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At study entry and during the follow-up period, extensive clinical,","text_display":" be approximately 4 years. At study entry and during the follow-up period, extensive clinical,","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1055,1070],[1055,1121],[245,1121]],"region":{"top_left_x":244,"top_left_y":1069,"width":811,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8f60ea636e044d4a3e16a8cccd6bc4e","type":"text","conversion_output":true,"text":"quality-of-life, and economic data are collected.","text_display":" quality-of-life, and economic data are collected.","confidence":1,"confidence_rate":1},{"cnt":[[236,1203],[522,1203],[522,1274],[236,1274]],"region":{"top_left_x":236,"top_left_y":1203,"width":287,"height":72},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c92c89f67174f919eff02ad10386a33","type":"section_header","conversion_output":false,"children_ids":["213f932feb4f4739a90456edc626a2e5"],"text":"","text_display":""},{"cnt":[[245,1212],[518,1212],[518,1265],[245,1265]],"region":{"top_left_x":244,"top_left_y":1211,"width":274,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"213f932feb4f4739a90456edc626a2e5","type":"text","conversion_output":true,"parent_id":"3c92c89f67174f919eff02ad10386a33","text":"3. 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Objective}","confidence":1,"confidence_rate":1},{"cnt":[[245,1405],[1682,1405],[1682,1457],[245,1457]],"region":{"top_left_x":244,"top_left_y":1405,"width":1439,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60abd0f5fd1a42649ca2283e35ebb3a0","type":"text","conversion_output":true,"text":"The primary objective of CABANA is to determine whether the treatment strategy of","text_display":"\n\nThe primary objective of CABANA is to determine whether the treatment strategy of","confidence":1,"confidence_rate":1},{"cnt":[[245,1454],[1794,1454],[1794,1506],[245,1506]],"region":{"top_left_x":244,"top_left_y":1454,"width":1550,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a0322fb4312470081d4797aa5d748c6","type":"text","conversion_output":true,"text":"percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation will","text_display":" percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation will","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,1502],[1867,1502],[1867,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1501,"width":1623,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"283ac7c409fe432bac659c36fcac1b26","type":"text","conversion_output":true,"text":"improve clinical outcomes compared to treating the arrhythmia with current state-of-the-art drug","text_display":" improve clinical outcomes compared to treating the arrhythmia with current state-of-the-art drug","confidence":1,"confidence_rate":1},{"cnt":[[245,1551],[1330,1551],[1330,1603],[245,1603]],"region":{"top_left_x":244,"top_left_y":1551,"width":1086,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dbc7b7fa5df4e6c8a54b7784eecb458","type":"text","conversion_output":true,"text":"therapy consisting of either rate control or rhythm control drugs.","text_display":" therapy consisting of either rate control or rhythm control drugs.","confidence":1,"confidence_rate":1},{"cnt":[[245,1646],[1734,1646],[1734,1697],[245,1697]],"region":{"top_left_x":244,"top_left_y":1645,"width":1490,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0456acf7ab740dba3220fd8e3f5e8a8","type":"text","conversion_output":true,"text":"The primary endpoint is the time to the first event among a composite of major clinical","text_display":"\n\nThe primary endpoint is the time to the first event among a composite of major clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,1693],[647,1693],[647,1745],[245,1745]],"region":{"top_left_x":244,"top_left_y":1692,"width":403,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be07b93e72984f4aa00cc95ee8b985f5","type":"text","conversion_output":true,"text":"outcomes consisting 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ablation will reduce the incidence of this composite endpoint in patients with untreated","confidence":1,"confidence_rate":1},{"cnt":[[245,2088],[1760,2088],[1760,2142],[245,2142]],"region":{"top_left_x":244,"top_left_y":2088,"width":1516,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5006e0fe57d74a54abd8e5819f2838fe","type":"text","conversion_output":true,"text":"or under-treated AF warranting therapy, compared to current state-of-the-art drug therapy.","text_display":" or under-treated AF warranting therapy, compared to current state-of-the-art drug 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Left atrial size, morphology, and function","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1824,1212],[1824,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1581,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"757bea0079ae41b08f70fa0426d53aa5","type":"text","conversion_output":true,"text":"To aid in the interpretation of the primary and several of the secondary endpoint comparisons,","text_display":"\n\nTo aid in the interpretation of the primary and several of the secondary endpoint comparisons,","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1880,1259],[1880,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1258,"width":1636,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d75e3af958f42e183feb6fe1489e110","type":"text","conversion_output":true,"text":"the individual components of the primary endpoint (in addition to death) will also be summarized","text_display":" the individual components of the primary endpoint (in addition to death) will also be summarized","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[947,1306],[947,1351],[245,1351]],"region":{"top_left_x":244,"top_left_y":1306,"width":704,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e0542a3510d47ea8d49006581e16577","type":"text","conversion_output":true,"text":"between the randomized arms of the trial.","text_display":" between the randomized arms of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[241,1448],[806,1448],[806,1515],[241,1515]],"region":{"top_left_x":240,"top_left_y":1448,"width":566,"height":67},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"124ac462357f448489f5f7f8075a4329","type":"section_header","conversion_output":false,"children_ids":["177f6941aef4495189c849cdd3b71230"],"text":"","text_display":""},{"cnt":[[245,1452],[801,1452],[801,1510],[245,1510]],"region":{"top_left_x":244,"top_left_y":1452,"width":558,"height":59},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"177f6941aef4495189c849cdd3b71230","type":"text","conversion_output":true,"parent_id":"124ac462357f448489f5f7f8075a4329","text":"4. 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No experimental drug or","text_display":" strategies that are used routinely across the U.S. and around the world. No experimental drug or","confidence":1,"confidence_rate":1},{"cnt":[[245,1659],[1835,1659],[1835,1708],[245,1708]],"region":{"top_left_x":244,"top_left_y":1658,"width":1591,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9a3bc7857844653913726c999646f94","type":"text","conversion_output":true,"text":"treatment is involved. The trial intervention is simply the random assignment of the subjects to","text_display":" treatment is involved. The trial intervention is simply the random assignment of the subjects to","confidence":1,"confidence_rate":1},{"cnt":[[245,1706],[1042,1706],[1042,1755],[245,1755]],"region":{"top_left_x":244,"top_left_y":1705,"width":798,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"add4ce323ed94bfb8a3a124993946f39","type":"text","conversion_output":true,"text":"one or the other of the two treatment strategies.","text_display":" one or the other of the two treatment strategies.","confidence":1,"confidence_rate":1},{"cnt":[[245,1800],[1854,1800],[1854,1852],[245,1852]],"region":{"top_left_x":244,"top_left_y":1800,"width":1611,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73aa29d218c34da4a5813962058ca626","type":"text","conversion_output":true,"text":"Eligible subjects who provided written informed consent and met all inclusion and no exclusion","text_display":"\n\nEligible subjects who provided written informed consent and met all inclusion and no exclusion","confidence":1,"confidence_rate":1},{"cnt":[[245,1850],[1846,1850],[1846,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1849,"width":1602,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c921ea43dd1e4879bbfba083a8b6d675","type":"text","conversion_output":true,"text":"criteria were randomly assigned in equal proportions ( \\(1: 1\\) ) to either the catheter ablation arm or","text_display":" criteria were randomly assigned in equal proportions ( \\(1: 1\\) ) to either the catheter ablation arm or","confidence":0.6133225683588535,"confidence_rate":0.9954415962617859},{"cnt":[[245,1899],[1760,1899],[1760,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1899,"width":1516,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55e995f3a1e8452ab811bcd2d2dfdb68","type":"text","conversion_output":true,"text":"the drug arm using permuted blocks, stratified by clinical site. Subject randomization was","text_display":" the drug arm using permuted blocks, stratified by clinical site. Subject randomization was","confidence":1,"confidence_rate":1},{"cnt":[[245,1946],[1818,1946],[1818,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1946,"width":1574,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5527b7b1d66c42c5a5122a1c68a28f92","type":"text","conversion_output":true,"text":"accomplished by telephone through a centralized toll-free Interactive Voice Response System","text_display":" accomplished by telephone through a centralized toll-free Interactive Voice Response System","confidence":1,"confidence_rate":1},{"cnt":[[245,1994],[385,1994],[385,2043],[245,2043]],"region":{"top_left_x":244,"top_left_y":1993,"width":141,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb14705706ea42a784e4f4880c30871c","type":"text","conversion_output":true,"text":"(IVRS).","text_display":" (IVRS).","confidence":1,"confidence_rate":1},{"cnt":[[243,2140],[909,2140],[909,2202],[243,2202]],"region":{"top_left_x":242,"top_left_y":2139,"width":667,"height":64},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fd4906cafe94d02a926dcc5cc46bb1e","type":"section_header","conversion_output":false,"children_ids":["8a3ef0cf020a48589f2b7eb5297d7488"],"text":"","text_display":""},{"cnt":[[245,2142],[904,2142],[904,2198],[245,2198]],"region":{"top_left_x":244,"top_left_y":2141,"width":661,"height":57},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a3ef0cf020a48589f2b7eb5297d7488","type":"text","conversion_output":true,"parent_id":"3fd4906cafe94d02a926dcc5cc46bb1e","text":"5. Primary Analysis Population","text_display":"\n\n\\section*{5. Primary Analysis Population}","confidence":1,"confidence_rate":1},{"cnt":[[245,2247],[1699,2247],[1699,2299],[245,2299]],"region":{"top_left_x":244,"top_left_y":2247,"width":1456,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8da2b72cda12423cb3a41b6dfb1a1b89","type":"text","conversion_output":true,"text":"Except where otherwise noted, all randomized subjects will be included in the analysis","text_display":"\n\nExcept where otherwise noted, all randomized subjects will be included in the analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,2299],[1865,2299],[1865,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2298,"width":1621,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ee1df3569604f7b9acf2cf553b99f50","type":"text","conversion_output":true,"text":"population for assessing the primary and secondary endpoints. All major treatment comparisons","text_display":" population for assessing the primary and secondary endpoints. All major treatment comparisons","confidence":1,"confidence_rate":1},{"cnt":[[245,2346],[1766,2346],[1766,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2346,"width":1523,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef7f9471539444ddabe2b900eabd3438","type":"text","conversion_output":true,"text":"between the randomized groups in the trial will be performed according to the principle of","text_display":" between the randomized groups in the trial will be performed according to the principle of","confidence":1,"confidence_rate":1},{"cnt":[[245,2393],[1865,2393],[1865,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2393,"width":1621,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2e8bef2b2ae4beeb287fe0b8da3bca0","type":"text","conversion_output":true,"text":"\"intention-to-treat\" (ITT); that is, subjects will be analyzed and endpoints attributed according to","text_display":" \"intention-to-treat\" (ITT); that is, subjects will be analyzed and endpoints attributed according to","confidence":1,"confidence_rate":1},{"cnt":[[245,2441],[1852,2441],[1852,2492],[245,2492]],"region":{"top_left_x":244,"top_left_y":2440,"width":1608,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46f931a59d7440018a94d3a8f631c288","type":"text","conversion_output":true,"text":"the treatment arm to which the patients were randomized, regardless of subsequent crossover or","text_display":" the treatment arm to which the patients were randomized, regardless of subsequent crossover or","confidence":1,"confidence_rate":1},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3691a67e0924f0bb46128fa28a2a33d","type":"page_info","conversion_output":false,"text":"4","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-06","page":6,"lines":[{"cnt":[[245,254],[1742,254],[1742,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1499,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f9c618a3ea54dac9bdc4d0770917ef3","type":"text","conversion_output":true,"text":"post-randomization medical care. As explained later in this document (section 10), some","text_display":"\npost-randomization medical care. As explained later in this document (section 10), some","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1332,301],[1332,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1089,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d8a5b3db67b4c1e96c52f527e48c669","type":"text","conversion_output":true,"text":"additional analyses will be conducted using \"on-treatment\" data.","text_display":" additional analyses will be conducted using \"on-treatment\" data.","confidence":1,"confidence_rate":1},{"cnt":[[236,451],[587,451],[587,518],[236,518]],"region":{"top_left_x":236,"top_left_y":451,"width":351,"height":67},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a7eed0f0931450e81534ec638a05a83","type":"section_header","conversion_output":false,"children_ids":["9d1f57ea1c6b4ae38198bbb046ea9666"],"text":"","text_display":""},{"cnt":[[245,460],[578,460],[578,511],[245,511]],"region":{"top_left_x":244,"top_left_y":459,"width":334,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d1f57ea1c6b4ae38198bbb046ea9666","type":"text","conversion_output":true,"parent_id":"5a7eed0f0931450e81534ec638a05a83","text":"6. Data Sources","text_display":"\n\n\\section*{6. Data Sources}","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[1830,563],[1830,612],[245,612]],"region":{"top_left_x":244,"top_left_y":562,"width":1587,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1c6f9d8267b42589981d92ff5e6abc9","type":"text","conversion_output":true,"text":"The enrolling clinical sites complete a series of electronic Case Report Forms (eCRF) for each","text_display":"\n\nThe enrolling clinical sites complete a series of electronic Case Report Forms (eCRF) for each","confidence":1,"confidence_rate":1},{"cnt":[[245,610],[1858,610],[1858,660],[245,660]],"region":{"top_left_x":244,"top_left_y":610,"width":1615,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ac616ab9c45478fae4581a92e787d96","type":"text","conversion_output":true,"text":"subject randomized, including demographic, clinical, and quality of life forms at enrollment and","text_display":" subject randomized, including demographic, clinical, and quality of life forms at enrollment and","confidence":1,"confidence_rate":1},{"cnt":[[245,657],[1863,657],[1863,707],[245,707]],"region":{"top_left_x":244,"top_left_y":657,"width":1619,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"377738bdbb744996b58e9d2d2ebe3042","type":"text","conversion_output":true,"text":"at specified follow-up intervals (the follow-up intervals are detailed in the study protocol), event","text_display":" at specified follow-up intervals (the follow-up intervals are detailed in the study protocol), event","confidence":1,"confidence_rate":1},{"cnt":[[245,705],[1755,705],[1755,758],[245,758]],"region":{"top_left_x":244,"top_left_y":704,"width":1512,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51c42852683d48cfa7b92e9532e2dadc","type":"text","conversion_output":true,"text":"forms for death, neurological events, bleeding, cardiac arrest, and other ancillary forms as","text_display":" forms for death, neurological events, bleeding, cardiac arrest, and other ancillary forms as","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[402,752],[402,806],[245,806]],"region":{"top_left_x":244,"top_left_y":751,"width":158,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dbce64496f74c16ad614a44d5e702a1","type":"text","conversion_output":true,"text":"required.","text_display":" required.","confidence":1,"confidence_rate":1},{"cnt":[[245,849],[1815,849],[1815,900],[245,900]],"region":{"top_left_x":244,"top_left_y":848,"width":1572,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe01824878d0440cb6bc1ac1dd6938dc","type":"text","conversion_output":true,"text":"Clinical data are collected using the InForm electronic data capture (EDC) system. Except as","text_display":"\n\nClinical data are collected using the InForm electronic data capture (EDC) system. Except as","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1772,898],[1772,947],[245,947]],"region":{"top_left_x":244,"top_left_y":898,"width":1529,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a37e75c6c044411d81db6186d30a8d3a","type":"text","conversion_output":true,"text":"noted below in section 9.8, rhythm data are collected using the \"CABANA Box,\" a rhythm","text_display":" noted below in section 9.8, rhythm data are collected using the \"CABANA Box,\" a rhythm","confidence":1,"confidence_rate":1},{"cnt":[[245,945],[1880,945],[1880,995],[245,995]],"region":{"top_left_x":244,"top_left_y":945,"width":1636,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11c3f02416bb42bba92e1b71330fb3de","type":"text","conversion_output":true,"text":"monitoring system provided for each patient by Medicomp. The rhythm monitoring data are sent","text_display":" monitoring system provided for each patient by Medicomp. The rhythm monitoring data are sent","confidence":1,"confidence_rate":1},{"cnt":[[245,993],[1854,993],[1854,1042],[245,1042]],"region":{"top_left_x":244,"top_left_y":992,"width":1611,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc3d633a81614175946f9c88cae87ee4","type":"text","conversion_output":true,"text":"from Medicomp to the Duke Clinical Research Institute (DCRI), where a determination is made","text_display":" from Medicomp to the Duke Clinical Research Institute (DCRI), where a determination is made","confidence":1,"confidence_rate":1},{"cnt":[[245,1040],[1828,1040],[1828,1089],[245,1089]],"region":{"top_left_x":244,"top_left_y":1039,"width":1585,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5525ad2ec45d42649c3f367602e9c4fa","type":"text","conversion_output":true,"text":"as to which rhythms should be sent to the ECG core lab in Seattle for review and adjudication.","text_display":" as to which rhythms should be sent to the ECG core lab in Seattle for review and adjudication.","confidence":1,"confidence_rate":1},{"cnt":[[245,1087],[1828,1087],[1828,1139],[245,1139]],"region":{"top_left_x":244,"top_left_y":1087,"width":1585,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dfe15c49a1846979cddcf01a59108d5","type":"text","conversion_output":true,"text":"The core lab sends adjudicated results back to the DCRI. Sites with any subjects not using the","text_display":" The core lab sends adjudicated results back to the DCRI. Sites with any subjects not using the","confidence":1,"confidence_rate":1},{"cnt":[[245,1134],[1734,1134],[1734,1188],[245,1188]],"region":{"top_left_x":244,"top_left_y":1134,"width":1490,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82cbcf9c14f248a8a531633586301998","type":"text","conversion_output":true,"text":"\"CABANA Box\" submit rhythm data on those subjects through a secure portal using the","text_display":" \"CABANA Box\" submit rhythm data on those subjects through a secure portal using the","confidence":1,"confidence_rate":1},{"cnt":[[245,1182],[1818,1182],[1818,1233],[245,1233]],"region":{"top_left_x":244,"top_left_y":1181,"width":1574,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b1dc20c0b6a4ec082fb50761a7be6a4","type":"text","conversion_output":true,"text":"CABANA sharepoint website, which is then processed and submitted to the ECG core lab for","text_display":" CABANA sharepoint website, which is then processed and submitted to the ECG core lab for","confidence":1,"confidence_rate":1},{"cnt":[[245,1231],[1781,1231],[1781,1283],[245,1283]],"region":{"top_left_x":244,"top_left_y":1231,"width":1538,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b11e5f6a769457ba65197df038f7f27","type":"text","conversion_output":true,"text":"adjudication. CT/MRI data are received and processed by Mayo Clinic's Imaging Analysis","text_display":" adjudication. CT/MRI data are received and processed by Mayo Clinic's Imaging Analysis","confidence":0.99853515625,"confidence_rate":0.999983891144227},{"cnt":[[245,1280],[1326,1280],[1326,1330],[245,1330]],"region":{"top_left_x":244,"top_left_y":1280,"width":1082,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1209c7d098c24efa955478b8b2c1f260","type":"text","conversion_output":true,"text":"Laboratory, and the information is then transferred to the DCRI.","text_display":" Laboratory, and the information is then transferred to the DCRI.","confidence":1,"confidence_rate":1},{"cnt":[[245,1377],[1828,1377],[1828,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1377,"width":1585,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c39be2fafed4c7b81a1c5595b39815a","type":"text","conversion_output":true,"text":"All data collected in the study are managed and analyzed at the CABANA Statistical and Data","text_display":"\n\nAll data collected in the study are managed and analyzed at the CABANA Statistical and Data","confidence":1,"confidence_rate":1},{"cnt":[[245,1422],[1800,1422],[1800,1474],[245,1474]],"region":{"top_left_x":244,"top_left_y":1422,"width":1557,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7203e4b3b03042c1820c56ab1a928691","type":"text","conversion_output":true,"text":"Coordinating Center at the DCRI. The InForm eCRF data are carefully reviewed, queried as","text_display":" Coordinating Center at the DCRI. The InForm eCRF data are carefully reviewed, queried as","confidence":1,"confidence_rate":1},{"cnt":[[245,1472],[1863,1472],[1863,1523],[245,1523]],"region":{"top_left_x":244,"top_left_y":1471,"width":1619,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52f7cf087f61455699c7753aa4ab6110","type":"text","conversion_output":true,"text":"needed, and then downloaded as raw SAS data files, and further review and checking of the data","text_display":" needed, and then downloaded as raw SAS data files, and further review and checking of the data","confidence":1,"confidence_rate":1},{"cnt":[[245,1521],[1779,1521],[1779,1571],[245,1571]],"region":{"top_left_x":244,"top_left_y":1521,"width":1535,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"add9c1c01ce34f6c9edb14e810de7090","type":"text","conversion_output":true,"text":"occur. The raw SAS data, analysis datasets, and analysis programs are stored on the secure","text_display":" occur. The raw SAS data, analysis datasets, and analysis programs are stored on the secure","confidence":1,"confidence_rate":1},{"cnt":[[245,1568],[1852,1568],[1852,1618],[245,1618]],"region":{"top_left_x":244,"top_left_y":1568,"width":1608,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b35ad750303b4475adecf4f6a21b0bed","type":"text","conversion_output":true,"text":"DCRI statistical server. Final analyses will be performed at the DCRI using SAS version 9.4 or","text_display":" DCRI statistical server. Final analyses will be performed at the DCRI using SAS version 9.4 or","confidence":1,"confidence_rate":1},{"cnt":[[245,1616],[1768,1616],[1768,1665],[245,1665]],"region":{"top_left_x":244,"top_left_y":1615,"width":1525,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0229fc6243104aafafa90b3cb7d96b28","type":"text","conversion_output":true,"text":"higher (SAS Institute Inc., Cary, NC). All programs written to create analysis datasets and","text_display":" higher (SAS Institute Inc., Cary, NC). All programs written to create analysis datasets and","confidence":1,"confidence_rate":1},{"cnt":[[245,1663],[1742,1663],[1742,1714],[245,1714]],"region":{"top_left_x":244,"top_left_y":1662,"width":1499,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f48e7afc1eb4baf9663f35ad83ccc1c","type":"text","conversion_output":true,"text":"perform analyses will be validated according to SOPs established by the DCRI Statistical","text_display":" perform analyses will be validated according to SOPs established by the DCRI Statistical","confidence":1,"confidence_rate":1},{"cnt":[[245,1712],[599,1712],[599,1764],[245,1764]],"region":{"top_left_x":244,"top_left_y":1712,"width":356,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8feb6ef68804375977c5b93bd3a717a","type":"text","conversion_output":true,"text":"Programming group.","text_display":" Programming group.","confidence":1,"confidence_rate":1},{"cnt":[[236,1850],[952,1850],[952,1923],[236,1923]],"region":{"top_left_x":236,"top_left_y":1849,"width":716,"height":74},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c950d0fbd684bddacd937e58786e8f1","type":"section_header","conversion_output":false,"children_ids":["be65dd79e58f49f08bf3d2b76d688684"],"text":"","text_display":""},{"cnt":[[245,1858],[943,1858],[943,1914],[245,1914]],"region":{"top_left_x":244,"top_left_y":1858,"width":700,"height":57},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be65dd79e58f49f08bf3d2b76d688684","type":"text","conversion_output":true,"parent_id":"9c950d0fbd684bddacd937e58786e8f1","text":"7. General Analysis Methodology","text_display":"\n\n\\section*{7. General Analysis Methodology}","confidence":1,"confidence_rate":1},{"cnt":[[245,1972],[1858,1972],[1858,2024],[245,2024]],"region":{"top_left_x":244,"top_left_y":1972,"width":1615,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94fbb0449de44aacbde77133b4e4ad25","type":"text","conversion_output":true,"text":"As stated previously and except where otherwise noted, all major treatment comparisons will be","text_display":"\n\nAs stated previously and except where otherwise noted, all major treatment comparisons will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2020],[1766,2020],[1766,2073],[245,2073]],"region":{"top_left_x":244,"top_left_y":2019,"width":1523,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73ad513818da480b9a5ab21d61834e69","type":"text","conversion_output":true,"text":"performed according to the principle of \"intention-to-treat.\" Subjects will be analyzed and","text_display":" performed according to the principle of \"intention-to-treat.\" Subjects will be analyzed and","confidence":1,"confidence_rate":1},{"cnt":[[245,2069],[1712,2069],[1712,2121],[245,2121]],"region":{"top_left_x":244,"top_left_y":2068,"width":1469,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c248c3c520e494eba0ff1f668471dee","type":"text","conversion_output":true,"text":"endpoints attributed according to the treatment arm to which patients were randomized,","text_display":" endpoints attributed according to the treatment arm to which patients were randomized,","confidence":1,"confidence_rate":1},{"cnt":[[245,2116],[1446,2116],[1446,2168],[245,2168]],"region":{"top_left_x":244,"top_left_y":2116,"width":1202,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f8f597a2eea435db65ff60f79307e4d","type":"text","conversion_output":true,"text":"regardless of subsequent crossover or post-randomization medical care.","text_display":" regardless of subsequent crossover or post-randomization medical care.","confidence":1,"confidence_rate":1},{"cnt":[[245,2213],[1757,2213],[1757,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2212,"width":1514,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"269cd127b34c49d9b6addc541f226aeb","type":"text","conversion_output":true,"text":"Appropriate statistical models and tests will be used to examine the effect of the treatment","text_display":"\n\nAppropriate statistical models and tests will be used to examine the effect of the treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,2260],[1815,2260],[1815,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1572,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b6c52fe2cdd41a2882994f859f86e24","type":"text","conversion_output":true,"text":"strategies on the primary and secondary endpoints. For time-to-first-event endpoints, the log-","text_display":" strategies on the primary and secondary endpoints. For time-to-first-event endpoints, the log","confidence":1,"confidence_rate":1},{"cnt":[[245,2303],[1766,2303],[1766,2359],[245,2359]],"region":{"top_left_x":244,"top_left_y":2303,"width":1523,"height":56},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79a1f76c122e4b74bbfd55f352d142f8","type":"text","conversion_output":true,"text":"rank test \\({ }^{1}\\) and Cox proportional hazards model \\({ }^{2}\\) will be used for statistically comparing the","text_display":"rank test \\({ }^{1}\\) and Cox proportional hazards model \\({ }^{2}\\) will be used for statistically comparing the","confidence":1,"confidence_rate":1},{"cnt":[[245,2357],[1861,2357],[1861,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2356,"width":1617,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ac0977ff5fa4839988a8fc0d91ce39a","type":"text","conversion_output":true,"text":"treatment groups unless otherwise specified. Additional perspective regarding the interpretation","text_display":" treatment groups unless otherwise specified. Additional perspective regarding the interpretation","confidence":1,"confidence_rate":1},{"cnt":[[245,2402],[1876,2402],[1876,2454],[245,2454]],"region":{"top_left_x":244,"top_left_y":2401,"width":1632,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f37321633fd9419ea01c0022f8e6f1e1","type":"text","conversion_output":true,"text":"of the data will be provided through extensive use of confidence intervals and graphical displays,","text_display":" of the data will be provided through extensive use of confidence intervals and graphical displays,","confidence":1,"confidence_rate":1},{"cnt":[[245,2445],[1749,2445],[1749,2503],[245,2503]],"region":{"top_left_x":244,"top_left_y":2444,"width":1505,"height":59},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d2565102c9340fbbb9fd6ef6225e786","type":"text","conversion_output":true,"text":"including plots of Kaplan-Meier \\({ }^{3}\\) event-rate estimates. All statistical comparisons will be","text_display":" including plots of Kaplan-Meier \\({ }^{3}\\) event-rate estimates. All statistical comparisons will be","confidence":1,"confidence_rate":1},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f575ec2f6c3a442f90d340ea09172693","type":"page_info","conversion_output":false,"text":"5","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-07","page":7,"lines":[{"cnt":[[245,251],[1768,251],[1768,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1525,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f72e281cb2db4bfc8960f5ec43997157","type":"text","conversion_output":true,"text":"performed using two-sided significance tests and a nominal level of significance of \\(\\alpha=0.05\\)","text_display":"\nperformed using two-sided significance tests and a nominal level of significance of \\(\\alpha=0.05\\)","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[245,301],[703,301],[703,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":459,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6963f81024fe46a2a08669a4a2103ea3","type":"text","conversion_output":true,"text":"unless otherwise specified.","text_display":" unless otherwise specified.","confidence":1,"confidence_rate":1},{"cnt":[[243,387],[975,387],[975,443],[243,443]],"region":{"top_left_x":242,"top_left_y":386,"width":734,"height":57},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7cb954a43453495992708fd9663a7ac3","type":"section_header","conversion_output":false,"children_ids":["a5afcb6c1fd743f7911e8597bbc3911e"],"text":"","text_display":""},{"cnt":[[245,391],[971,391],[971,436],[245,436]],"region":{"top_left_x":244,"top_left_y":391,"width":728,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5afcb6c1fd743f7911e8597bbc3911e","type":"text","conversion_output":true,"parent_id":"7cb954a43453495992708fd9663a7ac3","text":"7.1. Demographic and Baseline Analyses","text_display":"\n\n\\subsection*{7.1. Demographic and Baseline Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[245,498],[1833,498],[1833,546],[245,546]],"region":{"top_left_x":244,"top_left_y":498,"width":1589,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a942c3074c194c97a4e8f1af67013c61","type":"text","conversion_output":true,"text":"Descriptive summaries of the distribution of continuous baseline variables will be presented in","text_display":"\n\nDescriptive summaries of the distribution of continuous baseline variables will be presented in","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,541],[1704,541],[1704,595],[245,595]],"region":{"top_left_x":244,"top_left_y":541,"width":1460,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbb76c8b0dd94b4792e69232ccbbe207","type":"text","conversion_output":true,"text":"terms of percentiles (median, \\(25^{\\text {th }}\\) and \\(75^{\\text {th }}\\) percentiles), while discrete variables will be","text_display":" terms of percentiles (median, \\(25^{\\text {th }}\\) and \\(75^{\\text {th }}\\) percentiles), while discrete variables will be","confidence":0.9161369407083839,"confidence_rate":0.9992995300285795},{"cnt":[[245,593],[1760,593],[1760,642],[245,642]],"region":{"top_left_x":244,"top_left_y":592,"width":1516,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e8383d9991a42f4b296eb3665cc6adc","type":"text","conversion_output":true,"text":"summarized in terms of frequencies and percentages. Statistical comparisons of treatment","text_display":" summarized in terms of frequencies and percentages. Statistical comparisons of treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,642],[1824,642],[1824,690],[245,690]],"region":{"top_left_x":244,"top_left_y":642,"width":1581,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58d381223dc94d3e855f530b77c41e60","type":"text","conversion_output":true,"text":"groups with respect to baseline characteristics will be limited to selected variables and disease","text_display":" groups with respect to baseline characteristics will be limited to selected variables and disease","confidence":1,"confidence_rate":1},{"cnt":[[245,690],[1876,690],[1876,741],[245,741]],"region":{"top_left_x":244,"top_left_y":689,"width":1632,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c555e5fe6a8e434b88acfd335d52df08","type":"text","conversion_output":true,"text":"factors known to influence prognosis. These variables will include: age, sex, race, descriptors of","text_display":" factors known to influence prognosis. These variables will include: age, sex, race, descriptors of","confidence":1,"confidence_rate":1},{"cnt":[[245,739],[1824,739],[1824,788],[245,788]],"region":{"top_left_x":244,"top_left_y":739,"width":1581,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5f32329158944f882ac72ad95684bf5","type":"text","conversion_output":true,"text":"comorbidity, heart failure class, type of AF (paroxysmal, persistent or permanent), years since","text_display":" comorbidity, heart failure class, type of AF (paroxysmal, persistent or permanent), years since","confidence":0.9794921875,"confidence_rate":0.9997928112901707},{"cnt":[[245,786],[1738,786],[1738,836],[245,836]],"region":{"top_left_x":244,"top_left_y":786,"width":1495,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c32789d98014232882a838c46f8b610","type":"text","conversion_output":true,"text":"onset of AF, days from most recent qualifying episode of atrial fibrillation to enrollment,","text_display":" onset of AF, days from most recent qualifying episode of atrial fibrillation to enrollment,","confidence":0.7607421875,"confidence_rate":0.9971555036872908},{"cnt":[[245,834],[1818,834],[1818,883],[245,883]],"region":{"top_left_x":244,"top_left_y":833,"width":1574,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f871445e61e04fc1b0bb78a085993f53","type":"text","conversion_output":true,"text":"presence/absence of structural heart disease, and \\(CHA _{2} DS _{2}\\)-VASc score. For comparisons of","text_display":" presence/absence of structural heart disease, and \\(CHA _{2} DS _{2}\\)-VASc score. For comparisons of","confidence":0.9946346282958984,"confidence_rate":0.9999540197152142},{"cnt":[[245,883],[1790,883],[1790,930],[245,930]],"region":{"top_left_x":244,"top_left_y":883,"width":1546,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0756a043d00c4c24bbb4b83d58a3bc6f","type":"text","conversion_output":true,"text":"treatment groups with respect to continuous or ordinal baseline variables, the nonparametric","text_display":" treatment groups with respect to continuous or ordinal baseline variables, the nonparametric","confidence":1,"confidence_rate":1},{"cnt":[[245,928],[1768,928],[1768,978],[245,978]],"region":{"top_left_x":244,"top_left_y":928,"width":1525,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3646ce496f6e41b78837f8332ff4ad76","type":"text","conversion_output":true,"text":"Wilcoxon rank-sum test will be used. Group comparisons with respect to discrete baseline","text_display":" Wilcoxon rank-sum test will be used. Group comparisons with respect to discrete baseline","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1644,975],[1644,1027],[245,1027]],"region":{"top_left_x":244,"top_left_y":975,"width":1400,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23cad7a822984b5fa563ac95b94677d1","type":"text","conversion_output":true,"text":"variables will use the Pearson's chi-square test or Fisher's exact test as appropriate.","text_display":" variables will use the Pearson's chi-square test or Fisher's exact test as appropriate.","confidence":0.9936552047729492,"confidence_rate":0.9999308175129241},{"cnt":[[245,1085],[746,1085],[746,1141],[245,1141]],"region":{"top_left_x":244,"top_left_y":1084,"width":502,"height":57},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46ff0f6070214deaa634c5f07cc23bb9","type":"section_header","conversion_output":false,"children_ids":["c1d08df6cc184b098c3a587033b00653"],"text":"","text_display":""},{"cnt":[[249,1087],[741,1087],[741,1137],[249,1137]],"region":{"top_left_x":249,"top_left_y":1087,"width":493,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1d08df6cc184b098c3a587033b00653","type":"text","conversion_output":true,"parent_id":"46ff0f6070214deaa634c5f07cc23bb9","text":"7.2 Disposition of Subjects","text_display":"\n\n\\subsection*{7.2 Disposition of Subjects}","confidence":0.9990234375,"confidence_rate":0.999969467977117},{"cnt":[[245,1173],[1828,1173],[1828,1225],[245,1225]],"region":{"top_left_x":244,"top_left_y":1173,"width":1585,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fa900eeab014610804dfb424542b937","type":"text","conversion_output":true,"text":"The disposition of subjects (number randomized, number who received the randomly assigned","text_display":"\n\nThe disposition of subjects (number randomized, number who received the randomly assigned","confidence":1,"confidence_rate":1},{"cnt":[[245,1222],[1764,1220],[1764,1272],[245,1274]],"region":{"top_left_x":244,"top_left_y":1220,"width":1520,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbadc5967bec4921b687a71f2d6023ee","type":"text","conversion_output":true,"text":"treatment, number of treatment crossovers, number of patients who withdrew consent, and","text_display":" treatment, number of treatment crossovers, number of patients who withdrew consent, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1272],[1828,1272],[1828,1321],[245,1321]],"region":{"top_left_x":244,"top_left_y":1271,"width":1585,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e340d1b51e524b6ca0f59b35b5c54cc6","type":"text","conversion_output":true,"text":"number lost to follow-up) will be summarized overall and by treatment arm. The summary of","text_display":" number lost to follow-up) will be summarized overall and by treatment arm. The summary of","confidence":1,"confidence_rate":1},{"cnt":[[245,1319],[1854,1319],[1854,1369],[245,1369]],"region":{"top_left_x":244,"top_left_y":1319,"width":1611,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdcd38bedabd44779684285c666aa127","type":"text","conversion_output":true,"text":"treatment crossovers will distinguish the patients randomized to the drug arm who subsequently","text_display":" treatment crossovers will distinguish the patients randomized to the drug arm who subsequently","confidence":1,"confidence_rate":1},{"cnt":[[245,1366],[1833,1366],[1833,1416],[245,1416]],"region":{"top_left_x":244,"top_left_y":1366,"width":1589,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50b6a2fade6e48c7b96e97db2258b1ca","type":"text","conversion_output":true,"text":"underwent catheter ablation (crossed over to ablation) during the course of their follow-up and","text_display":" underwent catheter ablation (crossed over to ablation) during the course of their follow-up and","confidence":1,"confidence_rate":1},{"cnt":[[245,1414],[1858,1414],[1858,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1413,"width":1615,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7339be612bbd453fb3bd1efa827a0cb0","type":"text","conversion_output":true,"text":"the patients randomized to the ablation arm who never received an ablation. The distribution of","text_display":" the patients randomized to the ablation arm who never received an ablation. The distribution of","confidence":1,"confidence_rate":1},{"cnt":[[245,1461],[1800,1461],[1800,1510],[245,1510]],"region":{"top_left_x":244,"top_left_y":1460,"width":1557,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2728c6ee22b241eeb9bce5d6d3aeb827","type":"text","conversion_output":true,"text":"the length of follow-up for the overall study population and for each randomized arm will be","text_display":" the length of follow-up for the overall study population and for each randomized arm will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1504],[1755,1504],[1755,1558],[245,1558]],"region":{"top_left_x":244,"top_left_y":1503,"width":1512,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce233e373e07416caa245f3859530619","type":"text","conversion_output":true,"text":"characterized in terms of percentiles (median, \\(25^{\\text {th }}\\), and \\(75^{\\text {th }}\\) percentiles). The number and","text_display":" characterized in terms of percentiles (median, \\(25^{\\text {th }}\\), and \\(75^{\\text {th }}\\) percentiles). The number and","confidence":0.9936599708162248,"confidence_rate":0.9999495233968226},{"cnt":[[245,1558],[1807,1558],[1807,1609],[245,1609]],"region":{"top_left_x":244,"top_left_y":1557,"width":1563,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6a4d71ab5084dfea97ec7e254863e4c","type":"text","conversion_output":true,"text":"percentage of patients who had at least 3 years of follow-up, and at least 5 years of follow-up","text_display":" percentage of patients who had at least 3 years of follow-up, and at least 5 years of follow-up","confidence":1,"confidence_rate":1},{"cnt":[[245,1607],[1738,1607],[1738,1656],[245,1656]],"region":{"top_left_x":244,"top_left_y":1607,"width":1495,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd8736d3d26b46ac92dae8546c776d69","type":"text","conversion_output":true,"text":"will also be tabulated and reported. Among patients in the drug arm who crossed over to","text_display":" will also be tabulated and reported. Among patients in the drug arm who crossed over to","confidence":1,"confidence_rate":1},{"cnt":[[245,1654],[1850,1654],[1850,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1654,"width":1606,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01a42bae827c47f29735044e3c4ff05f","type":"text","conversion_output":true,"text":"ablation, the distribution of length of follow-up prior to the crossover will be described in terms","text_display":" ablation, the distribution of length of follow-up prior to the crossover will be described in terms","confidence":1,"confidence_rate":1},{"cnt":[[245,1702],[1811,1702],[1811,1751],[245,1751]],"region":{"top_left_x":244,"top_left_y":1701,"width":1568,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"091992a59c614493869facf27806b172","type":"text","conversion_output":true,"text":"of percentiles. Also the distribution of follow-up among patients who withdrew consent (i.e.,","text_display":" of percentiles. Also the distribution of follow-up among patients who withdrew consent (i.e.,","confidence":0.998046875,"confidence_rate":0.9999800508639274},{"cnt":[[245,1749],[1848,1749],[1848,1800],[245,1800]],"region":{"top_left_x":244,"top_left_y":1748,"width":1604,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83c24fa9f725464caa9a599e50116058","type":"text","conversion_output":true,"text":"patients who withdrew prior to the protocol-specified 3 years of follow-up) will be summarized","text_display":" patients who withdrew prior to the protocol-specified 3 years of follow-up) will be summarized","confidence":1,"confidence_rate":1},{"cnt":[[245,1796],[1772,1796],[1772,1848],[245,1848]],"region":{"top_left_x":244,"top_left_y":1796,"width":1529,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a61b255f5b9b46718d58170f9e2ae868","type":"text","conversion_output":true,"text":"in terms of percentiles. Additionally, the number and percentage of patients who withdrew","text_display":" in terms of percentiles. Additionally, the number and percentage of patients who withdrew","confidence":1,"confidence_rate":1},{"cnt":[[245,1843],[1549,1843],[1549,1897],[245,1897]],"region":{"top_left_x":244,"top_left_y":1843,"width":1306,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"556ef8cab6ab4160898a29c3aeb5e255","type":"text","conversion_output":true,"text":"consent before 3 years, after 3 to \\(<5\\) years, and after 5 years will be tabulated.","text_display":" consent before 3 years, after 3 to \\(<5\\) years, and after 5 years will be tabulated.","confidence":0.9970703125,"confidence_rate":0.999970061800863},{"cnt":[[243,1938],[578,1938],[578,1996],[243,1996]],"region":{"top_left_x":242,"top_left_y":1937,"width":336,"height":59},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebb73a821300419691ce563bb2ea955c","type":"section_header","conversion_output":false,"children_ids":["9522be4e6d8e482dbc46cadab7f998da"],"text":"","text_display":""},{"cnt":[[245,1942],[574,1942],[574,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1942,"width":330,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9522be4e6d8e482dbc46cadab7f998da","type":"text","conversion_output":true,"parent_id":"ebb73a821300419691ce563bb2ea955c","text":"7.3 Missing Data","text_display":"\n\n\\subsection*{7.3 Missing Data}","confidence":1,"confidence_rate":1},{"cnt":[[245,2030],[1820,2030],[1820,2080],[245,2080]],"region":{"top_left_x":244,"top_left_y":2030,"width":1576,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"502ee8cc2f6e4a01adedf12e0708c95c","type":"text","conversion_output":true,"text":"Missing data will be handled differently for covariates and endpoints. Data for covariates (see","text_display":"\n\nMissing data will be handled differently for covariates and endpoints. Data for covariates (see","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1878,2075],[1878,2127],[245,2127]],"region":{"top_left_x":244,"top_left_y":2075,"width":1634,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b34e0e768f994175aa8352df3781bb52","type":"text","conversion_output":true,"text":"Section 8.1) are expected to be complete or near complete for all patients. Where missing data do","text_display":" Section 8.1) are expected to be complete or near complete for all patients. Where missing data do","confidence":1,"confidence_rate":1},{"cnt":[[245,2125],[1848,2125],[1848,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2124,"width":1604,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"762057aa0d104480b1b5596d6a7d58de","type":"text","conversion_output":true,"text":"occur, using single-imputation methods, continuous variables will be imputed using the median","text_display":" occur, using single-imputation methods, continuous variables will be imputed using the median","confidence":1,"confidence_rate":1},{"cnt":[[245,2174],[1317,2174],[1317,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2174,"width":1073,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29d01f19e49e4155b7c4e282a7a77746","type":"text","conversion_output":true,"text":"value and categorical variables will be imputed using the mode.","text_display":" value and categorical variables will be imputed using the mode.","confidence":1,"confidence_rate":1},{"cnt":[[245,2260],[1815,2260],[1815,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1572,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0877413908d457f9e5014995086a79e","type":"text","conversion_output":true,"text":"Most primary and secondary endpoints are time-to-event analyses which rely on the ability to","text_display":"\n\nMost primary and secondary endpoints are time-to-event analyses which rely on the ability to","confidence":1,"confidence_rate":1},{"cnt":[[245,2307],[1732,2307],[1732,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2307,"width":1488,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f132a99ff7e8469bb513bcb716ae7f19","type":"text","conversion_output":true,"text":"calculate the time from randomization (or in some cases time from the end of the 90-day","text_display":" calculate the time from randomization (or in some cases time from the end of the 90-day","confidence":0.515625,"confidence_rate":0.9928261220614288},{"cnt":[[245,2355],[1846,2355],[1846,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2354,"width":1602,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d01e344b0aa54dccbea309d3371a4b98","type":"text","conversion_output":true,"text":"blanking period) to when the event occurred or the date of last contact for censored individuals.","text_display":" blanking period) to when the event occurred or the date of last contact for censored individuals.","confidence":1,"confidence_rate":1},{"cnt":[[245,2406],[1727,2406],[1727,2456],[245,2456]],"region":{"top_left_x":244,"top_left_y":2406,"width":1484,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"263bddf4718f4eeb915d2b87b6868fe7","type":"text","conversion_output":true,"text":"Here, missing data may occur when: 1) a visit form or question that indicates if an event","text_display":" Here, missing data may occur when: 1) a visit form or question that indicates if an event","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[245,2454],[1880,2454],[1880,2503],[245,2503]],"region":{"top_left_x":244,"top_left_y":2453,"width":1636,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f23674d759044847838bf0b01779f43a","type":"text","conversion_output":true,"text":"occurred (or not) is not completed, and 2) a form or question indicates that an event occurred, but","text_display":" occurred (or not) is not completed, and 2) a form or question indicates that an event occurred, but","confidence":0.998046875,"confidence_rate":0.9999812017648063},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48c6bb5c790248bcbf948dc0277f1e72","type":"page_info","conversion_output":false,"text":"6","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-08","page":8,"lines":[{"cnt":[[245,251],[1747,251],[1747,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1503,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44e204386932417d97e5c57ced90c3fe","type":"text","conversion_output":true,"text":"the event date is missing. The first category prevents the assignment of whether an event","text_display":"\nthe event date is missing. The first category prevents the assignment of whether an event","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[245,301],[1764,301],[1764,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1520,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32e6557e29934ac8901fd922a2223742","type":"text","conversion_output":true,"text":"occurred or not, while the second category prevents calculation of time to the event. In all","text_display":" occurred or not, while the second category prevents calculation of time to the event. In all","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1798,348],[1798,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1555,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2ba4d2c81794f45b7d8c4f1c40b1766","type":"text","conversion_output":true,"text":"analyses, we consider only non-missing data in the determination of whether or not an event","text_display":" analyses, we consider only non-missing data in the determination of whether or not an event","confidence":1,"confidence_rate":1},{"cnt":[[245,395],[1878,395],[1878,445],[245,445]],"region":{"top_left_x":244,"top_left_y":395,"width":1634,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f268a1d927a343daaab42754b5b96140","type":"text","conversion_output":true,"text":"occurred (i.e., cases in category 1 will not be considered). Time-to-event for known events when","text_display":" occurred (i.e., cases in category 1 will not be considered). Time-to-event for known events when","confidence":0.9975602623308077,"confidence_rate":0.9999765125962303},{"cnt":[[245,443],[1869,443],[1869,494],[245,494]],"region":{"top_left_x":244,"top_left_y":442,"width":1626,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2340908f6d6c45be868bb26b59eade65","type":"text","conversion_output":true,"text":"the event date is missing (category 2), will be assigned based on the visit with which the event is","text_display":" the event date is missing (category 2), will be assigned based on the visit with which the event is","confidence":0.6923828125,"confidence_rate":0.9964714680376995},{"cnt":[[245,490],[1880,490],[1880,541],[245,541]],"region":{"top_left_x":244,"top_left_y":489,"width":1636,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3232d0d55c7f40819f47ddaacfca927f","type":"text","conversion_output":true,"text":"recorded. For example, if the event is reported on the month 3 visit, then the time to event would","text_display":" recorded. For example, if the event is reported on the month 3 visit, then the time to event would","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1828,537],[1828,589],[245,589]],"region":{"top_left_x":244,"top_left_y":537,"width":1585,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ad4d8c9260643e3b77390e1b12c97dc","type":"text","conversion_output":true,"text":"be set to 91.26 days \\((365 / 12 * 3)\\). If the event is reported on the month 6 visit, then the time to","text_display":" be set to 91.26 days \\((365 / 12 * 3)\\). If the event is reported on the month 6 visit, then the time to","confidence":0.9990236759185791,"confidence_rate":0.9999912000297451},{"cnt":[[245,587],[1882,587],[1882,638],[245,638]],"region":{"top_left_x":244,"top_left_y":586,"width":1639,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60be264266084caf8122f6d6701eaa53","type":"text","conversion_output":true,"text":"event would be set to 182.52 days \\((365 / 12 * 6)\\), and so on for all visits up to month 96 . If patients","text_display":" event would be set to 182.52 days \\((365 / 12 * 6)\\), and so on for all visits up to month 96 . If patients","confidence":0.8902955055236816,"confidence_rate":0.9989812049149311},{"cnt":[[245,636],[1863,636],[1863,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1619,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f76a2905f58d4324986467ce6b1a5437","type":"text","conversion_output":true,"text":"do not experience an event, and have an event-free status associated with a visit but no visit date","text_display":" do not experience an event, and have an event-free status associated with a visit but no visit date","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1815,683],[1815,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1572,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d92a546dd914a4a96af2afedd8d2d35","type":"text","conversion_output":true,"text":"on their last known visit, they will be assigned a censor date in the same manner. For patients","text_display":" on their last known visit, they will be assigned a censor date in the same manner. For patients","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1846,730],[1846,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1602,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90c046fc2d814a70bf76dcf869dd275d","type":"text","conversion_output":true,"text":"with multiple events including a death, any imputed non-death event dates (e.g., cardiovascular","text_display":" with multiple events including a death, any imputed non-death event dates (e.g., cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[245,778],[1412,778],[1412,831],[245,831]],"region":{"top_left_x":244,"top_left_y":777,"width":1168,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b04858980bf1439da2cbc08dd4872b3f","type":"text","conversion_output":true,"text":"(CV) hospitalization) will be forced to occur before the date of death.","text_display":" (CV) hospitalization) will be forced to occur before the date of death.","confidence":1,"confidence_rate":1},{"cnt":[[245,872],[1843,872],[1843,926],[245,926]],"region":{"top_left_x":244,"top_left_y":872,"width":1600,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"853833adce4c492184f05ee14e319663","type":"text","conversion_output":true,"text":"If an event or censored status is reported, but both the visit number and event/censored date are","text_display":"\n\nIf an event or censored status is reported, but both the visit number and event/censored date are","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[245,922],[1828,922],[1828,973],[245,973]],"region":{"top_left_x":244,"top_left_y":921,"width":1585,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7935d46b7f1f49418d4ea90fe647925a","type":"text","conversion_output":true,"text":"missing, then the date of event/censor will be imputed using relevant data and considered on a","text_display":" missing, then the date of event/censor will be imputed using relevant data and considered on a","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[571,971],[571,1021],[245,1021]],"region":{"top_left_x":244,"top_left_y":971,"width":328,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddce42a4b4794a0aa962370aef82743f","type":"text","conversion_output":true,"text":"case-by-case basis.","text_display":" case-by-case basis.","confidence":1,"confidence_rate":1},{"cnt":[[236,1109],[896,1109],[896,1182],[236,1182]],"region":{"top_left_x":236,"top_left_y":1108,"width":660,"height":74},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9bcb50b228646aaa819b456058c6cab","type":"section_header","conversion_output":false,"children_ids":["afdcd01de4354d01b12e14486821292d"],"text":"","text_display":""},{"cnt":[[245,1117],[887,1117],[887,1175],[245,1175]],"region":{"top_left_x":244,"top_left_y":1117,"width":644,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afdcd01de4354d01b12e14486821292d","type":"text","conversion_output":true,"parent_id":"c9bcb50b228646aaa819b456058c6cab","text":"8. Primary Endpoint Analysis","text_display":"\n\n\\section*{8. Primary Endpoint Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[243,1216],[1803,1216],[1803,1270],[243,1270]],"region":{"top_left_x":242,"top_left_y":1216,"width":1561,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e812cb120954129917c4b24a03a78f7","type":"text","conversion_output":true,"text":"Primary Endpoint: Time from randomization to the first event among a composite of major","text_display":"\n\nPrimary Endpoint: Time from randomization to the first event among a composite of major","confidence":1,"confidence_rate":1},{"cnt":[[245,1265],[780,1265],[780,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1265,"width":536,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ab4f242970c41d6934953cb9a782c47","type":"text","conversion_output":true,"text":"clinical outcomes consisting of","text_display":" clinical outcomes consisting of","confidence":1,"confidence_rate":1},{"cnt":[[683,1319],[1040,1319],[1040,1369],[683,1369]],"region":{"top_left_x":683,"top_left_y":1319,"width":357,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f4d566ebf834643b1085bcd3aac4c0c","type":"text","conversion_output":true,"text":"- Death (all-cause)","text_display":"\n- Death (all-cause)","confidence":1,"confidence_rate":1},{"cnt":[[683,1366],[1029,1366],[1029,1420],[683,1420]],"region":{"top_left_x":683,"top_left_y":1366,"width":347,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ac5a9b39ff54056a1bd59911d71896e","type":"text","conversion_output":true,"text":"- Disabling stroke","text_display":"\n- Disabling stroke","confidence":1,"confidence_rate":1},{"cnt":[[683,1418],[1038,1418],[1038,1472],[683,1472]],"region":{"top_left_x":683,"top_left_y":1417,"width":355,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"023aef91df07444e9fba60d84e99705f","type":"text","conversion_output":true,"text":"- Serious bleeding","text_display":"\n- Serious bleeding","confidence":1,"confidence_rate":1},{"cnt":[[683,1470],[990,1470],[990,1517],[683,1517]],"region":{"top_left_x":683,"top_left_y":1469,"width":308,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d00411d5c524769b275e38f2dfe6a9b","type":"text","conversion_output":true,"text":"- Cardiac arrest","text_display":"\n- Cardiac arrest","confidence":1,"confidence_rate":1},{"cnt":[[245,1566],[1772,1566],[1772,1618],[245,1618]],"region":{"top_left_x":244,"top_left_y":1566,"width":1529,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d24db9fced1c4283913a94bdce74b630","type":"text","conversion_output":true,"text":"All possible events are carefully reviewed and adjudicated by a Clinical Events Committee","text_display":"\n\nAll possible events are carefully reviewed and adjudicated by a Clinical Events Committee","confidence":1,"confidence_rate":1},{"cnt":[[245,1611],[1381,1611],[1381,1665],[245,1665]],"region":{"top_left_x":244,"top_left_y":1611,"width":1138,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c45195bcfceb48ea905e5e26f4af0569","type":"text","conversion_output":true,"text":"(CEC) completely blinded to the randomized treatment assignment.","text_display":" (CEC) completely blinded to the randomized treatment assignment.","confidence":1,"confidence_rate":1},{"cnt":[[245,1710],[1755,1710],[1755,1760],[245,1760]],"region":{"top_left_x":244,"top_left_y":1710,"width":1512,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46251c569286489697d580bff0f06187","type":"text","conversion_output":true,"text":"Endpoint Definitions: Detailed definitions for each of the events are outlined in the CEC","text_display":"\n\nEndpoint Definitions: Detailed definitions for each of the events are outlined in the CEC","confidence":1,"confidence_rate":1},{"cnt":[[245,1757],[1800,1757],[1800,1807],[245,1807]],"region":{"top_left_x":244,"top_left_y":1757,"width":1557,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"633d6bdac3254d73932c9b70c36833ee","type":"text","conversion_output":true,"text":"charter. We note that a disabling stroke during follow-up must be documented by a neurologic","text_display":" charter. We note that a disabling stroke during follow-up must be documented by a neurologic","confidence":1,"confidence_rate":1},{"cnt":[[245,1805],[1867,1805],[1867,1854],[245,1854]],"region":{"top_left_x":244,"top_left_y":1804,"width":1623,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4af6c3c4c2514e1e8edced174deeeabb","type":"text","conversion_output":true,"text":"evaluation or brain CT / MR studies and result in a disabling, irreversible physical limitation defined","text_display":" evaluation or brain CT / MR studies and result in a disabling, irreversible physical limitation defined","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[245,1850],[1880,1850],[1880,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1849,"width":1636,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9f7ffeacd96484badef2d271bfade7c","type":"text","conversion_output":true,"text":"by a Rankin Stroke Scale \\(\\geq 2\\). Serious (or life-threatening) bleeding is considered to have occurred if","text_display":" by a Rankin Stroke Scale \\(\\geq 2\\). Serious (or life-threatening) bleeding is considered to have occurred if","confidence":0.9975595474243164,"confidence_rate":0.9999777871982178},{"cnt":[[245,1899],[1723,1899],[1723,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1899,"width":1480,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c48424c435f94469a8e6e1032df6e4d8","type":"text","conversion_output":true,"text":"intracranial bleeding or other bleeding occurs at any time during follow-up accompanied by","text_display":" intracranial bleeding or other bleeding occurs at any time during follow-up accompanied by","confidence":1,"confidence_rate":1},{"cnt":[[245,1942],[1841,1942],[1841,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1942,"width":1598,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4ba9187e26c43a2afbdd411cbc33327","type":"text","conversion_output":true,"text":"hemodynamic compromise that requires surgical intervention or a transfusion of \\(\\geq 3\\) units of blood.","text_display":" hemodynamic compromise that requires surgical intervention or a transfusion of \\(\\geq 3\\) units of blood.","confidence":1,"confidence_rate":1},{"cnt":[[245,1989],[1775,1989],[1775,2039],[245,2039]],"region":{"top_left_x":244,"top_left_y":1989,"width":1531,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c1b361004d64e2aaeef3403c96d97d9","type":"text","conversion_output":true,"text":"The serious bleeding definition does not include bleeding occurring with cardiac perforation or","text_display":" The serious bleeding definition does not include bleeding occurring with cardiac perforation or","confidence":1,"confidence_rate":1},{"cnt":[[245,2037],[440,2037],[440,2084],[245,2084]],"region":{"top_left_x":244,"top_left_y":2036,"width":197,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19e34e3907dd44948f028a96d2ff2732","type":"text","conversion_output":true,"text":"tamponade.","text_display":" tamponade.","confidence":1,"confidence_rate":1},{"cnt":[[245,2127],[1858,2127],[1858,2179],[245,2179]],"region":{"top_left_x":244,"top_left_y":2126,"width":1615,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4512c96bcab4a908c736dac2006a22d","type":"text","conversion_output":true,"text":"The time from randomization to the first event among the components of the primary composite","text_display":"\n\nThe time from randomization to the first event among the components of the primary composite","confidence":1,"confidence_rate":1},{"cnt":[[245,2176],[1813,2176],[1813,2228],[245,2228]],"region":{"top_left_x":244,"top_left_y":2176,"width":1570,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d359427e9eb145b8a9533b390858e525","type":"text","conversion_output":true,"text":"endpoint will be measured (in days) for those who experienced an event and calculated as the","text_display":" endpoint will be measured (in days) for those who experienced an event and calculated as the","confidence":1,"confidence_rate":1},{"cnt":[[245,2226],[1850,2226],[1850,2275],[245,2275]],"region":{"top_left_x":244,"top_left_y":2225,"width":1606,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f562595081843e6a4a12e59111f1525","type":"text","conversion_output":true,"text":"date of the first event minus the date of randomization. For patients who do not experience any","text_display":" date of the first event minus the date of randomization. For patients who do not experience any","confidence":1,"confidence_rate":1},{"cnt":[[245,2273],[1846,2273],[1846,2322],[245,2322]],"region":{"top_left_x":244,"top_left_y":2273,"width":1602,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a86ddd4e9ba4557a2080f543dc6b4b4","type":"text","conversion_output":true,"text":"of the component events or who withdraw consent or drop out of the study before experiencing","text_display":" of the component events or who withdraw consent or drop out of the study before experiencing","confidence":1,"confidence_rate":1},{"cnt":[[245,2320],[1807,2320],[1807,2370],[245,2370]],"region":{"top_left_x":244,"top_left_y":2320,"width":1563,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75d8a706c48646c69dc441318a40d2fe","type":"text","conversion_output":true,"text":"an event, time from randomization to the date of last contact will be used in the analysis, and","text_display":" an event, time from randomization to the date of last contact will be used in the analysis, and","confidence":1,"confidence_rate":1},{"cnt":[[245,2368],[1820,2368],[1820,2419],[245,2419]],"region":{"top_left_x":244,"top_left_y":2367,"width":1576,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3c87f85c48c40a4a6daf0c86e1b2c15","type":"text","conversion_output":true,"text":"those patients will be considered as censored observations in the time-to-event analysis. For","text_display":" those patients will be considered as censored observations in the time-to-event analysis. For","confidence":1,"confidence_rate":1},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0b04ed3600442969789b275f0e4f087","type":"page_info","conversion_output":false,"text":"7","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-09","page":9,"lines":[{"cnt":[[245,251],[1755,251],[1755,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1512,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e24accf18504f95aeddbdcd196ff9af","type":"text","conversion_output":true,"text":"interim analyses, the best available endpoint data will be used (i.e., adjudicated data when","text_display":"\ninterim analyses, the best available endpoint data will be used (i.e., adjudicated data when","confidence":0.998046875,"confidence_rate":0.9999798452048033},{"cnt":[[245,301],[1016,301],[1016,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":773,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"310c6336f8ee46f9b9b49a20ed35dc10","type":"text","conversion_output":true,"text":"available; otherwise site-reported event data).","text_display":" available; otherwise site-reported event data).","confidence":1,"confidence_rate":1},{"cnt":[[243,387],[1725,387],[1725,449],[243,449]],"region":{"top_left_x":242,"top_left_y":386,"width":1484,"height":64},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a87f8d2bc11246dba267b6fc74768c9a","type":"text","conversion_output":true,"text":"Statistical Methods: The log-rank test \\({ }^{1}\\) will be the primary analytic tool for statistically","text_display":"\n\nStatistical Methods: The log-rank test \\({ }^{1}\\) will be the primary analytic tool for statistically","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1841,447],[1841,494],[245,494]],"region":{"top_left_x":244,"top_left_y":446,"width":1598,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d03e05f0d2a8465dad1be1922fefdd91","type":"text","conversion_output":true,"text":"assessing outcome differences between the two randomized treatment strategies with respect to","text_display":" assessing outcome differences between the two randomized treatment strategies with respect to","confidence":1,"confidence_rate":1},{"cnt":[[245,492],[1794,492],[1794,544],[245,544]],"region":{"top_left_x":244,"top_left_y":491,"width":1550,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22c86a5d27c34ecdaf490756a5bcb631","type":"text","conversion_output":true,"text":"the primary composite endpoint. This analysis will be conducted using PROC LIFETEST in","text_display":" the primary composite endpoint. This analysis will be conducted using PROC LIFETEST in","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1779,541],[1779,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":1535,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d7bed21538f47ec9f93bcd736dfdb83","type":"text","conversion_output":true,"text":"SAS. A hazard ratio (HR) and \\(95 \\%\\) confidence interval (CI) summarizing the difference in","text_display":" SAS. A hazard ratio (HR) and \\(95 \\%\\) confidence interval (CI) summarizing the difference in","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[245,589],[1876,589],[1876,638],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":1632,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d0463e1efc64eb29dbe585b5848f7e1","type":"text","conversion_output":true,"text":"outcome between the two randomized arms will be computed using the Cox proportional hazards","text_display":" outcome between the two randomized arms will be computed using the Cox proportional hazards","confidence":1,"confidence_rate":1},{"cnt":[[245,629],[1665,629],[1665,685],[245,685]],"region":{"top_left_x":244,"top_left_y":629,"width":1422,"height":57},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b88b577896cf49f4b6ab853adb753cdd","type":"text","conversion_output":true,"text":"model \\({ }^{2}\\) (PROC PHREG in SAS), using treatment as the only predictor in the model.","text_display":" model \\({ }^{2}\\) (PROC PHREG in SAS), using treatment as the only predictor in the model.","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1721,730],[1721,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1477,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97c5337dc95b4afd9679a383068b5779","type":"text","conversion_output":true,"text":"In addition to the statistical hypothesis testing, cumulative event rates will be calculated","text_display":"\n\nIn addition to the statistical hypothesis testing, cumulative event rates will be calculated","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,776],[1811,776],[1811,831],[245,831]],"region":{"top_left_x":244,"top_left_y":775,"width":1568,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"983e6898d11b499497e8eb480abe3cb1","type":"text","conversion_output":true,"text":"according to the method of Kaplan and Meier \\({ }^{3}\\) for each randomized arm as a function of time","text_display":" according to the method of Kaplan and Meier \\({ }^{3}\\) for each randomized arm as a function of time","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[1721,829],[1721,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":1477,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"715543662de84a5bbdb2330c63c8d3d7","type":"text","conversion_output":true,"text":"from randomization, and the estimated event probabilities will be displayed graphically.","text_display":" from randomization, and the estimated event probabilities will be displayed graphically.","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1880,924],[1880,975],[245,975]],"region":{"top_left_x":244,"top_left_y":923,"width":1636,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe49f2d3fbbb47358f93f460711c77a8","type":"text","conversion_output":true,"text":"The methods described above will constitute the primary analysis of this endpoint. The primary","text_display":"\n\nThe methods described above will constitute the primary analysis of this endpoint. The primary","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[664,971],[664,1021],[245,1021]],"region":{"top_left_x":244,"top_left_y":971,"width":420,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db626e03823c4e22b0fb35f5b9b5eafa","type":"text","conversion_output":true,"text":"hypothesis is defined as:","text_display":" hypothesis is defined as:","confidence":1,"confidence_rate":1},{"cnt":[[859,1033],[1257,1033],[1257,1199],[859,1199]],"region":{"top_left_x":859,"top_left_y":1033,"width":398,"height":166},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77c68f5773a0419388969bd249749fb8","type":"math","conversion_output":true,"text":"\\[\n\\begin{array}{ll}\nH_{0}: & S_{a}(t)=S_{d}(t), \\text { vs. } \\\\\nH_{a}: & S_{a}(t) \\neq S_{d}(t)\n\\end{array}\n\\]","text_display":"\n\\[\n\\begin{array}{ll}\nH_{0}: & S_{a}(t)=S_{d}(t), \\text { vs. } \\\\\nH_{a}: & S_{a}(t) \\neq S_{d}(t)\n\\end{array}\n\\]","confidence":0.5473413594816634,"confidence_rate":0.9957647503155959},{"cnt":[[245,1242],[1811,1242],[1811,1291],[245,1291]],"region":{"top_left_x":244,"top_left_y":1241,"width":1568,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c8f6d92db20474ab41fa6808a2a83f8","type":"text","conversion_output":true,"text":"where \\(S _{ a }( t )\\) is the event-free survivor function for the ablation arm of the trial, and \\(S _{ d }( t )\\) is the","text_display":"\nwhere \\(S _{ a }( t )\\) is the event-free survivor function for the ablation arm of the trial, and \\(S _{ d }( t )\\) is the","confidence":0.9322261810302734,"confidence_rate":0.9995058980928636},{"cnt":[[245,1291],[1833,1291],[1833,1343],[245,1343]],"region":{"top_left_x":244,"top_left_y":1291,"width":1589,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50f3879a44b0441697284a7dece097c0","type":"text","conversion_output":true,"text":"event-free survivor function for the drug arm, both of which are a function of follow-up time \\(t\\).","text_display":" event-free survivor function for the drug arm, both of which are a function of follow-up time \\(t\\).","confidence":0.83984375,"confidence_rate":0.9983391006667152},{"cnt":[[245,1336],[1850,1336],[1850,1388],[245,1388]],"region":{"top_left_x":244,"top_left_y":1336,"width":1606,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7cadfd815f4b44dbae3a323a5a26c614","type":"text","conversion_output":true,"text":"In other words, we are testing whether the event-free survival experience of the two arms of the","text_display":" In other words, we are testing whether the event-free survival experience of the two arms of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1386],[1777,1386],[1777,1437],[245,1437]],"region":{"top_left_x":244,"top_left_y":1385,"width":1533,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c22363ea81d4b20a2f5f9799df196bd","type":"text","conversion_output":true,"text":"trial is the same vs. whether it is different. The above hypothesis will be tested at a 2 -sided","text_display":" trial is the same vs. whether it is different. The above hypothesis will be tested at a 2 -sided","confidence":0.9931783592328429,"confidence_rate":0.9999341847186379},{"cnt":[[245,1435],[1798,1435],[1798,1485],[245,1485]],"region":{"top_left_x":244,"top_left_y":1435,"width":1555,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45b5bc72c204429fbe8415a82ff373da","type":"text","conversion_output":true,"text":"significance level of 0.049 in the ITT population to account for a single interim analysis (see","text_display":" significance level of 0.049 in the ITT population to account for a single interim analysis (see","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,1482],[455,1482],[455,1532],[245,1532]],"region":{"top_left_x":244,"top_left_y":1482,"width":212,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d03ffe51bf2429185a00074e5859fdd","type":"text","conversion_output":true,"text":"Section 13).","text_display":" Section 13).","confidence":1,"confidence_rate":1},{"cnt":[[245,1573],[1796,1573],[1796,1622],[245,1622]],"region":{"top_left_x":244,"top_left_y":1572,"width":1553,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd3bc0ae710a49a0a3e920b4d4a5ecb9","type":"text","conversion_output":true,"text":"Because the Cox model will be used for calculating a hazard ratio and confidence interval to","text_display":"\n\nBecause the Cox model will be used for calculating a hazard ratio and confidence interval to","confidence":1,"confidence_rate":1},{"cnt":[[245,1620],[1792,1620],[1792,1669],[245,1669]],"region":{"top_left_x":244,"top_left_y":1619,"width":1548,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2e666fb0c8b4d698e5712127a5b25e9","type":"text","conversion_output":true,"text":"summarize the difference in outcome between the two randomized arms, the proportionality","text_display":" summarize the difference in outcome between the two randomized arms, the proportionality","confidence":1,"confidence_rate":1},{"cnt":[[245,1667],[1824,1667],[1824,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1667,"width":1581,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0886dfcc35f84345946e86cb5634da93","type":"text","conversion_output":true,"text":"assumption in the Cox model (i.e., constant hazard ratio over time) will be checked and tested","text_display":" assumption in the Cox model (i.e., constant hazard ratio over time) will be checked and tested","confidence":1,"confidence_rate":1},{"cnt":[[245,1714],[1867,1714],[1867,1766],[245,1766]],"region":{"top_left_x":244,"top_left_y":1714,"width":1623,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99ef7ded770043df982c1047405203ac","type":"text","conversion_output":true,"text":"through adding an interaction term (treatment* \\(\\log ( t )\\) ) to the Cox model, and by examining a plot","text_display":" through adding an interaction term (treatment* \\(\\log ( t )\\) ) to the Cox model, and by examining a plot","confidence":0.5023624456771358,"confidence_rate":0.9938170904886312},{"cnt":[[245,1764],[655,1764],[655,1811],[245,1811]],"region":{"top_left_x":244,"top_left_y":1763,"width":412,"height":49},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7757ecad81ea47edb6dffdf3324e25d4","type":"text","conversion_output":true,"text":"of Schoenfeld residuals.","text_display":" of Schoenfeld residuals.","confidence":1,"confidence_rate":1},{"cnt":[[245,1852],[1858,1852],[1858,1904],[245,1904]],"region":{"top_left_x":244,"top_left_y":1851,"width":1615,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"551014c3254248929c5c360a714f5196","type":"text","conversion_output":true,"text":"The hypothesis as expressed above will also be used for the time-to-event analyses of secondary","text_display":"\n\nThe hypothesis as expressed above will also be used for the time-to-event analyses of secondary","confidence":1,"confidence_rate":1},{"cnt":[[245,1901],[1403,1901],[1403,1953],[245,1953]],"region":{"top_left_x":244,"top_left_y":1901,"width":1159,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9f7f5a7c3144717813ea1018e258115","type":"text","conversion_output":true,"text":"endpoints described below using a 2 -sided significance level of 0.05 .","text_display":" endpoints described below using a 2 -sided significance level of 0.05 .","confidence":0.9282917976379395,"confidence_rate":0.9990929828266438},{"cnt":[[236,2013],[1386,2013],[1386,2075],[236,2075]],"region":{"top_left_x":236,"top_left_y":2013,"width":1150,"height":63},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26ef2b04471043a28b8fd91f94a34123","type":"section_header","conversion_output":false,"children_ids":["ac57745eedd64001949b4e288ee32429"],"text":"","text_display":""},{"cnt":[[245,2020],[1381,2020],[1381,2069],[245,2069]],"region":{"top_left_x":244,"top_left_y":2019,"width":1138,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac57745eedd64001949b4e288ee32429","type":"text","conversion_output":true,"parent_id":"26ef2b04471043a28b8fd91f94a34123","text":"8.1 Other Analyses of Primary Endpoint Data (as randomized):","text_display":"\n\n\\subsection*{8.1 Other Analyses of Primary Endpoint Data (as 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Using the Cox model, the effect of treatment","text_display":"\n\nTreatment comparison with covariate adjustment. 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Analysis of Secondary Endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[236,2271],[1124,2271],[1124,2335],[236,2335]],"region":{"top_left_x":236,"top_left_y":2270,"width":888,"height":66},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2016f2891fad476e8ff2d3ea8d5cd19b","type":"section_header","conversion_output":false,"children_ids":["b27c05f3fccf40009a1a5b2dfdd78fae"],"text":"","text_display":""},{"cnt":[[245,2277],[1119,2277],[1119,2329],[245,2329]],"region":{"top_left_x":244,"top_left_y":2277,"width":876,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b27c05f3fccf40009a1a5b2dfdd78fae","type":"text","conversion_output":true,"parent_id":"2016f2891fad476e8ff2d3ea8d5cd19b","text":"9.1 All-cause mortality (key secondary endpoint)","text_display":"\n\n\\subsection*{9.1 All-cause mortality (key secondary endpoint)}","confidence":1,"confidence_rate":1},{"cnt":[[245,2372],[1265,2372],[1265,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2371,"width":1022,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec868e964320467a921149be72023e17","type":"text","conversion_output":true,"text":"Endpoint Definition: Time from randomization until death.","text_display":"\n\nEndpoint Definition: Time from randomization until death.","confidence":1,"confidence_rate":1},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1268aa20f5384f9bb32cbcce46001b9f","type":"page_info","conversion_output":false,"text":"9","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-11","page":11,"lines":[{"cnt":[[245,254],[1798,254],[1798,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1555,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceb9a6427fef45c88ee2769e1b95cbda","type":"text","conversion_output":true,"text":"For subjects who have not met this endpoint (and thus are censored observations), time from","text_display":"\n\nFor subjects who have not met this endpoint (and thus are censored observations), time from","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1646,301],[1646,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1402,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32656b8d5da049569c8b7268e1c2004a","type":"text","conversion_output":true,"text":"randomization until the subject's last follow-up contact will be used in the analysis.","text_display":" randomization until the subject's last follow-up contact will be used in the analysis.","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1785,397],[1785,447],[245,447]],"region":{"top_left_x":244,"top_left_y":397,"width":1542,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f15ab941ab8413eaddded800929f09a","type":"text","conversion_output":true,"text":"Great effort will be made to gather mortality information on every randomized subject. For","text_display":"\n\nGreat effort will be made to gather mortality information on every randomized subject. For","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1824,447],[1824,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1581,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99ed81e2ef814d16a64d42fc71e83c55","type":"text","conversion_output":true,"text":"patients who withdraw consent or are lost to follow-up during the course of the trial, mortality","text_display":" patients who withdraw consent or are lost to follow-up during the course of the trial, mortality","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1835,494],[1835,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1591,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c1001d63ac2465581228609550e4337","type":"text","conversion_output":true,"text":"databases such as the National Death Index, the Social Security Death Index, Ancestry.com, as","text_display":" databases such as the National Death Index, the Social Security Death Index, Ancestry.com, as","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1824,541],[1824,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":1581,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5107ba80eefd490d8d75e4cf4f40cd83","type":"text","conversion_output":true,"text":"well as any other sources of information or national registries, will be consulted in an effort to","text_display":" well as any other sources of information or national registries, will be consulted in an effort to","confidence":1,"confidence_rate":1},{"cnt":[[245,589],[1813,589],[1813,638],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":1570,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e932b61157445758aec16fd437d8336","type":"text","conversion_output":true,"text":"determine whether the subjects have died. Any subject found through one of these sources to","text_display":" determine whether the subjects have died. Any subject found through one of these sources to","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[1738,636],[1738,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1495,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bd73966a718426d94e89a05fbb7e00f","type":"text","conversion_output":true,"text":"have died will be considered to have met this key secondary endpoint even if not enough","text_display":" have died will be considered to have met this key secondary endpoint even if not enough","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1837,683],[1837,735],[245,735]],"region":{"top_left_x":244,"top_left_y":683,"width":1593,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eef4ac1d6673445daeea6ce989a3b077","type":"text","conversion_output":true,"text":"information is available for the CEC to classify the mode of death. Subjects for whom no vital","text_display":" information is available for the CEC to classify the mode of death. Subjects for whom no vital","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1833,730],[1833,780],[245,780]],"region":{"top_left_x":244,"top_left_y":730,"width":1589,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4678a00f90b4e3a9b32e3fb56d75eda","type":"text","conversion_output":true,"text":"status information can be found in these database searches will be censored at the time of their","text_display":" status information can be found in these database searches will be censored at the time of their","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[245,780],[629,780],[629,831],[245,831]],"region":{"top_left_x":244,"top_left_y":779,"width":386,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00f5029f225041038623d33ca714b1b3","type":"text","conversion_output":true,"text":"last follow-up contact.","text_display":" last follow-up contact.","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1846,877],[1846,926],[245,926]],"region":{"top_left_x":244,"top_left_y":876,"width":1602,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c45768718174eee97f243c78a93b7ab","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this key secondary endpoint will use the same methods as","text_display":"\n\nStatistical Methods: The analysis of this key secondary endpoint will use the same methods as","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1751,924],[1751,973],[245,973]],"region":{"top_left_x":244,"top_left_y":923,"width":1507,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27ffef4abf9249db8403e61bd8ea5e75","type":"text","conversion_output":true,"text":"described for the primary endpoint in Section 8. Specifically, the log-rank test will be the","text_display":" described for the primary endpoint in Section 8. Specifically, the log-rank test will be the","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[1880,971],[1880,1023],[245,1023]],"region":{"top_left_x":244,"top_left_y":971,"width":1636,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88dbe2984ce942128e5e3a6fe4767e38","type":"text","conversion_output":true,"text":"primary analytic tool for statistically assessing mortality differences between the two randomized","text_display":" primary analytic tool for statistically assessing mortality differences between the two randomized","confidence":1,"confidence_rate":1},{"cnt":[[245,1021],[1850,1021],[1850,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1020,"width":1606,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b166a60b6594dc29d01af33faafa1d2","type":"text","conversion_output":true,"text":"treatment strategies. A hazard ratio and \\(95 \\%\\) confidence interval summarizing the difference in","text_display":" treatment strategies. A hazard ratio and \\(95 \\%\\) confidence interval summarizing the difference in","confidence":0.99462890625,"confidence_rate":0.9999472016886584},{"cnt":[[245,1068],[1876,1068],[1876,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1067,"width":1632,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d473a86388f414b8fa204f88aa3a62f","type":"text","conversion_output":true,"text":"outcome between the two randomized arms will be computed using the Cox model. The level of","text_display":" outcome between the two randomized arms will be computed using the Cox model. The level of","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[1863,1117],[1863,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1117,"width":1619,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8278a0f625d14166bbd82d761e3fb0f6","type":"text","conversion_output":true,"text":"significance for the assessment of this endpoint will be \\(\\alpha=0.05\\). Also, Kaplan-Meier cumulative","text_display":" significance for the assessment of this endpoint will be \\(\\alpha=0.05\\). Also, Kaplan-Meier cumulative","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1871,1164],[1871,1216],[245,1216]],"region":{"top_left_x":244,"top_left_y":1164,"width":1628,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"574925f14d5d4046b3c602075485066c","type":"text","conversion_output":true,"text":"event rates will be calculated for each randomized arm as a function of time from randomization,","text_display":" event rates will be calculated for each randomized arm as a function of time from randomization,","confidence":1,"confidence_rate":1},{"cnt":[[245,1214],[1369,1214],[1369,1265],[245,1265]],"region":{"top_left_x":244,"top_left_y":1213,"width":1125,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f03ec9afa074879ba87ae1f04a1c475","type":"text","conversion_output":true,"text":"and the estimated event probabilities will be displayed graphically.","text_display":" and the estimated event probabilities will be displayed graphically.","confidence":1,"confidence_rate":1},{"cnt":[[245,1311],[1828,1311],[1828,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1310,"width":1585,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46384222479f493dbd11ad0c37973ba1","type":"text","conversion_output":true,"text":"Supplementary analyses of this secondary endpoint will be performed using the same methods","text_display":"\n\nSupplementary analyses of this secondary endpoint will be performed using the same methods","confidence":1,"confidence_rate":1},{"cnt":[[245,1358],[1085,1358],[1085,1412],[245,1412]],"region":{"top_left_x":244,"top_left_y":1357,"width":841,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60cb83375953418a8092df266ac6a4fe","type":"text","conversion_output":true,"text":"described for the primary endpoint in Section 8.1.","text_display":" described for the primary endpoint in Section 8.1.","confidence":1,"confidence_rate":1},{"cnt":[[236,1446],[1287,1446],[1287,1510],[236,1510]],"region":{"top_left_x":236,"top_left_y":1445,"width":1051,"height":66},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4db7d4f395f749118e6509020503c163","type":"section_header","conversion_output":false,"children_ids":["fee20f5a21514b4ab6b972cafff06fcf"],"text":"","text_display":""},{"cnt":[[245,1452],[1280,1452],[1280,1504],[245,1504]],"region":{"top_left_x":244,"top_left_y":1452,"width":1037,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fee20f5a21514b4ab6b972cafff06fcf","type":"text","conversion_output":true,"parent_id":"4db7d4f395f749118e6509020503c163","text":"9.2 All-cause Mortality or Cardiovascular Hospitalization","text_display":"\n\n\\subsection*{9.2 All-cause Mortality or Cardiovascular Hospitalization}","confidence":1,"confidence_rate":1},{"cnt":[[245,1549],[1863,1549],[1863,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1549,"width":1619,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bd48497ca644acf86c78a8e94c0473f","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the first event in this composite endpoint (i.e.,","text_display":"\n\nEndpoint definition: Time from randomization to the first event in this composite endpoint (i.e.,","confidence":0.93701171875,"confidence_rate":0.9993623652367609},{"cnt":[[245,1598],[1796,1598],[1796,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1598,"width":1553,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7563a41ccbf742329d60b2048537b0b5","type":"text","conversion_output":true,"text":"time from randomization to either death or the subject's first cardiovascular hospitalization).","text_display":" time from randomization to either death or the subject's first cardiovascular hospitalization).","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,1693],[1865,1693],[1865,1742],[245,1742]],"region":{"top_left_x":244,"top_left_y":1692,"width":1621,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17b3c06a1ab4497fa4badb9508cce07e","type":"text","conversion_output":true,"text":"For subjects who have not experienced either component of this endpoint (i.e., who are censored","text_display":"\n\nFor subjects who have not experienced either component of this endpoint (i.e., who are censored","confidence":0.99072265625,"confidence_rate":0.9999067978802516},{"cnt":[[245,1740],[1852,1740],[1852,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1740,"width":1608,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"796ebdf8b783450fbe2f7d749fa4061a","type":"text","conversion_output":true,"text":"observations), time from randomization until the subject's last follow-up contact will be used in","text_display":" observations), time from randomization until the subject's last follow-up contact will be used in","confidence":1,"confidence_rate":1},{"cnt":[[245,1788],[458,1788],[458,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1787,"width":214,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9de53961e38a4c23b665da52014ff355","type":"text","conversion_output":true,"text":"the analysis.","text_display":" the analysis.","confidence":1,"confidence_rate":1},{"cnt":[[245,1886],[1837,1886],[1837,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1886,"width":1593,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32ca6258826747fd9e4dab9e2fa3dbbf","type":"text","conversion_output":true,"text":"The cause of hospitalization will be based on the site-reported data in the CABANA electronic","text_display":"\n\nThe cause of hospitalization will be based on the site-reported data in the CABANA electronic","confidence":1,"confidence_rate":1},{"cnt":[[245,1934],[1841,1934],[1841,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1933,"width":1598,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd77f4dac09d4e0eb8e599a5a7bf01f5","type":"text","conversion_output":true,"text":"data capture (EDC) system. For this endpoint, cardiovascular hospitalization will not include a","text_display":" data capture (EDC) system. For this endpoint, cardiovascular hospitalization will not include a","confidence":1,"confidence_rate":1},{"cnt":[[245,1981],[1858,1981],[1858,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1980,"width":1615,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d6c00e037044926b07c537522692bd8","type":"text","conversion_output":true,"text":"hospitalization to initiate therapy. For example, among patients randomized to the ablation arm,","text_display":" hospitalization to initiate therapy. For example, among patients randomized to the ablation arm,","confidence":1,"confidence_rate":1},{"cnt":[[245,2028],[1760,2028],[1760,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2028,"width":1516,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66db316083b940fc933b4003613978df","type":"text","conversion_output":true,"text":"the hospitalization to perform the ablation will not be counted for this secondary endpoint.","text_display":" the hospitalization to perform the ablation will not be counted for this secondary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1807,2075],[1807,2127],[245,2127]],"region":{"top_left_x":244,"top_left_y":2075,"width":1563,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83b055ee49b840369111d924f0252ec8","type":"text","conversion_output":true,"text":"Similarly, if a patient randomized to the drug arm is hospitalized to monitor the patient while","text_display":" Similarly, if a patient randomized to the drug arm is hospitalized to monitor the patient while","confidence":1,"confidence_rate":1},{"cnt":[[245,2127],[1622,2127],[1622,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2126,"width":1379,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d2d28bd400440d5aaf2ea88bdfa2178","type":"text","conversion_output":true,"text":"loading the initial drug therapy, that hospitalization will not be counted. All other","text_display":" loading the initial drug therapy, that hospitalization will not be counted. All other","confidence":1,"confidence_rate":1},{"cnt":[[245,2172],[1835,2172],[1835,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2172,"width":1591,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f82a2d4a0b249ff84da010f4ea6d2be","type":"text","conversion_output":true,"text":"hospitalizations designated by the clinical site as cardiovascular will be counted, including the","text_display":" hospitalizations designated by the clinical site as cardiovascular will be counted, including the","confidence":1,"confidence_rate":1},{"cnt":[[245,2219],[1854,2219],[1854,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2219,"width":1611,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65851ca8b2ad44eb877e7471a2665e36","type":"text","conversion_output":true,"text":"hospitalization of a patient randomized to the drug arm who is hospitalized for a therapy change","text_display":" hospitalization of a patient randomized to the drug arm who is hospitalized for a therapy change","confidence":1,"confidence_rate":1},{"cnt":[[245,2269],[1826,2269],[1826,2318],[245,2318]],"region":{"top_left_x":244,"top_left_y":2268,"width":1583,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e5366c283f14e08ba063dd3ac8db5ac","type":"text","conversion_output":true,"text":"(either a change to a different drug therapy or for crossing over to ablation). Hospitalization to","text_display":" (either a change to a different drug therapy or for crossing over to ablation). Hospitalization to","confidence":1,"confidence_rate":1},{"cnt":[[245,2316],[1867,2316],[1867,2368],[245,2368]],"region":{"top_left_x":244,"top_left_y":2316,"width":1623,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"082e134304da4bdc926d287cbc7c4ec6","type":"text","conversion_output":true,"text":"perform second or subsequent ablation procedures will be counted as a CV hospitalization event.","text_display":" perform second or subsequent ablation procedures will be counted as a CV hospitalization event.","confidence":0.9833984375,"confidence_rate":0.9998326048833174},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5d3a76509114363a4b0ed218710c486","type":"page_info","conversion_output":false,"text":"10","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-12","page":12,"lines":[{"cnt":[[245,254],[1775,254],[1775,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1531,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3b27a9b02d046d2b330f91c3f342205","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this secondary endpoint will use the same methods as","text_display":"\n\nStatistical Methods: The analysis of this secondary endpoint will use the same methods as","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1841,301],[1841,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1598,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef2911848e454f7cb13181388b20db4e","type":"text","conversion_output":true,"text":"described for the primary endpoint and key secondary endpoint in sections 8 and 9.1, including","text_display":" described for the primary endpoint and key secondary endpoint in sections 8 and 9.1, including","confidence":0.99658203125,"confidence_rate":0.999966433667778},{"cnt":[[245,348],[1751,348],[1751,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1507,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c971bd080cac4912bdf29953b8b250eb","type":"text","conversion_output":true,"text":"statistical testing using the log-rank test, calculation of a hazard ratio and \\(95 \\%\\) confidence","text_display":" statistical testing using the log-rank test, calculation of a hazard ratio and \\(95 \\%\\) confidence","confidence":0.9931640625,"confidence_rate":0.9999320873601193},{"cnt":[[245,397],[1867,397],[1867,445],[245,445]],"region":{"top_left_x":244,"top_left_y":397,"width":1623,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e28c6fa2a7843c1a7d14b4127516845","type":"text","conversion_output":true,"text":"interval using the Cox model, and Kaplan-Meier cumulative event rate calculations. The level of","text_display":" interval using the Cox model, and Kaplan-Meier cumulative event rate calculations. The level of","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,447],[1311,447],[1311,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1067,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36d627dd0bd34ec9903ea7e0e996ee7e","type":"text","conversion_output":true,"text":"significance for the assessment of this endpoint will be \\(\\alpha=0.05\\).","text_display":" significance for the assessment of this endpoint will be \\(\\alpha=0.05\\).","confidence":1,"confidence_rate":1},{"cnt":[[241,539],[1871,539],[1871,640],[241,640]],"region":{"top_left_x":240,"top_left_y":539,"width":1632,"height":102},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5ba4036fa614965988b847fc88dae4e","type":"section_header","conversion_output":false,"children_ids":["8833c1e7eec54644987a6aec4a5aa7bf","4ad1a43108674ab0a418584257ba3bb1"],"text":"","text_display":""},{"cnt":[[245,546],[1867,546],[1867,593],[245,593]],"region":{"top_left_x":244,"top_left_y":545,"width":1623,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8833c1e7eec54644987a6aec4a5aa7bf","type":"text","conversion_output":true,"parent_id":"b5ba4036fa614965988b847fc88dae4e","text":"9.3 All-cause Mortality, Stroke, or Hospitalization for Heart Failure or an Acute Ischemic","text_display":"\n\n\\subsection*{9.3 All-cause Mortality, Stroke, or Hospitalization for Heart Failure or an Acute Ischemic","confidence":1,"confidence_rate":1},{"cnt":[[245,593],[359,593],[359,634],[245,634]],"region":{"top_left_x":244,"top_left_y":592,"width":115,"height":42},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ad1a43108674ab0a418584257ba3bb1","type":"text","conversion_output":true,"parent_id":"b5ba4036fa614965988b847fc88dae4e","text":"Event","text_display":" Event}","confidence":1,"confidence_rate":1},{"cnt":[[245,688],[1785,688],[1785,737],[245,737]],"region":{"top_left_x":244,"top_left_y":687,"width":1542,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f1970f6452e4c65bca38abdb2d8b1c5","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the first event in this composite endpoint.","text_display":"\n\nEndpoint definition: Time from randomization to the first event in this composite endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[1687,782],[1687,831],[245,831]],"region":{"top_left_x":244,"top_left_y":782,"width":1443,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c01429f589b74269981d948315d64d1a","type":"text","conversion_output":true,"text":"For subjects who have not experienced any component of this endpoint (i.e., censored","text_display":"\nFor subjects who have not experienced any component of this endpoint (i.e., censored","confidence":0.998046875,"confidence_rate":0.9999780335577174},{"cnt":[[245,829],[1850,829],[1850,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":1606,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a911de5d673a4ad3b2e5a7ba899a7535","type":"text","conversion_output":true,"text":"observations), time from randomization until the subject's last follow-up contact will be used in","text_display":" observations), time from randomization until the subject's last follow-up contact will be used in","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,879],[1871,879],[1871,930],[245,930]],"region":{"top_left_x":244,"top_left_y":878,"width":1628,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0078d5056b643139514abc22092e908","type":"text","conversion_output":true,"text":"the analysis. The stroke component of this endpoint is defined the same as the stroke component","text_display":" the analysis. The stroke component of this endpoint is defined the same as the stroke component","confidence":1,"confidence_rate":1},{"cnt":[[245,928],[1848,928],[1848,978],[245,978]],"region":{"top_left_x":244,"top_left_y":928,"width":1604,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"daad5d9c80104d189a4451df19ffa98c","type":"text","conversion_output":true,"text":"of the primary endpoint, namely as a disabling stroke characterized by a Rankin Scale \\(\\geq 2\\). The","text_display":" of the primary endpoint, namely as a disabling stroke characterized by a Rankin Scale \\(\\geq 2\\). The","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1843,975],[1843,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1600,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0910e7e58117470581aad9929e1dbe62","type":"text","conversion_output":true,"text":"cause of hospitalization will be based on the site-reported data in the CABANA electronic data","text_display":" cause of hospitalization will be based on the site-reported data in the CABANA electronic data","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[634,1023],[634,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":390,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"370e5d0337c146819d057631fa7a8578","type":"text","conversion_output":true,"text":"capture (EDC) system.","text_display":" capture (EDC) system.","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[1772,1117],[1772,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":1529,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62854f1dc4024865844959211992dc31","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this secondary endpoint will use the same methods as","text_display":"\n\nStatistical Methods: The analysis of this secondary endpoint will use the same methods as","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1858,1164],[1858,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1615,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d541a0bf48b84e7082533ce0231e3763","type":"text","conversion_output":true,"text":"described for the primary endpoint and secondary endpoints in the sections above, including use","text_display":" described for the primary endpoint and secondary endpoints in the sections above, including use","confidence":1,"confidence_rate":1},{"cnt":[[245,1214],[1824,1214],[1824,1263],[245,1263]],"region":{"top_left_x":244,"top_left_y":1213,"width":1581,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5baf3cd904024ee7afa50f340cbf3258","type":"text","conversion_output":true,"text":"of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval calculated using the Cox model,","text_display":" of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval calculated using the Cox model,","confidence":0.96533203125,"confidence_rate":0.9996541464584943},{"cnt":[[245,1263],[1691,1263],[1691,1311],[245,1311]],"region":{"top_left_x":244,"top_left_y":1263,"width":1447,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9576839125a94c8cafde1f4dc93bb283","type":"text","conversion_output":true,"text":"and Kaplan-Meier cumulative event rate calculations. The level of significance for the","text_display":" and Kaplan-Meier cumulative event rate calculations. The level of significance for the","confidence":1,"confidence_rate":1},{"cnt":[[245,1315],[1055,1315],[1055,1362],[245,1362]],"region":{"top_left_x":244,"top_left_y":1314,"width":811,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89b0200eeab74b5695f52601f3ccfc9c","type":"text","conversion_output":true,"text":"assessment of this endpoint will also be \\(\\alpha=0.05\\).","text_display":" assessment of this endpoint will also be \\(\\alpha=0.05\\).","confidence":0.99853515625,"confidence_rate":0.9999742824766222},{"cnt":[[245,1409],[1708,1409],[1708,1459],[245,1459]],"region":{"top_left_x":244,"top_left_y":1409,"width":1465,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65508c7e656d4154956357ecc5a81349","type":"text","conversion_output":true,"text":"This endpoint is similar to the first co-primary endpoint of the Early treatment of Atrial","text_display":"\n\nThis endpoint is similar to the first co-primary endpoint of the Early treatment of Atrial","confidence":1,"confidence_rate":1},{"cnt":[[245,1452],[1693,1452],[1693,1506],[245,1506]],"region":{"top_left_x":244,"top_left_y":1452,"width":1449,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4afcf17ec4ea44e8919b56db2c59d831","type":"text","conversion_output":true,"text":"fibrillation for Stroke prevention Trial (EAST) \\({ }^{4}\\) with the exception that EAST is using","text_display":" fibrillation for Stroke prevention Trial (EAST) \\({ }^{4}\\) with the exception that EAST is using","confidence":1,"confidence_rate":1},{"cnt":[[245,1506],[1841,1506],[1841,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1506,"width":1598,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76f7c57b59e0460aae0ce4965c956e9d","type":"text","conversion_output":true,"text":"cardiovascular mortality rather than all-cause mortality as the death component of the endpoint","text_display":" cardiovascular mortality rather than all-cause mortality as the death component of the endpoint","confidence":1,"confidence_rate":1},{"cnt":[[245,1553],[1858,1553],[1858,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1553,"width":1615,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7f51ec1b9194f81a2e990fa9616f2f9","type":"text","conversion_output":true,"text":"and also a different definition of stroke (any stroke rather than a disabling stroke). Therefore, to","text_display":" and also a different definition of stroke (any stroke rather than a disabling stroke). Therefore, to","confidence":1,"confidence_rate":1},{"cnt":[[245,1603],[1854,1603],[1854,1650],[245,1650]],"region":{"top_left_x":244,"top_left_y":1602,"width":1611,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0faee975e620497c89e6d7a3ba943e7c","type":"text","conversion_output":true,"text":"provide results that can be compared to those of EAST, supplemental comparative analyses will","text_display":" provide results that can be compared to those of EAST, supplemental comparative analyses will","confidence":1,"confidence_rate":1},{"cnt":[[245,1650],[1858,1650],[1858,1697],[245,1697]],"region":{"top_left_x":244,"top_left_y":1650,"width":1615,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b2e73455d7d429c82db25bf7c2fd9a6","type":"text","conversion_output":true,"text":"be performed using cardiovascular mortality in this endpoint rather than all-cause mortality, and","text_display":" be performed using cardiovascular mortality in this endpoint rather than all-cause mortality, and","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1697],[1850,1697],[1850,1745],[245,1745]],"region":{"top_left_x":244,"top_left_y":1697,"width":1606,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9f251f04ff844f9bc736dcfb7ccc16b","type":"text","conversion_output":true,"text":"a definition of stroke that corresponds to the EAST definition. The statistical methods for these","text_display":" a definition of stroke that corresponds to the EAST definition. The statistical methods for these","confidence":1,"confidence_rate":1},{"cnt":[[245,1745],[1876,1745],[1876,1794],[245,1794]],"region":{"top_left_x":244,"top_left_y":1744,"width":1632,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cef7595b410c4817aae735f8620dfdb3","type":"text","conversion_output":true,"text":"analyses will employ the competing risk methodology described in the next section for analyzing","text_display":" analyses will employ the competing risk methodology described in the next section for analyzing","confidence":1,"confidence_rate":1},{"cnt":[[245,1792],[1809,1792],[1809,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1791,"width":1565,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fbabffbc4794eb7aedce757ec35d4c2","type":"text","conversion_output":true,"text":"cardiovascular death, as well as the approach described in the preceding paragraph where all-","text_display":" cardiovascular death, as well as the approach described in the preceding paragraph where all","confidence":1,"confidence_rate":1},{"cnt":[[245,1841],[1044,1841],[1044,1888],[245,1888]],"region":{"top_left_x":244,"top_left_y":1841,"width":801,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d45b2d82a5604ea89e8010ebba4fbc84","type":"text","conversion_output":true,"text":"cause mortality is a component of the endpoint.","text_display":"cause mortality is a component of the endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[243,1934],[724,1934],[724,1983],[243,1983]],"region":{"top_left_x":242,"top_left_y":1933,"width":483,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18f8ed22ed824bbb9ac34dda846b4b49","type":"section_header","conversion_output":false,"children_ids":["b769be93b247499791e84c4b65f2a1d5"],"text":"","text_display":""},{"cnt":[[245,1938],[720,1938],[720,1979],[245,1979]],"region":{"top_left_x":244,"top_left_y":1937,"width":476,"height":42},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b769be93b247499791e84c4b65f2a1d5","type":"text","conversion_output":true,"parent_id":"18f8ed22ed824bbb9ac34dda846b4b49","text":"9.4 Cardiovascular Death","text_display":"\n\n\\subsection*{9.4 Cardiovascular Death}","confidence":1,"confidence_rate":1},{"cnt":[[245,2032],[1876,2032],[1876,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2032,"width":1632,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0cb85ce17774908b5bd2fff6be5e71a","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the occurrence of a cardiovascular (CV) death.","text_display":"\n\nEndpoint definition: Time from randomization to the occurrence of a cardiovascular (CV) death.","confidence":1,"confidence_rate":1},{"cnt":[[245,2127],[1871,2127],[1871,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2126,"width":1628,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dba98625396e4dbb89494b1a7fbf8a44","type":"text","conversion_output":true,"text":"Patient deaths will be classified by the Clinical Events Committee (CEC) as to whether the mode","text_display":"\nPatient deaths will be classified by the Clinical Events Committee (CEC) as to whether the mode","confidence":0.9990236759185791,"confidence_rate":0.9999902320377446},{"cnt":[[245,2176],[1846,2176],[1846,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2176,"width":1602,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81c489ca507941dd8579d4f9b9f3b23a","type":"text","conversion_output":true,"text":"of death was due to a cardiovascular (CV) cause. If insufficient source documents are obtained","text_display":" of death was due to a cardiovascular (CV) cause. If insufficient source documents are obtained","confidence":1,"confidence_rate":1},{"cnt":[[245,2224],[1807,2224],[1807,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2223,"width":1563,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3505e6cae9724255a00715e5a2260e4e","type":"text","conversion_output":true,"text":"to allow CEC adjudication of the cause of death, and the CEC classifies the cause of death as","text_display":" to allow CEC adjudication of the cause of death, and the CEC classifies the cause of death as","confidence":1,"confidence_rate":1},{"cnt":[[245,2320],[245,2271],[1820,2273],[1820,2322]],"region":{"top_left_x":244,"top_left_y":2270,"width":1576,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d60c2ff5a98479dbc13908b1e799b52","type":"text","conversion_output":true,"text":"\"unknown,\" then the site-reported cause of death (if available) will be used. If neither the site","text_display":" \"unknown,\" then the site-reported cause of death (if available) will be used. 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As supplemental analyses, however, this endpoint will also be","text_display":" as a cardiovascular death. 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This methodology, rather than treating non-cardiovascular death as a","text_display":" a competing risk. 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The features of the Fine-Gray approach for handling","text_display":" event of interest (cardiovascular death). The features of the Fine-Gray approach for handling","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1796,683],[1796,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1553,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8edc3fd63ba4ecdb0a0c1df350cd49f","type":"text","conversion_output":true,"text":"competing risks data are available as part of the PHREG procedure in SAS. The cumulative","text_display":" competing risks data are available as part of the PHREG procedure in SAS. The cumulative","confidence":0.99755859375,"confidence_rate":0.9999737165675469},{"cnt":[[245,730],[1809,730],[1809,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1565,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e5f6b9ff0a340879a94612fba2f01c1","type":"text","conversion_output":true,"text":"incidence function for the two arms will be estimated, statistically compared, and graphically","text_display":" incidence function for the two arms will be estimated, statistically compared, and graphically","confidence":1,"confidence_rate":1},{"cnt":[[245,780],[1796,780],[1796,829],[245,829]],"region":{"top_left_x":244,"top_left_y":779,"width":1553,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5124ec001f59407ab23bf4ad8da5e60d","type":"text","conversion_output":true,"text":"presented using the PHREG software features in SAS. For subjects who have not died, time","text_display":" presented using the PHREG software features in SAS. For subjects who have not died, time","confidence":1,"confidence_rate":1},{"cnt":[[245,827],[1824,827],[1824,879],[245,879]],"region":{"top_left_x":244,"top_left_y":827,"width":1581,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3f0f90f0baf460293a61eddc27807ae","type":"text","conversion_output":true,"text":"from randomization until the subject's last follow-up contact will be used in the analysis. The","text_display":" from randomization until the subject's last follow-up contact will be used in the analysis. The","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1446,877],[1446,930],[245,930]],"region":{"top_left_x":244,"top_left_y":876,"width":1202,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c529e0f497e54273935b91435c78503a","type":"text","conversion_output":true,"text":"level of significance for the assessment of this endpoint will be \\(\\alpha=0.05\\).","text_display":" level of significance for the assessment of this endpoint will be \\(\\alpha=0.05\\).","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1794,975],[1794,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1550,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"547791ee89e4446684e6aabf243a8630","type":"text","conversion_output":true,"text":"Additional analysis of this secondary endpoint will be performed using the same methods as","text_display":"\n\nAdditional analysis of this secondary endpoint will be performed using the same methods as","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[1858,1023],[1858,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":1615,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33783b57969d4e7da5eb260b1d5dd1cb","type":"text","conversion_output":true,"text":"described for the primary endpoint and secondary endpoints in the sections above, including use","text_display":" described for the primary endpoint and secondary endpoints in the sections above, including use","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1815,1070],[1815,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1069,"width":1572,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"112f671e32fc4e07bc72e716e220a5cc","type":"text","conversion_output":true,"text":"of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval generated using the Cox model,","text_display":" of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval generated using the Cox model,","confidence":0.96826171875,"confidence_rate":0.9996807157579113},{"cnt":[[245,1117],[1876,1117],[1876,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":1632,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"705a7f8fdf3c4d288d5ac0e16b58bfd3","type":"text","conversion_output":true,"text":"and Kaplan-Meier cumulative event rate calculations. Patients who have died but whose cause of","text_display":" and Kaplan-Meier cumulative event rate calculations. Patients who have died but whose cause of","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1878,1164],[1878,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1634,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44749a8f53e740868fd84f961a6733b4","type":"text","conversion_output":true,"text":"death is classified by the CEC as non-cardiovascular will be censored at the time of their non-CV","text_display":" death is classified by the CEC as non-cardiovascular will be censored at the time of their non-CV","confidence":0.9941432476043701,"confidence_rate":0.9999424137127548},{"cnt":[[245,1214],[1837,1214],[1837,1263],[245,1263]],"region":{"top_left_x":244,"top_left_y":1213,"width":1593,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c8e658b0fec4fb79959465f383f1e50","type":"text","conversion_output":true,"text":"death. The number of such patients is expected to be relatively small in this study. The results","text_display":" death. The number of such patients is expected to be relatively small in this study. The results","confidence":1,"confidence_rate":1},{"cnt":[[245,1261],[1792,1261],[1792,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1261,"width":1548,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bb3769ed39a4ab28a1cda146b4fe625","type":"text","conversion_output":true,"text":"of these two different approaches will be carefully examined and synthesized into an overall","text_display":" of these two different approaches will be carefully examined and synthesized into an overall","confidence":1,"confidence_rate":1},{"cnt":[[245,1311],[1319,1311],[1319,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1310,"width":1076,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe6dfed6859b4247bb55311a7dfc827f","type":"text","conversion_output":true,"text":"interpretation of treatment differences with respect to CV death.","text_display":" interpretation of treatment differences with respect to CV death.","confidence":1,"confidence_rate":1},{"cnt":[[236,1401],[1072,1401],[1072,1463],[236,1463]],"region":{"top_left_x":236,"top_left_y":1400,"width":837,"height":64},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d810fa0c116f4fc4ac94594d910d4985","type":"section_header","conversion_output":false,"children_ids":["4f3aa40578ee479e9fca5a1c2b4381ae"],"text":"","text_display":""},{"cnt":[[245,1405],[1068,1405],[1068,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1405,"width":824,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f3aa40578ee479e9fca5a1c2b4381ae","type":"text","conversion_output":true,"parent_id":"d810fa0c116f4fc4ac94594d910d4985","text":"9.5 Cardiovascular Death or Disabling Stroke","text_display":"\n\n\\subsection*{9.5 Cardiovascular Death or Disabling Stroke}","confidence":1,"confidence_rate":1},{"cnt":[[245,1493],[1785,1493],[1785,1543],[245,1543]],"region":{"top_left_x":244,"top_left_y":1493,"width":1542,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2050a2ce4244d96aba649d074bc23d0","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the occurrence of either a cardiovascular","text_display":"\n\nEndpoint definition: Time from randomization to the occurrence of either a cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[245,1543],[675,1543],[675,1592],[245,1592]],"region":{"top_left_x":244,"top_left_y":1542,"width":431,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fc0723688af477587c4bb3c55b98b0c","type":"text","conversion_output":true,"text":"death or disabling stroke.","text_display":" death or disabling stroke.","confidence":1,"confidence_rate":1},{"cnt":[[245,1637],[1818,1637],[1818,1687],[245,1687]],"region":{"top_left_x":244,"top_left_y":1637,"width":1574,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86042f7b6dcf439ab47430246f117e94","type":"text","conversion_output":true,"text":"All potential strokes will be carefully reviewed and classified as disabling by the neurological","text_display":"\n\nAll potential strokes will be carefully reviewed and classified as disabling by the neurological","confidence":1,"confidence_rate":1},{"cnt":[[245,1684],[1800,1684],[1800,1734],[245,1734]],"region":{"top_left_x":244,"top_left_y":1684,"width":1557,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33bbdb36b5234a10b52ac4707e5e9f93","type":"text","conversion_output":true,"text":"events committee using the Rankin Stroke Scale as described in Section 8. The neurological","text_display":" events committee using the Rankin Stroke Scale as described in Section 8. The neurological","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1803,1732],[1803,1781],[245,1781]],"region":{"top_left_x":244,"top_left_y":1731,"width":1559,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"574d5820a88a4781bd9d981798277e54","type":"text","conversion_output":true,"text":"committee that reviews and adjudicates the strokes is an important part of the overall clinical","text_display":" committee that reviews and adjudicates the strokes is an important part of the overall clinical","confidence":0.9990236759185791,"confidence_rate":0.9999902320377446},{"cnt":[[245,1779],[1867,1779],[1867,1830],[245,1830]],"region":{"top_left_x":244,"top_left_y":1778,"width":1623,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c39059620f5441b9054929ee4d3da82","type":"text","conversion_output":true,"text":"events adjudication process. A disabling stroke will be defined as a stroke whose severity on the","text_display":" events adjudication process. A disabling stroke will be defined as a stroke whose severity on the","confidence":1,"confidence_rate":1},{"cnt":[[245,1828],[1846,1828],[1846,1876],[245,1876]],"region":{"top_left_x":244,"top_left_y":1828,"width":1602,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa61613343bf4253b540b485073e4632","type":"text","conversion_output":true,"text":"Rankin Scale is \\(\\geq 2\\). Cardiovascular deaths will be classified as described in Section 9.4 above.","text_display":" Rankin Scale is \\(\\geq 2\\). Cardiovascular deaths will be classified as described in Section 9.4 above.","confidence":1,"confidence_rate":1},{"cnt":[[245,1925],[1833,1925],[1833,1974],[245,1974]],"region":{"top_left_x":244,"top_left_y":1925,"width":1589,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df1bd5d60a334aefacf9103b2abf1d77","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this secondary endpoint will also use the competing risks","text_display":"\n\nStatistical Methods: The analysis of this secondary endpoint will also use the competing risks","confidence":1,"confidence_rate":1},{"cnt":[[245,1968],[1863,1968],[1863,2022],[245,2022]],"region":{"top_left_x":244,"top_left_y":1967,"width":1619,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f303f6ef25f9486889576bab9050392d","type":"text","conversion_output":true,"text":"methodology of Fine and Gray \\({ }^{5}\\) described in Section 9.4 for the secondary endpoint of CV death","text_display":" methodology of Fine and Gray \\({ }^{5}\\) described in Section 9.4 for the secondary endpoint of CV death","confidence":1,"confidence_rate":1},{"cnt":[[245,2020],[1813,2020],[1813,2069],[245,2069]],"region":{"top_left_x":244,"top_left_y":2019,"width":1570,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67311535a7604e02bda596d8f8c37243","type":"text","conversion_output":true,"text":"where death due to a non-cardiovascular cause is considered as a competing risk rather than a","text_display":" where death due to a non-cardiovascular cause is considered as a competing risk rather than a","confidence":1,"confidence_rate":1},{"cnt":[[245,2067],[1760,2067],[1760,2116],[245,2116]],"region":{"top_left_x":244,"top_left_y":2066,"width":1516,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ed2292fcf2f41978df3ecff864c28ea","type":"text","conversion_output":true,"text":"censoring event. The analysis will make use of the cumulative incidence function, and (as","text_display":" censoring event. The analysis will make use of the cumulative incidence function, and (as","confidence":1,"confidence_rate":1},{"cnt":[[245,2116],[1865,2116],[1865,2168],[245,2168]],"region":{"top_left_x":244,"top_left_y":2116,"width":1621,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1f272535ecc4327b11ac06b95b69e38","type":"text","conversion_output":true,"text":"described in Section 9.4) will be performed within the proportional hazards framework using the","text_display":" described in Section 9.4) will be performed within the proportional hazards framework using the","confidence":1,"confidence_rate":1},{"cnt":[[245,2166],[1865,2166],[1865,2215],[245,2215]],"region":{"top_left_x":244,"top_left_y":2165,"width":1621,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"768cf4749e004a639267c7d0778aab9f","type":"text","conversion_output":true,"text":"marginal failure sub-distribution associated with the event of interest. The cumulative incidence","text_display":" marginal failure sub-distribution associated with the event of interest. 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For subjects who have not died, time from randomization","text_display":" using the PHREG procedure in SAS. For subjects who have not died, time from randomization","confidence":1,"confidence_rate":1},{"cnt":[[245,2307],[1830,2307],[1830,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2307,"width":1587,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eefe14c9b4504bea87975ca81dff0e6b","type":"text","conversion_output":true,"text":"until the subject's last follow-up contact will be used in the analysis. The level of significance","text_display":" until the subject's last follow-up contact will be used in the analysis. The level of significance","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,2359],[1098,2359],[1098,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2358,"width":854,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8932dd6d96bf429783867dfadc5a0c65","type":"text","conversion_output":true,"text":"for the assessment of this endpoint will be \\(\\alpha=0.05\\).","text_display":" for the assessment of this endpoint will be \\(\\alpha=0.05\\).","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[1040,2548],[1089,2548],[1089,2593],[1040,2593]],"region":{"top_left_x":1039,"top_left_y":2548,"width":51,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8817cfa1bc2a4b1a82f67d60d5ee9a1e","type":"page_info","conversion_output":false,"text":"12","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-14","page":14,"lines":[{"cnt":[[245,254],[1732,254],[1732,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1488,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60478a49593d4bbe8731dfe03983cb0c","type":"text","conversion_output":true,"text":"As in the case of the cardiovascular death endpoint, additional analysis of this secondary","text_display":"\n\nAs in the case of the cardiovascular death endpoint, additional analysis of this secondary","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1798,301],[1798,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1555,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc4501b7a7044a1b8d54c886daf66cfa","type":"text","conversion_output":true,"text":"endpoint will be performed using the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval","text_display":" endpoint will be performed using the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[245,348],[1830,348],[1830,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1587,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b51b792db89741bc98b8f61c6eba9f50","type":"text","conversion_output":true,"text":"generated using the Cox model, and Kaplan-Meier cumulative event rate calculations. Patients","text_display":" generated using the Cox model, and Kaplan-Meier cumulative event rate calculations. Patients","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1837,397],[1837,445],[245,445]],"region":{"top_left_x":244,"top_left_y":397,"width":1593,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5c0601340b34a12917934509091dec1","type":"text","conversion_output":true,"text":"who have died but whose cause of death is classified by the CEC as non-cardiovascular will be","text_display":" who have died but whose cause of death is classified by the CEC as non-cardiovascular will be","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,443],[1811,443],[1811,494],[245,494]],"region":{"top_left_x":244,"top_left_y":442,"width":1568,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28563490af654bcbb1844fbd44df316e","type":"text","conversion_output":true,"text":"censored at the time of their non-CV death. Results of these two different approaches will be","text_display":" censored at the time of their non-CV death. Results of these two different approaches will be","confidence":1,"confidence_rate":1},{"cnt":[[245,492],[1833,492],[1833,541],[245,541]],"region":{"top_left_x":244,"top_left_y":491,"width":1589,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7eec73a3e5b447dcb6830581899202b5","type":"text","conversion_output":true,"text":"carefully compared and synthesized into an overall interpretation of treatment differences with","text_display":" carefully compared and synthesized into an overall interpretation of treatment differences with","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1177,541],[1177,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":934,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fd58aa8ea354f73bd06d32c81988d3c","type":"text","conversion_output":true,"text":"respect to the endpoint of CV death or disabling stroke.","text_display":" respect to the endpoint of CV death or disabling stroke.","confidence":1,"confidence_rate":1},{"cnt":[[236,632],[995,632],[995,692],[236,692]],"region":{"top_left_x":236,"top_left_y":631,"width":759,"height":61},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dfb30c6adde4d34922ad1b8222ed271","type":"section_header","conversion_output":false,"children_ids":["2a02ffe32acc4b71ac427f72bd337dcc"],"text":"","text_display":""},{"cnt":[[245,636],[986,636],[986,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":743,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a02ffe32acc4b71ac427f72bd337dcc","type":"text","conversion_output":true,"parent_id":"2dfb30c6adde4d34922ad1b8222ed271","text":"9.6 Arrhythmic Death or Cardiac Arrest","text_display":"\n\n\\subsection*{9.6 Arrhythmic Death or Cardiac Arrest}","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1846,730],[1846,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1602,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"978cf7d826064b5294472de946e7242f","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the occurrence of either an arrhythmic death","text_display":"\n\nEndpoint definition: Time from randomization to the occurrence of either an arrhythmic death","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[531,782],[531,823],[245,823]],"region":{"top_left_x":244,"top_left_y":782,"width":287,"height":41},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36c3f05ae8434fe1a043c0f223efcb5b","type":"text","conversion_output":true,"text":"or cardiac arrest.","text_display":" or cardiac arrest.","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1841,877],[1841,926],[245,926]],"region":{"top_left_x":244,"top_left_y":876,"width":1598,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33e9a77fb0fd45c5b226bdb841b88418","type":"text","conversion_output":true,"text":"Since cardiac arrest is a component of the primary endpoint, all potential cardiac arrests will be","text_display":"\n\nSince cardiac arrest is a component of the primary endpoint, all potential cardiac arrests will be","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1850,924],[1850,973],[245,973]],"region":{"top_left_x":244,"top_left_y":923,"width":1606,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"445fd11e3d5742a696a43f8b15f6fab6","type":"text","conversion_output":true,"text":"reviewed and adjudicated by the Clinical Endpoints Committee. As described earlier, the mode","text_display":" reviewed and adjudicated by the Clinical Endpoints Committee. As described earlier, the mode","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[1313,971],[1313,1021],[245,1021]],"region":{"top_left_x":244,"top_left_y":971,"width":1069,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df5aa4b789a144899344a81c320bc687","type":"text","conversion_output":true,"text":"of death is also classified by the Clinical Endpoints Committee.","text_display":" of death is also classified by the Clinical Endpoints Committee.","confidence":0.99951171875,"confidence_rate":0.9999929217569623},{"cnt":[[245,1066],[1880,1066],[1880,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1065,"width":1636,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc370694c004469797a7f5e95a7e4653","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this secondary endpoint will proceed in much the same way","text_display":"\n\nStatistical Methods: The analysis of this secondary endpoint will proceed in much the same way","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1854,1113],[1854,1164],[245,1164]],"region":{"top_left_x":244,"top_left_y":1112,"width":1611,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60faf16fec1649969a87d2438d64d679","type":"text","conversion_output":true,"text":"as described above for the endpoint of CV death or disabling stroke and use the competing risks","text_display":" as described above for the endpoint of CV death or disabling stroke and use the competing risks","confidence":1,"confidence_rate":1},{"cnt":[[245,1158],[1828,1158],[1828,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1158,"width":1585,"height":56},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf55b69075d24f45ad0289552ad03c74","type":"text","conversion_output":true,"text":"methodology of Fine and Gray \\({ }^{5}\\) described in previous sections. In this analysis, death due to a","text_display":" methodology of Fine and Gray \\({ }^{5}\\) described in previous sections. In this analysis, death due to a","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1867,1212],[1867,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1623,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8046be6c2393427b9a59cbd76daed73a","type":"text","conversion_output":true,"text":"cause other than arrhythmic is considered as a competing risk rather than a censoring event. The","text_display":" cause other than arrhythmic is considered as a competing risk rather than a censoring event. The","confidence":0.998046875,"confidence_rate":0.9999806434067887},{"cnt":[[245,1259],[1820,1259],[1820,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1258,"width":1576,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8d481a6ded04ca0839c9067bb139aa6","type":"text","conversion_output":true,"text":"analysis will make use of the cumulative incidence function, and will be performed within the","text_display":" analysis will make use of the cumulative incidence function, and will be performed within the","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1833,1306],[1833,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1306,"width":1589,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a07398bf63f475693d6fb737d55d712","type":"text","conversion_output":true,"text":"proportional hazards framework using the marginal failure sub-distribution associated with the","text_display":" proportional hazards framework using the marginal failure sub-distribution associated with the","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[1723,1354],[1723,1403],[245,1403]],"region":{"top_left_x":244,"top_left_y":1353,"width":1480,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52163dd871c44735b49ae493fe275154","type":"text","conversion_output":true,"text":"event of interest. The cumulative incidence function for the two arms will be estimated,","text_display":" event of interest. The cumulative incidence function for the two arms will be estimated,","confidence":1,"confidence_rate":1},{"cnt":[[245,1401],[1783,1401],[1783,1452],[245,1452]],"region":{"top_left_x":244,"top_left_y":1400,"width":1540,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2466d3301fb24635b3f50337af9a5457","type":"text","conversion_output":true,"text":"statistically compared, and graphically presented using the features available in the PHREG","text_display":" statistically compared, and graphically presented using the features available in the PHREG","confidence":1,"confidence_rate":1},{"cnt":[[245,1452],[1846,1452],[1846,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":1602,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"caef0f497f2a416e8993896ddd2e8c35","type":"text","conversion_output":true,"text":"procedure in SAS. For subjects who have not died, time from randomization until the subject's","text_display":" procedure in SAS. For subjects who have not died, time from randomization until the subject's","confidence":1,"confidence_rate":1},{"cnt":[[245,1500],[1841,1500],[1841,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1499,"width":1598,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7deb06d8a613449886a0cded0162bf15","type":"text","conversion_output":true,"text":"last follow-up contact will be used in the analysis. The level of significance for the assessment","text_display":" last follow-up contact will be used in the analysis. The level of significance for the assessment","confidence":1,"confidence_rate":1},{"cnt":[[245,1549],[784,1549],[784,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1549,"width":541,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b88078904234d4d9892b9d7fcd1af16","type":"text","conversion_output":true,"text":"of this endpoint will be \\(\\alpha=0.05\\).","text_display":" of this endpoint will be \\(\\alpha=0.05\\).","confidence":0.99951171875,"confidence_rate":0.9999880878636791},{"cnt":[[245,1646],[1828,1646],[1828,1695],[245,1695]],"region":{"top_left_x":244,"top_left_y":1645,"width":1585,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e91fde31ae448ffb462d7018849def2","type":"text","conversion_output":true,"text":"For this endpoint, we will also perform additional analysis using the log-rank test, hazard ratio","text_display":"\n\nFor this endpoint, we will also perform additional analysis using the log-rank test, hazard ratio","confidence":1,"confidence_rate":1},{"cnt":[[245,1693],[1781,1693],[1781,1742],[245,1742]],"region":{"top_left_x":244,"top_left_y":1692,"width":1538,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4838e7221db2442f9ab88c7191ab91f1","type":"text","conversion_output":true,"text":"and \\(95 \\%\\) confidence interval generated using the Cox model, and Kaplan-Meier cumulative","text_display":" and \\(95 \\%\\) confidence interval generated using the Cox model, and Kaplan-Meier cumulative","confidence":1,"confidence_rate":1},{"cnt":[[245,1740],[1876,1740],[1876,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1740,"width":1632,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"228743f4e4d244d7844e5924fd31b266","type":"text","conversion_output":true,"text":"event rate calculations. Patients who have died but whose cause of death is classified by the CEC","text_display":" event rate calculations. Patients who have died but whose cause of death is classified by the CEC","confidence":1,"confidence_rate":1},{"cnt":[[245,1788],[1871,1788],[1871,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1787,"width":1628,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87b843ebd21946e3a13c413710b24579","type":"text","conversion_output":true,"text":"as other than arrhythmic will be censored at the time of the non-arrhythmic death. The results of","text_display":" as other than arrhythmic will be censored at the time of the non-arrhythmic death. The results of","confidence":1,"confidence_rate":1},{"cnt":[[245,1835],[1876,1835],[1876,1886],[245,1886]],"region":{"top_left_x":244,"top_left_y":1834,"width":1632,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76138917313b4f829f98dc0f49ea130c","type":"text","conversion_output":true,"text":"these two different approaches will be compared and synthesized into an overall interpretation of","text_display":" these two different approaches will be compared and synthesized into an overall interpretation of","confidence":1,"confidence_rate":1},{"cnt":[[245,1884],[1708,1884],[1708,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1884,"width":1465,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23eb46dae4f44995b7a4f1c8bfa681e4","type":"text","conversion_output":true,"text":"treatment differences with respect to the endpoint of arrhythmic death or cardiac arrest.","text_display":" treatment differences with respect to the endpoint of arrhythmic death or cardiac arrest.","confidence":1,"confidence_rate":1},{"cnt":[[241,1977],[694,1977],[694,2030],[241,2030]],"region":{"top_left_x":240,"top_left_y":1976,"width":454,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25e7762d4ee14cc5b440f6320de50d1a","type":"section_header","conversion_output":false,"children_ids":["c9b2f2a618fa42eb981bebfdef749bdd"],"text":"","text_display":""},{"cnt":[[245,1981],[690,1981],[690,2026],[245,2026]],"region":{"top_left_x":244,"top_left_y":1980,"width":446,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9b2f2a618fa42eb981bebfdef749bdd","type":"text","conversion_output":true,"parent_id":"25e7762d4ee14cc5b440f6320de50d1a","text":"9.7 Heart Failure Death","text_display":"\n\n\\subsection*{9.7 Heart Failure Death}","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1747,2075],[1747,2127],[245,2127]],"region":{"top_left_x":244,"top_left_y":2075,"width":1503,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9668b1e1cada4d0287d508ae2b5451d5","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the occurrence of a heart failure death.","text_display":"\n\nEndpoint definition: Time from randomization to the occurrence of a heart failure death.","confidence":1,"confidence_rate":1},{"cnt":[[245,2170],[1820,2170],[1820,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2169,"width":1576,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9c8e5ce34e1446cb542200e346c2c38","type":"text","conversion_output":true,"text":"Classification of deaths as being due to heart failure will be performed by the blinded Clinical","text_display":"\nClassification of deaths as being due to heart failure will be performed by the blinded Clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,2219],[627,2219],[627,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2219,"width":384,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbdd85b88b6a43ad906c01062540db2c","type":"text","conversion_output":true,"text":"Endpoints Committee.","text_display":" Endpoints Committee.","confidence":1,"confidence_rate":1},{"cnt":[[245,2316],[1721,2316],[1721,2365],[245,2365]],"region":{"top_left_x":244,"top_left_y":2316,"width":1477,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50fee96837544863960dbb6f05490b54","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this endpoint will make use of the competing risks","text_display":"\n\nStatistical Methods: The analysis of this endpoint will make use of the competing risks","confidence":1,"confidence_rate":1},{"cnt":[[245,2359],[1863,2359],[1863,2413],[245,2413]],"region":{"top_left_x":244,"top_left_y":2358,"width":1619,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"875cd79b346c442b80de57a560bc18a6","type":"text","conversion_output":true,"text":"methodology of Fine and Gray \\({ }^{5}\\) described in previous sections for other secondary endpoints. In","text_display":" methodology of Fine and Gray \\({ }^{5}\\) described in previous sections for other secondary endpoints. In","confidence":1,"confidence_rate":1},{"cnt":[[245,2411],[1841,2411],[1841,2460],[245,2460]],"region":{"top_left_x":244,"top_left_y":2410,"width":1598,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1950feae33541fd8614643aefd2e2f7","type":"text","conversion_output":true,"text":"this case, death due to a cause other than heart failure will considered as a competing risk. The","text_display":" this case, death due to a cause other than heart failure will considered as a competing risk. The","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"503dcda6dd874368a878e02411df7c79","type":"page_info","conversion_output":false,"text":"13","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-15","page":15,"lines":[{"cnt":[[245,251],[1798,251],[1798,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1555,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c69cbb92cb524bc286f87649b736491b","type":"text","conversion_output":true,"text":"features of the Fine-Gray approach for handling competing risks data available as part of the","text_display":"\nfeatures of the Fine-Gray approach for handling competing risks data available as part of the","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,301],[1830,301],[1830,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1587,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b0c144d871042daaf14e9ded450e195","type":"text","conversion_output":true,"text":"PHREG procedure in SAS will be employed to estimate the cumulative incidence function for","text_display":" PHREG procedure in SAS will be employed to estimate the cumulative incidence function for","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1876,348],[1876,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1632,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cdd65fafa444676a6ff8a52d0e058c2","type":"text","conversion_output":true,"text":"each of the two arms, to statistically compare these functions, and graphically present them using","text_display":" each of the two arms, to statistically compare these functions, and graphically present them using","confidence":0.98779296875,"confidence_rate":0.9998807629443354},{"cnt":[[245,397],[1841,397],[1841,449],[245,449]],"region":{"top_left_x":244,"top_left_y":397,"width":1598,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8339515e85cf4c12aad147f2855640a7","type":"text","conversion_output":true,"text":"the software features in SAS. The level of significance for the assessment of this endpoint will","text_display":" the software features in SAS. The level of significance for the assessment of this endpoint will","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[518,447],[518,494],[245,494]],"region":{"top_left_x":244,"top_left_y":446,"width":274,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08c5ad82d0f14e9883929b2afe106559","type":"text","conversion_output":true,"text":"also be \\(\\alpha=0.05\\).","text_display":" also be \\(\\alpha=0.05\\).","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1809,541],[1809,593],[245,593]],"region":{"top_left_x":244,"top_left_y":541,"width":1565,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a72782e2725c45f2838466071773e48d","type":"text","conversion_output":true,"text":"Additional analysis of this secondary endpoint will also be performed using the log-rank test,","text_display":"\n\nAdditional analysis of this secondary endpoint will also be performed using the log-rank test,","confidence":1,"confidence_rate":1},{"cnt":[[245,589],[1878,589],[1878,642],[245,642]],"region":{"top_left_x":244,"top_left_y":588,"width":1634,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0afd2ed0aed64b61b84b5675e8f6eb38","type":"text","conversion_output":true,"text":"hazard ratio and \\(95 \\%\\) confidence interval (CI) generated using the Cox model, and Kaplan-Meier","text_display":" hazard ratio and \\(95 \\%\\) confidence interval (CI) generated using the Cox model, and Kaplan-Meier","confidence":0.7656972408294678,"confidence_rate":0.9973602384891076},{"cnt":[[245,638],[1833,638],[1833,690],[245,690]],"region":{"top_left_x":244,"top_left_y":638,"width":1589,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8064ff3b70d4e93b9405b78ae6a526f","type":"text","conversion_output":true,"text":"cumulative event rate calculations. For this analysis, patients who have died, but their death is","text_display":" cumulative event rate calculations. For this analysis, patients who have died, but their death is","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1833,683],[1833,737],[245,737]],"region":{"top_left_x":244,"top_left_y":683,"width":1589,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7da47612a3414873a1314e7ce7e21e19","type":"text","conversion_output":true,"text":"classified by the CEC as due to a cause other than heart failure, will be censored at the time of","text_display":" classified by the CEC as due to a cause other than heart failure, will be censored at the time of","confidence":0.998046875,"confidence_rate":0.9999808331754918},{"cnt":[[245,733],[1809,733],[1809,784],[245,784]],"region":{"top_left_x":244,"top_left_y":732,"width":1565,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5afcfbeb9fe3459ebe849bc9424d65b4","type":"text","conversion_output":true,"text":"their non-heart failure death. The results of the competing risk analysis and of this traditional","text_display":" their non-heart failure death. The results of the competing risk analysis and of this traditional","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[1807,782],[1807,834],[245,834]],"region":{"top_left_x":244,"top_left_y":782,"width":1563,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7909e3bd27d42c2a13297b50fe941cc","type":"text","conversion_output":true,"text":"analysis will be compared to synthesize an overall interpretation of the treatment differences.","text_display":" analysis will be compared to synthesize an overall interpretation of the treatment differences.","confidence":1,"confidence_rate":1},{"cnt":[[236,870],[853,870],[853,935],[236,935]],"region":{"top_left_x":236,"top_left_y":870,"width":617,"height":65},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5c04e870e674cba9a2a0a20c250a932","type":"section_header","conversion_output":false,"children_ids":["2e29e96710ab4047a6ac2b4b3cee5f98"],"text":"","text_display":""},{"cnt":[[245,877],[844,877],[844,926],[245,926]],"region":{"top_left_x":244,"top_left_y":876,"width":601,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e29e96710ab4047a6ac2b4b3cee5f98","type":"text","conversion_output":true,"parent_id":"f5c04e870e674cba9a2a0a20c250a932","text":"9.8 Recurrent Atrial Fibrillation","text_display":"\n\n\\subsection*{9.8 Recurrent Atrial Fibrillation}","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1695,975],[1695,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1452,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14f45aa323cd4a6ca038dc61adc1ba8c","type":"text","conversion_output":true,"text":"Endpoint definition: This particular outcome will be analyzed with different endpoint","text_display":"\n\nEndpoint definition: This particular outcome will be analyzed with different endpoint","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[1861,1023],[1861,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":1617,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c4e162a21ab48f7a697bae00e9bcfa8","type":"text","conversion_output":true,"text":"definitions in order to provide an overall perspective of the extent of the AF burden experienced","text_display":" definitions in order to provide an overall perspective of the extent of the AF burden experienced","confidence":0.7431640625,"confidence_rate":0.9972552695336833},{"cnt":[[245,1070],[1794,1070],[1794,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1069,"width":1550,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe0ca17a6c8d442182dd88b17f9b7db1","type":"text","conversion_output":true,"text":"by the study subjects. The first analysis will consider the first episode of recurrent AF as the","text_display":" by the study subjects. The first analysis will consider the first episode of recurrent AF as the","confidence":0.99560546875,"confidence_rate":0.9999588399537807},{"cnt":[[245,1117],[1820,1117],[1820,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1117,"width":1576,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cae74e3b44da4b41aebbed86acc36b09","type":"text","conversion_output":true,"text":"endpoint, defined as an episode \\(\\geq 30\\) seconds following the end of the 90 -day blanking period,","text_display":" endpoint, defined as an episode \\(\\geq 30\\) seconds following the end of the 90 -day blanking period,","confidence":0.9951171875,"confidence_rate":0.9999529359885383},{"cnt":[[245,1164],[1721,1164],[1721,1216],[245,1216]],"region":{"top_left_x":244,"top_left_y":1164,"width":1477,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"965fd71b8ffc427982ca58c3574c0ecf","type":"text","conversion_output":true,"text":"where the 90 -day blanking period begins at the time of receiving the randomly assigned","text_display":" where the 90 -day blanking period begins at the time of receiving the randomly assigned","confidence":0.8056640625,"confidence_rate":0.9977279700366193},{"cnt":[[245,1212],[1880,1212],[1880,1265],[245,1265]],"region":{"top_left_x":244,"top_left_y":1211,"width":1636,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c65b3449d1bb4e799fe215008f4b62a8","type":"text","conversion_output":true,"text":"treatment (either ablation or drug therapy). The endpoint will be defined as the time until the first","text_display":" treatment (either ablation or drug therapy). The endpoint will be defined as the time until the first","confidence":1,"confidence_rate":1},{"cnt":[[245,1261],[1790,1261],[1790,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1261,"width":1546,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4fdc0538669436e946e201b6dd19202","type":"text","conversion_output":true,"text":"recurrence of AF according to this definition. Similar analyses will be performed where the","text_display":" recurrence of AF according to this definition. Similar analyses will be performed where the","confidence":1,"confidence_rate":1},{"cnt":[[245,1311],[1766,1311],[1766,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1310,"width":1523,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f1edc0cbc824577855d80124a26bec8","type":"text","conversion_output":true,"text":"endpoint is defined as: (a) an episode of symptomatic recurrent AF , (b) an episode of atrial","text_display":" endpoint is defined as: (a) an episode of symptomatic recurrent AF , (b) an episode of atrial","confidence":0.951171875,"confidence_rate":0.9995187648504423},{"cnt":[[245,1358],[1721,1358],[1721,1407],[245,1407]],"region":{"top_left_x":244,"top_left_y":1357,"width":1477,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"715217a1807e416ca6404e6e2ea76ca3","type":"text","conversion_output":true,"text":"fibrillation or atrial flutter or atrial tachycardia, and (c) an episode of symptomatic atrial","text_display":" fibrillation or atrial flutter or atrial tachycardia, and (c) an episode of symptomatic atrial","confidence":1,"confidence_rate":1},{"cnt":[[245,1405],[1016,1405],[1016,1457],[245,1457]],"region":{"top_left_x":244,"top_left_y":1405,"width":773,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"171b16158c844f93a6cd3ba3457a8c21","type":"text","conversion_output":true,"text":"fibrillation, atrial flutter, or atrial tachycardia.","text_display":" fibrillation, atrial flutter, or atrial tachycardia.","confidence":1,"confidence_rate":1},{"cnt":[[243,1500],[1880,1500],[1880,1553],[243,1553]],"region":{"top_left_x":242,"top_left_y":1499,"width":1638,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"394e866047fc40cb95f9fd9153afb3b0","type":"text","conversion_output":true,"text":"Analysis Population: Because recurrent atrial fibrillation is defined with respect to the end of the","text_display":"\n\nAnalysis Population: Because recurrent atrial fibrillation is defined with respect to the end of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1549],[1835,1549],[1835,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1549,"width":1591,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"991c66fcf2df48899790bf0894de7941","type":"text","conversion_output":true,"text":"blanking period, which begins after receipt of the assigned treatment, all analyses for recurrent","text_display":" blanking period, which begins after receipt of the assigned treatment, all analyses for recurrent","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1867,1594],[1867,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1594,"width":1623,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3052bf20cc5049d294552215a31cd825","type":"text","conversion_output":true,"text":"atrial fibrillation will include only patients who have received their randomly assigned treatment","text_display":" atrial fibrillation will include only patients who have received their randomly assigned treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1644],[952,1644],[952,1695],[245,1695]],"region":{"top_left_x":244,"top_left_y":1643,"width":708,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ac5cd463a0a45ca831b4200a1b37a92","type":"text","conversion_output":true,"text":"and live to the end of the blanking period.","text_display":" and live to the end of the blanking period.","confidence":1,"confidence_rate":1},{"cnt":[[245,1740],[1878,1740],[1878,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1740,"width":1634,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c11a179350ca491e99e2514f6cfb70ad","type":"text","conversion_output":true,"text":"In addition, separate analyses will be performed according to the method used for monitoring AF","text_display":"\n\nIn addition, separate analyses will be performed according to the method used for monitoring AF","confidence":0.7060546875,"confidence_rate":0.9965254245219815},{"cnt":[[245,1788],[1772,1788],[1772,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1787,"width":1529,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4051ed2d8c504534a51086359ebe6d61","type":"text","conversion_output":true,"text":"recurrence. As indicated in Section 6 (Data Sources), rhythm data for many of the patients","text_display":" recurrence. As indicated in Section 6 (Data Sources), rhythm data for many of the patients","confidence":1,"confidence_rate":1},{"cnt":[[245,1835],[1803,1835],[1803,1886],[245,1886]],"region":{"top_left_x":244,"top_left_y":1834,"width":1559,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60cb791cbdca41f58812af64692fdc16","type":"text","conversion_output":true,"text":"enrolled in CABANA (approximately \\(2 / 3\\) of the randomized patients) are collected using the","text_display":" enrolled in CABANA (approximately \\(2 / 3\\) of the randomized patients) are collected using the","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[245,1882],[1785,1882],[1785,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1882,"width":1542,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1eb840af162c44cdad07ec6833e7128f","type":"text","conversion_output":true,"text":"\"CABANA Box,\" a robust rhythm monitoring system provided by Medicomp. The rhythm","text_display":" \"CABANA Box,\" a robust rhythm monitoring system provided by Medicomp. The rhythm","confidence":1,"confidence_rate":1},{"cnt":[[245,1934],[1858,1934],[1858,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1933,"width":1615,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8faaea0a6f6c4af8ad66fc61b0b6c1a9","type":"text","conversion_output":true,"text":"monitoring data are sent from Medicomp to the Duke Clinical Research Institute (DCRI), where","text_display":" monitoring data are sent from Medicomp to the Duke Clinical Research Institute (DCRI), where","confidence":1,"confidence_rate":1},{"cnt":[[245,1981],[1843,1981],[1843,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1980,"width":1600,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a2beb11880d426f82fb055de50db5ff","type":"text","conversion_output":true,"text":"a set of programmed rules are run to determine which rhythms should be submitted to the ECG","text_display":" a set of programmed rules are run to determine which rhythms should be submitted to the ECG","confidence":1,"confidence_rate":1},{"cnt":[[245,2028],[1783,2028],[1783,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2028,"width":1540,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e50bdb63744e4fd3afd29a1e2ee75d73","type":"text","conversion_output":true,"text":"core lab for review and adjudication. Following core lab review, the adjudicated results are","text_display":" core lab for review and adjudication. Following core lab review, the adjudicated results are","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1760,2075],[1760,2127],[245,2127]],"region":{"top_left_x":244,"top_left_y":2075,"width":1516,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0e1e56adf214d57914120ae29cd8124","type":"text","conversion_output":true,"text":"electronically transmitted back to the DCRI. Sites that are not using the \"CABANA Box\"","text_display":" electronically transmitted back to the DCRI. Sites that are not using the \"CABANA Box\"","confidence":1,"confidence_rate":1},{"cnt":[[245,2123],[1880,2123],[1880,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2122,"width":1636,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cabf0463d7514786947d98087b1a0aa1","type":"text","conversion_output":true,"text":"(generally these are international sites where use of the CABANA Box was not approved) submit","text_display":" (generally these are international sites where use of the CABANA Box was not approved) submit","confidence":1,"confidence_rate":1},{"cnt":[[245,2172],[1826,2172],[1826,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2172,"width":1583,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c5c70def98e42f8a71296bebc9efdf6","type":"text","conversion_output":true,"text":"rhythm data through a secure portal using the CABANA website, which is then processed and","text_display":" rhythm data through a secure portal using the CABANA website, which is then processed and","confidence":1,"confidence_rate":1},{"cnt":[[245,2219],[1689,2219],[1689,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2219,"width":1445,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88a640244a3047f68efd20907390f810","type":"text","conversion_output":true,"text":"submitted to the core lab for adjudication. Because the CABANA Box data are more","text_display":" submitted to the core lab for adjudication. Because the CABANA Box data are more","confidence":1,"confidence_rate":1},{"cnt":[[245,2264],[1858,2264],[1858,2318],[245,2318]],"region":{"top_left_x":244,"top_left_y":2264,"width":1615,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"791d4ea90398464f8cd614a32984cde2","type":"text","conversion_output":true,"text":"comprehensive and more routinely and rigorously collected, separate analyses of recurrent atrial","text_display":" comprehensive and more routinely and rigorously collected, separate analyses of recurrent atrial","confidence":1,"confidence_rate":1},{"cnt":[[245,2316],[1760,2316],[1760,2365],[245,2365]],"region":{"top_left_x":244,"top_left_y":2316,"width":1516,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0af5f4d1679b436caf0587f23a469883","type":"text","conversion_output":true,"text":"arrhythmias will be performed using (a) patients whose rhythms were monitored using the","text_display":" arrhythmias will be performed using (a) patients whose rhythms were monitored using the","confidence":1,"confidence_rate":1},{"cnt":[[245,2363],[1858,2363],[1858,2415],[245,2415]],"region":{"top_left_x":244,"top_left_y":2363,"width":1615,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4e5b198f3864cfc85e5d461f70eed91","type":"text","conversion_output":true,"text":"CABANA Box, (b) all remaining patients (i.e., non-CABANA Box patients), and (c) the pooled","text_display":" CABANA Box, (b) all remaining patients (i.e., non-CABANA Box patients), and (c) the pooled","confidence":1,"confidence_rate":1},{"cnt":[[245,2411],[1760,2411],[1760,2464],[245,2464]],"region":{"top_left_x":244,"top_left_y":2410,"width":1516,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f027ba5a0ef4ae682c196133e80c25b","type":"text","conversion_output":true,"text":"group of all patients (with use of CABANA Box as a covariate if justified). In the case of","text_display":" group of all patients (with use of CABANA Box as a covariate if justified). In the case of","confidence":1,"confidence_rate":1},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"077e4d31d4584987ac6f461cda9ce5ed","type":"page_info","conversion_output":false,"text":"14","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-16","page":16,"lines":[{"cnt":[[245,254],[1749,254],[1749,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1505,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"110bd5f2633a42f3ade804090df58b36","type":"text","conversion_output":true,"text":"patients who initially used the CABANA Box and later ceased to provide information via","text_display":"\npatients who initially used the CABANA Box and later ceased to provide information via","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1820,301],[1820,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1576,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1018796c891456087657930b229989e","type":"text","conversion_output":true,"text":"CABANA Box, the analysis will censor that data at the time of last CABANA Box recording.","text_display":" CABANA Box, the analysis will censor that data at the time of last CABANA Box recording.","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[245,348],[1828,348],[1828,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1585,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d0aa2eac56b421db6ab25856e4de45f","type":"text","conversion_output":true,"text":"The primary analysis of this endpoint will be the analysis of patients with CABANA Box data","text_display":" The primary analysis of this endpoint will be the analysis of patients with CABANA Box data","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1854,397],[1854,449],[245,449]],"region":{"top_left_x":244,"top_left_y":397,"width":1611,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ea37644ac774011ab8764c2f37c6cc3","type":"text","conversion_output":true,"text":"because of the more comprehensive collection of that rhythm monitoring information. Analysis","text_display":" because of the more comprehensive collection of that rhythm monitoring information. Analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1648,443],[1648,494],[245,494]],"region":{"top_left_x":244,"top_left_y":442,"width":1404,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ec2764f8c6045c28c59e9b7b2ea3528","type":"text","conversion_output":true,"text":"which includes non-CABANA Box patients (\"b\" and \"c\" above) will be considered","text_display":" which includes non-CABANA Box patients (\"b\" and \"c\" above) will be considered","confidence":1,"confidence_rate":1},{"cnt":[[245,492],[655,492],[655,544],[245,544]],"region":{"top_left_x":244,"top_left_y":491,"width":412,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75323113040543cdbb35cc6bc3f327b3","type":"text","conversion_output":true,"text":"supplementary analysis.","text_display":" supplementary analysis.","confidence":1,"confidence_rate":1},{"cnt":[[243,587],[1717,587],[1717,638],[243,638]],"region":{"top_left_x":242,"top_left_y":586,"width":1475,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"018c535cd33a4c67bcd9473277605a10","type":"text","conversion_output":true,"text":"Statistical Analysis: First, descriptive summaries of baseline characteristics of subjects","text_display":"\n\nStatistical Analysis: First, descriptive summaries of baseline characteristics of subjects","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[245,636],[1848,636],[1848,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1604,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7585338df26c4e1ea59d8b956097be90","type":"text","conversion_output":true,"text":"receiving their assigned treatment and living to the end of the blanking period in both treatment","text_display":" receiving their assigned treatment and living to the end of the blanking period in both treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1798,683],[1798,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1555,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a22406f488e4d60b41a79de31714946","type":"text","conversion_output":true,"text":"arms will be presented to determine how comparable the patients in the two arms are for this","text_display":" arms will be presented to determine how comparable the patients in the two arms are for this","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[1815,726],[1815,782],[245,782]],"region":{"top_left_x":244,"top_left_y":726,"width":1572,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e90fc47f0f14ce181597442931d8648","type":"text","conversion_output":true,"text":"analysis. Continuous variables will be presented in terms of percentiles (median, \\(25{ }^{\\text {th }}\\) and \\(75{ }^{\\text {th }}\\)","text_display":" analysis. Continuous variables will be presented in terms of percentiles (median, \\(25{ }^{\\text {th }}\\) and \\(75{ }^{\\text {th }}\\)","confidence":0.8045542240142822,"confidence_rate":0.9982755606686755},{"cnt":[[245,778],[1669,778],[1669,831],[245,831]],"region":{"top_left_x":244,"top_left_y":777,"width":1426,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dc0846742c84bf1b00bd802cb9b4fff","type":"text","conversion_output":true,"text":"percentiles), while discrete variables will be summarized in terms of frequencies and","text_display":" percentiles), while discrete variables will be summarized in terms of frequencies and","confidence":1,"confidence_rate":1},{"cnt":[[245,831],[460,831],[460,879],[245,879]],"region":{"top_left_x":244,"top_left_y":831,"width":216,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf19a51dddfe41f3b1f2cb0e4945e29b","type":"text","conversion_output":true,"text":"percentages.","text_display":" percentages.","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1826,924],[1826,973],[245,973]],"region":{"top_left_x":244,"top_left_y":923,"width":1583,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"955816394e3b4a08afdeb67ebf3ce86a","type":"text","conversion_output":true,"text":"The treatment arms will be compared using statistical methods described in the sections above","text_display":"\n\nThe treatment arms will be compared using statistical methods described in the sections above","confidence":1,"confidence_rate":1},{"cnt":[[245,965],[1876,965],[1876,1023],[245,1023]],"region":{"top_left_x":244,"top_left_y":964,"width":1632,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0c0a8bab4a940f4b8899d0cdc8598e0","type":"text","conversion_output":true,"text":"for other secondary endpoints, including the competing risk method of Fine and Gray \\({ }^{4}\\), as well as","text_display":" for other secondary endpoints, including the competing risk method of Fine and Gray \\({ }^{4}\\), as well as","confidence":1,"confidence_rate":1},{"cnt":[[245,1018],[1760,1018],[1760,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1018,"width":1516,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22bcf7acaf63445281f7ddebbc7230c4","type":"text","conversion_output":true,"text":"use of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval generated using the Cox","text_display":" use of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval generated using the Cox","confidence":0.99267578125,"confidence_rate":0.9999249908487245},{"cnt":[[245,1066],[1815,1066],[1815,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1065,"width":1572,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3efd21aca41841d1bc58ab96bf59c1c0","type":"text","conversion_output":true,"text":"model, and Kaplan-Meier cumulative event rate calculations. In this case, all-cause mortality","text_display":" model, and Kaplan-Meier cumulative event rate calculations. In this case, all-cause mortality","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1820,1113],[1820,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1112,"width":1576,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11b97d0bd0064633aa69cde1cd7c54b1","type":"text","conversion_output":true,"text":"will be a competing risk and zero-time (i.e., when the clock starts) for this analysis will be the","text_display":" will be a competing risk and zero-time (i.e., when the clock starts) for this analysis will be the","confidence":0.998046875,"confidence_rate":0.9999810192594005},{"cnt":[[245,1162],[1815,1162],[1815,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1162,"width":1572,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81f0f636c2f94fbba240a5cc10d33fc1","type":"text","conversion_output":true,"text":"end of the 90 -day blanking period. Analyses will be repeated with adjustment for the baseline","text_display":" end of the 90 -day blanking period. Analyses will be repeated with adjustment for the baseline","confidence":0.93115234375,"confidence_rate":0.9993009074148665},{"cnt":[[245,1212],[836,1212],[836,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1211,"width":592,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46d19696d94f443b9714a17d4b832760","type":"text","conversion_output":true,"text":"covariates described in section 8.1.","text_display":" covariates described in section 8.1.","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1858,1306],[1858,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1306,"width":1615,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae924489072747b783b7ab34682490be","type":"text","conversion_output":true,"text":"Of key interest will be whether the effect of ablation on recurrent atrial arrhythmias is similar or","text_display":"\n\nOf key interest will be whether the effect of ablation on recurrent atrial arrhythmias is similar or","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[1843,1354],[1843,1405],[245,1405]],"region":{"top_left_x":244,"top_left_y":1353,"width":1600,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc7111d46dc54c11985e31d872bdf325","type":"text","conversion_output":true,"text":"different according to the type of AF the patients experienced prior to enrolling in the trial (i.e.,","text_display":" different according to the type of AF the patients experienced prior to enrolling in the trial (i.e.,","confidence":0.83544921875,"confidence_rate":0.9983053459253841},{"cnt":[[245,1401],[1854,1401],[1854,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1400,"width":1611,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f79415264087441fa80c9f91eab32d7e","type":"text","conversion_output":true,"text":"whether the effect varies according to whether patients' baseline AF was paroxysmal, persistent","text_display":" whether the effect varies according to whether patients' baseline AF was paroxysmal, persistent","confidence":0.998046875,"confidence_rate":0.9999815564452184},{"cnt":[[245,1452],[1818,1452],[1818,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":1574,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdfe1b84acac44568b657e1e374ef6ec","type":"text","conversion_output":true,"text":"or long-standing persistent). This analysis will utilize the Cox model to test for an interaction","text_display":" or long-standing persistent). This analysis will utilize the Cox model to test for an interaction","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1497],[1712,1497],[1712,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1497,"width":1469,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0b230341d2a430a997aa4141ce177a8","type":"text","conversion_output":true,"text":"between the randomized treatment strategy and the baseline type of AF classified as (a)","text_display":" between the randomized treatment strategy and the baseline type of AF classified as (a)","confidence":1,"confidence_rate":1},{"cnt":[[245,1547],[1811,1547],[1811,1596],[245,1596]],"region":{"top_left_x":244,"top_left_y":1546,"width":1568,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49ef44bbd8b545b0b40c91a5c75fdab9","type":"text","conversion_output":true,"text":"paroxysmal or (b) persistent or longstanding persistent. In addition to the interaction test, the","text_display":" paroxysmal or (b) persistent or longstanding persistent. In addition to the interaction test, the","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1848,1594],[1848,1644],[245,1644]],"region":{"top_left_x":244,"top_left_y":1594,"width":1604,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8475b162308b4b73b70f93acc0f008ad","type":"text","conversion_output":true,"text":"effect of the treatment strategy characterized by a hazard ratio and \\(95 \\%\\) confidence interval and","text_display":" effect of the treatment strategy characterized by a hazard ratio and \\(95 \\%\\) confidence interval and","confidence":0.9990234375,"confidence_rate":0.9999906054321309},{"cnt":[[245,1641],[1768,1641],[1768,1691],[245,1691]],"region":{"top_left_x":244,"top_left_y":1641,"width":1525,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"caa317f9be5948bbbc0eed491ba37445","type":"text","conversion_output":true,"text":"Kaplan-Meier event rate calculations will be calculated and displayed for the subgroups of","text_display":" Kaplan-Meier event rate calculations will be calculated and displayed for the subgroups of","confidence":0.98876953125,"confidence_rate":0.9998811227862585},{"cnt":[[245,1689],[1747,1689],[1747,1740],[245,1740]],"region":{"top_left_x":244,"top_left_y":1688,"width":1503,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c0b67a7738b458792897b24831aec14","type":"text","conversion_output":true,"text":"patients whose baseline AF history was (a) paroxysmal and (b) persistent or longstanding","text_display":" patients whose baseline AF history was (a) paroxysmal and (b) persistent or longstanding","confidence":0.98486328125,"confidence_rate":0.9998360086286446},{"cnt":[[245,1738],[1835,1738],[1835,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1738,"width":1591,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6fe195d7d8e497bb17c0214c5f4081d","type":"text","conversion_output":true,"text":"persistent. Similar comparative analyses will be performed in subgroups defined by age (<65,","text_display":" persistent. Similar comparative analyses will be performed in subgroups defined by age (<65,","confidence":0.994140625,"confidence_rate":0.9999394182424788},{"cnt":[[245,1783],[1291,1783],[1291,1835],[245,1835]],"region":{"top_left_x":244,"top_left_y":1783,"width":1048,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f5746a88ef04bd6a399bbe042886960","type":"text","conversion_output":true,"text":"65-74, and \\(\\geq 75\\) ) and by \\(CHA _{2} DS _{2}\\)-VASc Score (0 or 1 vs \\(>1\\) ).","text_display":" 65-74, and \\(\\geq 75\\) ) and by \\(CHA _{2} DS _{2}\\)-VASc Score (0 or 1 vs \\(>1\\) ).","confidence":0.7257777138147503,"confidence_rate":0.9967012108318472},{"cnt":[[236,1878],[889,1878],[889,1938],[236,1938]],"region":{"top_left_x":236,"top_left_y":1877,"width":654,"height":61},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64860af0c6654c47974b9c975cc18117","type":"section_header","conversion_output":false,"children_ids":["4019dcc15ed84d4aa7d643a5f60fb5cf"],"text":"","text_display":""},{"cnt":[[245,1882],[883,1882],[883,1931],[245,1931]],"region":{"top_left_x":244,"top_left_y":1882,"width":640,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4019dcc15ed84d4aa7d643a5f60fb5cf","type":"text","conversion_output":true,"parent_id":"64860af0c6654c47974b9c975cc18117","text":"9.9 Cardiovascular Hospitalization","text_display":"\n\n\\subsection*{9.9 Cardiovascular Hospitalization}","confidence":1,"confidence_rate":1},{"cnt":[[245,1979],[1815,1979],[1815,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1978,"width":1572,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a3ea85cefba453da2a2d3fef11467a6","type":"text","conversion_output":true,"text":"A key part of the analysis and interpretation of the results of this endpoint will be the analysis","text_display":"\n\nA key part of the analysis and interpretation of the results of this endpoint will be the analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,2024],[1841,2024],[1841,2078],[245,2078]],"region":{"top_left_x":244,"top_left_y":2023,"width":1598,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c93a1ed23ede46da820ff4888867b07f","type":"text","conversion_output":true,"text":"performed in connection with secondary endpoint \\#2 (the composite of death or cardiovascular","text_display":" performed in connection with secondary endpoint \\#2 (the composite of death or cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[245,2073],[1785,2073],[1785,2125],[245,2125]],"region":{"top_left_x":244,"top_left_y":2073,"width":1542,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d63d4635f2be4c768d8e9911d90fd21a","type":"text","conversion_output":true,"text":"hospitalization). Analysis of cardiovascular hospitalization as an endpoint by itself must be","text_display":" hospitalization). Analysis of cardiovascular hospitalization as an endpoint by itself must be","confidence":1,"confidence_rate":1},{"cnt":[[245,2123],[1809,2123],[1809,2172],[245,2172]],"region":{"top_left_x":244,"top_left_y":2122,"width":1565,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2313f71c396d4db199964513db10a342","type":"text","conversion_output":true,"text":"analyzed and interpreted cautiously, particularly if there is a mortality difference between the","text_display":" analyzed and interpreted cautiously, particularly if there is a mortality difference between the","confidence":1,"confidence_rate":1},{"cnt":[[245,2170],[1764,2170],[1764,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":1520,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"669fe1edeb3045a18f48509a8973a27b","type":"text","conversion_output":true,"text":"two arms of the trial. If patients in one arm have lower mortality, that arm may have more","text_display":" two arms of the trial. If patients in one arm have lower mortality, that arm may have more","confidence":1,"confidence_rate":1},{"cnt":[[245,2217],[1869,2217],[1869,2267],[245,2267]],"region":{"top_left_x":244,"top_left_y":2217,"width":1626,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e1ba0a608c44a4dba652e383ae1d9b8","type":"text","conversion_output":true,"text":"hospitalizations simply because more patients are alive and at risk for needing to be hospitalized.","text_display":" hospitalizations simply because more patients are alive and at risk for needing to be hospitalized.","confidence":1,"confidence_rate":1},{"cnt":[[245,2264],[1772,2264],[1772,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2264,"width":1529,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e52510fc6dcd423eb8f95442453fd961","type":"text","conversion_output":true,"text":"Another important aspect of the analysis of this endpoint is that patients may have multiple","text_display":" Another important aspect of the analysis of this endpoint is that patients may have multiple","confidence":1,"confidence_rate":1},{"cnt":[[245,2312],[1846,2312],[1846,2363],[245,2363]],"region":{"top_left_x":244,"top_left_y":2311,"width":1602,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6baaa36c9d8f48e2a99df0199d7eb337","type":"text","conversion_output":true,"text":"hospitalizations, and so a comprehensive analysis of hospitalizations must take into account the","text_display":" hospitalizations, and so a comprehensive analysis of hospitalizations must take into account the","confidence":1,"confidence_rate":1},{"cnt":[[245,2359],[1792,2359],[1792,2413],[245,2413]],"region":{"top_left_x":244,"top_left_y":2358,"width":1548,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6ff437da0dd4ab9b815ffcdb4fe1496","type":"text","conversion_output":true,"text":"recurrent hospitalization events rather than simply the first one. Consequently, there will be","text_display":" recurrent hospitalization events rather than simply the first one. Consequently, there will be","confidence":0.99609375,"confidence_rate":0.9999604664448944},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"376d144ebf2c4ea8aa03584e56c16fb9","type":"page_info","conversion_output":false,"text":"15","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-17","page":17,"lines":[{"cnt":[[245,251],[1867,251],[1867,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1623,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d840212bc2bf40c68bac4ac91f1ed431","type":"text","conversion_output":true,"text":"several parts to the analysis of this endpoint in addition to a careful examination of the results of","text_display":"\nseveral parts to the analysis of this endpoint in addition to a careful examination of the results of","confidence":0.9990236759185791,"confidence_rate":0.9999907849387211},{"cnt":[[245,301],[1824,301],[1824,352],[245,352]],"region":{"top_left_x":244,"top_left_y":300,"width":1581,"height":53},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64c32c5827e44ae0a83b5c0653506c91","type":"text","conversion_output":true,"text":"the composite endpoint consisting of death or cardiovascular hospitalization (see Section 9.2).","text_display":" the composite endpoint consisting of death or cardiovascular hospitalization (see Section 9.2).","confidence":1,"confidence_rate":1},{"cnt":[[234,387],[606,387],[606,449],[234,449]],"region":{"top_left_x":234,"top_left_y":386,"width":372,"height":64},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0059dfbd0b864c31a9c2c6ec36e76350","type":"section_header","conversion_output":false,"children_ids":["548f92c476f643019b5e7b1a979f092d"],"text":"","text_display":""},{"cnt":[[243,395],[595,395],[595,440],[243,440]],"region":{"top_left_x":242,"top_left_y":395,"width":354,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"548f92c476f643019b5e7b1a979f092d","type":"text","conversion_output":true,"parent_id":"0059dfbd0b864c31a9c2c6ec36e76350","text":"Statistical Methods:","text_display":"\n\n\\section*{Statistical Methods:}","confidence":1,"confidence_rate":1},{"cnt":[[305,443],[1818,443],[1818,494],[305,494]],"region":{"top_left_x":305,"top_left_y":442,"width":1513,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18d61b1efc154a17bf46b5437e5262d8","type":"text","conversion_output":true,"text":"a. The first analysis will consider time until the first cardiovascular hospitalization in each","text_display":"\na. The first analysis will consider time until the first cardiovascular hospitalization in each","confidence":1,"confidence_rate":1},{"cnt":[[370,486],[1833,486],[1833,544],[370,544]],"region":{"top_left_x":369,"top_left_y":485,"width":1464,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4da6224deeea4531a0b899772c6fcd5c","type":"text","conversion_output":true,"text":"arm and use the competing risks methodology of Fine and Gray \\({ }^{5}\\) where death from any","text_display":" arm and use the competing risks methodology of Fine and Gray \\({ }^{5}\\) where death from any","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[370,541],[1820,541],[1820,591],[370,591]],"region":{"top_left_x":369,"top_left_y":541,"width":1451,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf92c9a56d91492dbb77f6e6dc78291d","type":"text","conversion_output":true,"text":"cause is considered as a competing risk. The analysis will make use of the cumulative","text_display":" cause is considered as a competing risk. The analysis will make use of the cumulative","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[370,589],[1807,589],[1807,638],[370,638]],"region":{"top_left_x":369,"top_left_y":588,"width":1438,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49e83c517bb1485398804d13a341b745","type":"text","conversion_output":true,"text":"incidence function, and will be performed within the proportional hazards framework","text_display":" incidence function, and will be performed within the proportional hazards framework","confidence":1,"confidence_rate":1},{"cnt":[[370,636],[1865,636],[1865,685],[370,685]],"region":{"top_left_x":369,"top_left_y":635,"width":1496,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"891a9e06c7b943cd92d4b16497754ed3","type":"text","conversion_output":true,"text":"using the approach described in Section 9.4. The cumulative incidence function for each","text_display":" using the approach described in Section 9.4. The cumulative incidence function for each","confidence":1,"confidence_rate":1},{"cnt":[[370,683],[1871,683],[1871,735],[370,735]],"region":{"top_left_x":369,"top_left_y":683,"width":1503,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e43e82725ec043f9877e60e24ed813e2","type":"text","conversion_output":true,"text":"of the two arms will be estimated, statistically compared, and graphically presented using","text_display":" of the two arms will be estimated, statistically compared, and graphically presented using","confidence":1,"confidence_rate":1},{"cnt":[[370,730],[1665,730],[1665,782],[370,782]],"region":{"top_left_x":369,"top_left_y":730,"width":1297,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54601f80891d41238f9213ebab83c877","type":"text","conversion_output":true,"text":"the PHREG procedure in SAS. For subjects who have not experienced a CV","text_display":" the PHREG procedure in SAS. For subjects who have not experienced a CV","confidence":0.9990234375,"confidence_rate":0.9999869728895492},{"cnt":[[370,778],[1867,778],[1867,831],[370,831]],"region":{"top_left_x":369,"top_left_y":777,"width":1498,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dedebc39ad0e4bc7b6fd262db2922e11","type":"text","conversion_output":true,"text":"hospitalization, time from randomization until the subject's last follow-up contact will be","text_display":" hospitalization, time from randomization until the subject's last follow-up contact will be","confidence":1,"confidence_rate":1},{"cnt":[[370,829],[1863,829],[1863,879],[370,879]],"region":{"top_left_x":369,"top_left_y":829,"width":1494,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01c43cad076740b4919817b345dc14ea","type":"text","conversion_output":true,"text":"used in the analysis. The level of significance for the assessment of this endpoint will be","text_display":" used in the analysis. The level of significance for the assessment of this endpoint will be","confidence":1,"confidence_rate":1},{"cnt":[[370,877],[511,877],[511,922],[370,922]],"region":{"top_left_x":369,"top_left_y":876,"width":143,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d479329193e74b33b078a1608179934f","type":"text","conversion_output":true,"text":"\\(\\alpha=0.05\\).","text_display":" \\(\\alpha=0.05\\).","confidence":1,"confidence_rate":1},{"cnt":[[305,924],[1846,924],[1846,978],[305,978]],"region":{"top_left_x":305,"top_left_y":923,"width":1541,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69771dcba0084bcb9913fa9ecc43b6ed","type":"text","conversion_output":true,"text":"b. An additional analysis of this endpoint will be performed using the log-rank test, hazard","text_display":"\nb. An additional analysis of this endpoint will be performed using the log-rank test, hazard","confidence":1,"confidence_rate":1},{"cnt":[[370,975],[1800,975],[1800,1025],[370,1025]],"region":{"top_left_x":369,"top_left_y":975,"width":1432,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6f21255ec1f4a258272b7cc97d49d6e","type":"text","conversion_output":true,"text":"ratio and \\(95 \\%\\) confidence interval generated using the Cox model, and Kaplan-Meier","text_display":" ratio and \\(95 \\%\\) confidence interval generated using the Cox model, and Kaplan-Meier","confidence":0.99853515625,"confidence_rate":0.9999835291504493},{"cnt":[[370,1023],[1876,1023],[1876,1072],[370,1072]],"region":{"top_left_x":369,"top_left_y":1022,"width":1507,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a370afaaf7c0496da2269a9b30609ef6","type":"text","conversion_output":true,"text":"cumulative event rate calculations. Patients who have died will be censored at the time of","text_display":" cumulative event rate calculations. Patients who have died will be censored at the time of","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[370,1070],[1687,1070],[1687,1119],[370,1119]],"region":{"top_left_x":369,"top_left_y":1069,"width":1318,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"065dbbf5f4d44500b36a8fd4e2d736f2","type":"text","conversion_output":true,"text":"their death. This analysis and the approach in (a) above will be compared and","text_display":" their death. This analysis and the approach in (a) above will be compared and","confidence":1,"confidence_rate":1},{"cnt":[[370,1117],[1796,1117],[1796,1171],[370,1171]],"region":{"top_left_x":369,"top_left_y":1117,"width":1428,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52d1b9fb74f54ac799a7dea9959b05d1","type":"text","conversion_output":true,"text":"summarized into an overall interpretation of treatment differences with respect to the","text_display":" summarized into an overall interpretation of treatment differences with respect to the","confidence":1,"confidence_rate":1},{"cnt":[[370,1164],[1171,1164],[1171,1216],[370,1216]],"region":{"top_left_x":369,"top_left_y":1164,"width":802,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"681174e2c2a547079df47b31385459c6","type":"text","conversion_output":true,"text":"endpoint of time to the first CV hospitalization.","text_display":" endpoint of time to the first CV hospitalization.","confidence":1,"confidence_rate":1},{"cnt":[[305,1212],[1841,1212],[1841,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1211,"width":1537,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f35ccb1c81c41b7b2e1e07e0dbd5dec","type":"text","conversion_output":true,"text":"c. The analyses described above will be extended to a multiple events analysis, designed to","text_display":"\nc. The analyses described above will be extended to a multiple events analysis, designed to","confidence":1,"confidence_rate":1},{"cnt":[[370,1261],[1820,1261],[1820,1313],[370,1313]],"region":{"top_left_x":369,"top_left_y":1261,"width":1451,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f643f8b189649eb99d24dc81aa581d5","type":"text","conversion_output":true,"text":"take into account multiple hospitalization events that may occur during the course of a","text_display":" take into account multiple hospitalization events that may occur during the course of a","confidence":1,"confidence_rate":1},{"cnt":[[370,1311],[1837,1311],[1837,1360],[370,1360]],"region":{"top_left_x":369,"top_left_y":1310,"width":1468,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fc7dcd2f7c54607978ecbf53bc37e6b","type":"text","conversion_output":true,"text":"patient's follow-up. When considering one event per patient as in (a) or (b) above (i.e.,","text_display":" patient's follow-up. When considering one event per patient as in (a) or (b) above (i.e.,","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[370,1358],[1729,1358],[1729,1407],[370,1407]],"region":{"top_left_x":369,"top_left_y":1357,"width":1361,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c7fec8b497e4df0bc9dfa202e18217e","type":"text","conversion_output":true,"text":"the time until the first event), those events are independent because they occur in","text_display":" the time until the first event), those events are independent because they occur in","confidence":1,"confidence_rate":1},{"cnt":[[370,1405],[1779,1405],[1779,1454],[370,1454]],"region":{"top_left_x":369,"top_left_y":1405,"width":1410,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a268c18dacc4fd8ad172d92156a11ca","type":"text","conversion_output":true,"text":"different patients. When considering multiple events for a patient, the events are no","text_display":" different patients. When considering multiple events for a patient, the events are no","confidence":1,"confidence_rate":1},{"cnt":[[370,1452],[1878,1452],[1878,1504],[370,1504]],"region":{"top_left_x":369,"top_left_y":1452,"width":1509,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93419a81227f4d4699dad2f7029b99ea","type":"text","conversion_output":true,"text":"longer all independent because some of them are occurring within the same patient. This","text_display":" longer all independent because some of them are occurring within the same patient. This","confidence":1,"confidence_rate":1},{"cnt":[[370,1502],[1869,1502],[1869,1553],[370,1553]],"region":{"top_left_x":369,"top_left_y":1501,"width":1501,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17dffb9a73d34379bf7f183108639cf7","type":"text","conversion_output":true,"text":"correlation (covariance) must be taken into account in deriving inferences. The multiple-","text_display":" correlation (covariance) must be taken into account in deriving inferences. The multiple","confidence":1,"confidence_rate":1},{"cnt":[[370,1549],[1652,1549],[1652,1601],[370,1601]],"region":{"top_left_x":369,"top_left_y":1549,"width":1284,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13b698ca659d4124b3517b928899f4ac","type":"text","conversion_output":true,"text":"event methods that will be used represent different extensions of Cox model","text_display":"event methods that will be used represent different extensions of Cox model","confidence":1,"confidence_rate":1},{"cnt":[[370,1594],[1828,1594],[1828,1648],[370,1648]],"region":{"top_left_x":369,"top_left_y":1594,"width":1460,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dab60e10a63d44b6a833fc3215af7327","type":"text","conversion_output":true,"text":"methodology, and take into account the timing of the events and the correlation among","text_display":" methodology, and take into account the timing of the events and the correlation among","confidence":1,"confidence_rate":1},{"cnt":[[370,1646],[1285,1646],[1285,1695],[370,1695]],"region":{"top_left_x":369,"top_left_y":1645,"width":916,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c0c55d5ebd448b5a68a1f4a1462c20d","type":"text","conversion_output":true,"text":"multiple events occurring within an individual patient.","text_display":" multiple events occurring within an individual patient.","confidence":1,"confidence_rate":1},{"cnt":[[370,1740],[1820,1740],[1820,1790],[370,1790]],"region":{"top_left_x":369,"top_left_y":1740,"width":1451,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04c5e401fdab443bb6097d8d5198e17d","type":"text","conversion_output":true,"text":"The main statistical approach will use a generalization of the Cox model developed by","text_display":"\n\nThe main statistical approach will use a generalization of the Cox model developed by","confidence":0.99267578125,"confidence_rate":0.9999183236409059},{"cnt":[[370,1781],[1833,1781],[1833,1841],[370,1841]],"region":{"top_left_x":369,"top_left_y":1781,"width":1464,"height":61},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f87c783ca864e988f5bb0db2e171898","type":"text","conversion_output":true,"text":"Andersen \\& Gill \\({ }^{6,7}\\), with robust standard errors to account for heterogeneity and for the","text_display":" Andersen \\& Gill \\({ }^{6,7}\\), with robust standard errors to account for heterogeneity and for the","confidence":1,"confidence_rate":1},{"cnt":[[370,1835],[1265,1835],[1265,1888],[370,1888]],"region":{"top_left_x":369,"top_left_y":1834,"width":897,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54ca1085caf741359f723d6161857f39","type":"text","conversion_output":true,"text":"correlation between recurrent events within a patient.","text_display":" correlation between recurrent events within a patient.","confidence":1,"confidence_rate":1},{"cnt":[[370,1931],[1863,1931],[1863,1983],[370,1983]],"region":{"top_left_x":369,"top_left_y":1931,"width":1494,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20aa7a9b29b54eefb36f4b133f381ef8","type":"text","conversion_output":true,"text":"Similar to time-to-1st event methods, a terminal event (death) could introduce bias in the","text_display":"\n\nSimilar to time-to-1st event methods, a terminal event (death) could introduce bias in the","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[370,1981],[1846,1981],[1846,2030],[370,2030]],"region":{"top_left_x":369,"top_left_y":1980,"width":1477,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c388611ff49449daba32de043a05e407","type":"text","conversion_output":true,"text":"recurrent events analysis, especially if there is a differential mortality between the study","text_display":" recurrent events analysis, especially if there is a differential mortality between the study","confidence":1,"confidence_rate":1},{"cnt":[[370,2024],[1858,2024],[1858,2078],[370,2078]],"region":{"top_left_x":369,"top_left_y":2023,"width":1490,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"071720659651424cab3b36c83cd1fa6a","type":"text","conversion_output":true,"text":"arms. Thus, the Ghosh and Lin \\({ }^{8}\\) nonparametric method can be utilized in calculating the","text_display":" arms. Thus, the Ghosh and Lin \\({ }^{8}\\) nonparametric method can be utilized in calculating the","confidence":0.9385063648223877,"confidence_rate":0.9993779813665084},{"cnt":[[370,2075],[1815,2075],[1815,2127],[370,2127]],"region":{"top_left_x":369,"top_left_y":2075,"width":1447,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb51085a47784ee19b05db4248ca8186","type":"text","conversion_output":true,"text":"cumulative rate of CV hospitalizations, while accounting for mortality as a competing","text_display":" cumulative rate of CV hospitalizations, while accounting for mortality as a competing","confidence":0.98046875,"confidence_rate":0.9997808628435241},{"cnt":[[370,2123],[1751,2123],[1751,2176],[370,2176]],"region":{"top_left_x":369,"top_left_y":2122,"width":1382,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c3c1bf1441d4ba19d0aa1ad1afe6ec2","type":"text","conversion_output":true,"text":"risk. In addition, the average number of CV hospitalizations per 100-person years","text_display":" risk. In addition, the average number of CV hospitalizations per 100-person years","confidence":1,"confidence_rate":1},{"cnt":[[370,2172],[1646,2172],[1646,2224],[370,2224]],"region":{"top_left_x":369,"top_left_y":2172,"width":1277,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9a72e326f1549ab97733314bf604a2d","type":"text","conversion_output":true,"text":"utilizing the Ghosh-Lin method can be calculated for each treatment group.","text_display":" utilizing the Ghosh-Lin method can be calculated for each treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[370,2264],[1826,2264],[1826,2318],[370,2318]],"region":{"top_left_x":369,"top_left_y":2264,"width":1458,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9b75c5374fb4dcbb9f8c20c54aded3e","type":"text","conversion_output":true,"text":"The Andersen-Gill recurrent events method will be performed using PROC PHREG in","text_display":"\n\nThe Andersen-Gill recurrent events method will be performed using PROC PHREG in","confidence":1,"confidence_rate":1},{"cnt":[[370,2316],[1858,2316],[1858,2365],[370,2365]],"region":{"top_left_x":369,"top_left_y":2316,"width":1490,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7644215a109840c9916a36ba819bbebd","type":"text","conversion_output":true,"text":"SAS software. However, the Ghosh-Lin method requires implementation of a validated","text_display":" SAS software. However, the Ghosh-Lin method requires implementation of a validated","confidence":1,"confidence_rate":1},{"cnt":[[370,2363],[761,2363],[761,2415],[370,2415]],"region":{"top_left_x":369,"top_left_y":2363,"width":392,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3965c1e8906b4bd7b312b84ec38b5a13","type":"text","conversion_output":true,"text":"package in R software.","text_display":" package in R 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Medical Costs, Resource Use and Cost Effectiveness.","text_display":"\n\n\\subsection*{9.10 Medical Costs, Resource Use and Cost Effectiveness.}","confidence":1,"confidence_rate":1},{"cnt":[[245,363],[1880,363],[1880,415],[245,415]],"region":{"top_left_x":244,"top_left_y":363,"width":1636,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cea1c9d6d524cbca4562e78b85bf189","type":"text","conversion_output":true,"text":"Cost data will be analyzed by the CABANA EQOL Coordinating Center in close collaboration","text_display":"\n\nCost data will be analyzed by the CABANA EQOL Coordinating Center in close collaboration","confidence":1,"confidence_rate":1},{"cnt":[[245,408],[1880,408],[1880,462],[245,462]],"region":{"top_left_x":244,"top_left_y":408,"width":1636,"height":54},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d85dc195b0545f489d618cd7996ef0e","type":"text","conversion_output":true,"text":"with the Data Coordinating Center, and the analysis approach will be detailed in a separate","text_display":" with the Data Coordinating Center, and the analysis approach will be detailed in a separate","confidence":0.9970715045928955,"confidence_rate":0.9999694505516451},{"cnt":[[245,455],[477,455],[477,509],[245,509]],"region":{"top_left_x":244,"top_left_y":455,"width":233,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8bc38bf69764f79826541a327ebdd61","type":"text","conversion_output":true,"text":"analytic plan.","text_display":" analytic 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Again, the analysis approach will be detailed","text_display":" collaboration with the Data Coordinating Center. Again, the analysis approach will be detailed","confidence":1,"confidence_rate":1},{"cnt":[[245,786],[696,786],[696,836],[245,836]],"region":{"top_left_x":244,"top_left_y":786,"width":453,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"348b71f261194e37a9abb75b391cf6a1","type":"text","conversion_output":true,"text":"in a separate analytic plan.","text_display":" in a separate analytic plan.","confidence":1,"confidence_rate":1},{"cnt":[[241,907],[1018,907],[1018,967],[241,967]],"region":{"top_left_x":240,"top_left_y":906,"width":779,"height":61},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74587e259d0a4ff48694c0f70c8a6b14","type":"section_header","conversion_output":false,"children_ids":["292d14b79ae8466e9c3f14e169ae8fad"],"text":"","text_display":""},{"cnt":[[245,911],[1012,911],[1012,960],[245,960]],"region":{"top_left_x":244,"top_left_y":910,"width":768,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"292d14b79ae8466e9c3f14e169ae8fad","type":"text","conversion_output":true,"parent_id":"74587e259d0a4ff48694c0f70c8a6b14","text":"9.12 Major Non-Endpoint Adverse Events.","text_display":"\n\n\\subsection*{9.12 Major Non-Endpoint Adverse Events.}","confidence":1,"confidence_rate":1},{"cnt":[[245,1021],[1871,1021],[1871,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1020,"width":1628,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0920073796874a16a67febb7bda1123f","type":"text","conversion_output":true,"text":"Major adverse events (AE) will be monitored and reported during the trial. For drug therapy, the","text_display":"\n\nMajor adverse events (AE) will be monitored and reported during the trial. For drug therapy, the","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1830,1070],[1830,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1069,"width":1587,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa13b6b1e8b54171afc57040231c831d","type":"text","conversion_output":true,"text":"major serious or life-threatening events include unanticipated hospitalizations for heart failure,","text_display":" major serious or life-threatening events include unanticipated hospitalizations for heart failure,","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[1841,1117],[1841,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":1598,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"525ffa7d938d4cc386604155bd158416","type":"text","conversion_output":true,"text":"drug-related pro-arrhythmic events, and pulmonary toxicity from amiodarone. For the ablation","text_display":" drug-related pro-arrhythmic events, and pulmonary toxicity from amiodarone. For the ablation","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1775,1164],[1775,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1531,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"857b2d00e1b247c6b0d40821129525f6","type":"text","conversion_output":true,"text":"arm, the major events include symptomatic pulmonary vein stenosis requiring intervention,","text_display":" arm, the major events include symptomatic pulmonary vein stenosis requiring intervention,","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1878,1212],[1878,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1634,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed3d7e92a97149289e82ee339325740c","type":"text","conversion_output":true,"text":"myocardial perforation/tamponade requiring intervention, and atrial-esophageal fistula formation.","text_display":" myocardial perforation/tamponade requiring intervention, and atrial-esophageal fistula formation.","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1762,1259],[1762,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1258,"width":1518,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a11d061579041b8b2d9835eae31dd53","type":"text","conversion_output":true,"text":"The frequency of each of these events (and other serious adverse events such as peripheral","text_display":" The frequency of each of these events (and other serious adverse events such as peripheral","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1807,1306],[1807,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1306,"width":1563,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6320427439e14b31a2391c0310e2fcf5","type":"text","conversion_output":true,"text":"thromboembolic events) will be descriptively tabulated using MedDRA System Organ Class.","text_display":" thromboembolic events) will be descriptively tabulated using MedDRA System Organ Class.","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[1798,1354],[1798,1405],[245,1405]],"region":{"top_left_x":244,"top_left_y":1353,"width":1555,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7278b541e4a64cc1b0c149d4677a5dd5","type":"text","conversion_output":true,"text":"Treatment comparisons with respect to these serious adverse events will be more descriptive","text_display":" Treatment comparisons with respect to these serious adverse events will be more descriptive","confidence":1,"confidence_rate":1},{"cnt":[[245,1403],[1813,1403],[1813,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1402,"width":1570,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06d44b206a204e1eaacb3e9d674737fd","type":"text","conversion_output":true,"text":"rather than statistically rigorous (since different adverse events are expected in the two arms),","text_display":" rather than statistically rigorous (since different adverse events are expected in the two arms),","confidence":1,"confidence_rate":1},{"cnt":[[245,1452],[1843,1452],[1843,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":1600,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3685f716e94840768625f4adb0269b7f","type":"text","conversion_output":true,"text":"bringing to bear clinical judgment as to the relative seriousness of these various adverse events.","text_display":" bringing to bear clinical judgment as to the relative seriousness of these various adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[245,1500],[1676,1500],[1676,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1499,"width":1432,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1981594cc5dd45a7ad509ad561dc9e2b","type":"text","conversion_output":true,"text":"Other adverse complications or adverse events of either therapy will be tabulated and","text_display":" Other adverse complications or adverse events of either therapy will be tabulated and","confidence":1,"confidence_rate":1},{"cnt":[[245,1547],[1815,1547],[1815,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1546,"width":1572,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d304cd0951aa474ba6c2ce2072be9b81","type":"text","conversion_output":true,"text":"descriptively summarized, using statistical comparisons of the treatment groups based on chi-","text_display":" descriptively summarized, using statistical comparisons of the treatment groups based on chi","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1807,1594],[1807,1646],[245,1646]],"region":{"top_left_x":244,"top_left_y":1594,"width":1563,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9900dde7d6064708839b1a5c51abd270","type":"text","conversion_output":true,"text":"square tests where appropriate, and interpreting such comparisons in the context of treatment","text_display":"square tests where appropriate, and interpreting such comparisons in the context of treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1641],[1360,1641],[1360,1695],[245,1695]],"region":{"top_left_x":244,"top_left_y":1641,"width":1116,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce406235d3964718aad022e2ad01d0ba","type":"text","conversion_output":true,"text":"differences in the primary and major secondary clinical endpoints.","text_display":" differences in the primary and major secondary clinical endpoints.","confidence":1,"confidence_rate":1},{"cnt":[[241,1762],[990,1762],[990,1824],[241,1824]],"region":{"top_left_x":240,"top_left_y":1761,"width":751,"height":64},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bc12339531c43e58338f6d17ddd9317","type":"section_header","conversion_output":false,"children_ids":["387072ced7bf4cb5abbc05e249771bc9"],"text":"","text_display":""},{"cnt":[[245,1766],[986,1766],[986,1820],[245,1820]],"region":{"top_left_x":244,"top_left_y":1766,"width":743,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"387072ced7bf4cb5abbc05e249771bc9","type":"text","conversion_output":true,"parent_id":"4bc12339531c43e58338f6d17ddd9317","text":"9.13 LA Size, Morphology and Function.","text_display":"\n\n\\subsection*{9.13 LA Size, Morphology and 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Of interest will be the change in atrial size (volume) and function","text_display":" function will be examined. Of interest will be the change in atrial size (volume) and function","confidence":1,"confidence_rate":1},{"cnt":[[245,1951],[1772,1951],[1772,2002],[245,2002]],"region":{"top_left_x":244,"top_left_y":1950,"width":1529,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1192325767014110839ffd5852cd2432","type":"text","conversion_output":true,"text":"(i.e., atrial ejection fraction) from the pre-treatment to the post-treatment study within each","text_display":" (i.e., atrial ejection fraction) from the pre-treatment to the post-treatment study within each","confidence":0.99658203125,"confidence_rate":0.9999657623526261},{"cnt":[[245,1998],[1863,1998],[1863,2047],[245,2047]],"region":{"top_left_x":244,"top_left_y":1998,"width":1619,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"171a48f96b1a44f68f70d938209360f8","type":"text","conversion_output":true,"text":"treatment arm, and then importantly, a comparison of whether the change in size and function in","text_display":" treatment arm, and then importantly, a comparison of whether the change in size and function in","confidence":1,"confidence_rate":1},{"cnt":[[245,2045],[1824,2045],[1824,2099],[245,2099]],"region":{"top_left_x":244,"top_left_y":2045,"width":1581,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8df20c428c24c03bfa85e76f4e80f34","type":"text","conversion_output":true,"text":"the patients randomized to ablation therapy differs from the change in size and function of the","text_display":" the patients randomized to ablation therapy differs from the change in size and function of the","confidence":1,"confidence_rate":1},{"cnt":[[245,2093],[866,2093],[866,2146],[245,2146]],"region":{"top_left_x":244,"top_left_y":2092,"width":622,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab0ab05749284309a161c1c7ccb72ea8","type":"text","conversion_output":true,"text":"patients randomized to drug therapy.","text_display":" patients randomized to drug therapy.","confidence":1,"confidence_rate":1},{"cnt":[[245,2204],[1880,2204],[1880,2254],[245,2254]],"region":{"top_left_x":244,"top_left_y":2204,"width":1636,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"906d7e4af4a24692996e51456ce64352","type":"text","conversion_output":true,"text":"The distribution of these measures from the pre- and post-treatment studies in each treatment arm","text_display":"\n\nThe distribution of these measures from the pre- and post-treatment studies in each treatment arm","confidence":1,"confidence_rate":1},{"cnt":[[245,2252],[1772,2252],[1772,2301],[245,2301]],"region":{"top_left_x":244,"top_left_y":2251,"width":1529,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91903bcfe69348dba267e4d367a06a4d","type":"text","conversion_output":true,"text":"will be descriptively characterized using summary descriptive statistics and graphical tools","text_display":" will be descriptively characterized using summary descriptive statistics and graphical tools","confidence":1,"confidence_rate":1},{"cnt":[[245,2299],[1848,2299],[1848,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2298,"width":1604,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89accb77a8ae4450bd8c536085842ac0","type":"text","conversion_output":true,"text":"including box and whisker plots. The statistical significance of the changes in left atrial volume","text_display":" including box and whisker plots. The statistical significance of the changes in left atrial volume","confidence":1,"confidence_rate":1},{"cnt":[[245,2346],[1854,2346],[1854,2398],[245,2398]],"region":{"top_left_x":244,"top_left_y":2346,"width":1611,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ef7bba589074729af42d326d2c7e35e","type":"text","conversion_output":true,"text":"and atrial ejection fraction from pre- to post-treatment studies within each treatment arm will be","text_display":" and atrial ejection fraction from pre- to post-treatment studies within each treatment arm will be","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,2393],[1807,2393],[1807,2447],[245,2447]],"region":{"top_left_x":244,"top_left_y":2393,"width":1563,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"476018f986f04ad1a33ea29acddad70d","type":"text","conversion_output":true,"text":"assessed using general linear models (GLM), including the baseline value as a covariate, and","text_display":" assessed using general linear models (GLM), including the baseline value as a covariate, and","confidence":0.9970703125,"confidence_rate":0.9999697531643026},{"cnt":[[245,2443],[1738,2443],[1738,2494],[245,2494]],"region":{"top_left_x":244,"top_left_y":2442,"width":1495,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3402873c8bdf455697db090583499483","type":"text","conversion_output":true,"text":"assessing treatment group differences. If there appears to be differences in other baseline","text_display":" assessing treatment group differences. If there appears to be differences in other baseline","confidence":1,"confidence_rate":1},{"cnt":[[1040,2548],[1089,2548],[1089,2593],[1040,2593]],"region":{"top_left_x":1039,"top_left_y":2548,"width":51,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff229ec47999453dbefeeb0e4895e56f","type":"page_info","conversion_output":false,"text":"17","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-19","page":19,"lines":[{"cnt":[[245,251],[1880,251],[1880,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1636,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c49dbe4cf864cd3b70f58ccdb3a458f","type":"text","conversion_output":true,"text":"covariates between groups, adjustment for covariates will be considered. Secondary analyses will","text_display":"\ncovariates between groups, adjustment for covariates will be considered. Secondary analyses will","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[965,301],[965,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":721,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84840cf12ff448dc829e6e3468ea534a","type":"text","conversion_output":true,"text":"use a paired-sample t-test instead of GLM.","text_display":" use a paired-sample t-test instead of GLM.","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[245,395],[1833,395],[1833,447],[245,447]],"region":{"top_left_x":244,"top_left_y":395,"width":1589,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"137b528ad02641569474760dfd3af267","type":"text","conversion_output":true,"text":"In dealing with this type of data, the completeness of which is dependent on obtaining both the","text_display":"\n\nIn dealing with this type of data, the completeness of which is dependent on obtaining both the","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1828,443],[1828,496],[245,496]],"region":{"top_left_x":244,"top_left_y":442,"width":1585,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"289b642ec830480295afdb90e9d4547f","type":"text","conversion_output":true,"text":"pre- and post-treatment studies, there will inherently be missing data resulting from patients in","text_display":" pre- and post-treatment studies, there will inherently be missing data resulting from patients in","confidence":1,"confidence_rate":1},{"cnt":[[245,492],[1828,492],[1828,544],[245,544]],"region":{"top_left_x":244,"top_left_y":491,"width":1585,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d5a8e10502e499db89ce93a63a8934e","type":"text","conversion_output":true,"text":"whom it was not possible to obtain both studies (because they died or failed to return for other","text_display":" whom it was not possible to obtain both studies (because they died or failed to return for other","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1876,537],[1876,591],[245,591]],"region":{"top_left_x":244,"top_left_y":537,"width":1632,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6dec0e11e2c04ea99fc644c1aaf7b9b8","type":"text","conversion_output":true,"text":"reasons to enable the follow-up measurements to be made). The completeness of the data will be","text_display":" reasons to enable the follow-up measurements to be made). The completeness of the data will be","confidence":1,"confidence_rate":1},{"cnt":[[245,589],[1777,589],[1777,638],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":1533,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7904645a01074f988d042d477d37a963","type":"text","conversion_output":true,"text":"fully described, and the statistical comparisons will be based on patients for whom both the","text_display":" fully described, and the statistical comparisons will be based on patients for whom both the","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[995,636],[995,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":751,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdd4cf383f434f52ac76ae67b1502d7c","type":"text","conversion_output":true,"text":"baseline and follow-up studies are available.","text_display":" baseline and follow-up studies are available.","confidence":1,"confidence_rate":1},{"cnt":[[241,786],[872,786],[872,862],[241,862]],"region":{"top_left_x":240,"top_left_y":786,"width":633,"height":76},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df147a09227e41aaaf54263fe8424221","type":"section_header","conversion_output":false,"children_ids":["c2a27718a4c44865839bddc434042d88"],"text":"","text_display":""},{"cnt":[[245,795],[866,795],[866,853],[245,853]],"region":{"top_left_x":244,"top_left_y":794,"width":622,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2a27718a4c44865839bddc434042d88","type":"text","conversion_output":true,"parent_id":"df147a09227e41aaaf54263fe8424221","text":"10. \"On-Treatment\" Analysis","text_display":"\n\n\\section*{10. \"On-Treatment\" Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[245,911],[1848,911],[1848,960],[245,960]],"region":{"top_left_x":244,"top_left_y":910,"width":1604,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f917e3b2cccd4d7d907ff94bc9faafdf","type":"text","conversion_output":true,"text":"The intention-to-treat analyses in this trial will constitute the primary analyses and will serve as","text_display":"\n\nThe intention-to-treat analyses in this trial will constitute the primary analyses and will serve as","confidence":1,"confidence_rate":1},{"cnt":[[245,958],[1755,958],[1755,1008],[245,1008]],"region":{"top_left_x":244,"top_left_y":958,"width":1512,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21bc190687b74afb97e553c143cd83df","type":"text","conversion_output":true,"text":"the standard for interpreting treatment differences in the key clinical outcomes. However,","text_display":" the standard for interpreting treatment differences in the key clinical outcomes. However,","confidence":1,"confidence_rate":1},{"cnt":[[245,1005],[1850,1005],[1850,1057],[245,1057]],"region":{"top_left_x":244,"top_left_y":1005,"width":1606,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"790bb2a5a2f24051b42016603003bb74","type":"text","conversion_output":true,"text":"because a number of patients in the drug arm may cross over to receive ablation during the trial,","text_display":" because a number of patients in the drug arm may cross over to receive ablation during the trial,","confidence":1,"confidence_rate":1},{"cnt":[[245,1055],[1826,1055],[1826,1106],[245,1106]],"region":{"top_left_x":244,"top_left_y":1054,"width":1583,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e325ec3bec848d7a3232a04ac51672d","type":"text","conversion_output":true,"text":"and some patients randomized to ablation may not undergo the procedure, we will supplement","text_display":" and some patients randomized to ablation may not undergo the procedure, we will supplement","confidence":1,"confidence_rate":1},{"cnt":[[245,1104],[1824,1104],[1824,1154],[245,1154]],"region":{"top_left_x":244,"top_left_y":1104,"width":1581,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ce9d90d25db4092b6670809737340dd","type":"text","conversion_output":true,"text":"the intent-to-treat comparisons of the primary endpoint and selected secondary endpoints with","text_display":" the intent-to-treat comparisons of the primary endpoint and selected secondary endpoints with","confidence":1,"confidence_rate":1},{"cnt":[[245,1152],[1846,1152],[1846,1201],[245,1201]],"region":{"top_left_x":244,"top_left_y":1151,"width":1602,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c2c2293f2834abbb2513463c35a97e1","type":"text","conversion_output":true,"text":"\"on-treatment\" comparisons. The \"on-treatment\" analysis will involve a comparison of patients","text_display":" \"on-treatment\" comparisons. The \"on-treatment\" analysis will involve a comparison of patients","confidence":0.9931640625,"confidence_rate":0.999930008474512},{"cnt":[[245,1199],[1800,1199],[1800,1248],[245,1248]],"region":{"top_left_x":244,"top_left_y":1198,"width":1557,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8f8b42a49df4c659791d1918bde3e47","type":"text","conversion_output":true,"text":"who received ablation (even if originally assigned to the drug arm) versus those who did not.","text_display":" who received ablation (even if originally assigned to the drug arm) versus those who did not.","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[245,1246],[1837,1246],[1837,1298],[245,1298]],"region":{"top_left_x":244,"top_left_y":1246,"width":1593,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ba27aedd1674b87a977e8128bb702a6","type":"text","conversion_output":true,"text":"Statistically, this will be accomplished using the Cox proportional hazards model with ablation","text_display":" Statistically, this will be accomplished using the Cox proportional hazards model with ablation","confidence":1,"confidence_rate":1},{"cnt":[[245,1293],[1790,1293],[1790,1345],[245,1345]],"region":{"top_left_x":244,"top_left_y":1293,"width":1546,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9ba2066765d4fc5a905e105496a71d6","type":"text","conversion_output":true,"text":"included in the analysis as a time-dependent covariate. This analysis will be repeated for the","text_display":" included in the analysis as a time-dependent covariate. This analysis will be repeated for the","confidence":1,"confidence_rate":1},{"cnt":[[245,1343],[1837,1343],[1837,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1342,"width":1593,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7daa934ee50488984bff220a96bda4c","type":"text","conversion_output":true,"text":"primary endpoint, all-cause mortality, all-cause mortality or cardiovascular hospitalization, all-","text_display":" primary endpoint, all-cause mortality, all-cause mortality or cardiovascular hospitalization, all","confidence":1,"confidence_rate":1},{"cnt":[[245,1392],[1644,1392],[1644,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1392,"width":1400,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77997e306c1e4e59821e6903815e3d33","type":"text","conversion_output":true,"text":"cause mortality, stroke, or hospitalization for heart failure or acute ischemic events,","text_display":"cause mortality, stroke, or hospitalization for heart failure or acute ischemic events,","confidence":1,"confidence_rate":1},{"cnt":[[245,1439],[1876,1439],[1876,1489],[245,1489]],"region":{"top_left_x":244,"top_left_y":1439,"width":1632,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1457affac974e919eb609f102738c02","type":"text","conversion_output":true,"text":"cardiovascular death, cardiovascular death or disabling stroke, arrhythmic death or cardiac arrest,","text_display":" cardiovascular death, cardiovascular death or disabling stroke, arrhythmic death or cardiac arrest,","confidence":1,"confidence_rate":1},{"cnt":[[245,1487],[1871,1487],[1871,1536],[245,1536]],"region":{"top_left_x":244,"top_left_y":1486,"width":1628,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6041d285854b4aae9dc870d920a68477","type":"text","conversion_output":true,"text":"heart failure death, and cardiovascular hospitalization with and without adjustment for covariates","text_display":" heart failure death, and cardiovascular hospitalization with and without adjustment for covariates","confidence":1,"confidence_rate":1},{"cnt":[[245,1534],[1820,1534],[1820,1583],[245,1583]],"region":{"top_left_x":244,"top_left_y":1533,"width":1576,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"778bdc4a1b5247b889ff575e5b490ef9","type":"text","conversion_output":true,"text":"listed in section 8.1. No analyses will include competing risks, and on-treatment analysis will","text_display":" listed in section 8.1. No analyses will include competing risks, and on-treatment analysis will","confidence":1,"confidence_rate":1},{"cnt":[[245,1581],[1828,1581],[1828,1631],[245,1631]],"region":{"top_left_x":244,"top_left_y":1581,"width":1585,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0704faf75d684371b6165d1db7c057fc","type":"text","conversion_output":true,"text":"not be conducted for multiple events analyses (section 9.9). For recurrent atrial fibrillation, we","text_display":" not be conducted for multiple events analyses (section 9.9). For recurrent atrial fibrillation, we","confidence":1,"confidence_rate":1},{"cnt":[[245,1629],[1729,1629],[1729,1680],[245,1680]],"region":{"top_left_x":244,"top_left_y":1628,"width":1486,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"debb48f9f4e74e9f908a010e14f09a47","type":"text","conversion_output":true,"text":"will only conduct this on-treatment analysis for the first episode of recurrent AF without","text_display":" will only conduct this on-treatment analysis for the first episode of recurrent AF without","confidence":0.994140625,"confidence_rate":0.9999418174502049},{"cnt":[[245,1678],[1721,1678],[1721,1729],[245,1729]],"region":{"top_left_x":244,"top_left_y":1677,"width":1477,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"753111e0ed3640d78c58167b6b48c4eb","type":"text","conversion_output":true,"text":"competing risks in the 3 patient populations (Cabana box, non-cabana box, and pooled).","text_display":" competing risks in the 3 patient populations (Cabana box, non-cabana box, and pooled).","confidence":1,"confidence_rate":1},{"cnt":[[245,1727],[1661,1727],[1661,1777],[245,1777]],"region":{"top_left_x":244,"top_left_y":1727,"width":1417,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a98493eefa934b66a345bb7b6bcbef7b","type":"text","conversion_output":true,"text":"Secondary analyses may consider other measures of recurrent atrial fibrillation (e.g.,","text_display":" Secondary analyses may consider other measures of recurrent atrial fibrillation (e.g.,","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[245,1775],[1665,1775],[1665,1824],[245,1824]],"region":{"top_left_x":244,"top_left_y":1774,"width":1422,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80817a4194ac439090c011e41540f1c9","type":"text","conversion_output":true,"text":"symptomatic recurrent AF , atrial fibrillation or atrial flutter or atrial tachycardia, and","text_display":" symptomatic recurrent AF , atrial fibrillation or atrial flutter or atrial tachycardia, and","confidence":0.8740234375,"confidence_rate":0.998680791633896},{"cnt":[[243,1822],[1345,1822],[1345,1876],[243,1876]],"region":{"top_left_x":242,"top_left_y":1821,"width":1103,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7bf09b3cb244ebfa4e657515142070a","type":"text","conversion_output":true,"text":"symptomatic atrial fibrillation, atrial flutter, or atrial tachycardia).","text_display":" symptomatic atrial fibrillation, atrial flutter, or atrial tachycardia).","confidence":1,"confidence_rate":1},{"cnt":[[245,1916],[1760,1916],[1760,1968],[245,1968]],"region":{"top_left_x":244,"top_left_y":1916,"width":1516,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eecf478f781b4900ae1d86830dd9366e","type":"text","conversion_output":true,"text":"The time-dependent ablation variable to be included in the analysis will be created using 3","text_display":"\n\nThe time-dependent ablation variable to be included in the analysis will be created using 3","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[245,1966],[1815,1966],[1815,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1965,"width":1572,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74cb0a183c8a44ea98d69ec39a1b3f2b","type":"text","conversion_output":true,"text":"different methods: For method 1 , the ablation variable starts as 0 (no ablation) for all patients.","text_display":" different methods: For method 1 , the ablation variable starts as 0 (no ablation) for all patients.","confidence":0.9848771095275879,"confidence_rate":0.999861478617751},{"cnt":[[245,2013],[1807,2013],[1807,2065],[245,2065]],"region":{"top_left_x":244,"top_left_y":2013,"width":1563,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c233288ff8424f65abdf181a97ef728c","type":"text","conversion_output":true,"text":"For patients who received ablation, the ablation variable is set to 1 at the time of ablation. In","text_display":" For patients who received ablation, the ablation variable is set to 1 at the time of ablation. In","confidence":1,"confidence_rate":1},{"cnt":[[245,2058],[1841,2058],[1841,2110],[245,2110]],"region":{"top_left_x":244,"top_left_y":2058,"width":1598,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afcf603d12ff4272bce52d9a4b050e27","type":"text","conversion_output":true,"text":"method 2, the ablation variable starts as 1 for all patients who were randomized to ablation and","text_display":" method 2, the ablation variable starts as 1 for all patients who were randomized to ablation and","confidence":0.9960973262786865,"confidence_rate":0.9999624015816049},{"cnt":[[245,2110],[1858,2110],[1858,2159],[245,2159]],"region":{"top_left_x":244,"top_left_y":2109,"width":1615,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30c9d752fc2f4246936caa21d87438f5","type":"text","conversion_output":true,"text":"actually received ablation. For all other patients, the ablation variable is started as 0 and set to 1","text_display":" actually received ablation. For all other patients, the ablation variable is started as 0 and set to 1","confidence":1,"confidence_rate":1},{"cnt":[[245,2157],[1760,2157],[1760,2206],[245,2206]],"region":{"top_left_x":244,"top_left_y":2157,"width":1516,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"472093aff5b54061a3c9814fff720012","type":"text","conversion_output":true,"text":"at the time of ablation if they received ablation during the trial. Method 3 has the ablation","text_display":" at the time of ablation if they received ablation during the trial. Method 3 has the ablation","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[245,2204],[1815,2204],[1815,2256],[245,2256]],"region":{"top_left_x":244,"top_left_y":2204,"width":1572,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57d64a51f44c4ff89307ce93c384f59b","type":"text","conversion_output":true,"text":"variable started as 1 for patients who were randomized to ablation. For all other patients (i.e.,","text_display":" variable started as 1 for patients who were randomized to ablation. For all other patients (i.e.,","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[245,2252],[1717,2252],[1717,2305],[245,2305]],"region":{"top_left_x":244,"top_left_y":2251,"width":1473,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d471d06a32e24ef58049e1cc7e31f4fc","type":"text","conversion_output":true,"text":"randomized to drug), the ablation variable is started as 0 and set to 1 at time of ablation.","text_display":" randomized to drug), the ablation variable is started as 0 and set to 1 at time of ablation.","confidence":1,"confidence_rate":1},{"cnt":[[245,2348],[1858,2348],[1858,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2348,"width":1615,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ddeb23361f24a10bc3032fcdefceafb","type":"text","conversion_output":true,"text":"Among the 3 methods described above, method 2 will be considered the main statistical method","text_display":"\n\nAmong the 3 methods described above, method 2 will be considered the main statistical method","confidence":0.9990234375,"confidence_rate":0.9999905142231666},{"cnt":[[245,2398],[1824,2398],[1824,2447],[245,2447]],"region":{"top_left_x":244,"top_left_y":2397,"width":1581,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfe9ac01717f417481752359f40065c1","type":"text","conversion_output":true,"text":"in handling cross-overs via a time-dependent variable in Cox model. The other 2 methods are","text_display":" in handling cross-overs via a time-dependent variable in Cox model. The other 2 methods are","confidence":1,"confidence_rate":1},{"cnt":[[245,2445],[823,2445],[823,2494],[245,2494]],"region":{"top_left_x":244,"top_left_y":2444,"width":579,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67b9ba930d054e2ca1d338b766624a09","type":"text","conversion_output":true,"text":"considered as sensitivity analyses.","text_display":" considered as sensitivity analyses.","confidence":1,"confidence_rate":1},{"cnt":[[1040,2548],[1089,2548],[1089,2593],[1040,2593]],"region":{"top_left_x":1039,"top_left_y":2548,"width":51,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"440d70eba4064def838e4fb3bb8fcafa","type":"page_info","conversion_output":false,"text":"18","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-20","page":20,"lines":[{"cnt":[[245,301],[1867,301],[1867,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1623,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a52183a3ae64e9696f8c340fca2e828","type":"text","conversion_output":true,"text":"Differential treatment effects for the primary endpoint and major secondary endpoints of interest","text_display":"\n\nDifferential treatment effects for the primary endpoint and major secondary endpoints of interest","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1792,348],[1792,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1548,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f49ec27e9324274ac4110098e032292","type":"text","conversion_output":true,"text":"using on-treatment analyses will also be conducted. Subgroups of interest will include those","text_display":" using on-treatment analyses will also be conducted. Subgroups of interest will include those","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[589,397],[589,440],[245,440]],"region":{"top_left_x":244,"top_left_y":397,"width":345,"height":44},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d7550aef52143f29a979e085796a5e5","type":"text","conversion_output":true,"text":"listed in section 8.1.","text_display":" listed in section 8.1.","confidence":1,"confidence_rate":1},{"cnt":[[245,490],[1768,490],[1768,541],[245,541]],"region":{"top_left_x":244,"top_left_y":489,"width":1525,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c903e842bc67495588db3cdb9b2921c5","type":"text","conversion_output":true,"text":"Because treatment assignment is no longer random, results can be biased by an association","text_display":"\n\nBecause treatment assignment is no longer random, results can be biased by an association","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1871,537],[1871,589],[245,589]],"region":{"top_left_x":244,"top_left_y":537,"width":1628,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"822e6f39a6014b8e93673bf5211f0fbf","type":"text","conversion_output":true,"text":"between the likelihood of treatment change and the risk of a clinical event (i.e., factors that make","text_display":" between the likelihood of treatment change and the risk of a clinical event (i.e., factors that make","confidence":0.9912149906158447,"confidence_rate":0.9999159671016559},{"cnt":[[245,587],[1798,587],[1798,638],[245,638]],"region":{"top_left_x":244,"top_left_y":586,"width":1555,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"195eb5f7ba8740be89009cd148000a0d","type":"text","conversion_output":true,"text":"a patient more likely to cross over may also make them more likely to have an event). Thus,","text_display":" a patient more likely to cross over may also make them more likely to have an event). Thus,","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[1841,636],[1841,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1598,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"529e27982f864627a9a05e3118e619e8","type":"text","conversion_output":true,"text":"such analyses will be cautiously interpreted. Each of the analyses described in this section will","text_display":" such analyses will be cautiously interpreted. Each of the analyses described in this section will","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1781,683],[1781,735],[245,735]],"region":{"top_left_x":244,"top_left_y":683,"width":1538,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddffbd8134fc4e3e92dc0cb04f6dc515","type":"text","conversion_output":true,"text":"be covariate adjusted using the covariates described in section 8.1 for the primary endpoint.","text_display":" be covariate adjusted using the covariates described in section 8.1 for the primary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[241,851],[797,851],[797,922],[241,922]],"region":{"top_left_x":240,"top_left_y":850,"width":558,"height":72},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5fde12788614ca788a2fbbbff43d10c","type":"section_header","conversion_output":false,"children_ids":["b2790f2034e94b02a5f0c35a61aa5d4a"],"text":"","text_display":""},{"cnt":[[245,859],[793,859],[793,915],[245,915]],"region":{"top_left_x":244,"top_left_y":859,"width":549,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2790f2034e94b02a5f0c35a61aa5d4a","type":"text","conversion_output":true,"parent_id":"c5fde12788614ca788a2fbbbff43d10c","text":"11. Per-Protocol Analysis","text_display":"\n\n\\section*{11. Per-Protocol Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[1777,971],[1777,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":971,"width":1533,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c25d9d54b4fe4a55942ad4b7bfa2e32d","type":"text","conversion_output":true,"text":"Using the methods described for the primary endpoint in Section 8, an analysis will also be","text_display":"\n\nUsing the methods described for the primary endpoint in Section 8, an analysis will also be","confidence":1,"confidence_rate":1},{"cnt":[[245,1018],[1850,1018],[1850,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1018,"width":1606,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0bd829a6e604ac0a9c4139ac033881e","type":"text","conversion_output":true,"text":"performed to compare the primary endpoint and the key secondary clinical outcomes of the two","text_display":" performed to compare the primary endpoint and the key secondary clinical outcomes of the two","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1783,1070],[1783,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1069,"width":1540,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d1c1be8da614ed1b54debcdd0da700b","type":"text","conversion_output":true,"text":"treatment strategies among the subset of patients who fully satisfied the inclusion/exclusion","text_display":" treatment strategies among the subset of patients who fully satisfied the inclusion/exclusion","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1811,1113],[1811,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1112,"width":1568,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acfa812d3b8e40a9a33aa47d9b9fc553","type":"text","conversion_output":true,"text":"criteria and received the treatment to which they were randomly allocated. This analysis will","text_display":" criteria and received the treatment to which they were randomly allocated. This analysis will","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1815,1164],[1815,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1572,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dba17ea7aff432da276b4240d05a99c","type":"text","conversion_output":true,"text":"include patients randomized to the drug arm who were treated with drug therapy, and patients","text_display":" include patients randomized to the drug arm who were treated with drug therapy, and patients","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1708,1212],[1708,1263],[245,1263]],"region":{"top_left_x":244,"top_left_y":1211,"width":1465,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c89f88ae53348f18632c11c6fbcf598","type":"text","conversion_output":true,"text":"randomized to the ablation arm who underwent the ablation within 6 months following","text_display":" randomized to the ablation arm who underwent the ablation within 6 months following","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1846,1259],[1846,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1258,"width":1602,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e3374a746ff4adfba1eb6e8f1a13b1c","type":"text","conversion_output":true,"text":"enrollment in the trial. The follow-up of drug-arm patients who crossed over to ablation will be","text_display":" enrollment in the trial. The follow-up of drug-arm patients who crossed over to ablation will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1308],[1777,1308],[1777,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1308,"width":1533,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb605cec0d1241f099e7713135994baa","type":"text","conversion_output":true,"text":"censored at the time of the ablation. Patients randomized to the ablation arm who were not","text_display":" censored at the time of the ablation. Patients randomized to the ablation arm who were not","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[1867,1354],[1867,1407],[245,1407]],"region":{"top_left_x":244,"top_left_y":1353,"width":1623,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cd59297dac7445297bd9eab35ed11dd","type":"text","conversion_output":true,"text":"ablated within 6 months will be excluded from this analysis. Additional sensitivity analyses will","text_display":" ablated within 6 months will be excluded from this analysis. Additional sensitivity analyses will","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[245,1403],[1858,1403],[1858,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1402,"width":1615,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"620dc421de874b8da253c058a99eef9f","type":"text","conversion_output":true,"text":"be performed in which the window for ablation is varied to include a shorter interval (3 months)","text_display":" be performed in which the window for ablation is varied to include a shorter interval (3 months)","confidence":0.990234375,"confidence_rate":0.9999028401515285},{"cnt":[[245,1452],[758,1452],[758,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":515,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69eb47f393d04629926c93eb8b10b957","type":"text","conversion_output":true,"text":"and a longer window (1 year).","text_display":" and a longer window (1 year).","confidence":0.77978515625,"confidence_rate":0.992710905897005},{"cnt":[[245,1575],[1841,1575],[1841,1626],[245,1626]],"region":{"top_left_x":244,"top_left_y":1574,"width":1598,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa15a4ea11b14b62b52e93017f597f9a","type":"text","conversion_output":true,"text":"The analyses outlined in Sections 10 and 11 will be strictly supplementary to the intent-to-treat","text_display":"\n\nThe analyses outlined in Sections 10 and 11 will be strictly supplementary to the intent-to-treat","confidence":0.99609375,"confidence_rate":0.9999637608481249},{"cnt":[[245,1624],[694,1624],[694,1674],[245,1674]],"region":{"top_left_x":244,"top_left_y":1624,"width":450,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebecce3db81a4a4782a6c25a350c495a","type":"text","conversion_output":true,"text":"analyses described earlier.","text_display":" analyses described earlier.","confidence":1,"confidence_rate":1},{"cnt":[[241,1792],[801,1792],[801,1861],[241,1861]],"region":{"top_left_x":240,"top_left_y":1791,"width":562,"height":70},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1851ce1bfc0047d8bfa65c75bb3e9f56","type":"section_header","conversion_output":false,"children_ids":["d69f5d1346ea4293b35a3ef3b85f41af"],"text":"","text_display":""},{"cnt":[[247,1796],[793,1796],[793,1854],[247,1854]],"region":{"top_left_x":247,"top_left_y":1796,"width":546,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d69f5d1346ea4293b35a3ef3b85f41af","type":"text","conversion_output":true,"parent_id":"1851ce1bfc0047d8bfa65c75bb3e9f56","text":"12. Multiple Comparisons","text_display":"\n\n\\section*{12. Multiple Comparisons}","confidence":1,"confidence_rate":1},{"cnt":[[245,1912],[1852,1912],[1852,1964],[245,1964]],"region":{"top_left_x":244,"top_left_y":1912,"width":1608,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30acf3514bb443c18e8cb8be7fbfd630","type":"text","conversion_output":true,"text":"With the primary hypothesis and the various secondary endpoints that have been outlined, there","text_display":"\n\nWith the primary hypothesis and the various secondary endpoints that have been outlined, there","confidence":1,"confidence_rate":1},{"cnt":[[245,1959],[1865,1959],[1865,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1959,"width":1621,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0ef203daead4a3a96dbd2a9ab22b40e","type":"text","conversion_output":true,"text":"is a multiplicity of analyses to be performed, which leads to an increased probability that at least","text_display":" is a multiplicity of analyses to be performed, which leads to an increased probability that at least","confidence":1,"confidence_rate":1},{"cnt":[[245,2007],[1848,2007],[1848,2058],[245,2058]],"region":{"top_left_x":244,"top_left_y":2006,"width":1604,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b70e44d2fc4d4932bc3371f7c0aa6cef","type":"text","conversion_output":true,"text":"one of the comparisons could be \"significant\" by chance. There are adjustments (e.g., based on","text_display":" one of the comparisons could be \"significant\" by chance. There are adjustments (e.g., based on","confidence":1,"confidence_rate":1},{"cnt":[[245,2056],[1880,2056],[1880,2108],[245,2108]],"region":{"top_left_x":244,"top_left_y":2056,"width":1636,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b25f713e47d430987e41d4f4794811c","type":"text","conversion_output":true,"text":"the Bonferroni inequality) that could be used to preserve the overall type I error level. To attempt","text_display":" the Bonferroni inequality) that could be used to preserve the overall type I error level. To attempt","confidence":1,"confidence_rate":1},{"cnt":[[245,2105],[1841,2105],[1841,2155],[245,2155]],"region":{"top_left_x":244,"top_left_y":2105,"width":1598,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7b6a25470f649e995a0f04342620c02","type":"text","conversion_output":true,"text":"to adjust for the effects of the repeated significance testing that will occur as part of the interim","text_display":" to adjust for the effects of the repeated significance testing that will occur as part of the interim","confidence":1,"confidence_rate":1},{"cnt":[[245,2153],[1800,2153],[1800,2202],[245,2202]],"region":{"top_left_x":244,"top_left_y":2152,"width":1557,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02f3b33cc2c94141b1e09a157acb3dce","type":"text","conversion_output":true,"text":"monitoring (discussed below), plus adjust for the multiplicity of secondary endpoints, would","text_display":" monitoring (discussed below), plus adjust for the multiplicity of secondary endpoints, would","confidence":1,"confidence_rate":1},{"cnt":[[245,2200],[1820,2200],[1820,2249],[245,2249]],"region":{"top_left_x":244,"top_left_y":2200,"width":1576,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d96aa9554bcb4e20900f9384cc73d949","type":"text","conversion_output":true,"text":"require that very small significance levels be used for every comparison. The overall level of","text_display":" require that very small significance levels be used for every comparison. The overall level of","confidence":1,"confidence_rate":1},{"cnt":[[245,2247],[1841,2247],[1841,2297],[245,2297]],"region":{"top_left_x":244,"top_left_y":2247,"width":1598,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92b7cb87d43644e79419a5f02b084f4d","type":"text","conversion_output":true,"text":"significance will be 0.049 for the assessment of the primary endpoint (see Section 13) and 0.05","text_display":" significance will be 0.049 for the assessment of the primary endpoint (see Section 13) and 0.05","confidence":0.998046875,"confidence_rate":0.9999808331754918},{"cnt":[[245,2295],[1794,2295],[1794,2346],[245,2346]],"region":{"top_left_x":244,"top_left_y":2294,"width":1550,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc940234ca9344b0a0c9606e21e514e2","type":"text","conversion_output":true,"text":"for all secondary endpoints. However, to account in part for the multiplicity of comparisons","text_display":" for all secondary endpoints. However, to account in part for the multiplicity of comparisons","confidence":1,"confidence_rate":1},{"cnt":[[245,2342],[1792,2342],[1792,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2341,"width":1548,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03c4384253424bfbb8a79d97272f2f83","type":"text","conversion_output":true,"text":"involving secondary endpoints, we will be conservative in the interpretation of the analyses,","text_display":" involving secondary endpoints, we will be conservative in the interpretation of the analyses,","confidence":1,"confidence_rate":1},{"cnt":[[245,2391],[1880,2391],[1880,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2391,"width":1636,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"287df214838041e89f27db9defa74c59","type":"text","conversion_output":true,"text":"taking into account the degree of significance, and looking for consistency across endpoints. The","text_display":" taking into account the degree of significance, and looking for consistency across endpoints. The","confidence":1,"confidence_rate":1},{"cnt":[[245,2436],[1852,2436],[1852,2490],[245,2490]],"region":{"top_left_x":244,"top_left_y":2436,"width":1608,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6eea23af3aea46e785ba6e8c6b93c8b7","type":"text","conversion_output":true,"text":"actual p -value for each comparison will be reported to aid in the overall interpretation. We have","text_display":" actual p -value for each comparison will be reported to aid in the overall interpretation. We have","confidence":0.8329224586486816,"confidence_rate":0.998324206373325},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9e8d4fbe83f41089a7e4e89d21ff89b","type":"page_info","conversion_output":false,"text":"19","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0438e85c-2dbd-4c22-b88d-c2b98e01b5fd-21","page":21,"lines":[{"cnt":[[245,254],[1837,254],[1837,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1593,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6eb152834b84e75b3d318702ef21191","type":"text","conversion_output":true,"text":"also pre-specified the primary and secondary outcome variables to avoid over-interpretation of","text_display":"\nalso pre-specified the primary and secondary outcome variables to avoid over-interpretation of","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[804,301],[804,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":560,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2b16cf376cb4fdb99de6d1039a41aeb","type":"text","conversion_output":true,"text":"strictly exploratory comparisons.","text_display":" strictly exploratory comparisons.","confidence":1,"confidence_rate":1},{"cnt":[[241,455],[690,455],[690,524],[241,524]],"region":{"top_left_x":240,"top_left_y":455,"width":450,"height":70},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"280788009b404aaa9e0ad47b6533fb8b","type":"section_header","conversion_output":false,"children_ids":["a06b5f96efb249d6a7b939a60c9f6642"],"text":"","text_display":""},{"cnt":[[245,460],[683,460],[683,518],[245,518]],"region":{"top_left_x":244,"top_left_y":459,"width":440,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a06b5f96efb249d6a7b939a60c9f6642","type":"text","conversion_output":true,"parent_id":"280788009b404aaa9e0ad47b6533fb8b","text":"13. Interim Analyses","text_display":"\n\n\\section*{13. Interim Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[245,576],[1850,576],[1850,625],[245,625]],"region":{"top_left_x":244,"top_left_y":575,"width":1606,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ea60791902c427481205b98b942490c","type":"text","conversion_output":true,"text":"For ethical reasons, an interim examination of key safety and endpoint data has been performed","text_display":"\n\nFor ethical reasons, an interim examination of key safety and endpoint data has been performed","confidence":1,"confidence_rate":1},{"cnt":[[245,623],[1863,623],[1863,672],[245,672]],"region":{"top_left_x":244,"top_left_y":623,"width":1619,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31cea2821cb2400f8b297e3074a54a3e","type":"text","conversion_output":true,"text":"at regular intervals during the course of the trial. The primary objective of these analyses was to","text_display":" at regular intervals during the course of the trial. The primary objective of these analyses was to","confidence":1,"confidence_rate":1},{"cnt":[[245,670],[1867,670],[1867,722],[245,722]],"region":{"top_left_x":244,"top_left_y":670,"width":1623,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4616189ff2774ec3ae26dff950211bee","type":"text","conversion_output":true,"text":"evaluate the accumulating data for an unacceptably high frequency of negative clinical outcomes","text_display":" evaluate the accumulating data for an unacceptably high frequency of negative clinical outcomes","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,718],[1785,718],[1785,769],[245,769]],"region":{"top_left_x":244,"top_left_y":717,"width":1542,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4728e85a77546a0a0498a358ed216c2","type":"text","conversion_output":true,"text":"in either of the treatment arms. In addition, the interim monitoring involved a review of the","text_display":" in either of the treatment arms. In addition, the interim monitoring involved a review of the","confidence":1,"confidence_rate":1},{"cnt":[[245,767],[1815,767],[1815,819],[245,819]],"region":{"top_left_x":244,"top_left_y":766,"width":1572,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1854cbca4240435fb5be9d3acc50ef5a","type":"text","conversion_output":true,"text":"aggregated event rates, patient recruitment, compliance with the study protocol, status of data","text_display":" aggregated event rates, patient recruitment, compliance with the study protocol, status of data","confidence":1,"confidence_rate":1},{"cnt":[[245,816],[1852,816],[1852,866],[245,866]],"region":{"top_left_x":244,"top_left_y":816,"width":1608,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ed3ebe176f3469caea51b19ad5597f7","type":"text","conversion_output":true,"text":"collection, and other factors which reflected the overall progress and integrity of the study. The","text_display":" collection, and other factors which reflected the overall progress and integrity of the study. The","confidence":1,"confidence_rate":1},{"cnt":[[245,864],[1833,864],[1833,913],[245,913]],"region":{"top_left_x":244,"top_left_y":863,"width":1589,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab8889dba05e4cf284d2cdfe6c44f1c3","type":"text","conversion_output":true,"text":"results of the interim analyses and status reports were carefully and confidentially reviewed by","text_display":" results of the interim analyses and status reports were carefully and confidentially reviewed by","confidence":0.99755859375,"confidence_rate":0.9999757983983905},{"cnt":[[245,911],[1364,911],[1364,960],[245,960]],"region":{"top_left_x":244,"top_left_y":910,"width":1121,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e702ef7b5ef146cfbe92a23f58c1354f","type":"text","conversion_output":true,"text":"an NHLBI-appointed Data and Safety Monitoring Board (DSMB).","text_display":" an NHLBI-appointed Data and Safety Monitoring Board (DSMB).","confidence":1,"confidence_rate":1},{"cnt":[[245,1036],[1807,1036],[1807,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1035,"width":1563,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d67c7b41aa89434c9db81bedc9c909a8","type":"text","conversion_output":true,"text":"The DSMB met at approximately 6 -month intervals to review the accumulating data. Prior to","text_display":"\n\nThe DSMB met at approximately 6 -month intervals to review the accumulating data. Prior to","confidence":0.874241828918457,"confidence_rate":0.9986295292450272},{"cnt":[[245,1083],[1837,1083],[1837,1132],[245,1132]],"region":{"top_left_x":244,"top_left_y":1082,"width":1593,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"135506c865784a118c8f0c5f0d1d5e95","type":"text","conversion_output":true,"text":"each meeting, the Statistical and Data Coordinating Center (SDCC) at the DCRI conducted the","text_display":" each meeting, the Statistical and Data Coordinating Center (SDCC) at the DCRI conducted the","confidence":1,"confidence_rate":1},{"cnt":[[245,1130],[1747,1130],[1747,1179],[245,1179]],"region":{"top_left_x":244,"top_left_y":1130,"width":1503,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faf6414762544770b70a75f39dcc96a6","type":"text","conversion_output":true,"text":"desired statistical analyses and prepared a summary report for review by the DSMB. The","text_display":" desired statistical analyses and prepared a summary report for review by the DSMB. The","confidence":1,"confidence_rate":1},{"cnt":[[245,1177],[1850,1177],[1850,1227],[245,1227]],"region":{"top_left_x":244,"top_left_y":1177,"width":1606,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2432f4942f03409d881e7dc98651ea6d","type":"text","conversion_output":true,"text":"extracted data files and analysis programs for each DSMB report were archived and maintained","text_display":" extracted data files and analysis programs for each DSMB report were archived and maintained","confidence":1,"confidence_rate":1},{"cnt":[[245,1227],[1846,1227],[1846,1276],[245,1276]],"region":{"top_left_x":244,"top_left_y":1226,"width":1602,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ea7ad7646694e71b38bbb7a3e9ea696","type":"text","conversion_output":true,"text":"at the DCRI. Reports were presented describing the progress of patient enrollment, the rates of","text_display":" at the DCRI. Reports were presented describing the progress of patient enrollment, the rates of","confidence":1,"confidence_rate":1},{"cnt":[[245,1276],[1850,1276],[1850,1326],[245,1326]],"region":{"top_left_x":244,"top_left_y":1276,"width":1606,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88c2a88c7fea48e4b5e27b5b522f282d","type":"text","conversion_output":true,"text":"compliance with therapy, and the frequency of protocol violations. The SDCC also reported on","text_display":" compliance with therapy, and the frequency of protocol violations. The SDCC also reported on","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,1323],[1790,1323],[1790,1373],[245,1373]],"region":{"top_left_x":244,"top_left_y":1323,"width":1546,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ad10f85b3b64370beb943c7486686a5","type":"text","conversion_output":true,"text":"the number (status) of data forms completed and the overall quality and completeness of the","text_display":" the number (status) of data forms completed and the overall quality and completeness of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1371],[460,1371],[460,1416],[245,1416]],"region":{"top_left_x":244,"top_left_y":1370,"width":216,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"720a5eeeb5e34d1a81b0bfdde8bda72b","type":"text","conversion_output":true,"text":"information.","text_display":" information.","confidence":1,"confidence_rate":1},{"cnt":[[245,1487],[1846,1487],[1846,1545],[245,1545]],"region":{"top_left_x":244,"top_left_y":1486,"width":1602,"height":59},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c51b06e1b43f4795a8681612478f5c9e","type":"text","conversion_output":true,"text":"In CABANA, a group sequential method similar to that proposed by O'Brien and Fleming \\({ }^{9}\\) was","text_display":"\n\nIn CABANA, a group sequential method similar to that proposed by O'Brien and Fleming \\({ }^{9}\\) was","confidence":0.9843823909759521,"confidence_rate":0.9998500983915757},{"cnt":[[245,1543],[1807,1543],[1807,1592],[245,1592]],"region":{"top_left_x":244,"top_left_y":1542,"width":1563,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"325300029be043e3a4cf9c8c7a25a633","type":"text","conversion_output":true,"text":"used as a guide in interpreting interim analyses. This procedure required large critical values","text_display":" used as a guide in interpreting interim analyses. This procedure required large critical values","confidence":1,"confidence_rate":1},{"cnt":[[245,1590],[1858,1590],[1858,1639],[245,1639]],"region":{"top_left_x":244,"top_left_y":1589,"width":1615,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"277877d72c9b437d9a1b3ab967c24513","type":"text","conversion_output":true,"text":"early in the study, but relaxed (i.e., decreased) the critical value as the trial progressed. Because","text_display":" early in the study, but relaxed (i.e., decreased) the critical value as the trial progressed. Because","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,1637],[1852,1637],[1852,1687],[245,1687]],"region":{"top_left_x":244,"top_left_y":1637,"width":1608,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0270dc858e654da4a13841056efac7d9","type":"text","conversion_output":true,"text":"of the conservatism early in the trial, the critical value at the final analysis is near the \"nominal\"","text_display":" of the conservatism early in the trial, the critical value at the final analysis is near the \"nominal\"","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[245,1680],[1800,1680],[1800,1734],[245,1734]],"region":{"top_left_x":244,"top_left_y":1680,"width":1557,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d10e87d3c7a4be9b817602d8e7d19b6","type":"text","conversion_output":true,"text":"critical value. The actual method used for the interim monitoring was the Lan and DeMets \\({ }^{10}\\)","text_display":" critical value. The actual method used for the interim monitoring was the Lan and DeMets \\({ }^{10}\\)","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1852,1732],[1852,1783],[245,1783]],"region":{"top_left_x":244,"top_left_y":1731,"width":1608,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27eb92300dae417aa962158c76e8d60e","type":"text","conversion_output":true,"text":"group sequential method with monitoring boundaries based on a two-sided, symmetric O'Brien-","text_display":" group sequential method with monitoring boundaries based on a two-sided, symmetric O'Brien","confidence":1,"confidence_rate":1},{"cnt":[[245,1781],[1833,1781],[1833,1833],[245,1833]],"region":{"top_left_x":244,"top_left_y":1781,"width":1589,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28eb31545d5242f8ac8c1d704fef0f24","type":"text","conversion_output":true,"text":"Fleming type spending function. The Lan-DeMets approach only required specification of the","text_display":"Fleming type spending function. The Lan-DeMets approach only required specification of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1833],[1751,1833],[1751,1884],[245,1884]],"region":{"top_left_x":244,"top_left_y":1832,"width":1507,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5a726089eb7487e9a7af6652332eab0","type":"text","conversion_output":true,"text":"rate at which the Type I error (which in this trial is \\(\\alpha=0.05\\) for the primary endpoint) was","text_display":" rate at which the Type I error (which in this trial is \\(\\alpha=0.05\\) for the primary endpoint) was","confidence":1,"confidence_rate":1},{"cnt":[[245,1882],[1869,1882],[1869,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1882,"width":1626,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1268d10a6934ec7800acf9dd83b2317","type":"text","conversion_output":true,"text":"\"spent\". The procedure allowed \"spending\" a portion of \\(\\alpha\\) at each interim analysis in such a way","text_display":" \"spent\". The procedure allowed \"spending\" a portion of \\(\\alpha\\) at each interim analysis in such a way","confidence":0.9956090442137793,"confidence_rate":0.9999572764044674},{"cnt":[[245,1934],[1846,1934],[1846,1981],[245,1981]],"region":{"top_left_x":244,"top_left_y":1933,"width":1602,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44d18912c2b34f02ab286ab829f43b18","type":"text","conversion_output":true,"text":"that at the end of the study, the total Type I error did not exceed 0.05 . The specific formulation","text_display":" that at the end of the study, the total Type I error did not exceed 0.05 . The specific formulation","confidence":0.9716796875,"confidence_rate":0.9997315400750793},{"cnt":[[245,1972],[1824,1972],[1824,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1972,"width":1581,"height":59},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3042056537f94aa6af51a3355f2b682d","type":"text","conversion_output":true,"text":"of the spending function is described in Chapter 5 of Proschan et al (formula 5.4) \\({ }^{11}\\). Since the","text_display":" of the spending function is described in Chapter 5 of Proschan et al (formula 5.4) \\({ }^{11}\\). 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Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. \\(2^{ nd }\\) edition. 2002,","text_display":"\n1. Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. \\(2^{ nd }\\) edition. 2002,","confidence":0.6202478408813477,"confidence_rate":0.9958552555443234},{"cnt":[[305,404],[1109,404],[1109,453],[305,453]],"region":{"top_left_x":305,"top_left_y":403,"width":804,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2178cbeeebdf483ebaa8d1cc9428ed1b","type":"text","conversion_output":true,"text":"John Wiley \\& Sons, Inc. Hoboken, New Jersey.","text_display":" John Wiley \\& Sons, Inc. 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J Royal Statist Soc B 1972;","confidence":1,"confidence_rate":1},{"cnt":[[305,498],[518,498],[518,544],[305,544]],"region":{"top_left_x":305,"top_left_y":498,"width":213,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2971c076d12c40dda4d9fdba36a75de3","type":"text","conversion_output":true,"text":"34:187-220.","text_display":" 34:187-220.","confidence":0.99951171875,"confidence_rate":0.9999694754347522},{"cnt":[[243,546],[1852,546],[1852,597],[243,597]],"region":{"top_left_x":242,"top_left_y":545,"width":1610,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f3ff592870645aab647b60ed3521be5","type":"text","conversion_output":true,"text":"3. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Statist","text_display":"\n3. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Statist","confidence":1,"confidence_rate":1},{"cnt":[[305,597],[715,597],[715,642],[305,642]],"region":{"top_left_x":305,"top_left_y":597,"width":411,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d7c9968ca624922a798271cec2f82cc","type":"text","conversion_output":true,"text":"Assn 1958; 53:457-481.","text_display":" Assn 1958; 53:457-481.","confidence":1,"confidence_rate":1},{"cnt":[[243,645],[1729,645],[1729,694],[243,694]],"region":{"top_left_x":242,"top_left_y":644,"width":1488,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18a1729e527f4000b27d4620b9238207","type":"text","conversion_output":true,"text":"4. Kirchhof P, Breithardt G, Camm AJ, Crijns HJ, Kuck K-H, Vardas P, Wegscheider K.","text_display":"\n4. 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