, and PT for each analysis","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[245,1199],[1824,1199],[1824,1250],[245,1250]],"region":{"top_left_x":244,"top_left_y":1198,"width":1581,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e055755bebad42b59d74008846274eeb","type":"text","conversion_output":true,"text":"period. This tabulation will be repeated for related AEs, SAEs, related SAEs, severe AEs, and","text_display":" period. This tabulation will be repeated for related AEs, SAEs, related SAEs, severe AEs, and","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[245,1246],[1755,1246],[1755,1298],[245,1298]],"region":{"top_left_x":244,"top_left_y":1246,"width":1512,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfb0ebf9abed4d2caeb9ba633210b49b","type":"text","conversion_output":true,"text":"related severe AEs for treatment period and follow-up period AEs. This tabulation will be","text_display":" related severe AEs for treatment period and follow-up period AEs. This tabulation will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1296],[1772,1296],[1772,1347],[245,1347]],"region":{"top_left_x":244,"top_left_y":1295,"width":1529,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7766a868aee4d40b36ad6322756c830","type":"text","conversion_output":true,"text":"repeated for SAEs for pretreatment period. Tabulations will be presented sorted by SOC in","text_display":" repeated for SAEs for pretreatment period. Tabulations will be presented sorted by SOC in","confidence":1,"confidence_rate":1},{"cnt":[[245,1345],[1858,1345],[1858,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1344,"width":1615,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2fdb83a2eec4612b2404dc1579b18f2","type":"text","conversion_output":true,"text":"alphabetical order and by PT within each SOC by descending frequency in the overall DX-2930","text_display":" alphabetical order and by PT within each SOC by descending frequency in the overall DX-2930","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[245,1392],[823,1392],[823,1446],[245,1446]],"region":{"top_left_x":244,"top_left_y":1392,"width":579,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"217916f5ee5b4bb3b6379952de3de632","type":"text","conversion_output":true,"text":"group and then the placebo group.","text_display":" group and then the placebo group.","confidence":1,"confidence_rate":1},{"cnt":[[245,1480],[1841,1480],[1841,1532],[245,1532]],"region":{"top_left_x":244,"top_left_y":1480,"width":1598,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e1bdf6d31f6496ba2aa3dbe029db099","type":"text","conversion_output":true,"text":"The number and percentage of subjects with an AE, as well as the total number of AEs, will be","text_display":"\n\nThe number and percentage of subjects with an AE, as well as the total number of AEs, will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1530],[1876,1530],[1876,1579],[245,1579]],"region":{"top_left_x":244,"top_left_y":1529,"width":1632,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef68823348584a0eb7062b125917b2a4","type":"text","conversion_output":true,"text":"summarized for each treatment group and overall DX-2930 by PT for treatment period AEs only.","text_display":" summarized for each treatment group and overall DX-2930 by PT for treatment period AEs only.","confidence":1,"confidence_rate":1},{"cnt":[[245,1577],[1764,1577],[1764,1626],[245,1626]],"region":{"top_left_x":244,"top_left_y":1576,"width":1520,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a62a03f8f99b49acb61469c6193f3499","type":"text","conversion_output":true,"text":"This tabulation will be repeated for related AEs and serious AEs for treatment period AEs.","text_display":" This tabulation will be repeated for related AEs and serious AEs for treatment period AEs.","confidence":1,"confidence_rate":1},{"cnt":[[245,1624],[1794,1624],[1794,1676],[245,1676]],"region":{"top_left_x":244,"top_left_y":1624,"width":1550,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c972e63d77864c27ac0043cfee0829ec","type":"text","conversion_output":true,"text":"Tabulations will be presented sorted by PT by descending frequency in the overall DX-2930","text_display":" Tabulations will be presented sorted by PT by descending frequency in the overall DX-2930","confidence":0.998046875,"confidence_rate":0.9999792019733479},{"cnt":[[245,1671],[823,1671],[823,1725],[245,1725]],"region":{"top_left_x":244,"top_left_y":1671,"width":579,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"265d856a371c4e888200881658f6a38e","type":"text","conversion_output":true,"text":"group and then the placebo group.","text_display":" group and then the placebo group.","confidence":1,"confidence_rate":1},{"cnt":[[245,1762],[1751,1762],[1751,1811],[245,1811]],"region":{"top_left_x":244,"top_left_y":1761,"width":1507,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7e418356ad648ec931ad511d1b4e0c6","type":"text","conversion_output":true,"text":"All AEs will be provided in subject listings. Listings will be presented separately for each","text_display":"\n\nAll AEs will be provided in subject listings. Listings will be presented separately for each","confidence":1,"confidence_rate":1},{"cnt":[[245,1809],[1863,1809],[1863,1858],[245,1858]],"region":{"top_left_x":244,"top_left_y":1808,"width":1619,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90e0d3e9ff9e47dc804f3f6f2f7179b1","type":"text","conversion_output":true,"text":"analysis period. In addition, subject listings of AEs causing discontinuation of study medication,","text_display":" analysis period. In addition, subject listings of AEs causing discontinuation of study medication,","confidence":0.99853515625,"confidence_rate":0.9999857678907678},{"cnt":[[245,1856],[1835,1856],[1835,1910],[245,1910]],"region":{"top_left_x":244,"top_left_y":1856,"width":1591,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b372c1fe7b3a44e0b01489add6c70bbe","type":"text","conversion_output":true,"text":"AEs leading to death, SAEs, related AEs, severe AEs, and AEs of special interest (AESIs) will","text_display":" AEs leading to death, SAEs, related AEs, severe AEs, and AEs of special interest (AESIs) will","confidence":1,"confidence_rate":1},{"cnt":[[245,1904],[468,1904],[468,1957],[245,1957]],"region":{"top_left_x":244,"top_left_y":1903,"width":225,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b282e06933334d45b54a212354c9f213","type":"text","conversion_output":true,"text":"be produced.","text_display":" be produced.","confidence":1,"confidence_rate":1},{"cnt":[[245,1996],[1747,1996],[1747,2047],[245,2047]],"region":{"top_left_x":244,"top_left_y":1995,"width":1503,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63d66e2271f94f6fb30d011f21a15c43","type":"text","conversion_output":true,"text":"Adverse events of special interest (AESI) for this study are hypersensitivity reactions and","text_display":"\n\nAdverse events of special interest (AESI) for this study are hypersensitivity reactions and","confidence":1,"confidence_rate":1},{"cnt":[[245,2041],[1858,2041],[1858,2095],[245,2095]],"region":{"top_left_x":244,"top_left_y":2041,"width":1615,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6e3477b67fe4466bcf20cf6061118ad","type":"text","conversion_output":true,"text":"disordered coagulation (hypercoagulability events and bleeding events). Standardized MedDRA","text_display":" disordered coagulation (hypercoagulability events and bleeding events). Standardized MedDRA","confidence":1,"confidence_rate":1},{"cnt":[[245,2093],[1880,2093],[1880,2142],[245,2142]],"region":{"top_left_x":244,"top_left_y":2092,"width":1636,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7da413f209ee493abc17cdb5a16f9575","type":"text","conversion_output":true,"text":"Queries (SMQ) for each AESI will be performed using the study data. The number and percentage","text_display":" Queries (SMQ) for each AESI will be performed using the study data. The number and percentage","confidence":1,"confidence_rate":1},{"cnt":[[245,2140],[1738,2140],[1738,2187],[245,2187]],"region":{"top_left_x":244,"top_left_y":2139,"width":1495,"height":49},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8de10b7af41a48169248d27c5fc11d03","type":"text","conversion_output":true,"text":"of subjects with an AESI, as well as the total number of AESIs, will be summarized for each","text_display":" of subjects with an AESI, as well as the total number of AESIs, will be summarized for each","confidence":1,"confidence_rate":1},{"cnt":[[245,2185],[1876,2185],[1876,2237],[245,2237]],"region":{"top_left_x":244,"top_left_y":2184,"width":1632,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdc74157b50c40b1a0816e13a71ad666","type":"text","conversion_output":true,"text":"treatment group and overall DX-2930 by SOC and PT. Separate summary tables will be created for","text_display":" treatment group and overall DX-2930 by SOC and PT. Separate summary tables will be created for","confidence":1,"confidence_rate":1},{"cnt":[[245,2230],[1790,2230],[1790,2282],[245,2282]],"region":{"top_left_x":244,"top_left_y":2230,"width":1546,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bca892c9e874b8cbb9346c1d30343c8","type":"text","conversion_output":true,"text":"each AESI and for those events with the SMQs classified as related, serious, related serious,","text_display":" each AESI and for those events with the SMQs classified as related, serious, related serious,","confidence":1,"confidence_rate":1},{"cnt":[[245,2282],[1697,2282],[1697,2331],[245,2331]],"region":{"top_left_x":244,"top_left_y":2281,"width":1454,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"115245a7a0464d30894b0c5ac7ac8282","type":"text","conversion_output":true,"text":"severe, and related severe. A listing detailing the PT within the SMQ will be provided.","text_display":" severe, and related severe. A listing detailing the PT within the SMQ will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[245,2587],[432,2587],[432,2632],[245,2632]],"region":{"top_left_x":244,"top_left_y":2586,"width":188,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6a0b81236124005ba69cbb9637317eb","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1884,2587],[1884,2632],[1676,2632]],"region":{"top_left_x":1675,"top_left_y":2586,"width":210,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"71ad8b279a2e41ab9ded671360deda5c","type":"page_info","conversion_output":false,"text":"Page 29 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-30","page":30,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57600af6ffc44d569d16e5c8f762ccad","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,168],[1880,168],[1880,208],[1676,208]],"region":{"top_left_x":1675,"top_left_y":167,"width":205,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e0d11a6da5b4dcc99543c207ab35e86","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[243,258],[1005,258],[1005,316],[243,316]],"region":{"top_left_x":242,"top_left_y":257,"width":764,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a8959b1ea584acd86b1987359d3a84e","type":"section_header","conversion_output":false,"children_ids":["69adc13d350548278c2361d475240697"],"text":"","text_display":""},{"cnt":[[249,262],[999,262],[999,312],[249,312]],"region":{"top_left_x":249,"top_left_y":262,"width":751,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69adc13d350548278c2361d475240697","type":"text","conversion_output":true,"parent_id":"0a8959b1ea584acd86b1987359d3a84e","text":"7.9.2 Clinical Laboratory Evaluation","text_display":"\n\n\\subsection*{7.9.2 Clinical Laboratory Evaluation}","confidence":1,"confidence_rate":1},{"cnt":[[245,350],[1248,350],[1248,397],[245,397]],"region":{"top_left_x":244,"top_left_y":350,"width":1005,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8b3c39a13d14a25aa070e6833f8fd04","type":"text","conversion_output":true,"text":"Laboratory test results will be presented in conventional units.","text_display":"\n\nLaboratory test results will be presented in conventional units.","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1674,443],[1674,490],[245,490]],"region":{"top_left_x":244,"top_left_y":442,"width":1430,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e88783660f834100b3792bb5a645c10b","type":"text","conversion_output":true,"text":"Baseline is defined as the last non-missing value prior to the first exposure to study drug.","text_display":"\nBaseline is defined as the last non-missing value prior to the first exposure to study drug.","confidence":1,"confidence_rate":1},{"cnt":[[245,529],[1858,529],[1858,578],[245,578]],"region":{"top_left_x":244,"top_left_y":528,"width":1615,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd797593a5a3430c9d75f8577f41c325","type":"text","conversion_output":true,"text":"Continuous laboratory test results (serum chemistry, hematology, and urine pH ) will be summarized","text_display":"\nContinuous laboratory test results (serum chemistry, hematology, and urine pH ) will be summarized","confidence":1,"confidence_rate":1},{"cnt":[[245,576],[569,576],[569,621],[245,621]],"region":{"top_left_x":244,"top_left_y":575,"width":326,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89935aab3eee43df837170cd688e0fc1","type":"text","conversion_output":true,"text":"as described below.","text_display":" as described below.","confidence":1,"confidence_rate":1},{"cnt":[[245,662],[1869,662],[1869,711],[245,711]],"region":{"top_left_x":244,"top_left_y":661,"width":1626,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b3b9d93c50a4552ba331171602493d9","type":"text","conversion_output":true,"text":"Actual values and changes from baseline in clinical laboratory tests for hematology, coagulation,","text_display":"\n\nActual values and changes from baseline in clinical laboratory tests for hematology, coagulation,","confidence":1,"confidence_rate":1},{"cnt":[[245,711],[1876,711],[1876,761],[245,761]],"region":{"top_left_x":244,"top_left_y":711,"width":1632,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5df9f7bfdf44ec2941facdf598fa492","type":"text","conversion_output":true,"text":"chemistries, and urinalysis will be summarized for each treatment group and overall DX-2930 by","text_display":" chemistries, and urinalysis will be summarized for each treatment group and overall DX-2930 by","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[245,761],[1850,761],[1850,810],[245,810]],"region":{"top_left_x":244,"top_left_y":760,"width":1606,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84e3f43174cd4676a5a9e3485a1ba423","type":"text","conversion_output":true,"text":"study visit. If more than one laboratory result is reported per study visit per parameter, the last non-","text_display":" study visit. If more than one laboratory result is reported per study visit per parameter, the last non","confidence":1,"confidence_rate":1},{"cnt":[[245,808],[1772,808],[1772,857],[245,857]],"region":{"top_left_x":244,"top_left_y":807,"width":1529,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b86b2e64caab4838b0890a12f1626abd","type":"text","conversion_output":true,"text":"missing result will be selected for analysis. All laboratory results will be presented in subject","text_display":"missing result will be selected for analysis. All laboratory results will be presented in subject","confidence":1,"confidence_rate":1},{"cnt":[[245,855],[385,855],[385,904],[245,904]],"region":{"top_left_x":244,"top_left_y":855,"width":141,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86ce279a4d8c4110bd387086e397e2f8","type":"text","conversion_output":true,"text":"listings.","text_display":" listings.","confidence":1,"confidence_rate":1},{"cnt":[[245,945],[1876,945],[1876,993],[245,993]],"region":{"top_left_x":244,"top_left_y":945,"width":1632,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47a55c55cb0448bc859e18a6b6c3b538","type":"text","conversion_output":true,"text":"Laboratory test results will be classified according to the reference ranges and clinical significance as","text_display":"\n\nLaboratory test results will be classified according to the reference ranges and clinical significance as","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[245,990],[1824,990],[1824,1038],[245,1038]],"region":{"top_left_x":244,"top_left_y":990,"width":1581,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10f0cbb3ef844e4f824435fe62d9531e","type":"text","conversion_output":true,"text":"determined by the investigator. The number of subjects with a non-missing result, and the number","text_display":" determined by the investigator. The number of subjects with a non-missing result, and the number","confidence":1,"confidence_rate":1},{"cnt":[[245,1036],[1876,1036],[1876,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1035,"width":1632,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6948ed9d293464abb81bc352299aee5","type":"text","conversion_output":true,"text":"and percentage of subjects with a clinically significant result less than the lower limit of normal, non-","text_display":" and percentage of subjects with a clinically significant result less than the lower limit of normal, non","confidence":0.9951171875,"confidence_rate":0.9999555030593207},{"cnt":[[245,1083],[1738,1083],[1738,1130],[245,1130]],"region":{"top_left_x":244,"top_left_y":1082,"width":1495,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cac340bffd2244e1b44a302ca7cbd85c","type":"text","conversion_output":true,"text":"clinically significant result less than the lower limit of normal, within the normal range, non-","text_display":"clinically significant result less than the lower limit of normal, within the normal range, non","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,1128],[1869,1128],[1869,1175],[245,1175]],"region":{"top_left_x":244,"top_left_y":1127,"width":1626,"height":49},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3aedcec3eb544142b98a44e6dca2ab2a","type":"text","conversion_output":true,"text":"clinically significant result more than the upper limit of normal, and clinically significant result more","text_display":"clinically significant result more than the upper limit of normal, and clinically significant result more","confidence":0.99853515625,"confidence_rate":0.9999866735644114},{"cnt":[[245,1173],[1867,1173],[1867,1222],[245,1222]],"region":{"top_left_x":244,"top_left_y":1173,"width":1623,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b052f4cb6bf4eca8c8c54d71cfb4468","type":"text","conversion_output":true,"text":"than the upper limit of normal will be summarized for each treatment group and overall DX-2930 by","text_display":" than the upper limit of normal will be summarized for each treatment group and overall DX-2930 by","confidence":0.9970703125,"confidence_rate":0.9999712358310027},{"cnt":[[245,1220],[1794,1220],[1794,1268],[245,1268]],"region":{"top_left_x":244,"top_left_y":1220,"width":1550,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b1214b3674e41d8bd4a1782a9977f72","type":"text","conversion_output":true,"text":"study visit. If more than one laboratory result is reported per study visit per parameter, the result","text_display":" study visit. If more than one laboratory result is reported per study visit per parameter, the result","confidence":1,"confidence_rate":1},{"cnt":[[245,1265],[1326,1265],[1326,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1265,"width":1082,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea62b81cf5f948fcaf38ea662b76914d","type":"text","conversion_output":true,"text":"yielding the most severe classification will be selected for analysis.","text_display":" yielding the most severe classification will be selected for analysis.","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[1858,1354],[1858,1403],[245,1403]],"region":{"top_left_x":244,"top_left_y":1353,"width":1615,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0e6224e99974ba0ab93f5bfda084d6b","type":"text","conversion_output":true,"text":"Categorical laboratory test results (urinalysis excluding pH ) will be summarized for treatment group","text_display":"\n\nCategorical laboratory test results (urinalysis excluding pH ) will be summarized for treatment group","confidence":1,"confidence_rate":1},{"cnt":[[245,1401],[1858,1401],[1858,1448],[245,1448]],"region":{"top_left_x":244,"top_left_y":1400,"width":1615,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93208ac5a8c0444f81f43505bfefcdaf","type":"text","conversion_output":true,"text":"and overall DX-2930 by study visit. If more than one laboratory result is reported per study visit per","text_display":" and overall DX-2930 by study visit. If more than one laboratory result is reported per study visit per","confidence":1,"confidence_rate":1},{"cnt":[[245,1444],[1665,1444],[1665,1493],[245,1493]],"region":{"top_left_x":244,"top_left_y":1443,"width":1422,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"444e8c6d2ed6463f875b3c3db40ef100","type":"text","conversion_output":true,"text":"parameter, the result yielding the most severe classification will be selected for analysis.","text_display":" parameter, the result yielding the most severe classification will be selected for analysis.","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[245,1512],[1813,1512],[1813,1560],[245,1560]],"region":{"top_left_x":244,"top_left_y":1512,"width":1570,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"481dd1a5b1804d54b98a32dd17d0c266","type":"text","conversion_output":true,"text":"Subjects with clinically significant abnormal laboratory test results will be listed. This listing will","text_display":"\n\nSubjects with clinically significant abnormal laboratory test results will be listed. This listing will","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[245,1558],[1790,1558],[1790,1605],[245,1605]],"region":{"top_left_x":244,"top_left_y":1557,"width":1546,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df31bec6313d4b898b6b6686b2171915","type":"text","conversion_output":true,"text":"include all results of the laboratory parameter that was abnormal and determined to be clinically","text_display":" include all results of the laboratory parameter that was abnormal and determined to be clinically","confidence":1,"confidence_rate":1},{"cnt":[[245,1603],[1583,1603],[1583,1652],[245,1652]],"region":{"top_left_x":244,"top_left_y":1602,"width":1340,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d15259cb2c04d2ba4e0720ee8453dd9","type":"text","conversion_output":true,"text":"significant by the investigator for a subject across study visit to identify any trends.","text_display":" significant by the investigator for a subject across study visit to identify any trends.","confidence":1,"confidence_rate":1},{"cnt":[[243,1689],[638,1689],[638,1747],[243,1747]],"region":{"top_left_x":242,"top_left_y":1688,"width":397,"height":59},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8336c3d9718046c8bfbc90b59cfbdd62","type":"section_header","conversion_output":false,"children_ids":["fb6fe51168e846eda98fd7a72911bb00"],"text":"","text_display":""},{"cnt":[[245,1693],[634,1693],[634,1742],[245,1742]],"region":{"top_left_x":244,"top_left_y":1692,"width":390,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb6fe51168e846eda98fd7a72911bb00","type":"text","conversion_output":true,"parent_id":"8336c3d9718046c8bfbc90b59cfbdd62","text":"7.9.3 Vital Signs","text_display":"\n\n\\subsection*{7.9.3 Vital Signs}","confidence":1,"confidence_rate":1},{"cnt":[[245,1781],[1676,1781],[1676,1828],[245,1828]],"region":{"top_left_x":244,"top_left_y":1781,"width":1432,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9f88fd459f642abbbc6feb2c140a541","type":"text","conversion_output":true,"text":"Baseline is defined as the last non-missing value prior to the first exposure to study drug.","text_display":"\n\nBaseline is defined as the last non-missing value prior to the first exposure to study drug.","confidence":1,"confidence_rate":1},{"cnt":[[245,1869],[1813,1869],[1813,1919],[245,1919]],"region":{"top_left_x":244,"top_left_y":1869,"width":1570,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18cc75ea3ca24dbaac9b469d24dab8cc","type":"text","conversion_output":true,"text":"Actual values and changes from baseline in vital signs will be summarized for each treatment","text_display":"\nActual values and changes from baseline in vital signs will be summarized for each treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1916],[1749,1916],[1749,1966],[245,1966]],"region":{"top_left_x":244,"top_left_y":1916,"width":1505,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03a0127e3796460f80f29769caa75c02","type":"text","conversion_output":true,"text":"group and DX-2930 overall by study visit and study time point. All vital sign data will be","text_display":" group and DX-2930 overall by study visit and study time point. All vital sign data will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1964],[724,1964],[724,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1963,"width":481,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5ca490cdde54ea29b9f6c164a9c8d99","type":"text","conversion_output":true,"text":"presented in subject listings.","text_display":" presented in subject listings.","confidence":1,"confidence_rate":1},{"cnt":[[245,2054],[1687,2054],[1687,2103],[245,2103]],"region":{"top_left_x":244,"top_left_y":2053,"width":1443,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2f52404b72747db845d2c54fe8194fa","type":"text","conversion_output":true,"text":"Vital sign values will be classified according to clinical significance as determined by the","text_display":"\n\nVital sign values will be classified according to clinical significance as determined by the","confidence":0.9990236759185791,"confidence_rate":0.9999899299373404},{"cnt":[[245,2101],[1824,2101],[1824,2148],[245,2148]],"region":{"top_left_x":244,"top_left_y":2101,"width":1581,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33c47e3965864acc95372d966b3bb970","type":"text","conversion_output":true,"text":"investigator. The number of subjects with a non-missing result, and the number and percentage of","text_display":" investigator. The number of subjects with a non-missing result, and the number and percentage of","confidence":1,"confidence_rate":1},{"cnt":[[245,2144],[1833,2144],[1833,2194],[245,2194]],"region":{"top_left_x":244,"top_left_y":2144,"width":1589,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81f0f375636548c8ac819c2c650aa6c7","type":"text","conversion_output":true,"text":"subjects with a non-clinically significant result and clinically significant result will be summarized","text_display":" subjects with a non-clinically significant result and clinically significant result will be summarized","confidence":1,"confidence_rate":1},{"cnt":[[245,2191],[1848,2191],[1848,2241],[245,2241]],"region":{"top_left_x":244,"top_left_y":2191,"width":1604,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86ade2e539e34d3cbde2e2d29c748299","type":"text","conversion_output":true,"text":"for each treatment group and overall DX-2930 by study visit and study time point. If more than one","text_display":" for each treatment group and overall DX-2930 by study visit and study time point. If more than one","confidence":1,"confidence_rate":1},{"cnt":[[245,2286],[245,2234],[1854,2237],[1854,2288]],"region":{"top_left_x":244,"top_left_y":2234,"width":1611,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2dfbec583bb4c5ab24132f7adc7d9ff","type":"text","conversion_output":true,"text":"vital sign result is reported per study visit and study time point per parameter, the result yielding the","text_display":" vital sign result is reported per study visit and study time point per parameter, the result yielding the","confidence":1,"confidence_rate":1},{"cnt":[[245,2282],[1852,2282],[1852,2331],[245,2331]],"region":{"top_left_x":244,"top_left_y":2281,"width":1608,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ff5547e4f6c4983ba3102027dcbd254","type":"text","conversion_output":true,"text":"most severe classification will be selected for analysis. Subjects with clinically significant vital sign","text_display":" most severe classification will be selected for analysis. Subjects with clinically significant vital sign","confidence":0.96484375,"confidence_rate":0.9996746973964459},{"cnt":[[245,2329],[1712,2329],[1712,2378],[245,2378]],"region":{"top_left_x":244,"top_left_y":2328,"width":1469,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b6eb08d0046450dacbca8c5f11d4e6d","type":"text","conversion_output":true,"text":"values will be listed. This listing will include all results of the vital sign parameter that was","text_display":" values will be listed. This listing will include all results of the vital sign parameter that was","confidence":1,"confidence_rate":1},{"cnt":[[245,2374],[1811,2374],[1811,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2374,"width":1568,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0733b7e3c5ac47c4bcefda6af7578aa4","type":"text","conversion_output":true,"text":"determined by the investigator to be clinically significant for a subject across study time points to","text_display":" determined by the investigator to be clinically significant for a subject across study time points to","confidence":0.99755859375,"confidence_rate":0.9999769399702094},{"cnt":[[245,2419],[563,2419],[563,2469],[245,2469]],"region":{"top_left_x":244,"top_left_y":2419,"width":319,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80c41241fa3444ada3bcab5036187bb2","type":"text","conversion_output":true,"text":"identify any trends.","text_display":" identify any trends.","confidence":1,"confidence_rate":1},{"cnt":[[247,2587],[432,2587],[432,2628],[247,2628]],"region":{"top_left_x":247,"top_left_y":2586,"width":185,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5404dbe7c3e4d97bd73ee5a3f92c724","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1880,2587],[1880,2628],[1676,2628]],"region":{"top_left_x":1675,"top_left_y":2586,"width":205,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c922ac8b7b149e3917a2d4fc6c3023d","type":"page_info","conversion_output":false,"text":"Page 30 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-31","page":31,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a281590284f416a871b86c40cc7466c","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,168],[1880,168],[1880,208],[1676,208]],"region":{"top_left_x":1675,"top_left_y":167,"width":205,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3f582aac89f45a08a4aef9b197ed1f6","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[243,258],[816,258],[816,316],[243,316]],"region":{"top_left_x":242,"top_left_y":257,"width":575,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1df8a309a9df47a6b9692fa837505c4e","type":"section_header","conversion_output":false,"children_ids":["b15023d6edeb434e81f5c3278be0bc5b"],"text":"","text_display":""},{"cnt":[[247,262],[812,262],[812,312],[247,312]],"region":{"top_left_x":247,"top_left_y":262,"width":566,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b15023d6edeb434e81f5c3278be0bc5b","type":"text","conversion_output":true,"parent_id":"1df8a309a9df47a6b9692fa837505c4e","text":"7.9.4 Electrocardiography","text_display":"\n\n\\subsection*{7.9.4 Electrocardiography}","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1796,348],[1796,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1553,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"236ea6990b62494380a78e9ce67b9822","type":"text","conversion_output":true,"text":"The number and percentage of subjects with normal, abnormal not clinically significant, and","text_display":"\n\nThe number and percentage of subjects with normal, abnormal not clinically significant, and","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1867,397],[1867,449],[245,449]],"region":{"top_left_x":244,"top_left_y":397,"width":1623,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7463a8518edb48858489b739ca2cc37b","type":"text","conversion_output":true,"text":"abnormal clinically significant ECG results, or ECG not performed, will be summarized for each","text_display":" abnormal clinically significant ECG results, or ECG not performed, will be summarized for each","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1783,447],[1783,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1540,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f274e0f2d4ac444b9aeafffb86024169","type":"text","conversion_output":true,"text":"treatment group and overall DX-2930 by study visit. Subjects with clinically significant ECG","text_display":" treatment group and overall DX-2930 by study visit. Subjects with clinically significant ECG","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1781,494],[1781,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1538,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6abf79d158114bfeae525f55380ed980","type":"text","conversion_output":true,"text":"results will be listed. This listing will include all results for a subject across study time points to","text_display":" results will be listed. This listing will include all results for a subject across study time points to","confidence":0.9975595474243164,"confidence_rate":0.9999773758546899},{"cnt":[[245,541],[561,541],[561,587],[245,587]],"region":{"top_left_x":244,"top_left_y":541,"width":317,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f603b3a97e654479b8040ca1b2ab0f71","type":"text","conversion_output":true,"text":"identify any trends.","text_display":" identify any trends.","confidence":1,"confidence_rate":1},{"cnt":[[245,627],[1076,627],[1076,677],[245,677]],"region":{"top_left_x":244,"top_left_y":627,"width":833,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dedd778137a4bcda712d23c2cfd265f","type":"text","conversion_output":true,"text":"All ECG data will be provided in subject listings.","text_display":"\n\nAll ECG data will be provided in subject listings.","confidence":1,"confidence_rate":1},{"cnt":[[243,713],[849,713],[849,771],[243,771]],"region":{"top_left_x":242,"top_left_y":713,"width":607,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c2e6c199a3546b5aa11cbdb15f480be","type":"section_header","conversion_output":false,"children_ids":["d383dfa8ca45480e84cafcc4f2b981ae"],"text":"","text_display":""},{"cnt":[[247,718],[844,718],[844,767],[247,767]],"region":{"top_left_x":247,"top_left_y":717,"width":598,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d383dfa8ca45480e84cafcc4f2b981ae","type":"text","conversion_output":true,"parent_id":"1c2e6c199a3546b5aa11cbdb15f480be","text":"7.9.5 Physical Examinations","text_display":"\n\n\\subsection*{7.9.5 Physical Examinations}","confidence":1,"confidence_rate":1},{"cnt":[[245,808],[1738,808],[1738,855],[245,855]],"region":{"top_left_x":244,"top_left_y":807,"width":1495,"height":49},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"395009a43b4d412f8b7d7577758cf67e","type":"text","conversion_output":true,"text":"Physical examination findings by body system will be classified as normal, abnormal not","text_display":"\n\nPhysical examination findings by body system will be classified as normal, abnormal not","confidence":1,"confidence_rate":1},{"cnt":[[245,855],[1811,855],[1811,904],[245,904]],"region":{"top_left_x":244,"top_left_y":855,"width":1568,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d648c95494dd42ca89b70dc1a7ac512f","type":"text","conversion_output":true,"text":"clinically significant, abnormal clinically significant or not performed by the investigator and","text_display":" clinically significant, abnormal clinically significant or not performed by the investigator and","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[245,902],[1850,902],[1850,952],[245,952]],"region":{"top_left_x":244,"top_left_y":902,"width":1606,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a30ae17e01a94a16a4174a7e83729f6d","type":"text","conversion_output":true,"text":"will be summarized for each treatment group and DX-2930 overall by study visit. Subjects with","text_display":" will be summarized for each treatment group and DX-2930 overall by study visit. Subjects with","confidence":1,"confidence_rate":1},{"cnt":[[245,950],[1777,950],[1777,999],[245,999]],"region":{"top_left_x":244,"top_left_y":949,"width":1533,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3342c8270f3a466a886d4009063b6082","type":"text","conversion_output":true,"text":"clinically significant abnormal physical examination findings will be listed. This listing will","text_display":" clinically significant abnormal physical examination findings will be listed. This listing will","confidence":1,"confidence_rate":1},{"cnt":[[245,997],[1734,997],[1734,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":996,"width":1490,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98f34dee1ae24b4a94120ffdb3b777f8","type":"text","conversion_output":true,"text":"include all results of the body system that was determined by the investigator to be clinically","text_display":" include all results of the body system that was determined by the investigator to be clinically","confidence":1,"confidence_rate":1},{"cnt":[[245,1044],[1384,1044],[1384,1094],[245,1094]],"region":{"top_left_x":244,"top_left_y":1044,"width":1140,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39aae113b67b4f9da4f1da25f256811e","type":"text","conversion_output":true,"text":"significant for a subject across study time points to identify any trends.","text_display":" significant for a subject 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Medications}","confidence":0.99951171875,"confidence_rate":0.9999889000502842},{"cnt":[[245,1311],[1745,1311],[1745,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1310,"width":1501,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2c36f77430c4eafaaf6d92454099548","type":"text","conversion_output":true,"text":"Prior and concomitant medications will be coded using the World Health Organization-Drug","text_display":"\n\nPrior and concomitant medications will be coded using the World Health Organization-Drug","confidence":1,"confidence_rate":1},{"cnt":[[245,1358],[922,1358],[922,1405],[245,1405]],"region":{"top_left_x":244,"top_left_y":1357,"width":678,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d6e055997a34593886d2e0f67a8e04b","type":"text","conversion_output":true,"text":"Dictionary (WHO-DD) Version 2015 Q3.","text_display":" Dictionary (WHO-DD) Version 2015 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continuing","text_display":" administration or medications with a start times prior to study drug administration but continuing","confidence":1,"confidence_rate":1},{"cnt":[[245,1676],[496,1676],[496,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1675,"width":253,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65a3f3af77cb41bdba396c359cecdf86","type":"text","conversion_output":true,"text":"after treatment.","text_display":" after treatment.","confidence":1,"confidence_rate":1},{"cnt":[[245,1766],[1785,1766],[1785,1815],[245,1815]],"region":{"top_left_x":244,"top_left_y":1766,"width":1542,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ff8842ab4e44fa79997f17e09247e26","type":"text","conversion_output":true,"text":"For medications with partial onset times, non-missing date parts will be used to determine if the","text_display":"\n\nFor medications with partial onset times, non-missing date parts will be used to determine if the","confidence":1,"confidence_rate":1},{"cnt":[[245,1813],[1798,1813],[1798,1863],[245,1863]],"region":{"top_left_x":244,"top_left_y":1813,"width":1555,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"905e910559ee4ab089f1b1e62d1e0d2e","type":"text","conversion_output":true,"text":"medication is concomitant or prior medication. If a determination cannot be made using the non-","text_display":" medication is concomitant or prior medication. If a determination cannot be made using the non","confidence":1,"confidence_rate":1},{"cnt":[[245,1858],[1850,1858],[1850,1908],[245,1908]],"region":{"top_left_x":244,"top_left_y":1858,"width":1606,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8368e5e5061d44a9a8e2eaedfa2c6a17","type":"text","conversion_output":true,"text":"missing date parts as to when the medication occurred relative to study drug administration then the","text_display":"missing date parts as to when the medication occurred relative to study drug administration then the","confidence":1,"confidence_rate":1},{"cnt":[[245,1904],[1158,1904],[1158,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1903,"width":915,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2974b289ed2a4a75872ccf7eb2f43965","type":"text","conversion_output":true,"text":"medication will be classified as concomitant medication.","text_display":" medication will be classified as concomitant medication.","confidence":1,"confidence_rate":1},{"cnt":[[245,1972],[1828,1972],[1828,2022],[245,2022]],"region":{"top_left_x":244,"top_left_y":1972,"width":1585,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73325b021a8942a895e2d1debfbc1c53","type":"text","conversion_output":true,"text":"The number and percentage of subjects with prior or concomitant medications will be summarized","text_display":"\n\nThe number and percentage of subjects with prior or concomitant medications will be summarized","confidence":1,"confidence_rate":1},{"cnt":[[245,2020],[1841,2020],[1841,2067],[245,2067]],"region":{"top_left_x":244,"top_left_y":2019,"width":1598,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a9aa04da3ad4be89cfec71e93208afa","type":"text","conversion_output":true,"text":"for each treatment group and overall DX-2930 by therapeutic class and preferred term. Therapeutic","text_display":" for each treatment group and overall DX-2930 by therapeutic class and preferred term. Therapeutic","confidence":1,"confidence_rate":1},{"cnt":[[245,2062],[1695,2062],[1695,2112],[245,2112]],"region":{"top_left_x":244,"top_left_y":2062,"width":1452,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac3eb20ae12a4c069a844595ac064c4c","type":"text","conversion_output":true,"text":"class will be based on the Therapeutic Subgroup corresponding to level 2 of the Anatomic","text_display":" class will be based on the Therapeutic Subgroup corresponding to level 2 of the Anatomic","confidence":1,"confidence_rate":1},{"cnt":[[245,2110],[1714,2110],[1714,2159],[245,2159]],"region":{"top_left_x":244,"top_left_y":2109,"width":1471,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08c0646548ca42e883f7bfe67893bf2c","type":"text","conversion_output":true,"text":"Therapeutic Chemical (ATC) classification system. Tabulations will be presented sorted by","text_display":" Therapeutic Chemical (ATC) classification system. Tabulations will be presented sorted by","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[245,2157],[1742,2157],[1742,2204],[245,2204]],"region":{"top_left_x":244,"top_left_y":2157,"width":1499,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3174167a3404452846f903bb414c8e1","type":"text","conversion_output":true,"text":"therapeutic class in alphabetical order and by PT within each therapeutic class by descending","text_display":" therapeutic class in alphabetical order and by PT within each therapeutic class by descending","confidence":1,"confidence_rate":1},{"cnt":[[245,2202],[1833,2202],[1833,2254],[245,2254]],"region":{"top_left_x":244,"top_left_y":2202,"width":1589,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"070b191f4ca04a0b81248a1aa0eee469","type":"text","conversion_output":true,"text":"frequency in the overall DX-2930 group and then the placebo group. A separate similar table will","text_display":" frequency in the overall DX-2930 group and then the placebo group. A separate similar table will","confidence":1,"confidence_rate":1},{"cnt":[[245,2247],[1732,2247],[1732,2301],[245,2301]],"region":{"top_left_x":244,"top_left_y":2247,"width":1488,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edb6af106d8041778c3126de823a3bd6","type":"text","conversion_output":true,"text":"be provided for rescue medications. All medications will be presented in subject listings.","text_display":" be provided for rescue medications. All medications will be presented in subject listings.","confidence":1,"confidence_rate":1},{"cnt":[[247,2587],[432,2587],[432,2628],[247,2628]],"region":{"top_left_x":247,"top_left_y":2586,"width":185,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5838725ba754e21bc37e341df490a96","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1880,2587],[1880,2628],[1676,2628]],"region":{"top_left_x":1675,"top_left_y":2586,"width":205,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"096b7b3f0a5f4d18b898a18ab08e70bc","type":"page_info","conversion_output":false,"text":"Page 31 of 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placebo comparison ordered by highest total monthly dose \\(\\left( H _{21}, H _{22}\\right.\\), and \\(\\left.H _{23}\\right)\\).","text_display":" treatment to placebo comparison ordered by highest total monthly dose \\(\\left( H _{21}, H _{22}\\right.\\), and \\(\\left.H _{23}\\right)\\).","confidence":0.7039737701416016,"confidence_rate":0.9973443341887221},{"cnt":[[245,2191],[1772,2191],[1772,2241],[245,2241]],"region":{"top_left_x":244,"top_left_y":2191,"width":1529,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d12bd9e5afc4fbab4406eef2d3d7191","type":"text","conversion_output":true,"text":"Family \\(3\\left(F_{3}\\right)\\) : Hypothesis tests for the second ranked secondary endpoint, one test for each","text_display":"\n\nFamily \\(3\\left(F_{3}\\right)\\) : Hypothesis tests for the second ranked secondary endpoint, one test for each","confidence":0.9936642581596971,"confidence_rate":0.9999416907107574},{"cnt":[[245,2239],[1794,2239],[1794,2288],[245,2288]],"region":{"top_left_x":244,"top_left_y":2238,"width":1550,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e17ed9edc5943e7b40bf8d63ea1404b","type":"text","conversion_output":true,"text":"active treatment to placebo comparison ordered by highest total monthly dose ( \\(H _{31}, H _{32}\\), and","text_display":" active treatment to placebo comparison ordered by highest total monthly dose ( \\(H _{31}, H _{32}\\), and","confidence":0.9307308197021484,"confidence_rate":0.9994019691101398},{"cnt":[[245,2290],[335,2290],[335,2335],[245,2335]],"region":{"top_left_x":244,"top_left_y":2290,"width":92,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16259164ba0743ca92437d353ade58f7","type":"text","conversion_output":true,"text":"\\(H _{33}\\) ).","text_display":" \\(H _{33}\\) ).","confidence":0.9985356330871582,"confidence_rate":0.9999267306770312},{"cnt":[[245,2376],[1841,2376],[1841,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2376,"width":1598,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c787cfa414a442158008b862415262d9","type":"text","conversion_output":true,"text":"The 3 sets of hypotheses in F1, F2, and F3 will be tested in a fixed sequence within each active","text_display":"\n\nThe 3 sets of hypotheses in F1, F2, and F3 will be tested in a fixed sequence within each active","confidence":0.9956073760986328,"confidence_rate":0.9999576710899393},{"cnt":[[245,2426],[1871,2426],[1871,2473],[245,2473]],"region":{"top_left_x":244,"top_left_y":2425,"width":1628,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db1c0ccad07e4c5494ffb54223fb6a5f","type":"text","conversion_output":true,"text":"treatment group to placebo group comparison or branch. Testing within a branch will continue in","text_display":" treatment group to placebo group comparison or branch. Testing within a branch will continue in","confidence":1,"confidence_rate":1},{"cnt":[[249,2587],[432,2587],[432,2628],[249,2628]],"region":{"top_left_x":249,"top_left_y":2586,"width":183,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"051134c9c00448cab2f8e3bdfe493f53","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1880,2587],[1880,2628],[1676,2628]],"region":{"top_left_x":1675,"top_left_y":2586,"width":205,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84a32ed7487e43168aa3de3670362d6d","type":"page_info","conversion_output":false,"text":"Page 35 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-36","page":36,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e11d60b9db814c5b8204cec4b20fa078","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,168],[1880,168],[1880,208],[1676,208]],"region":{"top_left_x":1675,"top_left_y":167,"width":205,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f46b9b51b6044349a3a465d4340bc3f","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,262],[1803,262],[1803,312],[245,312]],"region":{"top_left_x":244,"top_left_y":262,"width":1559,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bc084c20cbc45f69df548decd9dc8a7","type":"text","conversion_output":true,"text":"sequence until the first test that the null hypothesis cannot be rejected; statistical significance","text_display":"\nsequence until the first test that the null hypothesis cannot be rejected; statistical significance","confidence":1,"confidence_rate":1},{"cnt":[[245,309],[1622,309],[1622,359],[245,359]],"region":{"top_left_x":244,"top_left_y":309,"width":1379,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f75605b53a954bf98f448a666d19544a","type":"text","conversion_output":true,"text":"cannot be declared for that test or for any of the remaining tests within the branch.","text_display":" cannot be declared for that test or for any of the remaining tests within the branch.","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1869,397],[1869,449],[245,449]],"region":{"top_left_x":244,"top_left_y":397,"width":1626,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdf6d8693e954314bb4e90d51780c57c","type":"text","conversion_output":true,"text":"Within a family, hypotheses will be tested using a conservative Bonferroni-based procedure with","text_display":"\n\nWithin a family, hypotheses will be tested using a conservative Bonferroni-based procedure with","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1876,447],[1876,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1632,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96c336f4847c4f57ad3804012d6241f2","type":"text","conversion_output":true,"text":"equal weights for each test set at \\(1.67 \\%\\) significance level ( \\(\\alpha / 3\\) ). If the null hypothesis for a test is","text_display":" equal weights for each test set at \\(1.67 \\%\\) significance level ( \\(\\alpha / 3\\) ). If the null hypothesis for a test is","confidence":0.8190238046227023,"confidence_rate":0.9982804273166803},{"cnt":[[245,494],[1848,494],[1848,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1604,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93936fedcbeb4145aa2aae512b6a7063","type":"text","conversion_output":true,"text":"rejected, \\(\\alpha\\) will be propagated entirely to the next test in the sequence, which will then be tested","text_display":" rejected, \\(\\alpha\\) will be propagated entirely to the next test in the sequence, which will then be tested","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[776,541],[776,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":532,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc31bcbe3fe445a2a14acee908f9802f","type":"text","conversion_output":true,"text":"at the \\(1.67 \\%\\) significance level.","text_display":" at the \\(1.67 \\%\\) significance level.","confidence":0.99853515625,"confidence_rate":0.9999633527294652},{"cnt":[[245,632],[1858,632],[1858,681],[245,681]],"region":{"top_left_x":244,"top_left_y":631,"width":1615,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc55781a5d614f9a837730d1f23bb1af","type":"text","conversion_output":true,"text":"To further illustrate this approach, the test for the primary endpoint will be conducted first at the","text_display":"\n\nTo further illustrate this approach, the test for the primary endpoint will be conducted first at the","confidence":1,"confidence_rate":1},{"cnt":[[247,679],[1846,679],[1846,728],[247,728]],"region":{"top_left_x":247,"top_left_y":678,"width":1599,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7737618dffd4be59900845fd81bc605","type":"text","conversion_output":true,"text":"\\(1.67 \\%\\) significance level for each active treatment group compared with the placebo group and,","text_display":" \\(1.67 \\%\\) significance level for each active treatment group compared with the placebo group and,","confidence":0.99072265625,"confidence_rate":0.9999039154789536},{"cnt":[[245,726],[1871,726],[1871,776],[245,776]],"region":{"top_left_x":244,"top_left_y":726,"width":1628,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"915f8352081a4596a59641f29c276158","type":"text","conversion_output":true,"text":"if significant, the first secondary endpoint will be similarly tested at the \\(1.67 \\%\\) significance level.","text_display":" if significant, the first secondary endpoint will be similarly tested at the \\(1.67 \\%\\) significance level.","confidence":1,"confidence_rate":1},{"cnt":[[245,776],[1852,776],[1852,825],[245,825]],"region":{"top_left_x":244,"top_left_y":775,"width":1608,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ef1f024bf9e47588564b15c7dee5835","type":"text","conversion_output":true,"text":"The testing sequence will continue in order through the remaining secondary endpoints for each","text_display":" The testing sequence will continue in order through the remaining secondary endpoints for each","confidence":1,"confidence_rate":1},{"cnt":[[245,821],[1867,821],[1867,874],[245,874]],"region":{"top_left_x":244,"top_left_y":820,"width":1623,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99a2e1e691e54931a1704f65221dc93f","type":"text","conversion_output":true,"text":"active treatment group to placebo comparison or branch as long as the null hypothesis is rejected","text_display":" active treatment group to placebo comparison or branch as long as the null hypothesis is rejected","confidence":1,"confidence_rate":1},{"cnt":[[245,872],[776,872],[776,922],[245,922]],"region":{"top_left_x":244,"top_left_y":872,"width":532,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0900784d7ee447d49d1ef14b060b2619","type":"text","conversion_output":true,"text":"at the \\(1.67 \\%\\) significance level.","text_display":" at the \\(1.67 \\%\\) significance level.","confidence":1,"confidence_rate":1},{"cnt":[[245,958],[1863,958],[1863,1012],[245,1012]],"region":{"top_left_x":244,"top_left_y":958,"width":1619,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f805fce42a724d46ab3387a33e9602a3","type":"text","conversion_output":true,"text":"Testing within the last family (F3) will utilize the remaining \\(\\alpha\\) by applying the Holm-Bonferroni","text_display":"\n\nTesting within the last family (F3) will utilize the remaining \\(\\alpha\\) by applying the Holm-Bonferroni","confidence":0.9248046875,"confidence_rate":0.9992486217298514},{"cnt":[[245,1010],[432,1010],[432,1059],[245,1059]],"region":{"top_left_x":244,"top_left_y":1009,"width":188,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c293c615de554a09adce22e77aea5b70","type":"text","conversion_output":true,"text":"procedure.","text_display":" procedure.","confidence":1,"confidence_rate":1},{"cnt":[[241,1096],[924,1096],[924,1154],[241,1154]],"region":{"top_left_x":240,"top_left_y":1095,"width":684,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb4be5f684854d4bb83ba56f82d67a43","type":"section_header","conversion_output":false,"children_ids":["e9a992a7f2aa4d348530044379701a9f"],"text":"","text_display":""},{"cnt":[[245,1100],[917,1100],[917,1149],[245,1149]],"region":{"top_left_x":244,"top_left_y":1100,"width":674,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9a992a7f2aa4d348530044379701a9f","type":"text","conversion_output":true,"parent_id":"bb4be5f684854d4bb83ba56f82d67a43","text":"9.6 Examination of Subgroups","text_display":"\n\n\\subsection*{9.6 Examination of Subgroups}","confidence":0.985358476638794,"confidence_rate":0.9995531371958257},{"cnt":[[245,1188],[1798,1188],[1798,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1188,"width":1555,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"556519ef770c4617b466c9844617be33","type":"text","conversion_output":true,"text":"Subgroup analyses are planned for the primary efficacy endpoint and adverse events. Any p-","text_display":"\n\nSubgroup analyses are planned for the primary efficacy endpoint and adverse events. Any p","confidence":1,"confidence_rate":1},{"cnt":[[245,1237],[990,1237],[990,1287],[245,1287]],"region":{"top_left_x":244,"top_left_y":1237,"width":747,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abf1d585f5524ea4aeefa84a746098e0","type":"text","conversion_output":true,"text":"values that are presented will be descriptive.","text_display":"values that are presented will be descriptive.","confidence":1,"confidence_rate":1},{"cnt":[[245,1323],[896,1323],[896,1377],[245,1377]],"region":{"top_left_x":244,"top_left_y":1323,"width":652,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"965f70d89b29433cbd47a9f559063af5","type":"text","conversion_output":true,"text":"The following subgroups will be used:","text_display":"\n\nThe following subgroups will be 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Female)","confidence":1,"confidence_rate":1},{"cnt":[[245,1521],[776,1521],[776,1571],[245,1571]],"region":{"top_left_x":244,"top_left_y":1521,"width":532,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40a1290914c847beb1e29afb7d53f63f","type":"text","conversion_output":true,"text":"- Race Group (White, Other)","text_display":"\n- Race Group (White, Other)","confidence":1,"confidence_rate":1},{"cnt":[[245,1571],[1201,1571],[1201,1622],[245,1622]],"region":{"top_left_x":244,"top_left_y":1570,"width":957,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"952dc394dd3c4871abf8d4c75626e627","type":"text","conversion_output":true,"text":"- Weight Group ( \\(<50,50\\) to \\(<75,75\\) to \\(<100, \\geq 100 kg\\) )","text_display":"\n- Weight Group ( \\(<50,50\\) to \\(<75,75\\) to \\(<100, \\geq 100 kg\\) 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attacks/month)","text_display":"\n- Run-in Period HAE Attack Rate (1 to \\(<2,2\\) to \\(<3, \\geq 3\\) attacks/month)","confidence":0.8479385082256954,"confidence_rate":0.9978601219053536},{"cnt":[[245,1723],[1558,1723],[1558,1772],[245,1772]],"region":{"top_left_x":244,"top_left_y":1723,"width":1314,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eacf6cb971ad4917b03ad7a8dce79287","type":"text","conversion_output":true,"text":"- Pretreatment Period HAE Attack Rate ( 1 to \\(<2,2\\) to \\(<3, \\geq 3\\) attacks/month)","text_display":"\n- Pretreatment Period HAE Attack Rate ( 1 to \\(<2,2\\) to \\(<3, \\geq 3\\) attacks/month)","confidence":0.8148258319074113,"confidence_rate":0.997648964669329},{"cnt":[[245,1775],[1016,1775],[1016,1824],[245,1824]],"region":{"top_left_x":244,"top_left_y":1774,"width":773,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2261d45718540d2b716ef03b331630d","type":"text","conversion_output":true,"text":"- HAE Type (Type I, Type II, Unspecified)","text_display":"\n- HAE Type (Type I, Type II, Unspecified)","confidence":1,"confidence_rate":1},{"cnt":[[245,1826],[1154,1826],[1154,1876],[245,1876]],"region":{"top_left_x":244,"top_left_y":1826,"width":910,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4c6bedbde3a48f48f04e4e1be9637fe","type":"text","conversion_output":true,"text":"- Geographic Region (US, Canada, Jordan, Europe)","text_display":"\n- Geographic Region (US, Canada, Jordan, Europe)","confidence":1,"confidence_rate":1},{"cnt":[[245,1876],[1687,1876],[1687,1927],[245,1927]],"region":{"top_left_x":244,"top_left_y":1875,"width":1443,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11ae54532c904c75bf70de4a418638e6","type":"text","conversion_output":true,"text":"- Type of Long-term Prophylactic Therapy Prior to Study Randomization (C1-INH,","text_display":"\n- Type of Long-term Prophylactic Therapy Prior to Study Randomization (C1-INH,","confidence":1,"confidence_rate":1},{"cnt":[[305,1925],[1046,1925],[1046,1974],[305,1974]],"region":{"top_left_x":305,"top_left_y":1925,"width":742,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63b2baf7ddb64eed9247dcbf7c803c4f","type":"text","conversion_output":true,"text":"Androgens, Anti-fibrinolytics, Not on LTP)","text_display":" Androgens, Anti-fibrinolytics, Not on 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Data summaries will parallel those described for the primary analysis of the primary","text_display":" endpoint. Data summaries will parallel those described for the primary analysis of the primary","confidence":1,"confidence_rate":1},{"cnt":[[245,2114],[1334,2114],[1334,2168],[245,2168]],"region":{"top_left_x":244,"top_left_y":2114,"width":1091,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c09ed7762fb24b71ac929a24292f84ac","type":"text","conversion_output":true,"text":"efficacy endpoint and the primary analysis of the adverse events.","text_display":" efficacy endpoint and the primary analysis of the adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[241,2209],[799,2209],[799,2267],[241,2267]],"region":{"top_left_x":240,"top_left_y":2208,"width":560,"height":59},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca7e925b33834f02bc22a57996a8e56f","type":"section_header","conversion_output":false,"children_ids":["7658f00e1bdc4713aa647f8bb42517a4"],"text":"","text_display":""},{"cnt":[[245,2213],[795,2213],[795,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2212,"width":551,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7658f00e1bdc4713aa647f8bb42517a4","type":"text","conversion_output":true,"parent_id":"ca7e925b33834f02bc22a57996a8e56f","text":"9.7 Sensitivity Analyses","text_display":"\n\n\\subsection*{9.7 Sensitivity Analyses}","confidence":0.99951171875,"confidence_rate":0.999983158745329},{"cnt":[[245,2299],[1734,2299],[1734,2350],[245,2350]],"region":{"top_left_x":244,"top_left_y":2298,"width":1490,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9167a5d5f6d45c1bf9243e604f10d43","type":"text","conversion_output":true,"text":"The following sensitivity analyses will be performed on the primary efficacy endpoint to","text_display":"\n\nThe following sensitivity analyses will be performed on the primary efficacy endpoint to","confidence":1,"confidence_rate":1},{"cnt":[[245,2350],[1757,2350],[1757,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2350,"width":1514,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"483b6b9b6b544ad7a362fa9fe7bbd5e8","type":"text","conversion_output":true,"text":"evaluate the robustness of the results. Data summaries will parallel those described for the","text_display":" evaluate the robustness of the results. Data summaries will parallel those described for the","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,2398],[1089,2398],[1089,2447],[245,2447]],"region":{"top_left_x":244,"top_left_y":2397,"width":846,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6657fb3e64d44a2ba90d87ad3f3e45f","type":"text","conversion_output":true,"text":"primary analysis of the primary efficacy endpoint.","text_display":" primary analysis of the primary efficacy endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[245,2587],[432,2587],[432,2628],[245,2628]],"region":{"top_left_x":244,"top_left_y":2586,"width":188,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d547b660888d45508f0369196d0e3a4d","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1880,2587],[1880,2628],[1676,2628]],"region":{"top_left_x":1675,"top_left_y":2586,"width":205,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a57aff96856443894ba973b50b9f546","type":"page_info","conversion_output":false,"text":"Page 36 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-37","page":37,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9d1840e3def41338b9198983683d209","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,168],[1880,168],[1880,208],[1676,208]],"region":{"top_left_x":1675,"top_left_y":167,"width":205,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e1e884d94d54c318154b355a9efcf39","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,260],[1861,260],[1861,312],[247,312]],"region":{"top_left_x":247,"top_left_y":259,"width":1614,"height":53},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b0dec9caada41bd84d07734d47a6db1","type":"text","conversion_output":true,"text":"1. The primary analysis will be repeated using the Safety Population. Subjects will be analyzed","text_display":"\n1. The primary analysis will be repeated using the Safety Population. Subjects will be analyzed","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[305,309],[1772,309],[1772,359],[305,359]],"region":{"top_left_x":305,"top_left_y":309,"width":1468,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97831f8bd998466d8f7718457752d3a9","type":"text","conversion_output":true,"text":"according to the treatment actually received. This analysis will only be presented if the","text_display":" according to the treatment actually received. This analysis will only be presented if the","confidence":1,"confidence_rate":1},{"cnt":[[307,357],[1876,357],[1876,406],[307,406]],"region":{"top_left_x":307,"top_left_y":356,"width":1569,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f59a4944fe5d4fb4b358771e78cba1a1","type":"text","conversion_output":true,"text":"Safety Population is different from the ITT Population or if subjects did not receive treatment","text_display":" Safety Population is different from the ITT Population or if subjects did not receive treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,404],[569,404],[569,449],[305,449]],"region":{"top_left_x":305,"top_left_y":403,"width":265,"height":47},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb14dad4854c4efab318374b0fe7cbc3","type":"text","conversion_output":true,"text":"as randomized.","text_display":" as randomized.","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1764,494],[1764,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1520,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d87cd6e08ef4affaeec1f812fb62c3c","type":"text","conversion_output":true,"text":"2. The primary analysis will be repeated counting HAE attacks occurring on Day 14 after","text_display":"\n2. The primary analysis will be repeated counting HAE attacks occurring on Day 14 after","confidence":1,"confidence_rate":1},{"cnt":[[305,541],[1583,541],[1583,591],[305,591]],"region":{"top_left_x":305,"top_left_y":541,"width":1279,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95ee962472cc470c9d89e4645aa2a3e5","type":"text","conversion_output":true,"text":"administration of study drug through Day 182, instead of Day 0 to Day 182.","text_display":" administration of study drug through Day 182, instead of Day 0 to Day 182.","confidence":1,"confidence_rate":1},{"cnt":[[245,632],[1745,632],[1745,681],[245,681]],"region":{"top_left_x":244,"top_left_y":631,"width":1501,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f464bc36037a4e0b93ae2d19ab1f49be","type":"text","conversion_output":true,"text":"3. The primary analysis will be repeated counting HAE attacks occurring on Day 7 after","text_display":"\n3. The primary analysis will be repeated counting HAE attacks occurring on Day 7 after","confidence":1,"confidence_rate":1},{"cnt":[[305,679],[1583,679],[1583,728],[305,728]],"region":{"top_left_x":305,"top_left_y":678,"width":1279,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98f5ca5ebc36461393493f2d04c89df2","type":"text","conversion_output":true,"text":"administration of study drug through Day 182, instead of Day 0 to Day 182.","text_display":" administration of study drug through Day 182, instead of Day 0 to Day 182.","confidence":1,"confidence_rate":1},{"cnt":[[245,769],[1777,769],[1777,819],[245,819]],"region":{"top_left_x":244,"top_left_y":769,"width":1533,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2837c766ee9245b1898cf871d0c7d54b","type":"text","conversion_output":true,"text":"4. The primary analysis will be repeated using all subject reported HAE attacks instead of","text_display":"\n4. The primary analysis will be repeated using all subject reported HAE attacks instead of","confidence":1,"confidence_rate":1},{"cnt":[[305,816],[1489,816],[1489,866],[305,866]],"region":{"top_left_x":305,"top_left_y":816,"width":1184,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da1b86221c1b4032a380b1b1f3d52379","type":"text","conversion_output":true,"text":"limiting the analysis to those attacks that were investigator-confirmed.","text_display":" limiting the analysis to those attacks that were investigator-confirmed.","confidence":1,"confidence_rate":1},{"cnt":[[245,907],[1751,907],[1751,956],[245,956]],"region":{"top_left_x":244,"top_left_y":906,"width":1507,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"069781ffc69946938a3c4749d55a1329","type":"text","conversion_output":true,"text":"5. The primary analysis will be repeated using a generalized estimating equations (GEE)","text_display":"\n5. The primary analysis will be repeated using a generalized estimating equations (GEE)","confidence":1,"confidence_rate":1},{"cnt":[[305,954],[1803,954],[1803,1003],[305,1003]],"region":{"top_left_x":305,"top_left_y":953,"width":1498,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bf3e696ab7f4814bc47995cdd156899","type":"text","conversion_output":true,"text":"analysis method counting HAE attacks occurring on Day 14 after administration of study","text_display":" analysis method counting HAE attacks occurring on Day 14 after administration of study","confidence":1,"confidence_rate":1},{"cnt":[[305,1001],[1876,1001],[1876,1051],[305,1051]],"region":{"top_left_x":305,"top_left_y":1001,"width":1571,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a21c45268aa4cfdaa4af19373f08459","type":"text","conversion_output":true,"text":"drug through Day 182 in order to descriptively compare the results from this study with those","text_display":" drug through Day 182 in order to descriptively compare the results from this study with those","confidence":1,"confidence_rate":1},{"cnt":[[305,1100],[305,1046],[1515,1049],[1515,1103]],"region":{"top_left_x":304,"top_left_y":1046,"width":1211,"height":57},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13df82fa4b1b459797f145bbf7de3704","type":"text","conversion_output":true,"text":"from DX-2930-02 study. The methods for this analysis are listed below.","text_display":" from DX-2930-02 study. The methods for this analysis are listed below.","confidence":1,"confidence_rate":1},{"cnt":[[305,1139],[1783,1139],[1783,1190],[305,1190]],"region":{"top_left_x":305,"top_left_y":1138,"width":1479,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82030947d3f14ba9812fb8dd855657fb","type":"text","conversion_output":true,"text":"HAE attack rates for each active treatment group will be compared to the placebo group","text_display":"\n\nHAE attack rates for each active treatment group will be compared to the placebo group","confidence":1,"confidence_rate":1},{"cnt":[[305,1188],[1820,1188],[1820,1240],[305,1240]],"region":{"top_left_x":305,"top_left_y":1188,"width":1515,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ccb96f50b0d410cb8ee24909dd121a1","type":"text","conversion_output":true,"text":"using a mixed-model repeated measures (MMRM) analysis of covariance (ANCOVA) for","text_display":" using a mixed-model repeated measures (MMRM) analysis of covariance (ANCOVA) for","confidence":1,"confidence_rate":1},{"cnt":[[305,1233],[1824,1233],[1824,1287],[305,1287]],"region":{"top_left_x":305,"top_left_y":1233,"width":1520,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3109b9d2a4914b07a737bcee63b1bab3","type":"text","conversion_output":true,"text":"count data (assuming a Poisson distribution with log link function) using GEE. The model","text_display":" count data (assuming a Poisson distribution with log link function) using GEE. The model","confidence":1,"confidence_rate":1},{"cnt":[[305,1285],[1725,1285],[1725,1334],[305,1334]],"region":{"top_left_x":305,"top_left_y":1284,"width":1421,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac02a4888337440c82c9da08910c993b","type":"text","conversion_output":true,"text":"will include a fixed effect for treatment (categorical), pretreatment period attack rate","text_display":" will include a fixed effect for treatment (categorical), pretreatment period attack rate","confidence":1,"confidence_rate":1},{"cnt":[[305,1332],[1076,1332],[1076,1381],[305,1381]],"region":{"top_left_x":305,"top_left_y":1332,"width":772,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5be3acc957af4cd9bd8da1ff134aa1dc","type":"text","conversion_output":true,"text":"(continuous), and a random effect for subject.","text_display":" (continuous), and a random effect for subject.","confidence":1,"confidence_rate":1},{"cnt":[[305,1427],[1854,1427],[1854,1480],[305,1480]],"region":{"top_left_x":305,"top_left_y":1426,"width":1550,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"255223b0dc50419f9ab91d4c2b95b746","type":"text","conversion_output":true,"text":"Repeated measurement analysis will be employed, with a 7 -day time period (i.e., 168 hours)","text_display":"\n\nRepeated measurement analysis will be employed, with a 7 -day time period (i.e., 168 hours)","confidence":0.9579117866232991,"confidence_rate":0.9995785242770344},{"cnt":[[305,1474],[1858,1474],[1858,1525],[305,1525]],"region":{"top_left_x":305,"top_left_y":1473,"width":1554,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e74e5eb199340a7af20359ae900cfd3","type":"text","conversion_output":true,"text":"serving as the discrete unit of measurement. Subject weeks for which completed observation","text_display":" serving as the discrete unit of measurement. Subject weeks for which completed observation","confidence":1,"confidence_rate":1},{"cnt":[[305,1521],[1876,1521],[1876,1571],[305,1571]],"region":{"top_left_x":305,"top_left_y":1521,"width":1571,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"628fe48762364f1da7a083a020a1b413","type":"text","conversion_output":true,"text":"is less than the full 168 hours within a week will be treated as a full week if at least 3 or more","text_display":" is less than the full 168 hours within a week will be treated as a full week if at least 3 or more","confidence":0.9990236759185791,"confidence_rate":0.9999910385631244},{"cnt":[[305,1568],[1760,1568],[1760,1622],[305,1622]],"region":{"top_left_x":305,"top_left_y":1568,"width":1455,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6c6bb17eb394fdeac33c4fb291d9e03","type":"text","conversion_output":true,"text":"days of data were recorded during the week. Weeks with fewer than 3 days will not be","text_display":" days of data were recorded during the week. Weeks with fewer than 3 days will not be","confidence":0.998046875,"confidence_rate":0.9999787498471376},{"cnt":[[305,1620],[471,1620],[471,1665],[305,1665]],"region":{"top_left_x":305,"top_left_y":1619,"width":166,"height":47},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62475ac47a0f4212b39c17c932cf3f63","type":"text","conversion_output":true,"text":"included.","text_display":" included.","confidence":1,"confidence_rate":1},{"cnt":[[305,1708],[1850,1708],[1850,1760],[305,1760]],"region":{"top_left_x":305,"top_left_y":1708,"width":1545,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dace32a55a30442d81f024fb53e9dd10","type":"text","conversion_output":true,"text":"In the event that there are 0 events in one of the treatment groups, a small value of 0.000001","text_display":"\n\nIn the event that there are 0 events in one of the treatment groups, a small value of 0.000001","confidence":0.99853515625,"confidence_rate":0.9999854860688677},{"cnt":[[305,1757],[1085,1757],[1085,1803],[305,1803]],"region":{"top_left_x":305,"top_left_y":1757,"width":780,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8277fe73ba4d4bf584e6cccd2b41f95c","type":"text","conversion_output":true,"text":"will be added in order to calculate event rates.","text_display":" will be added in order to calculate event rates.","confidence":1,"confidence_rate":1},{"cnt":[[243,1824],[1824,1824],[1824,1876],[243,1876]],"region":{"top_left_x":242,"top_left_y":1824,"width":1583,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adf8544d48c24e9fa3e83bf9531f6940","type":"text","conversion_output":true,"text":"Additionally, as applicable, the following sensitivity analyses will be performed on secondary","text_display":"\n\nAdditionally, as applicable, the following sensitivity analyses will be performed on secondary","confidence":1,"confidence_rate":1},{"cnt":[[245,1873],[1803,1873],[1803,1923],[245,1923]],"region":{"top_left_x":244,"top_left_y":1873,"width":1559,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55d7bdd983314263acabbeeba1c70878","type":"text","conversion_output":true,"text":"and exploratory efficacy endpoints as detailed in Table 1. Data summaries will parallel those","text_display":" and exploratory efficacy endpoints as detailed in Table 1. Data summaries will parallel those","confidence":1,"confidence_rate":1},{"cnt":[[245,1921],[909,1921],[909,1972],[245,1972]],"region":{"top_left_x":244,"top_left_y":1920,"width":665,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2d7f812be2c49bf9df1328d90419cdc","type":"text","conversion_output":true,"text":"described for the each of the endpoints.","text_display":" described for the each of the endpoints.","confidence":1,"confidence_rate":1},{"cnt":[[245,2587],[432,2587],[432,2632],[245,2632]],"region":{"top_left_x":244,"top_left_y":2586,"width":188,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eaff39c8de9640dbb158095b037c22c8","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,2587],[1882,2587],[1882,2632],[1676,2632]],"region":{"top_left_x":1675,"top_left_y":2586,"width":208,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59e6d303b88943eaba3371e1f682d727","type":"page_info","conversion_output":false,"text":"Page 37 of 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Table No. & Title \\\\\n\\hline 14.1.1.1 & Analysis Population by Treatment Group - All Subjects \\\\\n\\hline 14.1.1.2 & Analysis Populations by Treatment Group and Site - All Subjects \\\\\n\\hline 14.1.2.1 & Subject Disposition by Treatment Group - ITT Population \\\\\n\\hline 14.1.2.2 & Subject Disposition by Treatment Group - Safety Population \\\\\n\\hline 14.1.3.1 & Demographic Characteristics by Treatment Group - ITT Population \\\\\n\\hline 14.1.3.2 & Demographic Characteristics by Treatment Group - Safety Population \\\\\n\\hline 14.1.4.1 & Baseline Characteristics by Treatment Group - ITT Population \\\\\n\\hline 14.1.4.2 & Baseline Characteristics by Treatment Group - Safety Population \\\\\n\\hline 14.1.5.1 & Medical History by System Organ class, Preferred Term, and Treatment Group - ITT Population \\\\\n\\hline 14.1.5.2 & Medical History by System Organ class, Preferred Term, and Treatment Group - Safety Population \\\\\n\\hline 14.1.6.1 & Prior Medications by Treatment Group - Safety Population \\\\\n\\hline 14.1.6.2 & Concomitant Medications and Therapies (Other than Rescue Medications) by Treatment Group Safety Population \\\\\n\\hline 14.1.6.3 & Rescue Medications by Treatment Group - Safety Population \\\\\n\\hline 14.1.7.1 & Summary of Protocol Deviation Type by Treatment Groups - ITT Population \\\\\n\\hline 14.1.8.1 & Treatment Compliance and Study Drug Exposure by Treatment Group - ITT Population \\\\\n\\hline 14.1.8.2 & Treatment Compliance and Study Drug Exposure by Treatment Group - Safety Population \\\\\n\\hline 14.2.1.1 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.2 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.1.3 & Poisson Regression of Investigator-confirmed HAE Attacks during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.4 & Poisson Regression of Investigator-confirmed HAE Attacks during Day 8 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.5 & Poisson Regression of All HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.6 & GEE Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 14 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.7 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Age Group and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.8 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Sex and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.9 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Race Group and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.10 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Weight Group and Treatment Group - ITT Population \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Table No. & Title \\\\\n\\hline 14.1.1.1 & Analysis Population by Treatment Group - All Subjects \\\\\n\\hline 14.1.1.2 & Analysis Populations by Treatment Group and Site - All Subjects \\\\\n\\hline 14.1.2.1 & Subject Disposition by Treatment Group - ITT Population \\\\\n\\hline 14.1.2.2 & Subject Disposition by Treatment Group - Safety Population \\\\\n\\hline 14.1.3.1 & Demographic Characteristics by Treatment Group - ITT Population \\\\\n\\hline 14.1.3.2 & Demographic Characteristics by Treatment Group - Safety Population \\\\\n\\hline 14.1.4.1 & Baseline Characteristics by Treatment Group - ITT Population \\\\\n\\hline 14.1.4.2 & Baseline Characteristics by Treatment Group - Safety Population \\\\\n\\hline 14.1.5.1 & Medical History by System Organ class, Preferred Term, and Treatment Group - ITT Population \\\\\n\\hline 14.1.5.2 & Medical History by System Organ class, Preferred Term, and Treatment Group - Safety Population \\\\\n\\hline 14.1.6.1 & Prior Medications by Treatment Group - Safety Population \\\\\n\\hline 14.1.6.2 & Concomitant Medications and Therapies (Other than Rescue Medications) by Treatment Group Safety Population \\\\\n\\hline 14.1.6.3 & Rescue Medications by Treatment Group - Safety Population \\\\\n\\hline 14.1.7.1 & Summary of Protocol Deviation Type by Treatment Groups - ITT Population \\\\\n\\hline 14.1.8.1 & Treatment Compliance and Study Drug Exposure by Treatment Group - ITT Population \\\\\n\\hline 14.1.8.2 & Treatment Compliance and Study Drug Exposure by Treatment Group - Safety Population \\\\\n\\hline 14.2.1.1 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.2 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.1.3 & Poisson Regression of Investigator-confirmed HAE Attacks during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.4 & Poisson Regression of Investigator-confirmed HAE Attacks during Day 8 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.5 & Poisson Regression of All HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.6 & GEE Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 14 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.7 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Age Group and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.8 & Poisson 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Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Type of Long-term Prophylactic Therapy Prior to Study Randomization and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.17 & Summary of Investigator-confirmed HAE Attacks by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.18 & Mean, Mean Change, and Mean Percent Change from Pretreatment Period in Number of Investigator-confirmed HAE Attacks per Month by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.1 & Poisson Regression of Investigator-confirmed HAE Attacks Requiring Acute Treatment during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.2.2 & Poisson Regression of Investigator-confirmed HAE Attacks Requiring Acute Treatment during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.2.3 & Poisson Regression of Investigator-confirmed HAE Attacks Requiring Acute Treatment during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.4 & Poisson Regression of Investigator-confirmed HAE Attacks Requiring Acute Treatment during Day 8 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.5 & Poisson Regression of All HAE Attacks Requiring Acute Treatment during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.6 & Mean, Mean Change, and Mean Percent Change from Pretreatment in Number of Investigatorconfirmed HAE Attacks Requiring Acute Treatment per Month by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.7 & Summary of Investigator-confirmed HAE Attacks Requiring Acute Treatment by Treatment Group ITT Population \\\\\n\\hline 14.2.3.1 & Poisson Regression of Moderate and Severe Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.3.2 & Poisson Regression of Moderate and Severe Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.3.3 & Poisson Regression of Moderate and Severe Investigator-confirmed HAE Attacks during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.3.4 & Poisson Regression of Moderate and Severe Investigator-confirmed HAE Attacks during Day 8 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.3.5 & Poisson Regression of All Moderate and Severe HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.3.6 & Summary of Moderate and Severe Investigator-confirmed HAE Attacks by Treatment Group - ITT Population \\\\\n\\hline 14.2.4.1 & Time to First Investigator-confirmed HAE Attack after Day 14 - ITT Population \\\\\n\\hline 14.2.4.2 & Time to First Investigator-confirmed HAE Attack after Day 14 - Safety Population \\\\\n\\hline 14.2.4.3 & Time to First Investigator-confirmed HAE Attack after Day 7 - ITT Population \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.2.1.11 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by BMI Group and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.12 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Run-in Period HAE Attack Rate Group and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.13 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Pretreatment Period HAE Attack Rate Group and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.14 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by HAE Type and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.15 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Geographic Region and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.16 & Poisson Regression of Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Type of Long-term Prophylactic Therapy Prior to Study Randomization and Treatment Group - ITT Population \\\\\n\\hline 14.2.1.17 & Summary of Investigator-confirmed HAE Attacks by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.18 & Mean, Mean Change, and Mean Percent Change from Pretreatment Period in Number of Investigator-confirmed HAE Attacks per Month by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.1 & Poisson Regression of Investigator-confirmed HAE Attacks Requiring Acute Treatment during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.2.2 & Poisson Regression of Investigator-confirmed HAE Attacks Requiring Acute Treatment during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.2.3 & Poisson Regression of Investigator-confirmed HAE Attacks Requiring Acute Treatment during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.4 & Poisson Regression of Investigator-confirmed HAE Attacks Requiring Acute Treatment during Day 8 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.5 & Poisson Regression of All HAE Attacks Requiring Acute Treatment during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.6 & Mean, Mean Change, and Mean Percent Change from Pretreatment in Number of Investigatorconfirmed HAE Attacks Requiring Acute Treatment per Month by Treatment Group - ITT Population \\\\\n\\hline 14.2.2.7 & Summary of Investigator-confirmed HAE Attacks Requiring Acute Treatment by Treatment Group ITT Population \\\\\n\\hline 14.2.3.1 & Poisson Regression of Moderate and Severe Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.3.2 & Poisson Regression of Moderate and Severe Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.3.3 & Poisson Regression of Moderate and Severe Investigator-confirmed HAE Attacks during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.3.4 & Poisson Regression of Moderate and Severe Investigator-confirmed HAE Attacks during Day 8 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.3.5 & Poisson Regression of All Moderate and Severe HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.3.6 & Summary of Moderate and Severe Investigator-confirmed HAE Attacks by Treatment Group - ITT Population \\\\\n\\hline 14.2.4.1 & Time to First Investigator-confirmed HAE Attack after Day 14 - ITT Population \\\\\n\\hline 14.2.4.2 & Time to First Investigator-confirmed HAE Attack after Day 14 - Safety Population \\\\\n\\hline 14.2.4.3 & Time to First Investigator-confirmed HAE Attack after Day 7 - ITT Population 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14.2.4.4 & Time to First HAE Attack after Day 14 - ITT Population \\\\\n\\hline 14.2.5.1 & Poisson Regression of Investigator-confirmed High-Morbidity HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.5.2 & Poisson Regression of Investigator-confirmed High-Morbidity HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.5.3 & Poisson Regression of Investigator-confirmed High-Morbidity HAE Attacks during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.5.4 & Poisson Regression of Investigator-confirmed High-Morbidity HAE Attacks during Day 7 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.5.5 & Poisson Regression of High-Morbidity HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.5.6 & Summary of Investigator-confirmed High-Morbidity HAE Attacks by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.1 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.2 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.6.3 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.4 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during Day 7 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.5 & Poisson Regression of HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.6 & Summary of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.1 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.2 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.7.3 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.4 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit during Day 7 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.5 & Poisson Regression of HAE Attacks resulting in an Emergency Department Visit during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.6 & Summary of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit by Treatment Group - ITT Population \\\\\n\\hline 14.2.8.1 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.8.2 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.8.3 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in Admission to the Hospital during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.8.4 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in Admission to the Hospital during Day 7 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.2.4.4 & Time to First HAE Attack after Day 14 - ITT Population \\\\\n\\hline 14.2.5.1 & Poisson Regression of Investigator-confirmed High-Morbidity HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.5.2 & Poisson Regression of Investigator-confirmed High-Morbidity HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.5.3 & Poisson Regression of Investigator-confirmed High-Morbidity HAE Attacks during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.5.4 & Poisson Regression of Investigator-confirmed High-Morbidity HAE Attacks during Day 7 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.5.5 & Poisson Regression of High-Morbidity HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.5.6 & Summary of Investigator-confirmed High-Morbidity HAE Attacks by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.1 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.2 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.6.3 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.4 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during Day 7 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.5 & Poisson Regression of HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.6 & Summary of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit or Admission to the Hospital by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.1 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.2 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.2.7.3 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.4 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit during Day 7 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.5 & Poisson Regression of HAE Attacks resulting in an Emergency Department Visit during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.6 & Summary of Investigator-confirmed HAE Attacks resulting in an Emergency Department Visit by Treatment Group - ITT Population \\\\\n\\hline 14.2.8.1 & Poisson Regression of Investigator-confirmed HAE Attacks resulting in Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.8.2 & Poisson 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14.2.8.5 & Poisson Regression of HAE Attacks resulting in an Emergency Department Visit during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.8.6 & Summary of Investigator-confirmed HAE Attacks resulting in Admission to the Hospital by Treatment Group - ITT Population \\\\\n\\hline 14.2.9.1 & Responder Analysis using Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Responder Threshold and Treatment Group- ITT Population \\\\\n\\hline 14.2.9.2 & Responder Analysis using Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Responder Threshold and Treatment Group- Safety Population \\\\\n\\hline 14.2.9.3 & Responder Analysis using Investigator-confirmed HAE Attacks during Day 14 to Day 182 by Responder Threshold and Treatment Group- ITT Population \\\\\n\\hline 14.2.9.4 & Responder Analysis using Investigator-confirmed HAE Attacks during Day 7 to Day 182 by Responder Threshold and Treatment Group- ITT Population \\\\\n\\hline 14.2.9.5 & Responder Analysis using All HAE Attacks during the Treatment Period (Day 0 to Day 182) by Responder Threshold and Treatment Group- ITT Population \\\\\n\\hline 14.2.10.1 & Characteristics of Investigator-confirmed HAE attacks during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.10.2 & Characteristics of Investigator-confirmed HAE attacks during the Treatment Period (Day 0 to Day 182) - Safety Population \\\\\n\\hline 14.2.10.3 & Characteristics of Investigator-confirmed HAE attacks during Day 14 to Day 182 - ITT Population \\\\\n\\hline 14.2.10.4 & Characteristics of Investigator-confirmed HAE attacks during Day 7 to Day 182 - ITT Population \\\\\n\\hline 14.2.10.5 & Characteristics of All HAE attacks during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.11.1 & Percentage of Investigator-confirmed HAE Attack-free Days during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.11.2 & Percentage of Investigator-confirmed HAE Attack-free Days during the Treatment Period (Day 0 to Day 182) - Safety Population \\\\\n\\hline 14.2.11.3 & Percentage of Investigator-confirmed HAE Attack-free Days during Day 14 to Day 182 - ITT Population \\\\\n\\hline 14.2.11.4 & Percentage of Investigator-confirmed HAE Attack-free Days during Day 7 to Day 182 - ITT Population \\\\\n\\hline 14.2.11.5 & Percentage of HAE Attack-free Days during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.12.1 & Subject Listing of Efficacy Parameters - ITT Population \\\\\n\\hline 14.2.13.1 & Plasma Concentrations of DX-2390 by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.2.14.1 & Plasma Kallikrein Activity by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.2.15.1 & Summary of EQ-5D-5L Dimensions and VAS Score by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.2.15.2 & Summary of Angioedema Quality of Life Items, Domains and Total Score by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.1.1.1 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.2 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Age Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.3 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Sex and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.4 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.2.8.5 & Poisson Regression of HAE Attacks resulting in an Emergency Department Visit during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.8.6 & Summary of Investigator-confirmed HAE Attacks resulting in Admission to the Hospital by Treatment Group - ITT Population \\\\\n\\hline 14.2.9.1 & Responder Analysis using Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Responder Threshold and Treatment Group- ITT Population \\\\\n\\hline 14.2.9.2 & Responder Analysis using Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Responder Threshold and Treatment Group- Safety Population \\\\\n\\hline 14.2.9.3 & Responder Analysis using Investigator-confirmed HAE Attacks during Day 14 to Day 182 by Responder Threshold and Treatment Group- ITT Population \\\\\n\\hline 14.2.9.4 & Responder Analysis using Investigator-confirmed HAE Attacks during Day 7 to Day 182 by Responder Threshold and Treatment Group- ITT Population \\\\\n\\hline 14.2.9.5 & Responder Analysis using All HAE Attacks during the Treatment Period (Day 0 to Day 182) by Responder Threshold and Treatment Group- ITT Population \\\\\n\\hline 14.2.10.1 & Characteristics of Investigator-confirmed HAE attacks during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.10.2 & Characteristics of Investigator-confirmed HAE attacks during the Treatment Period (Day 0 to Day 182) - Safety Population \\\\\n\\hline 14.2.10.3 & Characteristics of Investigator-confirmed HAE attacks during Day 14 to Day 182 - ITT Population \\\\\n\\hline 14.2.10.4 & Characteristics of Investigator-confirmed HAE attacks during Day 7 to Day 182 - ITT Population \\\\\n\\hline 14.2.10.5 & Characteristics of All HAE attacks during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.11.1 & Percentage of Investigator-confirmed HAE Attack-free Days during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.11.2 & Percentage of Investigator-confirmed HAE Attack-free Days during the Treatment Period (Day 0 to Day 182) - Safety Population \\\\\n\\hline 14.2.11.3 & Percentage of Investigator-confirmed HAE Attack-free Days during Day 14 to Day 182 - ITT Population \\\\\n\\hline 14.2.11.4 & Percentage of Investigator-confirmed HAE Attack-free Days during Day 7 to Day 182 - ITT Population \\\\\n\\hline 14.2.11.5 & Percentage of HAE Attack-free Days during the Treatment Period (Day 0 to Day 182) - ITT Population \\\\\n\\hline 14.2.12.1 & Subject Listing of Efficacy Parameters - ITT Population \\\\\n\\hline 14.2.13.1 & Plasma Concentrations of DX-2390 by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.2.14.1 & Plasma Kallikrein Activity by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.2.15.1 & Summary of EQ-5D-5L Dimensions and VAS Score by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.2.15.2 & Summary of Angioedema Quality of Life Items, Domains and Total Score by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.1.1.1 & 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& by Race Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.5 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Weight Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.6 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by BMI Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.7 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Run-in Period HAE Attack Rate Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.8 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Pretreatment Period HAE Attack Rate Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.9 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by HAE Type and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.10 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Geographic Region and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.11 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Type of Long-term Prophylactic Therapy Prior to Study Randomization and Treatment Group Safety Population \\\\\n\\hline 14.3.1.2.1 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.2 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.3 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Age Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.4 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Sex, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.5 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Race Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.6 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Weight Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.7 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by BMI Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.8 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Run-in Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.9 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Pretreatment Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.10 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by HAE Type, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.11 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Geographic Region, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.12 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Type of Long-term Prophylactic Therapy Prior to Study Randomization, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.1 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.2 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group and Preferred Term - Safety Population \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & by Race Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.5 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Weight Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.6 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by BMI Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.7 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Run-in Period HAE Attack Rate Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.8 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Pretreatment Period HAE Attack Rate Group and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.9 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by HAE Type and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.10 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Geographic Region and Treatment Group - Safety Population \\\\\n\\hline 14.3.1.1.11 & Summary of Treatment-Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Type of Long-term Prophylactic Therapy Prior to Study Randomization and Treatment Group Safety Population \\\\\n\\hline 14.3.1.2.1 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.2 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.3 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Age Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.4 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Sex, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.5 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Race Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.6 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Weight Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.7 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by BMI Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.8 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Run-in Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.9 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Pretreatment Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.10 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by HAE Type, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.11 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Geographic Region, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.2.12 & Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Type of 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14.3.1.3.3 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Age Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.4 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Sex, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.5 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Race Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.6 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Weight Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.7 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by BMI Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.8 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Run-in Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term Safety Population \\\\\n\\hline 14.3.1.3.9 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Pretreatment Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.10 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by HAE Type, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.11 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Geographic Region, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.12 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Type of Long-term Prophylactic Therapy Prior to Study Randomization, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.1 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.2 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.3 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Age Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.4 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Sex, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.5 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Race Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.6 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Weight Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.7 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by BMI Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.8 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Run-in Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term Safety Population \\\\\n\\hline 14.3.1.4.9 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Pretreatment Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.10 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by HAE Type, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.11 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Geographic Region, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.3.1.3.3 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Age Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.4 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Sex, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.5 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Race Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.6 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Weight Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.7 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by BMI Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.8 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Run-in Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term Safety Population \\\\\n\\hline 14.3.1.3.9 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Pretreatment Period HAE Attack Rate Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.10 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by HAE Type, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.11 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Geographic Region, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.3.12 & Related Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Type of Long-term Prophylactic Therapy Prior to Study Randomization, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.1 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.2 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.3 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Age Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.4 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Sex, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.5 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Race Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.6 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Weight Group, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.4.7 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by BMI 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14.3.1.4.12 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Type of Long-term Prophylactic Therapy Prior to Study Randomization, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.5.1 & Related Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.6.1 & Severe Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.7.1 & Related Severe Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.8.1 & Summary of Adverse Events during the Pretreatment Period (Prior to Day 0) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.8.2 & Adverse Events during the Pretreatment Period (Prior to Day 0) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.8.3 & Serious Adverse Events during the Pretreatment Period (Prior Day 0) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.1 & Summary of Treatment-Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.3.1.9.2 & Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.3 & Related Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.4 & Serious Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.5 & Related Serious Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.6 & Severe Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.7 & Related Severe Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.10.1 & Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term- Safety Population \\\\\n\\hline 14.3.1.10.2 & Related Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term- Safety Population \\\\\n\\hline 14.3.1.10.3 & Serious Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.10.4 & Related Serious Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.10.5 & Severe Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.10.6 & Related Severe Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.11.1 & Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.11.2 & Related Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.3.1.4.12 & Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Type of Long-term Prophylactic Therapy Prior to Study Randomization, Treatment Group, System Organ Class and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.5.1 & Related Serious Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.6.1 & Severe Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.7.1 & Related Severe Treatment Emergent Adverse Events during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.8.1 & Summary of Adverse Events during the Pretreatment Period (Prior to Day 0) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.8.2 & Adverse Events during the Pretreatment Period (Prior to Day 0) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.8.3 & Serious Adverse Events during the Pretreatment Period (Prior Day 0) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.1 & Summary of Treatment-Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group - Safety Population \\\\\n\\hline 14.3.1.9.2 & Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.3 & Related Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.4 & Serious Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.5 & Related Serious Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.6 & Severe Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.9.7 & Related Severe Treatment Emergent Adverse Events during the Follow-up Period (>Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.10.1 & Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term- Safety Population \\\\\n\\hline 14.3.1.10.2 & Related Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term- Safety Population \\\\\n\\hline 14.3.1.10.3 & Serious Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.10.4 & Related Serious Treatment Emergent Adverse Events of Hypersensitivity during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 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14.3.1.11.3 & Serious Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.11.4 & Related Serious Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.11.5 & Severe Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.11.6 & Related Severe Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.1 & Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.2 & Related Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.3 & Serious Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.4 & Related Serious Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.5 & Severe Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.6 & Related Severe Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.2.1 & Listing of Adverse Events Resulting in Death - All Subjects \\\\\n\\hline 14.3.2.2 & Listing of Serious Adverse Events - All Subjects \\\\\n\\hline 14.3.2.3 & Listing of Adverse Events Resulting in Study Drug Interrupted or Withdrawn - All Subjects \\\\\n\\hline 14.3.2.4 & Listing of Related Adverse Events - All Subjects \\\\\n\\hline 14.3.2.5 & Listing of Severe Adverse Events - All Subjects \\\\\n\\hline 14.3.2.6 & Listing of Hypersensitivity Adverse Events - All Subjects \\\\\n\\hline 14.3.2.7 & Listing of Bleeding Adverse Events - All Subjects \\\\\n\\hline 14.3.2.8 & Listing of Hypercoagulable Adverse Events - All Subjects \\\\\n\\hline 14.3.3 & No statistical table will be generated. Numbering reserved for SAE narratives per ICH. \\\\\n\\hline 14.3.4.1.1 & Actual Values and Change from Baseline in Hematology Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.1.2 & Categorical Hematology Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.1.3 & Listing of Clinically Significant Abnormal Hematology Results - Safety Population \\\\\n\\hline 14.3.4.2.1 & Actual Values and Change from Baseline in Coagulation Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.2.2 & Categorical Coagulation Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.2.3 & Listing of Clinically Significant Abnormal Coagulation Results - Safety Population \\\\\n\\hline 14.3.4.3.1 & Actual Values and Change from Baseline in Chemistry Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.3.2 & Categorical Chemistry Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.3.3 & Listing of Clinically Significant Abnormal Chemistry Results - Safety Population \\\\\n\\hline 14.3.4.4.1 & Actual Values and Change from Baseline in Urinalysis Results by Treatment Group and Study Visit \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.3.1.11.3 & Serious Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.11.4 & Related Serious Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.11.5 & Severe Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.11.6 & Related Severe Treatment Emergent Adverse Events of Bleeding during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.1 & Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.2 & Related Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.3 & Serious Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.4 & Related Serious Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.5 & Severe Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.1.12.6 & Related Severe Treatment Emergent Adverse Events of Hypercoagulable during the Treatment Period (Day 0 to Day 182) by Treatment Group, System Organ Class, and Preferred Term - Safety Population \\\\\n\\hline 14.3.2.1 & Listing of Adverse Events Resulting in Death - All Subjects \\\\\n\\hline 14.3.2.2 & Listing of Serious Adverse Events - All Subjects \\\\\n\\hline 14.3.2.3 & Listing of Adverse Events Resulting in Study Drug Interrupted or Withdrawn - All Subjects \\\\\n\\hline 14.3.2.4 & Listing of Related Adverse Events - All Subjects \\\\\n\\hline 14.3.2.5 & Listing of Severe Adverse Events - All Subjects \\\\\n\\hline 14.3.2.6 & Listing of Hypersensitivity Adverse Events - All Subjects \\\\\n\\hline 14.3.2.7 & Listing of Bleeding Adverse Events - All Subjects \\\\\n\\hline 14.3.2.8 & Listing of Hypercoagulable Adverse Events - All Subjects \\\\\n\\hline 14.3.3 & No statistical table will be generated. Numbering reserved for SAE narratives per ICH. \\\\\n\\hline 14.3.4.1.1 & Actual Values and Change from Baseline in Hematology Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.1.2 & Categorical Hematology Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.1.3 & Listing of Clinically Significant Abnormal Hematology Results - Safety Population \\\\\n\\hline 14.3.4.2.1 & Actual Values and Change from Baseline in Coagulation Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.2.2 & Categorical Coagulation Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.2.3 & Listing of Clinically Significant Abnormal Coagulation Results - Safety Population \\\\\n\\hline 14.3.4.3.1 & Actual Values and Change from Baseline in Chemistry Results by Treatment Group and Study Visit - Safety Population \\\\\n\\hline 14.3.4.3.2 & Categorical Chemistry Results by Treatment Group 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Figure No. & Title \\\\\n\\hline 14.2.1.1 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.2 & All HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.3 & Investigator-confirmed HAE Attacks during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.4 & Investigator-confirmed HAE Attacks during Day 8 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.5 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Age Group - ITT Population \\\\\n\\hline 14.2.1.6 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Sex - ITT Population \\\\\n\\hline 14.2.1.7 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Race Group - ITT Population \\\\\n\\hline 14.2.1.8 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Weight Group - ITT Population \\\\\n\\hline 14.2.1.9 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and BMI Group - ITT Population \\\\\n\\hline 14.2.1.10 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Run-in Period HAE Attack Rate Group - ITT Population \\\\\n\\hline 14.2.1.10 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Pretreatment Period HAE Attack Rate Group - ITT Population \\\\\n\\hline 14.2.1.11 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and HAE Type - ITT Population \\\\\n\\hline 14.2.1.12 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Geographic Region - ITT Population \\\\\n\\hline 14.2.1.12 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Type of Long-term Prophylactic Therapy Prior to Study Randomization ITT Population \\\\\n\\hline 14.2.2.1 & Investigator-confirmed HAE Attacks Requiring Acute Treatment during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.3.1 & Moderate and Severe Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.4.1 & Time to First HAE Attack After Day 14 by Treatment Group - ITT Population \\\\\n\\hline 14.2.5.1 & High-morbidity Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.6.1 & Investigator-confirmed HAE Attacks Requiring an Emergency Department Visit or Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.7.1 & Investigator-confirmed HAE Attacks Requiring an Emergency Department Visit during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.8.1 & Investigator-confirmed HAE Attacks Requiring Admission to the Hospital during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{10.1.2 List of Planned Figures}\n\\begin{tabular}{|l|l|}\n\\hline Figure No. & Title \\\\\n\\hline 14.2.1.1 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.2 & All HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.3 & Investigator-confirmed HAE Attacks during Day 14 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.4 & Investigator-confirmed HAE Attacks during Day 8 to Day 182 by Treatment Group - ITT Population \\\\\n\\hline 14.2.1.5 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Age Group - ITT Population \\\\\n\\hline 14.2.1.6 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Sex - ITT Population \\\\\n\\hline 14.2.1.7 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Race Group - ITT Population \\\\\n\\hline 14.2.1.8 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and Weight Group - ITT Population \\\\\n\\hline 14.2.1.9 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by Treatment Group and BMI Group - ITT Population \\\\\n\\hline 14.2.1.10 & Investigator-confirmed HAE Attacks during the Treatment Period (Day 0 to Day 182) by 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}(m)^{2}}\n\\]","confidence":0.8795690536499023,"confidence_rate":0.997330170284522},{"cnt":[[243,795],[604,795],[604,853],[243,853]],"region":{"top_left_x":242,"top_left_y":794,"width":362,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d59fa076a9aa4e568b14ce1bc41b4d3b","type":"section_header","conversion_output":false,"children_ids":["37849ade6a2a40a38017334363f9a56f"],"text":"","text_display":""},{"cnt":[[249,799],[599,799],[599,849],[249,849]],"region":{"top_left_x":249,"top_left_y":799,"width":351,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37849ade6a2a40a38017334363f9a56f","type":"text","conversion_output":true,"parent_id":"d59fa076a9aa4e568b14ce1bc41b4d3b","text":"10.2.3 Study Day","text_display":"\n\n\\subsection*{10.2.3 Study 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randomization.","text_display":" randomization, or start or stop date - date of randomization for dates prior to randomization.","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[243,993],[771,993],[771,1042],[243,1042]],"region":{"top_left_x":242,"top_left_y":992,"width":530,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30d1d77080a8469b8c20dfd24970d7fc","type":"section_header","conversion_output":false,"children_ids":["175ade8db8a54304bb2081a5581cf0ec"],"text":"","text_display":""},{"cnt":[[249,997],[765,997],[765,1038],[249,1038]],"region":{"top_left_x":249,"top_left_y":996,"width":516,"height":42},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"175ade8db8a54304bb2081a5581cf0ec","type":"text","conversion_output":true,"parent_id":"30d1d77080a8469b8c20dfd24970d7fc","text":"10.2.4 Durations of Events","text_display":"\n\n\\subsection*{10.2.4 Durations of 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If the attack stop","text_display":" missing, and stop date - start date +1 if both the start and stop time is missing. If the attack stop","confidence":0.998046875,"confidence_rate":0.9999825444841725},{"cnt":[[245,851],[1871,851],[1871,900],[245,900]],"region":{"top_left_x":244,"top_left_y":850,"width":1628,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"612ea4eb432a46c4af1ad555d5fee797","type":"text","conversion_output":true,"text":"time is not missing but the start time is missing, start time will be imputed as 0:00. If start time is","text_display":" time is not missing but the start time is missing, start time will be imputed as 0:00. If start time is","confidence":0.9834344184491783,"confidence_rate":0.9998453422831741},{"cnt":[[245,898],[1371,898],[1371,950],[245,950]],"region":{"top_left_x":244,"top_left_y":898,"width":1127,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"797dc4972b4a4d518b10cb37c18278f1","type":"text","conversion_output":true,"text":"not missing but the end time is missing it will be imputed as 23:59.","text_display":" not missing but the end time is missing it will be imputed as 23:59.","confidence":0.9980480668600649,"confidence_rate":0.9999732354178484},{"cnt":[[243,984],[885,984],[885,1046],[243,1046]],"region":{"top_left_x":242,"top_left_y":983,"width":644,"height":64},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b937c95af79a4d13900aff785e5ef209","type":"section_header","conversion_output":false,"children_ids":["5e415d4cd1ee4583bb3933dc9ae12a72"],"text":"","text_display":""},{"cnt":[[247,988],[881,988],[881,1042],[247,1042]],"region":{"top_left_x":247,"top_left_y":988,"width":634,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e415d4cd1ee4583bb3933dc9ae12a72","type":"text","conversion_output":true,"parent_id":"b937c95af79a4d13900aff785e5ef209","text":"10.2.7.2 HAE Attack Severity","text_display":"\n\n\\subsection*{10.2.7.2 HAE Attack Severity}","confidence":1,"confidence_rate":1},{"cnt":[[245,1079],[1803,1079],[1803,1128],[245,1128]],"region":{"top_left_x":244,"top_left_y":1078,"width":1559,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"beb616f94efc4a1cafc3d968d1eb98f2","type":"text","conversion_output":true,"text":"The overall severity of the subject's attack will be determined by the site using the following","text_display":"\n\nThe overall severity of the subject's attack will be determined by the site using the following","confidence":1,"confidence_rate":1},{"cnt":[[245,1126],[445,1126],[445,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1125,"width":201,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6821bef07ce5410ab895d954c76ea5d9","type":"text","conversion_output":true,"text":"definitions:","text_display":" definitions:","confidence":1,"confidence_rate":1},{"cnt":[[262,1216],[902,1216],[902,1265],[262,1265]],"region":{"top_left_x":262,"top_left_y":1216,"width":641,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"794c1911bf5e43569b8978b2e295c789","type":"text","conversion_output":true,"text":"- Mild: Transient or mild discomfort","text_display":"\n- Mild: Transient or mild discomfort","confidence":1,"confidence_rate":1},{"cnt":[[262,1268],[1566,1268],[1566,1321],[262,1321]],"region":{"top_left_x":262,"top_left_y":1267,"width":1305,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aea90d29463040dd83cb2d3dd8868d5b","type":"text","conversion_output":true,"text":"- Moderate: Mild to moderate limitation in activity - some assistance needed","text_display":"\n- Moderate: Mild to moderate limitation in activity - some assistance needed","confidence":1,"confidence_rate":1},{"cnt":[[262,1319],[1270,1319],[1270,1373],[262,1373]],"region":{"top_left_x":262,"top_left_y":1319,"width":1008,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2c8fc19d2fb439685d23fc7e55f0859","type":"text","conversion_output":true,"text":"- Severe: Marked limitation in activity, assistance required","text_display":"\n- Severe: Marked limitation in activity, assistance required","confidence":1,"confidence_rate":1},{"cnt":[[245,1409],[1818,1409],[1818,1461],[245,1461]],"region":{"top_left_x":244,"top_left_y":1409,"width":1574,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca3f1c768e2a4430883d65a1ede20c62","type":"text","conversion_output":true,"text":"To calculate the average attack severity per subject, a numeric value will be attributed to each","text_display":"\n\nTo calculate the average attack severity per subject, a numeric value will be attributed to each","confidence":1,"confidence_rate":1},{"cnt":[[245,1457],[1871,1457],[1871,1508],[245,1508]],"region":{"top_left_x":244,"top_left_y":1456,"width":1628,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64e83f2beeb54b16a758b8b65378ef44","type":"text","conversion_output":true,"text":"severity as follows: 1=Mild, 2=Moderate, and 3=Severe. Higher values will indicate more severe","text_display":" severity as follows: 1=Mild, 2=Moderate, and 3=Severe. Higher values will indicate more severe","confidence":0.3545685102324114,"confidence_rate":0.989581384095444},{"cnt":[[245,1506],[1248,1506],[1248,1555],[245,1555]],"region":{"top_left_x":244,"top_left_y":1506,"width":1005,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f436253490c45c783d69562f3d19c71","type":"text","conversion_output":true,"text":"attacks, while lower values will indicate less severe attacks.","text_display":" attacks, while lower values will indicate less severe attacks.","confidence":1,"confidence_rate":1},{"cnt":[[243,1590],[823,1590],[823,1652],[243,1652]],"region":{"top_left_x":242,"top_left_y":1589,"width":581,"height":64},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53abff249c81480ea62269bddf16c0f8","type":"section_header","conversion_output":false,"children_ids":["6bc25a772bf146028713b559ead7a7c3"],"text":"","text_display":""},{"cnt":[[245,1594],[819,1594],[819,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1594,"width":575,"height":54},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bc25a772bf146028713b559ead7a7c3","type":"text","conversion_output":true,"parent_id":"53abff249c81480ea62269bddf16c0f8","text":"10.2.8 Unique HAE Attacks","text_display":"\n\n\\subsection*{10.2.8 Unique HAE Attacks}","confidence":1,"confidence_rate":1},{"cnt":[[245,1684],[1880,1684],[1880,1738],[245,1738]],"region":{"top_left_x":244,"top_left_y":1684,"width":1636,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78363b4d9779482ebd3144277104cb2d","type":"text","conversion_output":true,"text":"To be counted as a unique attack distinct from the previous attack, the new symptoms must occur","text_display":"\n\nTo be counted as a unique attack distinct from the previous attack, the new symptoms must occur","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1317,1732],[1317,1785],[245,1785]],"region":{"top_left_x":244,"top_left_y":1731,"width":1073,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"519bcc992ace40ca83c968e48997cbc8","type":"text","conversion_output":true,"text":"at least 24 hours after resolution of the prior attack's symptoms.","text_display":" at least 24 hours after resolution of the prior attack's symptoms.","confidence":0.99755859375,"confidence_rate":0.9999669682301315},{"cnt":[[245,1873],[245,1822],[1854,1824],[1854,1876]],"region":{"top_left_x":244,"top_left_y":1821,"width":1611,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a95a20ac12f049e79e68f4a52b5f8c22","type":"text","conversion_output":true,"text":"That is there must be at least 24 hours between the stop date/ time of the first event and the start","text_display":"\n\nThat is there must be at least 24 hours between the stop date/ time of the first event and the start","confidence":0.990234375,"confidence_rate":0.9999091372630062},{"cnt":[[245,1869],[1871,1869],[1871,1923],[245,1923]],"region":{"top_left_x":244,"top_left_y":1869,"width":1628,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba63b0573fff41c79352015cd3749f93","type":"text","conversion_output":true,"text":"date/time of the next event, for attacks to be considered distinct from the previous attack. If there","text_display":" date/time of the next event, for attacks to be considered distinct from the previous attack. If there","confidence":1,"confidence_rate":1},{"cnt":[[245,1919],[1820,1919],[1820,1970],[245,1970]],"region":{"top_left_x":244,"top_left_y":1918,"width":1576,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4073162480f3471a813bba88545ae835","type":"text","conversion_output":true,"text":"is less than 24 hours between the stop date/time of the first event and the start date/time of the","text_display":" is less than 24 hours between the stop date/time of the first event and the start date/time of the","confidence":0.9990234375,"confidence_rate":0.9999907826873115},{"cnt":[[245,1968],[1119,1968],[1119,2015],[245,2015]],"region":{"top_left_x":244,"top_left_y":1967,"width":876,"height":49},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7d7c71938e2431ba4d2d0b111a3ff9c","type":"text","conversion_output":true,"text":"next event, the events will be counted as one attack.","text_display":" next event, the events will be counted as one attack.","confidence":1,"confidence_rate":1},{"cnt":[[243,2054],[763,2054],[763,2108],[243,2108]],"region":{"top_left_x":242,"top_left_y":2053,"width":521,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bd6ac444be64f00a9d769c45ec9ecc9","type":"section_header","conversion_output":false,"children_ids":["aa64b63d2ea94472bed84c2663dec903"],"text":"","text_display":""},{"cnt":[[247,2058],[758,2058],[758,2103],[247,2103]],"region":{"top_left_x":247,"top_left_y":2058,"width":512,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa64b63d2ea94472bed84c2663dec903","type":"text","conversion_output":true,"parent_id":"2bd6ac444be64f00a9d769c45ec9ecc9","text":"10.2.9 HAE Attack Rate","text_display":"\n\n\\subsection*{10.2.9 HAE Attack Rate}","confidence":1,"confidence_rate":1},{"cnt":[[243,2140],[1072,2140],[1072,2198],[243,2198]],"region":{"top_left_x":242,"top_left_y":2139,"width":831,"height":59},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4da909ecd7d4431aa6cb51d24bb306e6","type":"section_header","conversion_output":false,"children_ids":["c8bec355f21048448adabb9aa8545dcf"],"text":"","text_display":""},{"cnt":[[245,2144],[1068,2144],[1068,2194],[245,2194]],"region":{"top_left_x":244,"top_left_y":2144,"width":824,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8bec355f21048448adabb9aa8545dcf","type":"text","conversion_output":true,"parent_id":"4da909ecd7d4431aa6cb51d24bb306e6","text":"10.2.9.1 Pretreatment HAE Attack Rate","text_display":"\n\n\\subsection*{10.2.9.1 Pretreatment HAE Attack Rate}","confidence":1,"confidence_rate":1},{"cnt":[[245,2234],[1794,2234],[1794,2288],[245,2288]],"region":{"top_left_x":244,"top_left_y":2234,"width":1550,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c379724d1e474dab967e1537db1329d4","type":"text","conversion_output":true,"text":"The pretreatment HAE attack rate will be presented as the normalized number of attacks per","text_display":"\n\nThe pretreatment HAE attack rate will be presented as the normalized number of attacks per","confidence":1,"confidence_rate":1},{"cnt":[[245,2282],[1749,2282],[1749,2335],[245,2335]],"region":{"top_left_x":244,"top_left_y":2281,"width":1505,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73b758d47a564f50b09944f2ae4c9450","type":"text","conversion_output":true,"text":"month and calculated for each subject as the number of HAE attacks occurring during the","text_display":" month and calculated for each subject as the number of HAE attacks occurring during the","confidence":1,"confidence_rate":1},{"cnt":[[245,2331],[1818,2331],[1818,2383],[245,2383]],"region":{"top_left_x":244,"top_left_y":2331,"width":1574,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ae9e8b3b8f647e6bb5650af561def8e","type":"text","conversion_output":true,"text":"pretreatment period divided by the number of days the subject contributed to the pretreatment","text_display":" pretreatment period divided by the number of days the subject contributed to the pretreatment","confidence":1,"confidence_rate":1},{"cnt":[[245,2380],[741,2380],[741,2432],[245,2432]],"region":{"top_left_x":244,"top_left_y":2380,"width":498,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7074a0543dba48ee80d76b8d55fcbd64","type":"text","conversion_output":true,"text":"period multiplied by 28 days.","text_display":" period multiplied by 28 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59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-53","page":53,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf5faf0e4647406f91fd7961b1b7e07e","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1676,168],[1880,168],[1880,208],[1676,208]],"region":{"top_left_x":1675,"top_left_y":167,"width":205,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1383fa653b3f4cbdab714c8a87c06f25","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[243,258],[1087,258],[1087,312],[243,312]],"region":{"top_left_x":242,"top_left_y":257,"width":846,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0383893800e641449a3bde245169efaf","type":"section_header","conversion_output":false,"children_ids":["b505963a6703446995be3fbb2d1f180b"],"text":"","text_display":""},{"cnt":[[249,262],[1085,262],[1085,307],[249,307]],"region":{"top_left_x":249,"top_left_y":262,"width":836,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b505963a6703446995be3fbb2d1f180b","type":"text","conversion_output":true,"parent_id":"0383893800e641449a3bde245169efaf","text":"10.2.9.2 Run-in Period HAE Attack Rate","text_display":"\n\n\\subsection*{10.2.9.2 Run-in Period HAE Attack Rate}","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1798,348],[1798,400],[245,400]],"region":{"top_left_x":244,"top_left_y":348,"width":1555,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa94a256861641ccbab07bfc7400bb47","type":"text","conversion_output":true,"text":"The run-in period HAE attack rate will be presented as the normalized number of attacks per","text_display":"\n\nThe run-in period HAE attack rate will be presented as the normalized number of attacks per","confidence":1,"confidence_rate":1},{"cnt":[[245,400],[1798,400],[1798,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1555,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c153cc7b0104a16a995e3a4d44b7b11","type":"text","conversion_output":true,"text":"month and calculated for each subject as number of HAE attacks occurring during the run-in","text_display":" month and calculated for each subject as number of HAE attacks occurring during the run-in","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1837,447],[1837,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1593,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48eacf44cd2343b394d3d50d86da8685","type":"text","conversion_output":true,"text":"period divided by the number of days the subject contributed to the run-in period multiplied by","text_display":" period divided by the number of days the subject contributed to the run-in period multiplied by","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[389,494],[389,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":145,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76ba017a8eb94481affa38fe904068d2","type":"text","conversion_output":true,"text":"28 days.","text_display":" 28 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The first answer option gets 0 points, the second option 1 point, the","text_display":" option chosen by the subject. 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influenced by missing items.","confidence":1,"confidence_rate":1},{"cnt":[[245,1396],[1837,1396],[1837,1446],[245,1446]],"region":{"top_left_x":244,"top_left_y":1396,"width":1593,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51416100d47d44e79ec6a603c6c129bb","type":"text","conversion_output":true,"text":"An AE-QoL domain score should not be calculated if more than one item is left unanswered in","text_display":"\n\nAn AE-QoL domain score should not be calculated if more than one item is left unanswered in","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[245,1444],[1809,1444],[1809,1497],[245,1497]],"region":{"top_left_x":244,"top_left_y":1443,"width":1565,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b47334b7ce384dc5b6ac163a722164b8","type":"text","conversion_output":true,"text":"that domain. The AE-QoL total score should not be calculated if more than \\(25 \\%\\) of items ( \\(>4\\)","text_display":" that domain. The AE-QoL total score should not be calculated if more than \\(25 \\%\\) of items ( \\(>4\\)","confidence":0.9453916549682617,"confidence_rate":0.9994271438626545},{"cnt":[[245,1491],[707,1491],[707,1545],[245,1545]],"region":{"top_left_x":244,"top_left_y":1491,"width":463,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15b19f0f75254dfebd3f8bbcd7c933ce","type":"text","conversion_output":true,"text":"items) are left unanswered.","text_display":" items) are left unanswered.","confidence":1,"confidence_rate":1},{"cnt":[[245,1583],[1691,1583],[1691,1635],[245,1635]],"region":{"top_left_x":244,"top_left_y":1583,"width":1447,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87884d1f17604e1b8d39bc2aa2819496","type":"text","conversion_output":true,"text":"The minimal and highest possible domain and total scores are 0 and 100 , respectively.","text_display":"\n\nThe minimal and highest possible domain and total scores are 0 and 100 , respectively.","confidence":0.99755859375,"confidence_rate":0.9999748004067751},{"cnt":[[241,1678],[445,1678],[445,1729],[241,1729]],"region":{"top_left_x":240,"top_left_y":1677,"width":205,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b095fbc0f1d14e8391361b80f563169b","type":"section_header","conversion_output":false,"children_ids":["c1e84d3641694b058a14e007eee16bff"],"text":"","text_display":""},{"cnt":[[245,1680],[440,1680],[440,1725],[245,1725]],"region":{"top_left_x":244,"top_left_y":1680,"width":197,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1e84d3641694b058a14e007eee16bff","type":"text","conversion_output":true,"parent_id":"b095fbc0f1d14e8391361b80f563169b","text":"References","text_display":"\n\n\\section*{References}","confidence":1,"confidence_rate":1},{"cnt":[[245,1727],[1876,1727],[1876,1777],[245,1777]],"region":{"top_left_x":244,"top_left_y":1727,"width":1632,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91c8d1be0abc4750812d2348031c6be0","type":"text","conversion_output":true,"text":"Weller K, Groffik A, Magerl M, Tohme N, Martus P, Krause K, Metz M, Staubach P, Maurer M.","text_display":"\n\nWeller K, Groffik A, Magerl M, Tohme N, Martus P, Krause K, Metz M, Staubach P, Maurer M.","confidence":1,"confidence_rate":1},{"cnt":[[245,1775],[1841,1775],[1841,1826],[245,1826]],"region":{"top_left_x":244,"top_left_y":1774,"width":1598,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5537fdc2ff664ae9be25c7223ec93bd7","type":"text","conversion_output":true,"text":"Development and construct validation of the angioedema quality of life questionnaire. Allergy.","text_display":" Development and construct validation of the angioedema quality of life questionnaire. Allergy.","confidence":1,"confidence_rate":1},{"cnt":[[245,1822],[642,1822],[642,1871],[245,1871]],"region":{"top_left_x":244,"top_left_y":1821,"width":399,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0c3e503af69488dbda49680f029dd2e","type":"text","conversion_output":true,"text":"2012; 67(10): 1289-98.","text_display":" 2012; 67(10): 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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":[[339,1495],[505,1495],[505,1532],[339,1532]],"region":{"top_left_x":339,"top_left_y":1495,"width":166,"height":37},"line":188,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b73216703f4f4461b8597775752322e9","type":"text","conversion_output":true,"text":"with subject.","text_display":" with subject.","confidence":1,"confidence_rate":1},{"cnt":[[279,1525],[2486,1525],[2486,1571],[279,1571]],"region":{"top_left_x":279,"top_left_y":1525,"width":2207,"height":46},"line":189,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ba6e112b0e31484d916764daa5e1e20d","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":"\n5. 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":0.9990234375,"confidence_rate":0.9999944800172248},{"cnt":[[339,1568],[2499,1568],[2499,1609],[339,1609]],"region":{"top_left_x":339,"top_left_y":1568,"width":2160,"height":42},"line":190,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a851061dbc242f4ba7db19dc1fbf24e","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":[[339,1607],[2112,1607],[2112,1644],[339,1644]],"region":{"top_left_x":339,"top_left_y":1607,"width":1773,"height":37},"line":191,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e3b03b6952e4129987d5d11ac32593b","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":[[277,1637],[1566,1637],[1566,1687],[277,1687]],"region":{"top_left_x":277,"top_left_y":1637,"width":1290,"height":50},"line":192,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"610ae863fcca4967ac0c7c5b904f8fc0","type":"text","conversion_output":true,"text":"6. Samples for C1-INH, C4, and C1q assays will be obtained at screening for eligibility assessment.","text_display":"\n6. Samples for C1-INH, C4, and C1q assays will be obtained at screening for eligibility assessment.","confidence":0.9794921875,"confidence_rate":0.9998007792928741},{"cnt":[[277,1676],[2501,1676],[2501,1723],[277,1723]],"region":{"top_left_x":277,"top_left_y":1675,"width":2224,"height":49},"line":193,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cbdfdec946894a0d8c9c9d585ca765a0","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":0.99951171875,"confidence_rate":0.9999973016583471},{"cnt":[[339,1719],[1214,1719],[1214,1760],[339,1760]],"region":{"top_left_x":339,"top_left_y":1718,"width":875,"height":42},"line":194,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"576064d5051342b6bad167dce542ec4d","type":"text","conversion_output":true,"text":"Days 28, 56, 98, 126, 154, and Day 238 can be serum or urine-based.","text_display":" Days 28, 56, 98, 126, 154, and Day 238 can be serum or urine-based.","confidence":0.99951171875,"confidence_rate":0.9999934880145616},{"cnt":[[277,1749],[2469,1749],[2469,1798],[277,1798]],"region":{"top_left_x":277,"top_left_y":1748,"width":2192,"height":51},"line":195,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"415e25bca4ee48799e5579013157e130","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":0.9873046875,"confidence_rate":0.9999290214825443},{"cnt":[[339,1796],[2426,1796],[2426,1835],[339,1835]],"region":{"top_left_x":339,"top_left_y":1796,"width":2087,"height":39},"line":196,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad11455d41af43fd9537ce61f8fe3097","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":[[339,1830],[1296,1830],[1296,1869],[339,1869]],"region":{"top_left_x":339,"top_left_y":1830,"width":957,"height":40},"line":197,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3719ab61e2b246048136d8d867e2147d","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":[[247,1959],[432,1959],[432,2004],[247,2004]],"region":{"top_left_x":247,"top_left_y":1959,"width":185,"height":46},"line":198,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb5fdc5fdb4047dcbf6684fd06af00cc","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2299,1962],[2507,1962],[2507,2004],[2299,2004]],"region":{"top_left_x":2298,"top_left_y":1961,"width":210,"height":44},"line":199,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c368eea0613c4da2aa75d6d6d49dbf1d","type":"page_info","conversion_output":false,"text":"Page 58 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"3d09e21f-3e58-4e3d-b890-9e352356bdc0-59","page":59,"lines":[{"cnt":[[245,168],[776,168],[776,208],[245,208]],"region":{"top_left_x":244,"top_left_y":167,"width":532,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1969546072244421b54fbf9c591d3631","type":"page_info","conversion_output":false,"text":"DX-2930-03 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2303,168],[2507,168],[2507,208],[2303,208]],"region":{"top_left_x":2303,"top_left_y":167,"width":205,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fea9526b034e4500ba664ee869613de2","type":"page_info","conversion_output":false,"text":"May 24, 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[279,254],[1137,254],[1137,303],[279,303]],"region":{"top_left_x":279,"top_left_y":253,"width":858,"height":50},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1bcfdd3d98974c32bd0bee91996e4c4c","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":0.99951171875,"confidence_rate":0.9999932166827553},{"cnt":[[279,294],[2471,294],[2471,342],[279,342]],"region":{"top_left_x":279,"top_left_y":294,"width":2192,"height":48},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c7ddc110b6745dd8f0b1e1fd9bcbb43","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":"\n10. 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":0.6128072077362958,"confidence_rate":0.997491843521272},{"cnt":[[339,337],[1794,337],[1794,376],[339,376]],"region":{"top_left_x":339,"top_left_y":337,"width":1455,"height":39},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0cbcea6e1974a4da80d799979725fb6","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":0.9790139198303223,"confidence_rate":0.9998463203741582},{"cnt":[[279,367],[1601,367],[1601,415],[279,415]],"region":{"top_left_x":279,"top_left_y":367,"width":1322,"height":48},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6642e154a084c82a166c88b5f6feec7","type":"text","conversion_output":true,"text":"11. Clinical laboratory testing will include Hematology, Coagulation, Serum Chemistry, and Urinalysis.","text_display":"\n11. Clinical laboratory testing will include Hematology, Coagulation, Serum Chemistry, and Urinalysis.","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[279,406],[2408,406],[2408,453],[279,453]],"region":{"top_left_x":279,"top_left_y":406,"width":2130,"height":48},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7814829dd7024171bf2c5180f9554e5f","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":[[339,451],[2340,451],[2340,492],[339,492]],"region":{"top_left_x":339,"top_left_y":451,"width":2001,"height":41},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5bf9a1c31b14f4f80e6e8cffaae9d52","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":[[339,486],[2456,486],[2456,526],[339,526]],"region":{"top_left_x":339,"top_left_y":485,"width":2117,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"688ba36cd0fa4c86b5952ef86f12ceac","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":[[339,524],[2432,524],[2432,561],[339,561]],"region":{"top_left_x":339,"top_left_y":524,"width":2094,"height":37},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"625810a3bbac4a4eae0f6124a5d0181f","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":0.99853515625,"confidence_rate":0.9999916709569452},{"cnt":[[339,559],[1268,559],[1268,599],[339,599]],"region":{"top_left_x":339,"top_left_y":558,"width":929,"height":42},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"073b92d41f784b7a9c3405e7e1f96be7","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":[[279,589],[2275,589],[2275,638],[279,638]],"region":{"top_left_x":279,"top_left_y":588,"width":1997,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37586c00ac284fb9808c350eb088790f","type":"text","conversion_output":true,"text":"13. Quality of life data will be obtained using the EuroQoL Group 5-Dimension (EQ5D) Questionnaire at pre-dose on Days \\(0,98 \\pm 3\\), and \\(182 \\pm 3\\) and using the","text_display":"\n13. Quality of life data will be obtained using the EuroQoL Group 5-Dimension (EQ5D) Questionnaire at pre-dose on Days \\(0,98 \\pm 3\\), and \\(182 \\pm 3\\) and using the","confidence":0.9926886558532715,"confidence_rate":0.999954703476414},{"cnt":[[339,632],[2436,632],[2436,672],[339,672]],"region":{"top_left_x":339,"top_left_y":631,"width":2098,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f6c6abb213b45bdab3776b77db81812","type":"text","conversion_output":true,"text":"Angioedema-Quality of Life (AE-QoL) Questionnaire at pre-dose on Days \\(0,28 \\pm 3,56 \\pm 3,98 \\pm 3,126 \\pm 3,154 \\pm 3\\), and \\(182 \\pm 3\\). An additional quality of life assessment","text_display":" Angioedema-Quality of Life (AE-QoL) Questionnaire at pre-dose on Days \\(0,28 \\pm 3,56 \\pm 3,98 \\pm 3,126 \\pm 3,154 \\pm 3\\), and \\(182 \\pm 3\\). An additional quality of life assessment","confidence":0.9887795448303223,"confidence_rate":0.9999311982245408},{"cnt":[[339,670],[1420,670],[1420,709],[339,709]],"region":{"top_left_x":339,"top_left_y":670,"width":1082,"height":39},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"adc6c45cce8e4c1ca105c19dca6c3677","type":"text","conversion_output":true,"text":"(EQ5D and AE-QoL) will be conducted on Day \\(238 \\pm 3\\) for subjects not entering OLE.","text_display":" (EQ5D and AE-QoL) will be conducted on Day \\(238 \\pm 3\\) for subjects not entering OLE.","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[279,700],[2387,700],[2387,750],[279,750]],"region":{"top_left_x":279,"top_left_y":700,"width":2108,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56b7f89c2db74153a508b007e46260c5","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. 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","confidence":1,"confidence_rate":1},{"cnt":[[339,748],[2464,748],[2464,784],[339,784]],"region":{"top_left_x":339,"top_left_y":747,"width":2126,"height":38},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4780a01aa0644e3198e57527c4c44426","type":"text","conversion_output":true,"text":"completion 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","text_display":" completion 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","confidence":1,"confidence_rate":1},{"cnt":[[339,782],[638,782],[638,819],[339,819]],"region":{"top_left_x":339,"top_left_y":782,"width":300,"height":37},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e60115ba95f9457c8cb906c1b201b8dd","type":"text","conversion_output":true,"text":"the DX-2930-04 study.","text_display":" the DX-2930-04 study.","confidence":1,"confidence_rate":1},{"cnt":[[279,812],[2155,812],[2155,862],[279,862]],"region":{"top_left_x":279,"top_left_y":812,"width":1876,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0196a5a7aadc4d299717d901621b3063","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":"\n15. 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":1,"confidence_rate":1},{"cnt":[[247,1959],[432,1959],[432,2000],[247,2000]],"region":{"top_left_x":247,"top_left_y":1959,"width":185,"height":42},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e24f88530c741988192c247c82a2a0d","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2299,1959],[2507,1959],[2507,2004],[2299,2004]],"region":{"top_left_x":2298,"top_left_y":1959,"width":210,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b39982a55bc749248de0bddd2a3caae3","type":"page_info","conversion_output":false,"text":"Page 59 of 59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]}]}