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(2) are eligible for catheter ablation, (3) are eligible for \\(\\geq 2\\) membrane active drugs and/or \\(\\geq 2\\) rate control drugs, and (4) are \\(\\geq 65\\) yrs of age or < 65 yrs with one or more risk factors for stroke (hypertension, diabetes, heart failure, prior stroke or TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), or left atrial diameter \\(\\geq 5.0 cm\\) or left atrial volume \\(\\geq 40 cc / m ^{2}\\) ). Eligible subjects with persistent or longstanding persistent AF will require at least 1 documented episode. 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who have new onset or under-treated paroxysmal, persistent, or longstanding persistent AF who warrant therapy for their arrhythmia, that (1) Over the preceding 6 months have: \\\\\na) \\(\\geq 2\\) paroxysmal episodes (electrocardiographic documentation of at least 1 episode) lasting \\(\\geq 1\\) hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset) \\\\\nb) electrocardiographic documentation of 1 persistent AF episode: (sustained for \\(\\geq 7\\) days or cardioversion is performed more than 48 h after AF onset); \\\\\nc) electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration \\(>1\\) year). 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See main protocol for complete inclusion/exclusion criteria.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nSubjects who have new onset or under-treated paroxysmal, persistent, or longstanding persistent AF who warrant therapy for their arrhythmia, that (1) Over the preceding 6 months have: \\\\\na) \\(\\geq 2\\) paroxysmal episodes (electrocardiographic documentation of at least 1 episode) lasting \\(\\geq 1\\) hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset) \\\\\nb) electrocardiographic documentation of 1 persistent AF episode: (sustained for \\(\\geq 7\\) days or cardioversion is performed more than 48 h after AF onset); \\\\\nc) electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration \\(>1\\) year). 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SPONSOR & National Heart Lung and Blood Institute \\\\\n\\hline & treated AF warranting therapy. \\\\\n\\hline STUDY DESIGN & Multicenter, prospective, randomized, open-label clinical trial. \\\\\n\\hline TREATMENT REGIMEN(S) & One-half of the subjects will be randomly allocated to treatment with catheter ablation and one-half will be allocated to drug therapy for either rate control or rhythm control. \\\\\n\\hline DURATION OF STUDY PARTICIPATION & Enrollment will occur over approximately 4 years, and subjects will be followed for an average of approximately 5 years. \\\\\n\\hline NUMBER OF SUBJECTS & 2000-2200 with a 1:1 randomization ratio \\\\\n\\hline NUMBER OF SITES & \\begin{tabular}{l}\nTotal number: approximately 180 \\\\\nNorth American Sites: approximately 120 \\\\\nNon-North American Sites: approximately 60\n\\end{tabular} \\\\\n\\hline PRIMARY ENDPOINT & Composite of: 1) total mortality, 2) disabling stroke, 3) serious bleeding, or 4) cardiac arrest. \\\\\n\\hline & 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The Canadian Registry of AF (CARAF) showed that \\(63 \\%\\) of 757 patients with","text_display":" of patients. The Canadian Registry of AF (CARAF) showed that \\(63 \\%\\) of 757 patients with","confidence":1,"confidence_rate":1},{"cnt":[[305,1790],[1944,1790],[1944,1837],[305,1837]],"region":{"top_left_x":305,"top_left_y":1789,"width":1640,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"731193331a794cc6b94a6fbc42cb1487","type":"text","conversion_output":true,"text":"paroxysmal AF had recurrent arrhythmia over a 5 year period, with progression to permanent","text_display":" paroxysmal AF had recurrent arrhythmia over a 5 year period, with progression to permanent","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[305,1835],[1944,1835],[1944,1882],[305,1882]],"region":{"top_left_x":305,"top_left_y":1834,"width":1640,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3639dd042e2448bbb14ebb25c67df370","type":"text","conversion_output":true,"text":"AF seen in \\(25 \\%\\) [7]. Similar numbers have been documented by others [8, 9]. Although","text_display":" AF seen in \\(25 \\%\\) [7]. Similar numbers have been documented by others [8, 9]. Although","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[305,1878],[1944,1878],[1944,1927],[305,1927]],"region":{"top_left_x":305,"top_left_y":1877,"width":1640,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59463ebe3bd74d27868abf1bef8475cf","type":"text","conversion_output":true,"text":"progression to chronic AF in patients with little underlying heart disease may be as low as \\(31 \\%\\)","text_display":" progression to chronic AF in patients with little underlying heart disease may be as low as \\(31 \\%\\)","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[305,1921],[1944,1921],[1944,1970],[305,1970]],"region":{"top_left_x":305,"top_left_y":1920,"width":1640,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceff23b283444cc08b0f4672d99899bf","type":"text","conversion_output":true,"text":"over 3 decades [10], other reports document progression to chronic AF in \\(48-77 \\%\\) of patients","text_display":" over 3 decades [10], other reports document progression to chronic AF in \\(48-77 \\%\\) of patients","confidence":0.93115234375,"confidence_rate":0.9993009074148665},{"cnt":[[305,1966],[1944,1966],[1944,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1965,"width":1640,"height":49},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36f7e30ecf774d218064cecb4c1be2df","type":"text","conversion_output":true,"text":"over 8-14 years[11,12]. These differences are due, in part, to the extent of underlying disease","text_display":" over 8-14 years[11,12]. These differences are due, in part, to the extent of underlying disease","confidence":0.888671875,"confidence_rate":0.998820424186236},{"cnt":[[305,2007],[453,2007],[453,2056],[305,2056]],"region":{"top_left_x":305,"top_left_y":2006,"width":149,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe85ce64e87b465f8b0c08a3161478b5","type":"text","conversion_output":true,"text":"[13, 14].","text_display":" [13, 14].","confidence":0.96484375,"confidence_rate":0.9974468998715431},{"cnt":[[305,2097],[1940,2097],[1940,2144],[305,2144]],"region":{"top_left_x":305,"top_left_y":2096,"width":1636,"height":49},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d59109ff81a2491e8efd9531f7281c2a","type":"text","conversion_output":true,"text":"There is also reason to anticipate an increasing impact of this arrhythmia on mortality, stroke,","text_display":"\n\nThere is also reason to anticipate an increasing impact of this arrhythmia on mortality, stroke,","confidence":1,"confidence_rate":1},{"cnt":[[305,2140],[1944,2140],[1944,2189],[305,2189]],"region":{"top_left_x":305,"top_left_y":2139,"width":1640,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5f16ad947ec42aca4867616503cf6aa","type":"text","conversion_output":true,"text":"bleeding and cardiac arrest. In the Framingham study [15], both men and women between 55","text_display":" bleeding and cardiac arrest. In the Framingham study [15], both men and women between 55","confidence":1,"confidence_rate":1},{"cnt":[[305,2185],[1944,2185],[1944,2232],[305,2232]],"region":{"top_left_x":305,"top_left_y":2184,"width":1640,"height":49},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ae32a725eb443c2bd5def0b2d07c61e","type":"text","conversion_output":true,"text":"and 75 years of age with AF showed a near doubling of mortality over the course of 10 years.","text_display":" and 75 years of age with AF showed a near doubling of mortality over the course of 10 years.","confidence":1,"confidence_rate":1},{"cnt":[[305,2230],[1944,2230],[1944,2275],[305,2275]],"region":{"top_left_x":305,"top_left_y":2230,"width":1640,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29e88f71dd6640faad5992f86fe75c5f","type":"text","conversion_output":true,"text":"Within that time frame, the overall death rate was approximately \\(15 \\%\\) in patients without and","text_display":" Within that time frame, the overall death rate was approximately \\(15 \\%\\) in patients without and","confidence":1,"confidence_rate":1},{"cnt":[[305,2273],[1944,2273],[1944,2322],[305,2322]],"region":{"top_left_x":305,"top_left_y":2273,"width":1640,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83b5e8a9e5f047a795567742d3fe2ac3","type":"text","conversion_output":true,"text":"\\(55 \\%\\) in those with AF. This rate is further incremented in those individuals between the ages of","text_display":" \\(55 \\%\\) in those with AF. This rate is further incremented in those individuals between the ages of","confidence":1,"confidence_rate":1},{"cnt":[[305,2316],[1944,2316],[1944,2365],[305,2365]],"region":{"top_left_x":305,"top_left_y":2316,"width":1640,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d423fffde9624b9da73d9a752d7dddc2","type":"text","conversion_output":true,"text":"75 and 94 years, in whom the mortality rate increased from \\(30 \\%\\) to nearly \\(70 \\%\\) in the presence","text_display":" 75 and 94 years, in whom the mortality rate increased from \\(30 \\%\\) to nearly \\(70 \\%\\) in the presence","confidence":1,"confidence_rate":1},{"cnt":[[305,2359],[1944,2359],[1944,2408],[305,2408]],"region":{"top_left_x":305,"top_left_y":2358,"width":1640,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8884201417c44f679360753959084192","type":"text","conversion_output":true,"text":"of AF [15]. Up to \\(50 \\%\\) of individuals with a new stroke in both population-based and cohort","text_display":" of AF [15]. Up to \\(50 \\%\\) of individuals with a new stroke in both population-based and cohort","confidence":0.9990236759185791,"confidence_rate":0.9999900326925697},{"cnt":[[305,2402],[1944,2402],[1944,2451],[305,2451]],"region":{"top_left_x":305,"top_left_y":2401,"width":1640,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1aa8dab5a8874961a4bcfe1aef3ae3f1","type":"text","conversion_output":true,"text":"studies have underlying, potentially related, AF [16-18]. This risk increases from an attributable","text_display":" studies have underlying, potentially related, AF [16-18]. This risk increases from an attributable","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[305,2445],[1944,2445],[1944,2499],[305,2499]],"region":{"top_left_x":305,"top_left_y":2444,"width":1640,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"564982bdab6d4c76b942de6bee1a573f","type":"text","conversion_output":true,"text":"risk of \\(1.5 \\%\\) in the \\(6^{\\text {th }}\\) decade of life to \\(23.5 \\%\\) in \\(80-89\\) year olds [18]. The problem of AF","text_display":" risk of \\(1.5 \\%\\) in the \\(6^{\\text {th }}\\) decade of life to \\(23.5 \\%\\) in \\(80-89\\) year olds [18]. The problem of AF","confidence":0.6097500643358131,"confidence_rate":0.9958514347475679},{"cnt":[[309,2574],[967,2574],[967,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":658,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b024a2c4bfc346fdbaf2c3b648fa02af","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999889000502843},{"cnt":[[1616,2574],[1841,2574],[1841,2617],[1616,2617]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":44},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25f64f7d316c44278d0629ebe63ac526","type":"page_info","conversion_output":false,"text":"Page 13 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-15","page":15,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd96db01e57d46f9bb3d38642f2e1781","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[309,251],[1944,251],[1944,299],[309,299]],"region":{"top_left_x":309,"top_left_y":251,"width":1636,"height":48},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ee747f1ad894541aa08bfc9afdaf2cd","type":"text","conversion_output":true,"text":"associated stroke is corroborated by another population-based study from Olmsted County","text_display":"\nassociated stroke is corroborated by another population-based study from Olmsted County","confidence":1,"confidence_rate":1},{"cnt":[[309,296],[1940,296],[1940,342],[309,342]],"region":{"top_left_x":309,"top_left_y":296,"width":1632,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c38d75e9a7674cd9a6fbefae4f1cf20a","type":"text","conversion_output":true,"text":"demonstrating an increasing prevalence of stroke related to AF over the past 3 decades,","text_display":" demonstrating an increasing prevalence of stroke related to AF over the past 3 decades,","confidence":1,"confidence_rate":1},{"cnt":[[309,339],[1098,339],[1098,387],[309,387]],"region":{"top_left_x":309,"top_left_y":339,"width":789,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a23768728714fe399f11be58126d54a","type":"text","conversion_output":true,"text":"perhaps due to increasing AF occurrence [19].","text_display":" perhaps due to increasing AF occurrence [19].","confidence":1,"confidence_rate":1},{"cnt":[[305,421],[883,421],[883,471],[305,471]],"region":{"top_left_x":305,"top_left_y":421,"width":579,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf9901bad0954cc69f63513309d1a4d3","type":"section_header","conversion_output":false,"children_ids":["de7b9810ef4948e1b6fc7f2e28d92441"],"text":"","text_display":""},{"cnt":[[309,425],[879,425],[879,466],[309,466]],"region":{"top_left_x":309,"top_left_y":425,"width":570,"height":42},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de7b9810ef4948e1b6fc7f2e28d92441","type":"text","conversion_output":true,"parent_id":"cf9901bad0954cc69f63513309d1a4d3","text":"1.1.3 Health Care Costs of AF","text_display":"\n\n\\subsection*{1.1.3 Health Care Costs of AF}","confidence":1,"confidence_rate":1},{"cnt":[[305,471],[1940,471],[1940,518],[305,518]],"region":{"top_left_x":305,"top_left_y":470,"width":1636,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a24151df17e54ee6b2da9212b87ba659","type":"text","conversion_output":true,"text":"AF related illness is a rapidly increasing burden on the global health care system. Data from the","text_display":"\n\nAF related illness is a rapidly increasing burden on the global health care system. Data from the","confidence":1,"confidence_rate":1},{"cnt":[[305,516],[1940,516],[1940,561],[305,561]],"region":{"top_left_x":305,"top_left_y":515,"width":1636,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ca60186ca2949ff99dd4258afb1a38d","type":"text","conversion_output":true,"text":"2003 National Discharge Survey in the US, used to estimate the annual number and prevalence","text_display":" 2003 National Discharge Survey in the US, used to estimate the annual number and prevalence","confidence":1,"confidence_rate":1},{"cnt":[[307,559],[1944,559],[1944,604],[307,604]],"region":{"top_left_x":307,"top_left_y":558,"width":1638,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e4325694dc44fd3a9fe276397a78532","type":"text","conversion_output":true,"text":"of hospitalizations, showed an increase from 154,086 to 376,487 admissions for AF as the first","text_display":" of hospitalizations, showed an increase from 154,086 to 376,487 admissions for AF as the first","confidence":0.865234375,"confidence_rate":0.9986223321901757},{"cnt":[[305,604],[1940,604],[1940,649],[305,649]],"region":{"top_left_x":305,"top_left_y":603,"width":1636,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6c78c71a3f142acb41a8ceba21ba0e6","type":"text","conversion_output":true,"text":"listed diagnosis and from 787,750 to \\(2,283,673\\) for any AF diagnosis [20]. Other studies","text_display":" listed diagnosis and from 787,750 to \\(2,283,673\\) for any AF diagnosis [20]. Other studies","confidence":1,"confidence_rate":1},{"cnt":[[307,647],[1940,647],[1940,692],[307,692]],"region":{"top_left_x":307,"top_left_y":646,"width":1634,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a78d3be3d2745b7a1783863dd4c91e7","type":"text","conversion_output":true,"text":"document an increase in hospitalizations and nursing home need because of this arrhythmia","text_display":" document an increase in hospitalizations and nursing home need because of this arrhythmia","confidence":1,"confidence_rate":1},{"cnt":[[307,692],[1940,692],[1940,737],[307,737]],"region":{"top_left_x":307,"top_left_y":691,"width":1634,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e870a1133764ea8bc841476f4fdcf9c","type":"text","conversion_output":true,"text":"[20, 21]. A recent study suggested that the excess annual health care cost in the US is also 5","text_display":" [20, 21]. A recent study suggested that the excess annual health care cost in the US is also 5","confidence":0.9522363822907209,"confidence_rate":0.9995007167824838},{"cnt":[[305,735],[1940,735],[1940,780],[305,780]],"region":{"top_left_x":305,"top_left_y":734,"width":1636,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20fd940ff8ad42a2b42cd06d0fec495c","type":"text","conversion_output":true,"text":"times greater in patients with, than without AF [22]. An additional four-fold increase in expense","text_display":" times greater in patients with, than without AF [22]. An additional four-fold increase in expense","confidence":1,"confidence_rate":1},{"cnt":[[307,778],[1944,778],[1944,823],[307,823]],"region":{"top_left_x":307,"top_left_y":777,"width":1638,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a2c69a4db6d41fcb7df6f66278e89da","type":"text","conversion_output":true,"text":"has also been reported in patients with multiple yearly AF recurrences [23]. Similarly, the cost of","text_display":" has also been reported in patients with multiple yearly AF recurrences [23]. Similarly, the cost of","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[1940,821],[1940,866],[305,866]],"region":{"top_left_x":305,"top_left_y":820,"width":1636,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6279f9c59e1948f7b4c2792dbc4d6933","type":"text","conversion_output":true,"text":"AF-related care in the UK rose from \\(244,000,000\\) Pounds in 1995 to \\(459,000,000\\) Pounds in","text_display":" AF-related care in the UK rose from \\(244,000,000\\) Pounds in 1995 to \\(459,000,000\\) Pounds in","confidence":0.9507308006286621,"confidence_rate":0.9994998842451432},{"cnt":[[305,866],[1940,866],[1940,913],[305,913]],"region":{"top_left_x":305,"top_left_y":865,"width":1636,"height":49},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79b36ee37738499194b73cce5957dfe2","type":"text","conversion_output":true,"text":"2000[24]. The cost of AF hospitalization, the foremost driver of AF-related expense, is likewise","text_display":" 2000[24]. The cost of AF hospitalization, the foremost driver of AF-related expense, is likewise","confidence":0.95703125,"confidence_rate":0.9995652506305613},{"cnt":[[305,911],[1768,911],[1768,956],[305,956]],"region":{"top_left_x":305,"top_left_y":910,"width":1464,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b24ce620df94fc89a881751f6a638df","type":"text","conversion_output":true,"text":"increasing [24-25], presaging even greater increases in health care costs in the future.","text_display":" increasing [24-25], presaging even greater increases in health care costs in the future.","confidence":1,"confidence_rate":1},{"cnt":[[305,999],[1308,999],[1308,1068],[305,1068]],"region":{"top_left_x":305,"top_left_y":999,"width":1004,"height":69},"line":18,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"4cbf0060faa44f329aa8ab4f63b5691d","type":"section_header","conversion_output":false,"children_ids":["7353afa79165445e8dc9b45e411754da"],"text":"","text_display":""},{"cnt":[[309,1005],[1304,1005],[1304,1059],[309,1059]],"region":{"top_left_x":309,"top_left_y":1005,"width":996,"height":55},"line":19,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"7353afa79165445e8dc9b45e411754da","type":"text","conversion_output":true,"parent_id":"4cbf0060faa44f329aa8ab4f63b5691d","text":"1.2 Clinical Experience with Drug Therapy","text_display":"\n\n\\subsection*{1.2 Clinical Experience with Drug Therapy}","confidence":1,"confidence_rate":1},{"cnt":[[305,1059],[1940,1059],[1940,1106],[305,1106]],"region":{"top_left_x":305,"top_left_y":1059,"width":1636,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5cc0896f0ef47d89c5586aaa16e5348","type":"text","conversion_output":true,"text":"The medical approach to patients with AF by definition requires poly-pharmacy. Many patients","text_display":"\n\nThe medical approach to patients with AF by definition requires poly-pharmacy. Many patients","confidence":1,"confidence_rate":1},{"cnt":[[305,1104],[1940,1104],[1940,1149],[305,1149]],"region":{"top_left_x":305,"top_left_y":1104,"width":1636,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff95a0effd3d44a389fb2ae18e54e563","type":"text","conversion_output":true,"text":"with recurrent AF require rate control therapy. Others, in whom sinus rhythm is desirable,","text_display":" with recurrent AF require rate control therapy. Others, in whom sinus rhythm is desirable,","confidence":1,"confidence_rate":1},{"cnt":[[307,1145],[1944,1145],[1944,1192],[307,1192]],"region":{"top_left_x":307,"top_left_y":1145,"width":1638,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfe9f36202314161a7d0af56637ab58b","type":"text","conversion_output":true,"text":"require treatment with an anti-arrhythmic drug, while patients with risk factors for stroke or","text_display":" require treatment with an anti-arrhythmic drug, while patients with risk factors for stroke or","confidence":1,"confidence_rate":1},{"cnt":[[307,1190],[1940,1190],[1940,1235],[307,1235]],"region":{"top_left_x":307,"top_left_y":1190,"width":1634,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4e041ab33c54ca9a1dd7fa2a76834e5","type":"text","conversion_output":true,"text":"peripheral thromboembolic events require anti-thrombotic therapy. Many health care providers","text_display":" peripheral thromboembolic events require anti-thrombotic therapy. Many health care providers","confidence":1,"confidence_rate":1},{"cnt":[[305,1233],[1944,1233],[1944,1280],[305,1280]],"region":{"top_left_x":305,"top_left_y":1233,"width":1640,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9ba917bef274ca3b45f36cbbd7a68c9","type":"text","conversion_output":true,"text":"also remain unenthusiastic about the limited efficacy and increased proarrhythmic risks of","text_display":" also remain unenthusiastic about the limited efficacy and increased proarrhythmic risks of","confidence":1,"confidence_rate":1},{"cnt":[[305,1276],[986,1276],[986,1326],[305,1326]],"region":{"top_left_x":305,"top_left_y":1276,"width":682,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"310409caf7894a4e9c55ab42e0b7ca37","type":"text","conversion_output":true,"text":"membrane-active agents for AF control.","text_display":" membrane-active agents for AF control.","confidence":1,"confidence_rate":1},{"cnt":[[305,1360],[904,1360],[904,1416],[305,1416]],"region":{"top_left_x":305,"top_left_y":1359,"width":600,"height":57},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8547c8960afb4a07ba068aa92d85b2db","type":"section_header","conversion_output":false,"children_ids":["3d75d5b7aad44a93a6960c9119dd5ad6"],"text":"","text_display":""},{"cnt":[[309,1366],[898,1366],[898,1412],[309,1412]],"region":{"top_left_x":309,"top_left_y":1366,"width":590,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d75d5b7aad44a93a6960c9119dd5ad6","type":"text","conversion_output":true,"parent_id":"8547c8960afb4a07ba068aa92d85b2db","text":"1.2.1 Anti-Thrombotic Therapy","text_display":"\n\n\\subsection*{1.2.1 Anti-Thrombotic Therapy}","confidence":1,"confidence_rate":1},{"cnt":[[305,1409],[1940,1409],[1940,1454],[305,1454]],"region":{"top_left_x":305,"top_left_y":1409,"width":1636,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40f0b6d392114fb281723b210c495625","type":"text","conversion_output":true,"text":"The importance of anti-thrombotic therapy in the management of patients with AF has been","text_display":"\n\nThe importance of anti-thrombotic therapy in the management of patients with AF has been","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[305,1452],[1944,1452],[1944,1500],[305,1500]],"region":{"top_left_x":305,"top_left_y":1452,"width":1640,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64630013101349d4b0f83a048a0ff24e","type":"text","conversion_output":true,"text":"established by the AFASAK, SPAF, BAATAF, EAFT, CAFA and other trials demonstrating a","text_display":" established by the AFASAK, SPAF, BAATAF, EAFT, CAFA and other trials demonstrating a","confidence":1,"confidence_rate":1},{"cnt":[[305,1497],[1944,1497],[1944,1545],[305,1545]],"region":{"top_left_x":305,"top_left_y":1497,"width":1640,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03ed23d749e44bd1b0b6572805a3ad9b","type":"text","conversion_output":true,"text":"reduction in stroke risk with warfarin [26]. The response to aspirin or clopidogrel and aspirin has","text_display":" reduction in stroke risk with warfarin [26]. The response to aspirin or clopidogrel and aspirin has","confidence":1,"confidence_rate":1},{"cnt":[[305,1540],[1944,1540],[1944,1588],[305,1588]],"region":{"top_left_x":305,"top_left_y":1540,"width":1640,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0529bc19ae4c41dc81d60b336d8cec3b","type":"text","conversion_output":true,"text":"been disappointing, as shown in these and the recent ACTIVE Trial [27]. Both the AFFIRM and","text_display":" been disappointing, as shown in these and the recent ACTIVE Trial [27]. Both the AFFIRM and","confidence":1,"confidence_rate":1},{"cnt":[[305,1586],[1940,1586],[1940,1635],[305,1635]],"region":{"top_left_x":305,"top_left_y":1585,"width":1636,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc28ecba06da4deabc296f240862cb22","type":"text","conversion_output":true,"text":"RACE trials also clearly demonstrated excess stroke morbidity in patients discontinuing","text_display":" RACE trials also clearly demonstrated excess stroke morbidity in patients discontinuing","confidence":1,"confidence_rate":1},{"cnt":[[305,1629],[1940,1629],[1940,1676],[305,1676]],"region":{"top_left_x":305,"top_left_y":1628,"width":1636,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19258f4f02e240af9bfce3cde35b23ce","type":"text","conversion_output":true,"text":"anticoagulation and in those with inappropriate INRs [28, 29]. This finding may be related to the","text_display":" anticoagulation and in those with inappropriate INRs [28, 29]. This finding may be related to the","confidence":0.9931640625,"confidence_rate":0.9999327531479268},{"cnt":[[305,1671],[1944,1671],[1944,1721],[305,1721]],"region":{"top_left_x":305,"top_left_y":1671,"width":1640,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4793fef277c435aa35eeef914c4505b","type":"text","conversion_output":true,"text":"occurrence of asymptomatic AF seen in \\(40-60 \\%\\) of patients [30-33]. Perhaps the most crucial","text_display":" occurrence of asymptomatic AF seen in \\(40-60 \\%\\) of patients [30-33]. Perhaps the most crucial","confidence":0.9522387653123587,"confidence_rate":0.9995007423059533},{"cnt":[[305,1714],[1944,1714],[1944,1764],[305,1764]],"region":{"top_left_x":305,"top_left_y":1714,"width":1640,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4867dc82a2b5429cbc3d748669654848","type":"text","conversion_output":true,"text":"contribution of these trials is the clarion call to maintain anticoagulation, even if sinus rhythm","text_display":" contribution of these trials is the clarion call to maintain anticoagulation, even if sinus rhythm","confidence":1,"confidence_rate":1},{"cnt":[[305,1762],[1813,1762],[1813,1807],[305,1807]],"region":{"top_left_x":305,"top_left_y":1761,"width":1509,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb6a2ed29af04a00ac081a269064f8be","type":"text","conversion_output":true,"text":"has been restored. It remains unclear whether these data apply to post-ablation patients.","text_display":" has been restored. It remains unclear whether these data apply to post-ablation patients.","confidence":1,"confidence_rate":1},{"cnt":[[303,1841],[995,1841],[995,1897],[303,1897]],"region":{"top_left_x":302,"top_left_y":1841,"width":693,"height":57},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f55859054f4d41e4a11b5de414afd8f2","type":"section_header","conversion_output":false,"children_ids":["e61099900a8f488181a9ee839850774d"],"text":"","text_display":""},{"cnt":[[309,1848],[990,1848],[990,1893],[309,1893]],"region":{"top_left_x":309,"top_left_y":1847,"width":682,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e61099900a8f488181a9ee839850774d","type":"text","conversion_output":true,"parent_id":"f55859054f4d41e4a11b5de414afd8f2","text":"1.2.2 Drug Therapy for Rate Control","text_display":"\n\n\\subsection*{1.2.2 Drug Therapy for Rate Control}","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[309,1893],[1944,1893],[1944,1940],[309,1940]],"region":{"top_left_x":309,"top_left_y":1892,"width":1636,"height":49},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bd6cd8430244f058b294eef9b181702","type":"text","conversion_output":true,"text":"In many patients with new onset AF, therapy with single or combination rate control agents can","text_display":"\n\nIn many patients with new onset AF, therapy with single or combination rate control agents can","confidence":0.93896484375,"confidence_rate":0.9993640685470352},{"cnt":[[305,1936],[1944,1936],[1944,1983],[305,1983]],"region":{"top_left_x":305,"top_left_y":1935,"width":1640,"height":49},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d63c6d6387e46f39d754c0af7216b14","type":"text","conversion_output":true,"text":"be valuable [34]. Agents such as beta- or calcium channel blockers, or even digitalis may","text_display":" be valuable [34]. Agents such as beta- or calcium channel blockers, or even digitalis may","confidence":1,"confidence_rate":1},{"cnt":[[305,1981],[1944,1981],[1944,2026],[305,2026]],"region":{"top_left_x":305,"top_left_y":1980,"width":1640,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55df4947c32a46d1bb760ec5f4f5adc0","type":"text","conversion_output":true,"text":"control heart rate in the many patients treated aggressively. The AFFIRM trial demonstrated","text_display":" control heart rate in the many patients treated aggressively. The AFFIRM trial demonstrated","confidence":1,"confidence_rate":1},{"cnt":[[305,2024],[1944,2024],[1944,2071],[305,2071]],"region":{"top_left_x":305,"top_left_y":2023,"width":1640,"height":49},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74cdbfc5b269472b9a0099b3ea84ae91","type":"text","conversion_output":true,"text":"that \\(65 \\%\\) of patients so treated had appropriate rate control at 1 year, with \\(70 \\%\\) at 2 years, and","text_display":" that \\(65 \\%\\) of patients so treated had appropriate rate control at 1 year, with \\(70 \\%\\) at 2 years, and","confidence":0.99853515625,"confidence_rate":0.9999870273612914},{"cnt":[[305,2067],[1944,2067],[1944,2116],[305,2116]],"region":{"top_left_x":305,"top_left_y":2066,"width":1640,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9198cf2a14474ed48c03b07ac0453cec","type":"text","conversion_output":true,"text":"\\(75 \\%\\) at 3 years [28]. Comparable findings were seen in the RACE trial [29]. Nevertheless, these","text_display":" \\(75 \\%\\) at 3 years [28]. Comparable findings were seen in the RACE trial [29]. Nevertheless, these","confidence":1,"confidence_rate":1},{"cnt":[[305,2110],[1351,2110],[1351,2159],[305,2159]],"region":{"top_left_x":305,"top_left_y":2109,"width":1047,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"630488b191a84c4ca1266e08bcf25eb1","type":"text","conversion_output":true,"text":"patients may have a variety of other drug-related side effects.","text_display":" patients may have a variety of other drug-related side effects.","confidence":1,"confidence_rate":1},{"cnt":[[305,2196],[1246,2196],[1246,2249],[305,2249]],"region":{"top_left_x":305,"top_left_y":2195,"width":942,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e526db341b9243fd920cfdd7fcef3f7a","type":"section_header","conversion_output":false,"children_ids":["1bda8aaca0094339ad70511838163961"],"text":"","text_display":""},{"cnt":[[309,2200],[1240,2200],[1240,2245],[309,2245]],"region":{"top_left_x":309,"top_left_y":2200,"width":931,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bda8aaca0094339ad70511838163961","type":"text","conversion_output":true,"parent_id":"e526db341b9243fd920cfdd7fcef3f7a","text":"1.2.3 Drug Therapy for Maintaining Sinus Rhythm","text_display":"\n\n\\subsection*{1.2.3 Drug Therapy for Maintaining Sinus Rhythm}","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[305,2243],[1944,2243],[1944,2292],[305,2292]],"region":{"top_left_x":305,"top_left_y":2242,"width":1640,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25daae3fb6f54fb4a59cfbed983c0560","type":"text","conversion_output":true,"text":"Multiple small observational studies demonstrate a \\(40-50 \\%\\) chance of maintaining sinus rhythm","text_display":"\n\nMultiple small observational studies demonstrate a \\(40-50 \\%\\) chance of maintaining sinus rhythm","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[305,2288],[1944,2288],[1944,2333],[305,2333]],"region":{"top_left_x":305,"top_left_y":2288,"width":1640,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5382498fcd85459cb65b7d8cb46ed32a","type":"text","conversion_output":true,"text":"with membrane active anti-arrhythmic drugs over the course of one year. These data have","text_display":" with membrane active anti-arrhythmic drugs over the course of one year. These data have","confidence":1,"confidence_rate":1},{"cnt":[[305,2331],[1944,2331],[1944,2378],[305,2378]],"region":{"top_left_x":305,"top_left_y":2331,"width":1640,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23d9942f15864902a0c7f40b4b08856f","type":"text","conversion_output":true,"text":"been validated by recent larger comparative clinical trials. In AFFIRM, \\(82.4 \\%\\) of patients treated","text_display":" been validated by recent larger comparative clinical trials. In AFFIRM, \\(82.4 \\%\\) of patients treated","confidence":0.9892578125,"confidence_rate":0.9998971452770452},{"cnt":[[305,2376],[1944,2376],[1944,2421],[305,2421]],"region":{"top_left_x":305,"top_left_y":2376,"width":1640,"height":46},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2d58c7e12d944de8d4b7dcf4ae45e31","type":"text","conversion_output":true,"text":"with rhythm control drugs were in sinus rhythm at the end of 1 year, \\(73.3 \\%\\) at 3 years, and","text_display":" with rhythm control drugs were in sinus rhythm at the end of 1 year, \\(73.3 \\%\\) at 3 years, and","confidence":1,"confidence_rate":1},{"cnt":[[305,2419],[1944,2419],[1944,2469],[305,2469]],"region":{"top_left_x":305,"top_left_y":2419,"width":1640,"height":50},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb5294d6b12b4bd6ae7cfed526e61561","type":"text","conversion_output":true,"text":"\\(62.6 \\%\\) at 5 years [28]. This is in comparison with the \\(43 \\%\\) prevalence of sinus rhythm at 1 year,","text_display":" \\(62.6 \\%\\) at 5 years [28]. This is in comparison with the \\(43 \\%\\) prevalence of sinus rhythm at 1 year,","confidence":0.9912109375,"confidence_rate":0.9999182633950298},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eddf6c06f9ad4d319caaac3a3c3d2c3e","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1841,2574],[1841,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06cbeb22f2f3459d9635ce37613f689e","type":"page_info","conversion_output":false,"text":"Page 14 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-16","page":16,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b811bf557b50442a956016f759e51e0f","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1940,249],[1940,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1636,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30dbc3536a6542ab92a78f11a2990510","type":"text","conversion_output":true,"text":"which decremented to \\(34.6 \\%\\) at 5 years in those receiving AV Nodal blocking agents alone.","text_display":"\nwhich decremented to \\(34.6 \\%\\) at 5 years in those receiving AV Nodal blocking agents alone.","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[305,294],[1944,294],[1944,346],[305,346]],"region":{"top_left_x":305,"top_left_y":294,"width":1640,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bf992c5bf2045f481f7ad844f9762a3","type":"text","conversion_output":true,"text":"Many of these patients in sinus rhythm at the time of follow-up had recurrent arrhythmia during","text_display":" Many of these patients in sinus rhythm at the time of follow-up had recurrent arrhythmia during","confidence":1,"confidence_rate":1},{"cnt":[[305,339],[1944,339],[1944,389],[305,389]],"region":{"top_left_x":305,"top_left_y":339,"width":1640,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"664ceb7163b0493eb342f7b938ee8eb4","type":"text","conversion_output":true,"text":"the time between these evaluations. In the AFFIRM First Drug Study, \\(33 \\%\\) of patients taking","text_display":" the time between these evaluations. In the AFFIRM First Drug Study, \\(33 \\%\\) of patients taking","confidence":0.79833984375,"confidence_rate":0.9977044662986901},{"cnt":[[305,382],[1944,382],[1944,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1640,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f8a530c2b044116bbc09a5db9e62622","type":"text","conversion_output":true,"text":"amiodarone had an AF recurrence by 1 year, with \\(50 \\%\\) by 3 years. This was significantly better","text_display":" amiodarone had an AF recurrence by 1 year, with \\(50 \\%\\) by 3 years. This was significantly better","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[305,425],[1944,425],[1944,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1640,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f40d7f79c31748c5980bb6851e190e1a","type":"text","conversion_output":true,"text":"than the \\(52 \\% AF\\) recurrence in sotalol-treated patients at 1 year, and \\(71 \\%\\) recurrence at 3 years","text_display":" than the \\(52 \\% AF\\) recurrence in sotalol-treated patients at 1 year, and \\(71 \\%\\) recurrence at 3 years","confidence":0.9419779507443309,"confidence_rate":0.9994758092646531},{"cnt":[[305,468],[1946,468],[1946,518],[305,518]],"region":{"top_left_x":305,"top_left_y":468,"width":1642,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec5b7dccb1a94cd794957ab6fe559240","type":"text","conversion_output":true,"text":"[35]. The findings were similar in RACE, with only \\(39 \\%\\) remaining in sinus rhythm at the end of","text_display":" [35]. The findings were similar in RACE, with only \\(39 \\%\\) remaining in sinus rhythm at the end of","confidence":1,"confidence_rate":1},{"cnt":[[305,511],[1944,511],[1944,561],[305,561]],"region":{"top_left_x":305,"top_left_y":511,"width":1640,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"157f5be9221344018d8edec5ed18daa2","type":"text","conversion_output":true,"text":"the trial [29] and only \\(38 \\%\\) of patients at 2 years in the STAF Trial [36]. Overall improvements in","text_display":" the trial [29] and only \\(38 \\%\\) of patients at 2 years in the STAF Trial [36]. Overall improvements in","confidence":0.9907307624816895,"confidence_rate":0.9999145681978818},{"cnt":[[305,556],[1944,556],[1944,608],[305,608]],"region":{"top_left_x":305,"top_left_y":556,"width":1640,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"500ebbc677cb4bb68c1bcedc13f5e75c","type":"text","conversion_output":true,"text":"quality of life (QO) were comparable in rate and rhythm control patients in AFFIRM [28, 37].","text_display":" quality of life (QO) were comparable in rate and rhythm control patients in AFFIRM [28, 37].","confidence":1,"confidence_rate":1},{"cnt":[[305,602],[1944,602],[1944,651],[305,651]],"region":{"top_left_x":305,"top_left_y":601,"width":1640,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1702ceb6cc6f48b695d9f0795920e026","type":"text","conversion_output":true,"text":"Rate control therapy was also more cost effective in these comparative studies [37, 38, 39, 40,","text_display":" Rate control therapy was also more cost effective in these comparative studies [37, 38, 39, 40,","confidence":0.9546758608295249,"confidence_rate":0.9995362734658121},{"cnt":[[305,645],[1944,645],[1944,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1640,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b2f38c03dd441338fbc7cc13a69bb36","type":"text","conversion_output":true,"text":"41]. In addition to an increase in morbidity and mortality risk with rhythm control therapy","text_display":" 41]. In addition to an increase in morbidity and mortality risk with rhythm control therapy","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,690],[1944,690],[1944,741],[305,741]],"region":{"top_left_x":305,"top_left_y":689,"width":1640,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9e234d4b76441b4b3d6495b1b1091af","type":"text","conversion_output":true,"text":"attributable to pro-arrhythmia, AFFIRM rhythm control patients also had excess non-cardiac","text_display":" attributable to pro-arrhythmia, AFFIRM rhythm control patients also had excess non-cardiac","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[1205,735],[1205,784],[305,784]],"region":{"top_left_x":305,"top_left_y":734,"width":901,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18f7a380b6e74092b46336a0cb17a668","type":"text","conversion_output":true,"text":"mortality compared to their rate control counterparts.","text_display":" mortality compared to their rate control counterparts.","confidence":1,"confidence_rate":1},{"cnt":[[301,814],[1450,814],[1450,874],[301,874]],"region":{"top_left_x":300,"top_left_y":814,"width":1151,"height":61},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4205180f20494fc0a538a51ff639b783","type":"section_header","conversion_output":false,"children_ids":["ed91000f6ae34cb1bbe57faf8897d043"],"text":"","text_display":""},{"cnt":[[305,821],[1442,821],[1442,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1137,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed91000f6ae34cb1bbe57faf8897d043","type":"text","conversion_output":true,"parent_id":"4205180f20494fc0a538a51ff639b783","text":"1.2.4 Mortality Benefit of Drug Therapy in Randomized Trials","text_display":"\n\n\\subsection*{1.2.4 Mortality Benefit of Drug Therapy in Randomized Trials}","confidence":1,"confidence_rate":1},{"cnt":[[305,866],[1944,866],[1944,913],[305,913]],"region":{"top_left_x":305,"top_left_y":865,"width":1640,"height":49},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fae7ff9e8ef49f592cc6aa60e903afc","type":"text","conversion_output":true,"text":"The morbidity and mortality response to drug therapy for AF seen in these studies has been","text_display":"\n\nThe morbidity and mortality response to drug therapy for AF seen in these studies has been","confidence":1,"confidence_rate":1},{"cnt":[[305,907],[1944,907],[1944,958],[305,958]],"region":{"top_left_x":305,"top_left_y":906,"width":1640,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ce27f4f995b4ccfb5f4f0e0d2fd1bf5","type":"text","conversion_output":true,"text":"disappointing [28, 29, 36, 38, 42]. In the AFFIRM Trial, conducted in patients at increased risk","text_display":" disappointing [28, 29, 36, 38, 42]. In the AFFIRM Trial, conducted in patients at increased risk","confidence":0.970703125,"confidence_rate":0.9997056413622759},{"cnt":[[305,954],[1946,954],[1946,1003],[305,1003]],"region":{"top_left_x":305,"top_left_y":953,"width":1642,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c93d27539004069811cf72d095fb8ce","type":"text","conversion_output":true,"text":"because of age or the presence of risk factors for stroke, there was no statistically significant","text_display":" because of age or the presence of risk factors for stroke, there was no statistically significant","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[1944,997],[1944,1046],[305,1046]],"region":{"top_left_x":305,"top_left_y":996,"width":1640,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6cbd8bb9e274b5385fb45d59c46405e","type":"text","conversion_output":true,"text":"difference in mortality outcomes with rate ( \\(21.3 \\%\\) ) and rhythm ( \\(23.8 \\%\\) ) control strategies at 5 yrs","text_display":" difference in mortality outcomes with rate ( \\(21.3 \\%\\) ) and rhythm ( \\(23.8 \\%\\) ) control strategies at 5 yrs","confidence":0.9095612709220404,"confidence_rate":0.9991614763983256},{"cnt":[[305,1040],[1944,1040],[1944,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1640,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd3ae7d8ca5542be8d34cfc71a67d8f5","type":"text","conversion_output":true,"text":"[hazard ratio \\(1.15(0.99-1.34)\\) for rhythm control therapy; \\(p =0.08\\) ] [28]. Patients treated with","text_display":" [hazard ratio \\(1.15(0.99-1.34)\\) for rhythm control therapy; \\(p =0.08\\) ] [28]. Patients treated with","confidence":0.9463405609130859,"confidence_rate":0.9994894565406702},{"cnt":[[305,1085],[1944,1085],[1944,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1084,"width":1640,"height":49},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efb6210da91e436eb6335a4986312d33","type":"text","conversion_output":true,"text":"rhythm control were more likely to require rehospitalization ( \\(80.1 \\%\\) ) than rate control patients","text_display":" rhythm control were more likely to require rehospitalization ( \\(80.1 \\%\\) ) than rate control patients","confidence":0.9185357093811035,"confidence_rate":0.9991910464542493},{"cnt":[[305,1128],[1944,1128],[1944,1177],[305,1177]],"region":{"top_left_x":305,"top_left_y":1127,"width":1640,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1b28e97a39c47f587e9846ffa85dbb9","type":"text","conversion_output":true,"text":"\\((73.0 \\%)\\) [ \\(p<0.001\\) ] and rhythm control therapy was more expensive [43]. The outcome of the","text_display":" \\((73.0 \\%)\\) [ \\(p<0.001\\) ] and rhythm control therapy was more expensive [43]. The outcome of the","confidence":0.7637632009573281,"confidence_rate":0.9972255313919665},{"cnt":[[305,1173],[1946,1173],[1946,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":1642,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57c88a88b6d74d9b8a7a3be72d5516eb","type":"text","conversion_output":true,"text":"secondary endpoint of death, disabling stroke or anoxic encephalopathy, major bleed, or cardiac","text_display":" secondary endpoint of death, disabling stroke or anoxic encephalopathy, major bleed, or cardiac","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1944,1216],[1944,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1216,"width":1640,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd6ac8c0a9334edab389c94d6a22a900","type":"text","conversion_output":true,"text":"arrest was also similar in the two arms. Importantly, similar trends of mortality and composite","text_display":" arrest was also similar in the two arms. Importantly, similar trends of mortality and composite","confidence":1,"confidence_rate":1},{"cnt":[[305,1259],[1944,1259],[1944,1308],[305,1308]],"region":{"top_left_x":305,"top_left_y":1258,"width":1640,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"937380e699254b2798a8dbb083b32069","type":"text","conversion_output":true,"text":"endpoints were seen in RACE [29], PIAF [38], and STAF [36]. As suggested by accompanying","text_display":" endpoints were seen in RACE [29], PIAF [38], and STAF [36]. As suggested by accompanying","confidence":1,"confidence_rate":1},{"cnt":[[305,1302],[1944,1302],[1944,1354],[305,1354]],"region":{"top_left_x":305,"top_left_y":1301,"width":1640,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95bc6d4db07f48629ff8dc9c79317f42","type":"text","conversion_output":true,"text":"editorial opinion, only 40 to \\(50 \\%\\) of eligible patients were enrolled in these trials, in part because","text_display":" editorial opinion, only 40 to \\(50 \\%\\) of eligible patients were enrolled in these trials, in part because","confidence":0.9980475902557373,"confidence_rate":0.9999825508827679},{"cnt":[[305,1349],[1944,1349],[1944,1399],[305,1399]],"region":{"top_left_x":305,"top_left_y":1349,"width":1640,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee571144c0dd4495ae46bb0bb331f276","type":"text","conversion_output":true,"text":"of bias toward rhythm control in highly symptomatic patients. These data may not be directly","text_display":" of bias toward rhythm control in highly symptomatic patients. These data may not be directly","confidence":1,"confidence_rate":1},{"cnt":[[305,1392],[1207,1392],[1207,1442],[305,1442]],"region":{"top_left_x":305,"top_left_y":1392,"width":903,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d35432c188ca4b899c46334953c3339c","type":"text","conversion_output":true,"text":"applicable to younger patients without heart disease.","text_display":" applicable to younger patients without heart disease.","confidence":1,"confidence_rate":1},{"cnt":[[305,1478],[1944,1478],[1944,1528],[305,1528]],"region":{"top_left_x":305,"top_left_y":1478,"width":1640,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c93ec414fba4a359a2641a871479f60","type":"text","conversion_output":true,"text":"The outcomes of rate vs. rhythm control management strategies were also recently examined in","text_display":"\n\nThe outcomes of rate vs. rhythm control management strategies were also recently examined in","confidence":1,"confidence_rate":1},{"cnt":[[305,1523],[1944,1523],[1944,1575],[305,1575]],"region":{"top_left_x":305,"top_left_y":1523,"width":1640,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc65ed8f6de344069e032336463bad39","type":"text","conversion_output":true,"text":"patients with underlying heart failure. The AF CHF Trial [42] enrolled 1376 patients with one AF","text_display":" patients with underlying heart failure. The AF CHF Trial [42] enrolled 1376 patients with one AF","confidence":1,"confidence_rate":1},{"cnt":[[305,1568],[1944,1568],[1944,1620],[305,1620]],"region":{"top_left_x":305,"top_left_y":1568,"width":1640,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8d24c85837842358c0114c370288abc","type":"text","conversion_output":true,"text":"episode in 6 months and either Class II-IV CHF and an EF \\(\\leq 35 \\%\\), or Class I CHF with a CHF","text_display":" episode in 6 months and either Class II-IV CHF and an EF \\(\\leq 35 \\%\\), or Class I CHF with a CHF","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[305,1616],[1944,1616],[1944,1665],[305,1665]],"region":{"top_left_x":305,"top_left_y":1615,"width":1640,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2234eb02f0741438a39827a7e12a435","type":"text","conversion_output":true,"text":"hospitalization, or an EF \\(\\leq 25 \\%\\). 682 patients were randomized to rhythm control (Amiodarone","text_display":" hospitalization, or an EF \\(\\leq 25 \\%\\). 682 patients were randomized to rhythm control (Amiodarone","confidence":0.5304718017578125,"confidence_rate":0.9938037034181262},{"cnt":[[305,1661],[1944,1661],[1944,1712],[305,1712]],"region":{"top_left_x":305,"top_left_y":1660,"width":1640,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc10502ac76d4cffa3a0bc0e1f11a100","type":"text","conversion_output":true,"text":"in \\(82 \\%\\) ) versus 694 to rate control (beta blockers in \\(88 \\%\\) and Digoxin in \\(75 \\%\\) ) [42]. Thirty-one","text_display":" in \\(82 \\%\\) ) versus 694 to rate control (beta blockers in \\(88 \\%\\) and Digoxin in \\(75 \\%\\) ) [42]. Thirty-one","confidence":0.8020464435685426,"confidence_rate":0.9980323957484387},{"cnt":[[305,1706],[1944,1706],[1944,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1705,"width":1640,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e09079357e1f4f67bd7c6252961356ec","type":"text","conversion_output":true,"text":"percent had paroxysmal while \\(69 \\%\\) had persistent AF, and \\(31 \\%\\) had Class III or IV CHF. There","text_display":" percent had paroxysmal while \\(69 \\%\\) had persistent AF, and \\(31 \\%\\) had Class III or IV CHF. There","confidence":1,"confidence_rate":1},{"cnt":[[305,1749],[1944,1749],[1944,1798],[305,1798]],"region":{"top_left_x":305,"top_left_y":1748,"width":1640,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea93060be68243bfb3e31d394bdb0983","type":"text","conversion_output":true,"text":"was no difference in the primary endpoint of CV death in rhythm ( \\(26.7 \\%\\) ) vs. rate control","text_display":" was no difference in the primary endpoint of CV death in rhythm ( \\(26.7 \\%\\) ) vs. rate control","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,1792],[1944,1792],[1944,1841],[305,1841]],"region":{"top_left_x":305,"top_left_y":1791,"width":1640,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b7b03853bfe480c8fd8da00f8aa97fd","type":"text","conversion_output":true,"text":"patients \\((25.2 \\%)[ HR =1.06, Cl =0.86-1.30, p =0.59]\\) over 37 months of follow-up. There was no","text_display":" patients \\((25.2 \\%)[ HR =1.06, Cl =0.86-1.30, p =0.59]\\) over 37 months of follow-up. There was no","confidence":0.9772073695865148,"confidence_rate":0.9997845428582104},{"cnt":[[305,1835],[1944,1835],[1944,1886],[305,1886]],"region":{"top_left_x":305,"top_left_y":1834,"width":1640,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d590075172e546ccb6ed37d38bba54d7","type":"text","conversion_output":true,"text":"difference in total mortality ( \\(31.8 \\%\\) vs. \\(32.9 \\%, p =0.73\\) ), stroke risk ( \\(2.6 \\%\\) vs. \\(3.6 \\%, p =0.32\\) ),","text_display":" difference in total mortality ( \\(31.8 \\%\\) vs. \\(32.9 \\%, p =0.73\\) ), stroke risk ( \\(2.6 \\%\\) vs. \\(3.6 \\%, p =0.32\\) ),","confidence":0.9164413736684196,"confidence_rate":0.9992608057000274},{"cnt":[[305,1882],[1944,1882],[1944,1931],[305,1931]],"region":{"top_left_x":305,"top_left_y":1882,"width":1640,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5670ddd57ac54b2eb884d0905439dbb9","type":"text","conversion_output":true,"text":"worsening CHF ( \\(27.6 \\%\\) vs. \\(38.8 \\%, p =0.17\\) ) or the composite of CV death, stroke, or worsening","text_display":" worsening CHF ( \\(27.6 \\%\\) vs. \\(38.8 \\%, p =0.17\\) ) or the composite of CV death, stroke, or worsening","confidence":0.9985356330871582,"confidence_rate":0.9999860435245741},{"cnt":[[305,1925],[1944,1925],[1944,1974],[305,1974]],"region":{"top_left_x":305,"top_left_y":1925,"width":1640,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"401babc4299f46aaacedddbcceeaff61","type":"text","conversion_output":true,"text":"CHF ( \\(42.7 \\%\\) vs. \\(45.8 \\%, p =0.20\\) ). Bradycardia was more common in those treated to maintain","text_display":" CHF ( \\(42.7 \\%\\) vs. \\(45.8 \\%, p =0.20\\) ). Bradycardia was more common in those treated to maintain","confidence":0.9951248124716017,"confidence_rate":0.9999520883044638},{"cnt":[[305,1968],[1944,1968],[1944,2017],[305,2017]],"region":{"top_left_x":305,"top_left_y":1967,"width":1640,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b82eb8339f9b4b7da239650a5c1fa552","type":"text","conversion_output":true,"text":"sinus rhythm ( \\(8.5 \\%\\) vs. \\(4.9 \\%, p =0.007\\) ) and \\(21 \\%\\) of patients crossed over from rhythm to rate","text_display":" sinus rhythm ( \\(8.5 \\%\\) vs. \\(4.9 \\%, p =0.007\\) ) and \\(21 \\%\\) of patients crossed over from rhythm to rate","confidence":0.9805123475459823,"confidence_rate":0.9998177940060345},{"cnt":[[305,2013],[580,2013],[580,2065],[305,2065]],"region":{"top_left_x":305,"top_left_y":2013,"width":276,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f939943c044c49109447cab21af7ec79","type":"text","conversion_output":true,"text":"control therapy.","text_display":" control therapy.","confidence":1,"confidence_rate":1},{"cnt":[[305,2099],[1944,2099],[1944,2151],[305,2151]],"region":{"top_left_x":305,"top_left_y":2099,"width":1640,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc69fb38cacd42219cfd258277e4a527","type":"text","conversion_output":true,"text":"The findings of this trial, along with AFFIRM, RACE and STAF raise important questions","text_display":"\n\nThe findings of this trial, along with AFFIRM, RACE and STAF raise important questions","confidence":1,"confidence_rate":1},{"cnt":[[305,2144],[1944,2144],[1944,2194],[305,2194]],"region":{"top_left_x":305,"top_left_y":2144,"width":1640,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16abe04e99994d829c85015d56a4586d","type":"text","conversion_output":true,"text":"regarding the quest for maintaining sinus rhythm in patients with AF. These studies can be","text_display":" regarding the quest for maintaining sinus rhythm in patients with AF. These studies can be","confidence":1,"confidence_rate":1},{"cnt":[[305,2189],[1944,2189],[1944,2237],[305,2237]],"region":{"top_left_x":305,"top_left_y":2189,"width":1640,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"affab06036054a279a75cb6fd0b352e6","type":"text","conversion_output":true,"text":"interpreted as supporting the thesis that the restoration and maintenance of sinus rhythm does","text_display":" interpreted as supporting the thesis that the restoration and maintenance of sinus rhythm does","confidence":1,"confidence_rate":1},{"cnt":[[305,2230],[1946,2230],[1946,2282],[305,2282]],"region":{"top_left_x":305,"top_left_y":2230,"width":1642,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5dca3012f3a41fc989d0436a47a3ca4","type":"text","conversion_output":true,"text":"not alter over-all outcome. If true, this would indicate that 1 ) other factors are responsible for","text_display":" not alter over-all outcome. If true, this would indicate that 1 ) other factors are responsible for","confidence":0.8263623714447021,"confidence_rate":0.9982191399965699},{"cnt":[[305,2277],[1946,2277],[1946,2327],[305,2327]],"region":{"top_left_x":305,"top_left_y":2277,"width":1642,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d85ebe51d5b049a38ff88a8a13a1787c","type":"text","conversion_output":true,"text":"morbidity and mortality in AF patients, 2) AF is not a risk factor for either total or CV mortality, or","text_display":" morbidity and mortality in AF patients, 2) AF is not a risk factor for either total or CV mortality, or","confidence":1,"confidence_rate":1},{"cnt":[[305,2320],[1944,2320],[1944,2370],[305,2370]],"region":{"top_left_x":305,"top_left_y":2320,"width":1640,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d35b1de98004c4abf4802fc25317691","type":"text","conversion_output":true,"text":"3 ) this arrhythmia is simply a marker of CV risk related to underlying disease. Alternatively,","text_display":" 3 ) this arrhythmia is simply a marker of CV risk related to underlying disease. Alternatively,","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[305,2363],[1944,2363],[1944,2413],[305,2413]],"region":{"top_left_x":305,"top_left_y":2363,"width":1640,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83b3852c664a43989bb234046cd0fe54","type":"text","conversion_output":true,"text":"there may be significant benefit to sinus rhythm, which is offset in these trials by the pro-","text_display":" there may be significant benefit to sinus rhythm, which is offset in these trials by the pro","confidence":1,"confidence_rate":1},{"cnt":[[305,2408],[1944,2408],[1944,2460],[305,2460]],"region":{"top_left_x":305,"top_left_y":2408,"width":1640,"height":52},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58de3fe61aab4204acdd900fe579f613","type":"text","conversion_output":true,"text":"arrhythmia, heart failure, or organ toxicity attending anti-arrhythmic drug therapy. Disappointing","text_display":"arrhythmia, heart failure, or organ toxicity attending anti-arrhythmic drug therapy. Disappointing","confidence":1,"confidence_rate":1},{"cnt":[[305,2454],[1674,2454],[1674,2503],[305,2503]],"region":{"top_left_x":305,"top_left_y":2453,"width":1369,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5609617051d04d369243816b06b55ed9","type":"text","conversion_output":true,"text":"efficacy of drugs in maintaining sinus rhythm would further diminish their appeal.","text_display":" efficacy of drugs in maintaining sinus rhythm would further diminish their appeal.","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[969,2574],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":664,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7411cf28ed214d4b84cf97f0010c2d1c","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a559d910d0cf4b9e9b2ea0e0cbabeb1c","type":"page_info","conversion_output":false,"text":"Page 15 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-17","page":17,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65e69094a72e4666b84d1cbffe6f32a0","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1944,249],[1944,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1640,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e0f245d4a764c4e82d6716737dc0251","type":"text","conversion_output":true,"text":"Any recommendation for rhythm control must be tempered by a consideration of pro-arrhythmic","text_display":"\n\nAny recommendation for rhythm control must be tempered by a consideration of pro-arrhythmic","confidence":1,"confidence_rate":1},{"cnt":[[305,296],[1944,296],[1944,342],[305,342]],"region":{"top_left_x":305,"top_left_y":296,"width":1640,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d654fbff761495a829294c1b2fe0b8c","type":"text","conversion_output":true,"text":"risk and occurrence of intolerable side effects. In AFFIRM, \\(5 \\%\\) of patients had a pro-arrhythmic","text_display":" risk and occurrence of intolerable side effects. In AFFIRM, \\(5 \\%\\) of patients had a pro-arrhythmic","confidence":0.8145434856414795,"confidence_rate":0.9980104530106592},{"cnt":[[305,339],[1944,339],[1944,385],[305,385]],"region":{"top_left_x":305,"top_left_y":339,"width":1640,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"348e61ed73a245b8ab9bd36b90f9a267","type":"text","conversion_output":true,"text":"event [44], with drug discontinuation because of side effects in \\(10 \\%\\) of rate control and \\(30 \\%\\) of","text_display":" event [44], with drug discontinuation because of side effects in \\(10 \\%\\) of rate control and \\(30 \\%\\) of","confidence":0.943359375,"confidence_rate":0.9994500760618635},{"cnt":[[305,382],[1944,382],[1944,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1640,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2114901c04b542069fe13e9fc67695e8","type":"text","conversion_output":true,"text":"rhythm control patients [28,29]. In addition to poor efficacy, there also may be an inadequate","text_display":" rhythm control patients [28,29]. In addition to poor efficacy, there also may be an inadequate","confidence":0.80810546875,"confidence_rate":0.9978501657428775},{"cnt":[[305,425],[1940,425],[1940,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1636,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2cd64aceec24cd6aff6a7354db00011","type":"text","conversion_output":true,"text":"AF gradient between groups of patients due to appreciable undetected AF and accompanying","text_display":" AF gradient between groups of patients due to appreciable undetected AF and accompanying","confidence":1,"confidence_rate":1},{"cnt":[[305,471],[1940,471],[1940,518],[305,518]],"region":{"top_left_x":305,"top_left_y":470,"width":1636,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aba7225c61cd4d7f8f548fca11b15c07","type":"text","conversion_output":true,"text":"risk in rhythm control patients or unexpectedly common sinus rhythm in rate control patients,","text_display":" risk in rhythm control patients or unexpectedly common sinus rhythm in rate control patients,","confidence":1,"confidence_rate":1},{"cnt":[[305,511],[1940,511],[1940,561],[305,561]],"region":{"top_left_x":305,"top_left_y":511,"width":1636,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa2eb4e9d82c4a4e88b18710c35bfd34","type":"text","conversion_output":true,"text":"both limiting discernible differences between groups. Of note, \\(31 \\%\\) of patients in AFFIRM had","text_display":" both limiting discernible differences between groups. Of note, \\(31 \\%\\) of patients in AFFIRM had","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[305,559],[1515,559],[1515,608],[305,608]],"region":{"top_left_x":305,"top_left_y":558,"width":1210,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ced51295fc6a43d59a30cc8771bbe192","type":"text","conversion_output":true,"text":"paroxysmal AF and many of the rate control patients had sinus rhythm.","text_display":" paroxysmal AF and many of the rate control patients had sinus rhythm.","confidence":1,"confidence_rate":1},{"cnt":[[305,645],[1944,645],[1944,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1640,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed22739438df4f5fad35296f3e5a7b29","type":"text","conversion_output":true,"text":"Despite the pessimism potentially generated by these issues, the results of the recent ATHENA","text_display":"\n\nDespite the pessimism potentially generated by these issues, the results of the recent ATHENA","confidence":1,"confidence_rate":1},{"cnt":[[305,690],[1944,690],[1944,737],[305,737]],"region":{"top_left_x":305,"top_left_y":689,"width":1640,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce7eb63a72744f25af5e06c1fc4629db","type":"text","conversion_output":true,"text":"trial have provided incentive for the reconsideration of drug therapy for AF [45]. In comparing","text_display":" trial have provided incentive for the reconsideration of drug therapy for AF [45]. In comparing","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[1940,735],[1940,782],[305,782]],"region":{"top_left_x":305,"top_left_y":734,"width":1636,"height":49},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4da2bf80cff4f43bec713478c53932a","type":"text","conversion_output":true,"text":"the class III antiarrhythmic agent dronedarone in 2327 patients against placebo given to 2301","text_display":" the class III antiarrhythmic agent dronedarone in 2327 patients against placebo given to 2301","confidence":1,"confidence_rate":1},{"cnt":[[305,778],[1944,778],[1944,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":1640,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8af552929e94a07bd0978f35cead10b","type":"text","conversion_output":true,"text":"individuals, this study showed a \\(24 \\%\\) reduction in cardiovascular hospitalization or mortality","text_display":" individuals, this study showed a \\(24 \\%\\) reduction in cardiovascular hospitalization or mortality","confidence":0.99755859375,"confidence_rate":0.9999757983983905},{"cnt":[[305,821],[1944,821],[1944,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1640,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a7b42debab34f449ee782ed389a535c","type":"text","conversion_output":true,"text":"( \\(p, 0.0001\\) ), a \\(29 \\%\\) decreased in cardiovascular mortality ( \\(p=0.03\\) ), and a \\(26 \\%\\) decrease in","text_display":" ( \\(p, 0.0001\\) ), a \\(29 \\%\\) decreased in cardiovascular mortality ( \\(p=0.03\\) ), and a \\(26 \\%\\) decrease in","confidence":0.9151210784912109,"confidence_rate":0.9991790510867947},{"cnt":[[305,866],[1944,866],[1944,913],[305,913]],"region":{"top_left_x":305,"top_left_y":865,"width":1640,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8753201bb59e442694d43fa2c7eb832b","type":"text","conversion_output":true,"text":"cardiovascular hospitalization \\((p \\leq 0.0001)\\) with active therapy at \\(22 \\pm 5\\) months of follow-up. There","text_display":" cardiovascular hospitalization \\((p \\leq 0.0001)\\) with active therapy at \\(22 \\pm 5\\) months of follow-up. There","confidence":0.4405180119852048,"confidence_rate":0.9923675570453758},{"cnt":[[305,907],[1944,907],[1944,958],[305,958]],"region":{"top_left_x":305,"top_left_y":906,"width":1640,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"101f4b58116142a694b1d494fb704019","type":"text","conversion_output":true,"text":"were also significantly lower ACS and stroke rates with dronedarone therapy, in the setting of","text_display":" were also significantly lower ACS and stroke rates with dronedarone therapy, in the setting of","confidence":1,"confidence_rate":1},{"cnt":[[305,954],[1944,954],[1944,1003],[305,1003]],"region":{"top_left_x":305,"top_left_y":953,"width":1640,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3173ef25fb348aeb7526a3ee0836a13","type":"text","conversion_output":true,"text":"low proarrhythmia and heart failure rates. These data support the potential for cancelation of","text_display":" low proarrhythmia and heart failure rates. These data support the potential for cancelation of","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[1487,997],[1487,1046],[305,1046]],"region":{"top_left_x":305,"top_left_y":996,"width":1182,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8e83d72e4fd4dc1a7032d1749bb3602","type":"text","conversion_output":true,"text":"benefit from drug therapy by untoward toxicities of drug interventions.","text_display":" benefit from drug therapy by untoward toxicities of drug interventions.","confidence":1,"confidence_rate":1},{"cnt":[[305,1083],[1399,1083],[1399,1145],[305,1145]],"region":{"top_left_x":305,"top_left_y":1082,"width":1094,"height":64},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cee43e71ae049acae851c79a85edbf6","type":"section_header","conversion_output":false,"children_ids":["16b1143dd34c407b9ffbe7a55bc04d5d"],"text":"","text_display":""},{"cnt":[[309,1087],[1394,1087],[1394,1143],[309,1143]],"region":{"top_left_x":309,"top_left_y":1087,"width":1086,"height":56},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16b1143dd34c407b9ffbe7a55bc04d5d","type":"text","conversion_output":true,"parent_id":"2cee43e71ae049acae851c79a85edbf6","text":"1.3 Clinical Experience with Catheter Ablation","text_display":"\n\n\\subsection*{1.3 Clinical Experience with Catheter Ablation}","confidence":1,"confidence_rate":1},{"cnt":[[303,1139],[1137,1139],[1137,1192],[303,1192]],"region":{"top_left_x":302,"top_left_y":1138,"width":835,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f8c593e2be1451c881266298c566dcd","type":"section_header","conversion_output":false,"children_ids":["3c371ed304c2429c82f33fc8507d9bd2"],"text":"","text_display":""},{"cnt":[[309,1141],[1132,1141],[1132,1188],[309,1188]],"region":{"top_left_x":309,"top_left_y":1140,"width":824,"height":49},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c371ed304c2429c82f33fc8507d9bd2","type":"text","conversion_output":true,"parent_id":"3f8c593e2be1451c881266298c566dcd","text":"1.3.1 Single Center Ablation Success Rates","text_display":"\n\n\\subsection*{1.3.1 Single Center Ablation Success Rates}","confidence":1,"confidence_rate":1},{"cnt":[[305,1186],[1944,1186],[1944,1233],[305,1233]],"region":{"top_left_x":305,"top_left_y":1185,"width":1640,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37e2dc8c533f4b17babbb70f33790c08","type":"text","conversion_output":true,"text":"While these trials have established the benefit/risk ratios of pharmacologic rate and rhythm","text_display":"\n\nWhile these trials have established the benefit/risk ratios of pharmacologic rate and rhythm","confidence":1,"confidence_rate":1},{"cnt":[[305,1229],[1944,1229],[1944,1278],[305,1278]],"region":{"top_left_x":305,"top_left_y":1228,"width":1640,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adcd35499fca4f26a3589359c1a0277b","type":"text","conversion_output":true,"text":"control therapies, in the absence of longer-term studies, the comparative long-term outcomes of","text_display":" control therapies, in the absence of longer-term studies, the comparative long-term outcomes of","confidence":1,"confidence_rate":1},{"cnt":[[305,1274],[1944,1274],[1944,1321],[305,1321]],"region":{"top_left_x":305,"top_left_y":1274,"width":1640,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7df42bdf47e44e739a853804bc50b668","type":"text","conversion_output":true,"text":"ablative intervention remain unclear. This is particularly true in patients with advancing age or","text_display":" ablative intervention remain unclear. This is particularly true in patients with advancing age or","confidence":1,"confidence_rate":1},{"cnt":[[305,1315],[1944,1315],[1944,1364],[305,1364]],"region":{"top_left_x":305,"top_left_y":1314,"width":1640,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bdc2e8eb9d5462db850b8e1d38481dc","type":"text","conversion_output":true,"text":"underlying disease. Still, the outcome of the AF CHF trial, viewed within the context of AFFIRM,","text_display":" underlying disease. Still, the outcome of the AF CHF trial, viewed within the context of AFFIRM,","confidence":1,"confidence_rate":1},{"cnt":[[305,1360],[1944,1360],[1944,1407],[305,1407]],"region":{"top_left_x":305,"top_left_y":1359,"width":1640,"height":49},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7aa06c67aa6043d097e5425eca94ae16","type":"text","conversion_output":true,"text":"RACE, and STAF, argues strongly for alternative catheter-based or surgical intervention for AF","text_display":" RACE, and STAF, argues strongly for alternative catheter-based or surgical intervention for AF","confidence":1,"confidence_rate":1},{"cnt":[[305,1405],[1944,1405],[1944,1454],[305,1454]],"region":{"top_left_x":305,"top_left_y":1405,"width":1640,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6d6d44970d448a5bfa5a4b812ab2263","type":"text","conversion_output":true,"text":"elimination. The efficacy and safety outcomes of catheter ablation for AF are available in the","text_display":" elimination. The efficacy and safety outcomes of catheter ablation for AF are available in the","confidence":0.99755859375,"confidence_rate":0.9999753094831817},{"cnt":[[305,1448],[1944,1448],[1944,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1448,"width":1640,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfab3baf22a8460581638c547b942c79","type":"text","conversion_output":true,"text":"form of observational studies from individual centers [46-51]. These issues have been reviewed","text_display":" form of observational studies from individual centers [46-51]. These issues have been reviewed","confidence":1,"confidence_rate":1},{"cnt":[[305,1491],[1944,1491],[1944,1540],[305,1540]],"region":{"top_left_x":305,"top_left_y":1491,"width":1640,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60b7ac1707e148bbb76c0c89de900a9f","type":"text","conversion_output":true,"text":"in detail in the recent AF Ablation Consensus Statement [50] and the Venice Chart International","text_display":" in detail in the recent AF Ablation Consensus Statement [50] and the Venice Chart International","confidence":1,"confidence_rate":1},{"cnt":[[305,1536],[1944,1536],[1944,1583],[305,1583]],"region":{"top_left_x":305,"top_left_y":1536,"width":1640,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8535988675a342de84c7b2bd1e5666f4","type":"text","conversion_output":true,"text":"Consensus Document on AF Ablation [51]. These clinical studies document AF elimination rates","text_display":" Consensus Document on AF Ablation [51]. These clinical studies document AF elimination rates","confidence":1,"confidence_rate":1},{"cnt":[[305,1577],[1944,1577],[1944,1629],[305,1629]],"region":{"top_left_x":305,"top_left_y":1576,"width":1640,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91e0d61ee7ea45a2836eb3fd1752a2c9","type":"text","conversion_output":true,"text":"of \\(55-80 \\%\\) with lasso-guided ablation of paroxysmal AF [46], with a \\(70-90 \\%\\) success rate using","text_display":" of \\(55-80 \\%\\) with lasso-guided ablation of paroxysmal AF [46], with a \\(70-90 \\%\\) success rate using","confidence":0.9824647903442383,"confidence_rate":0.9998282596744892},{"cnt":[[305,1624],[1944,1624],[1944,1674],[305,1674]],"region":{"top_left_x":305,"top_left_y":1624,"width":1640,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c15e38245a38454a8afc858541a4ce55","type":"text","conversion_output":true,"text":"more aggressive wide area circumferential or high frequency, complex electrogram-guided","text_display":" more aggressive wide area circumferential or high frequency, complex electrogram-guided","confidence":1,"confidence_rate":1},{"cnt":[[305,1667],[1944,1667],[1944,1717],[305,1717]],"region":{"top_left_x":305,"top_left_y":1667,"width":1640,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50e20d3ae3f24bc9bd7f08b4186b549a","type":"text","conversion_output":true,"text":"ablative approaches [47,48]. The mechanism of beneficial effect is not completely established","text_display":" ablative approaches [47,48]. The mechanism of beneficial effect is not completely established","confidence":0.67578125,"confidence_rate":0.9960091494908929},{"cnt":[[305,1710],[1944,1710],[1944,1760],[305,1760]],"region":{"top_left_x":305,"top_left_y":1710,"width":1640,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"052380bcb3a44cc8a45667b84474b9b3","type":"text","conversion_output":true,"text":"but likely includes the isolation of AF-initiating triggers arising within pulmonary veins (PVs), the","text_display":" but likely includes the isolation of AF-initiating triggers arising within pulmonary veins (PVs), the","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[305,1755],[1944,1755],[1944,1803],[305,1803]],"region":{"top_left_x":305,"top_left_y":1755,"width":1640,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2120ce25546449cb2ec6b0659bb06a2","type":"text","conversion_output":true,"text":"alteration of parasympathetic and sympathetic nerve ganglia in the posterior LA, and the","text_display":" alteration of parasympathetic and sympathetic nerve ganglia in the posterior LA, and the","confidence":1,"confidence_rate":1},{"cnt":[[305,1800],[1944,1800],[1944,1848],[305,1848]],"region":{"top_left_x":305,"top_left_y":1800,"width":1640,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0359794b81434c10aa90d631b3084dc3","type":"text","conversion_output":true,"text":"disruption of candidate initiation and substrate-mediated maintenance mechanisms of AF [47].","text_display":" disruption of candidate initiation and substrate-mediated maintenance mechanisms of AF [47].","confidence":1,"confidence_rate":1},{"cnt":[[305,1843],[1944,1843],[1944,1893],[305,1893]],"region":{"top_left_x":305,"top_left_y":1843,"width":1640,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29a99475930046cf9f5897174d30ff47","type":"text","conversion_output":true,"text":"These studies have several limitations including absence of randomized enrollment, variability in","text_display":" These studies have several limitations including absence of randomized enrollment, variability in","confidence":1,"confidence_rate":1},{"cnt":[[305,1886],[1944,1886],[1944,1936],[305,1936]],"region":{"top_left_x":305,"top_left_y":1886,"width":1640,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05fedb3744ca47c3a22bf3b3fdbf2eba","type":"text","conversion_output":true,"text":"techniques, differences in end points, the inconsistent use of blanking periods, and an uncertain","text_display":" techniques, differences in end points, the inconsistent use of blanking periods, and an uncertain","confidence":1,"confidence_rate":1},{"cnt":[[305,1931],[1944,1931],[1944,1979],[305,1979]],"region":{"top_left_x":305,"top_left_y":1931,"width":1640,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2dde007e4d94259984b58338c1eb47d","type":"text","conversion_output":true,"text":"number of redo procedures. Moreover, the \\(60-70 \\%\\) ablation success rate seen in the recent","text_display":" number of redo procedures. Moreover, the \\(60-70 \\%\\) ablation success rate seen in the recent","confidence":0.8916015625,"confidence_rate":0.9988055480408351},{"cnt":[[305,1977],[1944,1977],[1944,2024],[305,2024]],"region":{"top_left_x":305,"top_left_y":1976,"width":1640,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"540dd1be08c44b0eb113a09df631af6d","type":"text","conversion_output":true,"text":"International AF Ablation Registry detailing outcome, suggests that the efficacy rate of ablation","text_display":" International AF Ablation Registry detailing outcome, suggests that the efficacy rate of ablation","confidence":1,"confidence_rate":1},{"cnt":[[305,2020],[1944,2020],[1944,2069],[305,2069]],"region":{"top_left_x":305,"top_left_y":2019,"width":1640,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1562a2e36aad4d83990545c816e2ae83","type":"text","conversion_output":true,"text":"may be less than seen in earlier observational studies [49]. Furthermore, recent data have","text_display":" may be less than seen in earlier observational studies [49]. Furthermore, recent data have","confidence":1,"confidence_rate":1},{"cnt":[[305,2062],[1480,2062],[1480,2112],[305,2112]],"region":{"top_left_x":305,"top_left_y":2062,"width":1176,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e696be373d4e4892877ad477f4a32c93","type":"text","conversion_output":true,"text":"suggested an increased recurrence rate 2-3 years after ablation [52].","text_display":" suggested an increased recurrence rate 2-3 years after ablation [52].","confidence":0.73974609375,"confidence_rate":0.99593466071005},{"cnt":[[305,2151],[1944,2151],[1944,2198],[305,2198]],"region":{"top_left_x":305,"top_left_y":2150,"width":1640,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7367975c58ed4fe49d585ffb383ac88f","type":"text","conversion_output":true,"text":"The complication rates of ablative intervention have been inadequately documented. While","text_display":"\n\nThe complication rates of ablative intervention have been inadequately documented. While","confidence":1,"confidence_rate":1},{"cnt":[[305,2196],[1944,2196],[1944,2241],[305,2241]],"region":{"top_left_x":305,"top_left_y":2195,"width":1640,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7614495e2dce4ed285366339d3c4ea01","type":"text","conversion_output":true,"text":"recent studies demonstrate a \\(1 \\%\\) stroke rate and a reduced PV stenosis rate down to \\(1-2 \\%\\) with","text_display":" recent studies demonstrate a \\(1 \\%\\) stroke rate and a reduced PV stenosis rate down to \\(1-2 \\%\\) with","confidence":0.8320732251740992,"confidence_rate":0.9982167876312862},{"cnt":[[305,2239],[1944,2239],[1944,2288],[305,2288]],"region":{"top_left_x":305,"top_left_y":2238,"width":1640,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf474ad23d524d12b339d2acd09c330e","type":"text","conversion_output":true,"text":"ablative intervention, the same International AF Ablation Registry suggested that serious","text_display":" ablative intervention, the same International AF Ablation Registry suggested that serious","confidence":1,"confidence_rate":1},{"cnt":[[305,2282],[1944,2282],[1944,2331],[305,2331]],"region":{"top_left_x":305,"top_left_y":2281,"width":1640,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c00af546a82401fbfcb27d534dd8b7e","type":"text","conversion_output":true,"text":"ablation events occur in up to \\(6 \\%\\) of patients [49]. The occurrence of stroke, PV stenosis,","text_display":" ablation events occur in up to \\(6 \\%\\) of patients [49]. The occurrence of stroke, PV stenosis,","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,2327],[1944,2327],[1944,2376],[305,2376]],"region":{"top_left_x":305,"top_left_y":2326,"width":1640,"height":51},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09e01efa7eaa46ef998f6812a94b6b3b","type":"text","conversion_output":true,"text":"tamponade, and the recently reported lethal atrial-esophageal fistulae [53] indicate that the true","text_display":" tamponade, and the recently reported lethal atrial-esophageal fistulae [53] indicate that the true","confidence":1,"confidence_rate":1},{"cnt":[[305,2372],[1334,2372],[1334,2421],[305,2421]],"region":{"top_left_x":305,"top_left_y":2371,"width":1030,"height":51},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f57fb828767048a4822b8c82337fa1e0","type":"text","conversion_output":true,"text":"complication rates of AF ablation have yet to be established.","text_display":" complication rates of AF ablation have yet to be established.","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[969,2574],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":664,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c7807d75ace4ffd80842cd403723657","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93bf46cb3ff94631bd79edfda595b66e","type":"page_info","conversion_output":false,"text":"Page 16 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-18","page":18,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ed8ea4a68af45f79d320d93508987fc","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[309,249],[1940,249],[1940,299],[309,299]],"region":{"top_left_x":309,"top_left_y":249,"width":1632,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f6e3ce8c9e04bef81d1c15abaad62eb","type":"text","conversion_output":true,"text":"Smaller, randomized ablation vs. drug studies include the CACAF [54], RAAFT [55], APAF [56],","text_display":"\n\nSmaller, randomized ablation vs. drug studies include the CACAF [54], RAAFT [55], APAF [56],","confidence":1,"confidence_rate":1},{"cnt":[[309,296],[1940,296],[1940,342],[309,342]],"region":{"top_left_x":309,"top_left_y":296,"width":1632,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bea6c438be4d4688b5dc3f4d4e2e5119","type":"text","conversion_output":true,"text":"and A4 [57] Trials. These trials randomized 67-198 patients to rhythm control therapy vs.","text_display":" and A4 [57] Trials. These trials randomized 67-198 patients to rhythm control therapy vs.","confidence":0.81494140625,"confidence_rate":0.9978253566672637},{"cnt":[[309,339],[1940,339],[1940,385],[309,385]],"region":{"top_left_x":309,"top_left_y":339,"width":1632,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24f4a9f492c84f56a8481c444cc83b2f","type":"text","conversion_output":true,"text":"primary AF ablation. Over a 12 -month follow-up period, a \\(76 \\%\\) average recurrence rate was","text_display":" primary AF ablation. Over a 12 -month follow-up period, a \\(76 \\%\\) average recurrence rate was","confidence":0.9990236759185791,"confidence_rate":0.9999902320377446},{"cnt":[[309,382],[1940,382],[1940,432],[309,432]],"region":{"top_left_x":309,"top_left_y":382,"width":1632,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"888d7dda1dd748e0bde6665a2f1affff","type":"text","conversion_output":true,"text":"seen in drug treated patients, which was greater than the \\(24 \\%\\) recurrence rate in ablated","text_display":" seen in drug treated patients, which was greater than the \\(24 \\%\\) recurrence rate in ablated","confidence":1,"confidence_rate":1},{"cnt":[[309,425],[1940,425],[1940,475],[309,475]],"region":{"top_left_x":309,"top_left_y":425,"width":1632,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe81ccfad4e54d708fa8dc4d6daa147a","type":"text","conversion_output":true,"text":"patients [54-57]. These studies also provide additional preliminary information. In the CACAF","text_display":" patients [54-57]. These studies also provide additional preliminary information. In the CACAF","confidence":0.99560546875,"confidence_rate":0.9999550600344739},{"cnt":[[309,468],[1940,468],[1940,518],[309,518]],"region":{"top_left_x":309,"top_left_y":468,"width":1632,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"418855a6f8774bef89115e6afab65fc8","type":"text","conversion_output":true,"text":"Trial [54], 1 of the ablation patients ( \\(1.5 \\%\\) ) and one patient in the control group ( \\(1.5 \\%\\) ) sustained","text_display":" Trial [54], 1 of the ablation patients ( \\(1.5 \\%\\) ) and one patient in the control group ( \\(1.5 \\%\\) ) sustained","confidence":0.9834063053131104,"confidence_rate":0.9998569938821044},{"cnt":[[309,516],[1940,516],[1940,561],[309,561]],"region":{"top_left_x":309,"top_left_y":515,"width":1632,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5540c9918d094d43afc5e40635491d5f","type":"text","conversion_output":true,"text":"a stroke, and 2 patients ( \\(3 \\%\\) ) in the drug control group died over the course of follow-up. In the","text_display":" a stroke, and 2 patients ( \\(3 \\%\\) ) in the drug control group died over the course of follow-up. In the","confidence":0.9248046875,"confidence_rate":0.9992895914377963},{"cnt":[[309,559],[1940,559],[1940,604],[309,604]],"region":{"top_left_x":309,"top_left_y":558,"width":1632,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"734e3cae7b714a99aa76060d137bb214","type":"text","conversion_output":true,"text":"RAAFT Trial [55], re-hospitalization was required in \\(19(54 \\%)\\) of anti-arrhythmic drug-treated","text_display":" RAAFT Trial [55], re-hospitalization was required in \\(19(54 \\%)\\) of anti-arrhythmic drug-treated","confidence":0.5806910991668701,"confidence_rate":0.994579381515825},{"cnt":[[309,602],[1940,602],[1940,649],[309,649]],"region":{"top_left_x":309,"top_left_y":601,"width":1632,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3522ddfee08412283cff6242c5823b2","type":"text","conversion_output":true,"text":"patients compared with only \\(3(9 \\%)\\) of those ablated ( \\(p <0.001\\) ). No mortality was seen in either","text_display":" patients compared with only \\(3(9 \\%)\\) of those ablated ( \\(p <0.001\\) ). No mortality was seen in either","confidence":0.9440035820007324,"confidence_rate":0.9994714670773325},{"cnt":[[307,647],[1940,647],[1940,694],[307,694]],"region":{"top_left_x":307,"top_left_y":646,"width":1634,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"062d395eb14b434fb6ab8072269cae73","type":"text","conversion_output":true,"text":"treatment group. In these studies, \\(20-73 \\%\\) of drug treated patients crossed over to ablative","text_display":" treatment group. In these studies, \\(20-73 \\%\\) of drug treated patients crossed over to ablative","confidence":0.9770617485046387,"confidence_rate":0.9997656292187969},{"cnt":[[307,692],[1940,692],[1940,737],[307,737]],"region":{"top_left_x":307,"top_left_y":691,"width":1634,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e65431255eb64326b329d0f6da2fa440","type":"text","conversion_output":true,"text":"therapy. Since patients over the age of 75 years were largely excluded, these early trial results","text_display":" therapy. Since patients over the age of 75 years were largely excluded, these early trial results","confidence":1,"confidence_rate":1},{"cnt":[[307,735],[1940,735],[1940,780],[307,780]],"region":{"top_left_x":307,"top_left_y":734,"width":1634,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"110320383df84be8affc9be93098fae7","type":"text","conversion_output":true,"text":"may not apply to the increasing elderly population of patients at risk for untoward AF-related","text_display":" may not apply to the increasing elderly population of patients at risk for untoward AF-related","confidence":1,"confidence_rate":1},{"cnt":[[305,778],[1940,778],[1940,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e850949789b488390b972190d464960","type":"text","conversion_output":true,"text":"morbidity and mortality. Nevertheless, these data show similar rates of AF elimination, all","text_display":" morbidity and mortality. Nevertheless, these data show similar rates of AF elimination, all","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[810,821],[810,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":505,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db6f2395fd1d49d1abee68e91fef9d92","type":"text","conversion_output":true,"text":"favoring ablative intervention.","text_display":" favoring ablative intervention.","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1940,911],[1940,956],[305,956]],"region":{"top_left_x":305,"top_left_y":910,"width":1636,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a072891926554d69a48db488b1f2a819","type":"text","conversion_output":true,"text":"At least 4 studies have assessed the outcome of catheter ablation for AF occurring in the setting","text_display":"\n\nAt least 4 studies have assessed the outcome of catheter ablation for AF occurring in the setting","confidence":1,"confidence_rate":1},{"cnt":[[305,954],[1940,954],[1940,999],[305,999]],"region":{"top_left_x":305,"top_left_y":953,"width":1636,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9bd83eff3a046428aecb18f7d6feefd","type":"text","conversion_output":true,"text":"of ventricular dysfunction [58-61]. In contrast to the AF CHF Trial, these studies show a","text_display":" of ventricular dysfunction [58-61]. In contrast to the AF CHF Trial, these studies show a","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[1940,997],[1940,1044],[305,1044]],"region":{"top_left_x":305,"top_left_y":996,"width":1636,"height":49},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22c049fae2ea4487a36fcf8bf30c33db","type":"text","conversion_output":true,"text":"substantial improvement in EF/CHF class in patients in whom sinus rhythm was restored and","text_display":" substantial improvement in EF/CHF class in patients in whom sinus rhythm was restored and","confidence":1,"confidence_rate":1},{"cnt":[[307,1040],[1940,1040],[1940,1089],[307,1089]],"region":{"top_left_x":307,"top_left_y":1039,"width":1634,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6dd485d1c13347159e4a564dcb243f85","type":"text","conversion_output":true,"text":"maintained by intervention. Accompanying data suggest that this is more likely in patients with","text_display":" maintained by intervention. Accompanying data suggest that this is more likely in patients with","confidence":1,"confidence_rate":1},{"cnt":[[307,1087],[1944,1087],[1944,1132],[307,1132]],"region":{"top_left_x":307,"top_left_y":1087,"width":1638,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c45a3fe2139f48018c674033e39fce91","type":"text","conversion_output":true,"text":"non-ischemic than ischemic cardiomyopathy. Short follow-up periods in these studies make it","text_display":" non-ischemic than ischemic cardiomyopathy. Short follow-up periods in these studies make it","confidence":1,"confidence_rate":1},{"cnt":[[305,1130],[1755,1130],[1755,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1130,"width":1451,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"524f8bee8be941bcab795df65084c7e8","type":"text","conversion_output":true,"text":"impossible to draw conclusions regarding mortality and/or morbidity benefit, however.","text_display":" impossible to draw conclusions regarding mortality and/or morbidity benefit, however.","confidence":0.9970703125,"confidence_rate":0.9999674006709831},{"cnt":[[305,1212],[823,1212],[823,1268],[305,1268]],"region":{"top_left_x":305,"top_left_y":1211,"width":518,"height":57},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48589396717045478098a3c5f6751e99","type":"section_header","conversion_output":false,"children_ids":["580599781a8a42d3a311f1c6e9e149a0"],"text":"","text_display":""},{"cnt":[[309,1216],[819,1216],[819,1263],[309,1263]],"region":{"top_left_x":309,"top_left_y":1216,"width":510,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"580599781a8a42d3a311f1c6e9e149a0","type":"text","conversion_output":true,"parent_id":"48589396717045478098a3c5f6751e99","text":"1.3.2 CABANA Pilot Study","text_display":"\n\n\\subsection*{1.3.2 CABANA Pilot Study}","confidence":1,"confidence_rate":1},{"cnt":[[309,1263],[1940,1263],[1940,1308],[309,1308]],"region":{"top_left_x":309,"top_left_y":1263,"width":1632,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a38b436c43f640e5904c4c2afd6055b5","type":"text","conversion_output":true,"text":"Sixty patients were enrolled in 10 centers and randomized to AF ablation versus drug therapy,","text_display":"\n\nSixty patients were enrolled in 10 centers and randomized to AF ablation versus drug therapy,","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[309,1306],[1940,1306],[1940,1351],[309,1351]],"region":{"top_left_x":309,"top_left_y":1306,"width":1632,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"caacb5bd23a048999f9a113d3c15cbce","type":"text","conversion_output":true,"text":"indicating the feasibility of randomizing patients with CABANA characteristics [62]. Of the","text_display":" indicating the feasibility of randomizing patients with CABANA characteristics [62]. Of the","confidence":1,"confidence_rate":1},{"cnt":[[309,1349],[1940,1349],[1940,1394],[309,1394]],"region":{"top_left_x":309,"top_left_y":1349,"width":1632,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8b2154d517f4becb17053973b03d8fe","type":"text","conversion_output":true,"text":"patients enrolled, \\(77 \\%\\) were men and \\(23 \\%\\) women. The average age was 59 years ( \\(37 \\% \\geq 65\\)","text_display":" patients enrolled, \\(77 \\%\\) were men and \\(23 \\%\\) women. The average age was 59 years ( \\(37 \\% \\geq 65\\)","confidence":0.9345703125,"confidence_rate":0.9993026307580638},{"cnt":[[305,1392],[1940,1392],[1940,1439],[305,1439]],"region":{"top_left_x":305,"top_left_y":1392,"width":1636,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"097c2f0f1fb54b23a9b70c044949394e","type":"text","conversion_output":true,"text":"yrs ). Among the 60 patients, \\(80 \\%\\) had hypertension, \\(71 \\%\\) had 2 or more co-morbidities, \\(28 \\%\\)","text_display":" yrs ). Among the 60 patients, \\(80 \\%\\) had hypertension, \\(71 \\%\\) had 2 or more co-morbidities, \\(28 \\%\\)","confidence":0.9709816910326481,"confidence_rate":0.9997248260294188},{"cnt":[[307,1437],[1940,1437],[1940,1485],[307,1485]],"region":{"top_left_x":307,"top_left_y":1437,"width":1634,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d086d99fcb6480c81f4e3cd5f547799","type":"text","conversion_output":true,"text":"had sleep apnea and \\(25 \\%\\) had a family history of AF. Thirty two percent of patients had","text_display":" had sleep apnea and \\(25 \\%\\) had a family history of AF. Thirty two percent of patients had","confidence":0.998046875,"confidence_rate":0.9999792019733479},{"cnt":[[307,1482],[1940,1482],[1940,1528],[307,1528]],"region":{"top_left_x":307,"top_left_y":1482,"width":1634,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb83a4b5c2dd4b1ebb794abfa77d14c7","type":"text","conversion_output":true,"text":"paroxysmal, \\(37 \\%\\) persistent, and \\(32 \\%\\) longstanding persistent AF. This pilot experience","text_display":" paroxysmal, \\(37 \\%\\) persistent, and \\(32 \\%\\) longstanding persistent AF. This pilot experience","confidence":0.9248411655426025,"confidence_rate":0.999186442896962},{"cnt":[[307,1525],[1940,1525],[1940,1571],[307,1571]],"region":{"top_left_x":307,"top_left_y":1525,"width":1634,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44b7f7fbd06b4246962d0647adab97e5","type":"text","conversion_output":true,"text":"suggests that the Pivotal study will provide relevant information for a broad spectrum of AF","text_display":" suggests that the Pivotal study will provide relevant information for a broad spectrum of AF","confidence":1,"confidence_rate":1},{"cnt":[[307,1568],[1940,1568],[1940,1618],[307,1618]],"region":{"top_left_x":307,"top_left_y":1568,"width":1634,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96d3fde2355546419ef3e97666e2a3d2","type":"text","conversion_output":true,"text":"patients. Only \\(7 \\%\\) of the pilot study patients had Canadian class 0 (asymptomatic) AF, \\(12 \\%\\)","text_display":" patients. Only \\(7 \\%\\) of the pilot study patients had Canadian class 0 (asymptomatic) AF, \\(12 \\%\\)","confidence":0.9805657435208559,"confidence_rate":0.9998017814198397},{"cnt":[[307,1611],[1940,1611],[1940,1661],[307,1661]],"region":{"top_left_x":307,"top_left_y":1611,"width":1634,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02270502041e44d0b52d48b0b93768b8","type":"text","conversion_output":true,"text":"class I, \\(19 \\%\\) class II, \\(51 \\%\\) class III, and \\(11 \\%\\) had class IV symptoms [63]. Twelve percent had","text_display":" class I, \\(19 \\%\\) class II, \\(51 \\%\\) class III, and \\(11 \\%\\) had class IV symptoms [63]. Twelve percent had","confidence":0.9591293334960938,"confidence_rate":0.9996064043628866},{"cnt":[[307,1656],[1940,1656],[1940,1704],[307,1704]],"region":{"top_left_x":307,"top_left_y":1656,"width":1634,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c61dd165f1b41e483283ab7a95be09b","type":"text","conversion_output":true,"text":"class I CHF symptoms, \\(31 \\%\\) were class II, and \\(5 \\%\\) had class III CHF. Twenty five percent had","text_display":" class I CHF symptoms, \\(31 \\%\\) were class II, and \\(5 \\%\\) had class III CHF. Twenty five percent had","confidence":0.99853515625,"confidence_rate":0.9999854860688677},{"cnt":[[305,1702],[1940,1702],[1940,1747],[305,1747]],"region":{"top_left_x":305,"top_left_y":1701,"width":1636,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7664d4c2ec644add817e976003a6d80d","type":"text","conversion_output":true,"text":"been on a single rhythm control drug, and \\(97 \\%\\) on rate control. Of these patients, \\(47 \\%\\) had","text_display":" been on a single rhythm control drug, and \\(97 \\%\\) on rate control. Of these patients, \\(47 \\%\\) had","confidence":0.79833984375,"confidence_rate":0.9977503252915101},{"cnt":[[305,1745],[1940,1745],[1940,1792],[305,1792]],"region":{"top_left_x":305,"top_left_y":1744,"width":1636,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab6bd1e0082c4f07a6ce4b4fdd80bb77","type":"text","conversion_output":true,"text":"required prior hospitalization for AF and \\(47 \\%\\) had been previously cardioverted. These patient","text_display":" required prior hospitalization for AF and \\(47 \\%\\) had been previously cardioverted. These patient","confidence":0.980015754699707,"confidence_rate":0.9998113576903148},{"cnt":[[305,1788],[1944,1788],[1944,1835],[305,1835]],"region":{"top_left_x":305,"top_left_y":1787,"width":1640,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab4813547045429ba0bdc48890297115","type":"text","conversion_output":true,"text":"characteristics are similar to AFFIRM patients and are very different from the typical catheter","text_display":" characteristics are similar to AFFIRM patients and are very different from the typical catheter","confidence":1,"confidence_rate":1},{"cnt":[[305,1833],[1525,1833],[1525,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1832,"width":1221,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"350e9b4c9b744dad9b1be0b6c762c537","type":"text","conversion_output":true,"text":"company PMA patients with paroxysmal AF and no other heart disease.","text_display":" company PMA patients with paroxysmal AF and no other heart disease.","confidence":1,"confidence_rate":1},{"cnt":[[305,1921],[1940,1921],[1940,1968],[305,1968]],"region":{"top_left_x":305,"top_left_y":1920,"width":1636,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9b6d8369d8e488bbaa834d833197f23","type":"text","conversion_output":true,"text":"Twenty-nine patients \\((48 \\%)\\) were randomized to ablation and 28 of them underwent ablation. All","text_display":"\n\nTwenty-nine patients \\((48 \\%)\\) were randomized to ablation and 28 of them underwent ablation. All","confidence":0.5377464294433594,"confidence_rate":0.9940526773858489},{"cnt":[[305,1964],[1940,1964],[1940,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1963,"width":1636,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"babd02456cdf4aa992ad20a661beead3","type":"text","conversion_output":true,"text":"31 patients \\((52 \\%)\\) randomized to drug therapy were treated with rate or rhythm control agents.","text_display":" 31 patients \\((52 \\%)\\) randomized to drug therapy were treated with rate or rhythm control agents.","confidence":0.99560546875,"confidence_rate":0.999955958813992},{"cnt":[[309,2007],[1940,2007],[1940,2056],[309,2056]],"region":{"top_left_x":309,"top_left_y":2006,"width":1632,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d96b8abd2d624b84b6742893a49e5ebb","type":"text","conversion_output":true,"text":"\\(13 \\%\\) of patients have been treated with rate-control only, \\(16 \\%\\) with rhythm control agents only,","text_display":" \\(13 \\%\\) of patients have been treated with rate-control only, \\(16 \\%\\) with rhythm control agents only,","confidence":0.994631290435791,"confidence_rate":0.9999467026790176},{"cnt":[[305,2054],[1940,2054],[1940,2099],[305,2099]],"region":{"top_left_x":305,"top_left_y":2053,"width":1636,"height":47},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00397f158ac542158844e581189b4d7e","type":"text","conversion_output":true,"text":"and both in \\(71 \\%\\). The overall enrollment rate in this start-up pilot study exceeded the 0.7","text_display":" and both in \\(71 \\%\\). The overall enrollment rate in this start-up pilot study exceeded the 0.7","confidence":1,"confidence_rate":1},{"cnt":[[305,2097],[1940,2097],[1940,2142],[305,2142]],"region":{"top_left_x":305,"top_left_y":2096,"width":1636,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae8b9786c0304cd993c4d4511f0fa5ff","type":"text","conversion_output":true,"text":"patients/center/month needed to complete the pivotal study. In addition, following the change in","text_display":" patients/center/month needed to complete the pivotal study. In addition, following the change in","confidence":1,"confidence_rate":1},{"cnt":[[305,2140],[1944,2140],[1944,2185],[305,2185]],"region":{"top_left_x":305,"top_left_y":2139,"width":1640,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66712a6d68454bed8a0d2ea4a5cb2c57","type":"text","conversion_output":true,"text":"focus from ablation expert-driven enrollment to non-ablationist co-PI recruitment, enrollment","text_display":" focus from ablation expert-driven enrollment to non-ablationist co-PI recruitment, enrollment","confidence":0.821864128112793,"confidence_rate":0.9980001636503296},{"cnt":[[305,2183],[1940,2183],[1940,2230],[305,2230]],"region":{"top_left_x":305,"top_left_y":2182,"width":1636,"height":49},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c66dee3d6a54c58a4e4f25c6200d83e","type":"text","conversion_output":true,"text":"increased to 1.1 patients/site/month. The pilot study demonstrated the feasibility of recruiting","text_display":" increased to 1.1 patients/site/month. The pilot study demonstrated the feasibility of recruiting","confidence":1,"confidence_rate":1},{"cnt":[[305,2228],[1940,2228],[1940,2275],[305,2275]],"region":{"top_left_x":305,"top_left_y":2227,"width":1636,"height":49},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a44fb7e48f8e41c098bb30f614e7586f","type":"text","conversion_output":true,"text":"and enrolling patients, identified the expected demographics of Pivotal Trial subjects, and has","text_display":" and enrolling patients, identified the expected demographics of Pivotal Trial subjects, and has","confidence":1,"confidence_rate":1},{"cnt":[[305,2271],[1446,2271],[1446,2318],[305,2318]],"region":{"top_left_x":305,"top_left_y":2270,"width":1141,"height":49},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b30618a9733a452c95c43367bcbd140e","type":"text","conversion_output":true,"text":"been very helpful in optimizing the study design of the Pivotal Trial.","text_display":" been very helpful in optimizing the study design of the Pivotal Trial.","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b87e9f012bc413e845b0e8304866b05","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1837,2574],[1837,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":222,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1645c8946dd24d8692adbb588ec772e6","type":"page_info","conversion_output":false,"text":"Page 17 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-19","page":19,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41488a15fffd4d0a8c0c233e5ba2a834","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1354,249],[1354,314],[305,314]],"region":{"top_left_x":305,"top_left_y":249,"width":1049,"height":65},"line":2,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"ff22eefed3794192a53c04b180c6d2ac","type":"section_header","conversion_output":false,"children_ids":["90e4e37ad3fa44939e76f6cbd5b8cf96"],"text":"","text_display":""},{"cnt":[[309,254],[1351,254],[1351,309],[309,309]],"region":{"top_left_x":309,"top_left_y":253,"width":1043,"height":57},"line":3,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"90e4e37ad3fa44939e76f6cbd5b8cf96","type":"text","conversion_output":true,"parent_id":"ff22eefed3794192a53c04b180c6d2ac","text":"1.4 Rationale For Maintaining Sinus Rhythm","text_display":"\n\n\\subsection*{1.4 Rationale For Maintaining Sinus Rhythm}","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[309,309],[1940,309],[1940,354],[309,354]],"region":{"top_left_x":309,"top_left_y":309,"width":1632,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce19f80934c34d53885d165aa21462c9","type":"text","conversion_output":true,"text":"None of the trials to date address the far-reaching question of the merit of maintaining sinus","text_display":"\n\nNone of the trials to date address the far-reaching question of the merit of maintaining sinus","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[309,352],[1940,352],[1940,397],[309,397]],"region":{"top_left_x":309,"top_left_y":352,"width":1632,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1347ead9714145d0b777be42bb8d1684","type":"text","conversion_output":true,"text":"rhythm for reducing morbidity and mortality. Recent data from the AFFIRM trial provide a","text_display":" rhythm for reducing morbidity and mortality. Recent data from the AFFIRM trial provide a","confidence":1,"confidence_rate":1},{"cnt":[[309,397],[1940,397],[1940,440],[309,440]],"region":{"top_left_x":309,"top_left_y":397,"width":1632,"height":44},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c07306d910334c08b8619dce03357d80","type":"text","conversion_output":true,"text":"glimpse into this issue. In a post-hoc, time-dependent covariate assessment of the relationship","text_display":" glimpse into this issue. In a post-hoc, time-dependent covariate assessment of the relationship","confidence":1,"confidence_rate":1},{"cnt":[[309,438],[1944,438],[1944,483],[309,483]],"region":{"top_left_x":309,"top_left_y":438,"width":1636,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee7fe67ec1684959922188dc3c7e1cc8","type":"text","conversion_output":true,"text":"between cardiac rhythm and survival, warfarin and sinus rhythm were associated with a lower","text_display":" between cardiac rhythm and survival, warfarin and sinus rhythm were associated with a lower","confidence":1,"confidence_rate":1},{"cnt":[[309,483],[1944,483],[1944,531],[309,531]],"region":{"top_left_x":309,"top_left_y":483,"width":1636,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba2826a4f8824fd9adfdb219b2a00e53","type":"text","conversion_output":true,"text":"risk of death \\([ HR =0.53 CI =0.39-0.72( p <0.0001)][64]\\). Similarly, 18 of 19 primary endpoint","text_display":" risk of death \\([ HR =0.53 CI =0.39-0.72( p <0.0001)][64]\\). Similarly, 18 of 19 primary endpoint","confidence":0.6368502261650557,"confidence_rate":0.9959431991143947},{"cnt":[[309,529],[1940,529],[1940,574],[309,574]],"region":{"top_left_x":309,"top_left_y":528,"width":1632,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a34f54dc9f848beaa8b2da27cce9cab","type":"text","conversion_output":true,"text":"events in the STAF trial occurred in those patients remaining in AF [36]. Nearly identical findings","text_display":" events in the STAF trial occurred in those patients remaining in AF [36]. Nearly identical findings","confidence":1,"confidence_rate":1},{"cnt":[[309,571],[1940,571],[1940,617],[309,617]],"region":{"top_left_x":309,"top_left_y":571,"width":1632,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5570c6ba692847d4b9aac8acbe896d3b","type":"text","conversion_output":true,"text":"were seen in patients in the DIAMOND studies, which reviewed the effect of dofetilide on total","text_display":" were seen in patients in the DIAMOND studies, which reviewed the effect of dofetilide on total","confidence":1,"confidence_rate":1},{"cnt":[[309,614],[1940,614],[1940,660],[309,660]],"region":{"top_left_x":309,"top_left_y":614,"width":1632,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c17d831c8b441a7a3a3ea18788e3e3d","type":"text","conversion_output":true,"text":"mortality in the setting of a prior MI or CHF [65]. The probability of survival in patients treated","text_display":" mortality in the setting of a prior MI or CHF [65]. The probability of survival in patients treated","confidence":1,"confidence_rate":1},{"cnt":[[309,657],[1940,657],[1940,707],[309,707]],"region":{"top_left_x":309,"top_left_y":657,"width":1632,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e95a939abaf4fbfaabf2624b4caec47","type":"text","conversion_output":true,"text":"with dofetilide, who remained in sinus rhythm, was \\(60 \\%\\) at 36 months as compared to \\(30 \\%\\) in","text_display":" with dofetilide, who remained in sinus rhythm, was \\(60 \\%\\) at 36 months as compared to \\(30 \\%\\) in","confidence":1,"confidence_rate":1},{"cnt":[[309,700],[1940,700],[1940,750],[309,750]],"region":{"top_left_x":309,"top_left_y":700,"width":1632,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5103a8edc74b475491ad6572d783a219","type":"text","conversion_output":true,"text":"those remaining in AF, an effect also seen in the placebo group. Pappone et al [48] in his","text_display":" those remaining in AF, an effect also seen in the placebo group. Pappone et al [48] in his","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[309,748],[1940,748],[1940,793],[309,793]],"region":{"top_left_x":309,"top_left_y":747,"width":1632,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f9368b3fcc54e17bbad731542de352b","type":"text","conversion_output":true,"text":"comparative report noted that \\(72 \\%\\) of all adverse events were observed in patients remaining in","text_display":" comparative report noted that \\(72 \\%\\) of all adverse events were observed in patients remaining in","confidence":0.99462890625,"confidence_rate":0.9999472016886584},{"cnt":[[309,791],[1940,791],[1940,836],[309,836]],"region":{"top_left_x":309,"top_left_y":790,"width":1632,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"747efdb5bdfb438dabc4dfd52b1d92b4","type":"text","conversion_output":true,"text":"AF. In contrast, patients maintaining sinus rhythm in the RACE trial did not show improved","text_display":" AF. In contrast, patients maintaining sinus rhythm in the RACE trial did not show improved","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[309,834],[1944,834],[1944,881],[309,881]],"region":{"top_left_x":309,"top_left_y":833,"width":1636,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"945606d61a244fc5bf00e9d27d16c4ff","type":"text","conversion_output":true,"text":"survival [66]. It remains unknown whether the ability to maintain sinus rhythm is a marker of","text_display":" survival [66]. It remains unknown whether the ability to maintain sinus rhythm is a marker of","confidence":1,"confidence_rate":1},{"cnt":[[309,924],[309,877],[1944,879],[1944,926]],"region":{"top_left_x":309,"top_left_y":876,"width":1636,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b641771bc7d4b2d9c9be045c17a8d61","type":"text","conversion_output":true,"text":"improved outcome, or whether sinus rhythm per se confers a mortality benefit. The post-hoc","text_display":" improved outcome, or whether sinus rhythm per se confers a mortality benefit. The post-hoc","confidence":1,"confidence_rate":1},{"cnt":[[309,922],[1671,922],[1671,969],[309,969]],"region":{"top_left_x":309,"top_left_y":921,"width":1363,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f834dccfedb2471999e4574f034dbd70","type":"text","conversion_output":true,"text":"nature of the analyses limit the value of these results for guiding clinical practice.","text_display":" nature of the analyses limit the value of these results for guiding clinical practice.","confidence":1,"confidence_rate":1},{"cnt":[[305,1010],[1940,1010],[1940,1057],[305,1057]],"region":{"top_left_x":305,"top_left_y":1009,"width":1636,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0533283204c24be5a52efd5241ea07d2","type":"text","conversion_output":true,"text":"The data from Nademanee and coworkers [67] also bear directly on the feasibility of the","text_display":"\n\nThe data from Nademanee and coworkers [67] also bear directly on the feasibility of the","confidence":1,"confidence_rate":1},{"cnt":[[309,1100],[309,1051],[1940,1053],[1940,1102]],"region":{"top_left_x":309,"top_left_y":1050,"width":1632,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"490171d3d93a435c9f29d2d601c06628","type":"text","conversion_output":true,"text":"CABANA trial. Their study examined mortality and stroke outcomes in 540 patients with","text_display":" CABANA trial. Their study examined mortality and stroke outcomes in 540 patients with","confidence":1,"confidence_rate":1},{"cnt":[[305,1096],[1944,1096],[1944,1145],[305,1145]],"region":{"top_left_x":305,"top_left_y":1095,"width":1640,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae59282b42ad455aa27923bd6b26a87a","type":"text","conversion_output":true,"text":"AFFIRM characteristics (age \\(>65\\) or the presence of hypertension, diabetes, atrial enlargement","text_display":" AFFIRM characteristics (age \\(>65\\) or the presence of hypertension, diabetes, atrial enlargement","confidence":0.80517578125,"confidence_rate":0.9978568082034325},{"cnt":[[307,1143],[1940,1143],[1940,1188],[307,1188]],"region":{"top_left_x":307,"top_left_y":1142,"width":1634,"height":47},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e908077740a4435f8733571ee7a1795e","type":"text","conversion_output":true,"text":"or ventricular dysfunction in patients <65yrs). Their mean age was 69 years, with 165 patients","text_display":" or ventricular dysfunction in patients <65yrs). Their mean age was 69 years, with 165 patients","confidence":0.6522274017333984,"confidence_rate":0.9959381573825334},{"cnt":[[307,1186],[1940,1186],[1940,1231],[307,1231]],"region":{"top_left_x":307,"top_left_y":1185,"width":1634,"height":47},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fed38864f0c436aa3b7bd57c0b197d6","type":"text","conversion_output":true,"text":"\\(\\geq 75\\) years of age, and 124 with an EF<40\\%. Fourty\\% had paroxysmal, \\(26 \\%\\) had persistent, and","text_display":" \\(\\geq 75\\) years of age, and 124 with an EF<40\\%. Fourty\\% had paroxysmal, \\(26 \\%\\) had persistent, and","confidence":0.9056353289633989,"confidence_rate":0.9989993034489575},{"cnt":[[305,1229],[1940,1229],[1940,1276],[305,1276]],"region":{"top_left_x":305,"top_left_y":1228,"width":1636,"height":49},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b6a527e174d4d08bb510c928d9d367f","type":"text","conversion_output":true,"text":"\\(34 \\%\\) had permanent AF. Each patient underwent ablation (once in 374, while 121 underwent 2","text_display":" \\(34 \\%\\) had permanent AF. Each patient underwent ablation (once in 374, while 121 underwent 2","confidence":0.6689453125,"confidence_rate":0.9957768063711208},{"cnt":[[307,1274],[1940,1274],[1940,1319],[307,1319]],"region":{"top_left_x":307,"top_left_y":1274,"width":1634,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01ea358ca4144498b104a8646c0e8398","type":"text","conversion_output":true,"text":"sessions, 43 underwent 3 sessions and 2 patients 4 sessions). 492 were followed for \\(4.2 \\pm 1.1\\)","text_display":" sessions, 43 underwent 3 sessions and 2 patients 4 sessions). 492 were followed for \\(4.2 \\pm 1.1\\)","confidence":0.9980475902557373,"confidence_rate":0.9999822336289093},{"cnt":[[307,1317],[1940,1317],[1940,1364],[307,1364]],"region":{"top_left_x":307,"top_left_y":1316,"width":1634,"height":49},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e15c6de6d5424009a3523e361f851fcc","type":"text","conversion_output":true,"text":"years. The \\(2.7 \\%\\) long term mortality rate in \\(431(86 \\%)\\) patients remaining in sinus rhythm was","text_display":" years. The \\(2.7 \\%\\) long term mortality rate in \\(431(86 \\%)\\) patients remaining in sinus rhythm was","confidence":0.8848772048950195,"confidence_rate":0.9988016363067166},{"cnt":[[307,1362],[1940,1362],[1940,1407],[307,1407]],"region":{"top_left_x":307,"top_left_y":1362,"width":1634,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6cd298ea37945e3b1c96a309b1597a3","type":"text","conversion_output":true,"text":"substantially better than the \\(16 \\%\\) death rate in the \\(63(14 \\%)\\) who remained in \\(AF ( p <0.0001)\\).","text_display":" substantially better than the \\(16 \\%\\) death rate in the \\(63(14 \\%)\\) who remained in \\(AF ( p <0.0001)\\).","confidence":0.741356943500953,"confidence_rate":0.9972830334297061},{"cnt":[[307,1405],[1940,1405],[1940,1452],[307,1452]],"region":{"top_left_x":307,"top_left_y":1405,"width":1634,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abbb394802754a0788136c8eeffedfeb","type":"text","conversion_output":true,"text":"Sinus rhythm was the most important independent predictor of survival ( \\(p=0.002\\) ), whereas EF","text_display":" Sinus rhythm was the most important independent predictor of survival ( \\(p=0.002\\) ), whereas EF","confidence":0.7789224479347467,"confidence_rate":0.9975293561716085},{"cnt":[[307,1450],[1940,1450],[1940,1497],[307,1497]],"region":{"top_left_x":307,"top_left_y":1450,"width":1634,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7c7229314a84f3894810d601c21df43","type":"text","conversion_output":true,"text":"and warfarin had little prognostic value in these patients. These studies taken together, along","text_display":" and warfarin had little prognostic value in these patients. These studies taken together, along","confidence":1,"confidence_rate":1},{"cnt":[[305,1491],[1940,1491],[1940,1540],[305,1540]],"region":{"top_left_x":305,"top_left_y":1491,"width":1636,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95162921c69e48a68e50de7a2668a3e7","type":"text","conversion_output":true,"text":"with data from population-based studies, provide the rationale for a large, multi-center trial to","text_display":" with data from population-based studies, provide the rationale for a large, multi-center trial to","confidence":1,"confidence_rate":1},{"cnt":[[307,1538],[1940,1538],[1940,1583],[307,1583]],"region":{"top_left_x":307,"top_left_y":1538,"width":1634,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c147c1f95c7a44ce89c60eae7cd3b90c","type":"text","conversion_output":true,"text":"prospectively examine the impact of sinus rhythm on total mortality, disabling stroke, serious","text_display":" prospectively examine the impact of sinus rhythm on total mortality, disabling stroke, serious","confidence":1,"confidence_rate":1},{"cnt":[[307,1581],[1940,1581],[1940,1626],[307,1626]],"region":{"top_left_x":307,"top_left_y":1581,"width":1634,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3bf2cff4c274bc78333f188cd9c31f5","type":"text","conversion_output":true,"text":"bleeding and cardiac arrest in patients with AF. Information from a well-designed randomized","text_display":" bleeding and cardiac arrest in patients with AF. Information from a well-designed randomized","confidence":1,"confidence_rate":1},{"cnt":[[307,1624],[1944,1624],[1944,1671],[307,1671]],"region":{"top_left_x":307,"top_left_y":1624,"width":1638,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87c5cc0e54224cebbf2ceae0d8efd374","type":"text","conversion_output":true,"text":"mortality trial is critically needed to provide a reasoned basis for the continued application of","text_display":" mortality trial is critically needed to provide a reasoned basis for the continued application of","confidence":1,"confidence_rate":1},{"cnt":[[307,1667],[1944,1667],[1944,1714],[307,1714]],"region":{"top_left_x":307,"top_left_y":1667,"width":1638,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bc47291edd54429b113d7e8bf8a3d5a","type":"text","conversion_output":true,"text":"advanced ablation technology, justifying its concomitant cost, or its earlier application as first","text_display":" advanced ablation technology, justifying its concomitant cost, or its earlier application as first","confidence":1,"confidence_rate":1},{"cnt":[[305,1712],[595,1712],[595,1760],[305,1760]],"region":{"top_left_x":305,"top_left_y":1712,"width":291,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"565f186c8c3f431d87f9b2ab1816eba9","type":"text","conversion_output":true,"text":"line therapy [68].","text_display":" line therapy [68].","confidence":1,"confidence_rate":1},{"cnt":[[305,1809],[1201,1809],[1201,1876],[305,1876]],"region":{"top_left_x":305,"top_left_y":1808,"width":896,"height":68},"line":36,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"668ed024c5c14fdfb3d50b5a4b03785f","type":"section_header","conversion_output":false,"children_ids":["5683eac6326445b8873868061ef47d8d"],"text":"","text_display":""},{"cnt":[[309,1813],[1197,1813],[1197,1871],[309,1871]],"region":{"top_left_x":309,"top_left_y":1813,"width":888,"height":59},"line":37,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"5683eac6326445b8873868061ef47d8d","type":"text","conversion_output":true,"parent_id":"668ed024c5c14fdfb3d50b5a4b03785f","text":"1.5 Rationale for Rhythm Monitoring","text_display":"\n\n\\subsection*{1.5 Rationale for Rhythm Monitoring}","confidence":1,"confidence_rate":1},{"cnt":[[309,1869],[1940,1869],[1940,1914],[309,1914]],"region":{"top_left_x":309,"top_left_y":1869,"width":1632,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aac9de381a6741dc9726498b19a0b1d5","type":"text","conversion_output":true,"text":"Most studies examining outcomes of drug and ablative therapy use symptomatic episodes of AF","text_display":"\n\nMost studies examining outcomes of drug and ablative therapy use symptomatic episodes of AF","confidence":1,"confidence_rate":1},{"cnt":[[307,1912],[1940,1912],[1940,1957],[307,1957]],"region":{"top_left_x":307,"top_left_y":1912,"width":1634,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99f34e29dc254d11aac2866c4f6e0d0e","type":"text","conversion_output":true,"text":"for establishing endpoints. While this allows assessment of AF burden and quality of life, it is an","text_display":" for establishing endpoints. While this allows assessment of AF burden and quality of life, it is an","confidence":1,"confidence_rate":1},{"cnt":[[307,1955],[1938,1955],[1938,2002],[307,2002]],"region":{"top_left_x":307,"top_left_y":1955,"width":1631,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8745e11232644940b53d0bf172505872","type":"text","conversion_output":true,"text":"inadequate basis for making critical decisions regarding ongoing anticoagulation. Presumably,","text_display":" inadequate basis for making critical decisions regarding ongoing anticoagulation. Presumably,","confidence":1,"confidence_rate":1},{"cnt":[[307,2000],[1940,2000],[1940,2047],[307,2047]],"region":{"top_left_x":307,"top_left_y":2000,"width":1634,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2901d171d4d74666946fc0736365b076","type":"text","conversion_output":true,"text":"AFFIRM patients demonstrating excess morbidity after discontinuation of warfarin were felt to","text_display":" AFFIRM patients demonstrating excess morbidity after discontinuation of warfarin were felt to","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[307,2045],[1940,2045],[1940,2090],[307,2090]],"region":{"top_left_x":307,"top_left_y":2045,"width":1634,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a3d3dae68e84a06b98c40422db57ea5","type":"text","conversion_output":true,"text":"have complete control of their AF by anti-arrhythmic drug therapy [28]. Their subsequent events","text_display":" have complete control of their AF by anti-arrhythmic drug therapy [28]. Their subsequent events","confidence":1,"confidence_rate":1},{"cnt":[[307,2088],[1940,2088],[1940,2133],[307,2133]],"region":{"top_left_x":307,"top_left_y":2088,"width":1634,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85929d873cbc46feb9bb512c1135c8df","type":"text","conversion_output":true,"text":"may have been due to undetected silent AF or some other underlying factor. Other studies","text_display":" may have been due to undetected silent AF or some other underlying factor. Other studies","confidence":1,"confidence_rate":1},{"cnt":[[305,2131],[1940,2131],[1940,2176],[305,2176]],"region":{"top_left_x":305,"top_left_y":2131,"width":1636,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3d71b28a0b345e99f255db756e083e8","type":"text","conversion_output":true,"text":"have documented a moderate prevalence of asymptomatic or \"silent\" AF in other settings [30-","text_display":" have documented a moderate prevalence of asymptomatic or \"silent\" AF in other settings [30","confidence":0.98681640625,"confidence_rate":0.9998617671721652},{"cnt":[[307,2174],[1944,2174],[1944,2221],[307,2221]],"region":{"top_left_x":307,"top_left_y":2174,"width":1638,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb0af63b3e9746a99bbd2c919739089b","type":"text","conversion_output":true,"text":"33, 70-72]. Additionally, \\(10-40 \\%\\) of successfully ablated, asymptomatic patients may have silent","text_display":"33, 70-72]. Additionally, \\(10-40 \\%\\) of successfully ablated, asymptomatic patients may have silent","confidence":0.9315903186798096,"confidence_rate":0.999312254729843},{"cnt":[[305,2219],[1940,2219],[1940,2267],[305,2267]],"region":{"top_left_x":305,"top_left_y":2219,"width":1636,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a10f042b71a492e8d62df50eb94bf65","type":"text","conversion_output":true,"text":"AF [71, 72], which raises the possibility of continuing stroke risk or other morbidity, even though","text_display":" AF [71, 72], which raises the possibility of continuing stroke risk or other morbidity, even though","confidence":0.9990234375,"confidence_rate":0.9999906054321309},{"cnt":[[307,2264],[1940,2264],[1940,2310],[307,2310]],"region":{"top_left_x":307,"top_left_y":2264,"width":1634,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc6ce08fa007490da29d05846f6b6578","type":"text","conversion_output":true,"text":"symptoms are eliminated [73]. Of note, others have reported far lower asymptomatic AF rates","text_display":" symptoms are eliminated [73]. Of note, others have reported far lower asymptomatic AF rates","confidence":0.998046875,"confidence_rate":0.9999796352611579},{"cnt":[[307,2307],[1944,2307],[1944,2355],[307,2355]],"region":{"top_left_x":307,"top_left_y":2307,"width":1638,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7948d81fddf3484faa6d278b48ba7c05","type":"text","conversion_output":true,"text":"[48, 74, 75]. In addition, patients with asymptomatic AF may be at equivalent risk as their","text_display":" [48, 74, 75]. In addition, patients with asymptomatic AF may be at equivalent risk as their","confidence":0.9921875,"confidence_rate":0.9999183035721159},{"cnt":[[307,2350],[1940,2350],[1940,2400],[307,2400]],"region":{"top_left_x":307,"top_left_y":2350,"width":1634,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8cbde62dd8f4c7e882eece6d8e01e1c","type":"text","conversion_output":true,"text":"symptomatic counterparts. These issues, and the need to establish simple treatment efficacy,","text_display":" symptomatic counterparts. These issues, and the need to establish simple treatment efficacy,","confidence":1,"confidence_rate":1},{"cnt":[[305,2396],[1618,2396],[1618,2443],[305,2443]],"region":{"top_left_x":305,"top_left_y":2395,"width":1313,"height":48},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a41006f02d9f4edf8a1d7eddb5e5bd4b","type":"text","conversion_output":true,"text":"provide a clear rationale for careful monitoring to establish treatment efficacy.","text_display":" provide a clear rationale for careful monitoring to establish treatment efficacy.","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25676e5fc88d442b90c499daa53690f2","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1841,2574],[1841,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb9f911b64154ffeb384d731dfdd08e9","type":"page_info","conversion_output":false,"text":"Page 18 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-20","page":20,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dca7c5574bb84778aee2958a4335350c","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[303,249],[1644,249],[1644,312],[303,312]],"region":{"top_left_x":302,"top_left_y":249,"width":1342,"height":63},"line":2,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"d4c994574ef9417f8f74da49a2b03510","type":"section_header","conversion_output":false,"children_ids":["8c71115b2e0340d5a9d6414f6d269212"],"text":"","text_display":""},{"cnt":[[309,254],[1635,254],[1635,307],[309,307]],"region":{"top_left_x":309,"top_left_y":253,"width":1326,"height":55},"line":3,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"8c71115b2e0340d5a9d6414f6d269212","type":"text","conversion_output":true,"parent_id":"d4c994574ef9417f8f74da49a2b03510","text":"1.6 Rationale for Cost and Quality of Life Investigations","text_display":"\n\n\\subsection*{1.6 Rationale for Cost and Quality of Life Investigations}","confidence":0.99951171875,"confidence_rate":0.999992122603638},{"cnt":[[305,305],[1940,305],[1940,354],[305,354]],"region":{"top_left_x":305,"top_left_y":305,"width":1636,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c2307c4830f4504930706697eb49278","type":"text","conversion_output":true,"text":"AF is responsible for almost 500,000 in-patient hospitalizations in the US every year [20-21].","text_display":"\n\nAF is responsible for almost 500,000 in-patient hospitalizations in the US every year [20-21].","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[305,352],[1944,352],[1944,397],[305,397]],"region":{"top_left_x":305,"top_left_y":352,"width":1640,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f93f91476b5f4e2a84e674245d59e262","type":"text","conversion_output":true,"text":"The direct medical costs associated with AF account for several billion dollars of excess health","text_display":" The direct medical costs associated with AF account for several billion dollars of excess health","confidence":1,"confidence_rate":1},{"cnt":[[305,395],[1944,395],[1944,443],[305,443]],"region":{"top_left_x":305,"top_left_y":395,"width":1640,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6c39b2288e14277bc1d00aec899bb7c","type":"text","conversion_output":true,"text":"care spending per year in this country. At the individual level, AF increases medical spending","text_display":" care spending per year in this country. At the individual level, AF increases medical spending","confidence":1,"confidence_rate":1},{"cnt":[[305,438],[1944,438],[1944,486],[305,486]],"region":{"top_left_x":305,"top_left_y":438,"width":1640,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c70de8611f054964bff752eda51b1c8e","type":"text","conversion_output":true,"text":"from 9 to 22 times that for similar patients without AF. The cost effectiveness of ablation has","text_display":" from 9 to 22 times that for similar patients without AF. The cost effectiveness of ablation has","confidence":1,"confidence_rate":1},{"cnt":[[305,481],[1944,481],[1944,531],[305,531]],"region":{"top_left_x":305,"top_left_y":481,"width":1640,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d1bd57a46e54166944f0da14879f68d","type":"text","conversion_output":true,"text":"been evaluated in preliminary studies only [76, 77]. Although case control studies have","text_display":" been evaluated in preliminary studies only [76, 77]. Although case control studies have","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[305,526],[1944,526],[1944,574],[305,574]],"region":{"top_left_x":305,"top_left_y":526,"width":1640,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"438b9ccfe9154464aa6ff52f6beb690b","type":"text","conversion_output":true,"text":"suggested that AF-related impairment of QoL is between that of having an MI and heart failure,","text_display":" suggested that AF-related impairment of QoL is between that of having an MI and heart failure,","confidence":0.9643726348876953,"confidence_rate":0.9996336276524659},{"cnt":[[305,571],[1944,571],[1944,617],[305,617]],"region":{"top_left_x":305,"top_left_y":571,"width":1640,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ba2886c990d42a499ba90517f5e8602","type":"text","conversion_output":true,"text":"improvement is expected with treatment [28, 29, 26, 38, 78-80]. Preliminary data suggest that","text_display":" improvement is expected with treatment [28, 29, 26, 38, 78-80]. Preliminary data suggest that","confidence":0.99609375,"confidence_rate":0.9999600630493264},{"cnt":[[305,614],[1944,614],[1944,662],[305,662]],"region":{"top_left_x":305,"top_left_y":614,"width":1640,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"270ab4d8a0ed49dca96585761d2df130","type":"text","conversion_output":true,"text":"AF ablation can restore QoL to levels comparable to age/sex matched general populations [81,","text_display":" AF ablation can restore QoL to levels comparable to age/sex matched general populations [81,","confidence":0.9951171875,"confidence_rate":0.9999495397022695},{"cnt":[[305,657],[1944,657],[1944,707],[305,707]],"region":{"top_left_x":305,"top_left_y":657,"width":1640,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5442f5a045ba4e068ec1f5c357b30809","type":"text","conversion_output":true,"text":"82]. Given the epidemic growth of this arrhythmia in the aging US population, more effective","text_display":" 82]. Given the epidemic growth of this arrhythmia in the aging US population, more effective","confidence":0.9970703125,"confidence_rate":0.9999697531643026},{"cnt":[[305,700],[1944,700],[1944,750],[305,750]],"region":{"top_left_x":305,"top_left_y":700,"width":1640,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c657811d3dea42169041cd995072085d","type":"text","conversion_output":true,"text":"therapy offers the potential of relieving suffering in a growing number of citizens. As part of the","text_display":" therapy offers the potential of relieving suffering in a growing number of citizens. As part of the","confidence":1,"confidence_rate":1},{"cnt":[[305,746],[1944,746],[1944,793],[305,793]],"region":{"top_left_x":305,"top_left_y":745,"width":1640,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93ad0156829d40bca8cebd1b8bc8e5e6","type":"text","conversion_output":true,"text":"CABANA research program, we plan to examine economic and QoL outcomes comprehensively","text_display":" CABANA research program, we plan to examine economic and QoL outcomes comprehensively","confidence":1,"confidence_rate":1},{"cnt":[[305,791],[1944,791],[1944,838],[305,838]],"region":{"top_left_x":305,"top_left_y":790,"width":1640,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc401840a3ed4607aafcbc6a8e356579","type":"text","conversion_output":true,"text":"using state-of-the-art tools and techniques used in recent or ongoing trials (OAT, STICH and","text_display":" using state-of-the-art tools and techniques used in recent or ongoing trials (OAT, STICH and","confidence":1,"confidence_rate":1},{"cnt":[[305,834],[529,834],[529,883],[305,883]],"region":{"top_left_x":305,"top_left_y":833,"width":224,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a052f53a92344ad934e6c6a1975fb95","type":"text","conversion_output":true,"text":"SCD-HeFT).","text_display":" SCD-HeFT).","confidence":1,"confidence_rate":1},{"cnt":[[301,915],[1326,915],[1326,986],[301,986]],"region":{"top_left_x":300,"top_left_y":915,"width":1026,"height":72},"line":17,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"c94d9bf21f6b485bab4b51702b4c9fe1","type":"section_header","conversion_output":false,"children_ids":["04bdf91a38e54c52aa53d7618edcd777"],"text":"","text_display":""},{"cnt":[[309,922],[1319,922],[1319,982],[309,982]],"region":{"top_left_x":309,"top_left_y":921,"width":1011,"height":61},"line":18,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"04bdf91a38e54c52aa53d7618edcd777","type":"text","conversion_output":true,"parent_id":"c94d9bf21f6b485bab4b51702b4c9fe1","text":"1.7 Rationale for Cardiac Imaging Studies","text_display":"\n\n\\subsection*{1.7 Rationale for Cardiac Imaging Studies}","confidence":1,"confidence_rate":1},{"cnt":[[305,975],[1944,975],[1944,1025],[305,1025]],"region":{"top_left_x":305,"top_left_y":975,"width":1640,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cf626d046094d4fbe45dbf318af9efe","type":"text","conversion_output":true,"text":"Atrial remodeling, occurring with AF has been well documented, although it is difficult to know","text_display":"\n\nAtrial remodeling, occurring with AF has been well documented, although it is difficult to know","confidence":1,"confidence_rate":1},{"cnt":[[305,1023],[1944,1023],[1944,1068],[305,1068]],"region":{"top_left_x":305,"top_left_y":1022,"width":1640,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99925baf3f8a4f2094b8b311dd4178f7","type":"text","conversion_output":true,"text":"whether changes in atrial structure precede or follow this arrhythmia or are simply triggered by","text_display":" whether changes in atrial structure precede or follow this arrhythmia or are simply triggered by","confidence":1,"confidence_rate":1},{"cnt":[[305,1066],[1944,1066],[1944,1113],[305,1113]],"region":{"top_left_x":305,"top_left_y":1065,"width":1640,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"713cad2e1844426f9e1c1f77d389b546","type":"text","conversion_output":true,"text":"underlying disease. It also remains uncertain whether a reversal of atrial dysfunction occurs","text_display":" underlying disease. It also remains uncertain whether a reversal of atrial dysfunction occurs","confidence":1,"confidence_rate":1},{"cnt":[[305,1109],[1944,1109],[1944,1158],[305,1158]],"region":{"top_left_x":305,"top_left_y":1108,"width":1640,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"daba6c8284774b22a987d1e96aa55b8d","type":"text","conversion_output":true,"text":"following ablation. In theory, elimination of AF should produce both electrical and anatomic","text_display":" following ablation. In theory, elimination of AF should produce both electrical and anatomic","confidence":1,"confidence_rate":1},{"cnt":[[305,1154],[1944,1154],[1944,1201],[305,1201]],"region":{"top_left_x":305,"top_left_y":1153,"width":1640,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17372eeb699d422ea3ab417ef18fbad8","type":"text","conversion_output":true,"text":"remodeling, regardless of the therapy employed. At present, LA size and function outcomes","text_display":" remodeling, regardless of the therapy employed. At present, LA size and function outcomes","confidence":1,"confidence_rate":1},{"cnt":[[305,1197],[1944,1197],[1944,1244],[305,1244]],"region":{"top_left_x":305,"top_left_y":1196,"width":1640,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67ddb6ebde064700a9a20270799e4349","type":"text","conversion_output":true,"text":"following ablation are contradictory [83-88]. These data suggest an improvement in LA size and","text_display":" following ablation are contradictory [83-88]. These data suggest an improvement in LA size and","confidence":1,"confidence_rate":1},{"cnt":[[305,1242],[1944,1242],[1944,1291],[305,1291]],"region":{"top_left_x":305,"top_left_y":1241,"width":1640,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f152d78095d643b9afe48341ac5915b6","type":"text","conversion_output":true,"text":"function following more limited PV isolation, although this might be offset by the scarring","text_display":" function following more limited PV isolation, although this might be offset by the scarring","confidence":1,"confidence_rate":1},{"cnt":[[305,1285],[1944,1285],[1944,1334],[305,1334]],"region":{"top_left_x":305,"top_left_y":1284,"width":1640,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"873dca7419544ed9882bb0eb2c637540","type":"text","conversion_output":true,"text":"produced by more aggressive intervention. We also have preliminary data suggesting that LA","text_display":" produced by more aggressive intervention. We also have preliminary data suggesting that LA","confidence":1,"confidence_rate":1},{"cnt":[[305,1328],[1944,1328],[1944,1377],[305,1377]],"region":{"top_left_x":305,"top_left_y":1327,"width":1640,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dde9950a0a294e25b9a71f9b2b6188ea","type":"text","conversion_output":true,"text":"dysfunction remains beyond the typical 1-2 month time frame used in deciding to stop anti-","text_display":" dysfunction remains beyond the typical 1-2 month time frame used in deciding to stop anti","confidence":0.94580078125,"confidence_rate":0.9994136107013143},{"cnt":[[305,1371],[1944,1371],[1944,1420],[305,1420]],"region":{"top_left_x":305,"top_left_y":1370,"width":1640,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5c0eb94daeb4717862f3cd0f68a8ff7","type":"text","conversion_output":true,"text":"coagulation after restoring sinus rhythm [89]. CT / MR Image Analysis will be required to","text_display":"coagulation after restoring sinus rhythm [89]. CT / MR Image Analysis will be required to","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[305,1418],[1944,1418],[1944,1465],[305,1465]],"region":{"top_left_x":305,"top_left_y":1417,"width":1640,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce14d5bc8c4349fcaf3e9b5b9b2da9ef","type":"text","conversion_output":true,"text":"document the occurrence of LA remodeling following AF elimination with ablation or drug","text_display":" document the occurrence of LA remodeling following AF elimination with ablation or drug","confidence":1,"confidence_rate":1},{"cnt":[[305,1461],[1944,1461],[1944,1508],[305,1508]],"region":{"top_left_x":305,"top_left_y":1460,"width":1640,"height":49},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ed1218c18d045f3a5c382b7822bed58","type":"text","conversion_output":true,"text":"therapy and establish its impact on overall outcome, stroke risk, and the need for post-ablation","text_display":" therapy and establish its impact on overall outcome, stroke risk, and the need for post-ablation","confidence":1,"confidence_rate":1},{"cnt":[[305,1504],[1944,1504],[1944,1553],[305,1553]],"region":{"top_left_x":305,"top_left_y":1503,"width":1640,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"393cc3fa58b04050aab1ca2200e8fee4","type":"text","conversion_output":true,"text":"anti-coagulation. The real-life prevalence of catastrophic atrial-esophageal fistula formation and","text_display":" anti-coagulation. The real-life prevalence of catastrophic atrial-esophageal fistula formation and","confidence":1,"confidence_rate":1},{"cnt":[[305,1547],[1949,1547],[1949,1592],[305,1592]],"region":{"top_left_x":305,"top_left_y":1546,"width":1644,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8919e4a9c294548ab4cf0993bfe3255","type":"text","conversion_output":true,"text":"PV stenosis will also be established. While some of this desired information could be obtained","text_display":" PV stenosis will also be established. While some of this desired information could be obtained","confidence":1,"confidence_rate":1},{"cnt":[[305,1590],[1944,1590],[1944,1639],[305,1639]],"region":{"top_left_x":305,"top_left_y":1589,"width":1640,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ff1ac8c2834425db1c99c43d18d3cd8","type":"text","conversion_output":true,"text":"echocardiographically, this approach is problematic given difficulties in standardizing image","text_display":" echocardiographically, this approach is problematic given difficulties in standardizing image","confidence":1,"confidence_rate":1},{"cnt":[[305,1637],[1949,1637],[1949,1687],[305,1687]],"region":{"top_left_x":305,"top_left_y":1637,"width":1644,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67fb9dd47caa47199697c09defe115a3","type":"text","conversion_output":true,"text":"acquisition and interpretation. Furthermore, the echo approach cannot be used to assess","text_display":" acquisition and interpretation. Furthermore, the echo approach cannot be used to assess","confidence":1,"confidence_rate":1},{"cnt":[[305,1680],[1949,1680],[1949,1729],[305,1729]],"region":{"top_left_x":305,"top_left_y":1680,"width":1644,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00092fd958c040cfbc4a3a206f1b95b6","type":"text","conversion_output":true,"text":"pulmonary vein or esophageal status. CT or MR imaging can be standardized both in terms of","text_display":" pulmonary vein or esophageal status. CT or MR imaging can be standardized both in terms of","confidence":1,"confidence_rate":1},{"cnt":[[305,1725],[814,1725],[814,1772],[305,1772]],"region":{"top_left_x":305,"top_left_y":1725,"width":510,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa150d0139ed44269c84ceaed69012dd","type":"text","conversion_output":true,"text":"acquisition and interpretation.","text_display":" acquisition and interpretation.","confidence":1,"confidence_rate":1},{"cnt":[[303,1822],[995,1822],[995,1886],[303,1886]],"region":{"top_left_x":302,"top_left_y":1821,"width":693,"height":66},"line":37,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"04da04d0a8ca45a6abd18bd3dc3cc1aa","type":"section_header","conversion_output":false,"children_ids":["76cf18f40e074e1b987dfafaf310945d"],"text":"","text_display":""},{"cnt":[[309,1826],[990,1826],[990,1884],[309,1884]],"region":{"top_left_x":309,"top_left_y":1826,"width":682,"height":59},"line":38,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"76cf18f40e074e1b987dfafaf310945d","type":"text","conversion_output":true,"parent_id":"04da04d0a8ca45a6abd18bd3dc3cc1aa","text":"1.8 Significance of the Trial","text_display":"\n\n\\subsection*{1.8 Significance of the Trial}","confidence":1,"confidence_rate":1},{"cnt":[[305,1880],[1944,1880],[1944,1927],[305,1927]],"region":{"top_left_x":305,"top_left_y":1879,"width":1640,"height":49},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f950ce305354c62a4c7e7d01c48ec48","type":"text","conversion_output":true,"text":"This trial is of substantial importance at multiple levels. Clinically, the trial will establish whether","text_display":"\n\nThis trial is of substantial importance at multiple levels. Clinically, the trial will establish whether","confidence":1,"confidence_rate":1},{"cnt":[[305,1925],[1944,1925],[1944,1972],[305,1972]],"region":{"top_left_x":305,"top_left_y":1925,"width":1640,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ede32bbbf34b4a749e048191be7ca4b8","type":"text","conversion_output":true,"text":"the emerging role of aggressive catheter ablation in the treatment of AF is justified by patient","text_display":" the emerging role of aggressive catheter ablation in the treatment of AF is justified by patient","confidence":1,"confidence_rate":1},{"cnt":[[305,1968],[1944,1968],[1944,2017],[305,2017]],"region":{"top_left_x":305,"top_left_y":1967,"width":1640,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a96a7f36e414f1289c3b78bca96aa7f","type":"text","conversion_output":true,"text":"outcomes. This is an expensive approach, potentially complicated by life threatening events,","text_display":" outcomes. This is an expensive approach, potentially complicated by life threatening events,","confidence":1,"confidence_rate":1},{"cnt":[[305,2011],[1944,2009],[1944,2058],[305,2060]],"region":{"top_left_x":305,"top_left_y":2008,"width":1640,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1032ad9e02540e58ecb2eda88cdacc8","type":"text","conversion_output":true,"text":"which is now performed in thousands of patients without clear evidence of long-term benefit.","text_display":" which is now performed in thousands of patients without clear evidence of long-term benefit.","confidence":1,"confidence_rate":1},{"cnt":[[305,2054],[1944,2054],[1944,2103],[305,2103]],"region":{"top_left_x":305,"top_left_y":2053,"width":1640,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e90c41b4c0ae45cb8b6a6ac74cbb0ff0","type":"text","conversion_output":true,"text":"The issues raised above have not been settled for \"curative ablation\". The impact of age, AF","text_display":" The issues raised above have not been settled for \"curative ablation\". The impact of age, AF","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,2099],[1944,2099],[1944,2151],[305,2151]],"region":{"top_left_x":305,"top_left_y":2099,"width":1640,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bed1451201d416a84af970f7b3933eb","type":"text","conversion_output":true,"text":"type, and underlying disease on the outcome of ablation and drug therapy remain unclear. This","text_display":" type, and underlying disease on the outcome of ablation and drug therapy remain unclear. This","confidence":1,"confidence_rate":1},{"cnt":[[305,2144],[1944,2144],[1944,2191],[305,2191]],"region":{"top_left_x":305,"top_left_y":2144,"width":1640,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49ed84dd349843f488a3f972b07112b8","type":"text","conversion_output":true,"text":"study will answer these questions, will document the effect of ablation on AF recurrence and","text_display":" study will answer these questions, will document the effect of ablation on AF recurrence and","confidence":1,"confidence_rate":1},{"cnt":[[305,2187],[1944,2187],[1944,2237],[305,2237]],"region":{"top_left_x":305,"top_left_y":2187,"width":1640,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54150e779aaa4d9ca59c5441f097dfeb","type":"text","conversion_output":true,"text":"specifically examine health care costs, cost effectiveness, and quality of life outcomes. This","text_display":" specifically examine health care costs, cost effectiveness, and quality of life outcomes. This","confidence":1,"confidence_rate":1},{"cnt":[[305,2230],[1944,2230],[1944,2279],[305,2279]],"region":{"top_left_x":305,"top_left_y":2230,"width":1640,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93b303a036ab4896a65e0e27b59ca6c3","type":"text","conversion_output":true,"text":"study will also assess the role of earlier therapy for AF and the related utility of ablation as first","text_display":" study will also assess the role of earlier therapy for AF and the related utility of ablation as first","confidence":1,"confidence_rate":1},{"cnt":[[305,2273],[1072,2273],[1072,2322],[305,2322]],"region":{"top_left_x":305,"top_left_y":2273,"width":768,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61bf1289b623438b9a06922f58ac9aee","type":"text","conversion_output":true,"text":"line therapy in patients warranting treatment.","text_display":" line therapy in patients warranting treatment.","confidence":1,"confidence_rate":1},{"cnt":[[305,2361],[1944,2361],[1944,2413],[305,2413]],"region":{"top_left_x":305,"top_left_y":2361,"width":1640,"height":52},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cae5e77032db4aedbe0f79637bbf3897","type":"text","conversion_output":true,"text":"Scientifically, the trial will determine whether the attainment of normal sinus rhythm is a mortality","text_display":"\n\nScientifically, the trial will determine whether the attainment of normal sinus rhythm is a mortality","confidence":1,"confidence_rate":1},{"cnt":[[305,2406],[1944,2406],[1944,2456],[305,2456]],"region":{"top_left_x":305,"top_left_y":2406,"width":1640,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5f7f16ce70e4514b47d115ffc29c075","type":"text","conversion_output":true,"text":"and stroke advantage. No trial to date has prospectively addressed this issue, nor will any","text_display":" and stroke advantage. No trial to date has prospectively addressed this issue, nor will any","confidence":1,"confidence_rate":1},{"cnt":[[305,2451],[1944,2451],[1944,2499],[305,2499]],"region":{"top_left_x":305,"top_left_y":2451,"width":1640,"height":48},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"047a66fdadf5448b98079f2378b92561","type":"text","conversion_output":true,"text":"currently envisioned \\(1-2 yr\\) study be sufficiently powered for this purpose. The trial should also","text_display":" currently envisioned \\(1-2 yr\\) study be sufficiently powered for this purpose. The trial should also","confidence":0.9501953125,"confidence_rate":0.9995226586046675},{"cnt":[[305,2574],[969,2574],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":664,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"62a975521f03472ba411cd9de4ddd2e2","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5835866ba6f34153ae153f6f2028e425","type":"page_info","conversion_output":false,"text":"Page 19 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-21","page":21,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22d7840fdbf24c699124861247b6626e","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[309,249],[1940,249],[1940,299],[309,299]],"region":{"top_left_x":309,"top_left_y":249,"width":1632,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7859fe0bf2fb4d92bf8b32f56117db1f","type":"text","conversion_output":true,"text":"provide outcomes-based support for the role of AF as a modifiable risk factor of increased","text_display":"\nprovide outcomes-based support for the role of AF as a modifiable risk factor of increased","confidence":1,"confidence_rate":1},{"cnt":[[309,296],[1940,296],[1940,342],[309,342]],"region":{"top_left_x":309,"top_left_y":296,"width":1632,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f596ab016df74d8d88a2b3597c9597cc","type":"text","conversion_output":true,"text":"morbidity and mortality. The trial will also establish the determinants of ablation outcome. The","text_display":" morbidity and mortality. The trial will also establish the determinants of ablation outcome. The","confidence":1,"confidence_rate":1},{"cnt":[[309,339],[1944,339],[1944,385],[309,385]],"region":{"top_left_x":309,"top_left_y":339,"width":1636,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bad09ae22839435c87764eb0619023cf","type":"text","conversion_output":true,"text":"CT/MR Imaging will also elucidate the structural abnormalities contributing to the occurrence of","text_display":" CT/MR Imaging will also elucidate the structural abnormalities contributing to the occurrence of","confidence":0.994140625,"confidence_rate":0.9999418174502049},{"cnt":[[309,382],[1940,382],[1940,432],[309,432]],"region":{"top_left_x":309,"top_left_y":382,"width":1632,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0b003258f0149dea5937b8eaff5cb5d","type":"text","conversion_output":true,"text":"AF in a diverse population of patients and the modulation of those factors by drug or ablative","text_display":" AF in a diverse population of patients and the modulation of those factors by drug or ablative","confidence":0.99755859375,"confidence_rate":0.9999753094831817},{"cnt":[[309,430],[522,430],[522,471],[309,471]],"region":{"top_left_x":309,"top_left_y":429,"width":214,"height":42},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3dec99055be46b6a5ed45d89809db09","type":"text","conversion_output":true,"text":"intervention.","text_display":" intervention.","confidence":1,"confidence_rate":1},{"cnt":[[309,516],[1940,516],[1940,561],[309,561]],"region":{"top_left_x":309,"top_left_y":515,"width":1632,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3666dc1d00454cc29a57d1af288f4fd9","type":"text","conversion_output":true,"text":"From a health care policy standpoint, this trial will help establish the place for medical and non-","text_display":"\n\nFrom a health care policy standpoint, this trial will help establish the place for medical and non","confidence":1,"confidence_rate":1},{"cnt":[[309,559],[1940,559],[1940,604],[309,604]],"region":{"top_left_x":309,"top_left_y":558,"width":1632,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2637b7601cf64325ab230e5fbdedc91e","type":"text","conversion_output":true,"text":"pharmacologic therapies for this escalating national healthcare dilemma. Aggressive","text_display":"pharmacologic therapies for this escalating national healthcare dilemma. Aggressive","confidence":1,"confidence_rate":1},{"cnt":[[309,604],[1940,604],[1940,649],[309,649]],"region":{"top_left_x":309,"top_left_y":603,"width":1632,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"917a6416f685430ab6e2092ddf6c8313","type":"text","conversion_output":true,"text":"intervention in an increasing number of patients and resulting mushrooming financial burden to","text_display":" intervention in an increasing number of patients and resulting mushrooming financial burden to","confidence":1,"confidence_rate":1},{"cnt":[[309,645],[1940,645],[1940,694],[309,694]],"region":{"top_left_x":309,"top_left_y":644,"width":1632,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c109516f903495bb78d4c7b4df09332","type":"text","conversion_output":true,"text":"society is already taking place at a time of increasingly constrained funding for health care. The","text_display":" society is already taking place at a time of increasingly constrained funding for health care. The","confidence":1,"confidence_rate":1},{"cnt":[[309,692],[1940,692],[1940,737],[309,737]],"region":{"top_left_x":309,"top_left_y":691,"width":1632,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"895e4c9f72ca4d7fb4664700eb8e185d","type":"text","conversion_output":true,"text":"Quality of Life and cost components of the trial will firmly establish whether AF ablation","text_display":" Quality of Life and cost components of the trial will firmly establish whether AF ablation","confidence":1,"confidence_rate":1},{"cnt":[[309,735],[1940,735],[1940,780],[309,780]],"region":{"top_left_x":309,"top_left_y":734,"width":1632,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63c0f7f7bc094a298ecbf48e48ec1df6","type":"text","conversion_output":true,"text":"represents good value for the money and is an efficient way of improving health in the affected","text_display":" represents good value for the money and is an efficient way of improving health in the affected","confidence":1,"confidence_rate":1},{"cnt":[[309,778],[1944,778],[1944,827],[309,827]],"region":{"top_left_x":309,"top_left_y":777,"width":1636,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9beeff0853dc41ea8ff8d1dcfe8373ee","type":"text","conversion_output":true,"text":"population relative to alternative health care expenditures. It will also allow much better","text_display":" population relative to alternative health care expenditures. It will also allow much better","confidence":1,"confidence_rate":1},{"cnt":[[309,821],[1940,821],[1940,870],[309,870]],"region":{"top_left_x":309,"top_left_y":820,"width":1632,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"972a51a143e649e889f120fa98ef8b28","type":"text","conversion_output":true,"text":"estimation of the impact of the diffusion of ablation technology into the overall health care","text_display":" estimation of the impact of the diffusion of ablation technology into the overall health care","confidence":1,"confidence_rate":1},{"cnt":[[309,868],[1940,868],[1940,913],[309,913]],"region":{"top_left_x":309,"top_left_y":867,"width":1632,"height":47},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"506d63fb822c4cc7bc71f698b1b88c92","type":"text","conversion_output":true,"text":"system. A critical window of opportunity for a randomized trial is now present, and the outcome","text_display":" system. A critical window of opportunity for a randomized trial is now present, and the outcome","confidence":1,"confidence_rate":1},{"cnt":[[309,911],[1936,911],[1936,958],[309,958]],"region":{"top_left_x":309,"top_left_y":910,"width":1627,"height":49},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9923b2d00aa0470fb4d95ef5d068c6bf","type":"text","conversion_output":true,"text":"of this landmark trial will likely shape therapy decisions and health care policy for years to come.","text_display":" of this landmark trial will likely shape therapy decisions and health care policy for years to come.","confidence":1,"confidence_rate":1},{"cnt":[[305,1040],[724,1040],[724,1111],[305,1111]],"region":{"top_left_x":305,"top_left_y":1039,"width":420,"height":72},"line":17,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"cf39f945ce324456b2c60d84ea60b311","type":"section_header","conversion_output":false,"children_ids":["82d89d6a22274ba390a8117cce9b9e20"],"text":"","text_display":""},{"cnt":[[309,1044],[720,1044],[720,1106],[309,1106]],"region":{"top_left_x":309,"top_left_y":1044,"width":411,"height":63},"line":18,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"82d89d6a22274ba390a8117cce9b9e20","type":"text","conversion_output":true,"parent_id":"cf39f945ce324456b2c60d84ea60b311","text":"2.0 Objectives","text_display":"\n\n\\subsection*{2.0 Objectives}","confidence":1,"confidence_rate":1},{"cnt":[[305,1169],[1609,1169],[1609,1231],[305,1231]],"region":{"top_left_x":305,"top_left_y":1168,"width":1305,"height":64},"line":19,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"0629fb891a6c4348bd4da3e8c243a238","type":"section_header","conversion_output":false,"children_ids":["64fefb70fa414349a6c5bbefdbe9fc55"],"text":"","text_display":""},{"cnt":[[309,1173],[1605,1173],[1605,1227],[309,1227]],"region":{"top_left_x":309,"top_left_y":1173,"width":1296,"height":54},"line":20,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"64fefb70fa414349a6c5bbefdbe9fc55","type":"text","conversion_output":true,"parent_id":"0629fb891a6c4348bd4da3e8c243a238","text":"Changes to the Protocol from the Original Study Design","text_display":"\n\n\\section*{Changes to the Protocol from the Original Study Design}","confidence":1,"confidence_rate":1},{"cnt":[[305,1227],[1940,1227],[1940,1274],[305,1274]],"region":{"top_left_x":305,"top_left_y":1226,"width":1636,"height":49},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fcc7307b68c4438be3680e3fe2c4e80","type":"text","conversion_output":true,"text":"Although CABANA was originally mandated to be a mortality trial, a careful assessment of the","text_display":"\n\nAlthough CABANA was originally mandated to be a mortality trial, a careful assessment of the","confidence":1,"confidence_rate":1},{"cnt":[[305,1268],[1940,1268],[1940,1317],[305,1317]],"region":{"top_left_x":305,"top_left_y":1267,"width":1636,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e07938e9bd246bdb31783c9e29589b3","type":"text","conversion_output":true,"text":"progress of the trial was undertaken by the study leadership in early 2013. Completely blinded","text_display":" progress of the trial was undertaken by the study leadership in early 2013. 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Careful consideration of these issues led to a decision to (a) change","text_display":" slower rate than projected. 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The","confidence":1,"confidence_rate":1},{"cnt":[[309,1261],[1944,1261],[1944,1308],[309,1308]],"region":{"top_left_x":309,"top_left_y":1261,"width":1636,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"584a92dd34a1424ea5bd7b3579fd1007","type":"text","conversion_output":true,"text":"composite of total mortality, stroke or cardiovascular hospitalization will also be assessed.","text_display":" composite of total mortality, stroke or cardiovascular hospitalization will also be assessed.","confidence":1,"confidence_rate":1},{"cnt":[[309,1302],[1944,1302],[1944,1351],[309,1351]],"region":{"top_left_x":309,"top_left_y":1301,"width":1636,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20fa1cd94f184df08a49c12ed2f5aaf6","type":"text","conversion_output":true,"text":"Hypothesis: Catheter ablation for AF will be significantly ( \\(\\geq 25 \\%\\) ) more effective than","text_display":" Hypothesis: Catheter ablation for AF will be significantly ( \\(\\geq 25 \\%\\) ) more effective than","confidence":0.99072265625,"confidence_rate":0.9999018927461621},{"cnt":[[309,1349],[1944,1349],[1944,1396],[309,1396]],"region":{"top_left_x":309,"top_left_y":1349,"width":1636,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67ed05a2e95345ee8076618bc0073edb","type":"text","conversion_output":true,"text":"pharmacologic therapy, in reducing cardiovascular hospitalization, the composite of total","text_display":" pharmacologic therapy, in reducing cardiovascular hospitalization, the composite of total","confidence":1,"confidence_rate":1},{"cnt":[[309,1392],[1944,1392],[1944,1439],[309,1439]],"region":{"top_left_x":309,"top_left_y":1392,"width":1636,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"629fa88dc9464062ab5585c9b796b305","type":"text","conversion_output":true,"text":"mortality or cardiovascular hospitalization, and the composite of total mortality, stroke or","text_display":" mortality or cardiovascular hospitalization, and the composite of total mortality, stroke or","confidence":1,"confidence_rate":1},{"cnt":[[309,1435],[827,1435],[827,1485],[309,1485]],"region":{"top_left_x":309,"top_left_y":1435,"width":519,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80bf4993f25f4b438d81b1e0737139f3","type":"text","conversion_output":true,"text":"cardiovascular hospitalization.","text_display":" cardiovascular hospitalization.","confidence":1,"confidence_rate":1},{"cnt":[[305,1521],[1115,1521],[1115,1575],[305,1575]],"region":{"top_left_x":305,"top_left_y":1521,"width":811,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10abc0df9a1d4bf9ae2086950ff98a1b","type":"section_header","conversion_output":false,"children_ids":["19414fca75ad4cdaa70a8a67c8fcdfbf"],"text":"","text_display":""},{"cnt":[[309,1525],[1111,1525],[1111,1571],[309,1571]],"region":{"top_left_x":309,"top_left_y":1525,"width":802,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19414fca75ad4cdaa70a8a67c8fcdfbf","type":"text","conversion_output":true,"parent_id":"10abc0df9a1d4bf9ae2086950ff98a1b","text":"2.2.3 Freedom from Heart Failure Mortality","text_display":"\n\n\\subsection*{2.2.3 Freedom from Heart Failure Mortality}","confidence":0.9990234375,"confidence_rate":0.9999792121384572},{"cnt":[[305,1568],[1944,1568],[1944,1618],[305,1618]],"region":{"top_left_x":305,"top_left_y":1568,"width":1640,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f16bd3ee0db4e6995ba1e0b10bbc90d","type":"text","conversion_output":true,"text":"AF may be seen in \\(40-50 \\%\\) of heart failure patients. Furthermore, heart failure may occur","text_display":"\n\nAF may be seen in \\(40-50 \\%\\) of heart failure patients. Furthermore, heart failure may occur","confidence":0.990234375,"confidence_rate":0.9998977800014001},{"cnt":[[305,1611],[1944,1611],[1944,1661],[305,1661]],"region":{"top_left_x":305,"top_left_y":1611,"width":1640,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"360b667f9876441e81adb2960859d5c3","type":"text","conversion_output":true,"text":"because of uncontrolled ventricular response rates or as an adverse consequence of drug","text_display":" because of uncontrolled ventricular response rates or as an adverse consequence of drug","confidence":1,"confidence_rate":1},{"cnt":[[305,1656],[1944,1656],[1944,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1656,"width":1640,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef585510a81047afb2d2a9904b4ab437","type":"text","conversion_output":true,"text":"therapy. Heart failure related mortality may be affected differently by the ablative elimination of","text_display":" therapy. Heart failure related mortality may be affected differently by the ablative elimination of","confidence":1,"confidence_rate":1},{"cnt":[[305,1702],[1089,1702],[1089,1747],[305,1747]],"region":{"top_left_x":305,"top_left_y":1701,"width":785,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3b0686fb19e4a2383c4316b7b7bc9ef","type":"text","conversion_output":true,"text":"AF than by ongoing pharmacologic treatment.","text_display":" AF than by ongoing pharmacologic treatment.","confidence":1,"confidence_rate":1},{"cnt":[[305,1783],[1205,1783],[1205,1833],[305,1833]],"region":{"top_left_x":305,"top_left_y":1783,"width":901,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7803ca2bcdb24232a6e7db5f2f1da39e","type":"section_header","conversion_output":false,"children_ids":["da7f05a95e67418c9042c3254e4b058d"],"text":"","text_display":""},{"cnt":[[309,1788],[1205,1788],[1205,1828],[309,1828]],"region":{"top_left_x":309,"top_left_y":1787,"width":897,"height":42},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da7f05a95e67418c9042c3254e4b058d","type":"text","conversion_output":true,"parent_id":"7803ca2bcdb24232a6e7db5f2f1da39e","text":"2.2.4 Freedom from Recurrent Atrial Fibrillation","text_display":"\n\n\\subsection*{2.2.4 Freedom from Recurrent Atrial Fibrillation}","confidence":0.9965858445502818,"confidence_rate":0.9999354738370316},{"cnt":[[309,1830],[1944,1830],[1944,1880],[309,1880]],"region":{"top_left_x":309,"top_left_y":1830,"width":1636,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25aadc0d47ee4ede857a612059269d3a","type":"text","conversion_output":true,"text":"The purpose of therapy is to eliminate accompanying symptoms in affected individuals. An","text_display":"\n\nThe purpose of therapy is to eliminate accompanying symptoms in affected individuals. An","confidence":1,"confidence_rate":1},{"cnt":[[309,1876],[1944,1876],[1944,1923],[309,1923]],"region":{"top_left_x":309,"top_left_y":1875,"width":1636,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a6d142ca102421cb09e13705675973f","type":"text","conversion_output":true,"text":"additional secondary endpoint will be the elimination of AF, comparing complete freedom from","text_display":" additional secondary endpoint will be the elimination of AF, comparing complete freedom from","confidence":0.99658203125,"confidence_rate":0.9999647034750034},{"cnt":[[309,1921],[1944,1921],[1944,1966],[309,1966]],"region":{"top_left_x":309,"top_left_y":1920,"width":1636,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"293041eeee6b4ca4b3b5ba4b8d053b7b","type":"text","conversion_output":true,"text":"and time to recurrent AF outcomes of ablation and drug therapy. Time to second AF recurrence","text_display":" and time to recurrent AF outcomes of ablation and drug therapy. Time to second AF recurrence","confidence":1,"confidence_rate":1},{"cnt":[[309,1964],[1944,1964],[1944,2013],[309,2013]],"region":{"top_left_x":309,"top_left_y":1963,"width":1636,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ce3cfe2213245a380ed16bd4b0559a3","type":"text","conversion_output":true,"text":"and AF burden will also be established. Freedom from AF after each ablation performed in an","text_display":" and AF burden will also be established. Freedom from AF after each ablation performed in an","confidence":1,"confidence_rate":1},{"cnt":[[309,2007],[1057,2007],[1057,2056],[309,2056]],"region":{"top_left_x":309,"top_left_y":2006,"width":749,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6be9e906e8f478291b38012a898cd7c","type":"text","conversion_output":true,"text":"individual subject will be separately tracked.","text_display":" individual subject will be separately tracked.","confidence":1,"confidence_rate":1},{"cnt":[[305,2093],[879,2093],[879,2144],[305,2144]],"region":{"top_left_x":305,"top_left_y":2092,"width":574,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bc073fac0a445989192e0e4458ced9d","type":"section_header","conversion_output":false,"children_ids":["ac879e70223a491eb28fec380c94f756"],"text":"","text_display":""},{"cnt":[[309,2097],[874,2097],[874,2142],[309,2142]],"region":{"top_left_x":309,"top_left_y":2096,"width":566,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac879e70223a491eb28fec380c94f756","type":"text","conversion_output":true,"parent_id":"3bc073fac0a445989192e0e4458ced9d","text":"2.2.5 Cost / Economic Impact","text_display":"\n\n\\subsection*{2.2.5 Cost / Economic Impact}","confidence":0.9921941757202148,"confidence_rate":0.9997625600357942},{"cnt":[[309,2140],[1944,2140],[1944,2185],[309,2185]],"region":{"top_left_x":309,"top_left_y":2139,"width":1636,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab76d5fb974d41569c5a3be4b5a8d396","type":"text","conversion_output":true,"text":"AF is responsible for almost 500,000 in-patient hospitalizations in the US every year and several","text_display":"\n\nAF is responsible for almost 500,000 in-patient hospitalizations in the US every year and several","confidence":0.8243043422698975,"confidence_rate":0.9981075236835439},{"cnt":[[309,2183],[1944,2183],[1944,2230],[309,2230]],"region":{"top_left_x":309,"top_left_y":2182,"width":1636,"height":49},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee9d56ad596943ddacd3c6fc193bd76b","type":"text","conversion_output":true,"text":"billion dollars of excess health care expenditures. For patients, AF increases medical spending","text_display":" billion dollars of excess health care expenditures. For patients, AF increases medical spending","confidence":1,"confidence_rate":1},{"cnt":[[305,2226],[1944,2226],[1944,2275],[305,2275]],"region":{"top_left_x":305,"top_left_y":2225,"width":1640,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6deccfab393e421e9b1cf7a9411c5b9c","type":"text","conversion_output":true,"text":"from 9-22 times that of comparable patients without AF, and this effect is likely to have even","text_display":" from 9-22 times that of comparable patients without AF, and this effect is likely to have even","confidence":1,"confidence_rate":1},{"cnt":[[305,2271],[1944,2271],[1944,2318],[305,2318]],"region":{"top_left_x":305,"top_left_y":2270,"width":1640,"height":49},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60890d9063754cafbe3b551f001d0ca0","type":"text","conversion_output":true,"text":"greater impact on health care spending in the future given the growth in number of AF patients","text_display":" greater impact on health care spending in the future given the growth in number of AF patients","confidence":1,"confidence_rate":1},{"cnt":[[305,2316],[1944,2316],[1944,2361],[305,2361]],"region":{"top_left_x":305,"top_left_y":2316,"width":1640,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e2e576275d74b3883dce00cb37e4888","type":"text","conversion_output":true,"text":"expected and the increasingly complicated therapies used for these patients. As part of","text_display":" expected and the increasingly complicated therapies used for these patients. As part of","confidence":1,"confidence_rate":1},{"cnt":[[305,2359],[1938,2359],[1938,2408],[305,2408]],"region":{"top_left_x":305,"top_left_y":2358,"width":1633,"height":51},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e9e3d9ed8cc44639098d13862e8b149","type":"text","conversion_output":true,"text":"CABANA, we will examine the economic impact of AF ablation using state-of-the-art techniques.","text_display":" CABANA, we will examine the economic impact of AF ablation using state-of-the-art techniques.","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94a02265b2744f2fbed13906f401cfb1","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1841,2574],[1841,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84c731fa4878424191cbc5f1e127adb3","type":"page_info","conversion_output":false,"text":"Page 21 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-23","page":23,"lines":[{"cnt":[[372,155],[1794,155],[1794,200],[372,200]],"region":{"top_left_x":371,"top_left_y":154,"width":1423,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5fa4a16e843642e1a90b34a414368729","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[698,249],[698,301],[305,301]],"region":{"top_left_x":305,"top_left_y":249,"width":394,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d5afdf5c0b54885ad148c4bdf28c1bc","type":"section_header","conversion_output":false,"children_ids":["a72985bd4bf14dce8d95458cf4554285"],"text":"","text_display":""},{"cnt":[[309,254],[694,254],[694,299],[309,299]],"region":{"top_left_x":309,"top_left_y":253,"width":385,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a72985bd4bf14dce8d95458cf4554285","type":"text","conversion_output":true,"parent_id":"1d5afdf5c0b54885ad148c4bdf28c1bc","text":"2.2.6 Quality of Life","text_display":"\n\n\\subsection*{2.2.6 Quality of Life}","confidence":1,"confidence_rate":1},{"cnt":[[305,296],[1940,296],[1940,342],[305,342]],"region":{"top_left_x":305,"top_left_y":296,"width":1636,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"687c5d977be645b98d02d48c358944d9","type":"text","conversion_output":true,"text":"AF also causes significant impairment of quality of life, at a level between that of an MI and","text_display":"\n\nAF also causes significant impairment of quality of life, at a level between that of an MI and","confidence":0.81494140625,"confidence_rate":0.9980529545047286},{"cnt":[[305,339],[1940,339],[1940,385],[305,385]],"region":{"top_left_x":305,"top_left_y":339,"width":1636,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d70c1bfb348f4d27b44622da97c92741","type":"text","conversion_output":true,"text":"heart failure. Preliminary case control data further suggest that ablative therapy for AF can","text_display":" heart failure. Preliminary case control data further suggest that ablative therapy for AF can","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[1940,382],[1940,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1636,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1164c27d39c24f97bb9ca903cef4c6be","type":"text","conversion_output":true,"text":"restore QOL to levels comparable to age and sex matched general populations. Given the","text_display":" restore QOL to levels comparable to age and sex matched general populations. Given the","confidence":1,"confidence_rate":1},{"cnt":[[305,425],[1940,425],[1940,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1636,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82d19f8b8cb94525994d881f110700ad","type":"text","conversion_output":true,"text":"epidemic growth of this arrhythmia in an aging population, a more effective therapy offers the","text_display":" epidemic growth of this arrhythmia in an aging population, a more effective therapy offers the","confidence":1,"confidence_rate":1},{"cnt":[[305,471],[1944,471],[1944,518],[305,518]],"region":{"top_left_x":305,"top_left_y":470,"width":1640,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7d0a4f3e6cc4e269351d4547b2da99c","type":"text","conversion_output":true,"text":"potential to relieve suffering in a growing number of US citizens. Therefore, QOL assessment","text_display":" potential to relieve suffering in a growing number of US citizens. Therefore, QOL assessment","confidence":1,"confidence_rate":1},{"cnt":[[305,516],[797,516],[797,556],[305,556]],"region":{"top_left_x":305,"top_left_y":515,"width":493,"height":42},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d29bd908cef43ae830f82159d2d5f0c","type":"text","conversion_output":true,"text":"must be included in this trial.","text_display":" must be included in this trial.","confidence":1,"confidence_rate":1},{"cnt":[[305,597],[730,597],[730,647],[305,647]],"region":{"top_left_x":305,"top_left_y":597,"width":426,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75030e4bcd4240afac7ff064fc173284","type":"section_header","conversion_output":false,"children_ids":["2ae16438b8fa44d8b5d5d3aa87b9cd0c"],"text":"","text_display":""},{"cnt":[[305,602],[728,602],[728,642],[305,642]],"region":{"top_left_x":305,"top_left_y":601,"width":424,"height":42},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ae16438b8fa44d8b5d5d3aa87b9cd0c","type":"text","conversion_output":true,"parent_id":"75030e4bcd4240afac7ff064fc173284","text":"2.2.7 Adverse Events","text_display":"\n\n\\subsection*{2.2.7 Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[305,645],[1944,645],[1944,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1640,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff6a0a9b165e4faeb29f6ca8e12ce2fd","type":"text","conversion_output":true,"text":"This trial must provide a clear delineation of the \"down side\" of therapy and track serious","text_display":"\n\nThis trial must provide a clear delineation of the \"down side\" of therapy and track serious","confidence":1,"confidence_rate":1},{"cnt":[[305,692],[1944,692],[1944,737],[305,737]],"region":{"top_left_x":305,"top_left_y":691,"width":1640,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fb83e85823248ecab13e61ae3f7b8a2","type":"text","conversion_output":true,"text":"untoward events unique to each approach. Although strict comparisons will be difficult because","text_display":" untoward events unique to each approach. Although strict comparisons will be difficult because","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[1944,735],[1944,782],[305,782]],"region":{"top_left_x":305,"top_left_y":734,"width":1640,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ba1516a3fe9466fa1b882eb3a8ff67c","type":"text","conversion_output":true,"text":"of therapy-specific adverse events, additional analyses will look at each event type descriptively.","text_display":" of therapy-specific adverse events, additional analyses will look at each event type descriptively.","confidence":1,"confidence_rate":1},{"cnt":[[305,778],[1944,778],[1944,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":1640,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c648dce22bf548b68083f3bca7f7e2b6","type":"text","conversion_output":true,"text":"With drug therapy, unanticipated heart failure hospitalization, pro-arrhythmic events,","text_display":" With drug therapy, unanticipated heart failure hospitalization, pro-arrhythmic events,","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[1944,821],[1944,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1640,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d2c52f8f2b1455c8bf37d54e84d8453","type":"text","conversion_output":true,"text":"amiodarone pulmonary toxicity, and disabling stroke remain most concerning. For AF ablation","text_display":" amiodarone pulmonary toxicity, and disabling stroke remain most concerning. For AF ablation","confidence":1,"confidence_rate":1},{"cnt":[[305,866],[1944,866],[1944,913],[305,913]],"region":{"top_left_x":305,"top_left_y":865,"width":1640,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a9ac39b4e3c42f49e30bfc24413d5dc","type":"text","conversion_output":true,"text":"the adverse events of greatest concern include pulmonary vein (PV) stenosis, atrial-esophageal","text_display":" the adverse events of greatest concern include pulmonary vein (PV) stenosis, atrial-esophageal","confidence":1,"confidence_rate":1},{"cnt":[[305,907],[1944,907],[1944,956],[305,956]],"region":{"top_left_x":305,"top_left_y":906,"width":1640,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80ea572d49c7413aad1bef6f5509286e","type":"text","conversion_output":true,"text":"fistula formation, and disabling stroke occurrence with ablative therapy. Of note, we will also","text_display":" fistula formation, and disabling stroke occurrence with ablative therapy. Of note, we will also","confidence":1,"confidence_rate":1},{"cnt":[[305,954],[1944,954],[1944,1001],[305,1001]],"region":{"top_left_x":305,"top_left_y":953,"width":1640,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee487cb6fc8544bbabccb56916ae6607","type":"text","conversion_output":true,"text":"track descriptively other complications and adverse events of both therapies and these will be","text_display":" track descriptively other complications and adverse events of both therapies and these will be","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[1944,997],[1944,1044],[305,1044]],"region":{"top_left_x":305,"top_left_y":996,"width":1640,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f92eeb4169ac400bb4ea2c468994d377","type":"text","conversion_output":true,"text":"recorded. We anticipate that the rate of serious adverse events will be similar in both treatment","text_display":" recorded. We anticipate that the rate of serious adverse events will be similar in both treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,1040],[1485,1040],[1485,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1180,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1d2d3b23453402e947955e002fa4018","type":"text","conversion_output":true,"text":"arms, although the specific complications will vary in type and extent.","text_display":" arms, although the specific complications will vary in type and extent.","confidence":1,"confidence_rate":1},{"cnt":[[301,1126],[836,1126],[836,1175],[301,1175]],"region":{"top_left_x":300,"top_left_y":1125,"width":536,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"700fc3fc1608426bbcecc802bacc0fe1","type":"section_header","conversion_output":false,"children_ids":["f02a6c685bec4468953d9a78b5ca1797"],"text":"","text_display":""},{"cnt":[[305,1130],[831,1130],[831,1171],[305,1171]],"region":{"top_left_x":305,"top_left_y":1130,"width":527,"height":41},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f02a6c685bec4468953d9a78b5ca1797","type":"text","conversion_output":true,"parent_id":"700fc3fc1608426bbcecc802bacc0fe1","text":"2.2.8 LA Size and Function","text_display":"\n\n\\subsection*{2.2.8 LA Size and Function}","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1944,1173],[1944,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":1640,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff92d9d0c7e84c518232f37eca646693","type":"text","conversion_output":true,"text":"The impact of long-term drug or ablative therapy on LA size and function is unknown [83-89].","text_display":"\n\nThe impact of long-term drug or ablative therapy on LA size and function is unknown [83-89].","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1944,1216],[1944,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1216,"width":1640,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"953ce4200c844ff395e0e4633a224146","type":"text","conversion_output":true,"text":"Further, the relationship between structure and function measures and morbidity and mortality","text_display":" Further, the relationship between structure and function measures and morbidity and mortality","confidence":1,"confidence_rate":1},{"cnt":[[305,1261],[1944,1261],[1944,1308],[305,1308]],"region":{"top_left_x":305,"top_left_y":1261,"width":1640,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b3e44f6a05b4149b77254b6a8a06e87","type":"text","conversion_output":true,"text":"have not been examined. In addition to screening for PV stenosis, the CT / MR studies will","text_display":" have not been examined. In addition to screening for PV stenosis, the CT / MR studies will","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[305,1302],[1944,1302],[1944,1351],[305,1351]],"region":{"top_left_x":305,"top_left_y":1301,"width":1640,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77325850224843419a4102255fe071e0","type":"text","conversion_output":true,"text":"examine these questions in both drug and ablation patients and provide mechanistic information","text_display":" examine these questions in both drug and ablation patients and provide mechanistic information","confidence":1,"confidence_rate":1},{"cnt":[[305,1349],[1270,1349],[1270,1399],[305,1399]],"region":{"top_left_x":305,"top_left_y":1349,"width":965,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03674496ed5142bc9656bda1c8ef2ec0","type":"text","conversion_output":true,"text":"above and beyond descriptive long-term outcomes data.","text_display":" above and beyond descriptive long-term outcomes data.","confidence":1,"confidence_rate":1},{"cnt":[[301,1435],[913,1435],[913,1508],[301,1508]],"region":{"top_left_x":300,"top_left_y":1435,"width":614,"height":74},"line":29,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"66e9169f00ce4d10a3a9e19286421730","type":"section_header","conversion_output":false,"children_ids":["303ed42fbc0c4f5896902db2897a49ec"],"text":"","text_display":""},{"cnt":[[305,1439],[904,1439],[904,1506],[305,1506]],"region":{"top_left_x":305,"top_left_y":1439,"width":600,"height":68},"line":30,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"303ed42fbc0c4f5896902db2897a49ec","type":"text","conversion_output":true,"parent_id":"66e9169f00ce4d10a3a9e19286421730","text":"3.0 Subject Selection","text_display":"\n\n\\subsection*{3.0 Subject Selection}","confidence":0.9990234375,"confidence_rate":0.9999624222580676},{"cnt":[[305,1543],[1944,1543],[1944,1592],[305,1592]],"region":{"top_left_x":305,"top_left_y":1542,"width":1640,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cbb7be7a838450091397ec09a501640","type":"text","conversion_output":true,"text":"The intent of the CABANA trial is to enroll patients who have new onset or under-treated","text_display":"\n\nThe intent of the CABANA trial is to enroll patients who have new onset or under-treated","confidence":1,"confidence_rate":1},{"cnt":[[305,1590],[1944,1590],[1944,1637],[305,1637]],"region":{"top_left_x":305,"top_left_y":1589,"width":1640,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e582595f0d44ce4837ec16dfbe83a51","type":"text","conversion_output":true,"text":"paroxysmal, persistent, or longstanding persistent AF who warrant therapy for their arrhythmia.","text_display":" paroxysmal, persistent, or longstanding persistent AF who warrant therapy for their arrhythmia.","confidence":1,"confidence_rate":1},{"cnt":[[305,1633],[1944,1633],[1944,1680],[305,1680]],"region":{"top_left_x":305,"top_left_y":1632,"width":1640,"height":49},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f00d1d9d705b4687960af756bbeeb009","type":"text","conversion_output":true,"text":"The vast majority of patients will be sufficiently symptomatic to cross the \"therapy threshold\" to","text_display":" The vast majority of patients will be sufficiently symptomatic to cross the \"therapy threshold\" to","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[305,1676],[1944,1676],[1944,1725],[305,1725]],"region":{"top_left_x":305,"top_left_y":1675,"width":1640,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43bdf85a57674f6da5df34704064569d","type":"text","conversion_output":true,"text":"active rate or rhythm control. Asymptomatic patients will be less common, but may be enrolled,","text_display":" active rate or rhythm control. Asymptomatic patients will be less common, but may be enrolled,","confidence":1,"confidence_rate":1},{"cnt":[[305,1719],[1946,1719],[1946,1768],[305,1768]],"region":{"top_left_x":305,"top_left_y":1718,"width":1642,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47f7ff9851b64d33a51a9b1f7f974ea3","type":"text","conversion_output":true,"text":"if their AF is jeopardizing ventricular function, felt to be aggravating underlying disease, or","text_display":" if their AF is jeopardizing ventricular function, felt to be aggravating underlying disease, or","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[305,1764],[1944,1764],[1944,1811],[305,1811]],"region":{"top_left_x":305,"top_left_y":1763,"width":1640,"height":49},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77e6d6535ba24864a4c14819b30fec93","type":"text","conversion_output":true,"text":"requiring therapy to prevent sequelae of AF. Each patient will be screened for the","text_display":" requiring therapy to prevent sequelae of AF. Each patient will be screened for the","confidence":0.9624204635620117,"confidence_rate":0.9995598227513294},{"cnt":[[305,1809],[1841,1809],[1841,1858],[305,1858]],"region":{"top_left_x":305,"top_left_y":1808,"width":1537,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a1799f715c54ebfb6c0e847b7b09ff9","type":"text","conversion_output":true,"text":"inclusion/exclusion criteria listed below, which are similar to those of the AFFIRM trial [64].","text_display":" inclusion/exclusion criteria listed below, which are similar to those of the AFFIRM trial [64].","confidence":1,"confidence_rate":1},{"cnt":[[301,1893],[844,1893],[844,1953],[301,1953]],"region":{"top_left_x":300,"top_left_y":1892,"width":545,"height":61},"line":38,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"0d7c6158d81246c6b0f4ed0924337b06","type":"section_header","conversion_output":false,"children_ids":["4de79db35b0f40cab57007d2de8c21a3"],"text":"","text_display":""},{"cnt":[[305,1899],[840,1899],[840,1949],[305,1949]],"region":{"top_left_x":305,"top_left_y":1899,"width":536,"height":50},"line":39,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"4de79db35b0f40cab57007d2de8c21a3","type":"text","conversion_output":true,"parent_id":"0d7c6158d81246c6b0f4ed0924337b06","text":"3.1 Inclusion Criteria","text_display":"\n\n\\subsection*{3.1 Inclusion Criteria}","confidence":1,"confidence_rate":1},{"cnt":[[305,1951],[1536,1951],[1536,2000],[305,2000]],"region":{"top_left_x":305,"top_left_y":1950,"width":1232,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7247737c8b449339bbbf9e986446bc1","type":"text","conversion_output":true,"text":"To be eligible for the trial, subjects must meet all of the following criteria:","text_display":"\n\nTo be eligible for the trial, subjects must meet all of the following criteria:","confidence":1,"confidence_rate":1},{"cnt":[[370,1994],[1040,1994],[1040,2043],[370,2043]],"region":{"top_left_x":369,"top_left_y":1993,"width":671,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e832049fed14e3391714a1141460708","type":"text","conversion_output":true,"text":"1. Over the preceding 6 months have:","text_display":"\n1. Over the preceding 6 months have:","confidence":0.9833984375,"confidence_rate":0.9996195970787979},{"cnt":[[430,2041],[1944,2041],[1944,2088],[430,2088]],"region":{"top_left_x":429,"top_left_y":2041,"width":1516,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e100ce4cdcab4805a52393b19c3873e2","type":"text","conversion_output":true,"text":"a) \\(\\geq 2\\) paroxysmal (electrocardiographic documentation of at least 1) AF episodes","text_display":"\na) \\(\\geq 2\\) paroxysmal (electrocardiographic documentation of at least 1) AF episodes","confidence":0.9941432476043701,"confidence_rate":0.9999324853777124},{"cnt":[[430,2084],[1944,2084],[1944,2133],[430,2133]],"region":{"top_left_x":429,"top_left_y":2083,"width":1516,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ece9fe0f99f4316896679ab28fb77eb","type":"text","conversion_output":true,"text":"lasting \\(\\geq 1\\) hour in duration: (that terminate spontaneously within 7 days or cardioversion","text_display":" lasting \\(\\geq 1\\) hour in duration: (that terminate spontaneously within 7 days or cardioversion","confidence":1,"confidence_rate":1},{"cnt":[[430,2127],[1115,2127],[1115,2176],[430,2176]],"region":{"top_left_x":429,"top_left_y":2126,"width":687,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3830e40702a44c7f8299817ac6debd6a","type":"text","conversion_output":true,"text":"is performed within 48h of AF onset): or","text_display":" is performed within 48h of AF onset): or","confidence":0.60009765625,"confidence_rate":0.9887160824780038},{"cnt":[[430,2170],[1944,2170],[1944,2219],[430,2219]],"region":{"top_left_x":429,"top_left_y":2169,"width":1516,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90188f621e8541bd991f2df688f4750b","type":"text","conversion_output":true,"text":"b) electrocardiographic documentation of 1 persistent AF episode: (sustained for \\(\\geq 7\\)","text_display":"\nb) electrocardiographic documentation of 1 persistent AF episode: (sustained for \\(\\geq 7\\)","confidence":0.99560546875,"confidence_rate":0.9999510654686117},{"cnt":[[430,2213],[1609,2213],[1609,2262],[430,2262]],"region":{"top_left_x":429,"top_left_y":2212,"width":1181,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e0fb79aefa14a26baf61cbc070d622d","type":"text","conversion_output":true,"text":"days or cardioversion is performed more than 48 h after AF onset): or","text_display":" days or cardioversion is performed more than 48 h after AF onset): or","confidence":0.8804292678833008,"confidence_rate":0.998389327817658},{"cnt":[[432,2260],[1944,2260],[1944,2310],[432,2310]],"region":{"top_left_x":431,"top_left_y":2260,"width":1514,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8745c535eb8048d9a2e7f2b5e3b42102","type":"text","conversion_output":true,"text":"c) electrocardiographic documentation of 1 longstanding persistent AF episode:","text_display":"\nc) electrocardiographic documentation of 1 longstanding persistent AF episode:","confidence":0.998535871389322,"confidence_rate":0.9999829629184545},{"cnt":[[432,2303],[1055,2303],[1055,2353],[432,2353]],"region":{"top_left_x":431,"top_left_y":2303,"width":624,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1443a6d591b04877a6779e99ceaba669","type":"text","conversion_output":true,"text":"(continuous AF of duration \\(>1\\) year).","text_display":" (continuous AF of duration \\(>1\\) year).","confidence":0.95654296875,"confidence_rate":0.9989907467250445},{"cnt":[[370,2346],[1886,2346],[1886,2396],[370,2396]],"region":{"top_left_x":369,"top_left_y":2346,"width":1518,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6a9ce2096484df1b3e68c07b919c44f","type":"text","conversion_output":true,"text":"2. Warrant active therapy (within the past 3 months) beyond simple ongoing observation","text_display":"\n2. Warrant active therapy (within the past 3 months) beyond simple ongoing observation","confidence":1,"confidence_rate":1},{"cnt":[[370,2391],[1944,2391],[1944,2438],[370,2438]],"region":{"top_left_x":369,"top_left_y":2391,"width":1576,"height":48},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ee76614504d4bc89aaf06a280022217","type":"text","conversion_output":true,"text":"3. Be eligible for catheter ablation and \\(\\geq 2\\) sequential rhythm control and/or \\(\\geq 2\\) rate control","text_display":"\n3. Be eligible for catheter ablation and \\(\\geq 2\\) sequential rhythm control and/or \\(\\geq 2\\) rate control","confidence":1,"confidence_rate":1},{"cnt":[[430,2436],[548,2436],[548,2481],[430,2481]],"region":{"top_left_x":429,"top_left_y":2436,"width":119,"height":46},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3782e2de21bf40e9976dd3c7e9b3ffe5","type":"text","conversion_output":true,"text":"drugs.","text_display":" drugs.","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[969,2574],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":664,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2fb88712a98a441f8e74a09b32ecea59","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9935b13827a47959c2bad8fb003583f","type":"page_info","conversion_output":false,"text":"Page 22 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-24","page":24,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e64427d60e5142cfb0c198507e0db35e","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[370,249],[1940,249],[1940,299],[370,299]],"region":{"top_left_x":369,"top_left_y":249,"width":1572,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49af4134a9b64b4fb8630d3106bad269","type":"text","conversion_output":true,"text":"4. Be \\(\\geq 65 yrs\\) of age, or <65 yrs with one or more of the following risk factors for stroke:","text_display":"\n4. Be \\(\\geq 65 yrs\\) of age, or <65 yrs with one or more of the following risk factors for stroke:","confidence":0.8162562847137451,"confidence_rate":0.997991851717139},{"cnt":[[434,296],[1940,296],[1940,342],[434,342]],"region":{"top_left_x":433,"top_left_y":296,"width":1508,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d5e9fa248004601843f6ea389b3cbbd","type":"text","conversion_output":true,"text":"Hypertension (treated and/or defined as a BP \\(>140 / 90 mmHg\\) ) [90], Diabetes (treated","text_display":" Hypertension (treated and/or defined as a BP \\(>140 / 90 mmHg\\) ) [90], Diabetes (treated","confidence":1,"confidence_rate":1},{"cnt":[[434,339],[1940,339],[1940,385],[434,385]],"region":{"top_left_x":433,"top_left_y":339,"width":1508,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a3d8e9cd5e34de5bac735f0d463531f","type":"text","conversion_output":true,"text":"and/or defined as a fasting glucose \\(\\geq 126 mg / dl\\) ) [91], Congestive heart failure (including","text_display":" and/or defined as a fasting glucose \\(\\geq 126 mg / dl\\) ) [91], Congestive heart failure (including","confidence":0.8654880523681641,"confidence_rate":0.9985984422388948},{"cnt":[[434,385],[1940,385],[1940,432],[434,432]],"region":{"top_left_x":433,"top_left_y":384,"width":1508,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15af1ef3fcce47b680e4409e966289c2","type":"text","conversion_output":true,"text":"systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic","text_display":" systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic","confidence":1,"confidence_rate":1},{"cnt":[[432,425],[1940,425],[1940,475],[432,475]],"region":{"top_left_x":431,"top_left_y":425,"width":1510,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa2c3b2870074e9bae7d9819899500ad","type":"text","conversion_output":true,"text":"vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size \\(>5.0\\)","text_display":" vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size \\(>5.0\\)","confidence":0.94677734375,"confidence_rate":0.9994183465566607},{"cnt":[[434,466],[1940,466],[1940,518],[434,518]],"region":{"top_left_x":433,"top_left_y":466,"width":1508,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"462e0eb6568b4c27b314eb2d813a5e74","type":"text","conversion_output":true,"text":"cm (or volume index \\(\\geq 40 cc / m ^{2}\\) ), or \\(EF \\leq 35\\). Subjects \\(<65 yrs\\) of age whose only risk","text_display":" cm (or volume index \\(\\geq 40 cc / m ^{2}\\) ), or \\(EF \\leq 35\\). Subjects \\(<65 yrs\\) of age whose only risk","confidence":0.9563229084014893,"confidence_rate":0.9996150770960801},{"cnt":[[432,516],[1818,516],[1818,561],[432,561]],"region":{"top_left_x":431,"top_left_y":515,"width":1387,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d40ebb832c074bf5ac47cb0ada90d43b","type":"text","conversion_output":true,"text":"factor is hypertension must have a second risk factor or LV hypertrophy to qualify.","text_display":" factor is hypertension must have a second risk factor or LV hypertrophy to qualify.","confidence":1,"confidence_rate":1},{"cnt":[[370,559],[1596,559],[1596,604],[370,604]],"region":{"top_left_x":369,"top_left_y":558,"width":1228,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dd79b79265d44528b335c9ef1ebc4cd","type":"text","conversion_output":true,"text":"5. Have the capacity to understand and sign an informed consent form.","text_display":"\n5. Have the capacity to understand and sign an informed consent form.","confidence":0.99951171875,"confidence_rate":0.9999934000150488},{"cnt":[[370,604],[793,604],[793,649],[370,649]],"region":{"top_left_x":369,"top_left_y":603,"width":424,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2d4b536148f424d9ef3d2a7a88c2676","type":"text","conversion_output":true,"text":"6 . Be \\(\\geq 18\\) years of age.","text_display":"\n\n6 . Be \\(\\geq 18\\) years of age.","confidence":0.6632535441312939,"confidence_rate":0.9868422353625365},{"cnt":[[309,690],[1944,690],[1944,737],[309,737]],"region":{"top_left_x":309,"top_left_y":689,"width":1636,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61399c0db22d4760aa52f6b9e875a7ec","type":"text","conversion_output":true,"text":"NOTE: Subjects may have recent onset AF (in the past \\(4-6\\) months), AF present for a longer","text_display":"\nNOTE: Subjects may have recent onset AF (in the past \\(4-6\\) months), AF present for a longer","confidence":0.6905431747436523,"confidence_rate":0.9961899901706791},{"cnt":[[307,735],[1940,735],[1940,780],[307,780]],"region":{"top_left_x":307,"top_left_y":734,"width":1634,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cfdca6c2a104188be1e6217b8976963","type":"text","conversion_output":true,"text":"time period, or may have been treated with a single anti-arrhythmic drug, providing they remain","text_display":" time period, or may have been treated with a single anti-arrhythmic drug, providing they remain","confidence":1,"confidence_rate":1},{"cnt":[[305,778],[1940,778],[1940,825],[305,825]],"region":{"top_left_x":305,"top_left_y":777,"width":1636,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3fa2ff0e28445398f0491b8af6f4c5e","type":"text","conversion_output":true,"text":"realistically eligible for \\(\\geq 2\\) membrane active drugs and/or \\(\\geq 2\\) rate control agents. Patients","text_display":" realistically eligible for \\(\\geq 2\\) membrane active drugs and/or \\(\\geq 2\\) rate control agents. Patients","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[1944,821],[1944,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1640,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7301768b54948a9987ea727b9f16e5c","type":"text","conversion_output":true,"text":"receiving new drug therapy initiated within the previous 3 months may continue that therapy if","text_display":" receiving new drug therapy initiated within the previous 3 months may continue that therapy if","confidence":1,"confidence_rate":1},{"cnt":[[305,868],[1940,868],[1940,913],[305,913]],"region":{"top_left_x":305,"top_left_y":867,"width":1636,"height":47},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60b811717ecf461fb530c0242e01301a","type":"text","conversion_output":true,"text":"randomized to the drug therapy arm. Reasonable expectation of a response to therapy must be","text_display":" randomized to the drug therapy arm. Reasonable expectation of a response to therapy must be","confidence":1,"confidence_rate":1},{"cnt":[[307,911],[1940,911],[1940,956],[307,956]],"region":{"top_left_x":307,"top_left_y":910,"width":1634,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"743834d266b348ee8d1ac1cfd360a123","type":"text","conversion_output":true,"text":"present. Subjects will not be excluded because of advancing age or underlying heart disease.","text_display":" present. Subjects will not be excluded because of advancing age or underlying heart disease.","confidence":1,"confidence_rate":1},{"cnt":[[307,954],[1940,954],[1940,999],[307,999]],"region":{"top_left_x":307,"top_left_y":953,"width":1634,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd1536d45b9e4b4f86cbb6e8b25e23b7","type":"text","conversion_output":true,"text":"Subjects with a history of a single episode of paroxysmal AF do not meet the \"crossing the","text_display":" Subjects with a history of a single episode of paroxysmal AF do not meet the \"crossing the","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[1940,997],[1940,1044],[305,1044]],"region":{"top_left_x":305,"top_left_y":996,"width":1636,"height":49},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c857a1a338874ce6ab2a467e361c28b2","type":"text","conversion_output":true,"text":"threshold/warranting therapy\" litmus test. Subjects with persistent or long-standing persistent AF","text_display":" threshold/warranting therapy\" litmus test. Subjects with persistent or long-standing persistent AF","confidence":1,"confidence_rate":1},{"cnt":[[305,1042],[1940,1042],[1940,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1041,"width":1636,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fa2c41bc5364ad1bf0f58eaf74dcd5c","type":"text","conversion_output":true,"text":"will require at least 1 documented episode, if it is of sufficient clinical importance that drug or","text_display":" will require at least 1 documented episode, if it is of sufficient clinical importance that drug or","confidence":1,"confidence_rate":1},{"cnt":[[307,1087],[1944,1087],[1944,1132],[307,1132]],"region":{"top_left_x":307,"top_left_y":1087,"width":1638,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62dfd0688deb4b05a0633b623b1a627d","type":"text","conversion_output":true,"text":"ablative therapy is warranted. Subjects can be randomized before cardioversion, even if","text_display":" ablative therapy is warranted. Subjects can be randomized before cardioversion, even if","confidence":1,"confidence_rate":1},{"cnt":[[305,1130],[1940,1130],[1940,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1130,"width":1636,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c60304d6e674591beaa04c217e2b1d0","type":"text","conversion_output":true,"text":"restoration of sinus rhythm is a desired endpoint of therapy. Patients may have documented","text_display":" restoration of sinus rhythm is a desired endpoint of therapy. Patients may have documented","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1583,1173],[1583,1218],[305,1218]],"region":{"top_left_x":305,"top_left_y":1173,"width":1279,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7a064b6b94d49b0b0982f63c8a512f9","type":"text","conversion_output":true,"text":"atrial flutter in addition to atrial fibrillation and remain eligible for enrollment.","text_display":" atrial flutter in addition to atrial fibrillation and remain eligible for enrollment.","confidence":1,"confidence_rate":1},{"cnt":[[303,1259],[862,1259],[862,1317],[303,1317]],"region":{"top_left_x":302,"top_left_y":1258,"width":560,"height":59},"line":23,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"2de2ae322ad2499e9cb746dd523cdeae","type":"section_header","conversion_output":false,"children_ids":["7e77543cdb944c878ba449415c2c8174"],"text":"","text_display":""},{"cnt":[[309,1263],[855,1263],[855,1313],[309,1313]],"region":{"top_left_x":309,"top_left_y":1263,"width":547,"height":50},"line":24,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"7e77543cdb944c878ba449415c2c8174","type":"text","conversion_output":true,"parent_id":"2de2ae322ad2499e9cb746dd523cdeae","text":"3.2 Exclusion Criteria","text_display":"\n\n\\subsection*{3.2 Exclusion Criteria}","confidence":1,"confidence_rate":1},{"cnt":[[309,1317],[1781,1317],[1781,1364],[309,1364]],"region":{"top_left_x":309,"top_left_y":1316,"width":1473,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e47dcf70f994a3697609a8d7bfccbbd","type":"text","conversion_output":true,"text":"If a subject has any of the following criteria, he or she may not be enrolled in the study:","text_display":"\n\nIf a subject has any of the following criteria, he or she may not be enrolled in the study:","confidence":1,"confidence_rate":1},{"cnt":[[372,1362],[1721,1362],[1721,1407],[372,1407]],"region":{"top_left_x":371,"top_left_y":1362,"width":1350,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc98860791804455a1b79c0cd710f8b6","type":"text","conversion_output":true,"text":"1. Lone AF in the absence of risk factors for stroke in patients \\(<65\\) years of age","text_display":"\n1. Lone AF in the absence of risk factors for stroke in patients \\(<65\\) years of age","confidence":0.8217525482177734,"confidence_rate":0.9977966336183403},{"cnt":[[370,1405],[1944,1405],[1944,1454],[370,1454]],"region":{"top_left_x":369,"top_left_y":1405,"width":1576,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b411bc8dcdc74cafa5ebefe5e47293ae","type":"text","conversion_output":true,"text":"2. Patients who in the opinion of the managing clinician should not yet receive any therapy","text_display":"\n2. Patients who in the opinion of the managing clinician should not yet receive any therapy","confidence":1,"confidence_rate":1},{"cnt":[[432,1452],[544,1452],[544,1489],[432,1489]],"region":{"top_left_x":431,"top_left_y":1452,"width":113,"height":37},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd3aaa712cc0457999afc47b005df02a","type":"text","conversion_output":true,"text":"for AF","text_display":" for AF","confidence":1,"confidence_rate":1},{"cnt":[[370,1491],[1940,1491],[1940,1540],[370,1540]],"region":{"top_left_x":369,"top_left_y":1491,"width":1572,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc26a430151e485eab380d88c40ddf9f","type":"text","conversion_output":true,"text":"3. Patients who have failed \\(\\geq 2\\) membrane active anti-arrhythmic drugs at a therapeutic dose","text_display":"\n3. Patients who have failed \\(\\geq 2\\) membrane active anti-arrhythmic drugs at a therapeutic dose","confidence":1,"confidence_rate":1},{"cnt":[[434,1538],[1192,1538],[1192,1583],[434,1583]],"region":{"top_left_x":433,"top_left_y":1538,"width":760,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"335bca2db9a546a883c15fb5288a81cf","type":"text","conversion_output":true,"text":"due to inefficacy or side effects (Table 5.2.2)","text_display":" due to inefficacy or side effects (Table 5.2.2)","confidence":1,"confidence_rate":1},{"cnt":[[370,1581],[1826,1581],[1826,1626],[370,1626]],"region":{"top_left_x":369,"top_left_y":1581,"width":1458,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb31d6c637014266be98b93079eb302e","type":"text","conversion_output":true,"text":"4. An efficacy failure of full dose amiodarone treatment \\(\\geq 8\\) weeks duration at any time","text_display":"\n4. An efficacy failure of full dose amiodarone treatment \\(\\geq 8\\) weeks duration at any time","confidence":1,"confidence_rate":1},{"cnt":[[370,1624],[1944,1624],[1944,1669],[370,1669]],"region":{"top_left_x":369,"top_left_y":1624,"width":1576,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fcd985388cf420da02c1d16bb511049","type":"text","conversion_output":true,"text":"5. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent","text_display":"\n5. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent","confidence":1,"confidence_rate":1},{"cnt":[[434,1669],[1068,1669],[1068,1714],[434,1714]],"region":{"top_left_x":433,"top_left_y":1669,"width":635,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d5553fdd1f249b386288103cc191af1","type":"text","conversion_output":true,"text":"major surgical procedures, or trauma","text_display":" major surgical procedures, or trauma","confidence":1,"confidence_rate":1},{"cnt":[[370,1712],[1940,1712],[1940,1760],[370,1760]],"region":{"top_left_x":369,"top_left_y":1712,"width":1572,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c235ce5ccbb4b05bad740650e2f8c77","type":"text","conversion_output":true,"text":"6. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3","text_display":"\n6. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3","confidence":0.9494819641113281,"confidence_rate":0.9994427494717415},{"cnt":[[434,1757],[569,1757],[569,1798],[434,1798]],"region":{"top_left_x":433,"top_left_y":1757,"width":137,"height":42},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1461e228ed7140d585e1bd8d31dcaa50","type":"text","conversion_output":true,"text":"months","text_display":" months","confidence":1,"confidence_rate":1},{"cnt":[[370,1800],[1369,1800],[1369,1848],[370,1848]],"region":{"top_left_x":369,"top_left_y":1800,"width":1000,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be4d1a3eeaee472a8fc51cb57c99611f","type":"text","conversion_output":true,"text":"7. Hypertrophic obstructive cardiomyopathy (outflow track)","text_display":"\n7. Hypertrophic obstructive cardiomyopathy (outflow track)","confidence":1,"confidence_rate":1},{"cnt":[[370,1843],[1798,1843],[1798,1893],[370,1893]],"region":{"top_left_x":369,"top_left_y":1843,"width":1430,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01efdb27bda246678bf868bbdc705fc3","type":"text","conversion_output":true,"text":"8. Class IV angina or Class IV CHF (including past or planned heart transplantation)","text_display":"\n8. Class IV angina or Class IV CHF (including past or planned heart transplantation)","confidence":1,"confidence_rate":1},{"cnt":[[370,1886],[1626,1886],[1626,1936],[370,1936]],"region":{"top_left_x":369,"top_left_y":1886,"width":1258,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bf78b60fb8c4941905e0e046b25f16f","type":"text","conversion_output":true,"text":"9. Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF)","text_display":"\n9. Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF)","confidence":1,"confidence_rate":1},{"cnt":[[374,1934],[1865,1934],[1865,1979],[374,1979]],"region":{"top_left_x":373,"top_left_y":1933,"width":1492,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6718549a02d4823b1628ed53ef47d93","type":"text","conversion_output":true,"text":"10. Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs","text_display":"\n10. Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs","confidence":1,"confidence_rate":1},{"cnt":[[374,1977],[1412,1977],[1412,2022],[374,2022]],"region":{"top_left_x":373,"top_left_y":1976,"width":1039,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b8890f0d5fc4eec85cfa24dc028b28b","type":"text","conversion_output":true,"text":"11. Prior LA catheter ablation with the intention of treating AF","text_display":"\n11. Prior LA catheter ablation with the intention of treating AF","confidence":0.982421875,"confidence_rate":0.9997430119410061},{"cnt":[[374,2020],[1510,2020],[1510,2067],[374,2067]],"region":{"top_left_x":373,"top_left_y":2019,"width":1138,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7dc76c714b7042898a3ffd283673efe8","type":"text","conversion_output":true,"text":"12. Prior surgical interventions for AF such as the MAZE procedure","text_display":"\n12. Prior surgical interventions for AF such as the MAZE procedure","confidence":1,"confidence_rate":1},{"cnt":[[374,2065],[831,2065],[831,2105],[374,2105]],"region":{"top_left_x":373,"top_left_y":2064,"width":459,"height":42},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e29a9ab7f1a4bcab0df4d39706f7d6d","type":"text","conversion_output":true,"text":"13. Prior AV nodal ablation","text_display":"\n13. Prior AV nodal ablation","confidence":1,"confidence_rate":1},{"cnt":[[374,2105],[1407,2105],[1407,2155],[374,2155]],"region":{"top_left_x":373,"top_left_y":2105,"width":1035,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94804e2136874284a3be081c81e9c7fe","type":"text","conversion_output":true,"text":"14. Patients with other arrhythmias requiring ablative therapy","text_display":"\n14. Patients with other arrhythmias requiring ablative therapy","confidence":1,"confidence_rate":1},{"cnt":[[374,2153],[1381,2153],[1381,2198],[374,2198]],"region":{"top_left_x":373,"top_left_y":2152,"width":1009,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d169a11b673f4deaafb4a972f91bea12","type":"text","conversion_output":true,"text":"15. Contraindication to appropriate anti-coagulation therapy","text_display":"\n15. Contraindication to appropriate anti-coagulation therapy","confidence":0.99951171875,"confidence_rate":0.9999924861744118},{"cnt":[[374,2196],[952,2196],[952,2241],[374,2241]],"region":{"top_left_x":373,"top_left_y":2195,"width":579,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efed17b4055a449dbbfde42398d87191","type":"text","conversion_output":true,"text":"16. Renal failure requiring dialysis","text_display":"\n16. Renal failure requiring dialysis","confidence":1,"confidence_rate":1},{"cnt":[[374,2239],[1377,2239],[1377,2288],[374,2288]],"region":{"top_left_x":373,"top_left_y":2238,"width":1005,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1afdee59e7f042389a9ad99a8dd60e56","type":"text","conversion_output":true,"text":"17. Medical conditions limiting expected survival to \\(<1\\) year","text_display":"\n17. Medical conditions limiting expected survival to \\(<1\\) year","confidence":0.859375,"confidence_rate":0.9977738066796666},{"cnt":[[372,2282],[1764,2282],[1764,2331],[372,2331]],"region":{"top_left_x":371,"top_left_y":2281,"width":1393,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7440363949554a1bbb958c81e3650a7c","type":"text","conversion_output":true,"text":"18. Women of childbearing potential (unless post-menopausal or surgically sterile)","text_display":"\n18. Women of childbearing potential (unless post-menopausal or surgically sterile)","confidence":1,"confidence_rate":1},{"cnt":[[374,2329],[1944,2329],[1944,2374],[374,2374]],"region":{"top_left_x":373,"top_left_y":2328,"width":1572,"height":47},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"323ec45360854f88ad79749898d9375c","type":"text","conversion_output":true,"text":"19. Participation in any other clinical mortality trial (Participation in other non-mortality trials","text_display":"\n19. 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Randomization will","text_display":" to a strategy of drug therapy for rate or rhythm control vs. catheter ablation. Randomization will","confidence":1,"confidence_rate":1},{"cnt":[[305,2428],[1944,2428],[1944,2477],[305,2477]],"region":{"top_left_x":305,"top_left_y":2427,"width":1640,"height":51},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca34c9b970e34be59cdcc8eaf4b98983","type":"text","conversion_output":true,"text":"be accomplished by telephone or internet using a centralized, interactive voice and web","text_display":" be accomplished by telephone or internet using a centralized, interactive voice and web","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[967,2574],[967,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":662,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d4228afbcff743de8d727c7058f53995","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999777947999976},{"cnt":[[1611,2574],[1841,2574],[1841,2615],[1611,2615]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2e73a538ab75486a87dd212dfb7e3b99","type":"page_info","conversion_output":false,"text":"Page 24 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-26","page":26,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dfe55a62f66b461e961477fc99eec555","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[309,249],[1944,249],[1944,299],[309,299]],"region":{"top_left_x":309,"top_left_y":249,"width":1636,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ef52004a3a34fcf9e6e4da7822c7ede","type":"text","conversion_output":true,"text":"randomization system (IXRS). The enrollment scheme is based on permuted block","text_display":"\nrandomization system (IXRS). The enrollment scheme is based on permuted block","confidence":1,"confidence_rate":1},{"cnt":[[309,296],[1106,296],[1106,342],[309,342]],"region":{"top_left_x":309,"top_left_y":296,"width":798,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1acb584f45746aa848e3b229b4e2e2b","type":"text","conversion_output":true,"text":"randomization with stratification by clinical site.","text_display":" randomization with stratification by clinical site.","confidence":0.99951171875,"confidence_rate":0.9999912786005654},{"cnt":[[301,380],[1195,380],[1195,436],[301,436]],"region":{"top_left_x":300,"top_left_y":380,"width":895,"height":57},"line":4,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"e2b29561c1e04f3089f4640bd8972ad4","type":"section_header","conversion_output":false,"children_ids":["54d2cf88d37b42c7a450a826df416b9f"],"text":"","text_display":""},{"cnt":[[309,387],[1190,387],[1190,432],[309,432]],"region":{"top_left_x":309,"top_left_y":386,"width":882,"height":46},"line":5,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"54d2cf88d37b42c7a450a826df416b9f","type":"text","conversion_output":true,"parent_id":"e2b29561c1e04f3089f4640bd8972ad4","text":"4.4 Post Randomization Procedures","text_display":"\n\n\\subsection*{4.4 Post Randomization Procedures}","confidence":1,"confidence_rate":1},{"cnt":[[309,438],[1940,438],[1940,483],[309,483]],"region":{"top_left_x":309,"top_left_y":438,"width":1632,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6d593e17836473591807012fb30d172","type":"text","conversion_output":true,"text":"For morbidity and mortality end points, intention-to-treat analysis will begin at randomization. All","text_display":"\n\nFor morbidity and mortality end points, intention-to-treat analysis will begin at randomization. All","confidence":1,"confidence_rate":1},{"cnt":[[309,483],[1944,483],[1944,529],[309,529]],"region":{"top_left_x":309,"top_left_y":483,"width":1636,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"564e800b8eea49d992346cf800aecdd9","type":"text","conversion_output":true,"text":"therapies will be established and optimized in a 3 -month treatment initiation period, during which","text_display":" therapies will be established and optimized in a 3 -month treatment initiation period, during which","confidence":0.97998046875,"confidence_rate":0.9998110212478646},{"cnt":[[309,529],[1944,529],[1944,574],[309,574]],"region":{"top_left_x":309,"top_left_y":528,"width":1636,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87ae427e9172460cac362eee0880a3e5","type":"text","conversion_output":true,"text":"patients may receive alternative drugs or undergo repeat ablation if AF recurs. The duration of","text_display":" patients may receive alternative drugs or undergo repeat ablation if AF recurs. The duration of","confidence":1,"confidence_rate":1},{"cnt":[[309,571],[1944,571],[1944,617],[309,617]],"region":{"top_left_x":309,"top_left_y":571,"width":1636,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"767664a19e4c49b0b3cfb2793ca38e51","type":"text","conversion_output":true,"text":"this \"blanking period\" is derived from standard clinical practice and the AF Ablation Consensus","text_display":" this \"blanking period\" is derived from standard clinical practice and the AF Ablation Consensus","confidence":0.99365234375,"confidence_rate":0.99993632314463},{"cnt":[[309,614],[1944,614],[1944,660],[309,660]],"region":{"top_left_x":309,"top_left_y":614,"width":1636,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfef6f555b3141a6be91b1777f10c395","type":"text","conversion_output":true,"text":"Document [50,51]. 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Any AF occurring","confidence":0.9619140625,"confidence_rate":0.9996193845658965},{"cnt":[[309,748],[1944,748],[1944,793],[309,793]],"region":{"top_left_x":309,"top_left_y":747,"width":1636,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1de26fa4e0ea4043ae8b88926160d9bb","type":"text","conversion_output":true,"text":"after the 3 -month blanking period will be considered a treatment failure for the AF recurrence","text_display":" after the 3 -month blanking period will be considered a treatment failure for the AF recurrence","confidence":0.955078125,"confidence_rate":0.9995538652218587},{"cnt":[[309,791],[1944,791],[1944,836],[309,836]],"region":{"top_left_x":309,"top_left_y":790,"width":1636,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b80eb67bf944e9f906417b2c6f4caa3","type":"text","conversion_output":true,"text":"secondary endpoint. 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This information","text_display":" the course of routine clinical care as dictated by their attending physician. This information","confidence":1,"confidence_rate":1},{"cnt":[[309,1057],[1944,1057],[1944,1104],[309,1104]],"region":{"top_left_x":309,"top_left_y":1057,"width":1636,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9274d7ec2a384b3183a41e61325d807c","type":"text","conversion_output":true,"text":"should be, consistent with established guidelines, consensus documents, and good clinical","text_display":" should be, consistent with established guidelines, consensus documents, and good clinical","confidence":1,"confidence_rate":1},{"cnt":[[309,1102],[1944,1102],[1944,1147],[309,1147]],"region":{"top_left_x":309,"top_left_y":1102,"width":1636,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98ddc374071b4cbbb7d4bda561e0dcd0","type":"text","conversion_output":true,"text":"practice. Selected baseline testing data will be collected in order to characterize the type, cause","text_display":" practice. Selected baseline testing data will be collected in order to characterize the type, cause","confidence":1,"confidence_rate":1},{"cnt":[[309,1145],[1944,1145],[1944,1192],[309,1192]],"region":{"top_left_x":309,"top_left_y":1145,"width":1636,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9390a22c581c40d7a4b9ca983e24b207","type":"text","conversion_output":true,"text":"and severity of the patient's AF and the treatments received prior to enrollment. The baseline","text_display":" and severity of the patient's AF and the treatments received prior to enrollment. 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The TTE will also assess LA size and","text_display":" diastolic dysfunction, or other structural abnormalities. 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The TEE may be performed up to 48 hours before the procedure in patients on","text_display":" persistent AF. The TEE may be performed up to 48 hours before the procedure in patients on","confidence":0.9765625,"confidence_rate":0.9997580239072923},{"cnt":[[305,1936],[1944,1936],[1944,1983],[305,1983]],"region":{"top_left_x":305,"top_left_y":1935,"width":1640,"height":49},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2637d7f0143744c3b973c367c15d6541","type":"text","conversion_output":true,"text":"continuous anticoagulation therapy, such as warfarin at a therapeutic INR or in those","text_display":" continuous anticoagulation therapy, such as warfarin at a therapeutic INR or in those","confidence":1,"confidence_rate":1},{"cnt":[[305,1981],[1790,1981],[1790,2030],[305,2030]],"region":{"top_left_x":305,"top_left_y":1980,"width":1485,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d48bc721e7ac4439bb1abfa0551e6c95","type":"text","conversion_output":true,"text":"appropriately bridged with intravenous un-fractionated or low molecular weight heparin.","text_display":" appropriately bridged with intravenous un-fractionated or low molecular weight heparin.","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[305,2067],[1944,2067],[1944,2116],[305,2116]],"region":{"top_left_x":305,"top_left_y":2066,"width":1640,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39e4a2e1c59e4d739736cde7282e046a","type":"text","conversion_output":true,"text":"The performance of a pre-treatment TEE in patients with paroxysmal AF is left to the discretion","text_display":"\n\nThe performance of a pre-treatment TEE in patients with paroxysmal AF is left to the discretion","confidence":1,"confidence_rate":1},{"cnt":[[305,2110],[1944,2110],[1944,2159],[305,2159]],"region":{"top_left_x":305,"top_left_y":2109,"width":1640,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80e6dea3e1474104bee391600a457f98","type":"text","conversion_output":true,"text":"of the investigator (5.4.4), but is not required in CABANA. Data on the performance and results","text_display":" of the investigator (5.4.4), but is not required in CABANA. Data on the performance and results","confidence":1,"confidence_rate":1},{"cnt":[[305,2155],[1944,2155],[1944,2202],[305,2202]],"region":{"top_left_x":305,"top_left_y":2154,"width":1640,"height":49},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efbf1a3d9c0040dbaa4e0907ef8287c5","type":"text","conversion_output":true,"text":"of all TEEs performed as part of routine care will be collected in the eCRF, however. TEE data","text_display":" of all TEEs performed as part of routine care will be collected in the eCRF, however. TEE data","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[305,2200],[1944,2200],[1944,2247],[305,2247]],"region":{"top_left_x":305,"top_left_y":2200,"width":1640,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f172cdfa519b4808aad253ca481ff008","type":"text","conversion_output":true,"text":"may also be used to confirm atrial size and morphology. The approach to cardioversion in drug","text_display":" may also be used to confirm atrial size and morphology. The approach to cardioversion in drug","confidence":1,"confidence_rate":1},{"cnt":[[305,2243],[1755,2243],[1755,2292],[305,2292]],"region":{"top_left_x":305,"top_left_y":2242,"width":1451,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4ee3ddd4de348cdac57b44bc384cd4b","type":"text","conversion_output":true,"text":"treated patients should follow the recommendations of AF Treatment Guidelines [92].","text_display":" treated patients should follow the recommendations of AF Treatment Guidelines [92].","confidence":1,"confidence_rate":1},{"cnt":[[305,2329],[1944,2329],[1944,2378],[305,2378]],"region":{"top_left_x":305,"top_left_y":2328,"width":1640,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb067d73892546fe89c70a402c654269","type":"text","conversion_output":true,"text":"In those centers where routine clinical practice includes the performance of pre-ablation and","text_display":"\n\nIn those centers where routine clinical practice includes the performance of pre-ablation and","confidence":0.9985356330871582,"confidence_rate":0.9999850466409257},{"cnt":[[305,2376],[1944,2376],[1944,2426],[305,2426]],"region":{"top_left_x":305,"top_left_y":2376,"width":1640,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b93a345be934d08867d2be6bd7793ae","type":"text","conversion_output":true,"text":"post-ablation CT/MR studies, relevant data from these studies will be collected to serve as a","text_display":" post-ablation CT/MR studies, relevant data from these studies will be collected to serve as a","confidence":1,"confidence_rate":1},{"cnt":[[305,2419],[1944,2419],[1944,2469],[305,2469]],"region":{"top_left_x":305,"top_left_y":2419,"width":1640,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79faab8f7bc348dca7ac1cc67d1f95c4","type":"text","conversion_output":true,"text":"baseline for comparative quantitative LA size, morphology, and function studies, as well as","text_display":" baseline for comparative quantitative LA size, morphology, and function studies, as well as","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[969,2574],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":664,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f8164070dafe4c2490a8ce4db98d1f63","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"54d9fa03769743f7b003a4f132734a98","type":"page_info","conversion_output":false,"text":"Page 25 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-27","page":27,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5dd9b9f6459437fab08940717a30d1d","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1940,249],[1940,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1636,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"878dbe8960bf4425a1b71982bd3f7d4f","type":"text","conversion_output":true,"text":"subsequent follow-up PV and esophageal investigations. In addition at those centers, up to 150","text_display":"\nsubsequent follow-up PV and esophageal investigations. In addition at those centers, up to 150","confidence":1,"confidence_rate":1},{"cnt":[[305,296],[1940,296],[1940,342],[305,342]],"region":{"top_left_x":305,"top_left_y":296,"width":1636,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb6e1118df844ee8aec58cd00a0a1ff4","type":"text","conversion_output":true,"text":"patients randomized to drug therapy will be asked to undergo one research CT/MR scan prior to","text_display":" patients randomized to drug therapy will be asked to undergo one research CT/MR scan prior to","confidence":1,"confidence_rate":1},{"cnt":[[305,339],[1940,339],[1940,385],[305,385]],"region":{"top_left_x":305,"top_left_y":339,"width":1636,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8617bc69d3804721a80fa6cee5126963","type":"text","conversion_output":true,"text":"initiating therapy. This will allow the CABANA study to evaluate and compare atrial structure and","text_display":" initiating therapy. This will allow the CABANA study to evaluate and compare atrial structure and","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,382],[1940,382],[1940,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aedde79d91754907a0232c1909f908ed","type":"text","conversion_output":true,"text":"function in response to drug or ablative therapy. These drug-treated patients will be recruited","text_display":" function in response to drug or ablative therapy. These drug-treated patients will be recruited","confidence":1,"confidence_rate":1},{"cnt":[[305,425],[1940,425],[1940,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1636,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a41f6e58d2442ecb3975ea850f4208d","type":"text","conversion_output":true,"text":"from selected centers that are committed to CT/MR assessment of all enrolled patients (both","text_display":" from selected centers that are committed to CT/MR assessment of all enrolled patients (both","confidence":1,"confidence_rate":1},{"cnt":[[305,468],[1944,468],[1944,518],[305,518]],"region":{"top_left_x":305,"top_left_y":468,"width":1640,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04bc09ab114c4c15a668b850b05dbe69","type":"text","conversion_output":true,"text":"study arms). Since randomization is performed (stratified) within each site, this component of","text_display":" study arms). Since randomization is performed (stratified) within each site, this component of","confidence":1,"confidence_rate":1},{"cnt":[[305,516],[1940,516],[1940,561],[305,561]],"region":{"top_left_x":305,"top_left_y":515,"width":1636,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5a633f54db247f5acf3011dfc49dda6","type":"text","conversion_output":true,"text":"the study will still benefit from the overall study randomization. Optimally, the pre-therapy scans","text_display":" the study will still benefit from the overall study randomization. Optimally, the pre-therapy scans","confidence":1,"confidence_rate":1},{"cnt":[[305,559],[1485,559],[1485,606],[305,606]],"region":{"top_left_x":305,"top_left_y":558,"width":1180,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"584abf3d5de44cbbba32f3dc358bb563","type":"text","conversion_output":true,"text":"performed in all patients should be within 4 months prior to treatment.","text_display":" performed in all patients should be within 4 months prior to treatment.","confidence":0.99560546875,"confidence_rate":0.9999442519896117},{"cnt":[[305,645],[1940,645],[1940,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1636,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"474045fe566049d7bf4b7d76c81f9a2b","type":"text","conversion_output":true,"text":"In addition to these clinically dictated studies, baseline economic and QOL data will be obtained","text_display":"\n\nIn addition to these clinically dictated studies, baseline economic and QOL data will be obtained","confidence":1,"confidence_rate":1},{"cnt":[[305,692],[1467,692],[1467,735],[305,735]],"region":{"top_left_x":305,"top_left_y":691,"width":1163,"height":44},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3650c15c63754359bf64fe1dabfcfea1","type":"text","conversion_output":true,"text":"after informed consent is obtained, but before randomization occurs.","text_display":" after informed consent is obtained, but before randomization occurs.","confidence":1,"confidence_rate":1},{"cnt":[[303,778],[767,778],[767,831],[303,831]],"region":{"top_left_x":302,"top_left_y":777,"width":465,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cb2d580b2fc429ea20e93fe4a1cf215","type":"section_header","conversion_output":false,"children_ids":["ff5cf4781dc440cabbc279bafe8fb546"],"text":"","text_display":""},{"cnt":[[305,782],[763,782],[763,827],[305,827]],"region":{"top_left_x":305,"top_left_y":782,"width":458,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff5cf4781dc440cabbc279bafe8fb546","type":"text","conversion_output":true,"parent_id":"2cb2d580b2fc429ea20e93fe4a1cf215","text":"4.4.2 Patient Follow Up","text_display":"\n\n\\subsection*{4.4.2 Patient Follow Up}","confidence":1,"confidence_rate":1},{"cnt":[[305,825],[1944,825],[1944,874],[305,874]],"region":{"top_left_x":305,"top_left_y":825,"width":1640,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e51778e3db2d49feaaf2982d65357d25","type":"text","conversion_output":true,"text":"Follow-up in all patients will occur at 3,6 , and 12 months following randomization during the first","text_display":"\n\nFollow-up in all patients will occur at 3,6 , and 12 months following randomization during the first","confidence":0.9985356330871582,"confidence_rate":0.9999867979236713},{"cnt":[[305,870],[1940,870],[1940,917],[305,917]],"region":{"top_left_x":305,"top_left_y":870,"width":1636,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92062dbf7f514b84942739cb7d89a76e","type":"text","conversion_output":true,"text":"year and every 6 months thereafter, with clinic visits, phone follow-up, and other testing as","text_display":" year and every 6 months thereafter, with clinic visits, phone follow-up, and other testing as","confidence":0.99853515625,"confidence_rate":0.9999854860688677},{"cnt":[[305,915],[1940,915],[1940,960],[305,960]],"region":{"top_left_x":305,"top_left_y":915,"width":1636,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1693c60e962c404aba7a39cd6e6eeffb","type":"text","conversion_output":true,"text":"described below. Economic and QOL data, including a full follow-up questionnaire of validated","text_display":" described below. Economic and QOL data, including a full follow-up questionnaire of validated","confidence":1,"confidence_rate":1},{"cnt":[[305,958],[1940,958],[1940,1005],[305,1005]],"region":{"top_left_x":305,"top_left_y":958,"width":1636,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bba3deec4d974fc38ee4902687402c12","type":"text","conversion_output":true,"text":"scales, ie, SF-36, DASI, Toronto Atrial Fibrillation Severity Scale, AF Effects on QOL (AFEQT),","text_display":" scales, ie, SF-36, DASI, Toronto Atrial Fibrillation Severity Scale, AF Effects on QOL (AFEQT),","confidence":1,"confidence_rate":1},{"cnt":[[305,1001],[1940,1001],[1940,1051],[305,1051]],"region":{"top_left_x":305,"top_left_y":1001,"width":1636,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f1d89f551d84500b25cc5fecf4d4106","type":"text","conversion_output":true,"text":"Work Productivity and Activity Impairment Instrument (WPAI), Stanford Presenteeism scale, will","text_display":" Work Productivity and Activity Impairment Instrument (WPAI), Stanford Presenteeism scale, will","confidence":1,"confidence_rate":1},{"cnt":[[305,1044],[1940,1044],[1940,1094],[305,1094]],"region":{"top_left_x":305,"top_left_y":1044,"width":1636,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52da373c43294d1cbe1975abb24ddf33","type":"text","conversion_output":true,"text":"be repeated by trained telephone interviewer staff from the EQOL Coordinating Center (EQOL","text_display":" be repeated by trained telephone interviewer staff from the EQOL Coordinating Center (EQOL","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[305,1087],[1940,1087],[1940,1137],[305,1137]],"region":{"top_left_x":305,"top_left_y":1087,"width":1636,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f543609e29f42bf9a41cd098456ce81","type":"text","conversion_output":true,"text":"CC) for patients enrolled in North America and by the Site Coordinator in sites outside North","text_display":" CC) for patients enrolled in North America and by the Site Coordinator in sites outside North","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,1134],[466,1134],[466,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1134,"width":162,"height":42},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce81ffcb6e8a4f8da294ae488e1fb890","type":"text","conversion_output":true,"text":"America.","text_display":" America.","confidence":1,"confidence_rate":1},{"cnt":[[307,1220],[1940,1220],[1940,1268],[307,1268]],"region":{"top_left_x":307,"top_left_y":1220,"width":1634,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88de19baae38402daafbeb8862d7d5c6","type":"text","conversion_output":true,"text":"Follow-up visits/calls at 3 and 6 months should be completed within 30 days \\(+/\\) - of the due date","text_display":"\n\nFollow-up visits/calls at 3 and 6 months should be completed within 30 days \\(+/\\) - of the due date","confidence":0.9728466598317027,"confidence_rate":0.9997564119338488},{"cnt":[[305,1263],[1661,1263],[1661,1313],[305,1313]],"region":{"top_left_x":305,"top_left_y":1263,"width":1356,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fb873715b554131a3834cde6f2d08f1","type":"text","conversion_output":true,"text":"(Ex: 3 month visit: completed between 60 days and 120 days of randomization).","text_display":" (Ex: 3 month visit: completed between 60 days and 120 days of randomization).","confidence":1,"confidence_rate":1},{"cnt":[[305,1354],[1940,1354],[1940,1401],[305,1401]],"region":{"top_left_x":305,"top_left_y":1353,"width":1636,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a37f852455444992a36b13e6d735f077","type":"text","conversion_output":true,"text":"Follow-up visits/calls at 12 months and every 6 months thereafter should be completed within 60","text_display":"\n\nFollow-up visits/calls at 12 months and every 6 months thereafter should be completed within 60","confidence":1,"confidence_rate":1},{"cnt":[[305,1396],[1944,1396],[1944,1446],[305,1446]],"region":{"top_left_x":305,"top_left_y":1396,"width":1640,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00ae4af30660434abeaec45fb4fcf4b7","type":"text","conversion_output":true,"text":"days +/- of the due date (Ex: 12 month visit: completed between 300 days and 420 days of","text_display":" days +/- of the due date (Ex: 12 month visit: completed between 300 days and 420 days of","confidence":0.99462890625,"confidence_rate":0.9999472016886584},{"cnt":[[305,1439],[578,1439],[578,1489],[305,1489]],"region":{"top_left_x":305,"top_left_y":1439,"width":273,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cdc6d85b2cd417dbf9e79f88b13b535","type":"text","conversion_output":true,"text":"randomization).","text_display":" randomization).","confidence":1,"confidence_rate":1},{"cnt":[[305,1525],[1940,1525],[1940,1575],[305,1575]],"region":{"top_left_x":305,"top_left_y":1525,"width":1636,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad30d9b6a1524eb284cf802144ba075c","type":"text","conversion_output":true,"text":"Medical bills for patients enrolled at US sites will be collected throughout the trial by the EQOL","text_display":"\n\nMedical bills for patients enrolled at US sites will be collected throughout the trial by the EQOL","confidence":1,"confidence_rate":1},{"cnt":[[305,1573],[1940,1573],[1940,1620],[305,1620]],"region":{"top_left_x":305,"top_left_y":1572,"width":1636,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5c08d77aff54e99b09066e47680f763","type":"text","conversion_output":true,"text":"Coordinating Center economic team. The Site Coordinators will complete a one page Rapid","text_display":" Coordinating Center economic team. The Site Coordinators will complete a one page Rapid","confidence":0.9985356330871582,"confidence_rate":0.9999840714296225},{"cnt":[[305,1616],[1940,1616],[1940,1663],[305,1663]],"region":{"top_left_x":305,"top_left_y":1615,"width":1636,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f92cbe798708405ba1d62b0290d299d7","type":"text","conversion_output":true,"text":"Report Form (RRF) at each CABANA study visit documenting any interim hospitalizations","text_display":" Report Form (RRF) at each CABANA study visit documenting any interim hospitalizations","confidence":1,"confidence_rate":1},{"cnt":[[305,1659],[1940,1659],[1940,1708],[305,1708]],"region":{"top_left_x":305,"top_left_y":1658,"width":1636,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"512271897c3b4582bce91b6c3a65b0ff","type":"text","conversion_output":true,"text":"and/or ER visits since last contact. These forms will be forwarded to the EQOL Coordinating","text_display":" and/or ER visits since last contact. These forms will be forwarded to the EQOL Coordinating","confidence":1,"confidence_rate":1},{"cnt":[[305,1704],[1940,1704],[1940,1751],[305,1751]],"region":{"top_left_x":305,"top_left_y":1703,"width":1636,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84b3bb42bdc4407f9adc8e4c871cae9f","type":"text","conversion_output":true,"text":"Center for processing. As part of the economic and QOL data in CABANA, two EQ-5D forms","text_display":" Center for processing. 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Symptom Index (MAFSI) will be collected by the Site Coordinator at 3 and 12","text_display":" Atrial Fibrillation Symptom Index (MAFSI) will be collected by the Site Coordinator at 3 and 12","confidence":0.9781974784239702,"confidence_rate":0.9997839085604168},{"cnt":[[305,1835],[1940,1835],[1940,1884],[305,1884]],"region":{"top_left_x":305,"top_left_y":1834,"width":1636,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99cf2768c63649a1bef8cc47348eb6bb","type":"text","conversion_output":true,"text":"months following randomization during the first year and yearly thereafter throughout the trial","text_display":" months following randomization during the first year and yearly thereafter throughout the 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all patients enrolled will","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,2230],[1944,2230],[1944,2279],[305,2279]],"region":{"top_left_x":305,"top_left_y":2230,"width":1640,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e7e386e768d498782c0ed3d3d66d86d","type":"text","conversion_output":true,"text":"receive a single 'CABANA Box' recording system to be used for both patient activated event","text_display":" receive a single 'CABANA Box' recording system to be used for both patient activated event","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[305,2275],[1944,2275],[1944,2322],[305,2322]],"region":{"top_left_x":305,"top_left_y":2275,"width":1640,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b827ac25a8a34abb9ced40e7ef406675","type":"text","conversion_output":true,"text":"monitoring (throughout the trial), 24 hour autodetect/autocapture (AD:AC) event monitoring and","text_display":" monitoring (throughout the trial), 24 hour autodetect/autocapture (AD:AC) event monitoring and","confidence":1,"confidence_rate":1},{"cnt":[[305,2320],[1944,2320],[1944,2365],[305,2365]],"region":{"top_left_x":305,"top_left_y":2320,"width":1640,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bf7c857ae344b4b85bc5398d57cc096","type":"text","conversion_output":true,"text":"96 hour full disclosure Holter monitoring throughout the study. 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After the first year, they will be asked for a 24","confidence":1,"confidence_rate":1},{"cnt":[[305,2454],[305,2404],[1940,2406],[1940,2456]],"region":{"top_left_x":305,"top_left_y":2404,"width":1636,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53cb34cfd49c43a88276d383dda7d755","type":"text","conversion_output":true,"text":"hour recording twice a year and a 96 hour recording twice a year. Fingertip recordings as well","text_display":" hour recording twice a year and a 96 hour recording twice a year. Fingertip recordings as well","confidence":1,"confidence_rate":1},{"cnt":[[305,2451],[1940,2451],[1940,2499],[305,2499]],"region":{"top_left_x":305,"top_left_y":2451,"width":1636,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36cc5bbd04f143828381d1a791ffef11","type":"text","conversion_output":true,"text":"as \\(A D: A C\\) recordings can be transferred via telephone download from the patient's home to the","text_display":" as \\(A D: A C\\) recordings can be transferred via telephone download from the patient's home to the","confidence":0.6669414043426514,"confidence_rate":0.9959576614704412},{"cnt":[[305,2574],[967,2574],[967,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":662,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f459e3f9059f41c48e3fdd2d9fe42695","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999777947999976},{"cnt":[[1611,2574],[1841,2574],[1841,2617],[1611,2617]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":44},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"237954802e1a45a687921f2a3d28fd56","type":"page_info","conversion_output":false,"text":"Page 26 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-28","page":28,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5c08564cb1c4fc285722b5681fefc15","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1940,249],[1940,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1636,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0331d52d7def45ea8455a8cb4b621c1b","type":"text","conversion_output":true,"text":"CABANA monitoring center. Holter recordings will require downloading of information at the","text_display":"\n\nCABANA monitoring center. Holter recordings will require downloading of information at the","confidence":1,"confidence_rate":1},{"cnt":[[305,296],[1940,296],[1940,342],[305,342]],"region":{"top_left_x":305,"top_left_y":296,"width":1636,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1701e454747044349981502711c5a3a9","type":"text","conversion_output":true,"text":"enrolling site for data transfer to the CABANA monitoring center. All recordings will be made","text_display":" enrolling site for data transfer to the CABANA monitoring center. All recordings will be made","confidence":1,"confidence_rate":1},{"cnt":[[305,339],[1291,339],[1291,387],[305,387]],"region":{"top_left_x":305,"top_left_y":339,"width":987,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9395b550f1494668b00613c85688a954","type":"text","conversion_output":true,"text":"available to the enrolling center for use in clinical practice.","text_display":" available to the enrolling center for use in clinical practice.","confidence":1,"confidence_rate":1},{"cnt":[[305,425],[1940,425],[1940,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdc8473468f5436f87a640ac17e31ce1","type":"text","conversion_output":true,"text":"Follow up monitoring with an alternative system will be required in centers unable to use the","text_display":"\n\nFollow up monitoring with an alternative system will be required in centers unable to use the","confidence":1,"confidence_rate":1},{"cnt":[[305,468],[587,468],[587,513],[305,513]],"region":{"top_left_x":305,"top_left_y":468,"width":282,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a6becd07d414498825de8034ee671fb","type":"text","conversion_output":true,"text":"\"CABANA Box\".","text_display":" \"CABANA Box\".","confidence":1,"confidence_rate":1},{"cnt":[[305,559],[1940,559],[1940,606],[305,606]],"region":{"top_left_x":305,"top_left_y":558,"width":1636,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"992d7a420b5e4461aabb4f5150b8b1a9","type":"text","conversion_output":true,"text":"CT/MR imaging studies will be performed where clinically indicated or otherwise part of routine","text_display":"\n\nCT/MR imaging studies will be performed where clinically indicated or otherwise part of routine","confidence":1,"confidence_rate":1},{"cnt":[[305,602],[1940,602],[1940,649],[305,649]],"region":{"top_left_x":305,"top_left_y":601,"width":1636,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6028a970673447f990661d6aa2aa3511","type":"text","conversion_output":true,"text":"clinical care on ablation subjects after ablation therapy (between 90 days post ablation and the","text_display":" clinical care on ablation subjects after ablation therapy (between 90 days post ablation and the","confidence":1,"confidence_rate":1},{"cnt":[[305,645],[1940,645],[1940,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1636,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b5bc3e61ee84b30a386f877285bf6f5","type":"text","conversion_output":true,"text":"6 month follow-up) and as indicated for PV stenosis management throughout the trial. The 150","text_display":" 6 month follow-up) and as indicated for PV stenosis management throughout the trial. The 150","confidence":1,"confidence_rate":1},{"cnt":[[305,692],[1940,692],[1940,737],[305,737]],"region":{"top_left_x":305,"top_left_y":691,"width":1636,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afd8fac394324c189e9008e7646c3897","type":"text","conversion_output":true,"text":"drug therapy patients that received the CT/MR scan prior to initiating drug therapy, will also","text_display":" drug therapy patients that received the CT/MR scan prior to initiating drug therapy, will also","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[1944,735],[1944,780],[305,780]],"region":{"top_left_x":305,"top_left_y":734,"width":1640,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a489814b52de4344a37cebf570d21354","type":"text","conversion_output":true,"text":"undergo one research CT/MR scan after therapy is fully established (between 90 days post","text_display":" undergo one research CT/MR scan after therapy is fully established (between 90 days post","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,778],[1944,778],[1944,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":1640,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"172726e7bddb45abb756843f5d59a1a6","type":"text","conversion_output":true,"text":"drug treatment initiation and the 6 month follow-up). CT/MR data will be electronically","text_display":" drug treatment initiation and the 6 month follow-up). CT/MR data will be electronically","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[1944,821],[1944,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1640,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0a521325cbb45bb9046da333e2759f6","type":"text","conversion_output":true,"text":"transferred to a server at the Mayo Biomedical Imaging Resource, the CABANA Trial Image","text_display":" transferred to a server at the Mayo Biomedical Imaging Resource, the CABANA Trial Image","confidence":1,"confidence_rate":1},{"cnt":[[305,866],[1944,866],[1944,913],[305,913]],"region":{"top_left_x":305,"top_left_y":865,"width":1640,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2188d0abf72144f3bfe47ce79d1ad2a7","type":"text","conversion_output":true,"text":"Analysis Lab. Scans will be anonymized at the site using a software tool provided by the","text_display":" Analysis Lab. Scans will be anonymized at the site using a software tool provided by the","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1944,911],[1944,958],[305,958]],"region":{"top_left_x":305,"top_left_y":910,"width":1640,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c9c8adf8b6240edb55d5ba4dd93532a","type":"text","conversion_output":true,"text":"Imaging Center. Each clinical center will also perform standard site radiology evaluation and","text_display":" Imaging Center. 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months","text_display":" every 6 months by telephone until the last subject enrolled reaches approximately 36 months","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,1173],[479,1173],[479,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":175,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a762266f9614422099d91fca794c8451","type":"text","conversion_output":true,"text":"follow-up.","text_display":" follow-up.","confidence":1,"confidence_rate":1},{"cnt":[[305,1259],[1927,1259],[1927,1308],[305,1308]],"region":{"top_left_x":305,"top_left_y":1258,"width":1623,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3655f22a4a50455da44aa771b0514297","type":"text","conversion_output":true,"text":"Follow-up data will also be obtained at the time of treatment discontinuation, with a crossover in","text_display":"\n\nFollow-up data will also be obtained at the 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Drugs which have been approved by appropriate","confidence":1,"confidence_rate":1},{"cnt":[[309,647],[1742,647],[1742,694],[309,694]],"region":{"top_left_x":309,"top_left_y":646,"width":1434,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f1e6549465646a188b011b97fc53be7","type":"text","conversion_output":true,"text":"regulatory agencies outside of the United States may be used within that jurisdiction.","text_display":" regulatory agencies outside of the United States may be used within that jurisdiction.","confidence":1,"confidence_rate":1},{"cnt":[[305,730],[778,730],[778,776],[305,776]],"region":{"top_left_x":305,"top_left_y":730,"width":473,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c108619739cb464bb4bb17f9d3e7cf91","type":"section_header","conversion_output":false,"children_ids":["1d6d38dde215463a836e5a24af2fb512"],"text":"","text_display":""},{"cnt":[[309,735],[776,735],[776,776],[309,776]],"region":{"top_left_x":309,"top_left_y":734,"width":467,"height":42},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d6d38dde215463a836e5a24af2fb512","type":"text","conversion_output":true,"parent_id":"c108619739cb464bb4bb17f9d3e7cf91","text":"5.2.4 AV Nodal Ablation","text_display":"\n\n\\subsection*{5.2.4 AV Nodal Ablation}","confidence":1,"confidence_rate":1},{"cnt":[[305,778],[1940,778],[1940,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b117433ca55446fba3fab51c6c669b32","type":"text","conversion_output":true,"text":"Ablation of the AV conduction system may be considered as an alternate measure in patients","text_display":"\n\nAblation of the AV conduction system may be considered as an alternate measure in patients","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[1940,821],[1940,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1636,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07f521c5c9c94a008310fcb6ff9518c4","type":"text","conversion_output":true,"text":"with inadequate rate control refractory to at least 3 rate control agents or 2 membrane-active","text_display":" with inadequate rate control refractory to at least 3 rate control agents or 2 membrane-active","confidence":1,"confidence_rate":1},{"cnt":[[305,868],[683,868],[683,913],[305,913]],"region":{"top_left_x":305,"top_left_y":867,"width":379,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da972f0607d74c0792c105362f40e0a8","type":"text","conversion_output":true,"text":"anti-arrhythmic drugs.","text_display":" anti-arrhythmic drugs.","confidence":1,"confidence_rate":1},{"cnt":[[305,950],[879,950],[879,1003],[305,1003]],"region":{"top_left_x":305,"top_left_y":949,"width":574,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b8bc0d8c3db4cbf97ceafc230f11039","type":"section_header","conversion_output":false,"children_ids":["f6fef0a11ffe421e9830c6b08e11d9a2"],"text":"","text_display":""},{"cnt":[[309,954],[874,954],[874,999],[309,999]],"region":{"top_left_x":309,"top_left_y":953,"width":566,"height":47},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6fef0a11ffe421e9830c6b08e11d9a2","type":"text","conversion_output":true,"parent_id":"5b8bc0d8c3db4cbf97ceafc230f11039","text":"5.2.5 Changing Drug Therapy","text_display":"\n\n\\subsection*{5.2.5 Changing Drug Therapy}","confidence":1,"confidence_rate":1},{"cnt":[[309,997],[1940,997],[1940,1044],[309,1044]],"region":{"top_left_x":309,"top_left_y":996,"width":1632,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9c2d3b7bdf649baabf71466c6cfad38","type":"text","conversion_output":true,"text":"During follow-up, patients may have recurrent AF, which constitutes an endpoint for the AF","text_display":"\n\nDuring follow-up, patients may have recurrent AF, which constitutes an endpoint for the AF","confidence":1,"confidence_rate":1},{"cnt":[[309,1040],[1940,1040],[1940,1089],[309,1089]],"region":{"top_left_x":309,"top_left_y":1039,"width":1632,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"230b3b6459104d92b8c8a46d6aa5836c","type":"text","conversion_output":true,"text":"Recurrence secondary endpoint. Nevertheless, these patients will continue to be followed","text_display":" Recurrence secondary endpoint. Nevertheless, these patients will continue to be followed","confidence":1,"confidence_rate":1},{"cnt":[[309,1087],[1940,1087],[1940,1132],[309,1132]],"region":{"top_left_x":309,"top_left_y":1087,"width":1632,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4230ad42f5f54f18a1a12470de3ff30b","type":"text","conversion_output":true,"text":"throughout the study to establish the occurrence of the primary and the secondary composite","text_display":" throughout the study to establish the occurrence of the primary and the secondary composite","confidence":1,"confidence_rate":1},{"cnt":[[309,1130],[1940,1130],[1940,1175],[309,1175]],"region":{"top_left_x":309,"top_left_y":1130,"width":1632,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17ac76332c654eadb97812fbce7fd0ef","type":"text","conversion_output":true,"text":"endpoints. These patients may require other drug therapy, which can be instituted during follow-","text_display":" endpoints. These patients may require other drug therapy, which can be instituted during follow","confidence":1,"confidence_rate":1},{"cnt":[[309,1173],[1051,1173],[1051,1222],[309,1222]],"region":{"top_left_x":309,"top_left_y":1173,"width":742,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe9c540f24024e9ba8e631e576fc2bc4","type":"text","conversion_output":true,"text":"up, without patient withdrawal from the trial.","text_display":"up, without patient withdrawal from the trial.","confidence":1,"confidence_rate":1},{"cnt":[[305,1257],[1021,1257],[1021,1311],[305,1311]],"region":{"top_left_x":305,"top_left_y":1256,"width":716,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acf0dbaa689244aabbcf5864b0877699","type":"section_header","conversion_output":false,"children_ids":["b675fe226ab64dbeb456f63ef55cdd68"],"text":"","text_display":""},{"cnt":[[309,1261],[1016,1261],[1016,1308],[309,1308]],"region":{"top_left_x":309,"top_left_y":1261,"width":708,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b675fe226ab64dbeb456f63ef55cdd68","type":"text","conversion_output":true,"parent_id":"acf0dbaa689244aabbcf5864b0877699","text":"5.2.6 Cross-Over to Ablative Therapy","text_display":"\n\n\\subsection*{5.2.6 Cross-Over to Ablative Therapy}","confidence":0.99951171875,"confidence_rate":0.9999880878636791},{"cnt":[[309,1306],[1940,1306],[1940,1351],[309,1351]],"region":{"top_left_x":309,"top_left_y":1306,"width":1632,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88227634281a4d95940e496a83365b9e","type":"text","conversion_output":true,"text":"During follow-up, drug arm patients with recurrences may be treated with additional anti-","text_display":"\n\nDuring follow-up, drug arm patients with recurrences may be treated with additional anti","confidence":1,"confidence_rate":1},{"cnt":[[309,1349],[1940,1349],[1940,1396],[309,1396]],"region":{"top_left_x":309,"top_left_y":1349,"width":1632,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78ab43a72d4e44aea07c0612d6cc01ed","type":"text","conversion_output":true,"text":"arrhythmic drugs or alternative rate control agents. Of note, most patients included to date in","text_display":"arrhythmic drugs or alternative rate control agents. Of note, most patients included to date in","confidence":1,"confidence_rate":1},{"cnt":[[309,1392],[1940,1392],[1940,1439],[309,1439]],"region":{"top_left_x":309,"top_left_y":1392,"width":1632,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2f8aa01bf014f7d932ec9a514551ed2","type":"text","conversion_output":true,"text":"single center trials were treated for over one year before undergoing ablation. Thus, it is","text_display":" single center trials were treated for over one year before undergoing ablation. Thus, it is","confidence":1,"confidence_rate":1},{"cnt":[[309,1435],[1940,1435],[1940,1485],[309,1485]],"region":{"top_left_x":309,"top_left_y":1435,"width":1632,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"126ff21deb454c31bf888864d006eac1","type":"text","conversion_output":true,"text":"anticipated that most patients will be treated for at least 12 months in the drug therapy arm and","text_display":" anticipated that most patients will be treated for at least 12 months in the drug therapy arm and","confidence":1,"confidence_rate":1},{"cnt":[[309,1480],[1940,1480],[1940,1528],[309,1528]],"region":{"top_left_x":309,"top_left_y":1480,"width":1632,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"103863e50d0644f095d4a6a68eefdb9b","type":"text","conversion_output":true,"text":"that patients will be fully informed of this at the time of the consent process. Cross over ablative","text_display":" that patients will be fully informed of this at the time of the consent process. Cross over ablative","confidence":1,"confidence_rate":1},{"cnt":[[309,1525],[1940,1525],[1940,1571],[309,1571]],"region":{"top_left_x":309,"top_left_y":1525,"width":1632,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"203bfcb6c76643db854c400d2eeba312","type":"text","conversion_output":true,"text":"intervention is strongly discouraged. Crossovers must be approved by the CABANA Trial","text_display":" intervention is strongly discouraged. Crossovers must be approved by the CABANA Trial","confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[309,1568],[1940,1568],[1940,1618],[309,1618]],"region":{"top_left_x":309,"top_left_y":1568,"width":1632,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17281afe189345f2a5362a12f6d4aac3","type":"text","conversion_output":true,"text":"Administrative Center. Before approval is granted for a patient randomized to drug","text_display":" Administrative Center. Before approval is granted for a patient randomized to drug","confidence":1,"confidence_rate":1},{"cnt":[[307,1611],[1940,1611],[1940,1661],[307,1661]],"region":{"top_left_x":307,"top_left_y":1611,"width":1634,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"226ddc68af49409ab01dce6c818cd79a","type":"text","conversion_output":true,"text":"therapy to be crossed over to ablation, sites will be required to provide rationale and","text_display":" therapy to be crossed over to ablation, sites will be required to provide rationale and","confidence":0.9990234375,"confidence_rate":0.99998938006022},{"cnt":[[305,1656],[1386,1656],[1386,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1656,"width":1081,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d16aa8123712463b8c1a74c678433fb1","type":"text","conversion_output":true,"text":"documentation that drug therapy options have been exhausted.","text_display":" documentation that drug therapy options have been exhausted.","confidence":1,"confidence_rate":1},{"cnt":[[305,1740],[1467,1740],[1467,1794],[305,1794]],"region":{"top_left_x":305,"top_left_y":1740,"width":1163,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54b621ea2a75433cb041b9eaa7ef5710","type":"section_header","conversion_output":false,"children_ids":["a465ae36159d4709a9ca4a4719a23a62"],"text":"","text_display":""},{"cnt":[[309,1745],[1463,1745],[1463,1790],[309,1790]],"region":{"top_left_x":309,"top_left_y":1744,"width":1155,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a465ae36159d4709a9ca4a4719a23a62","type":"text","conversion_output":true,"parent_id":"54b621ea2a75433cb041b9eaa7ef5710","text":"5.2.7 Compliance with Treatment Protocols /Site Performance","text_display":"\n\n\\subsection*{5.2.7 Compliance with Treatment Protocols /Site Performance}","confidence":0.9736804962158203,"confidence_rate":0.9995833358632039},{"cnt":[[309,1788],[1940,1788],[1940,1835],[309,1835]],"region":{"top_left_x":309,"top_left_y":1787,"width":1632,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67132f3e788a4aa3852f7400dde8f0c3","type":"text","conversion_output":true,"text":"The success of the trial will be enhanced by careful consideration of 1) participating Site","text_display":"\n\nThe success of the trial will be enhanced by careful consideration of 1) participating Site","confidence":0.8693289756774902,"confidence_rate":0.9985423794325418},{"cnt":[[309,1833],[1940,1833],[1940,1880],[309,1880]],"region":{"top_left_x":309,"top_left_y":1832,"width":1632,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0283fa30b9cc4c4d93aa8b051a67c92a","type":"text","conversion_output":true,"text":"Qualification, 2) Procedure Standardization, 3) Site performance, and 4) Follow-up tracking.","text_display":" Qualification, 2) Procedure Standardization, 3) Site performance, and 4) Follow-up tracking.","confidence":1,"confidence_rate":1},{"cnt":[[309,1876],[1944,1876],[1944,1923],[309,1923]],"region":{"top_left_x":309,"top_left_y":1875,"width":1636,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53e1bc82083144d6a8bdf1c1f827b0b7","type":"text","conversion_output":true,"text":"High standards in each of these areas will provide the greatest assurance that optimal, protocol-","text_display":" High standards in each of these areas will provide the greatest assurance that optimal, protocol","confidence":1,"confidence_rate":1},{"cnt":[[309,1921],[1940,1921],[1940,1966],[309,1966]],"region":{"top_left_x":309,"top_left_y":1920,"width":1632,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51b1989fa26c4a3585be67a36ed49e44","type":"text","conversion_output":true,"text":"dictated therapy is being delivered and that patients have the best opportunity of responding to","text_display":"dictated therapy is being delivered and that patients have the best opportunity of responding to","confidence":1,"confidence_rate":1},{"cnt":[[309,1964],[1944,1964],[1944,2009],[309,2009]],"region":{"top_left_x":309,"top_left_y":1963,"width":1636,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"210b4fa1d799469e8e562f9cd44f0afa","type":"text","conversion_output":true,"text":"it. Each site will be required to provide documentation of expertise in the medical management","text_display":" it. Each site will be required to provide documentation of expertise in the medical management","confidence":1,"confidence_rate":1},{"cnt":[[309,2007],[1940,2007],[1940,2054],[309,2054]],"region":{"top_left_x":309,"top_left_y":2006,"width":1632,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1308af493e09449cbb9d0b01b9169486","type":"text","conversion_output":true,"text":"of AF, including at least 2 of the following: 1) successful participation in AFFIRM, RACE, STAF,","text_display":" of AF, including at least 2 of the following: 1) successful participation in AFFIRM, RACE, STAF,","confidence":0.6720349788665771,"confidence_rate":0.9961857075036761},{"cnt":[[309,2050],[1940,2050],[1940,2099],[309,2099]],"region":{"top_left_x":309,"top_left_y":2049,"width":1632,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"166335f5b99b4058b8777e2de0ee6e06","type":"text","conversion_output":true,"text":"PIAF or other multi-center clinical trials; 2 ) medical management of at least 30 patients with AF;","text_display":" PIAF or other multi-center clinical trials; 2 ) medical management of at least 30 patients with AF;","confidence":0.6140331854112446,"confidence_rate":0.9955761206335888},{"cnt":[[309,2093],[1940,2093],[1940,2142],[309,2142]],"region":{"top_left_x":309,"top_left_y":2092,"width":1632,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea8d7205f8784d81902b0e3c3a4adddf","type":"text","conversion_output":true,"text":"3) site expertise in clinical practice, research, or quality assurance registries or databases; 4) an","text_display":" 3) site expertise in clinical practice, research, or quality assurance registries or databases; 4) an","confidence":0.92626953125,"confidence_rate":0.9992777136515861},{"cnt":[[309,2140],[1944,2140],[1944,2185],[309,2185]],"region":{"top_left_x":309,"top_left_y":2139,"width":1636,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75f4c8cf8a234262a2a376b099b4a6d4","type":"text","conversion_output":true,"text":"active AF clinic; or 5 ) treatment of \\(>20\\) patients with sotalol, dofetilide or amiodarone. Patient","text_display":" active AF clinic; or 5 ) treatment of \\(>20\\) patients with sotalol, dofetilide or amiodarone. Patient","confidence":0.7920204703896161,"confidence_rate":0.9978631300244258},{"cnt":[[309,2183],[1944,2183],[1944,2230],[309,2230]],"region":{"top_left_x":309,"top_left_y":2182,"width":1636,"height":49},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c92921bd3c7c4ee98980c3520be5ef4e","type":"text","conversion_output":true,"text":"compliance with medical therapy in rate control patients will be judged from achievement and","text_display":" compliance with medical therapy in rate control patients will be judged from achievement and","confidence":1,"confidence_rate":1},{"cnt":[[309,2226],[1944,2226],[1944,2275],[309,2275]],"region":{"top_left_x":309,"top_left_y":2225,"width":1636,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84ae71359950400d8516960a8d65e960","type":"text","conversion_output":true,"text":"maintenance of rate control targets noted in Section 5.2. Rates of sinus rhythm among rhythm","text_display":" maintenance of rate control targets noted in Section 5.2. Rates of sinus rhythm among rhythm","confidence":1,"confidence_rate":1},{"cnt":[[309,2271],[1944,2271],[1944,2318],[309,2318]],"region":{"top_left_x":309,"top_left_y":2270,"width":1636,"height":49},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f83594b0d71c46068c8304f2263609e6","type":"text","conversion_output":true,"text":"control patients in the medical arm will be monitored and benchmarked against recent clinical","text_display":" control patients in the medical arm will be monitored and benchmarked against recent clinical","confidence":1,"confidence_rate":1},{"cnt":[[309,2316],[1944,2316],[1944,2361],[309,2361]],"region":{"top_left_x":309,"top_left_y":2316,"width":1636,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98c6acc14ade4ec6bc356a851dc321d5","type":"text","conversion_output":true,"text":"trials including AFFIRM, AF CHF and ATHENA. Frequent phone contacts and newsletters will","text_display":" trials including AFFIRM, AF CHF and ATHENA. Frequent phone contacts and newsletters will","confidence":1,"confidence_rate":1},{"cnt":[[309,2359],[1944,2359],[1944,2408],[309,2408]],"region":{"top_left_x":309,"top_left_y":2358,"width":1636,"height":51},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c927bc9ded554af98aab1aa4de65b122","type":"text","conversion_output":true,"text":"encourage compliance during the therapy initiation phase. These communications will then be","text_display":" encourage compliance during the therapy initiation phase. These communications will then be","confidence":1,"confidence_rate":1},{"cnt":[[309,2402],[1944,2402],[1944,2451],[309,2451]],"region":{"top_left_x":309,"top_left_y":2401,"width":1636,"height":51},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33750261a98348d688c96584779cf794","type":"text","conversion_output":true,"text":"continued regularly during the follow-up phase. Since we desire participation by a true cross","text_display":" continued regularly during the follow-up phase. Since we desire participation by a true cross","confidence":1,"confidence_rate":1},{"cnt":[[309,2445],[1940,2445],[1940,2494],[309,2494]],"region":{"top_left_x":309,"top_left_y":2444,"width":1632,"height":51},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b87fb6f1f083445ea724f8f572756239","type":"text","conversion_output":true,"text":"section of individuals with AF, enrollment will not be based on availability of health insurance.","text_display":" section of individuals with AF, enrollment will not be based on availability of health insurance.","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"195ac769fc994a27912e85b8ad5bfa9b","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1841,2574],[1841,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":42},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"501b5498dad74e0da0454e2a35a35923","type":"page_info","conversion_output":false,"text":"Page 30 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-32","page":32,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb1247b66bce43c6acabf45e7c719103","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1940,249],[1940,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1636,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"420eebc371ad4291a65e71637b1ed2d6","type":"text","conversion_output":true,"text":"The IDE: G050233 approval establishes the approach of this trial as a CMS B2 therapy. As has","text_display":"\n\nThe IDE: G050233 approval establishes the approach of this trial as a CMS B2 therapy. As has","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,288],[1938,288],[1938,346],[305,346]],"region":{"top_left_x":305,"top_left_y":287,"width":1633,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67346f884c394ccd81694a532cbce165","type":"text","conversion_output":true,"text":"been seen in the Pilot Study, the therapies in this trial can be billed to Medicare \\(/ 3^{\\text {rd }}\\) party payers.","text_display":" been seen in the Pilot Study, the therapies in this trial can be billed to Medicare \\(/ 3^{\\text {rd }}\\) party payers.","confidence":0.9849116279667669,"confidence_rate":0.9998753900625357},{"cnt":[[301,378],[1646,378],[1646,449],[301,449]],"region":{"top_left_x":300,"top_left_y":378,"width":1346,"height":72},"line":4,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"7638ccc11a6e433c9e370739c39d3031","type":"section_header","conversion_output":false,"children_ids":["ba1a82390b1445ef8142fdda68d950eb"],"text":"","text_display":""},{"cnt":[[309,382],[1639,382],[1639,443],[309,443]],"region":{"top_left_x":309,"top_left_y":382,"width":1331,"height":61},"line":5,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"ba1a82390b1445ef8142fdda68d950eb","type":"text","conversion_output":true,"parent_id":"7638ccc11a6e433c9e370739c39d3031","text":"5.3 Primary Catheter Ablation for AF (Ablation Therapy)","text_display":"\n\n\\subsection*{5.3 Primary Catheter Ablation for AF (Ablation Therapy)}","confidence":1,"confidence_rate":1},{"cnt":[[301,432],[907,432],[907,488],[301,488]],"region":{"top_left_x":300,"top_left_y":431,"width":607,"height":57},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7af42a21dd034dc59b0596fa3323bce0","type":"section_header","conversion_output":false,"children_ids":["5ef09ab3d1854c45a0fda01ddffe70a7"],"text":"","text_display":""},{"cnt":[[309,438],[900,438],[900,483],[309,483]],"region":{"top_left_x":309,"top_left_y":438,"width":592,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ef09ab3d1854c45a0fda01ddffe70a7","type":"text","conversion_output":true,"parent_id":"7af42a21dd034dc59b0596fa3323bce0","text":"5.3.1 Pre-ablation Assessment","text_display":"\n\n\\subsection*{5.3.1 Pre-ablation Assessment}","confidence":1,"confidence_rate":1},{"cnt":[[309,481],[1940,481],[1940,531],[309,531]],"region":{"top_left_x":309,"top_left_y":481,"width":1632,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47f3894a94f14fb5b47c84e5ac575cd6","type":"text","conversion_output":true,"text":"Pre-ablation assessment using standard practice patterns as outlined in the AF Ablation","text_display":"\n\nPre-ablation assessment using standard practice patterns as outlined in the AF Ablation","confidence":1,"confidence_rate":1},{"cnt":[[305,524],[1940,524],[1940,574],[305,574]],"region":{"top_left_x":305,"top_left_y":524,"width":1636,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcf4a79e2814422caa9a77aa1f4fb61d","type":"text","conversion_output":true,"text":"Consensus and Venice Chart Documents [50,51], will provide baseline data for safety and","text_display":" Consensus and Venice Chart Documents [50,51], will provide baseline data for safety and","confidence":0.98046875,"confidence_rate":0.9997856261840925},{"cnt":[[305,569],[1940,569],[1940,617],[305,617]],"region":{"top_left_x":305,"top_left_y":569,"width":1636,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2b7b2eeca8f40a3b78373fce94814ae","type":"text","conversion_output":true,"text":"efficacy outcomes analyses. All patients who are randomized to ablative intervention will also","text_display":" efficacy outcomes analyses. All patients who are randomized to ablative intervention will also","confidence":1,"confidence_rate":1},{"cnt":[[305,614],[1944,614],[1944,662],[305,662]],"region":{"top_left_x":305,"top_left_y":614,"width":1640,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77d493c7d56347409a806e17698c925b","type":"text","conversion_output":true,"text":"undergo baseline CT or MR scanning. These studies will form the basis for comparisons of","text_display":" undergo baseline CT or MR scanning. These studies will form the basis for comparisons of","confidence":1,"confidence_rate":1},{"cnt":[[305,657],[1184,657],[1184,707],[305,707]],"region":{"top_left_x":305,"top_left_y":657,"width":879,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aed72ae5518d4eeab51258c12b9be60d","type":"text","conversion_output":true,"text":"change in LA function with ablative or drug therapy.","text_display":" change in LA function with ablative or drug therapy.","confidence":1,"confidence_rate":1},{"cnt":[[301,735],[793,735],[793,799],[301,799]],"region":{"top_left_x":300,"top_left_y":734,"width":493,"height":66},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"463afc29733348c3877791477d3c798d","type":"section_header","conversion_output":false,"children_ids":["a6dda9c3f89f4001925a4d311a7ad012"],"text":"","text_display":""},{"cnt":[[305,743],[784,743],[784,793],[305,793]],"region":{"top_left_x":305,"top_left_y":743,"width":480,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6dda9c3f89f4001925a4d311a7ad012","type":"text","conversion_output":true,"parent_id":"463afc29733348c3877791477d3c798d","text":"5.3.2 Ablation Therapies","text_display":"\n\n\\subsection*{5.3.2 Ablation Therapies}","confidence":0.99853515625,"confidence_rate":0.9999494523919701},{"cnt":[[305,791],[1944,791],[1944,838],[305,838]],"region":{"top_left_x":305,"top_left_y":790,"width":1640,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b50c8dd957542d3b2469c505d2f0b34","type":"text","conversion_output":true,"text":"A potential limitation of any trial examining ablative intervention for AF is the number of different","text_display":"\n\nA potential limitation of any trial examining ablative intervention for AF is the number of different","confidence":0.93505859375,"confidence_rate":0.9993667469616127},{"cnt":[[305,834],[1940,834],[1940,883],[305,883]],"region":{"top_left_x":305,"top_left_y":833,"width":1636,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae5e38d23b4c4a43a4734cf341c0c153","type":"text","conversion_output":true,"text":"methodologies used for the primary curative ablation. The NHLBI Work Group on AF Ablation,","text_display":" methodologies used for the primary curative ablation. The NHLBI Work Group on AF Ablation,","confidence":1,"confidence_rate":1},{"cnt":[[305,877],[1944,877],[1944,926],[305,926]],"region":{"top_left_x":305,"top_left_y":876,"width":1640,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10add0db9d53441690232bd73d666f02","type":"text","conversion_output":true,"text":"the AF Ablation Consensus [50] and the Venice Chart [50] documents all agreed that pulmonary","text_display":" the AF Ablation Consensus [50] and the Venice Chart [50] documents all agreed that pulmonary","confidence":1,"confidence_rate":1},{"cnt":[[305,922],[1940,922],[1940,969],[305,969]],"region":{"top_left_x":305,"top_left_y":921,"width":1636,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f683be1827504b9190cff59791e7abe0","type":"text","conversion_output":true,"text":"vein (PV) isolation is the starting point for AF ablation. PV isolation is therefore the minimum","text_display":" vein (PV) isolation is the starting point for AF ablation. PV isolation is therefore the minimum","confidence":0.98486328125,"confidence_rate":0.999848997063426},{"cnt":[[305,967],[1944,967],[1944,1016],[305,1016]],"region":{"top_left_x":305,"top_left_y":966,"width":1640,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16195dc9f92447a4b0fe9760a5c019d8","type":"text","conversion_output":true,"text":"required ablation procedure for every patient in the trial. This may be a variation of: 1) Circular","text_display":" required ablation procedure for every patient in the trial. This may be a variation of: 1) Circular","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[305,1010],[1944,1010],[1944,1059],[305,1059]],"region":{"top_left_x":305,"top_left_y":1009,"width":1640,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a5a2b0d8636463c88aa7305fe849342","type":"text","conversion_output":true,"text":"mapping catheter-guided ablation as described by Haissaguerre et al. [50, 93, 94], 2) Antral","text_display":" mapping catheter-guided ablation as described by Haissaguerre et al. [50, 93, 94], 2) Antral","confidence":0.86328125,"confidence_rate":0.9984855320589341},{"cnt":[[305,1053],[1944,1053],[1944,1102],[305,1102]],"region":{"top_left_x":305,"top_left_y":1052,"width":1640,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"442da677145f4089bdaab2445176a5cf","type":"text","conversion_output":true,"text":"Isolation using a circular-guided approach as described by Natale et al. [95, 96], or 3) Wide area","text_display":" Isolation using a circular-guided approach as described by Natale et al. [95, 96], or 3) Wide area","confidence":0.9946362947812304,"confidence_rate":0.9999477863968654},{"cnt":[[305,1096],[1944,1096],[1944,1145],[305,1145]],"region":{"top_left_x":305,"top_left_y":1095,"width":1640,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"502f5e3c9ebe4bc880d9dca259ad55b1","type":"text","conversion_output":true,"text":"circumferential ablation [48, 97, 98]. As described in the AF Ablation Consensus Documents","text_display":" circumferential ablation [48, 97, 98]. As described in the AF Ablation Consensus Documents","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[305,1141],[1944,1141],[1944,1190],[305,1190]],"region":{"top_left_x":305,"top_left_y":1140,"width":1640,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adf23f4359044947839fe97816511c3f","type":"text","conversion_output":true,"text":"[50,51], the approach in most expert ablation centers has evolved toward larger circumferential","text_display":" [50,51], the approach in most expert ablation centers has evolved toward larger circumferential","confidence":0.9800758361816406,"confidence_rate":0.9997987669855529},{"cnt":[[305,1186],[1944,1186],[1944,1233],[305,1233]],"region":{"top_left_x":305,"top_left_y":1185,"width":1640,"height":49},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ef6d0bad6d04bc8a55a4bb53a30549d","type":"text","conversion_output":true,"text":"ablation outside the PVs. The selection of ablation guidance systems (circular mapping","text_display":" ablation outside the PVs. The selection of ablation guidance systems (circular mapping","confidence":1,"confidence_rate":1},{"cnt":[[305,1229],[1944,1229],[1944,1278],[305,1278]],"region":{"top_left_x":305,"top_left_y":1228,"width":1640,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65bd74bef2114710afda67c287a20d2e","type":"text","conversion_output":true,"text":"catheters, fluoroscopy, mapping systems and intracardiac ultrasound) is left to the discretion of","text_display":" catheters, fluoroscopy, mapping systems and intracardiac ultrasound) is left to the discretion of","confidence":1,"confidence_rate":1},{"cnt":[[305,1274],[1940,1274],[1940,1321],[305,1321]],"region":{"top_left_x":305,"top_left_y":1274,"width":1636,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"daf41e7fd4314c79a1e70473d5e5117e","type":"text","conversion_output":true,"text":"the site PI, providing that site has performed at least 100 AF ablation cases with that approach.","text_display":" the site PI, providing that site has performed at least 100 AF ablation cases with that approach.","confidence":0.5110476389527321,"confidence_rate":0.9937458775828988},{"cnt":[[305,1315],[1263,1315],[1263,1364],[305,1364]],"region":{"top_left_x":305,"top_left_y":1314,"width":959,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3abeb59b250410d8345a69e4363d6ca","type":"text","conversion_output":true,"text":"The acute endpoint of ablation is the isolation of all PVs.","text_display":" The acute endpoint of ablation is the isolation of all PVs.","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[305,1401],[1944,1401],[1944,1454],[305,1454]],"region":{"top_left_x":305,"top_left_y":1400,"width":1640,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e635171bd23495ea44eb999f0cbbeb9","type":"text","conversion_output":true,"text":"Adjunctive procedures such as enlarging the field of ablation for the targeting of complex","text_display":"\n\nAdjunctive procedures such as enlarging the field of ablation for the targeting of complex","confidence":1,"confidence_rate":1},{"cnt":[[305,1448],[1944,1448],[1944,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1448,"width":1640,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56d1f6329c204ca6b70a78efa33a340b","type":"text","conversion_output":true,"text":"fractionated atrial electrograms [47], sites of apparent ganglia [99], or the use of additional linear","text_display":" fractionated atrial electrograms [47], sites of apparent ganglia [99], or the use of additional linear","confidence":1,"confidence_rate":1},{"cnt":[[305,1491],[1944,1491],[1944,1540],[305,1540]],"region":{"top_left_x":305,"top_left_y":1491,"width":1640,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6187e6af0c0d4397bdcd47b54a054e08","type":"text","conversion_output":true,"text":"lesions is allowed, but only after wider area or antral PV isolation. The methods for each of","text_display":" lesions is allowed, but only after wider area or antral PV isolation. The methods for each of","confidence":1,"confidence_rate":1},{"cnt":[[305,1586],[305,1536],[1944,1538],[1944,1588]],"region":{"top_left_x":305,"top_left_y":1536,"width":1640,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf40485cdc41483e91a0d1f049588260","type":"text","conversion_output":true,"text":"these are as outlined in the AF Ablation Consensus Document [50]. Each ablative approach and","text_display":" these are as outlined in the AF Ablation Consensus Document [50]. Each ablative approach and","confidence":1,"confidence_rate":1},{"cnt":[[305,1581],[1940,1581],[1940,1629],[305,1629]],"region":{"top_left_x":305,"top_left_y":1581,"width":1636,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03d4b19cb463407aa8d9ea6a5e2e5999","type":"text","conversion_output":true,"text":"adjunctive measures will be carefully tracked to establish overall contribution to outcomes.","text_display":" adjunctive measures will be carefully tracked to establish overall contribution to outcomes.","confidence":1,"confidence_rate":1},{"cnt":[[305,1624],[1944,1624],[1944,1674],[305,1674]],"region":{"top_left_x":305,"top_left_y":1624,"width":1640,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e32f2691c33a4858937c1c05ec5eb002","type":"text","conversion_output":true,"text":"Additional factors such as 1) termination of AF with ablation, 2) non-inducibility with atrial","text_display":" Additional factors such as 1) termination of AF with ablation, 2) non-inducibility with atrial","confidence":0.6368958950042725,"confidence_rate":0.9954533063672881},{"cnt":[[305,1667],[1940,1667],[1940,1717],[305,1717]],"region":{"top_left_x":305,"top_left_y":1667,"width":1636,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e75bd329c0fc4f24b65d22e0d9176921","type":"text","conversion_output":true,"text":"stimulation, and 3) absence of immediately recurrent AF with \\(10-20 mcg / min\\) of isoproterenol,","text_display":" stimulation, and 3) absence of immediately recurrent AF with \\(10-20 mcg / min\\) of isoproterenol,","confidence":0.9532134211622179,"confidence_rate":0.9995437569320101},{"cnt":[[305,1710],[1944,1710],[1944,1760],[305,1760]],"region":{"top_left_x":305,"top_left_y":1710,"width":1640,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a111574833e419d9829a832c1fe61a6","type":"text","conversion_output":true,"text":"although controversial, will be tracked. Of note: ablation of the AV conduction system is not","text_display":" although controversial, will be tracked. Of note: ablation of the AV conduction system is not","confidence":1,"confidence_rate":1},{"cnt":[[305,1755],[1296,1755],[1296,1807],[305,1807]],"region":{"top_left_x":305,"top_left_y":1755,"width":991,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5762a271199465ea9e6a0fa71e74164","type":"text","conversion_output":true,"text":"considered an alternative for primary ablative intervention.","text_display":" considered an alternative for primary ablative intervention.","confidence":1,"confidence_rate":1},{"cnt":[[301,1835],[947,1835],[947,1897],[301,1897]],"region":{"top_left_x":300,"top_left_y":1834,"width":648,"height":64},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a45a9cfbbe6c4de98d69c83925f3c526","type":"section_header","conversion_output":false,"children_ids":["cd1762c16ee149fca603d5cd22dda783"],"text":"","text_display":""},{"cnt":[[305,1843],[939,1843],[939,1893],[305,1893]],"region":{"top_left_x":305,"top_left_y":1843,"width":634,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd1762c16ee149fca603d5cd22dda783","type":"text","conversion_output":true,"parent_id":"a45a9cfbbe6c4de98d69c83925f3c526","text":"5.3.3 Approved Ablation Devices","text_display":"\n\n\\subsection*{5.3.3 Approved Ablation Devices}","confidence":1,"confidence_rate":1},{"cnt":[[305,1886],[1893,1886],[1893,1936],[305,1936]],"region":{"top_left_x":305,"top_left_y":1886,"width":1588,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27c6ebfa8010455187458ed258f70033","type":"text","conversion_output":true,"text":"The specific choice of ablation catheters is left to the investigator, but must be one or more of","text_display":"\n\nThe specific choice of ablation catheters is left to the investigator, but must be one or more of","confidence":1,"confidence_rate":1},{"cnt":[[305,1931],[1841,1931],[1841,1981],[305,1981]],"region":{"top_left_x":305,"top_left_y":1931,"width":1537,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"019218f02ff0402d9db879c6de3d6528","type":"text","conversion_output":true,"text":"the catheters listed below (see also Appendix B). 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Unlike the AFFIRM","confidence":1,"confidence_rate":1},{"cnt":[[309,2071],[1944,2071],[1944,2118],[309,2118]],"region":{"top_left_x":309,"top_left_y":2071,"width":1636,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef36ee66badc44e5a56451a680064333","type":"text","conversion_output":true,"text":"trial, patients receiving rhythm control therapy will also be required to receive adequate","text_display":" trial, patients receiving rhythm control therapy will also be required to receive adequate","confidence":1,"confidence_rate":1},{"cnt":[[309,2116],[1944,2116],[1944,2163],[309,2163]],"region":{"top_left_x":309,"top_left_y":2116,"width":1636,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b009b34dcd4b40b2b2247778dca28a15","type":"text","conversion_output":true,"text":"anticoagulation (warfarin, dabigatran, rivaroxiban or apixaban) for the duration of the trial. In the","text_display":" anticoagulation (warfarin, dabigatran, rivaroxiban or apixaban) for the duration of the trial. In the","confidence":1,"confidence_rate":1},{"cnt":[[309,2161],[1944,2161],[1944,2206],[309,2206]],"region":{"top_left_x":309,"top_left_y":2161,"width":1636,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c6c0a8446f44381acb6cf01b0b19aab","type":"text","conversion_output":true,"text":"use of warfarin therapy, target INRs of 2 to 3 will be required, unless higher INRs are mandated","text_display":" use of warfarin therapy, target INRs of 2 to 3 will be required, unless higher INRs are mandated","confidence":1,"confidence_rate":1},{"cnt":[[309,2204],[844,2204],[844,2254],[309,2254]],"region":{"top_left_x":309,"top_left_y":2204,"width":536,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4103c7322094b96a95c62b33587da2c","type":"text","conversion_output":true,"text":"because of underlying disease.","text_display":" because of underlying disease.","confidence":1,"confidence_rate":1},{"cnt":[[305,2288],[1528,2288],[1528,2340],[305,2340]],"region":{"top_left_x":305,"top_left_y":2288,"width":1223,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ac7c7bd1c4d42af96fdd756239f7cd6","type":"section_header","conversion_output":false,"children_ids":["d875d9d416094e8885e8710c749a422c"],"text":"","text_display":""},{"cnt":[[309,2290],[1523,2290],[1523,2340],[309,2340]],"region":{"top_left_x":309,"top_left_y":2290,"width":1215,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d875d9d416094e8885e8710c749a422c","type":"text","conversion_output":true,"parent_id":"8ac7c7bd1c4d42af96fdd756239f7cd6","text":"5.4.2 Guidelines for Anticoagulation Therapy in Ablation Patients","text_display":"\n\n\\subsection*{5.4.2 Guidelines for Anticoagulation Therapy in Ablation Patients}","confidence":0.9990236759185791,"confidence_rate":0.9999860457974148},{"cnt":[[305,2338],[1944,2338],[1944,2383],[305,2383]],"region":{"top_left_x":305,"top_left_y":2337,"width":1640,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28500fb2b75d471588154c6117af7ac0","type":"text","conversion_output":true,"text":"Anticoagulation before, during, and after the ablative intervention will follow the guidelines of the","text_display":"\n\nAnticoagulation before, during, and after the ablative intervention will follow the guidelines of the","confidence":1,"confidence_rate":1},{"cnt":[[305,2380],[1944,2380],[1944,2428],[305,2428]],"region":{"top_left_x":305,"top_left_y":2380,"width":1640,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01ff87ad97d14efd85045ea92224bac7","type":"text","conversion_output":true,"text":"AF Ablation Consensus Document [50]. Prior to the ablative intervention, patients with","text_display":" AF Ablation Consensus Document [50]. Prior to the ablative intervention, patients with","confidence":1,"confidence_rate":1},{"cnt":[[305,2426],[1944,2423],[1944,2471],[305,2473]],"region":{"top_left_x":305,"top_left_y":2423,"width":1640,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f4262444ee44bb3b00b2db7ac05e6e3","type":"text","conversion_output":true,"text":"persistent and long-standing persistent AF should receive adequate anticoagulation (i.e. at least","text_display":" persistent and long-standing persistent AF should receive adequate anticoagulation (i.e. at least","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f66b031c0724d4987df49311a38f76a","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1841,2574],[1841,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ba509c7f5804539aed5edeec6ec2020","type":"page_info","conversion_output":false,"text":"Page 32 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-34","page":34,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8283a31055c54a86aec6740176cd1fac","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1944,249],[1944,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1640,"height":50},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c17b07a74fb1441497ae8fd2864a7313","type":"text","conversion_output":true,"text":"one month of warfarin anticoagulation (INRs: 2-3)), or have a TEE excluding intra-atrial","text_display":"\none month of warfarin anticoagulation (INRs: 2-3)), or have a TEE excluding intra-atrial","confidence":0.9960954189300537,"confidence_rate":0.9999579339617074},{"cnt":[[305,294],[1944,294],[1944,342],[305,342]],"region":{"top_left_x":305,"top_left_y":294,"width":1640,"height":48},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"11c8f23ec58b4bc19e1d32c9b9838e86","type":"text","conversion_output":true,"text":"thrombus at the time of the intervention. During the ablative intervention, maintaining an ACT","text_display":" thrombus at the time of the intervention. During the ablative intervention, maintaining an ACT","confidence":1,"confidence_rate":1},{"cnt":[[305,339],[1944,339],[1944,387],[305,387]],"region":{"top_left_x":305,"top_left_y":339,"width":1640,"height":48},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d1a74b44e19497ab044b34b19c14561","type":"text","conversion_output":true,"text":"between 300 and 400 seconds is strongly recommended. Following the ablative intervention,","text_display":" between 300 and 400 seconds is strongly recommended. Following the ablative intervention,","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[1944,382],[1944,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1640,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c03fbde716c4470b8544ce5f82b71c4b","type":"text","conversion_output":true,"text":"patients will be started on IV heparin or subcutaneous injections of low molecular weight heparin","text_display":" patients will be started on IV heparin or subcutaneous injections of low molecular weight heparin","confidence":1,"confidence_rate":1},{"cnt":[[305,430],[1944,430],[1944,475],[305,475]],"region":{"top_left_x":305,"top_left_y":429,"width":1640,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae82db1562b24e8fafbf5ab01aa06ec2","type":"text","conversion_output":true,"text":"beginning 4 to 6 hours after all sheaths are removed, and appropriate anticoagulation","text_display":" beginning 4 to 6 hours after all sheaths are removed, and appropriate anticoagulation","confidence":1,"confidence_rate":1},{"cnt":[[305,473],[1944,473],[1944,518],[305,518]],"region":{"top_left_x":305,"top_left_y":472,"width":1640,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48258b6b28464a9882131946db42b65c","type":"text","conversion_output":true,"text":"reinstituted the evening of the intervention. Thereafter, low molecular weight heparin is to be","text_display":" reinstituted the evening of the intervention. Thereafter, low molecular weight heparin is to be","confidence":1,"confidence_rate":1},{"cnt":[[305,516],[1946,516],[1946,561],[305,561]],"region":{"top_left_x":305,"top_left_y":515,"width":1642,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88e529cef29e4f968d690a185b3a809a","type":"text","conversion_output":true,"text":"maintained until anticoagulated appropriately or standard dose warfarin achieves a target INR of","text_display":" maintained until anticoagulated appropriately or standard dose warfarin achieves a target INR of","confidence":1,"confidence_rate":1},{"cnt":[[305,559],[1944,559],[1944,604],[305,604]],"region":{"top_left_x":305,"top_left_y":558,"width":1640,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41ec9e03d550451da145b3d17c3cf631","type":"text","conversion_output":true,"text":"2 to 3 , unless the ablation was performed at a therapeutic INR in patients maintained on","text_display":" 2 to 3 , unless the ablation was performed at a therapeutic INR in patients maintained on","confidence":0.9228515625,"confidence_rate":0.9991640279725426},{"cnt":[[305,602],[1944,602],[1944,649],[305,649]],"region":{"top_left_x":305,"top_left_y":601,"width":1640,"height":48},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4936c62b8e86445b8788f715661b7be9","type":"text","conversion_output":true,"text":"warfarin through the ablation. One month following the ablation, dabigatran, rivaroxiban or","text_display":" warfarin through the ablation. One month following the ablation, dabigatran, rivaroxiban or","confidence":1,"confidence_rate":1},{"cnt":[[305,647],[1944,647],[1944,694],[305,694]],"region":{"top_left_x":305,"top_left_y":646,"width":1640,"height":48},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fcd0ba7758a54fd582e18d5c79b15ee3","type":"text","conversion_output":true,"text":"apixaban may be substituted for warfarin, following recently written guidelines. Three to six","text_display":" apixaban may be substituted for warfarin, following recently written guidelines. Three to six","confidence":1,"confidence_rate":1},{"cnt":[[305,692],[1944,692],[1944,737],[305,737]],"region":{"top_left_x":305,"top_left_y":691,"width":1640,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aea1038cb8c74d4dafc67373f06f2829","type":"text","conversion_output":true,"text":"months after ablation, warfarin may be replaced by full dose aspirin in patients with a CHADs","text_display":" months after ablation, warfarin may be replaced by full dose aspirin in patients with a CHADs","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[1944,735],[1944,780],[305,780]],"region":{"top_left_x":305,"top_left_y":734,"width":1640,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc640c52ebc24a17a4d6602dd78838c8","type":"text","conversion_output":true,"text":"score \\(\\leq 1\\). This would include patients with hypertension without hypertrophy, or those \\(<65\\)","text_display":" score \\(\\leq 1\\). 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In those patients with a CHADs","text_display":" asymptomatic AF by standard or full-disclosure monitoring. In those patients with a CHADs","confidence":1,"confidence_rate":1},{"cnt":[[305,866],[1944,866],[1944,913],[305,913]],"region":{"top_left_x":305,"top_left_y":865,"width":1640,"height":49},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f73ba483001c498eb048b8baf6aa9348","type":"text","conversion_output":true,"text":"score \\(\\geq 2\\), adequate anticoagulation is to be continued throughout the trial. Randomization of","text_display":" score \\(\\geq 2\\), adequate anticoagulation is to be continued throughout the trial. Randomization of","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1944,911],[1944,956],[305,956]],"region":{"top_left_x":305,"top_left_y":910,"width":1640,"height":47},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5cd1f1e51d5f472b98b210e4172dc28c","type":"text","conversion_output":true,"text":"warfarin discontinuation is precluded by the low post-ablation stroke rates that would require at","text_display":" warfarin discontinuation is precluded by the low post-ablation stroke rates that would require at","confidence":1,"confidence_rate":1},{"cnt":[[305,954],[1944,954],[1944,1003],[305,1003]],"region":{"top_left_x":305,"top_left_y":953,"width":1640,"height":51},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4769855e88744219989fd4753a4148a8","type":"text","conversion_output":true,"text":"least 10,000 patients for detecting differences in stroke prevalence. Nevertheless, the","text_display":" least 10,000 patients for detecting differences in stroke prevalence. Nevertheless, the","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[305,999],[1944,999],[1944,1046],[305,1046]],"region":{"top_left_x":305,"top_left_y":999,"width":1640,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e923ca224754169996ada6c59ace81d","type":"text","conversion_output":true,"text":"characteristics, follow-up monitoring results, and long-term anticoagulation status of ablation","text_display":" characteristics, follow-up monitoring results, and long-term anticoagulation status of ablation","confidence":1,"confidence_rate":1},{"cnt":[[305,1042],[1944,1042],[1944,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1041,"width":1640,"height":49},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15be204c2e3c441ca2d2ecc4dbee10dc","type":"text","conversion_output":true,"text":"patients will be compared to descriptively identify predictors of events and profiles of patients at","text_display":" patients will be compared to descriptively identify predictors of events and profiles of patients at","confidence":1,"confidence_rate":1},{"cnt":[[305,1087],[1944,1087],[1944,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1087,"width":1640,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85a3fcfa628e4a9a809f927d7defd874","type":"text","conversion_output":true,"text":"high risk for warfarin discontinuation. The utility of trans-telephonic, auto-detection / full","text_display":" high risk for warfarin discontinuation. 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These agents may be used as replacement therapy for","text_display":" warfarin or dabigatran will be approved. These agents may be used as replacement therapy for","confidence":1,"confidence_rate":1},{"cnt":[[305,1394],[1944,1394],[1944,1442],[305,1442]],"region":{"top_left_x":305,"top_left_y":1394,"width":1640,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87097023aad047ffa4981cd6275b5427","type":"text","conversion_output":true,"text":"warfarin on approval of local regulatory agencies and the Innovative Antithrombotic","text_display":" warfarin on approval of local regulatory agencies and the Innovative Antithrombotic","confidence":1,"confidence_rate":1},{"cnt":[[305,1435],[887,1435],[887,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1435,"width":583,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72fdf7b85ba94869997ee14b5a1a803c","type":"text","conversion_output":true,"text":"Therapies/Executive Committees.","text_display":" Therapies/Executive Committees.","confidence":1,"confidence_rate":1},{"cnt":[[301,1517],[1244,1517],[1244,1577],[301,1577]],"region":{"top_left_x":300,"top_left_y":1516,"width":944,"height":61},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2a8448f1ae04824b93007fc63ef3992","type":"section_header","conversion_output":false,"children_ids":["be4684932529412c9eb4b47405e79fbf"],"text":"","text_display":""},{"cnt":[[305,1521],[1240,1521],[1240,1571],[305,1571]],"region":{"top_left_x":305,"top_left_y":1521,"width":935,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be4684932529412c9eb4b47405e79fbf","type":"text","conversion_output":true,"parent_id":"d2a8448f1ae04824b93007fc63ef3992","text":"5.4.4 Items Left to the Discretion of the Physician","text_display":"\n\n\\subsection*{5.4.4 Items Left to the Discretion of the Physician}","confidence":1,"confidence_rate":1},{"cnt":[[305,1568],[1940,1568],[1940,1618],[305,1618]],"region":{"top_left_x":305,"top_left_y":1568,"width":1636,"height":50},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dbfa5aa92d4d4ecbb08c7057e2d25a8b","type":"text","conversion_output":true,"text":"Specific items left to the investigators discretion include: 1) specific choice of rate control vs.","text_display":"\n\nSpecific items left to the investigators discretion include: 1) specific choice of rate control vs.","confidence":1,"confidence_rate":1},{"cnt":[[305,1611],[1944,1611],[1944,1661],[305,1661]],"region":{"top_left_x":305,"top_left_y":1611,"width":1640,"height":50},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49cdc8c413eb497a9904d6645d6e6dc9","type":"text","conversion_output":true,"text":"rhythm control drug therapy and specific drugs to be used; 2) hospitalization to initiate anti-","text_display":" rhythm control drug therapy and specific drugs to be used; 2) hospitalization to initiate anti","confidence":0.99462890625,"confidence_rate":0.9999461457508662},{"cnt":[[305,1656],[1944,1656],[1944,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1656,"width":1640,"height":48},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3eaece37104b45feaf39f4eb9b6f78c3","type":"text","conversion_output":true,"text":"arrhythmic drug therapy; 3) choice of TEE guided direct current cardioversion (DCCV) vs.","text_display":"arrhythmic drug therapy; 3) choice of TEE guided direct current cardioversion (DCCV) vs.","confidence":0.99560546875,"confidence_rate":0.9999526439645051},{"cnt":[[305,1697],[1944,1697],[1944,1747],[305,1747]],"region":{"top_left_x":305,"top_left_y":1697,"width":1640,"height":50},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a2867b6ad244204a9ff115208e6b01f","type":"text","conversion_output":true,"text":"DCCV after 4 weeks of appropriate anticoagulation therapy, such as warfarin to an INR of 2-3;","text_display":" DCCV after 4 weeks of appropriate anticoagulation therapy, such as warfarin to an INR of 2-3;","confidence":0.9931700215674937,"confidence_rate":0.9999321467626776},{"cnt":[[305,1745],[1944,1745],[1944,1794],[305,1794]],"region":{"top_left_x":305,"top_left_y":1744,"width":1640,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bba940c2390647718bf8566cfcfd5604","type":"text","conversion_output":true,"text":"4) pre-ablation TEE assessment in patients with simple paroxysmal AF and hypertension","text_display":" 4) pre-ablation TEE assessment in patients with simple paroxysmal AF and hypertension","confidence":0.9980475902557373,"confidence_rate":0.99997828558931},{"cnt":[[305,1788],[1946,1788],[1946,1837],[305,1837]],"region":{"top_left_x":305,"top_left_y":1787,"width":1642,"height":50},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30c71336639744a8bc760cd85b494348","type":"text","conversion_output":true,"text":"without hypertrophy; 5) continuation of warfarin to maintain a therapeutic INR at the time of","text_display":" without hypertrophy; 5) continuation of warfarin to maintain a therapeutic INR at the time of","confidence":1,"confidence_rate":1},{"cnt":[[305,1830],[1747,1830],[1747,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1830,"width":1442,"height":50},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06475b46e8334f808f9f38aebcac7841","type":"text","conversion_output":true,"text":"catheter ablation; 6 ) selection of warfarin versus dabigatran, rivaroxiban or apixaban.","text_display":" catheter ablation; 6 ) selection of warfarin versus dabigatran, rivaroxiban or apixaban.","confidence":0.7076063428539783,"confidence_rate":0.9964036973171575},{"cnt":[[301,1912],[1775,1912],[1775,1987],[301,1987]],"region":{"top_left_x":300,"top_left_y":1912,"width":1475,"height":76},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"528f26ea8a2e49f580c91754847a1bab","type":"section_header","conversion_output":false,"children_ids":["6552d42742be4026a19c8dd3fb2ca09c"],"text":"","text_display":""},{"cnt":[[305,1919],[1768,1919],[1768,1979],[305,1979]],"region":{"top_left_x":305,"top_left_y":1918,"width":1464,"height":61},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6552d42742be4026a19c8dd3fb2ca09c","type":"text","conversion_output":true,"parent_id":"528f26ea8a2e49f580c91754847a1bab","text":"5.5 Management of Arrhythmia Recurrences During Follow-Up","text_display":"\n\n\\subsection*{5.5 Management of Arrhythmia Recurrences During Follow-Up}","confidence":0.99951171875,"confidence_rate":0.999992122603638},{"cnt":[[305,1977],[1944,1977],[1944,2024],[305,2024]],"region":{"top_left_x":305,"top_left_y":1976,"width":1640,"height":48},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6aeaff93f3bf489785a06129784484a3","type":"text","conversion_output":true,"text":"During the 3 months of \"therapy initiation\", patients randomized to drug therapy may receive","text_display":"\n\nDuring the 3 months of \"therapy initiation\", patients randomized to drug therapy may receive","confidence":1,"confidence_rate":1},{"cnt":[[305,2020],[1944,2020],[1944,2069],[305,2069]],"region":{"top_left_x":305,"top_left_y":2019,"width":1640,"height":50},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"569c3b7b544b404197750451fd764e61","type":"text","conversion_output":true,"text":"alternative drugs. Patients in the ablation arm may undergo repeat ablation in those cases","text_display":" alternative drugs. Patients in the ablation arm may undergo repeat ablation in those cases","confidence":1,"confidence_rate":1},{"cnt":[[305,2062],[1944,2062],[1944,2112],[305,2112]],"region":{"top_left_x":305,"top_left_y":2062,"width":1640,"height":50},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"63ac305e283c4251b4ae8b1e2ca650ee","type":"text","conversion_output":true,"text":"where the recurrent arrhythmia is not felt to be due to the irritation and inflammation of the","text_display":" where the recurrent arrhythmia is not felt to be due to the irritation and inflammation of the","confidence":1,"confidence_rate":1},{"cnt":[[305,2108],[1944,2108],[1944,2155],[305,2155]],"region":{"top_left_x":305,"top_left_y":2107,"width":1640,"height":48},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d814dc1e97e74afeb860fc27fe6bde57","type":"text","conversion_output":true,"text":"ablative intervention. These patients may also be treated with rhythm control drug therapy,","text_display":" ablative intervention. These patients may also be treated with rhythm control drug therapy,","confidence":1,"confidence_rate":1},{"cnt":[[305,2153],[1944,2153],[1944,2198],[305,2198]],"region":{"top_left_x":305,"top_left_y":2152,"width":1640,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d3bfdceb534471185ba6a44c156a4e9","type":"text","conversion_output":true,"text":"providing it is discontinued by the end of the blanking or \"therapy initiation phase\". Any event","text_display":" providing it is discontinued by the end of the blanking or \"therapy initiation phase\". Any event","confidence":1,"confidence_rate":1},{"cnt":[[305,2196],[1944,2196],[1944,2243],[305,2243]],"region":{"top_left_x":305,"top_left_y":2195,"width":1640,"height":48},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87eb8010ed8c4cf2a9499adc273d014b","type":"text","conversion_output":true,"text":"occurring during this period will be tracked as an \"Early Event\". Long-term follow-up with","text_display":" occurring during this period will be tracked as an \"Early Event\". Long-term follow-up with","confidence":1,"confidence_rate":1},{"cnt":[[305,2239],[1944,2239],[1944,2288],[305,2288]],"region":{"top_left_x":305,"top_left_y":2238,"width":1640,"height":51},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fa460d255404aa28b7940e6b76cc4e9","type":"text","conversion_output":true,"text":"respect to efficacy will begin 3 months after the initiation of drug therapy or ablation therapy.","text_display":" respect to efficacy will begin 3 months after the initiation of drug therapy or ablation therapy.","confidence":1,"confidence_rate":1},{"cnt":[[305,2282],[1944,2282],[1944,2331],[305,2331]],"region":{"top_left_x":305,"top_left_y":2281,"width":1640,"height":51},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8bbc84e009c4fc88ca4f14d3840158c","type":"text","conversion_output":true,"text":"These events will be used for the determination of overall freedom from recurrent AF, but will","text_display":" These events will be used for the determination of overall freedom from recurrent AF, but will","confidence":0.989750862121582,"confidence_rate":0.9998959445863984},{"cnt":[[305,2325],[1944,2325],[1944,2374],[305,2374]],"region":{"top_left_x":305,"top_left_y":2324,"width":1640,"height":51},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c69a94bb4e7644c2994a8f2ba2710b67","type":"text","conversion_output":true,"text":"not be of sufficient importance to remove the patient from the trial. Patients achieving a","text_display":" not be of sufficient importance to remove the patient from the trial. Patients achieving a","confidence":1,"confidence_rate":1},{"cnt":[[305,2372],[1944,2372],[1944,2421],[305,2421]],"region":{"top_left_x":305,"top_left_y":2371,"width":1640,"height":51},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b7b3496b9984937ad5aee10fadf38bd","type":"text","conversion_output":true,"text":"secondary endpoint through non-fatal events will be followed throughout the remaining follow-up","text_display":" secondary endpoint through non-fatal events will be followed throughout the remaining follow-up","confidence":1,"confidence_rate":1},{"cnt":[[305,2415],[432,2415],[432,2464],[305,2464]],"region":{"top_left_x":305,"top_left_y":2414,"width":127,"height":51},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d542d002680d4016a63818d5fe542cfd","type":"text","conversion_output":true,"text":"period.","text_display":" period.","confidence":1,"confidence_rate":1},{"cnt":[[305,2572],[969,2572],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2571,"width":664,"height":44},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3bf2dd90548f48749e336f13b0ec84db","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2572],[1841,2572],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2571,"width":231,"height":48},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6278b4c9d87470a969728f9eb79d025","type":"page_info","conversion_output":false,"text":"Page 33 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-35","page":35,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8c8c43fda914e44871ec463177bb13a","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[301,249],[1687,249],[1687,322],[301,322]],"region":{"top_left_x":300,"top_left_y":249,"width":1387,"height":74},"line":2,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"6d32c74cd912456396ba6f4c208cb406","type":"section_header","conversion_output":false,"children_ids":["8f82264b89454265a700f5f8ea9cfb27"],"text":"","text_display":""},{"cnt":[[309,254],[1682,254],[1682,318],[309,318]],"region":{"top_left_x":309,"top_left_y":253,"width":1374,"height":65},"line":3,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"8f82264b89454265a700f5f8ea9cfb27","type":"text","conversion_output":true,"parent_id":"6d32c74cd912456396ba6f4c208cb406","text":"6.0 Definitions \\& Adjudication for Study Endpoints","text_display":"\n\n\\subsection*{6.0 Definitions \\& Adjudication for Study Endpoints}","confidence":0.993175745010376,"confidence_rate":0.9998755050828789},{"cnt":[[305,357],[879,357],[879,421],[305,421]],"region":{"top_left_x":305,"top_left_y":356,"width":574,"height":66},"line":4,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"81fc13ddf19748a09bf110a1e5813c83","type":"section_header","conversion_output":false,"children_ids":["0542bb402e2b40b7aface8889486c510"],"text":"","text_display":""},{"cnt":[[309,361],[872,361],[872,415],[309,415]],"region":{"top_left_x":309,"top_left_y":360,"width":564,"height":55},"line":5,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"0542bb402e2b40b7aface8889486c510","type":"text","conversion_output":true,"parent_id":"81fc13ddf19748a09bf110a1e5813c83","text":"6.1 Primary Endpoints","text_display":"\n\n\\subsection*{6.1 Primary Endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[309,417],[1944,417],[1944,462],[309,462]],"region":{"top_left_x":309,"top_left_y":416,"width":1636,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb9ef063c72542e6be6be65b131963b4","type":"text","conversion_output":true,"text":"The primary endpoint is the composite of total mortality, disabling stroke, serious bleeding or","text_display":"\n\nThe primary endpoint is the composite of total mortality, disabling stroke, serious bleeding or","confidence":1,"confidence_rate":1},{"cnt":[[309,460],[1944,460],[1944,505],[309,505]],"region":{"top_left_x":309,"top_left_y":459,"width":1636,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2922fd29559c44e086d49f68444cafb9","type":"text","conversion_output":true,"text":"cardiac arrest. All components will be adjudicated by an independent Clinical Events","text_display":" cardiac arrest. All components will be adjudicated by an independent Clinical Events","confidence":1,"confidence_rate":1},{"cnt":[[309,503],[1944,503],[1944,552],[309,552]],"region":{"top_left_x":309,"top_left_y":502,"width":1636,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d97778435704786a80c16a63b49b078","type":"text","conversion_output":true,"text":"Committee (CEC) and the most proximate cause of the event established. A Disabling Stroke","text_display":" Committee (CEC) and the most proximate cause of the event established. A Disabling Stroke","confidence":1,"confidence_rate":1},{"cnt":[[305,546],[1944,546],[1944,593],[305,593]],"region":{"top_left_x":305,"top_left_y":545,"width":1640,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fe3efb0efe74348b6eb498f8a8546ec","type":"text","conversion_output":true,"text":"will be considered present using a modification of a Rankin Stroke score [100], and will be","text_display":" will be considered present using a modification of a Rankin Stroke score [100], and will be","confidence":1,"confidence_rate":1},{"cnt":[[305,589],[1944,589],[1944,638],[305,638]],"region":{"top_left_x":305,"top_left_y":588,"width":1640,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcece552e07b4c5d8fc831262cd545e8","type":"text","conversion_output":true,"text":"adjudicated by a Neurologic Events Committee. Serious (or Life-threatening) bleeding will be","text_display":" adjudicated by a Neurologic Events Committee. 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These events will be tracked regardless of treatment randomization. The","text_display":" catheter ablation [101]. These events will be tracked regardless of treatment randomization. The","confidence":1,"confidence_rate":1},{"cnt":[[305,722],[1944,722],[1944,769],[305,769]],"region":{"top_left_x":305,"top_left_y":721,"width":1640,"height":49},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c55524673ed4f129e01d0dc6aec2d28","type":"text","conversion_output":true,"text":"definition for each of these events is listed in the CEC Charter. When there is disagreement","text_display":" definition for each of these events is listed in the CEC Charter. When there is disagreement","confidence":1,"confidence_rate":1},{"cnt":[[305,765],[1944,765],[1944,814],[305,814]],"region":{"top_left_x":305,"top_left_y":764,"width":1640,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc3422e7a8204da1a91a0c0d850f9b22","type":"text","conversion_output":true,"text":"between the CEC and the principal investigator, the CEC's decision will be considered final.","text_display":" between the CEC and the principal investigator, the CEC's decision will be considered final.","confidence":1,"confidence_rate":1},{"cnt":[[305,810],[1944,810],[1944,857],[305,857]],"region":{"top_left_x":305,"top_left_y":809,"width":1640,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93ab51017bb54eb2bc94fbd78ebfcf40","type":"text","conversion_output":true,"text":"Procedures for adjudicating events are described in the CEC Charter, which is available upon","text_display":" Procedures for adjudicating events are described in the CEC Charter, which is available upon","confidence":1,"confidence_rate":1},{"cnt":[[305,855],[1944,855],[1944,900],[305,900]],"region":{"top_left_x":305,"top_left_y":855,"width":1640,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9204426f241e460c977a27e1ddb14391","type":"text","conversion_output":true,"text":"request. The CEC will also confirm whether a death is cardiac/vascular/non-cardiovascular in","text_display":" request. The CEC will also confirm whether a death is cardiac/vascular/non-cardiovascular in","confidence":1,"confidence_rate":1},{"cnt":[[305,898],[1944,898],[1944,943],[305,943]],"region":{"top_left_x":305,"top_left_y":898,"width":1640,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a038b195b137452a8d868dcee7116f8f","type":"text","conversion_output":true,"text":"origin; as well as witnessed/un-witnessed; or sudden/non-sudden. Cardiac mortality will be","text_display":" origin; as well as witnessed/un-witnessed; or sudden/non-sudden. Cardiac mortality will be","confidence":1,"confidence_rate":1},{"cnt":[[305,941],[1944,941],[1944,990],[305,990]],"region":{"top_left_x":305,"top_left_y":941,"width":1640,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5213f6eaab64d30b2a9431b27f5cf6f","type":"text","conversion_output":true,"text":"further categorized as tachyarrhythmic, bradyarrhythmic, heart failure, or due to other cardiac","text_display":" further categorized as tachyarrhythmic, bradyarrhythmic, heart failure, or due to other cardiac","confidence":1,"confidence_rate":1},{"cnt":[[305,984],[1944,984],[1944,1033],[305,1033]],"region":{"top_left_x":305,"top_left_y":983,"width":1640,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94447cfba77c42769f8026b0f5669819","type":"text","conversion_output":true,"text":"causes using the events adjudication form. Hospitalization will also be tracked with specific","text_display":" causes using the events adjudication form. Hospitalization will also be tracked with specific","confidence":1,"confidence_rate":1},{"cnt":[[305,1027],[1944,1027],[1944,1079],[305,1079]],"region":{"top_left_x":305,"top_left_y":1026,"width":1640,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97a265a356cf4cfbae7ba67ceb4628ba","type":"text","conversion_output":true,"text":"reason for admission (heart failure, acute ischemic event, etc.) determined by the site principal","text_display":" reason for admission (heart failure, acute ischemic event, etc.) determined by the site principal","confidence":1,"confidence_rate":1},{"cnt":[[305,1074],[941,1074],[941,1119],[305,1119]],"region":{"top_left_x":305,"top_left_y":1074,"width":637,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45823aff97e84bffb8014dfb6bde8e17","type":"text","conversion_output":true,"text":"investigator as reported in the eCRF.","text_display":" investigator as reported in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[303,1160],[1403,1160],[1403,1222],[303,1222]],"region":{"top_left_x":302,"top_left_y":1160,"width":1101,"height":63},"line":22,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"cdda5f17275746ca8ad85e2f9ce303f3","type":"section_header","conversion_output":false,"children_ids":["4f0051d62731499eab443df7104f8b7e"],"text":"","text_display":""},{"cnt":[[309,1164],[1399,1164],[1399,1218],[309,1218]],"region":{"top_left_x":309,"top_left_y":1164,"width":1090,"height":55},"line":23,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"4f0051d62731499eab443df7104f8b7e","type":"text","conversion_output":true,"parent_id":"cdda5f17275746ca8ad85e2f9ce303f3","text":"6.2 Secondary Endpoints \\& Safety Endpoints","text_display":"\n\n\\subsection*{6.2 Secondary Endpoints \\& Safety Endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[309,1216],[1944,1216],[1944,1265],[309,1265]],"region":{"top_left_x":309,"top_left_y":1216,"width":1636,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"171ce34e4bf24d31b60ecab7c326027f","type":"text","conversion_output":true,"text":"Secondary endpoint events, including total mortality and a composite of total mortality or","text_display":"\n\nSecondary endpoint events, including total mortality and a composite of total mortality or","confidence":1,"confidence_rate":1},{"cnt":[[309,1263],[1119,1263],[1119,1308],[309,1308]],"region":{"top_left_x":309,"top_left_y":1263,"width":811,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea4fc6dd3bc24e049d89d4ea56274916","type":"text","conversion_output":true,"text":"cardiovascular hospitalization will be confirmed.","text_display":" cardiovascular hospitalization will be confirmed.","confidence":0.99951171875,"confidence_rate":0.9999909555872323},{"cnt":[[309,1306],[1944,1306],[1944,1351],[309,1351]],"region":{"top_left_x":309,"top_left_y":1306,"width":1636,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"501f168b82b94eccabc7108e041cf963","type":"text","conversion_output":true,"text":"While hospitalization for any atrial fibrillation, atrial flutter or atrial tachycardia in both treatment","text_display":"\nWhile hospitalization for any atrial fibrillation, atrial flutter or atrial tachycardia in both treatment","confidence":1,"confidence_rate":1},{"cnt":[[309,1349],[1944,1349],[1944,1394],[309,1394]],"region":{"top_left_x":309,"top_left_y":1349,"width":1636,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba3ca115515b4e76b4e0ce44b5155c21","type":"text","conversion_output":true,"text":"arms will be carefully tracked and compared, it will be considered as an \"AF recurrence\" and","text_display":" arms will be carefully tracked and compared, it will be considered as an \"AF recurrence\" and","confidence":1,"confidence_rate":1},{"cnt":[[309,1392],[1946,1392],[1946,1439],[309,1439]],"region":{"top_left_x":309,"top_left_y":1392,"width":1638,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a4a340ab48c43baab10a53711fcbb57","type":"text","conversion_output":true,"text":"counted against efficacy, not safety. Therefore, AF recurrence and/or worsening of AF need","text_display":" counted against efficacy, not safety. Therefore, AF recurrence and/or worsening of AF need","confidence":1,"confidence_rate":1},{"cnt":[[309,1437],[947,1437],[947,1485],[309,1485]],"region":{"top_left_x":309,"top_left_y":1437,"width":639,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d33267f746c647c0a67b8c47ab8a31d0","type":"text","conversion_output":true,"text":"not be reported as an adverse event.","text_display":" not be reported as an adverse event.","confidence":1,"confidence_rate":1},{"cnt":[[305,1525],[862,1525],[862,1586],[305,1586]],"region":{"top_left_x":305,"top_left_y":1525,"width":557,"height":61},"line":30,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"f80a8ab74c6844599fc7f26a1c94dbe3","type":"section_header","conversion_output":false,"children_ids":["eeaf4019dcef4208af93552e530c6d6d"],"text":"","text_display":""},{"cnt":[[309,1530],[857,1530],[857,1583],[309,1583]],"region":{"top_left_x":309,"top_left_y":1529,"width":549,"height":55},"line":31,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"eeaf4019dcef4208af93552e530c6d6d","type":"text","conversion_output":true,"parent_id":"f80a8ab74c6844599fc7f26a1c94dbe3","text":"7.0 Adverse Events","text_display":"\n\n\\subsection*{7.0 Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[305,1633],[1944,1633],[1944,1680],[305,1680]],"region":{"top_left_x":305,"top_left_y":1632,"width":1640,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"536d1770b6dc4d079f36a43807bb3c9a","type":"text","conversion_output":true,"text":"Adverse events, defined as any undesirable medical occurrence in a clinical study patient which","text_display":"\n\nAdverse events, defined as any undesirable medical occurrence in a clinical study patient which","confidence":1,"confidence_rate":1},{"cnt":[[307,1676],[1944,1676],[1944,1725],[307,1725]],"region":{"top_left_x":307,"top_left_y":1675,"width":1638,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75b672f601a847d3a8fd365b6a7f0a0a","type":"text","conversion_output":true,"text":"occurs during the course of the study and can be attributed to a device, procedure, or","text_display":" occurs during the course of the study and can be attributed to a device, procedure, or","confidence":1,"confidence_rate":1},{"cnt":[[307,1721],[1841,1721],[1841,1768],[307,1768]],"region":{"top_left_x":307,"top_left_y":1720,"width":1535,"height":49},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85394f08c88d4754af93f682f773e17e","type":"text","conversion_output":true,"text":"medications required by a procedure, protocol, or trial will be tracked throughout the study.","text_display":" medications required by a procedure, protocol, or trial will be tracked throughout the study.","confidence":1,"confidence_rate":1},{"cnt":[[305,1809],[1944,1809],[1944,1854],[305,1854]],"region":{"top_left_x":305,"top_left_y":1808,"width":1640,"height":47},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5adddbc7668b4bd7b136369cc9eee216","type":"text","conversion_output":true,"text":"An adverse event (AE) will be considered present if 1) there are untoward signs, symptoms,","text_display":"\n\nAn adverse event (AE) will be considered present if 1) there are untoward signs, symptoms,","confidence":0.6669867876917124,"confidence_rate":0.9957460732478658},{"cnt":[[305,1852],[1944,1852],[1944,1899],[305,1899]],"region":{"top_left_x":305,"top_left_y":1851,"width":1640,"height":49},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5023080994544bba147a371faf62a46","type":"text","conversion_output":true,"text":"illnesses, or other medical events that develop or worsen in severity during the course of the","text_display":" illnesses, or other medical events that develop or worsen in severity during the course of the","confidence":1,"confidence_rate":1},{"cnt":[[305,1895],[1944,1895],[1944,1944],[305,1944]],"region":{"top_left_x":305,"top_left_y":1894,"width":1640,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f35e542ffe94f36b987f7097a23941c","type":"text","conversion_output":true,"text":"study, 2 ) they are clinically relevant and if they are clinically related to the study. Note: Disease,","text_display":" study, 2 ) they are clinically relevant and if they are clinically related to the study. Note: Disease,","confidence":0.9622156620025635,"confidence_rate":0.9996530631463751},{"cnt":[[305,1938],[1944,1938],[1944,1987],[305,1987]],"region":{"top_left_x":305,"top_left_y":1937,"width":1640,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0486bbd8bb740c6928bbc6134ec7a57","type":"text","conversion_output":true,"text":"signs symptoms, and or laboratory abnormalities already existing at randomization are not","text_display":" signs symptoms, and or laboratory abnormalities already existing at randomization are not","confidence":1,"confidence_rate":1},{"cnt":[[305,1985],[1944,1985],[1944,2030],[305,2030]],"region":{"top_left_x":305,"top_left_y":1985,"width":1640,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7441166c2534d9ab161ed60d64d3641","type":"text","conversion_output":true,"text":"considered adverse events unless they represent an intensity or frequency exacerbation. An","text_display":" considered adverse events unless they represent an intensity or frequency exacerbation. An","confidence":1,"confidence_rate":1},{"cnt":[[305,2028],[1944,2028],[1944,2073],[305,2073]],"region":{"top_left_x":305,"top_left_y":2028,"width":1640,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3e9ccb62ed44c0b86180a2acb3ce77c","type":"text","conversion_output":true,"text":"adverse event designation should reflect the reason for a diagnosis or abnormal measurement.","text_display":" adverse event designation should reflect the reason for a diagnosis or abnormal measurement.","confidence":1,"confidence_rate":1},{"cnt":[[305,2071],[1944,2071],[1944,2121],[305,2121]],"region":{"top_left_x":305,"top_left_y":2071,"width":1640,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"979623d2a0274378a6ad8d823d42ed5b","type":"text","conversion_output":true,"text":"Procedures planned prior to randomization and the conditions leading to these measures are","text_display":" Procedures planned prior to randomization and the conditions leading to these measures are","confidence":1,"confidence_rate":1},{"cnt":[[305,2116],[649,2116],[649,2159],[305,2159]],"region":{"top_left_x":305,"top_left_y":2116,"width":344,"height":44},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4da0bebc987845efa04c0de490d09b64","type":"text","conversion_output":true,"text":"not adverse events.","text_display":" not adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[305,2204],[1944,2204],[1944,2249],[305,2249]],"region":{"top_left_x":305,"top_left_y":2204,"width":1640,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"502d1da26cdb4f478bf48330970b10cf","type":"text","conversion_output":true,"text":"An event inherent to an intervention/medication that is expected to occur for a projected","text_display":"\n\nAn event inherent to an intervention/medication that is expected to occur for a projected","confidence":1,"confidence_rate":1},{"cnt":[[305,2247],[1944,2247],[1944,2295],[305,2295]],"region":{"top_left_x":305,"top_left_y":2247,"width":1640,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"474a4a13fd174fea93c5e261a0f000eb","type":"text","conversion_output":true,"text":"duration in some or all subjects is considered unavoidable. Unavoidable adverse events will not","text_display":" duration in some or all subjects is considered unavoidable. Unavoidable adverse events will not","confidence":1,"confidence_rate":1},{"cnt":[[305,2290],[1944,2290],[1944,2340],[305,2340]],"region":{"top_left_x":305,"top_left_y":2290,"width":1640,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c47f1774998f48ac8102436685508989","type":"text","conversion_output":true,"text":"be tracked during the trial (examples: pain at catheter insertion sites during and after a","text_display":" be tracked during the trial (examples: pain at catheter insertion sites during and after a","confidence":1,"confidence_rate":1},{"cnt":[[305,2333],[1644,2333],[1644,2383],[305,2383]],"region":{"top_left_x":305,"top_left_y":2333,"width":1339,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3616979beef542b999a4806b944f79bc","type":"text","conversion_output":true,"text":"procedure; pain at injection sites; palpitations; nausea due to anesthesia, etc.).","text_display":" procedure; pain at injection sites; palpitations; nausea due to anesthesia, etc.).","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[967,2574],[967,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":658,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd23509e18544263acafe19ab645202b","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999889000502843},{"cnt":[[1616,2574],[1841,2574],[1841,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f2b4a150a884dadbb5985328d28b47f","type":"page_info","conversion_output":false,"text":"Page 34 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-36","page":36,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0dd7f23a8a2490c845c6035d0d32e3d","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1906,249],[1906,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1601,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5821a2b133164344833b0c231175829c","type":"text","conversion_output":true,"text":"The DCRI will evaluate any safety information that is spontaneously reported in the time frame","text_display":"\n\nThe DCRI will evaluate any safety information that is spontaneously reported in the time frame","confidence":1,"confidence_rate":1},{"cnt":[[305,296],[1912,296],[1912,342],[305,342]],"region":{"top_left_x":305,"top_left_y":296,"width":1608,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdd75e4dc9064cd2b9cd88da51ea4e1a","type":"text","conversion_output":true,"text":"specified in the protocol. For each subject, adverse events occurring after randomization must","text_display":" specified in the protocol. For each subject, adverse events occurring after randomization must","confidence":1,"confidence_rate":1},{"cnt":[[305,339],[1841,339],[1841,387],[305,387]],"region":{"top_left_x":305,"top_left_y":339,"width":1537,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c3771ce7d034d8892d9ac817c318073","type":"text","conversion_output":true,"text":"be recorded on the applicable Adverse Events page(s) in the electronic Case Report Form","text_display":" be recorded on the applicable Adverse Events page(s) in the electronic Case Report Form","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[1882,382],[1882,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1578,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3e167575a104c629378732ec022aa11","type":"text","conversion_output":true,"text":"(eCRF). Recording should be done in a concise manner using standard, acceptable medical","text_display":" (eCRF). Recording should be done in a concise manner using standard, acceptable medical","confidence":1,"confidence_rate":1},{"cnt":[[305,425],[1940,425],[1940,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1636,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"210e01eb40c6476caee08a735c621b78","type":"text","conversion_output":true,"text":"terms. The adverse event recorded should not be a procedure or a clinical measurement (i.e., a","text_display":" terms. The adverse event recorded should not be a procedure or a clinical measurement (i.e., a","confidence":1,"confidence_rate":1},{"cnt":[[305,471],[1880,471],[1880,518],[305,518]],"region":{"top_left_x":305,"top_left_y":470,"width":1575,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba6fd73581dd42a0a7185cfbb832cd07","type":"text","conversion_output":true,"text":"laboratory value or vital sign) but should reflect the reason for the procedure or the diagnosis","text_display":" laboratory value or vital sign) but should reflect the reason for the procedure or the diagnosis","confidence":1,"confidence_rate":1},{"cnt":[[305,516],[1852,516],[1852,561],[305,561]],"region":{"top_left_x":305,"top_left_y":515,"width":1547,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33bcd6b9222f4c1fa6a1fc8b80fb8fd1","type":"text","conversion_output":true,"text":"based on the abnormal measurement. It is the responsibility of the Principal Investigator to","text_display":" based on the abnormal measurement. It is the responsibility of the Principal Investigator to","confidence":1,"confidence_rate":1},{"cnt":[[305,559],[1794,559],[1794,606],[305,606]],"region":{"top_left_x":305,"top_left_y":558,"width":1489,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c49a117c1ae74b26807c5f2952917651","type":"text","conversion_output":true,"text":"oversee the safety of the patients enrolled in the study at his/her site. This responsibility","text_display":" oversee the safety of the patients enrolled in the study at his/her site. 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Events}","confidence":1,"confidence_rate":1},{"cnt":[[305,1229],[1944,1229],[1944,1276],[305,1276]],"region":{"top_left_x":305,"top_left_y":1228,"width":1640,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"705892ae67fc4fde8ac7f1a7f57e0c0f","type":"text","conversion_output":true,"text":"An anticipated event is one that has been identified in previous studies, published literature, or","text_display":"\n\nAn anticipated event is one that has been identified in previous studies, published literature, or","confidence":1,"confidence_rate":1},{"cnt":[[305,1274],[1944,1274],[1944,1321],[305,1321]],"region":{"top_left_x":305,"top_left_y":1274,"width":1640,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c916843af21448138cf49000ddafedd0","type":"text","conversion_output":true,"text":"product labeling to be related to the disease state or therapies. A listing of commonly occurring","text_display":" product labeling to be related to the disease state or therapies. A listing of commonly occurring","confidence":1,"confidence_rate":1},{"cnt":[[305,1317],[1944,1317],[1944,1364],[305,1364]],"region":{"top_left_x":305,"top_left_y":1316,"width":1640,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"719ab8eec97a4275a751abc43f5ec24d","type":"text","conversion_output":true,"text":"'anticipated/expected' events in the population being studied can be found in Appendix A. An","text_display":" 'anticipated/expected' events in the population being studied can be found in Appendix A. An","confidence":0.9970703125,"confidence_rate":0.9999697531643026},{"cnt":[[305,1362],[1944,1362],[1944,1407],[305,1407]],"region":{"top_left_x":305,"top_left_y":1362,"width":1640,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b407fddb473430db48cbeb8e504660a","type":"text","conversion_output":true,"text":"unanticipated/unexpected adverse event is any adverse event that has not been reported in","text_display":" unanticipated/unexpected adverse event is any adverse event that has not been reported in","confidence":1,"confidence_rate":1},{"cnt":[[305,1405],[1944,1405],[1944,1452],[305,1452]],"region":{"top_left_x":305,"top_left_y":1405,"width":1640,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ba3351c51c74683b3eb6fa08aeeeb84","type":"text","conversion_output":true,"text":"previous studies, published literature, product labeling, or which is not anticipated in the","text_display":" previous studies, published literature, product labeling, or which is not anticipated in the","confidence":1,"confidence_rate":1},{"cnt":[[305,1448],[1042,1448],[1042,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1448,"width":737,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e33bf7e0c346453d9ca7dd3641883a3d","type":"text","conversion_output":true,"text":"population being studied (see appendix A).","text_display":" population being studied (see appendix A).","confidence":1,"confidence_rate":1},{"cnt":[[301,1530],[868,1530],[868,1583],[301,1583]],"region":{"top_left_x":300,"top_left_y":1529,"width":568,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"867bd3afd7fe47e885db0cf5fa59b010","type":"section_header","conversion_output":false,"children_ids":["783623a339654b6bb5440525dde3d930"],"text":"","text_display":""},{"cnt":[[305,1534],[862,1534],[862,1579],[305,1579]],"region":{"top_left_x":305,"top_left_y":1533,"width":557,"height":47},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"783623a339654b6bb5440525dde3d930","type":"text","conversion_output":true,"parent_id":"867bd3afd7fe47e885db0cf5fa59b010","text":"7.1.2 Serious Adverse Event","text_display":"\n\n\\subsection*{7.1.2 Serious Adverse Event}","confidence":1,"confidence_rate":1},{"cnt":[[305,1577],[1723,1577],[1723,1626],[305,1626]],"region":{"top_left_x":305,"top_left_y":1576,"width":1419,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2149f27d5b746c0bc2c69a03d57fd21","type":"text","conversion_output":true,"text":"An adverse event that warrants additional action, includes any untoward event that:","text_display":"\n\nAn adverse event that warrants additional action, includes any untoward event that:","confidence":1,"confidence_rate":1},{"cnt":[[370,1624],[556,1624],[556,1669],[370,1669]],"region":{"top_left_x":369,"top_left_y":1624,"width":188,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbca58b4e1854c46a0aaf3d48c04acb7","type":"text","conversion_output":true,"text":"1. Is fatal","text_display":"\n1. Is fatal","confidence":1,"confidence_rate":1},{"cnt":[[370,1667],[737,1667],[737,1717],[370,1717]],"region":{"top_left_x":369,"top_left_y":1667,"width":368,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3d27dedd0f247beb8ae1134610c5bd9","type":"text","conversion_output":true,"text":"2. Is life-threatening","text_display":"\n2. Is life-threatening","confidence":1,"confidence_rate":1},{"cnt":[[370,1710],[1944,1710],[1944,1760],[370,1760]],"region":{"top_left_x":369,"top_left_y":1710,"width":1576,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fc8f609657a4537a637ef8557f968d6","type":"text","conversion_output":true,"text":"3. Requires inpatient hospitalization or prolongation of existing hospitalization \\(>48\\) hours.","text_display":"\n3. Requires inpatient hospitalization or prolongation of existing hospitalization \\(>48\\) hours.","confidence":1,"confidence_rate":1},{"cnt":[[432,1755],[1063,1755],[1063,1803],[432,1803]],"region":{"top_left_x":431,"top_left_y":1755,"width":633,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef3ea955d1b84eaeaee074c8d9a7ad20","type":"text","conversion_output":true,"text":"Exceptions- therefore not reportable:","text_display":" Exceptions- therefore not reportable:","confidence":1,"confidence_rate":1},{"cnt":[[494,1800],[1944,1800],[1944,1850],[494,1850]],"region":{"top_left_x":494,"top_left_y":1800,"width":1451,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91c1c91af6eb446d81626eec98947e4f","type":"text","conversion_output":true,"text":"a. Preplanned (prior to the study) hospital admissions unless the hospitalization is","text_display":"\na. 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Hospitalization for elective procedure (e.g. cardioversion).","text_display":"\nd. Hospitalization for elective procedure (e.g. cardioversion).","confidence":1,"confidence_rate":1},{"cnt":[[494,2065],[1553,2065],[1553,2110],[494,2110]],"region":{"top_left_x":494,"top_left_y":2064,"width":1060,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a143c62d49334ca5971a6abb35779f92","type":"text","conversion_output":true,"text":"e. Emergency room visits that do not result in hospitalization.","text_display":"\ne. Emergency room visits that do not result in hospitalization.","confidence":1,"confidence_rate":1},{"cnt":[[494,2105],[1944,2105],[1944,2155],[494,2155]],"region":{"top_left_x":494,"top_left_y":2105,"width":1451,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"909c437025454ae8ad5bcf61d6ad1c67","type":"text","conversion_output":true,"text":"f. Hospitalization to titrate or optimize medical therapy to treat recurrence of atrial","text_display":"\nf. Hospitalization to titrate or optimize medical therapy to treat recurrence of atrial","confidence":1,"confidence_rate":1},{"cnt":[[554,2153],[741,2153],[741,2194],[554,2194]],"region":{"top_left_x":554,"top_left_y":2152,"width":188,"height":42},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7de571c0cac14967a3db44e89ffac18d","type":"text","conversion_output":true,"text":"fibrillation.","text_display":" fibrillation.","confidence":1,"confidence_rate":1},{"cnt":[[367,2243],[367,2192],[1403,2194],[1403,2245]],"region":{"top_left_x":367,"top_left_y":2191,"width":1037,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8f8f5b24ebb41bda16184230cc399b0","type":"text","conversion_output":true,"text":"4. Results in persistent or significant disability or incapacity.","text_display":"\n4. Results in persistent or significant disability or incapacity.","confidence":1,"confidence_rate":1},{"cnt":[[370,2239],[1240,2239],[1240,2288],[370,2288]],"region":{"top_left_x":369,"top_left_y":2238,"width":871,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4687dc71723467a8d9927d762e623b2","type":"text","conversion_output":true,"text":"5. Results in a congenital anomaly or birth defect.","text_display":"\n5. Results in a congenital anomaly or birth defect.","confidence":1,"confidence_rate":1},{"cnt":[[370,2282],[1944,2282],[1944,2331],[370,2331]],"region":{"top_left_x":369,"top_left_y":2281,"width":1576,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df33ec99aff643bf8ec4590dd5b12f1a","type":"text","conversion_output":true,"text":"6. Important medical events that may not result in death, be life-threatening, or require","text_display":"\n6. Important medical events that may not result in death, be life-threatening, or require","confidence":1,"confidence_rate":1},{"cnt":[[430,2327],[1944,2327],[1944,2374],[430,2374]],"region":{"top_left_x":429,"top_left_y":2326,"width":1516,"height":49},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"124025e7d0234bdeb9904f82f8f92337","type":"text","conversion_output":true,"text":"inpatient hospitalization may be considered an SAE when, based on appropriate medical","text_display":" inpatient hospitalization may be considered an SAE when, based on appropriate medical","confidence":1,"confidence_rate":1},{"cnt":[[430,2372],[1944,2372],[1944,2421],[430,2421]],"region":{"top_left_x":429,"top_left_y":2371,"width":1516,"height":51},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9e5b83c5c764bea931036c257e51c18","type":"text","conversion_output":true,"text":"judgment, they may jeopardize the patient and may require medical or surgical","text_display":" judgment, they may jeopardize the patient and may require medical or surgical","confidence":1,"confidence_rate":1},{"cnt":[[430,2415],[1403,2415],[1403,2464],[430,2464]],"region":{"top_left_x":429,"top_left_y":2414,"width":974,"height":51},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf1af1a4a9f642579ef4c9de7c548b86","type":"text","conversion_output":true,"text":"intervention to prevent one of the outcomes listed above.","text_display":" intervention to prevent one of the outcomes listed above.","confidence":1,"confidence_rate":1},{"cnt":[[305,2572],[969,2572],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2571,"width":664,"height":44},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cffca3c1feb04d698f06175906270f46","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49676306fd66427b960da09b31d322df","type":"page_info","conversion_output":false,"text":"Page 35 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-37","page":37,"lines":[{"cnt":[[372,155],[1794,155],[1794,200],[372,200]],"region":{"top_left_x":371,"top_left_y":154,"width":1423,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c0847cc855a4e34877a0b8ffb8e79ca","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[301,245],[1347,245],[1347,303],[301,303]],"region":{"top_left_x":300,"top_left_y":244,"width":1048,"height":59},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b8bdd158b52479881bdb0317d6ef6c2","type":"section_header","conversion_output":false,"children_ids":["bac511197d994b45af778c6504d018b7"],"text":"","text_display":""},{"cnt":[[305,249],[1343,249],[1343,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1038,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bac511197d994b45af778c6504d018b7","type":"text","conversion_output":true,"parent_id":"5b8bdd158b52479881bdb0317d6ef6c2","text":"7.1.3 Adverse Event Intensity or Severity Classification","text_display":"\n\n\\subsection*{7.1.3 Adverse Event Intensity or Severity Classification}","confidence":0.99853515625,"confidence_rate":0.9999759688513347},{"cnt":[[305,296],[1835,296],[1835,342],[305,342]],"region":{"top_left_x":305,"top_left_y":296,"width":1530,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c207960b256c4013953f65ecc6244227","type":"text","conversion_output":true,"text":"The intensity or severity of each AE will be classified according to the following guidelines:","text_display":"\n\nThe intensity or severity of each AE will be classified according to the following guidelines:","confidence":1,"confidence_rate":1},{"cnt":[[372,339],[1940,339],[1940,385],[372,385]],"region":{"top_left_x":371,"top_left_y":339,"width":1570,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6156417725d4e2c9e368c1d7a374d9f","type":"text","conversion_output":true,"text":"1. Mild: Any event that results in minimal transient impairment of a body function and does","text_display":"\n1. Mild: Any event that results in minimal transient impairment of a body function and does","confidence":1,"confidence_rate":1},{"cnt":[[432,382],[1940,382],[1940,432],[432,432]],"region":{"top_left_x":431,"top_left_y":382,"width":1510,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6531508ea5b64f5c852b5240cd9cf44b","type":"text","conversion_output":true,"text":"not threaten damage to a body structure, and/or does not require intervention other than","text_display":" not threaten damage to a body structure, and/or does not require intervention other than","confidence":1,"confidence_rate":1},{"cnt":[[434,425],[922,425],[922,475],[434,475]],"region":{"top_left_x":433,"top_left_y":425,"width":489,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f9430e89634426fa9e755df53e0f668","type":"text","conversion_output":true,"text":"monitoring (easily tolerated).","text_display":" monitoring (easily tolerated).","confidence":1,"confidence_rate":1},{"cnt":[[370,468],[1944,468],[1944,518],[370,518]],"region":{"top_left_x":369,"top_left_y":468,"width":1576,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b45da655d244a599e49d68be870e39f","type":"text","conversion_output":true,"text":"2. Moderate: Any event which results in moderate transient impairment of a body function","text_display":"\n2. Moderate: Any event which results in moderate transient impairment of a body function","confidence":1,"confidence_rate":1},{"cnt":[[432,516],[1480,516],[1480,561],[432,561]],"region":{"top_left_x":431,"top_left_y":515,"width":1050,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f90e25bb24814e6292fe6305a550c133","type":"text","conversion_output":true,"text":"or damage to a body structure, or which requires intervention.","text_display":" or damage to a body structure, or which requires intervention.","confidence":1,"confidence_rate":1},{"cnt":[[370,559],[1944,559],[1944,604],[370,604]],"region":{"top_left_x":369,"top_left_y":558,"width":1576,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41c51ad732f44d1186a05cf8fe07c6d8","type":"text","conversion_output":true,"text":"3. Severe: Any event which is life threatening, results or could result in significant","text_display":"\n3. Severe: Any event which is life threatening, results or could result in significant","confidence":1,"confidence_rate":1},{"cnt":[[434,602],[1944,602],[1944,649],[434,649]],"region":{"top_left_x":433,"top_left_y":601,"width":1512,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ce8e2aa0bf4421ba3878124cfe4969f","type":"text","conversion_output":true,"text":"permanent impairment of a body function or damage to a body structure, requires","text_display":" permanent impairment of a body function or damage to a body structure, requires","confidence":1,"confidence_rate":1},{"cnt":[[434,645],[1944,645],[1944,694],[434,694]],"region":{"top_left_x":433,"top_left_y":644,"width":1512,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bfdf1f71cc748108b4b642a2c5a2357","type":"text","conversion_output":true,"text":"significant and timely intervention to prevent permanent impairment of a body function or","text_display":" significant and timely intervention to prevent permanent impairment of a body function or","confidence":1,"confidence_rate":1},{"cnt":[[432,692],[1944,692],[1944,737],[432,737]],"region":{"top_left_x":431,"top_left_y":691,"width":1514,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73477d21b3ae40e6a1a81fce7d86a5ff","type":"text","conversion_output":true,"text":"damage to a body structure, or which is intolerable or places the subject at immediate","text_display":" damage to a body structure, or which is intolerable or places the subject at immediate","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[434,735],[651,735],[651,778],[434,778]],"region":{"top_left_x":433,"top_left_y":734,"width":218,"height":44},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05644b14ae10405c98efd30663f7c4da","type":"text","conversion_output":true,"text":"risk of harm.","text_display":" risk of harm.","confidence":1,"confidence_rate":1},{"cnt":[[301,814],[1377,814],[1377,872],[301,872]],"region":{"top_left_x":300,"top_left_y":814,"width":1078,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49373042a6fe415c9aeaab804d67a0f7","type":"section_header","conversion_output":false,"children_ids":["89829c525cd246bfab4ef074908a1ebb"],"text":"","text_display":""},{"cnt":[[305,821],[1373,821],[1373,868],[305,868]],"region":{"top_left_x":305,"top_left_y":820,"width":1068,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89829c525cd246bfab4ef074908a1ebb","type":"text","conversion_output":true,"parent_id":"49373042a6fe415c9aeaab804d67a0f7","text":"7.1.4 Causal Relationship to Medical or Ablative Therapy","text_display":"\n\n\\subsection*{7.1.4 Causal Relationship to Medical or Ablative Therapy}","confidence":0.99755859375,"confidence_rate":0.999959928813662},{"cnt":[[432,864],[1944,864],[1944,913],[432,913]],"region":{"top_left_x":431,"top_left_y":863,"width":1514,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"148c9115397d43dc8f82fb97c9bde4df","type":"text","conversion_output":true,"text":"The International Council of Harmonization (ICH) Guidelines (1995) indicate that","text_display":"\n\nThe International Council of Harmonization (ICH) Guidelines (1995) indicate that","confidence":1,"confidence_rate":1},{"cnt":[[434,911],[1944,911],[1944,956],[434,956]],"region":{"top_left_x":433,"top_left_y":910,"width":1512,"height":47},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05a1bb60e93c4fb1b1bba8889929893d","type":"text","conversion_output":true,"text":"\"reasonable causal relationship\" means that \"there are facts [evidence] or arguments to","text_display":" \"reasonable causal relationship\" means that \"there are facts [evidence] or arguments to","confidence":1,"confidence_rate":1},{"cnt":[[434,954],[1944,954],[1944,1001],[434,1001]],"region":{"top_left_x":433,"top_left_y":953,"width":1512,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1bdd258371a4b949f32c71a7688f15c","type":"text","conversion_output":true,"text":"suggest a causal relationship.\" The causality assessment must be made by the","text_display":" suggest a causal relationship.\" The causality assessment must be made by the","confidence":1,"confidence_rate":1},{"cnt":[[432,997],[1944,997],[1944,1044],[432,1044]],"region":{"top_left_x":431,"top_left_y":996,"width":1514,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a5d86bfd78e4ea3b79b20ecaf4597b3","type":"text","conversion_output":true,"text":"investigator based on information available at the time that the adverse event eCRF is","text_display":" investigator based on information available at the time that the adverse event eCRF is","confidence":1,"confidence_rate":1},{"cnt":[[432,1040],[1944,1040],[1944,1089],[432,1089]],"region":{"top_left_x":431,"top_left_y":1039,"width":1514,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecb57e0cdc5946f39f7ce003ad96c23d","type":"text","conversion_output":true,"text":"completed. The initial causality assessment may be revised as new information","text_display":" completed. The initial causality assessment may be revised as new information","confidence":1,"confidence_rate":1},{"cnt":[[432,1087],[767,1087],[767,1128],[432,1128]],"region":{"top_left_x":431,"top_left_y":1087,"width":336,"height":41},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ec0e04213444d3db0d7ac3e5a9e8117","type":"text","conversion_output":true,"text":"becomes available.","text_display":" becomes available.","confidence":1,"confidence_rate":1},{"cnt":[[372,1173],[1940,1173],[1940,1222],[372,1222]],"region":{"top_left_x":371,"top_left_y":1173,"width":1570,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c3735fc762041f592206e7e37b5080e","type":"text","conversion_output":true,"text":"1. Definitely related: there is a reasonable temporal relationship to study therapy or device","text_display":"\n1. Definitely related: there is a reasonable temporal relationship to study therapy or device","confidence":1,"confidence_rate":1},{"cnt":[[494,1216],[1944,1216],[1944,1265],[494,1265]],"region":{"top_left_x":494,"top_left_y":1216,"width":1451,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"209099feaf494691a2aebff3f672228a","type":"text","conversion_output":true,"text":"a. follows a known response pattern (e.g., study drug, treatment or device is known","text_display":"\na. follows a known response pattern (e.g., study drug, treatment or device is known","confidence":1,"confidence_rate":1},{"cnt":[[556,1263],[857,1263],[857,1308],[556,1308]],"region":{"top_left_x":556,"top_left_y":1263,"width":302,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"237f068df09544569d4dcf28c6405257","type":"text","conversion_output":true,"text":"to cause this AE)","text_display":" to cause this AE)","confidence":1,"confidence_rate":1},{"cnt":[[494,1302],[1551,1302],[1551,1351],[494,1351]],"region":{"top_left_x":494,"top_left_y":1301,"width":1058,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddbb6acc9c694eeba5065f3f77595454","type":"text","conversion_output":true,"text":"b. there is no alternative etiology or explanation for the event","text_display":"\nb. there is no alternative etiology or explanation for the event","confidence":1,"confidence_rate":1},{"cnt":[[370,1349],[1592,1349],[1592,1394],[370,1394]],"region":{"top_left_x":369,"top_left_y":1349,"width":1223,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b57f4d4201343b3976d3ae051fd749e","type":"text","conversion_output":true,"text":"2. Probably related: there is a reasonable temporal relationship which","text_display":"\n2. Probably related: there is a reasonable temporal relationship which","confidence":1,"confidence_rate":1},{"cnt":[[494,1392],[1199,1392],[1199,1439],[494,1439]],"region":{"top_left_x":494,"top_left_y":1392,"width":705,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19ebc8203a4545659f9030919b7530f6","type":"text","conversion_output":true,"text":"a. follows a suspected response pattern","text_display":"\na. follows a suspected response pattern","confidence":1,"confidence_rate":1},{"cnt":[[494,1435],[1835,1435],[1835,1482],[494,1482]],"region":{"top_left_x":494,"top_left_y":1435,"width":1341,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45585b10e14d49159b1e9d0756c18672","type":"text","conversion_output":true,"text":"b. no evidence for a more likely alternative etiology though could be unrelated","text_display":"\nb. no evidence for a more likely alternative etiology though could be unrelated","confidence":1,"confidence_rate":1},{"cnt":[[370,1480],[1549,1480],[1549,1528],[370,1528]],"region":{"top_left_x":369,"top_left_y":1480,"width":1181,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8dc1b57985745bb9228a981cca516d6","type":"text","conversion_output":true,"text":"3. Possibly related: there is a reasonable temporal relationship but","text_display":"\n3. Possibly related: there is a reasonable temporal relationship but","confidence":0.99951171875,"confidence_rate":0.9999933096045984},{"cnt":[[494,1525],[1944,1525],[1944,1571],[494,1571]],"region":{"top_left_x":494,"top_left_y":1525,"width":1451,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da609d3f6cba4e1caea0f9e3c420e6c8","type":"text","conversion_output":true,"text":"a. equivocal evidence that the event is study related as opposed to an alternative","text_display":"\na. equivocal evidence that the event is study related as opposed to an alternative","confidence":1,"confidence_rate":1},{"cnt":[[559,1568],[700,1568],[700,1618],[559,1618]],"region":{"top_left_x":558,"top_left_y":1568,"width":143,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2f8ac27f78543fa825f2f8957c614b5","type":"text","conversion_output":true,"text":"etiology","text_display":" etiology","confidence":1,"confidence_rate":1},{"cnt":[[370,1611],[1691,1611],[1691,1661],[370,1661]],"region":{"top_left_x":369,"top_left_y":1611,"width":1322,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24c547ef8ab54550be665c6a8177199e","type":"text","conversion_output":true,"text":"4. Probably not related: there is not a reasonable temporal relationship OR","text_display":"\n4. Probably not related: there is not a reasonable temporal relationship OR","confidence":0.99169921875,"confidence_rate":0.9998958126206443},{"cnt":[[494,1659],[1429,1659],[1429,1704],[494,1704]],"region":{"top_left_x":494,"top_left_y":1658,"width":935,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0b3987e605f42f6801d195c47f91a91","type":"text","conversion_output":true,"text":"a. good evidence for a more likely alternative etiology","text_display":"\na. good evidence for a more likely alternative etiology","confidence":1,"confidence_rate":1},{"cnt":[[370,1697],[1319,1697],[1319,1747],[370,1747]],"region":{"top_left_x":369,"top_left_y":1697,"width":951,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"431208b11b354845bd35b5e6882387e3","type":"text","conversion_output":true,"text":"5. Not related: there is not a temporal relationship OR","text_display":"\n5. Not related: there is not a temporal relationship OR","confidence":1,"confidence_rate":1},{"cnt":[[494,1745],[1863,1745],[1863,1794],[494,1794]],"region":{"top_left_x":494,"top_left_y":1744,"width":1369,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4adf628047442e0b18a8f12cc28f9a3","type":"text","conversion_output":true,"text":"a. clear and compelling evidence that the event is due to an alternative etiology","text_display":"\na. clear and compelling evidence that the event is due to an alternative etiology","confidence":1,"confidence_rate":1},{"cnt":[[303,1826],[1016,1826],[1016,1878],[303,1878]],"region":{"top_left_x":302,"top_left_y":1826,"width":715,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78d41be6a22d4ddca3e7ff9a459af74c","type":"section_header","conversion_output":false,"children_ids":["2f8192ae0e874e9fa06eec1126707885"],"text":"","text_display":""},{"cnt":[[305,1830],[1010,1830],[1010,1876],[305,1876]],"region":{"top_left_x":305,"top_left_y":1830,"width":705,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f8192ae0e874e9fa06eec1126707885","type":"text","conversion_output":true,"parent_id":"78d41be6a22d4ddca3e7ff9a459af74c","text":"7.1.5 Device Related Adverse Events","text_display":"\n\n\\subsection*{7.1.5 Device Related Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[372,1873],[1940,1873],[1940,1923],[372,1923]],"region":{"top_left_x":371,"top_left_y":1873,"width":1570,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ad6ff1443204f15b4a8dddb708e96f0","type":"text","conversion_output":true,"text":"1. Device-related: any adverse event for which a causal relationship between the device","text_display":"\n1. Device-related: any adverse event for which a causal relationship between the device","confidence":1,"confidence_rate":1},{"cnt":[[432,1921],[1944,1921],[1944,1966],[432,1966]],"region":{"top_left_x":431,"top_left_y":1920,"width":1514,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19cfb01da7eb48d9bef039ea5737f284","type":"text","conversion_output":true,"text":"and the event is a reasonable possibility. The likelihood that the event is device related","text_display":" and the event is a reasonable possibility. The likelihood that the event is device related","confidence":1,"confidence_rate":1},{"cnt":[[432,1964],[1944,1964],[1944,2009],[432,2009]],"region":{"top_left_x":431,"top_left_y":1963,"width":1514,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"082d986341ec4957850ca5e47cdbc5e6","type":"text","conversion_output":true,"text":"will also be sub-classified using the approach in 7.1.4 above. The event will be further","text_display":" will also be sub-classified using the approach in 7.1.4 above. 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Third, it was considered important for the overall sample to be large","confidence":1,"confidence_rate":1},{"cnt":[[305,1474],[1944,1474],[1944,1519],[305,1519]],"region":{"top_left_x":305,"top_left_y":1473,"width":1640,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7fd6b4acc6fc4d4baf0456d3c21cf345","type":"text","conversion_output":true,"text":"enough to permit a prudent examination of treatment effects in selected subgroups of patients","text_display":" enough to permit a prudent examination of treatment effects in selected subgroups of patients","confidence":0.9970715045928955,"confidence_rate":0.9999700740004459},{"cnt":[[305,1517],[1944,1517],[1944,1566],[305,1566]],"region":{"top_left_x":305,"top_left_y":1516,"width":1640,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2d6eada749b4354abcc6c7ce502bea9","type":"text","conversion_output":true,"text":"where AF ablation might be particularly advantageous, or where the question of a treatment","text_display":" where AF ablation might be particularly advantageous, or where the question of a treatment","confidence":0.9951171875,"confidence_rate":0.9999484774075793},{"cnt":[[305,1560],[1944,1560],[1944,1609],[305,1609]],"region":{"top_left_x":305,"top_left_y":1559,"width":1640,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f04b5bff65a04776b0057ec93e93b7bf","type":"text","conversion_output":true,"text":"benefit from this invasive procedure is particularly relevant. Important pre-specified subgroups","text_display":" benefit from this invasive procedure is particularly relevant. Important pre-specified subgroups","confidence":1,"confidence_rate":1},{"cnt":[[305,1605],[1944,1605],[1944,1652],[305,1652]],"region":{"top_left_x":305,"top_left_y":1604,"width":1640,"height":49},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9d5ba44eb7e4ad2bd2dbbf1937fc31d","type":"text","conversion_output":true,"text":"of interest in this study include those defined by age, gender, race, AF type (paroxysmal,","text_display":" of interest in this study include those defined by age, gender, race, AF type (paroxysmal,","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[305,1646],[1946,1646],[1946,1695],[305,1695]],"region":{"top_left_x":305,"top_left_y":1645,"width":1642,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b92d19459bac4c82b15cc81691a9ef91","type":"text","conversion_output":true,"text":"persistent, or long-standing persistent), AF duration, heart failure class, presence/absence of","text_display":" persistent, or long-standing persistent), AF duration, heart failure class, presence/absence of","confidence":1,"confidence_rate":1},{"cnt":[[305,1693],[1944,1693],[1944,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1692,"width":1640,"height":47},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e518da6aebd46908feea972dbb97d52","type":"text","conversion_output":true,"text":"underlying structural heart disease, presence/absence of hypertension, and ejection fraction.","text_display":" underlying structural heart disease, presence/absence of hypertension, and ejection fraction.","confidence":1,"confidence_rate":1},{"cnt":[[305,1736],[1944,1736],[1944,1783],[305,1783]],"region":{"top_left_x":305,"top_left_y":1735,"width":1640,"height":49},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85b573cacad7481caa2a59378965396b","type":"text","conversion_output":true,"text":"Finally, the sample size was determined to provide a reasonable level of confidence of detecting","text_display":" Finally, the sample size was determined to provide a reasonable level of confidence of detecting","confidence":1,"confidence_rate":1},{"cnt":[[305,1779],[1944,1779],[1944,1828],[305,1828]],"region":{"top_left_x":305,"top_left_y":1778,"width":1640,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e58c2eb5fd674d41a2469374e278d70a","type":"text","conversion_output":true,"text":"clinically important therapeutic effects even if current projections of event rates and treatment","text_display":" clinically important therapeutic effects even if current projections of event rates and treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,1824],[887,1824],[887,1871],[305,1871]],"region":{"top_left_x":305,"top_left_y":1824,"width":583,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0a8345b86ed43eaaf028f9288d82c66","type":"text","conversion_output":true,"text":"differences prove to be optimistic.","text_display":" differences prove to be optimistic.","confidence":1,"confidence_rate":1},{"cnt":[[305,1912],[1944,1912],[1944,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1912,"width":1640,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a886de0892348b8a40311a26d666328","type":"text","conversion_output":true,"text":"As described in Section 2.0, the study was originally designed with total mortality as the primary","text_display":"\n\nAs described in Section 2.0, the study was originally designed with total mortality as the primary","confidence":1,"confidence_rate":1},{"cnt":[[305,1955],[1944,1955],[1944,2004],[305,2004]],"region":{"top_left_x":305,"top_left_y":1955,"width":1640,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"991ecd3659ad43f89090be78cd6158f3","type":"text","conversion_output":true,"text":"endpoint. However, in early 2013 a careful assessment of the progress of the trial was","text_display":" endpoint. However, in early 2013 a careful assessment of the progress of the trial was","confidence":1,"confidence_rate":1},{"cnt":[[305,2000],[1944,2000],[1944,2047],[305,2047]],"region":{"top_left_x":305,"top_left_y":2000,"width":1640,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"514ff00f927445b6b8a84c0188b51633","type":"text","conversion_output":true,"text":"undertaken by the study leadership. Completely blinded to any treatment-specific outcome data,","text_display":" undertaken by the study leadership. Completely blinded to any treatment-specific outcome data,","confidence":1,"confidence_rate":1},{"cnt":[[305,2045],[1944,2045],[1944,2090],[305,2090]],"region":{"top_left_x":305,"top_left_y":2045,"width":1640,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8088c6bb9af04c988734065b96f5d044","type":"text","conversion_output":true,"text":"the two major issues addressed by the leadership group were (1) a lower than expected","text_display":" the two major issues addressed by the leadership group were (1) a lower than expected","confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[305,2088],[1944,2088],[1944,2136],[305,2136]],"region":{"top_left_x":305,"top_left_y":2088,"width":1640,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7aa0e660b9734a1e953c9ac7f3aaf252","type":"text","conversion_output":true,"text":"aggregated mortality rate, and (2) accrual of patients at a rate much slower than projected.","text_display":" aggregated mortality rate, and (2) accrual of patients at a rate much slower than projected.","confidence":1,"confidence_rate":1},{"cnt":[[305,2131],[1944,2131],[1944,2179],[305,2179]],"region":{"top_left_x":305,"top_left_y":2131,"width":1640,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"103e1f540f894829a3950153ada2662e","type":"text","conversion_output":true,"text":"Careful consideration of these issues led to a decision to (a) change the primary endpoint of the","text_display":" Careful consideration of these issues led to a decision to (a) change the primary endpoint of the","confidence":1,"confidence_rate":1},{"cnt":[[305,2174],[1944,2174],[1944,2224],[305,2224]],"region":{"top_left_x":305,"top_left_y":2174,"width":1640,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0019608f39da4ae5a1e59b3e8f1f2d53","type":"text","conversion_output":true,"text":"trial from total mortality to the key secondary endpoint consisting of the composite of death,","text_display":" trial from total mortality to the key secondary endpoint consisting of the composite of death,","confidence":1,"confidence_rate":1},{"cnt":[[305,2217],[1944,2217],[1944,2267],[305,2267]],"region":{"top_left_x":305,"top_left_y":2217,"width":1640,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c37198973ed4a5199738ce70513f48c","type":"text","conversion_output":true,"text":"disabling stroke, serious bleeding, or cardiac arrest, and (b) reduce the sample size to a number","text_display":" disabling stroke, serious bleeding, or cardiac arrest, and (b) reduce the sample size to a number","confidence":1,"confidence_rate":1},{"cnt":[[305,2264],[1944,2264],[1944,2310],[305,2310]],"region":{"top_left_x":305,"top_left_y":2264,"width":1640,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fda4db385d0d4b9e832c4c81d2a7a2e6","type":"text","conversion_output":true,"text":"that was consistent with the new primary endpoint. The following paragraphs, which outlined the","text_display":" that was consistent with the new primary endpoint. The following paragraphs, which outlined the","confidence":1,"confidence_rate":1},{"cnt":[[305,2307],[1944,2307],[1944,2357],[305,2357]],"region":{"top_left_x":305,"top_left_y":2307,"width":1640,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d417af497e543a6a2ff5ba7eaea01b2","type":"text","conversion_output":true,"text":"key considerations in determining the original sample size, are also relevant for the revised","text_display":" key considerations in determining the original sample size, are also relevant for the revised","confidence":1,"confidence_rate":1},{"cnt":[[305,2350],[529,2350],[529,2400],[305,2400]],"region":{"top_left_x":305,"top_left_y":2350,"width":224,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2817d32c42a4e83aac48347fb33b10d","type":"text","conversion_output":true,"text":"sample size.","text_display":" sample size.","confidence":1,"confidence_rate":1},{"cnt":[[305,2572],[969,2572],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2571,"width":664,"height":44},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9fde6759bf54825b2ec00fd657d5115","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0347313656a4b5da2d0074f3a5440b7","type":"page_info","conversion_output":false,"text":"Page 39 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-41","page":41,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed747ee7f02140b8b48c605b3bfa473d","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1940,249],[1940,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1636,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e51804216ebb4579a9eecbddf6597007","type":"text","conversion_output":true,"text":"A combination of data from recent AF trials that reflect patient outcomes when treated with drug","text_display":"\n\nA combination of data from recent AF trials that reflect patient outcomes when treated with drug","confidence":1,"confidence_rate":1},{"cnt":[[305,296],[1944,296],[1944,342],[305,342]],"region":{"top_left_x":305,"top_left_y":296,"width":1640,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"653330e545714dbda260787010ea1c3b","type":"text","conversion_output":true,"text":"therapy (rate control or rhythm control) provide useful information on the range of outcomes that","text_display":" therapy (rate control or rhythm control) provide useful information on the range of outcomes that","confidence":1,"confidence_rate":1},{"cnt":[[305,339],[1940,339],[1940,385],[305,385]],"region":{"top_left_x":305,"top_left_y":339,"width":1636,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33159f4caa3a45b982ed0ed585535a9c","type":"text","conversion_output":true,"text":"would be expected among the patients enrolled in the drug arm of CABANA. These studies","text_display":" would be expected among the patients enrolled in the drug arm of CABANA. These studies","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[1940,382],[1940,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"935443edc5054b3596e10f6510f49d0a","type":"text","conversion_output":true,"text":"include AFFIRM, RACE, STAF, PIAF and AF CHF. Since the study population in CABANA will","text_display":" include AFFIRM, RACE, STAF, PIAF and AF CHF. Since the study population in CABANA will","confidence":1,"confidence_rate":1},{"cnt":[[305,425],[1940,425],[1940,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1636,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc33839f99a7434d91cee62a6acda035","type":"text","conversion_output":true,"text":"be most like patients enrolled in the AFFIRM trial, the most reliable estimates of mortality and","text_display":" be most like patients enrolled in the AFFIRM trial, the most reliable estimates of mortality and","confidence":1,"confidence_rate":1},{"cnt":[[305,468],[1940,468],[1940,518],[305,518]],"region":{"top_left_x":305,"top_left_y":468,"width":1636,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"521f3f827b3a4959a079c76e6804b474","type":"text","conversion_output":true,"text":"other endpoint events applicable to the drug arm of CABANA can be obtained from the AFFIRM","text_display":" other endpoint events applicable to the drug arm of CABANA can be obtained from the AFFIRM","confidence":1,"confidence_rate":1},{"cnt":[[305,516],[1940,516],[1940,561],[305,561]],"region":{"top_left_x":305,"top_left_y":515,"width":1636,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0299fa9043494ec08640a0bff93e0913","type":"text","conversion_output":true,"text":"data. The five-year mortality in AFFIRM was \\(23.8 \\%\\) in patients assigned to receive rhythm","text_display":" data. The five-year mortality in AFFIRM was \\(23.8 \\%\\) in patients assigned to receive rhythm","confidence":0.99462890625,"confidence_rate":0.9999439018867602},{"cnt":[[305,559],[1940,559],[1940,604],[305,604]],"region":{"top_left_x":305,"top_left_y":558,"width":1636,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa97afb30f8d43899a2fceccf97d857c","type":"text","conversion_output":true,"text":"control drugs and \\(21.3 \\%\\) in patients assigned to rate control drugs. The crude death rate based","text_display":" control drugs and \\(21.3 \\%\\) in patients assigned to rate control drugs. The crude death rate based","confidence":1,"confidence_rate":1},{"cnt":[[305,602],[1940,602],[1940,649],[305,649]],"region":{"top_left_x":305,"top_left_y":601,"width":1636,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe0321691c7549d58c1810ae40b42f37","type":"text","conversion_output":true,"text":"on a mean follow-up of 3.5 years was \\(16.4 \\%\\). However, the Kaplan-Meier curves in the primary","text_display":" on a mean follow-up of 3.5 years was \\(16.4 \\%\\). However, the Kaplan-Meier curves in the primary","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[305,645],[1940,645],[1940,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1636,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1024e9e82f2e4442a2cceb5e4d6aa0c0","type":"text","conversion_output":true,"text":"AFFIRM publication reflect mortality rates at 3 years of \\(13 \\%\\) in the rhythm control arm and \\(11 \\%\\)","text_display":" AFFIRM publication reflect mortality rates at 3 years of \\(13 \\%\\) in the rhythm control arm and \\(11 \\%\\)","confidence":0.9965834617614746,"confidence_rate":0.9999670929651705},{"cnt":[[305,692],[1940,692],[1940,737],[305,737]],"region":{"top_left_x":305,"top_left_y":691,"width":1636,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff481bb0a12646f8bb1644938876e790","type":"text","conversion_output":true,"text":"in the rate control arm. At 3.5 years, mortality was approximately \\(16 \\%\\) in the rhythm control arm","text_display":" in the rate control arm. At 3.5 years, mortality was approximately \\(16 \\%\\) in the rhythm control arm","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[1940,735],[1940,780],[305,780]],"region":{"top_left_x":305,"top_left_y":734,"width":1636,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66835879b03b4a9ba1855952c07f08d1","type":"text","conversion_output":true,"text":"and \\(14 \\%\\) in the rate control arm. Based on this information, the mortality rate in the drug-treated","text_display":" and \\(14 \\%\\) in the rate control arm. Based on this information, the mortality rate in the drug-treated","confidence":0.93359375,"confidence_rate":0.9993519657956015},{"cnt":[[305,778],[1940,778],[1940,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89a94e98d8a44343818b43d1a6cd0c7f","type":"text","conversion_output":true,"text":"arm of CABANA was projected to be approximately \\(12 \\%\\) after 3 years of follow-up and \\(15 \\%\\)","text_display":" arm of CABANA was projected to be approximately \\(12 \\%\\) after 3 years of follow-up and \\(15 \\%\\)","confidence":0.9985356330871582,"confidence_rate":0.9999847351149894},{"cnt":[[305,821],[1940,821],[1940,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1636,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff478df20f644153bc61b47559a4453c","type":"text","conversion_output":true,"text":"after 3.5 years of follow-up ( 3.5 years is the average duration of follow-up originally projected for","text_display":" after 3.5 years of follow-up ( 3.5 years is the average duration of follow-up originally projected for","confidence":1,"confidence_rate":1},{"cnt":[[305,866],[1940,866],[1940,913],[305,913]],"region":{"top_left_x":305,"top_left_y":865,"width":1636,"height":49},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce2ff48692514a4b80570547f3053a2a","type":"text","conversion_output":true,"text":"CABANA). With the original secondary endpoint elevated to become the primary endpoint, the","text_display":" CABANA). With the original secondary endpoint elevated to become the primary endpoint, the","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1783,911],[1783,956],[305,956]],"region":{"top_left_x":305,"top_left_y":910,"width":1479,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66ea6d9261784933b709f93d0150f45a","type":"text","conversion_output":true,"text":"incidence of the new primary endpoint is expected to be higher than the mortality rates.","text_display":" incidence of the new primary endpoint is expected to be higher than the mortality rates.","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[1940,997],[1940,1044],[305,1044]],"region":{"top_left_x":305,"top_left_y":996,"width":1636,"height":49},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1833f6eb8bbb4df58949a9608c546be3","type":"text","conversion_output":true,"text":"In addition to the control (drug) arm event rate, a key driver of the sample size is the magnitude","text_display":"\n\nIn addition to the control (drug) arm event rate, a key driver of the sample size is the magnitude","confidence":1,"confidence_rate":1},{"cnt":[[305,1040],[1940,1040],[1940,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1636,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"599cbb82831247c891198afe23717766","type":"text","conversion_output":true,"text":"of the treatment effect (i.e., the reduction in the primary endpoint expected in the ablation arm).","text_display":" of the treatment effect (i.e., the reduction in the primary endpoint expected in the ablation arm).","confidence":1,"confidence_rate":1},{"cnt":[[305,1087],[1940,1087],[1940,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1087,"width":1636,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c854e111d624582bbef51b5071ab5e3","type":"text","conversion_output":true,"text":"A synthesis of information from multiple published sources [48, 58-61, 67] suggests that the","text_display":" A synthesis of information from multiple published sources [48, 58-61, 67] suggests that the","confidence":0.99853515625,"confidence_rate":0.9999848875607663},{"cnt":[[305,1130],[1940,1130],[1940,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1130,"width":1636,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07b961ea40b54a5595e57f549ff7ed15","type":"text","conversion_output":true,"text":"event rate in ablation-treated patients has been relatively low (less than \\(3 \\%\\) per year), which","text_display":" event rate in ablation-treated patients has been relatively low (less than \\(3 \\%\\) per year), which","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,1173],[1940,1173],[1940,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":1636,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e0dd40c3a394d27867e61599bfebb6d","type":"text","conversion_output":true,"text":"translates to a projected 3 -year event rate of \\(8-9 \\%\\) or a 3.5 year rate of \\(10 \\%\\) or less in the","text_display":" translates to a projected 3 -year event rate of \\(8-9 \\%\\) or a 3.5 year rate of \\(10 \\%\\) or less in the","confidence":0.99658203125,"confidence_rate":0.9999688748175845},{"cnt":[[305,1216],[1674,1216],[1674,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1216,"width":1369,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"555cea7487124b86815ef51fd3e56adb","type":"text","conversion_output":true,"text":"ablation arm of the trial (i.e., a reduction by one-third compared to the drug arm).","text_display":" ablation arm of the trial (i.e., a reduction by one-third compared to the drug arm).","confidence":1,"confidence_rate":1},{"cnt":[[305,1306],[1940,1306],[1940,1351],[305,1351]],"region":{"top_left_x":305,"top_left_y":1306,"width":1636,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0fc8a9f4ed549d68bbcebfaaa1c2980","type":"text","conversion_output":true,"text":"Another important factor that must be considered in sample size calculations is the extent to","text_display":"\n\nAnother important factor that must be considered in sample size calculations is the extent to","confidence":1,"confidence_rate":1},{"cnt":[[305,1349],[1940,1349],[1940,1394],[305,1394]],"region":{"top_left_x":305,"top_left_y":1349,"width":1636,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c62df3ca383426692d3bbcc2dd5fcd1","type":"text","conversion_output":true,"text":"which patients randomized to the drug arm may cross over to receive an ablation during the","text_display":" which patients randomized to the drug arm may cross over to receive an ablation during the","confidence":1,"confidence_rate":1},{"cnt":[[305,1439],[305,1390],[1940,1392],[1940,1442]],"region":{"top_left_x":305,"top_left_y":1390,"width":1636,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a847cbe5bfc41e089be61840c809a71","type":"text","conversion_output":true,"text":"course of their follow-up (if the AF and its symptoms are not adequately controlled by drugs).","text_display":" course of their follow-up (if the AF and its symptoms are not adequately controlled by drugs).","confidence":1,"confidence_rate":1},{"cnt":[[305,1435],[1940,1435],[1940,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1435,"width":1636,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ca2b2c71435415eaaadf90378a370de","type":"text","conversion_output":true,"text":"Although there are strict guidelines regarding changes to a patient's assigned therapy, in certain","text_display":" Although there are strict guidelines regarding changes to a patient's assigned therapy, in certain","confidence":1,"confidence_rate":1},{"cnt":[[305,1480],[1944,1480],[1944,1528],[305,1528]],"region":{"top_left_x":305,"top_left_y":1480,"width":1640,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da9fbd2ae0ef49999bce49b4ad9bef63","type":"text","conversion_output":true,"text":"instances a downstream change may be clinically indicated. All crossovers and reasons for","text_display":" instances a downstream change may be clinically indicated. All crossovers and reasons for","confidence":1,"confidence_rate":1},{"cnt":[[305,1525],[1940,1525],[1940,1571],[305,1571]],"region":{"top_left_x":305,"top_left_y":1525,"width":1636,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce43888601a5415e9ab7a463b0185460","type":"text","conversion_output":true,"text":"them must be carefully documented. However, crossovers of drug-arm patients to receive","text_display":" them must be carefully documented. However, crossovers of drug-arm patients to receive","confidence":1,"confidence_rate":1},{"cnt":[[305,1568],[1940,1568],[1940,1618],[305,1618]],"region":{"top_left_x":305,"top_left_y":1568,"width":1636,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8de77d805d934bae9fc730dbe24906cd","type":"text","conversion_output":true,"text":"ablation will have the impact of reducing the event rate of patients randomized to drug therapy","text_display":" ablation will have the impact of reducing the event rate of patients randomized to drug therapy","confidence":1,"confidence_rate":1},{"cnt":[[305,1611],[1940,1611],[1940,1661],[305,1661]],"region":{"top_left_x":305,"top_left_y":1611,"width":1636,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b21c8c145e64dd9a13699900027f5e2","type":"text","conversion_output":true,"text":"(assuming ablation is effective), and diminishing the magnitude of the treatment effect.","text_display":" (assuming ablation is effective), and diminishing the magnitude of the treatment effect.","confidence":1,"confidence_rate":1},{"cnt":[[305,1659],[1940,1659],[1940,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1658,"width":1636,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5471e0ef76ca458096ecd0c490a75d4c","type":"text","conversion_output":true,"text":"Allowance for these crossovers is essential in determining the appropriate sample size. It is","text_display":" Allowance for these crossovers is essential in determining the appropriate sample size. It is","confidence":1,"confidence_rate":1},{"cnt":[[305,1697],[1944,1697],[1944,1747],[305,1747]],"region":{"top_left_x":305,"top_left_y":1697,"width":1640,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4badf0977794daca708bef6c5d73dfc","type":"text","conversion_output":true,"text":"possible that up to \\(25-30 \\%\\) of patients randomized to the drug arm will cross over to ablation at","text_display":" possible that up to \\(25-30 \\%\\) of patients randomized to the drug arm will cross over to ablation at","confidence":1,"confidence_rate":1},{"cnt":[[305,1745],[1940,1745],[1940,1792],[305,1792]],"region":{"top_left_x":305,"top_left_y":1744,"width":1636,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1c344e8d7194a90975480aff183e043","type":"text","conversion_output":true,"text":"some point during follow-up. Although the length of follow-up in the CABANA Pilot study was","text_display":" some point during follow-up. Although the length of follow-up in the CABANA Pilot study was","confidence":1,"confidence_rate":1},{"cnt":[[305,1788],[1944,1788],[1944,1837],[305,1837]],"region":{"top_left_x":305,"top_left_y":1787,"width":1640,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aae09eeb631e416ea4e18620aa05ba7e","type":"text","conversion_output":true,"text":"only 1 year, the rate of crossover to ablation of patients randomized to drug therapy was only","text_display":" only 1 year, the rate of crossover to ablation of patients randomized to drug therapy was only","confidence":1,"confidence_rate":1},{"cnt":[[305,1833],[415,1833],[415,1876],[305,1876]],"region":{"top_left_x":305,"top_left_y":1832,"width":110,"height":44},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f3ac2ee28314c0a96dea0f75c26360a","type":"text","conversion_output":true,"text":"\\(9.7 \\%\\).","text_display":" \\(9.7 \\%\\).","confidence":1,"confidence_rate":1},{"cnt":[[305,1921],[1940,1921],[1940,1966],[305,1966]],"region":{"top_left_x":305,"top_left_y":1920,"width":1636,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42963234aa1849e8a96a95159e3eba6d","type":"text","conversion_output":true,"text":"In addition to drug-arm patients crossing over to ablation, there may also be patients","text_display":"\n\nIn addition to drug-arm patients crossing over to ablation, there may also be patients","confidence":1,"confidence_rate":1},{"cnt":[[305,1964],[1940,1964],[1940,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1963,"width":1636,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f7df2d4af52474f866b4cb937eafd75","type":"text","conversion_output":true,"text":"randomized to the ablation arm who require drug therapy. The number of patients randomized","text_display":" randomized to the ablation arm who require drug therapy. The number of patients randomized","confidence":1,"confidence_rate":1},{"cnt":[[305,2007],[1940,2007],[1940,2056],[305,2056]],"region":{"top_left_x":305,"top_left_y":2006,"width":1636,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e438c668e9f54b1f896baf3eff5d6647","type":"text","conversion_output":true,"text":"to ablation, that following randomization decline the procedure and are treated with drugs, is","text_display":" to ablation, that following randomization decline the procedure and are treated with drugs, is","confidence":1,"confidence_rate":1},{"cnt":[[305,2052],[1940,2052],[1940,2099],[305,2099]],"region":{"top_left_x":305,"top_left_y":2051,"width":1636,"height":49},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55ccd64bfd7340099af3935d73d581b7","type":"text","conversion_output":true,"text":"expected to be small and inconsequential in the sample size calculations. However, there will","text_display":" expected to be small and inconsequential in the sample size calculations. However, there will","confidence":1,"confidence_rate":1},{"cnt":[[305,2097],[1940,2097],[1940,2142],[305,2142]],"region":{"top_left_x":305,"top_left_y":2096,"width":1636,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"350d002f19a6463cbb844f4281af8b49","type":"text","conversion_output":true,"text":"be patients randomized to ablation that during the course of their follow-up after the ablation are","text_display":" be patients randomized to ablation that during the course of their follow-up after the ablation are","confidence":1,"confidence_rate":1},{"cnt":[[305,2140],[1944,2140],[1944,2185],[305,2185]],"region":{"top_left_x":305,"top_left_y":2139,"width":1640,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"653310f5e684462e942cc1d9206bf5e1","type":"text","conversion_output":true,"text":"treated with drugs, including in some cases membrane-active antiarrhythmic drugs. For","text_display":" treated with drugs, including in some cases membrane-active antiarrhythmic drugs. For","confidence":1,"confidence_rate":1},{"cnt":[[305,2183],[1944,2183],[1944,2230],[305,2230]],"region":{"top_left_x":305,"top_left_y":2182,"width":1640,"height":49},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76b682c95b684533942b96a88327170d","type":"text","conversion_output":true,"text":"purposes of sample size calculations, these patients are assumed to receive the full benefit of","text_display":" purposes of sample size calculations, these patients are assumed to receive the full benefit of","confidence":1,"confidence_rate":1},{"cnt":[[305,2228],[1940,2228],[1940,2275],[305,2275]],"region":{"top_left_x":305,"top_left_y":2227,"width":1636,"height":49},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75be56dd79a24150bd6b08b80a55a20d","type":"text","conversion_output":true,"text":"ablation in reducing clinical outcomes, although one might argue that antiarrhythmic drugs, with","text_display":" ablation in reducing clinical outcomes, although one might argue that antiarrhythmic drugs, with","confidence":1,"confidence_rate":1},{"cnt":[[305,2271],[1785,2271],[1785,2318],[305,2318]],"region":{"top_left_x":305,"top_left_y":2270,"width":1481,"height":49},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83fad6cf8e31402892f5c0286ed79b46","type":"text","conversion_output":true,"text":"their possible proarrhythmic effects, might attenuate the clinical benefits of the ablation.","text_display":" their possible proarrhythmic effects, might attenuate the clinical benefits of the ablation.","confidence":1,"confidence_rate":1},{"cnt":[[305,2359],[1944,2359],[1944,2408],[305,2408]],"region":{"top_left_x":305,"top_left_y":2358,"width":1640,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8079df5162e64b19977044ce10d5cbef","type":"text","conversion_output":true,"text":"Since the primary treatment comparisons in this study will be based on time-to-event","text_display":"\n\nSince the primary treatment comparisons in this study will be based on time-to-event","confidence":1,"confidence_rate":1},{"cnt":[[305,2402],[1944,2402],[1944,2451],[305,2451]],"region":{"top_left_x":305,"top_left_y":2401,"width":1640,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30cd1aa1ffbf48a08e0ab3e7278e6e8e","type":"text","conversion_output":true,"text":"methodology using the log-rank test [102] or equivalently, the Cox proportional hazards model","text_display":" methodology using the log-rank test [102] or equivalently, the Cox proportional hazards model","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[967,2574],[967,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":662,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"45dbb41a8f9548fa93bc2e6606582a3e","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999777947999976},{"cnt":[[1611,2574],[1841,2574],[1841,2617],[1611,2617]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":44},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8401b85a1d11445ba1530a29305a7e03","type":"page_info","conversion_output":false,"text":"Page 40 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-42","page":42,"lines":[{"cnt":[[372,155],[1794,155],[1794,200],[372,200]],"region":{"top_left_x":371,"top_left_y":154,"width":1423,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8320762b485e4590b89a8f53df4c2195","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[309,251],[1940,251],[1940,299],[309,299]],"region":{"top_left_x":309,"top_left_y":251,"width":1632,"height":48},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"157160fc9e5b4630a818b1213f02caf3","type":"text","conversion_output":true,"text":"[103], the approach used for calculating sample size requirements for CABANA was based on","text_display":"\n[103], the approach used for calculating sample size requirements for CABANA was based on","confidence":1,"confidence_rate":1},{"cnt":[[309,296],[1635,296],[1635,342],[309,342]],"region":{"top_left_x":309,"top_left_y":296,"width":1326,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf6ce351dc6543bdab13f58e3161a25c","type":"text","conversion_output":true,"text":"the method of Schoenfeld [104] developed for the proportional hazards model.","text_display":" the method of Schoenfeld [104] developed for the proportional hazards model.","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[1940,382],[1940,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1636,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"702e6d0c052744a3ab9c59b207050eda","type":"text","conversion_output":true,"text":"To provide an adequate number of patients in the trial that will be relatively robust under various","text_display":"\n\nTo provide an adequate number of patients in the trial that will be relatively robust under various","confidence":1,"confidence_rate":1},{"cnt":[[307,430],[1940,430],[1940,475],[307,475]],"region":{"top_left_x":307,"top_left_y":429,"width":1634,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1217416302542e7beea10aee3191ebd","type":"text","conversion_output":true,"text":"assumptions regarding the control-arm event rates and the magnitude of the treatment benefit,","text_display":" assumptions regarding the control-arm event rates and the magnitude of the treatment benefit,","confidence":1,"confidence_rate":1},{"cnt":[[305,471],[1940,471],[1940,518],[305,518]],"region":{"top_left_x":305,"top_left_y":470,"width":1636,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ade2edec5f0e4293b7980613c2cfac66","type":"text","conversion_output":true,"text":"\\(2,000-2,200\\) patients will be enrolled. With a minimum follow-up of 3 years (amounting to an","text_display":" \\(2,000-2,200\\) patients will be enrolled. With a minimum follow-up of 3 years (amounting to an","confidence":1,"confidence_rate":1},{"cnt":[[305,516],[1940,516],[1940,561],[305,561]],"region":{"top_left_x":305,"top_left_y":515,"width":1636,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b85cff2fa25c4c6abc0087aeb60b55f8","type":"text","conversion_output":true,"text":"average follow-up of approximately 5 years), 2,200 patients will provide \\(90 \\%\\) power for detecting","text_display":" average follow-up of approximately 5 years), 2,200 patients will provide \\(90 \\%\\) power for detecting","confidence":0.9575400352478027,"confidence_rate":0.9996056437195034},{"cnt":[[305,559],[1940,559],[1940,604],[305,604]],"region":{"top_left_x":305,"top_left_y":558,"width":1636,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6100d7faa3434fa18579ce67077a9131","type":"text","conversion_output":true,"text":"a \\(30 \\%\\) reduction in the new primary endpoint, and 2,000 patients will provide \\(88 \\%\\) power,","text_display":" a \\(30 \\%\\) reduction in the new primary endpoint, and 2,000 patients will provide \\(88 \\%\\) power,","confidence":1,"confidence_rate":1},{"cnt":[[307,604],[1940,604],[1940,649],[307,649]],"region":{"top_left_x":307,"top_left_y":603,"width":1634,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24d3f934695e4f9ea0704961128964e3","type":"text","conversion_output":true,"text":"assuming a 3 -year event rate in the drug arm of \\(12 \\%\\) and allowing for a \\(2 \\%\\) loss to follow-up.","text_display":" assuming a 3 -year event rate in the drug arm of \\(12 \\%\\) and allowing for a \\(2 \\%\\) loss to follow-up.","confidence":1,"confidence_rate":1},{"cnt":[[305,647],[1944,647],[1944,694],[305,694]],"region":{"top_left_x":305,"top_left_y":646,"width":1640,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc25e6635d104871a273f4bea8c91180","type":"text","conversion_output":true,"text":"Thus, the study will have high power for detecting an important benefit if the control arm event","text_display":" Thus, the study will have high power for detecting an important benefit if the control arm event","confidence":1,"confidence_rate":1},{"cnt":[[305,692],[1940,692],[1940,737],[305,737]],"region":{"top_left_x":305,"top_left_y":691,"width":1636,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e650f48a99843629a6f9576a82468db","type":"text","conversion_output":true,"text":"rate is consistent with the rate expected based on previous studies. A sample size in this range","text_display":" rate is consistent with the rate expected based on previous studies. A sample size in this range","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[1944,735],[1944,780],[305,780]],"region":{"top_left_x":305,"top_left_y":734,"width":1640,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9567faeb6d054f47a32b51c793e26dfc","type":"text","conversion_output":true,"text":"will also provide acceptable power ( \\(86 \\%\\) with 2200 patients and \\(82 \\%\\) with 2000 patients) for","text_display":" will also provide acceptable power ( \\(86 \\%\\) with 2200 patients and \\(82 \\%\\) with 2000 patients) for","confidence":1,"confidence_rate":1},{"cnt":[[305,778],[1940,778],[1940,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":1636,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fb8ee43eb9542b999dbf2ea68befd70","type":"text","conversion_output":true,"text":"detecting a \\(25 \\%\\) reduction with ablation in the primary endpoint if the 3 -year drug arm event rate","text_display":" detecting a \\(25 \\%\\) reduction with ablation in the primary endpoint if the 3 -year drug arm event rate","confidence":0.9985356330871582,"confidence_rate":0.999986555685367},{"cnt":[[305,821],[1940,821],[1940,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5f18c970b0140cca8dd98dfcf47cca0","type":"text","conversion_output":true,"text":"is \\(15 \\%\\). Thus we will have good power for detecting a more conservative estimate of the benefit","text_display":" is \\(15 \\%\\). Thus we will have good power for detecting a more conservative estimate of the benefit","confidence":1,"confidence_rate":1},{"cnt":[[305,868],[1940,868],[1940,913],[305,913]],"region":{"top_left_x":305,"top_left_y":867,"width":1636,"height":47},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"072e7714fe8d4f0c91690031c5b7bd4c","type":"text","conversion_output":true,"text":"in the composite endpoint if the control arm event rate is higher, but still consistent with previous","text_display":" in the composite endpoint if the control arm event rate is higher, but still consistent with previous","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1940,911],[1940,956],[305,956]],"region":{"top_left_x":305,"top_left_y":910,"width":1636,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe6fcc8c49fe46cdb4422dc4d70c2c12","type":"text","conversion_output":true,"text":"studies. A \\(25-30 \\%\\) reduction in primary events will be highly important from a clinical and public","text_display":" studies. A \\(25-30 \\%\\) reduction in primary events will be highly important from a clinical and public","confidence":0.984375,"confidence_rate":0.9998500268950131},{"cnt":[[305,954],[1940,954],[1940,1001],[305,1001]],"region":{"top_left_x":305,"top_left_y":953,"width":1636,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f0bcc6a0c224197a567929f9f86fb71","type":"text","conversion_output":true,"text":"health standpoint, given the large population of patients in this country and throughout the world","text_display":" health standpoint, given the large population of patients in this country and throughout the world","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[647,997],[647,1038],[305,1038]],"region":{"top_left_x":305,"top_left_y":996,"width":342,"height":42},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1876605dbad44d9bbc8233a244a1862d","type":"text","conversion_output":true,"text":"who suffer from AF.","text_display":" who suffer from AF.","confidence":0.966796875,"confidence_rate":0.9985940366908452},{"cnt":[[305,1085],[1940,1085],[1940,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1084,"width":1636,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cbb6405c1a949eea5242f45fa7e128f","type":"text","conversion_output":true,"text":"This number of patients \\((2,000-2,200)\\) will also provide adequate power for detecting a \\(25 \\%\\)","text_display":"\n\nThis number of patients \\((2,000-2,200)\\) will also provide adequate power for detecting a \\(25 \\%\\)","confidence":0.60009765625,"confidence_rate":0.9947492678016232},{"cnt":[[305,1130],[1940,1130],[1940,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1130,"width":1636,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71b05537992c483096b5cfce76075e90","type":"text","conversion_output":true,"text":"reduction in other important secondary composite endpoints listed in section 2.2 such as the","text_display":" reduction in other important secondary composite endpoints listed in section 2.2 such as the","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1940,1173],[1940,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":1636,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7cf5eb1b8880448dae657dc74aa3ba0a","type":"text","conversion_output":true,"text":"endpoints that involve cardiovascular hospitalization where the incidence is expected to be","text_display":" endpoints that involve cardiovascular hospitalization where the incidence is expected to be","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[930,1216],[930,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1216,"width":626,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe2c7e4e40e14fe0b7aab7fd833e0789","type":"text","conversion_output":true,"text":"higher than for the primary endpoint.","text_display":" higher than for the primary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[303,1302],[887,1302],[887,1369],[303,1369]],"region":{"top_left_x":302,"top_left_y":1301,"width":586,"height":68},"line":23,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"e8ad857e994248f5bbc8afdbee728607","type":"section_header","conversion_output":false,"children_ids":["cdf6e457e8ae470081cc63f3fb06b948"],"text":"","text_display":""},{"cnt":[[305,1306],[883,1306],[883,1364],[305,1364]],"region":{"top_left_x":305,"top_left_y":1306,"width":579,"height":59},"line":24,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"cdf6e457e8ae470081cc63f3fb06b948","type":"text","conversion_output":true,"parent_id":"e8ad857e994248f5bbc8afdbee728607","text":"8.2 Statistical Analysis","text_display":"\n\n\\subsection*{8.2 Statistical Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[305,1362],[1944,1362],[1944,1407],[305,1407]],"region":{"top_left_x":305,"top_left_y":1362,"width":1640,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63c5acc112d74275bbf4daa3deaf6e6c","type":"text","conversion_output":true,"text":"Statistical analyses will be performed by the Coordinating Center. All major treatment","text_display":"\n\nStatistical analyses will be performed by the Coordinating Center. All major treatment","confidence":0.9990236759185791,"confidence_rate":0.9999892659807285},{"cnt":[[305,1405],[1940,1405],[1940,1450],[305,1450]],"region":{"top_left_x":305,"top_left_y":1405,"width":1636,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c716b2250fa3437cbb08daf20b9c8033","type":"text","conversion_output":true,"text":"comparisons will be performed by intention to treat, and endpoints will be attributed to the","text_display":" comparisons will be performed by intention to treat, and endpoints will be attributed to the","confidence":1,"confidence_rate":1},{"cnt":[[305,1450],[1944,1450],[1944,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1450,"width":1640,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76375c0ffbc04e7eb28e181a298a9926","type":"text","conversion_output":true,"text":"treatment arm to which the patients were randomized, regardless of treatment crossover or","text_display":" treatment arm to which the patients were randomized, regardless of treatment crossover or","confidence":1,"confidence_rate":1},{"cnt":[[305,1491],[1940,1491],[1940,1540],[305,1540]],"region":{"top_left_x":305,"top_left_y":1491,"width":1636,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d1c6eca8dd741afbaa1eabaedea478a","type":"text","conversion_output":true,"text":"post-randomization medical care. Statistical comparisons will be performed using two-sided","text_display":" post-randomization medical care. Statistical comparisons will be performed using two-sided","confidence":1,"confidence_rate":1},{"cnt":[[305,1538],[617,1538],[617,1583],[305,1583]],"region":{"top_left_x":305,"top_left_y":1538,"width":312,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f862dc22d1e64a0f9c60bc8e9270a036","type":"text","conversion_output":true,"text":"significance tests.","text_display":" significance tests.","confidence":1,"confidence_rate":1},{"cnt":[[305,1620],[1046,1620],[1046,1674],[305,1674]],"region":{"top_left_x":305,"top_left_y":1619,"width":742,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d2c48035c624b88b146d52e46f86c23","type":"section_header","conversion_output":false,"children_ids":["2f2d44236cee43dcb422b6c923ca0e6d"],"text":"","text_display":""},{"cnt":[[305,1624],[1042,1624],[1042,1669],[305,1669]],"region":{"top_left_x":305,"top_left_y":1624,"width":737,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f2d44236cee43dcb422b6c923ca0e6d","type":"text","conversion_output":true,"parent_id":"2d2c48035c624b88b146d52e46f86c23","text":"8.2.1 Analysis of the Primary Endpoint","text_display":"\n\n\\subsection*{8.2.1 Analysis of the Primary Endpoint}","confidence":1,"confidence_rate":1},{"cnt":[[305,1669],[1940,1669],[1940,1714],[305,1714]],"region":{"top_left_x":305,"top_left_y":1669,"width":1636,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca3bcd13eba647cab761434badb9036b","type":"text","conversion_output":true,"text":"The log-rank test will be the primary analytic tool for comparing outcome differences between","text_display":"\n\nThe log-rank test will be the primary analytic tool for comparing outcome differences between","confidence":1,"confidence_rate":1},{"cnt":[[305,1712],[1940,1712],[1940,1760],[305,1760]],"region":{"top_left_x":305,"top_left_y":1712,"width":1636,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6f143e8c9114aa3a3a315474cd48ae4","type":"text","conversion_output":true,"text":"the two therapies. Kaplan-Meier estimates of cumulative event rates as a function of follow-up","text_display":" the two therapies. Kaplan-Meier estimates of cumulative event rates as a function of follow-up","confidence":1,"confidence_rate":1},{"cnt":[[305,1757],[1940,1757],[1940,1803],[305,1803]],"region":{"top_left_x":305,"top_left_y":1757,"width":1636,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e072abf7235412ebfe0705a7225423e","type":"text","conversion_output":true,"text":"time will be calculated and displayed. Relative risks will be expressed as hazard ratios with","text_display":" time will be calculated and displayed. Relative risks will be expressed as hazard ratios with","confidence":1,"confidence_rate":1},{"cnt":[[305,1800],[1648,1800],[1648,1846],[305,1846]],"region":{"top_left_x":305,"top_left_y":1800,"width":1343,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e56830c5c0746b08859fcd5954d3e12","type":"text","conversion_output":true,"text":"\\(95 \\%\\) confidence intervals generated using the Cox proportional hazards model.","text_display":" \\(95 \\%\\) confidence intervals generated using the Cox proportional hazards model.","confidence":0.9926843643188477,"confidence_rate":0.9999082226346565},{"cnt":[[307,1886],[1936,1886],[1936,1936],[307,1936]],"region":{"top_left_x":307,"top_left_y":1886,"width":1629,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b74b41406614198bd337afe2f8f8d60","type":"text","conversion_output":true,"text":"Supplementary analysis involving covariate adjustment will be performed with the Cox model.","text_display":"\n\nSupplementary analysis involving covariate adjustment will be performed with the Cox model.","confidence":1,"confidence_rate":1},{"cnt":[[305,1934],[1940,1934],[1940,1979],[305,1979]],"region":{"top_left_x":305,"top_left_y":1933,"width":1636,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28c9bd873a2341d6ab2bff66c84406df","type":"text","conversion_output":true,"text":"Such adjustment will be limited to a relatively small, prospectively defined set of patient","text_display":" Such adjustment will be limited to a relatively small, prospectively defined set of patient","confidence":1,"confidence_rate":1},{"cnt":[[305,1977],[1940,1977],[1940,2022],[305,2022]],"region":{"top_left_x":305,"top_left_y":1976,"width":1636,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce0c49feafdd460f914e7272c403bb83","type":"text","conversion_output":true,"text":"characteristics that are known a priori to have a strong prognostic relationship with the primary","text_display":" characteristics that are known a priori to have a strong prognostic relationship with the primary","confidence":1,"confidence_rate":1},{"cnt":[[305,2020],[1940,2020],[1940,2067],[305,2067]],"region":{"top_left_x":305,"top_left_y":2019,"width":1636,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d3c1d0492e14d9590a174e41f1ed638","type":"text","conversion_output":true,"text":"endpoint. The covariate-adjusted analysis will serve as a prelude to supplementary analyses","text_display":" endpoint. The covariate-adjusted analysis will serve as a prelude to supplementary analyses","confidence":1,"confidence_rate":1},{"cnt":[[305,2062],[1940,2062],[1940,2108],[305,2108]],"region":{"top_left_x":305,"top_left_y":2062,"width":1636,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"076ec2e3e949410abe7c0eeb86b4c988","type":"text","conversion_output":true,"text":"examining differential treatment effects. The covariates will include age, sex, race, heart failure","text_display":" examining differential treatment effects. The covariates will include age, sex, race, heart failure","confidence":1,"confidence_rate":1},{"cnt":[[305,2105],[1940,2105],[1940,2155],[305,2155]],"region":{"top_left_x":305,"top_left_y":2105,"width":1636,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56234f3e62ae4f53aa2200675f807281","type":"text","conversion_output":true,"text":"class, presence/absence of structural heart disease, whether the patients' AF is paroxysmal,","text_display":" class, presence/absence of structural heart disease, whether the patients' AF is paroxysmal,","confidence":1,"confidence_rate":1},{"cnt":[[305,2151],[1940,2151],[1940,2198],[305,2198]],"region":{"top_left_x":305,"top_left_y":2150,"width":1636,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66ba453d82334c4ebedd6b8611d2c60e","type":"text","conversion_output":true,"text":"persistent or long-standing persistent, duration of AF, presence/absence of hypertension, and","text_display":" persistent or long-standing persistent, duration of AF, presence/absence of hypertension, and","confidence":1,"confidence_rate":1},{"cnt":[[305,2196],[1944,2196],[1944,2241],[305,2241]],"region":{"top_left_x":305,"top_left_y":2195,"width":1640,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40f228b6464343b7b14c893064cdf4cc","type":"text","conversion_output":true,"text":"ejection fraction. Cox model analyses may also be performed using appropriate groupings of","text_display":" ejection fraction. Cox model analyses may also be performed using appropriate groupings of","confidence":1,"confidence_rate":1},{"cnt":[[305,2239],[806,2239],[806,2279],[305,2279]],"region":{"top_left_x":305,"top_left_y":2238,"width":501,"height":42},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5a30ea1c410460a997c91c5b1ebe617","type":"text","conversion_output":true,"text":"sites as a stratification factor.","text_display":" sites as a stratification factor.","confidence":1,"confidence_rate":1},{"cnt":[[305,2327],[1940,2327],[1940,2374],[305,2374]],"region":{"top_left_x":305,"top_left_y":2326,"width":1636,"height":49},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7769506cee44347bfcf46ba71b5620a","type":"text","conversion_output":true,"text":"If the data provide evidence of an overall difference in outcome between treatment groups, an","text_display":"\n\nIf the data provide evidence of an overall difference in outcome between treatment groups, an","confidence":1,"confidence_rate":1},{"cnt":[[305,2372],[1944,2372],[1944,2417],[305,2417]],"region":{"top_left_x":305,"top_left_y":2371,"width":1640,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9152379c580c425b881b6da72ce31fe7","type":"text","conversion_output":true,"text":"assessment will be made of whether the therapeutic effect is similar for all patients, or whether it","text_display":" assessment will be made of whether the therapeutic effect is similar for all patients, or whether it","confidence":1,"confidence_rate":1},{"cnt":[[305,2415],[1940,2415],[1940,2462],[305,2462]],"region":{"top_left_x":305,"top_left_y":2414,"width":1636,"height":49},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"246b1015fb5c4a47a20369448fee2286","type":"text","conversion_output":true,"text":"varies according to specific patient characteristics. This analysis will focus on whether the","text_display":" varies according to specific patient characteristics. This analysis will focus on whether the","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[965,2574],[965,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":660,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21a4743fba5743a1b7f5e699994e51a5","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999889000502842},{"cnt":[[1611,2574],[1841,2574],[1841,2615],[1611,2615]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1bc5dd6992514cb5a1d5d277a4dfd1bb","type":"page_info","conversion_output":false,"text":"Page 41 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-43","page":43,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8c1254188d8c4d26917db4e362b4fb45","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[309,249],[1938,249],[1938,299],[309,299]],"region":{"top_left_x":309,"top_left_y":249,"width":1629,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bff12c1a3a6540048d567797a1914633","type":"text","conversion_output":true,"text":"relative therapeutic benefit differs according to patient age, sex, race, type of AF, duration of AF,","text_display":"\nrelative therapeutic benefit differs according to patient age, sex, race, type of AF, duration of AF,","confidence":0.8154296875,"confidence_rate":0.9980769450220677},{"cnt":[[309,296],[1944,296],[1944,342],[309,342]],"region":{"top_left_x":309,"top_left_y":296,"width":1636,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d06fa81bb5ad4d059135f9b615742806","type":"text","conversion_output":true,"text":"heart failure class, presence/absence of structural heart disease, presence/absence of","text_display":" heart failure class, presence/absence of structural heart disease, presence/absence of","confidence":1,"confidence_rate":1},{"cnt":[[309,339],[1944,339],[1944,385],[309,385]],"region":{"top_left_x":309,"top_left_y":339,"width":1636,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03a46ce38da54ec9924e792aca78b318","type":"text","conversion_output":true,"text":"hypertension, and ejection fraction. These analyses will utilize the Cox model by testing for","text_display":" hypertension, and ejection fraction. These analyses will utilize the Cox model by testing for","confidence":1,"confidence_rate":1},{"cnt":[[309,382],[1944,382],[1944,432],[309,432]],"region":{"top_left_x":309,"top_left_y":382,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a47a76726458407cbad87b2d3126db27","type":"text","conversion_output":true,"text":"interactions between treatment and these specific baseline variables. In addition to the formal","text_display":" interactions between treatment and these specific baseline variables. 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These descriptive hazard ratios will be carefully","text_display":" patients defined by the variables listed above. 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For drug therapy, the major events","text_display":"specific differences in the nature of the adverse events. 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For the ablation arm, the major events include myocardial","text_display":" pulmonary toxicity from amiodarone. For the ablation arm, the major events include myocardial","confidence":1,"confidence_rate":1},{"cnt":[[309,1087],[1944,1087],[1944,1132],[309,1132]],"region":{"top_left_x":309,"top_left_y":1087,"width":1636,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44fabd8d0d24434c9c8c309aa2c5d201","type":"text","conversion_output":true,"text":"perforation with tamponade requiring resuscitation, symptomatic pulmonary vein stenosis","text_display":" perforation with tamponade requiring resuscitation, symptomatic pulmonary vein stenosis","confidence":1,"confidence_rate":1},{"cnt":[[309,1130],[1944,1130],[1944,1175],[309,1175]],"region":{"top_left_x":309,"top_left_y":1130,"width":1636,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"286b6ac1a4ad4cdb9a6d44ed31328729","type":"text","conversion_output":true,"text":"requiring intervention, and atrial-esophageal fistula formation. 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Treatment","confidence":1,"confidence_rate":1},{"cnt":[[309,1216],[1944,1216],[1944,1265],[309,1265]],"region":{"top_left_x":309,"top_left_y":1216,"width":1636,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89961e1363794d43b1bfeec88435b710","type":"text","conversion_output":true,"text":"comparisons with respect to these serious adverse events will of necessity be more informal","text_display":" comparisons with respect to these serious adverse events will of necessity be more informal","confidence":1,"confidence_rate":1},{"cnt":[[309,1263],[1944,1263],[1944,1308],[309,1308]],"region":{"top_left_x":309,"top_left_y":1263,"width":1636,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c25e98d3de649d3876a14dce39e6415","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":[[309,1306],[1944,1306],[1944,1351],[309,1351]],"region":{"top_left_x":309,"top_left_y":1306,"width":1636,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf7e7d0c6d30484cb2c7414d977dba8f","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":[[309,1349],[1944,1349],[1944,1396],[309,1396]],"region":{"top_left_x":309,"top_left_y":1349,"width":1636,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1490ec0dbcc744abb6b8ef27a1a70929","type":"text","conversion_output":true,"text":"Adverse complications or adverse events of either therapy will be carefully tabulated and","text_display":" Adverse complications or adverse events of either therapy will be carefully tabulated and","confidence":1,"confidence_rate":1},{"cnt":[[309,1392],[1944,1392],[1944,1439],[309,1439]],"region":{"top_left_x":309,"top_left_y":1392,"width":1636,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91788ef49ef04983a5e03143e0554100","type":"text","conversion_output":true,"text":"descriptively summarized, using statistical comparisons of the treatment groups where","text_display":" descriptively summarized, using statistical comparisons of the treatment groups where","confidence":1,"confidence_rate":1},{"cnt":[[309,1435],[1944,1435],[1944,1485],[309,1485]],"region":{"top_left_x":309,"top_left_y":1435,"width":1636,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f98dfaf3d764ee88c97ee55b166391a","type":"text","conversion_output":true,"text":"appropriate, and interpreting such comparisons in the context of treatment differences in the","text_display":" appropriate, and interpreting such comparisons in the context of treatment differences in the","confidence":1,"confidence_rate":1},{"cnt":[[309,1482],[1124,1482],[1124,1528],[309,1528]],"region":{"top_left_x":309,"top_left_y":1482,"width":815,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4732fb12f1ab4a87889d09f91fbd4a95","type":"text","conversion_output":true,"text":"primary and major secondary clinical endpoints.","text_display":" primary and major secondary clinical 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The statistical significance of the changes in left atrial size and","text_display":" such as box and whisker plots. 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A two-sample comparison of the two groups with respect","text_display":"sample test such as the paired-t test. 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This comparison will","text_display":" baseline value as a covariate, and assessing treatment group differences. This comparison will","confidence":1,"confidence_rate":1},{"cnt":[[305,2269],[1944,2269],[1944,2318],[305,2318]],"region":{"top_left_x":305,"top_left_y":2268,"width":1640,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d0ac5cc5eb84dd7ba38d580b55b13c8","type":"text","conversion_output":true,"text":"be performed for the changes in atrial size (left atrial volume) and also for atrial function (atrial","text_display":" be performed for the changes in atrial size (left atrial volume) and also for atrial function (atrial","confidence":0.998046875,"confidence_rate":0.9999815564452184},{"cnt":[[305,2316],[606,2316],[606,2365],[305,2365]],"region":{"top_left_x":305,"top_left_y":2316,"width":301,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74d7ba7566814028b5f7bb282303cf13","type":"text","conversion_output":true,"text":"ejection fraction).","text_display":" ejection fraction).","confidence":1,"confidence_rate":1},{"cnt":[[309,2402],[1944,2402],[1944,2451],[309,2451]],"region":{"top_left_x":309,"top_left_y":2401,"width":1636,"height":51},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65fc24a128444ba9a4d0f1d30c18e65f","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":[[309,2445],[1944,2445],[1944,2494],[309,2494]],"region":{"top_left_x":309,"top_left_y":2444,"width":1636,"height":51},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c1c2fca742948ce99b03e07a0661ec5","type":"text","conversion_output":true,"text":"baseline and follow-up studies, there will inherently be missing data resulting from patients in","text_display":" baseline and follow-up studies, there will inherently be missing data resulting from patients in","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[969,2574],[969,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":660,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2db1b266a9943478d051c9082f9b592","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999889000502843},{"cnt":[[1616,2574],[1841,2574],[1841,2617],[1616,2617]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":44},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2ff348b8e64c494a8a0d8754d036b6ac","type":"page_info","conversion_output":false,"text":"Page 42 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-44","page":44,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc8556fe78a943f98b203be98835c58d","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1944,249],[1944,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1640,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"911610f3f43c4231a6118f2210dfe13a","type":"text","conversion_output":true,"text":"whom it is not possible to obtain both studies (because they die or fail to return for other","text_display":"\nwhom it is not possible to obtain both studies (because they die or fail to return for other","confidence":1,"confidence_rate":1},{"cnt":[[305,296],[1944,296],[1944,342],[305,342]],"region":{"top_left_x":305,"top_left_y":296,"width":1640,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8979967c8b4e487b9ce6d19c53caf5e9","type":"text","conversion_output":true,"text":"reasons to enable the follow-up measurements to be made). Every effort will be made to","text_display":" reasons to enable the follow-up measurements to be made). Every effort will be made to","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[305,339],[1944,339],[1944,385],[305,385]],"region":{"top_left_x":305,"top_left_y":339,"width":1640,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27f56e559742467db867f80f1a1b1faf","type":"text","conversion_output":true,"text":"minimize the amount of missing data. However, because some data are expected to be","text_display":" minimize the amount of missing data. However, because some data are expected to be","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[1944,382],[1944,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1640,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a0caf3ac4864805849a6338508bfc0b","type":"text","conversion_output":true,"text":"missing, several missing data strategies will be employed in order to assess the sensitivity of","text_display":" missing, several missing data strategies will be employed in order to assess the sensitivity of","confidence":1,"confidence_rate":1},{"cnt":[[305,425],[1944,425],[1944,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1640,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3eac9f5e593b4fa395db2d6eaf77e358","type":"text","conversion_output":true,"text":"the conclusions to the approach used. The approaches that will be considered include (1)","text_display":" the conclusions to the approach used. The approaches that will be considered include (1)","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[305,471],[1944,471],[1944,518],[305,518]],"region":{"top_left_x":305,"top_left_y":470,"width":1640,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0305f732c324e089f09c24e057ce57b","type":"text","conversion_output":true,"text":"analyzing only patients with complete data; ( 2 ) assigning \"worst case\" scores to missing","text_display":" analyzing only patients with complete data; ( 2 ) assigning \"worst case\" scores to missing","confidence":0.9345703125,"confidence_rate":0.9993097443142344},{"cnt":[[305,516],[1944,516],[1944,561],[305,561]],"region":{"top_left_x":305,"top_left_y":515,"width":1640,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38ae8c2e8ca647e280a9fac2e5c32430","type":"text","conversion_output":true,"text":"observations; (3) carry forward previously observed data to the observation period missed; and","text_display":" observations; (3) carry forward previously observed data to the observation period missed; and","confidence":0.99072265625,"confidence_rate":0.999905856489015},{"cnt":[[305,559],[1944,559],[1944,606],[305,606]],"region":{"top_left_x":305,"top_left_y":558,"width":1640,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b64ef37b295d4f44809002975eefab5e","type":"text","conversion_output":true,"text":"(4) use of likelihood-based methods to impute missing data. By synthesizing the results from","text_display":" (4) use of likelihood-based methods to impute missing data. By synthesizing the results from","confidence":1,"confidence_rate":1},{"cnt":[[305,604],[1944,602],[1944,650],[305,652]],"region":{"top_left_x":305,"top_left_y":601,"width":1640,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04efcbd43c6e41e2bd99e3e5c8cebe42","type":"text","conversion_output":true,"text":"these different but complementary approaches, it will be possible to provide a comprehensive","text_display":" these different but complementary approaches, it will be possible to provide a comprehensive","confidence":1,"confidence_rate":1},{"cnt":[[305,645],[1259,645],[1259,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":954,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"328127a8ad4e4989953c8608342593da","type":"text","conversion_output":true,"text":"assessment with respect to these key mechanistic data.","text_display":" assessment with respect to these key mechanistic data.","confidence":1,"confidence_rate":1},{"cnt":[[301,726],[904,726],[904,784],[301,784]],"region":{"top_left_x":300,"top_left_y":726,"width":605,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c623bf535d54fa787ec1adc25a0dd84","type":"section_header","conversion_output":false,"children_ids":["6a46b6bbe3e94bb8b61780c0873e739d"],"text":"","text_display":""},{"cnt":[[305,730],[900,730],[900,780],[305,780]],"region":{"top_left_x":305,"top_left_y":730,"width":596,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a46b6bbe3e94bb8b61780c0873e739d","type":"text","conversion_output":true,"parent_id":"4c623bf535d54fa787ec1adc25a0dd84","text":"8.2.5 \"On-Treatment\" Analysis","text_display":"\n\n\\subsection*{8.2.5 \"On-Treatment\" Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[305,778],[1946,778],[1946,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":1642,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1501a52a0aee4c94bcf6cbb5238613d5","type":"text","conversion_output":true,"text":"Although the intention to treat analyses will serve as the standard for interpreting treatment","text_display":"\n\nAlthough the intention to treat analyses will serve as the standard for interpreting treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[1944,821],[1944,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1640,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"107fc838fca843ccb78dfee0f73bbac1","type":"text","conversion_output":true,"text":"differences in the key clinical outcomes and constitute the primary analyses in the trial, because","text_display":" differences in the key clinical outcomes and constitute the primary analyses in the trial, because","confidence":0.99853515625,"confidence_rate":0.9999857678907678},{"cnt":[[305,866],[1944,866],[1944,913],[305,913]],"region":{"top_left_x":305,"top_left_y":865,"width":1640,"height":49},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1671aea4b5e7488f9090453aa185ba45","type":"text","conversion_output":true,"text":"a number of patients from the drug arm may cross over to receive ablation during the trial, we","text_display":" a number of patients from the drug arm may cross over to receive ablation during the trial, we","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1946,911],[1946,956],[305,956]],"region":{"top_left_x":305,"top_left_y":910,"width":1642,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"410c295b7451457eabd264626699f02b","type":"text","conversion_output":true,"text":"will supplement the intent to treat comparisons with \"on-treatment\" comparisons. The \"on-","text_display":" will supplement the intent to treat comparisons with \"on-treatment\" comparisons. The \"on","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[305,954],[1944,954],[1944,1001],[305,1001]],"region":{"top_left_x":305,"top_left_y":953,"width":1640,"height":49},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bc725b43ff24bc18ec530b1c5467e99","type":"text","conversion_output":true,"text":"treatment\" analysis will involve a comparison of patients who received ablation (even if originally","text_display":"treatment\" analysis will involve a comparison of patients who received ablation (even if originally","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[1944,997],[1944,1044],[305,1044]],"region":{"top_left_x":305,"top_left_y":996,"width":1640,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2682a3cc56654489bccb115eb23c01dc","type":"text","conversion_output":true,"text":"assigned to the drug arm) versus those who did not. Statistically, this will be accomplished","text_display":" assigned to the drug arm) versus those who did not. Statistically, this will be accomplished","confidence":1,"confidence_rate":1},{"cnt":[[305,1040],[1944,1040],[1944,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1640,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85b7ea6ab50f49228f56c99865ae23e8","type":"text","conversion_output":true,"text":"using the Cox proportional hazards model with ablation included in the analysis as a time-","text_display":" using the Cox proportional hazards model with ablation included in the analysis as a time","confidence":1,"confidence_rate":1},{"cnt":[[305,1087],[1946,1087],[1946,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1087,"width":1642,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a50fcaa2b795441c9b1cdbb0443bd97e","type":"text","conversion_output":true,"text":"dependent covariate. Thus, event-free follow-up time for a patient in the drug arm who later","text_display":"dependent covariate. Thus, event-free follow-up time for a patient in the drug arm who later","confidence":1,"confidence_rate":1},{"cnt":[[305,1130],[1944,1130],[1944,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1130,"width":1640,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"535f84b6f67a437580b8b949caa4af2a","type":"text","conversion_output":true,"text":"crosses over to ablation would be credited to the drug arm until the time of crossover, and at","text_display":" crosses over to ablation would be credited to the drug arm until the time of crossover, and at","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1944,1173],[1944,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":1640,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"539d8bbbd0d94fc281809bce57983c55","type":"text","conversion_output":true,"text":"that point, the patient would be shifted to the ablation group. Because treatment assignment is","text_display":" that point, the patient would be shifted to the ablation group. Because treatment assignment is","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1944,1216],[1944,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1216,"width":1640,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"888874538d704d1e905ad6372f353186","type":"text","conversion_output":true,"text":"no longer random, results can be biased by an association between the likelihood of treatment","text_display":" no longer random, results can be biased by an association between the likelihood of treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,1261],[1944,1261],[1944,1308],[305,1308]],"region":{"top_left_x":305,"top_left_y":1261,"width":1640,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cffd7c5e0b247b8b348588304503767","type":"text","conversion_output":true,"text":"change and the risk of a clinical event (i.e., factors that make a patient more likely to cross over","text_display":" change and the risk of a clinical event (i.e., factors that make a patient more likely to cross over","confidence":1,"confidence_rate":1},{"cnt":[[305,1306],[1944,1306],[1944,1354],[305,1354]],"region":{"top_left_x":305,"top_left_y":1306,"width":1640,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7814bb2dc49546f18e0f4ee68bee1f48","type":"text","conversion_output":true,"text":"may also make them more likely to have an event). Thus such analyses should be cautiously","text_display":" may also make them more likely to have an event). Thus such analyses should be cautiously","confidence":1,"confidence_rate":1},{"cnt":[[305,1349],[1944,1349],[1944,1396],[305,1396]],"region":{"top_left_x":305,"top_left_y":1349,"width":1640,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b305ce24c934c06aeecff3b4f7dfe15","type":"text","conversion_output":true,"text":"interpreted. The \"on-treatment\" analyses will also include an assessment of freedom from AF in","text_display":" interpreted. The \"on-treatment\" analyses will also include an assessment of freedom from AF in","confidence":1,"confidence_rate":1},{"cnt":[[305,1392],[1944,1392],[1944,1442],[305,1442]],"region":{"top_left_x":305,"top_left_y":1392,"width":1640,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15bc28914c4e48359a6a8b2745034275","type":"text","conversion_output":true,"text":"ablation patients after each ablation performed, including those undertaken after the end of the","text_display":" ablation patients after each ablation performed, including those undertaken after the end of the","confidence":1,"confidence_rate":1},{"cnt":[[305,1435],[587,1435],[587,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1435,"width":282,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f638a85e20f45adbbeeb39461c0a3d6","type":"text","conversion_output":true,"text":"blanking period.","text_display":" blanking period.","confidence":1,"confidence_rate":1},{"cnt":[[305,1523],[1944,1523],[1944,1573],[305,1573]],"region":{"top_left_x":305,"top_left_y":1523,"width":1640,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7d63108eec04117b62976aff2f74624","type":"text","conversion_output":true,"text":"An analysis using a time-dependent covariate with the Cox model will also be conducted to","text_display":"\n\nAn analysis using a time-dependent covariate with the Cox model will also be conducted to","confidence":1,"confidence_rate":1},{"cnt":[[305,1568],[1944,1568],[1944,1618],[305,1618]],"region":{"top_left_x":305,"top_left_y":1568,"width":1640,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b770b6f0e4fa48f9ae2c38fd1dacac81","type":"text","conversion_output":true,"text":"examine the prognostic relationships of sinus rhythm with clinical outcomes. The analyses","text_display":" examine the prognostic relationships of sinus rhythm with clinical outcomes. The analyses","confidence":1,"confidence_rate":1},{"cnt":[[305,1611],[1944,1611],[1944,1661],[305,1661]],"region":{"top_left_x":305,"top_left_y":1611,"width":1640,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"806ef962b23c48df9543b9d3f2f66177","type":"text","conversion_output":true,"text":"described in this section will be covariate adjusted for baseline prognostic factors that are","text_display":" described in this section will be covariate adjusted for baseline prognostic factors that are","confidence":1,"confidence_rate":1},{"cnt":[[305,1656],[1944,1656],[1944,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1656,"width":1640,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"000c398541fc4bf886796ec416e86877","type":"text","conversion_output":true,"text":"related to the clinical outcomes of interest. These analyses will be strictly exploratory and","text_display":" related to the clinical outcomes of interest. These analyses will be strictly exploratory and","confidence":1,"confidence_rate":1},{"cnt":[[305,1697],[1216,1697],[1216,1749],[305,1749]],"region":{"top_left_x":305,"top_left_y":1697,"width":912,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67bc218445bd44aa92fd69e9b69f6522","type":"text","conversion_output":true,"text":"supplementary to the primary intent to treat analyses.","text_display":" supplementary to the primary intent to treat analyses.","confidence":1,"confidence_rate":1},{"cnt":[[301,1779],[754,1779],[754,1841],[301,1841]],"region":{"top_left_x":300,"top_left_y":1778,"width":455,"height":64},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a197c46823d34f61b95b756a496a8b29","type":"section_header","conversion_output":false,"children_ids":["e378e76a860646c482bf199718aec563"],"text":"","text_display":""},{"cnt":[[305,1788],[748,1788],[748,1835],[305,1835]],"region":{"top_left_x":305,"top_left_y":1787,"width":443,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e378e76a860646c482bf199718aec563","type":"text","conversion_output":true,"parent_id":"a197c46823d34f61b95b756a496a8b29","text":"8.2.6 Interim Analyses","text_display":"\n\n\\subsection*{8.2.6 Interim Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[305,1830],[1946,1830],[1946,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1830,"width":1642,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9943ab9c72643b0b227b600df6b252b","type":"text","conversion_output":true,"text":"For ethical reasons, an interim examination of key safety and endpoint data will be performed at","text_display":"\n\nFor ethical reasons, an interim examination of key safety and endpoint data will be performed at","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[305,1876],[1944,1876],[1944,1923],[305,1923]],"region":{"top_left_x":305,"top_left_y":1875,"width":1640,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2c61c04083048d0a52034a9764ef41b","type":"text","conversion_output":true,"text":"regular intervals during the course of the trial. The primary objective of these analyses will be to","text_display":" regular intervals during the course of the trial. The primary objective of these analyses will be to","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[305,1921],[1944,1921],[1944,1966],[305,1966]],"region":{"top_left_x":305,"top_left_y":1920,"width":1640,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b93e6a4f68d94b479fbd1582b321b97b","type":"text","conversion_output":true,"text":"evaluate the accumulating data for an unacceptably high frequency of negative clinical","text_display":" evaluate the accumulating data for an unacceptably high frequency of negative clinical","confidence":1,"confidence_rate":1},{"cnt":[[305,1964],[1944,1964],[1944,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1963,"width":1640,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"add4704846104829936045e1a2c9fb16","type":"text","conversion_output":true,"text":"outcomes in any of the treatment arms. In addition, the interim monitoring will also involve a","text_display":" outcomes in any of the treatment arms. In addition, the interim monitoring will also involve a","confidence":1,"confidence_rate":1},{"cnt":[[305,2007],[1944,2007],[1944,2056],[305,2056]],"region":{"top_left_x":305,"top_left_y":2006,"width":1640,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2850fc4b700c46cbbfc7d67280059bcb","type":"text","conversion_output":true,"text":"review of the control arm event rates, patient recruitment, compliance with the study protocol,","text_display":" review of the control arm event rates, patient recruitment, compliance with the study protocol,","confidence":1,"confidence_rate":1},{"cnt":[[305,2052],[1944,2052],[1944,2099],[305,2099]],"region":{"top_left_x":305,"top_left_y":2051,"width":1640,"height":49},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bc3097aae9f487e9411f7936ce634bd","type":"text","conversion_output":true,"text":"status of data collection, and other factors which reflect the overall progress and integrity of the","text_display":" status of data collection, and other factors which reflect the overall progress and integrity of the","confidence":1,"confidence_rate":1},{"cnt":[[305,2093],[1944,2093],[1944,2142],[305,2142]],"region":{"top_left_x":305,"top_left_y":2092,"width":1640,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4dfc86956504104831131291d03211a","type":"text","conversion_output":true,"text":"study. The results of the interim analyses and status reports will be carefully and confidentially","text_display":" study. The results of the interim analyses and status reports will be carefully and confidentially","confidence":1,"confidence_rate":1},{"cnt":[[305,2140],[1622,2140],[1622,2189],[305,2189]],"region":{"top_left_x":305,"top_left_y":2139,"width":1318,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe51048c9a26476ba704827ee00369de","type":"text","conversion_output":true,"text":"reviewed by an NHLBI-appointed Data and Safety Monitoring Board (DSMB).","text_display":" reviewed by an NHLBI-appointed Data and Safety Monitoring Board (DSMB).","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[305,2226],[1946,2226],[1946,2275],[305,2275]],"region":{"top_left_x":305,"top_left_y":2225,"width":1642,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"501a43b56f8a4279bfd192470745191e","type":"text","conversion_output":true,"text":"The DSMB will meet at approximately 6 -month intervals to review the accumulating data. Prior","text_display":"\n\nThe DSMB will meet at approximately 6 -month intervals to review the accumulating data. Prior","confidence":0.9145922660827637,"confidence_rate":0.9991164606117876},{"cnt":[[305,2271],[1944,2271],[1944,2318],[305,2318]],"region":{"top_left_x":305,"top_left_y":2270,"width":1640,"height":49},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d4bd1591e7546549c71650f1367f871","type":"text","conversion_output":true,"text":"to each meeting, the Statistical and Data Coordinating Center will conduct the desired statistical","text_display":" to each meeting, the Statistical and Data Coordinating Center will conduct the desired statistical","confidence":0.9990234375,"confidence_rate":0.9999905142231666},{"cnt":[[305,2316],[1944,2316],[1944,2363],[305,2363]],"region":{"top_left_x":305,"top_left_y":2316,"width":1640,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbc78eb1951947e3b568766e091e96a6","type":"text","conversion_output":true,"text":"analyses and prepare a summary report that will be carefully reviewed by the DSMB. The","text_display":" analyses and prepare a summary report that will be carefully reviewed by the DSMB. The","confidence":1,"confidence_rate":1},{"cnt":[[305,2359],[1944,2359],[1944,2408],[305,2408]],"region":{"top_left_x":305,"top_left_y":2358,"width":1640,"height":51},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89c5aaac947046dd83a608fc0e9877fc","type":"text","conversion_output":true,"text":"extracted data files and analysis programs for each DSMB report will be archived and","text_display":" extracted data files and analysis programs for each DSMB report will be archived and","confidence":1,"confidence_rate":1},{"cnt":[[305,2402],[1944,2402],[1944,2451],[305,2451]],"region":{"top_left_x":305,"top_left_y":2401,"width":1640,"height":51},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4a44c64734542fc8a75f579ceb2b69d","type":"text","conversion_output":true,"text":"maintained at the Data Coordinating Center for the life of the study. Reports will be presented","text_display":" maintained at the Data Coordinating Center for the life of the study. Reports will be presented","confidence":0.998046875,"confidence_rate":0.9999804498427488},{"cnt":[[305,2445],[1944,2445],[1944,2494],[305,2494]],"region":{"top_left_x":305,"top_left_y":2444,"width":1640,"height":51},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06f385aadb58488bacb33694b16e9cbb","type":"text","conversion_output":true,"text":"describing the progress of patient enrollment, the rates of compliance with therapy, and the","text_display":" describing the progress of patient enrollment, the rates of compliance with therapy, and the","confidence":1,"confidence_rate":1},{"cnt":[[305,2572],[969,2572],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2571,"width":664,"height":44},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c89333a2ea5947a4a323a4c66be115aa","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f9d09f37e3443bdb7af249f0d02dd51","type":"page_info","conversion_output":false,"text":"Page 43 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-45","page":45,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed62814909bb4e0cab147c959d87875b","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1944,249],[1944,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1640,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9484d4f60624ed1a378a9ad04b38e05","type":"text","conversion_output":true,"text":"frequency of protocol violations. The Data Coordinating Center will also report on the number","text_display":"\nfrequency of protocol violations. The Data Coordinating Center will also report on the number","confidence":1,"confidence_rate":1},{"cnt":[[305,296],[1944,296],[1944,346],[305,346]],"region":{"top_left_x":305,"top_left_y":296,"width":1640,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7024d92c77d54c4d903f4a7dfc3cd4b7","type":"text","conversion_output":true,"text":"(status) of data forms completion, the number of outstanding queries, the number of queries","text_display":" (status) of data forms completion, the number of outstanding queries, the number of queries","confidence":1,"confidence_rate":1},{"cnt":[[305,339],[1558,339],[1558,389],[305,389]],"region":{"top_left_x":305,"top_left_y":339,"width":1253,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5740ee354adc484783f6b9288629beea","type":"text","conversion_output":true,"text":"completed, and the number of forms reviewed through on-site monitoring.","text_display":" completed, and the number of forms reviewed through on-site monitoring.","confidence":1,"confidence_rate":1},{"cnt":[[305,425],[1944,425],[1944,475],[305,475]],"region":{"top_left_x":305,"top_left_y":425,"width":1640,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c2ddabbad4c43e6abad835e59d91238","type":"text","conversion_output":true,"text":"These interim safety and efficacy reports introduce well-recognized statistical problems related","text_display":"\n\nThese interim safety and efficacy reports introduce well-recognized statistical problems related","confidence":1,"confidence_rate":1},{"cnt":[[305,468],[1944,468],[1944,518],[305,518]],"region":{"top_left_x":305,"top_left_y":468,"width":1640,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"358f6cfa48b8448886a194e977d4ec5a","type":"text","conversion_output":true,"text":"to the multiplicity of statistical tests performed on an accumulating set of data. To properly","text_display":" to the multiplicity of statistical tests performed on an accumulating set of data. To properly","confidence":1,"confidence_rate":1},{"cnt":[[305,511],[1944,511],[1944,561],[305,561]],"region":{"top_left_x":305,"top_left_y":511,"width":1640,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"906a7f32b40a47b495f5d6339110d0cf","type":"text","conversion_output":true,"text":"account for the repeated interim testing in CABANA, a group sequential method similar to that","text_display":" account for the repeated interim testing in CABANA, a group sequential method similar to that","confidence":1,"confidence_rate":1},{"cnt":[[305,556],[1944,556],[1944,608],[305,608]],"region":{"top_left_x":305,"top_left_y":556,"width":1640,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73d62cac45ca47108dc93b2a4fc81256","type":"text","conversion_output":true,"text":"proposed by O'Brien and Fleming [105] as a guide in interpreting interim analyses will be used.","text_display":" proposed by O'Brien and Fleming [105] as a guide in interpreting interim analyses will be used.","confidence":1,"confidence_rate":1},{"cnt":[[305,602],[1944,602],[1944,651],[305,651]],"region":{"top_left_x":305,"top_left_y":601,"width":1640,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbfb84ccf507447fb53e1396be7dbd7a","type":"text","conversion_output":true,"text":"This procedure requires large critical values early in the study, but relaxes (i.e., decreases) the","text_display":" This procedure requires large critical values early in the study, but relaxes (i.e., decreases) the","confidence":1,"confidence_rate":1},{"cnt":[[305,645],[1944,645],[1944,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1640,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6816402dfa7440b5b6287b94e02736cd","type":"text","conversion_output":true,"text":"critical value as the trial progresses. Because of the conservatism early in the trial, the critical","text_display":" critical value as the trial progresses. Because of the conservatism early in the trial, the critical","confidence":1,"confidence_rate":1},{"cnt":[[305,690],[1944,690],[1944,737],[305,737]],"region":{"top_left_x":305,"top_left_y":689,"width":1640,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2903525293734aad8fef52404be2c66c","type":"text","conversion_output":true,"text":"value at the final analysis is near the \"nominal\" critical value. Hence the sample size","text_display":" value at the final analysis is near the \"nominal\" critical value. Hence the sample size","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[1944,735],[1944,782],[305,782]],"region":{"top_left_x":305,"top_left_y":734,"width":1640,"height":49},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"302edf1b771b4305b38ac2b6642090cb","type":"text","conversion_output":true,"text":"requirements with this group sequential procedure remain essentially the same as the","text_display":" requirements with this group sequential procedure remain essentially the same as the","confidence":1,"confidence_rate":1},{"cnt":[[305,778],[1944,778],[1944,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":1640,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c37def7afb234775946bf38ca7ad0178","type":"text","conversion_output":true,"text":"conventional fixed sample size estimate. The actual method for this interim monitoring that will","text_display":" conventional fixed sample size estimate. The actual method for this interim monitoring that will","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[1944,821],[1944,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1640,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c25efb4775a46fba130db3a320753f1","type":"text","conversion_output":true,"text":"be employed in CABANA is the \"spending function\" approach to group sequential testing","text_display":" be employed in CABANA is the \"spending function\" approach to group sequential testing","confidence":1,"confidence_rate":1},{"cnt":[[305,864],[1946,864],[1946,915],[305,915]],"region":{"top_left_x":305,"top_left_y":863,"width":1642,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2494350b277e422c96e35cb25044a266","type":"text","conversion_output":true,"text":"developed by Lan and DeMets [106]. The Lan-DeMets approach only requires specification of","text_display":" developed by Lan and DeMets [106]. The Lan-DeMets approach only requires specification of","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1944,911],[1944,960],[305,960]],"region":{"top_left_x":305,"top_left_y":910,"width":1640,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb2d49ab8e534783b95d0e7fa9ca3315","type":"text","conversion_output":true,"text":"the rate at which the Type I error (which in this trial will be \\(\\alpha=0.05\\) for the primary endpoint) will","text_display":" the rate at which the Type I error (which in this trial will be \\(\\alpha=0.05\\) for the primary endpoint) will","confidence":1,"confidence_rate":1},{"cnt":[[305,958],[1944,958],[1944,1008],[305,1008]],"region":{"top_left_x":305,"top_left_y":958,"width":1640,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebfd2102dda545758d771aca2f52d33d","type":"text","conversion_output":true,"text":"be \"spent\". This procedure allows \"spending\" a portion of \\(\\alpha\\) at each interim analysis in such a","text_display":" be \"spent\". This procedure allows \"spending\" a portion of \\(\\alpha\\) at each interim analysis in such a","confidence":0.9936552047729492,"confidence_rate":0.9999375998980743},{"cnt":[[305,1001],[1944,1001],[1944,1051],[305,1051]],"region":{"top_left_x":305,"top_left_y":1001,"width":1640,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0782a7bd0e054b0cb03b8c505dd78d59","type":"text","conversion_output":true,"text":"way that at the end of the study, the total Type I error does not exceed 0.05 . One such","text_display":" way that at the end of the study, the total Type I error does not exceed 0.05 . One such","confidence":0.9501953125,"confidence_rate":0.999467977788476},{"cnt":[[305,1044],[1944,1044],[1944,1096],[305,1096]],"region":{"top_left_x":305,"top_left_y":1044,"width":1640,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bb2d2dea20042b6a22bbbee33b0b990","type":"text","conversion_output":true,"text":"spending function generates boundaries that are nearly identical to the O'Brien-Fleming","text_display":" spending function generates boundaries that are nearly identical to the O'Brien-Fleming","confidence":1,"confidence_rate":1},{"cnt":[[305,1091],[1944,1091],[1944,1141],[305,1141]],"region":{"top_left_x":305,"top_left_y":1091,"width":1640,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bad188b1ceef4a1b8d198308e4a7c0fb","type":"text","conversion_output":true,"text":"boundaries. It is this approach that will be used in CABANA, namely two-sided, symmetric","text_display":" boundaries. It is this approach that will be used in CABANA, namely two-sided, symmetric","confidence":1,"confidence_rate":1},{"cnt":[[305,1134],[1944,1134],[1944,1184],[305,1184]],"region":{"top_left_x":305,"top_left_y":1134,"width":1640,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f662ff60d508402587f21a4ce0d20985","type":"text","conversion_output":true,"text":"O'Brien-Fleming type boundaries generated using the flexible Lan-DeMets approach to group","text_display":" O'Brien-Fleming type boundaries generated using the flexible Lan-DeMets approach to group","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[305,1177],[1944,1177],[1944,1227],[305,1227]],"region":{"top_left_x":305,"top_left_y":1177,"width":1640,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5969c0c2937f4149b61d941e021f36b4","type":"text","conversion_output":true,"text":"sequential testing. Since the number of looks and the increments between looks need not be","text_display":" sequential testing. Since the number of looks and the increments between looks need not be","confidence":1,"confidence_rate":1},{"cnt":[[305,1222],[1944,1222],[1944,1274],[305,1274]],"region":{"top_left_x":305,"top_left_y":1222,"width":1640,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff8cb0078df64455b56c936d568e15cb","type":"text","conversion_output":true,"text":"predetermined, it allows flexibility in the monitoring process for accommodating additional","text_display":" predetermined, it allows flexibility in the monitoring process for accommodating additional","confidence":1,"confidence_rate":1},{"cnt":[[305,1268],[1944,1268],[1944,1317],[305,1317]],"region":{"top_left_x":305,"top_left_y":1267,"width":1640,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa6a655614c648b1a0cb23782c8d584a","type":"text","conversion_output":true,"text":"comparative examinations of the data in response to concerns of the DSMB that may arise","text_display":" comparative examinations of the data in response to concerns of the DSMB that may arise","confidence":1,"confidence_rate":1},{"cnt":[[305,1311],[801,1311],[801,1360],[305,1360]],"region":{"top_left_x":305,"top_left_y":1310,"width":497,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e778b82f679f40e09709d58cbda45e8c","type":"text","conversion_output":true,"text":"during the course of the trial.","text_display":" during the course of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[305,1396],[1946,1396],[1946,1446],[305,1446]],"region":{"top_left_x":305,"top_left_y":1396,"width":1642,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcbccb4581634f29a79e8d7faf704788","type":"text","conversion_output":true,"text":"The analytic approach that will be used at the interim analyses for assessing treatment","text_display":"\n\nThe analytic approach that will be used at the interim analyses for assessing treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,1439],[1944,1439],[1944,1491],[305,1491]],"region":{"top_left_x":305,"top_left_y":1439,"width":1640,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf075aecff8a401b9f1f5a4d0f211e38","type":"text","conversion_output":true,"text":"differences will be the time-to-event analysis methods described previously, except that","text_display":" differences will be the time-to-event analysis methods described previously, except that","confidence":1,"confidence_rate":1},{"cnt":[[305,1485],[1944,1485],[1944,1536],[305,1536]],"region":{"top_left_x":305,"top_left_y":1484,"width":1640,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"217b73601aaf4527b7776c43aa4a7be9","type":"text","conversion_output":true,"text":"interpretation of statistical significance associated with treatment comparisons will be guided","text_display":" interpretation of statistical significance associated with treatment comparisons will be guided","confidence":1,"confidence_rate":1},{"cnt":[[305,1530],[1424,1530],[1424,1579],[305,1579]],"region":{"top_left_x":305,"top_left_y":1529,"width":1120,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a822e430f482412eb7bfe6e47027ba3d","type":"text","conversion_output":true,"text":"using the group sequential monitoring boundaries outlined above.","text_display":" using the group sequential monitoring boundaries outlined above.","confidence":0.9990234375,"confidence_rate":0.9999858401053562},{"cnt":[[305,1618],[1944,1618],[1944,1665],[305,1665]],"region":{"top_left_x":305,"top_left_y":1617,"width":1640,"height":49},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a264713477644a55a0e37b899940519c","type":"text","conversion_output":true,"text":"Judgment concerning the continuation or termination of the study will involve not only the","text_display":"\n\nJudgment concerning the continuation or termination of the study will involve not only the","confidence":1,"confidence_rate":1},{"cnt":[[305,1663],[1944,1663],[1944,1712],[305,1712]],"region":{"top_left_x":305,"top_left_y":1662,"width":1640,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99615fddc55c4601a4e41f582e89cc21","type":"text","conversion_output":true,"text":"degree of statistical significance observed at the interim analysis, but also the likelihood of","text_display":" degree of statistical significance observed at the interim analysis, but also the likelihood of","confidence":1,"confidence_rate":1},{"cnt":[[305,1706],[1944,1706],[1944,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1705,"width":1640,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5071513704bf4002a441670aefce6ba5","type":"text","conversion_output":true,"text":"achieving significance should enrollment continue to the originally projected sample size. As an","text_display":" achieving significance should enrollment continue to the originally projected sample size. As an","confidence":1,"confidence_rate":1},{"cnt":[[305,1749],[1944,1749],[1944,1798],[305,1798]],"region":{"top_left_x":305,"top_left_y":1748,"width":1640,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1306f8b9aa34179b07633a9f24b2c89","type":"text","conversion_output":true,"text":"aid in this latter assessment, the Coordinating Center will supplement the group sequential","text_display":" aid in this latter assessment, the Coordinating Center will supplement the group sequential","confidence":1,"confidence_rate":1},{"cnt":[[305,1792],[1944,1792],[1944,1841],[305,1841]],"region":{"top_left_x":305,"top_left_y":1791,"width":1640,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ffd9d6852ff4b1392a5583fe81712bf","type":"text","conversion_output":true,"text":"analyses outlined above with calculations of conditional power, namely the conditional","text_display":" analyses outlined above with calculations of conditional power, namely the conditional","confidence":1,"confidence_rate":1},{"cnt":[[305,1839],[1944,1839],[1944,1888],[305,1888]],"region":{"top_left_x":305,"top_left_y":1839,"width":1640,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"593521c562474494a527d4be5d710447","type":"text","conversion_output":true,"text":"probability that the treatment comparison will be significant at the end of the trial at the \\(\\alpha\\) level","text_display":" probability that the treatment comparison will be significant at the end of the trial at the \\(\\alpha\\) level","confidence":0.9980478286743164,"confidence_rate":0.9999819068368716},{"cnt":[[305,1884],[1944,1884],[1944,1931],[305,1931]],"region":{"top_left_x":305,"top_left_y":1884,"width":1640,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cd517d49b024d64a6e7370f8ff3b952","type":"text","conversion_output":true,"text":"used in the design, given the hypothesized treatment difference and the data observed to date.","text_display":" used in the design, given the hypothesized treatment difference and the data observed to date.","confidence":1,"confidence_rate":1},{"cnt":[[305,1927],[1944,1927],[1944,1979],[305,1979]],"region":{"top_left_x":305,"top_left_y":1927,"width":1640,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ba9863bfda44701b0281bb55a7b0bf6","type":"text","conversion_output":true,"text":"After approximately \\(50 \\%\\) of the total events have occurred, conditional power for the primary","text_display":" After approximately \\(50 \\%\\) of the total events have occurred, conditional power for the primary","confidence":0.9951171875,"confidence_rate":0.999951053474153},{"cnt":[[305,1972],[1944,1972],[1944,2022],[305,2022]],"region":{"top_left_x":305,"top_left_y":1972,"width":1640,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1361dbb984274050b17a85ad37d6385e","type":"text","conversion_output":true,"text":"treatment comparison will be computed and provided to the DSMB as part of the interim study","text_display":" treatment comparison will be computed and provided to the DSMB as part of the interim study","confidence":1,"confidence_rate":1},{"cnt":[[305,2020],[445,2020],[445,2065],[305,2065]],"region":{"top_left_x":305,"top_left_y":2019,"width":140,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1042cd05e5a49e6855915fab81c1dab","type":"text","conversion_output":true,"text":"reports.","text_display":" reports.","confidence":1,"confidence_rate":1},{"cnt":[[301,2099],[846,2099],[846,2153],[301,2153]],"region":{"top_left_x":300,"top_left_y":2099,"width":547,"height":54},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4bdd0134b5ba4e39a0318d504c983a9b","type":"section_header","conversion_output":true,"text":"8.2.7 Multiple Comparisons","text_display":"\n\n\\subsection*{8.2.7 Multiple Comparisons}","confidence":0.9931640625,"confidence_rate":0.999778753202848},{"cnt":[[305,2148],[1944,2148],[1944,2196],[305,2196]],"region":{"top_left_x":305,"top_left_y":2148,"width":1640,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb938d747b074a33a20ada6462348145","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":[[305,2191],[1944,2191],[1944,2241],[305,2241]],"region":{"top_left_x":305,"top_left_y":2191,"width":1640,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ae2b7e4b27f4324921a2f049d2a034e","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":[[305,2234],[1944,2234],[1944,2284],[305,2284]],"region":{"top_left_x":305,"top_left_y":2234,"width":1640,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20e3a947a5514ce497ee29e6ddc8d380","type":"text","conversion_output":true,"text":"one of the comparisons could be \"significant\" by chance. Although adjustments (e.g., based on","text_display":" one of the comparisons could be \"significant\" by chance. Although adjustments (e.g., based on","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,2277],[1944,2277],[1944,2327],[305,2327]],"region":{"top_left_x":305,"top_left_y":2277,"width":1640,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0df2f5e4d9814c34b552153d48c1737f","type":"text","conversion_output":true,"text":"the Bonferroni inequality) could be used to preserve the overall type I error level, to adjust for","text_display":" the Bonferroni inequality) could be used to preserve the overall type I error level, to adjust for","confidence":1,"confidence_rate":1},{"cnt":[[305,2322],[1944,2322],[1944,2374],[305,2374]],"region":{"top_left_x":305,"top_left_y":2322,"width":1640,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a611996e05e456ca2f92e934ac6ab0c","type":"text","conversion_output":true,"text":"the effects of the repeated significance testing that will occur as part of the interim monitoring","text_display":" the effects of the repeated significance testing that will occur as part of the interim monitoring","confidence":1,"confidence_rate":1},{"cnt":[[305,2368],[1944,2368],[1944,2417],[305,2417]],"region":{"top_left_x":305,"top_left_y":2367,"width":1640,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed97b62fb9ce46d49e535e398617cb41","type":"text","conversion_output":true,"text":"(discussed above), plus adjust for the multiplicity of secondary endpoints, would require that","text_display":" (discussed above), plus adjust for the multiplicity of secondary endpoints, would require that","confidence":1,"confidence_rate":1},{"cnt":[[305,2411],[1946,2411],[1946,2460],[305,2460]],"region":{"top_left_x":305,"top_left_y":2410,"width":1642,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e2e6aa50f28448ab97cfb3e3d6466f0","type":"text","conversion_output":true,"text":"very small significance levels be used for every comparison. Although the overall level of","text_display":" very small significance levels be used for every comparison. Although the overall level of","confidence":1,"confidence_rate":1},{"cnt":[[305,2454],[1944,2454],[1944,2505],[305,2505]],"region":{"top_left_x":305,"top_left_y":2453,"width":1640,"height":53},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80b2e058271b4a99b9f44aad02533e52","type":"text","conversion_output":true,"text":"significance for the assessment of the primary composite endpoint will be 0.05 , to account in","text_display":" significance for the assessment of the primary composite endpoint will be 0.05 , to account in","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[969,2574],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":664,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"95438dc31c9d4ef9ad69a61e374c8178","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"79dc916db96e400280f2ce36f96f2e0b","type":"page_info","conversion_output":false,"text":"Page 44 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-46","page":46,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2151c56283c04db9ad15f97fc6daf786","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[309,251],[1940,251],[1940,299],[309,299]],"region":{"top_left_x":309,"top_left_y":251,"width":1632,"height":48},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78a7e6f46c26487696f9377b32c22336","type":"text","conversion_output":true,"text":"part for the multiplicity of comparisons involving secondary endpoints, a conservative approach","text_display":"\npart for the multiplicity of comparisons involving secondary endpoints, a conservative approach","confidence":1,"confidence_rate":1},{"cnt":[[305,296],[1940,296],[1940,342],[305,342]],"region":{"top_left_x":305,"top_left_y":296,"width":1636,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fafa26e05ba44302af1e8c3ad939c8ed","type":"text","conversion_output":true,"text":"will be taken while interpreting those results, taking into account the degree of significance, and","text_display":" will be taken while interpreting those results, taking into account the degree of significance, and","confidence":1,"confidence_rate":1},{"cnt":[[305,339],[1940,339],[1940,385],[305,385]],"region":{"top_left_x":305,"top_left_y":339,"width":1636,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92f845ca49b04e39b4df3a722c3990ac","type":"text","conversion_output":true,"text":"looking for consistency across endpoints. The actual p -value for each comparison will be","text_display":" looking for consistency across endpoints. The actual p -value for each comparison will be","confidence":0.9951210021972656,"confidence_rate":0.9999510918063551},{"cnt":[[305,385],[1033,385],[1033,432],[305,432]],"region":{"top_left_x":305,"top_left_y":384,"width":729,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01b191d95b6346f093431aa4068f5947","type":"text","conversion_output":true,"text":"reported to aid in the overall interpretation.","text_display":" reported to aid in the overall interpretation.","confidence":1,"confidence_rate":1},{"cnt":[[305,466],[954,466],[954,522],[305,522]],"region":{"top_left_x":305,"top_left_y":466,"width":649,"height":57},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57aa42320f4544489426bdea9359ec47","type":"section_header","conversion_output":false,"children_ids":["10fae9c2a92846aba69ff25c55d26f26"],"text":"","text_display":""},{"cnt":[[309,473],[950,473],[950,518],[309,518]],"region":{"top_left_x":309,"top_left_y":472,"width":641,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10fae9c2a92846aba69ff25c55d26f26","type":"text","conversion_output":true,"parent_id":"57aa42320f4544489426bdea9359ec47","text":"8.2.8 Health Economics Analyses","text_display":"\n\n\\subsection*{8.2.8 Health Economics Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[305,516],[1940,516],[1940,561],[305,561]],"region":{"top_left_x":305,"top_left_y":515,"width":1636,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f9e70c96ef9482884e855d64754e1b1","type":"text","conversion_output":true,"text":"The health economic analyses for CABANA will consist of two major parts, an empirical","text_display":"\n\nThe health economic analyses for CABANA will consist of two major parts, an empirical","confidence":1,"confidence_rate":1},{"cnt":[[305,559],[1940,559],[1940,604],[305,604]],"region":{"top_left_x":305,"top_left_y":558,"width":1636,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f4e98d506b5418cbb940995eae36674","type":"text","conversion_output":true,"text":"intention to treat cost comparison and a cost effectiveness analysis. Primary statistical","text_display":" intention to treat cost comparison and a cost effectiveness analysis. Primary statistical","confidence":1,"confidence_rate":1},{"cnt":[[305,602],[1940,602],[1940,649],[305,649]],"region":{"top_left_x":305,"top_left_y":601,"width":1636,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a8f4a256e864419a1e8f24668098c9c","type":"text","conversion_output":true,"text":"comparisons between the two treatment arms of empirical costs will be performed by intention-","text_display":" comparisons between the two treatment arms of empirical costs will be performed by intention-","confidence":1,"confidence_rate":1},{"cnt":[[305,645],[1944,645],[1944,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1640,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e03ea50b4427486fa571831641f56b0a","type":"text","conversion_output":true,"text":"to-treat. The patients enrolled outside the United States will be excluded from the primary cost","text_display":"to-treat. The patients enrolled outside the United States will be excluded from the primary cost","confidence":1,"confidence_rate":1},{"cnt":[[305,692],[1940,692],[1940,737],[305,737]],"region":{"top_left_x":305,"top_left_y":691,"width":1636,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59c3d5370ab14c0e91aef323477e4b65","type":"text","conversion_output":true,"text":"intention-to-treat analyses. Confidence limits around the observed cost differences will be","text_display":" intention-to-treat analyses. Confidence limits around the observed cost differences will be","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[952,735],[952,780],[305,780]],"region":{"top_left_x":305,"top_left_y":734,"width":647,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c428f07a525a4a63a3231adbeb27bd36","type":"text","conversion_output":true,"text":"constructed using bootstrap methods.","text_display":" constructed using bootstrap methods.","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[1940,821],[1940,870],[305,870]],"region":{"top_left_x":305,"top_left_y":820,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62b15050f0f7499eaa8448d0348addf2","type":"text","conversion_output":true,"text":"The cost-effectiveness analyses will estimate the incremental cost required to add an extra life","text_display":"\n\nThe cost-effectiveness analyses will estimate the incremental cost required to add an extra life","confidence":1,"confidence_rate":1},{"cnt":[[305,868],[1944,868],[1944,913],[305,913]],"region":{"top_left_x":305,"top_left_y":867,"width":1640,"height":47},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ad041940e6244e28adb01a384d8c5fd","type":"text","conversion_output":true,"text":"year with the investigational ablation arm relative to control medical therapy. In secondary","text_display":" year with the investigational ablation arm relative to control medical therapy. In secondary","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1940,911],[1940,956],[305,956]],"region":{"top_left_x":305,"top_left_y":910,"width":1636,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fce4b214638c4d4e991c750bf097fa59","type":"text","conversion_output":true,"text":"analyses, we will incorporate utility weights to estimate the incremental cost per quality adjusted","text_display":" analyses, we will incorporate utility weights to estimate the incremental cost per quality adjusted","confidence":1,"confidence_rate":1},{"cnt":[[305,954],[1940,954],[1940,1001],[305,1001]],"region":{"top_left_x":305,"top_left_y":953,"width":1636,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee498ec7c997444da02d8ee46bab4028","type":"text","conversion_output":true,"text":"life year gained with ablation, relative to medical therapy. These analyses will be conducted","text_display":" life year gained with ablation, relative to medical therapy. These analyses will be conducted","confidence":1,"confidence_rate":1},{"cnt":[[305,997],[1940,997],[1940,1042],[305,1042]],"region":{"top_left_x":305,"top_left_y":996,"width":1636,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"746aecd92f124412986fca66eac744f4","type":"text","conversion_output":true,"text":"from a societal perspective and will use a lifetime time horizon so that the estimated incremental","text_display":" from a societal perspective and will use a lifetime time horizon so that the estimated incremental","confidence":1,"confidence_rate":1},{"cnt":[[305,1040],[1940,1040],[1940,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1636,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"158a84d1ee9e4e82926aad631ce1ef49","type":"text","conversion_output":true,"text":"cost-effectiveness and cost-utility ratios can be compared with societal benchmarks. We will","text_display":" cost-effectiveness and cost-utility ratios can be compared with societal benchmarks. We will","confidence":1,"confidence_rate":1},{"cnt":[[305,1087],[1940,1087],[1940,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1087,"width":1636,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"295e0341350c4dc6a65eebdc0ee27425","type":"text","conversion_output":true,"text":"also calculate within-trial cost-effectiveness/cost-utility ratios, although these ratios are limited in","text_display":" also calculate within-trial cost-effectiveness/cost-utility ratios, although these ratios are limited in","confidence":1,"confidence_rate":1},{"cnt":[[305,1130],[1944,1130],[1944,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1130,"width":1640,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf35cccc381747e6975c19aed8bc8670","type":"text","conversion_output":true,"text":"their value due to their failure to account for long-term benefits and costs and the absence of","text_display":" their value due to their failure to account for long-term benefits and costs and the absence of","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1944,1173],[1944,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":1640,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd05f11fc7f747fcbdfd17e356770d90","type":"text","conversion_output":true,"text":"comparative benchmarks. Costs will be adjusted for inflation and both costs and life expectancy","text_display":" comparative benchmarks. Costs will be adjusted for inflation and both costs and life expectancy","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1940,1216],[1940,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1216,"width":1636,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4df3272939314a7ab33d40b9754001d9","type":"text","conversion_output":true,"text":"will be discounted to present value at a \\(3 \\%\\) annual discount rate. Adjustments for censored data","text_display":" will be discounted to present value at a \\(3 \\%\\) annual discount rate. Adjustments for censored data","confidence":1,"confidence_rate":1},{"cnt":[[305,1261],[1940,1261],[1940,1308],[305,1308]],"region":{"top_left_x":305,"top_left_y":1261,"width":1636,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99ac16fe95b14bae9c321ae97abf8a9e","type":"text","conversion_output":true,"text":"due to staggered entry will be made following the approach of Bang and Tsiatis [107]. Extensive","text_display":" due to staggered entry will be made following the approach of Bang and Tsiatis [107]. Extensive","confidence":1,"confidence_rate":1},{"cnt":[[305,1306],[954,1306],[954,1351],[305,1351]],"region":{"top_left_x":305,"top_left_y":1306,"width":649,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49b4fbb099bc499a94a88f7e689fdcd6","type":"text","conversion_output":true,"text":"sensitivity analyses will be performed.","text_display":" sensitivity analyses will be performed.","confidence":0.99951171875,"confidence_rate":0.9999889000502843},{"cnt":[[303,1388],[995,1388],[995,1446],[303,1446]],"region":{"top_left_x":302,"top_left_y":1387,"width":693,"height":59},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4174dc558c2a46a193934abf1ea3d526","type":"section_header","conversion_output":false,"children_ids":["4faed66713f54a9fae0e169a629c800a"],"text":"","text_display":""},{"cnt":[[305,1392],[990,1392],[990,1437],[305,1437]],"region":{"top_left_x":305,"top_left_y":1392,"width":686,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4faed66713f54a9fae0e169a629c800a","type":"text","conversion_output":true,"parent_id":"4174dc558c2a46a193934abf1ea3d526","text":"8.2.9 Quality of Life (QOL) Analyses","text_display":"\n\n\\subsection*{8.2.9 Quality of Life (QOL) Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[305,1435],[1938,1435],[1938,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1435,"width":1633,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4574549f41e547a8826082379d9d17a3","type":"text","conversion_output":true,"text":"For each of the QOL measures examined in this study, data analysis will proceed in two stages.","text_display":"\n\nFor each of the QOL measures examined in this study, data analysis will proceed in two stages.","confidence":1,"confidence_rate":1},{"cnt":[[305,1480],[1940,1480],[1940,1528],[305,1528]],"region":{"top_left_x":305,"top_left_y":1480,"width":1636,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bdb11005c8846cd821cc7e5efdb2e1f","type":"text","conversion_output":true,"text":"First, we will provide simple descriptive and comparative analyses by intention-to-treat. Second,","text_display":" First, we will provide simple descriptive and comparative analyses by intention-to-treat. Second,","confidence":1,"confidence_rate":1},{"cnt":[[305,1525],[1944,1525],[1944,1571],[305,1571]],"region":{"top_left_x":305,"top_left_y":1525,"width":1640,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d2612337ca34c11adb3bb8c57d9affd","type":"text","conversion_output":true,"text":"we will examine changes over time from baseline and identify the major determinants of those","text_display":" we will examine changes over time from baseline and identify the major determinants of those","confidence":1,"confidence_rate":1},{"cnt":[[305,1568],[1940,1568],[1940,1618],[305,1618]],"region":{"top_left_x":305,"top_left_y":1568,"width":1636,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50848092db494828a520cb9d02586b66","type":"text","conversion_output":true,"text":"changes using regression analysis. Since there is currently no consensus in the statistical","text_display":" changes using regression analysis. Since there is currently no consensus in the statistical","confidence":1,"confidence_rate":1},{"cnt":[[305,1611],[1940,1611],[1940,1661],[305,1661]],"region":{"top_left_x":305,"top_left_y":1611,"width":1636,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a4905c4d6fd4763a9d688dc5a4cbd79","type":"text","conversion_output":true,"text":"literature about the best way to deal with the multiple comparisons problem arising from testing","text_display":" literature about the best way to deal with the multiple comparisons problem arising from testing","confidence":1,"confidence_rate":1},{"cnt":[[305,1659],[1944,1659],[1944,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1658,"width":1640,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62280973dcbe4a2584913b7ffa8809fd","type":"text","conversion_output":true,"text":"each individual scale separately, we propose two complementary approaches. First, we will pre-","text_display":" each individual scale separately, we propose two complementary approaches. 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Second, we will use the average of post-baseline values in the","text_display":" a secondary (exploratory) status. 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Statistical power estimates for this part of our analysis show that we should have in","text_display":" points. Statistical power estimates for this part of our analysis show that we should have in","confidence":1,"confidence_rate":1},{"cnt":[[305,1921],[1708,1921],[1708,1966],[305,1966]],"region":{"top_left_x":305,"top_left_y":1920,"width":1404,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f746ea3bbd8c480290888b65b08e51d4","type":"text","conversion_output":true,"text":"excess of \\(90 \\%\\) power to detect \\(\\frac{1}{4}\\) SD differences in our 3 principal QOL endpoints.","text_display":" excess of \\(90 \\%\\) power to detect \\(\\frac{1}{4}\\) SD differences in our 3 principal QOL endpoints.","confidence":0.9668285769876093,"confidence_rate":0.9996627161703271},{"cnt":[[303,2011],[1420,2011],[1420,2082],[303,2082]],"region":{"top_left_x":302,"top_left_y":2010,"width":1119,"height":72},"line":40,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"6aad974305c342109d0fd56a436316e3","type":"section_header","conversion_output":false,"children_ids":["91b7064cc41a454babdb49fa61c5ac81"],"text":"","text_display":""},{"cnt":[[305,2015],[1416,2015],[1416,2078],[305,2078]],"region":{"top_left_x":305,"top_left_y":2015,"width":1111,"height":63},"line":41,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"91b7064cc41a454babdb49fa61c5ac81","type":"text","conversion_output":true,"parent_id":"6aad974305c342109d0fd56a436316e3","text":"9.0 Data Management and Quality Control","text_display":"\n\n\\subsection*{9.0 Data Management and Quality Control}","confidence":1,"confidence_rate":1},{"cnt":[[301,2118],[1098,2118],[1098,2176],[301,2176]],"region":{"top_left_x":300,"top_left_y":2118,"width":798,"height":59},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7891894120dd48259401cee5a53cf332","type":"section_header","conversion_output":false,"children_ids":["63a49b5e560749e2bfa9ffb135b59a8b"],"text":"","text_display":""},{"cnt":[[305,2123],[1094,2123],[1094,2172],[305,2172]],"region":{"top_left_x":305,"top_left_y":2122,"width":789,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63a49b5e560749e2bfa9ffb135b59a8b","type":"text","conversion_output":true,"parent_id":"7891894120dd48259401cee5a53cf332","text":"9.1 Study Data Collection -- All Patients","text_display":"\n\n\\subsection*{9.1 Study Data Collection -- All Patients}","confidence":1,"confidence_rate":1},{"cnt":[[305,2170],[1944,2170],[1944,2219],[305,2219]],"region":{"top_left_x":305,"top_left_y":2169,"width":1640,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c60c8286525b4525b2b00b18939eecea","type":"text","conversion_output":true,"text":"The full study dataset will be collected for subjects who enter the randomized/ treatment phase","text_display":"\n\nThe full study dataset will be collected for subjects who enter the randomized/ treatment phase","confidence":1,"confidence_rate":1},{"cnt":[[305,2217],[1944,2217],[1944,2262],[305,2262]],"region":{"top_left_x":305,"top_left_y":2217,"width":1640,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43faecd486e4472486710d390223896d","type":"text","conversion_output":true,"text":"of the study. The primary data collection system for CABANA is based on the electronic data","text_display":" of the study. The primary data collection system for CABANA is based on the electronic data","confidence":1,"confidence_rate":1},{"cnt":[[305,2260],[1944,2260],[1944,2305],[305,2305]],"region":{"top_left_x":305,"top_left_y":2260,"width":1640,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7b62c8b54014f2285472f71af82d2de","type":"text","conversion_output":true,"text":"capture (EDC) system, InForm \\({ }^{\\text {TM }}\\). All data collected at any point in the trial, except the economic","text_display":" capture (EDC) system, InForm \\({ }^{\\text {TM }}\\). All data collected at any point in the trial, except the economic","confidence":0.9951226694975048,"confidence_rate":0.999958914596167},{"cnt":[[305,2303],[1944,2303],[1944,2350],[305,2350]],"region":{"top_left_x":305,"top_left_y":2303,"width":1640,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c86bfe8b9884b63a9b343d08561245c","type":"text","conversion_output":true,"text":"and quality of life information and core lab data are entered into this system. Data from the","text_display":" and quality of life information and core lab data are entered into this system. Data from the","confidence":1,"confidence_rate":1},{"cnt":[[305,2346],[1944,2346],[1944,2396],[305,2396]],"region":{"top_left_x":305,"top_left_y":2346,"width":1640,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6adb1963b5dd49d8bff54b73f434a1d0","type":"text","conversion_output":true,"text":"CT/MR Imaging Lab, the ECG Core Lab, and the Medicomp Monitoring Core Lab are","text_display":" CT/MR Imaging Lab, the ECG Core Lab, and the Medicomp Monitoring Core Lab are","confidence":1,"confidence_rate":1},{"cnt":[[305,2391],[1605,2391],[1605,2438],[305,2438]],"region":{"top_left_x":305,"top_left_y":2391,"width":1300,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29acf23879554749adfd34eda6bcf113","type":"text","conversion_output":true,"text":"transferred electronically to the Data Coordinating Center on a regular basis.","text_display":" transferred electronically to the Data Coordinating Center on a regular basis.","confidence":0.99267578125,"confidence_rate":0.9999114355783123},{"cnt":[[305,2574],[965,2574],[965,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":660,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c37294025f14bcb926e1307739b0e91","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999889000502843},{"cnt":[[1611,2574],[1841,2574],[1841,2617],[1611,2617]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":44},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c3724907b2f4833a670a1f184060616","type":"page_info","conversion_output":false,"text":"Page 45 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-47","page":47,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6bd9e18e04c8442f9124aad2292d8f46","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[303,247],[1111,247],[1111,305],[303,305]],"region":{"top_left_x":302,"top_left_y":247,"width":809,"height":59},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e0f879fea5f48b59c56d0e14ecfe41a","type":"section_header","conversion_output":false,"children_ids":["e59072f5e5a84611b29aca2a696c7a78"],"text":"","text_display":""},{"cnt":[[305,251],[1106,251],[1106,301],[305,301]],"region":{"top_left_x":305,"top_left_y":251,"width":802,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e59072f5e5a84611b29aca2a696c7a78","type":"text","conversion_output":true,"parent_id":"9e0f879fea5f48b59c56d0e14ecfe41a","text":"9.2 Electronic Case Report Form (eCRF)","text_display":"\n\n\\subsection*{9.2 Electronic Case Report Form (eCRF)}","confidence":0.99951171875,"confidence_rate":0.9999886419133848},{"cnt":[[305,301],[1940,301],[1940,346],[305,346]],"region":{"top_left_x":305,"top_left_y":300,"width":1636,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fc7779a4518484991fb5e9113b810b0","type":"text","conversion_output":true,"text":"This study will use web-based electronic CRFs (e-CRFs) developed through a validated,","text_display":"\n\nThis study will use web-based electronic CRFs (e-CRFs) developed through a validated,","confidence":1,"confidence_rate":1},{"cnt":[[305,344],[1944,344],[1944,391],[305,391]],"region":{"top_left_x":305,"top_left_y":343,"width":1640,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cea1599b18e449afb4af6cc417dbba4b","type":"text","conversion_output":true,"text":"Electronic Record, Electronic Signatures (ERES) compliant platform (21 CFR Part 11). 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This will be maintained at the site according to the requirements for records","confidence":1,"confidence_rate":1},{"cnt":[[305,1089],[475,1089],[475,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1089,"width":170,"height":44},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b49afb22af334a5aa5d9e1664d7955c3","type":"text","conversion_output":true,"text":"retention.","text_display":" retention.","confidence":1,"confidence_rate":1},{"cnt":[[305,1175],[1944,1175],[1944,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1175,"width":1640,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fb92575c3384b4a99ce5973b77b4b9f","type":"text","conversion_output":true,"text":"Components of the eCRF in CABANA include enrollment and demographics form; a form for","text_display":"\n\nComponents of the eCRF in CABANA include enrollment and demographics form; a form for","confidence":1,"confidence_rate":1},{"cnt":[[305,1220],[1944,1220],[1944,1268],[305,1268]],"region":{"top_left_x":305,"top_left_y":1220,"width":1640,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96a7a71c4d2b4cdfa2903a793aa1dee2","type":"text","conversion_output":true,"text":"recording relevant history, symptoms, physical exam, ECG data and other baseline presenting","text_display":" recording relevant history, symptoms, physical exam, ECG data and other baseline presenting","confidence":1,"confidence_rate":1},{"cnt":[[305,1265],[1944,1265],[1944,1313],[305,1313]],"region":{"top_left_x":305,"top_left_y":1265,"width":1640,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c3ae249c37b4c1e9771af00b9ad8ce9","type":"text","conversion_output":true,"text":"characteristics; forms to document the details of the drug therapy and ablation procedure;","text_display":" characteristics; forms to document the details of the drug therapy and ablation procedure;","confidence":1,"confidence_rate":1},{"cnt":[[305,1311],[1944,1311],[1944,1356],[305,1356]],"region":{"top_left_x":305,"top_left_y":1310,"width":1640,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c59b34c957246b69e0685b9337ab114","type":"text","conversion_output":true,"text":"follow-up forms for use at the regular follow-up visits and tracking the patient's clinical course","text_display":" follow-up forms for use at the regular follow-up visits and tracking the patient's clinical course","confidence":1,"confidence_rate":1},{"cnt":[[305,1354],[1944,1354],[1944,1399],[305,1399]],"region":{"top_left_x":305,"top_left_y":1353,"width":1640,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb3be1b9bc75403089fdab8b1c0ff687","type":"text","conversion_output":true,"text":"over time; and event forms for recording the circumstances and details surrounding the","text_display":" over time; and event forms for recording the circumstances and details surrounding the","confidence":1,"confidence_rate":1},{"cnt":[[305,1396],[1944,1396],[1944,1446],[305,1446]],"region":{"top_left_x":305,"top_left_y":1396,"width":1640,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae3128b6f41247018924d51c5b302027","type":"text","conversion_output":true,"text":"occurrence of a death, stroke, cardiac arrest, or bleeding event as well as other adverse events.","text_display":" occurrence of a death, stroke, cardiac arrest, or bleeding event as well as other adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[305,1439],[1944,1439],[1944,1489],[305,1489]],"region":{"top_left_x":305,"top_left_y":1439,"width":1640,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02e6b5cf1e39478885e56e03a5664271","type":"text","conversion_output":true,"text":"In addition to the eCRF, there are specialized additional forms for collecting various components","text_display":" In addition to the eCRF, there are specialized additional forms for collecting various components","confidence":1,"confidence_rate":1},{"cnt":[[305,1485],[1944,1485],[1944,1532],[305,1532]],"region":{"top_left_x":305,"top_left_y":1484,"width":1640,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5ad896e53cd41bd951f63343dfb80cc","type":"text","conversion_output":true,"text":"of the quality of life and health status information. Detailed instructions for completing the","text_display":" of the quality of life and health status information. Detailed instructions for completing the","confidence":1,"confidence_rate":1},{"cnt":[[305,1525],[1944,1525],[1944,1575],[305,1575]],"region":{"top_left_x":305,"top_left_y":1525,"width":1640,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d8b0f3683c945ecab804c76b6a09597","type":"text","conversion_output":true,"text":"various data forms, along with a detailed Manual of Operations will be provided to each of the","text_display":" various data forms, along with a detailed Manual of Operations will be provided to each of the","confidence":1,"confidence_rate":1},{"cnt":[[305,1573],[522,1573],[522,1613],[305,1613]],"region":{"top_left_x":305,"top_left_y":1572,"width":218,"height":42},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3ae67437e904eaa8d2204bae24c49b7","type":"text","conversion_output":true,"text":"clinical sites","text_display":" clinical sites","confidence":1,"confidence_rate":1},{"cnt":[[301,1661],[986,1661],[986,1717],[301,1717]],"region":{"top_left_x":300,"top_left_y":1660,"width":687,"height":57},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28534c7c6fa942e18502c6b3da673fef","type":"section_header","conversion_output":false,"children_ids":["58253a98f3a642b1b6cd28e2c5521d97"],"text":"","text_display":""},{"cnt":[[305,1663],[982,1663],[982,1712],[305,1712]],"region":{"top_left_x":305,"top_left_y":1662,"width":677,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58253a98f3a642b1b6cd28e2c5521d97","type":"text","conversion_output":true,"parent_id":"28534c7c6fa942e18502c6b3da673fef","text":"9.3 Data Management and Quality","text_display":"\n\n\\subsection*{9.3 Data Management and Quality}","confidence":1,"confidence_rate":1},{"cnt":[[305,1710],[1944,1710],[1944,1760],[305,1760]],"region":{"top_left_x":305,"top_left_y":1710,"width":1640,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97cfc915d5474003a09e4c9c8769c4fd","type":"text","conversion_output":true,"text":"Any out-of-range values and missing or inconsistent key variables are flagged and","text_display":"\n\nAny out-of-range values and missing or inconsistent key variables are flagged and","confidence":1,"confidence_rate":1},{"cnt":[[305,1757],[1944,1757],[1944,1803],[305,1803]],"region":{"top_left_x":305,"top_left_y":1757,"width":1640,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f590838d77c74de191caa1f1a6ddff07","type":"text","conversion_output":true,"text":"addressed/answered at the site in real time during the data entry process. When a query is","text_display":" addressed/answered at the site in real time during the data entry process. When a query is","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[305,1800],[1944,1800],[1944,1848],[305,1848]],"region":{"top_left_x":305,"top_left_y":1800,"width":1640,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efaf6beaf8e4445b9f21bcecf1b21b70","type":"text","conversion_output":true,"text":"generated on a particular variable, a flag is set in a field in the database enabling the system to","text_display":" generated on a particular variable, a flag is set in a field in the database enabling the system to","confidence":1,"confidence_rate":1},{"cnt":[[305,1843],[1944,1843],[1944,1893],[305,1893]],"region":{"top_left_x":305,"top_left_y":1843,"width":1640,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81baa287386d4d348bacac0760baed52","type":"text","conversion_output":true,"text":"track the queries and produce reports of outstanding queries. Queries can also be generated","text_display":" track the queries and produce reports of outstanding queries. Queries can also be generated","confidence":1,"confidence_rate":1},{"cnt":[[305,1886],[1944,1886],[1944,1936],[305,1936]],"region":{"top_left_x":305,"top_left_y":1886,"width":1640,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b50916af43c4cdc9c3c8e649e5504ab","type":"text","conversion_output":true,"text":"from manual review of the data forms. These queries will be entered into the database and","text_display":" from manual review of the data forms. These queries will be entered into the database and","confidence":1,"confidence_rate":1},{"cnt":[[305,1934],[1944,1934],[1944,1979],[305,1979]],"region":{"top_left_x":305,"top_left_y":1933,"width":1640,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05da45c08fd844b59c5d3dae1e3f779e","type":"text","conversion_output":true,"text":"tracked in the same manner as the computer-generated queries. At regular intervals, all data","text_display":" tracked in the same manner as the computer-generated queries. At regular intervals, all data","confidence":1,"confidence_rate":1},{"cnt":[[305,1972],[1944,1972],[1944,2022],[305,2022]],"region":{"top_left_x":305,"top_left_y":1972,"width":1640,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"189b993e464c46b1bc1e984ff49ecfbf","type":"text","conversion_output":true,"text":"will be transferred from InForm \\({ }^{\\text {TM }}\\) to SAS for statistical summarization, data description, and data","text_display":" will be transferred from InForm \\({ }^{\\text {TM }}\\) to SAS for statistical summarization, data description, and data","confidence":0.9941492043435574,"confidence_rate":0.9999506904710759},{"cnt":[[305,2020],[1944,2020],[1944,2069],[305,2069]],"region":{"top_left_x":305,"top_left_y":2019,"width":1640,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cb6c66e143e483a9aeae18a05f1115f","type":"text","conversion_output":true,"text":"analysis. Further cross-checking of the data is performed in SAS, and discrepant observations","text_display":" analysis. Further cross-checking of the data is performed in SAS, and discrepant observations","confidence":1,"confidence_rate":1},{"cnt":[[305,2062],[1412,2062],[1412,2112],[305,2112]],"region":{"top_left_x":305,"top_left_y":2062,"width":1107,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53199bdd35de4defb7f059ffd36d7b6f","type":"text","conversion_output":true,"text":"flagged and appropriately resolved through a data query system.","text_display":" flagged and appropriately resolved through a data query system.","confidence":1,"confidence_rate":1},{"cnt":[[305,2151],[1944,2151],[1944,2198],[305,2198]],"region":{"top_left_x":305,"top_left_y":2150,"width":1640,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6dc1e29016454066ac063e27d047df28","type":"text","conversion_output":true,"text":"The Data Coordinating Center will perform internal database quality-control checks, and data","text_display":"\n\nThe Data Coordinating Center will perform internal database quality-control checks, and data","confidence":0.998046875,"confidence_rate":0.9999798452048033},{"cnt":[[305,2196],[1944,2196],[1944,2243],[305,2243]],"region":{"top_left_x":305,"top_left_y":2195,"width":1640,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9defa7f52ddc4624939b7645a29f6fa5","type":"text","conversion_output":true,"text":"audits throughout the course of the trial. All clinical site patient-related payments are prompted","text_display":" audits throughout the course of the trial. All clinical site patient-related payments are prompted","confidence":1,"confidence_rate":1},{"cnt":[[305,2239],[1609,2239],[1609,2288],[305,2288]],"region":{"top_left_x":305,"top_left_y":2238,"width":1305,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81b4b3cf67fb49368b8e796cf07ff083","type":"text","conversion_output":true,"text":"by completion of data forms with appropriate responses to all data elements.","text_display":" by completion of data forms with appropriate responses to all data elements.","confidence":1,"confidence_rate":1},{"cnt":[[301,2322],[1227,2322],[1227,2383],[301,2383]],"region":{"top_left_x":300,"top_left_y":2322,"width":927,"height":61},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a75e209ae3044ea786e5fbaaf07ad615","type":"section_header","conversion_output":false,"children_ids":["101531d340434fed8d68b94843806b09"],"text":"","text_display":""},{"cnt":[[305,2329],[1222,2329],[1222,2378],[305,2378]],"region":{"top_left_x":305,"top_left_y":2328,"width":918,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"101531d340434fed8d68b94843806b09","type":"text","conversion_output":true,"parent_id":"a75e209ae3044ea786e5fbaaf07ad615","text":"9.4 Economic and Quality of Life (EQOL) Data","text_display":"\n\n\\subsection*{9.4 Economic and Quality of Life (EQOL) Data}","confidence":0.99853515625,"confidence_rate":0.9999700837601018},{"cnt":[[305,2376],[1944,2376],[1944,2426],[305,2426]],"region":{"top_left_x":305,"top_left_y":2376,"width":1640,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2162371a1ac46b8a9d5ba2fd5b9f4d3","type":"text","conversion_output":true,"text":"For the CABANA study the economic and quality of life studies will be fully integrated into the","text_display":"\n\nFor the CABANA study the economic and quality of life studies will be fully integrated into the","confidence":1,"confidence_rate":1},{"cnt":[[305,2423],[1944,2423],[1944,2473],[305,2473]],"region":{"top_left_x":305,"top_left_y":2423,"width":1640,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1cfe5334ff04a13836b07a2808246d4","type":"text","conversion_output":true,"text":"clinical trial, including their inclusion in the main trial Informed Consent Form. The EQOL data","text_display":" clinical trial, including their inclusion in the main trial Informed Consent Form. 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Key variables (inclusion/exclusion criteria, adherence to treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,735],[1944,735],[1944,782],[305,782]],"region":{"top_left_x":305,"top_left_y":734,"width":1640,"height":49},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"990e00d01f124dbd821c642ba93c6d39","type":"text","conversion_output":true,"text":"assignment and safety) on the eCRF will be compared with each subject's source documents.","text_display":" assignment and safety) on the eCRF will be compared with each subject's source documents.","confidence":1,"confidence_rate":1},{"cnt":[[305,778],[1089,778],[1089,827],[305,827]],"region":{"top_left_x":305,"top_left_y":777,"width":785,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6014760055d044f8af8ed99d8334ecae","type":"text","conversion_output":true,"text":"Any discrepancies will be noted and resolved.","text_display":" Any discrepancies will be noted and resolved.","confidence":1,"confidence_rate":1},{"cnt":[[305,864],[1944,864],[1944,913],[305,913]],"region":{"top_left_x":305,"top_left_y":863,"width":1640,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef61ba8ddf284c8783f42df74394efb6","type":"text","conversion_output":true,"text":"During monitoring visits, the site will make their computer and/or high speed Internet access","text_display":"\n\nDuring monitoring visits, the site will make their computer and/or high speed Internet access","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1923,911],[1923,958],[305,958]],"region":{"top_left_x":305,"top_left_y":910,"width":1618,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"859430a57e604dc99ecd9973c30a93fe","type":"text","conversion_output":true,"text":"available to the CRA, so that he/she may verify the data entries with the source documentation.","text_display":" available to the CRA, so that he/she may verify the data entries with the source documentation.","confidence":1,"confidence_rate":1},{"cnt":[[301,990],[892,990],[892,1051],[301,1051]],"region":{"top_left_x":300,"top_left_y":990,"width":592,"height":61},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54565629184d4be2a22e130482cb5564","type":"section_header","conversion_output":false,"children_ids":["d41619775a134b7badf94fb2820e5c5e"],"text":"","text_display":""},{"cnt":[[305,997],[885,997],[885,1044],[305,1044]],"region":{"top_left_x":305,"top_left_y":996,"width":581,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d41619775a134b7badf94fb2820e5c5e","type":"text","conversion_output":true,"parent_id":"54565629184d4be2a22e130482cb5564","text":"11.1.1 Initiating / Training Sites","text_display":"\n\n\\subsection*{11.1.1 Initiating / Training Sites}","confidence":0.9970703125,"confidence_rate":0.9999247723826933},{"cnt":[[305,1040],[1944,1040],[1944,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1640,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7fa43524537e4fffa72ff8315d3689ca","type":"text","conversion_output":true,"text":"Over the first year of the trial, sites will come on-line for active participation once all local","text_display":"\n\nOver the first year of the trial, sites will come on-line for active participation once all local","confidence":1,"confidence_rate":1},{"cnt":[[305,1085],[1944,1085],[1944,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1084,"width":1640,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cab81f346f94a6fab707944ca4b89f0","type":"text","conversion_output":true,"text":"regulatory requirements have been met. Unconditional IRB/EC approval will be required at","text_display":" regulatory requirements have been met. Unconditional IRB/EC approval will be required at","confidence":1,"confidence_rate":1},{"cnt":[[305,1130],[1944,1130],[1944,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1130,"width":1640,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f89d628ff38b4853afb44beafde96584","type":"text","conversion_output":true,"text":"each site. Training for data collection and reporting must be completed. Individual sites will also","text_display":" each site. Training for data collection and reporting must be completed. Individual sites will also","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1944,1173],[1944,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":1640,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6774c19ea0ab4a4eae39cd312e54da7b","type":"text","conversion_output":true,"text":"be trained at the time of the first general investigator meeting held at the beginning of the trial.","text_display":" be trained at the time of the first general investigator meeting held at the beginning of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1944,1216],[1944,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1216,"width":1640,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8f1529852694f66b54b39686110ab82","type":"text","conversion_output":true,"text":"The specific site's ablation and clinical investigators and the clinical study coordinator will be","text_display":" The specific site's ablation and clinical investigators and the clinical study coordinator will be","confidence":1,"confidence_rate":1},{"cnt":[[305,1263],[896,1263],[896,1308],[305,1308]],"region":{"top_left_x":305,"top_left_y":1263,"width":591,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65dcd5df60864cc2adf3dc992848ea92","type":"text","conversion_output":true,"text":"required to attend these meetings.","text_display":" required to attend these meetings.","confidence":1,"confidence_rate":1},{"cnt":[[303,1343],[780,1343],[780,1399],[303,1399]],"region":{"top_left_x":302,"top_left_y":1342,"width":478,"height":57},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59d7d87b69c44282bdda47c5c5e5527f","type":"section_header","conversion_output":false,"children_ids":["64fa2a203ea043859a30e1623b059cd3"],"text":"","text_display":""},{"cnt":[[305,1349],[776,1349],[776,1394],[305,1394]],"region":{"top_left_x":305,"top_left_y":1349,"width":471,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64fa2a203ea043859a30e1623b059cd3","type":"text","conversion_output":true,"parent_id":"59d7d87b69c44282bdda47c5c5e5527f","text":"11.1.2 Terminating a Site","text_display":"\n\n\\subsection*{11.1.2 Terminating a Site}","confidence":1,"confidence_rate":1},{"cnt":[[305,1392],[1858,1392],[1858,1439],[305,1439]],"region":{"top_left_x":305,"top_left_y":1392,"width":1554,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51024273135c4fa2b6e06cebe53f2d82","type":"text","conversion_output":true,"text":"Any activated site may be terminated from the trial for failure to enroll any subjects, within a","text_display":"\n\nAny activated site may be terminated from the trial for failure to enroll any subjects, within a","confidence":1,"confidence_rate":1},{"cnt":[[305,1437],[1919,1437],[1919,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1437,"width":1614,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7eb494475624af1b65ef96a8e50f3fc","type":"text","conversion_output":true,"text":"reasonable period of time. 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Unless CABANA Administration has consented to any such","confidence":1,"confidence_rate":1},{"cnt":[[309,2443],[1944,2443],[1944,2490],[309,2490]],"region":{"top_left_x":309,"top_left_y":2442,"width":1636,"height":49},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09f3a936d6194cfe95d457c7a9cbdcae","type":"text","conversion_output":true,"text":"deviations in writing, CABANA Administration will not assume any resulting responsibility or","text_display":" deviations in writing, CABANA Administration will not assume any resulting responsibility or","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a546d08d729e4be39550a8194e8795b8","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1841,2574],[1841,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"614edbfa00d6415ebf14555287da7ba1","type":"page_info","conversion_output":false,"text":"Page 49 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-51","page":51,"lines":[{"cnt":[[372,155],[1794,155],[1794,200],[372,200]],"region":{"top_left_x":371,"top_left_y":154,"width":1423,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb31bf902b8942fbb49586714cd0ffde","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[1940,249],[1940,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":1636,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aca25782deca4c9db6019b67ff7bc976","type":"text","conversion_output":true,"text":"liability. Prior approval is generally not expected in situations where unforeseen circumstances","text_display":"\nliability. 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The major goal of CABANAgene is to create the resource.","text_display":" approaches that are anticipated. 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Go AS, Hylek EM, Phillips KA, Chang YC, Henault LE, Selby JV, Singer DE. Prevalence of","text_display":"\n1. Go AS, Hylek EM, Phillips KA, Chang YC, Henault LE, Selby JV, Singer DE. Prevalence of","confidence":1,"confidence_rate":1},{"cnt":[[370,404],[1944,404],[1944,449],[370,449]],"region":{"top_left_x":369,"top_left_y":403,"width":1576,"height":47},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e501fe8655ed40b2a5005f3f7c77b4ad","type":"text","conversion_output":true,"text":"diagnosed AF in Adults. National implications for rhythm management and stroke","text_display":" diagnosed AF in Adults. National implications for rhythm management and stroke","confidence":1,"confidence_rate":1},{"cnt":[[370,447],[1916,447],[1916,492],[370,492]],"region":{"top_left_x":369,"top_left_y":446,"width":1548,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4c1160ac5244d5ba80928f07894b63f","type":"text","conversion_output":true,"text":"prevention: the Anticoagulation and Risk Factors In AF (ATRIA). JAMA 2001; 285:2370-75.","text_display":" prevention: the Anticoagulation and Risk Factors In AF (ATRIA). JAMA 2001; 285:2370-75.","confidence":1,"confidence_rate":1},{"cnt":[[292,490],[1940,490],[1940,537],[292,537]],"region":{"top_left_x":292,"top_left_y":489,"width":1649,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a8af069238c40ecb4cfd3e6575c3084","type":"text","conversion_output":true,"text":"2. Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RBD,","text_display":"\n2. Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RBD,","confidence":1,"confidence_rate":1},{"cnt":[[370,535],[1944,535],[1944,580],[370,580]],"region":{"top_left_x":369,"top_left_y":534,"width":1576,"height":47},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c9cd7ecde8a4a20b198c5cd429ffc07","type":"text","conversion_output":true,"text":"Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of AF. The","text_display":" Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of AF. The","confidence":1,"confidence_rate":1},{"cnt":[[370,578],[1351,578],[1351,625],[370,625]],"region":{"top_left_x":369,"top_left_y":577,"width":983,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"208d64516a2443558fa936e84bf38cef","type":"text","conversion_output":true,"text":"Framingham Heart study. Circulation 2004; 110:1042-46.","text_display":" Framingham Heart study. Circulation 2004; 110:1042-46.","confidence":1,"confidence_rate":1},{"cnt":[[292,623],[1944,623],[1944,668],[292,668]],"region":{"top_left_x":292,"top_left_y":623,"width":1653,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71b8d1db21154d1fa3414b2c576cb5fe","type":"text","conversion_output":true,"text":"3. Greenlee R, Vidaillet H. Recent progress in the epidemiology of atrial fibrillation. Current","text_display":"\n3. Greenlee R, Vidaillet H. Recent progress in the epidemiology of atrial fibrillation. Current","confidence":0.9599802494049072,"confidence_rate":0.9995916577117308},{"cnt":[[370,666],[1046,666],[1046,711],[370,711]],"region":{"top_left_x":369,"top_left_y":666,"width":678,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ad4d55bc78d48f1bda83c15a60fa26c","type":"text","conversion_output":true,"text":"Opinion in Cardiology. 2005;20(1):7-14.","text_display":" Opinion in Cardiology. 2005;20(1):7-14.","confidence":0.9931671619415283,"confidence_rate":0.9998441873950266},{"cnt":[[292,709],[1944,709],[1944,758],[292,758]],"region":{"top_left_x":292,"top_left_y":708,"width":1653,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88622b9157864902a09b0b6f99a04a1c","type":"text","conversion_output":true,"text":"4. Maisel WH, Stevenson LW. AF in heart failure: Epidemiology, pathophysiology, and","text_display":"\n4. Maisel WH, Stevenson LW. 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CATHETER & DESCRIPTION & SIZE & PMA\\# \\\\\n\\hline Biosense Webster & NAVI-STAR & \\(7 F / 4 mm\\) & P990025 \\\\\n\\hline Biosense Webster & NAVI-STAR DS & \\(7 F / 8 mm\\) & P010068 \\\\\n\\hline Biosense Webster & CELSIUS Braided Tip & \\(7 F / 4-5 mm\\) & P950005 \\\\\n\\hline Biosense Webster & CELSIUS Braided Tip & \\(8 F / 4-5 mm\\) & P950005 \\\\\n\\hline Biosense Webster & CELCIUS Long Reach & \\(7 F / 4-5 mm\\) & P950005 \\\\\n\\hline Biosense Webster & CELCIUS Long Reach & \\(8 F / 4-5 mm\\) & P950005 \\\\\n\\hline Biosense Webster & NAVI-STAR \\({ }^{\\text {TM }}\\) and CELSIUS \\({ }^{\\text {TM }}\\) Thermo-Cool & \\(7.5 F / 3.5 mm\\) & P030031 \\\\\n\\hline Biosense Webster & Navistar® RMT & \\(7 F / 4 mm\\) & P990025 \\\\\n\\hline Biosense Webster & Navistar® RMT & \\(7 F / 8 mm\\) & P010068 \\\\\n\\hline Biosense Webster & Celsius® RMT & \\(7 F / 4 mm\\) & P950005 \\\\\n\\hline Biosense Webster & ThermoCool® SF & \\(8 F / 3.5 mm\\) & P990071 \\\\\n\\hline Medtronic Cryocath LP & Freezor® & \\(7 F / 4 mm\\) & P020045 \\\\\n\\hline Medtronic Cryocath LP & Freezor® Xtra & \\(7 F / 6 mm\\) & P020045 \\\\\n\\hline Medtronic Cryocath LP & Freezor® MAX & \\(9 F / 8 mm\\) & P020045 \\\\\n\\hline Medtronic Cryocath LP & Arctic Front(R) & 23 mm 28 mm & P100010 \\\\\n\\hline Medtronic & Cardiac Ablation System & & P100008 \\\\\n\\hline St. Jude Medical & Livewire TC \\({ }^{\\text {™ }}\\) XLS \\({ }^{\\text {™ }}\\) Medium Sweep & \\(7 F / 4 mm\\) & P960016 \\\\\n\\hline St. Jude Medical & Livewire TC \\({ }^{\\text {™ }}\\) XLS \\({ }^{\\text {™ }}\\) Large Sweep & \\(7 F / 4 mm\\) & P960016 \\\\\n\\hline St. Jude Medical & Livewire TC \\({ }^{\\text {™ }}\\) XLS \\({ }^{\\text {™ }}\\) Medium Curl & \\(7 F / 4 mm\\) & P960016 \\\\\n\\hline St. Jude Medical & Livewire TC TM XLS TM Large Curl & \\(7 F / 4 mm\\) & P960016 \\\\\n\\hline St. Jude Medical & Livewire TC ™ XLS ™ Medium Sweep & \\(7 F / 5 mm\\) & P960016/S006 \\\\\n\\hline St. Jude Medical & Livewire TC TM XLS TM Large Sweep & \\(7 F / 5 mm\\) & P960016/S006 \\\\\n\\hline St. Jude Medical & Livewire TC ™ XLS ™ Medium Curl & \\(7 F / 5 mm\\) & P960016/S006 \\\\\n\\hline St. Jude Medical & Livewire TC TM XLS TM Large Curl & \\(7 F / 5 mm\\) & P960016/S006 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {™ }}\\) Dual8-small & \\(7 F / 8 mm\\) & P040042 \\\\\n\\hline St. Jude Medical & Therapy™ Dual 8-medium & \\(7 F / 8 mm\\) & P040042 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {TM }}\\) Dual 8- large & \\(7 F / 8 mm\\) & P040042 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {™ }}\\) Dual 8- X-large & \\(7 F / 8 mm\\) & P040042 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {™ }}\\) Dual -8 extended & \\(7 F / 8 mm\\) & P040042 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {™ }}\\) Dual -8 far reach & \\(7 F / 8 mm\\) & P040042 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {™ }}\\) Thermocouple small & \\(7 F / 4 mm\\) & P040014 \\\\\n\\hline St. Jude Medical & Therapy™ Thermocouple medium & \\(7 F / 4 mm\\) & P040014 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {™ }}\\) Thermocouple large & \\(7 F / 4 mm\\) & P040014 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {™ }}\\) Thermocouple X-large & \\(7 F / 4 mm\\) & P040014 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {™ }}\\) Thermocouple extended & \\(7 F / 4 mm\\) & P040014 \\\\\n\\hline St. Jude Medical & Therapy \\({ }^{\\text {™ }}\\) Thermocouple far reach & \\(7 F / 4 mm\\) & P040014 \\\\\n\\hline St. Jude Medical & Safire \\({ }^{\\text {TM }}\\) Sm/Med/Lg Sweep & \\(7 F / 4 mm\\) & P960016/S014 \\\\\n\\hline St. Jude Medical & Safire \\({ }^{\\text {TM }} Sm / Med / Lg\\) Curl & \\(7 F / 4 mm\\) & P960016/S014 \\\\\n\\hline St. Jude Medical & Safire \\({ }^{\\text {™ }}\\) Sm/Med/Lg Sweep & \\(7 F / 5 mm\\) & P960016/S014 \\\\\n\\hline St. Jude Medical & Safire \\({ }^{\\text {TM }}\\) Sm/Med/Lg Curl & \\(7 F / 5 mm\\) & P960016/S014 \\\\\n\\hline St. Jude Medical & Therapy Cool Path Med Curve & \\(7 F / 5 mm\\) & P060019 \\\\\n\\hline St. Jude Medical & Therapy Cool Path Large Curve & \\(7 F / 5 mm\\) & P060019 \\\\\n\\hline St. Jude Medical & Therapy Cool Path X-Large Med Curve & \\(7 F / 5 mm\\) & P060019 \\\\\n\\hline St. Jude Medical & Therapy Cool Path Flutter Curve & \\(7 F / 5 mm\\) & P060019 \\\\\n\\hline Bard & Stinger & \\(4 \\& 5 mm\\) & P000020 \\\\\n\\hline Boston Scientific & Blazer II RF & \\(7 F / 4 mm\\) & P920047 \\\\\n\\hline Boston Scientific & Blazer II XP & \\(8 F / 8 mm\\) & P020025 \\\\\n\\hline Boston Scientific & Blazer RPM & \\(8 F / 5 mm\\) & P020047 \\\\\n\\hline Boston Scientific & Chilli II Cooled & 7 F 4 mm & P980003 \\\\\n\\hline Boston Scientific & SteeroCath & \\(7 F / 4 mm\\) & P920047 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline CATHETER & DESCRIPTION & SIZE & PMA\\# \\\\\n\\hline Biosense Webster & NAVI-STAR & \\(7 F / 4 mm\\) & P990025 \\\\\n\\hline Biosense Webster & NAVI-STAR DS & \\(7 F / 8 mm\\) & P010068 \\\\\n\\hline Biosense Webster & CELSIUS Braided Tip & \\(7 F / 4-5 mm\\) & P950005 \\\\\n\\hline Biosense Webster & CELSIUS Braided Tip & \\(8 F / 4-5 mm\\) & P950005 \\\\\n\\hline Biosense Webster & CELCIUS Long Reach & \\(7 F / 4-5 mm\\) & P950005 \\\\\n\\hline Biosense Webster & CELCIUS Long Reach & \\(8 F / 4-5 mm\\) & P950005 \\\\\n\\hline Biosense Webster & NAVI-STAR \\({ }^{\\text {TM }}\\) and CELSIUS \\({ }^{\\text {TM }}\\) Thermo-Cool & \\(7.5 F / 3.5 mm\\) & P030031 \\\\\n\\hline Biosense Webster & Navistar® RMT & \\(7 F / 4 mm\\) & P990025 \\\\\n\\hline Biosense Webster & Navistar® RMT & \\(7 F / 8 mm\\) & P010068 \\\\\n\\hline Biosense Webster & Celsius® RMT & \\(7 F / 4 mm\\) & P950005 \\\\\n\\hline Biosense Webster & ThermoCool® SF & \\(8 F / 3.5 mm\\) & P990071 \\\\\n\\hline Medtronic Cryocath LP & Freezor® & \\(7 F / 4 mm\\) & P020045 \\\\\n\\hline 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The traditional approach interrogates a small number of well-","text_display":" their target molecules. The traditional approach interrogates a small number of well","confidence":1,"confidence_rate":1},{"cnt":[[434,1534],[2004,1534],[2004,1579],[434,1579]],"region":{"top_left_x":433,"top_left_y":1533,"width":1572,"height":47},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e264b4d620e4ebd8214722abb2372a0","type":"text","conversion_output":true,"text":"characterized variants in a candidate gene, and relates these to the phenotype of interest; in","text_display":"characterized variants in a candidate gene, and relates these to the phenotype of interest; in","confidence":1,"confidence_rate":1},{"cnt":[[434,1577],[2004,1577],[2004,1624],[434,1624]],"region":{"top_left_x":433,"top_left_y":1576,"width":1572,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94af2ed2687243448c0547b71dadba5e","type":"text","conversion_output":true,"text":"CABANA, such phenotypes may include beneficial drug effect, failure of drug or ablation, or","text_display":" CABANA, such phenotypes may include beneficial drug effect, failure of drug or ablation, or","confidence":1,"confidence_rate":1},{"cnt":[[434,1620],[2004,1620],[2004,1669],[434,1669]],"region":{"top_left_x":433,"top_left_y":1619,"width":1572,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bc5f8a7a1db4935a74760441ac83b2e","type":"text","conversion_output":true,"text":"adverse drug effect. Newer \"next-generation\" sequencing technologies can interrogate","text_display":" adverse drug effect. Newer \"next-generation\" sequencing technologies can interrogate","confidence":1,"confidence_rate":1},{"cnt":[[432,1663],[2004,1663],[2004,1712],[432,1712]],"region":{"top_left_x":431,"top_left_y":1662,"width":1574,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df9434adc0554f3ebb548151d6a9921f","type":"text","conversion_output":true,"text":"whole candidate genes or pathways, and analytical approaches to identifying true positive","text_display":" whole candidate genes or pathways, and analytical approaches to identifying true positive","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[434,1710],[1106,1710],[1106,1755],[434,1755]],"region":{"top_left_x":433,"top_left_y":1710,"width":674,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0160b8d2db01463a9ce11f1188c9145a","type":"text","conversion_output":true,"text":"signals in this work are in development.","text_display":" signals in this work are in development.","confidence":1,"confidence_rate":1},{"cnt":[[391,1749],[2004,1749],[2004,1798],[391,1798]],"region":{"top_left_x":391,"top_left_y":1748,"width":1614,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d099cb0bd2c46c0a4943daed9a3ec96","type":"text","conversion_output":true,"text":"3. \"Unbiased\" approaches: Human genomes contain millions of common polymorphisms, such","text_display":"\n3. \"Unbiased\" approaches: Human genomes contain millions of common polymorphisms, such","confidence":1,"confidence_rate":1},{"cnt":[[434,1796],[2004,1796],[2004,1841],[434,1841]],"region":{"top_left_x":433,"top_left_y":1796,"width":1572,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8335853a80b64bb888066de47815a688","type":"text","conversion_output":true,"text":"as single nucleotide polymorphisms (SNPs) or copy number variations (CNVs). The","text_display":" as single nucleotide polymorphisms (SNPs) or copy number variations (CNVs). The","confidence":1,"confidence_rate":1},{"cnt":[[434,1835],[2004,1835],[2004,1888],[434,1888]],"region":{"top_left_x":433,"top_left_y":1834,"width":1572,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2ad7a6e7aa3409186cee5b8fbe9c621","type":"text","conversion_output":true,"text":"genome-wide association study (GWAS) paradigm \\({ }^{8,9}\\) compares hundreds of thousands of","text_display":" genome-wide association study (GWAS) paradigm \\({ }^{8,9}\\) compares hundreds of thousands of","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[434,1882],[2004,1882],[2004,1931],[434,1931]],"region":{"top_left_x":433,"top_left_y":1882,"width":1572,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3103024a7c8e4add8ea1fa29dbc5af2b","type":"text","conversion_output":true,"text":"such variants in cases and controls (or across a continuous trait) to identify, in an unbiased","text_display":" such variants in cases and controls (or across a continuous trait) to identify, in an unbiased","confidence":1,"confidence_rate":1},{"cnt":[[432,1927],[2004,1927],[2004,1974],[432,1974]],"region":{"top_left_x":431,"top_left_y":1927,"width":1574,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"702d6172f03c4885afc2f80b6cf2ca0c","type":"text","conversion_output":true,"text":"fashion, loci modulating the trait. Because GWAS searches for common variants that confer","text_display":" fashion, loci modulating the trait. Because GWAS searches for common variants that confer","confidence":1,"confidence_rate":1},{"cnt":[[434,1968],[2004,1968],[2004,2017],[434,2017]],"region":{"top_left_x":433,"top_left_y":1967,"width":1572,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b2dba1f0e5a44b2a0918df2cbd2dcf7","type":"text","conversion_output":true,"text":"modest odds ratios, large cohorts are required, \\({ }^{10,11}\\) and there is a high risk of false positive","text_display":" modest odds ratios, large cohorts are required, \\({ }^{10,11}\\) and there is a high risk of false positive","confidence":1,"confidence_rate":1},{"cnt":[[434,2015],[2004,2015],[2004,2065],[434,2065]],"region":{"top_left_x":433,"top_left_y":2015,"width":1572,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"972831b2843e4ddcbd072e145231edeb","type":"text","conversion_output":true,"text":"associations; thus, the accrual of a very large well-ascertained cohorts (as in this proposal)","text_display":" associations; thus, the accrual of a very large well-ascertained cohorts (as in this proposal)","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[434,2058],[2004,2058],[2004,2108],[434,2108]],"region":{"top_left_x":433,"top_left_y":2058,"width":1572,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c492262c103491d9ef3a5787928c73e","type":"text","conversion_output":true,"text":"represents an important enabling tool for these studies. A compromise approach has been","text_display":" represents an important enabling tool for these studies. A compromise approach has been","confidence":1,"confidence_rate":1},{"cnt":[[434,2105],[2004,2105],[2004,2151],[434,2151]],"region":{"top_left_x":433,"top_left_y":2105,"width":1572,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4527423820f49319ed7e83c77a20afc","type":"text","conversion_output":true,"text":"to focus not on high priority single genes or single variants, but to cast a somewhat wider","text_display":" to focus not on high priority single genes or single variants, but to cast a somewhat wider","confidence":1,"confidence_rate":1},{"cnt":[[434,2144],[2004,2144],[2004,2194],[434,2194]],"region":{"top_left_x":433,"top_left_y":2144,"width":1572,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e78eb6e02bf74e77a493765158057265","type":"text","conversion_output":true,"text":"net and focus on variation in genes within a \"pathway\", e.g. a cholesterol \\({ }^{12}\\) or thrombosis","text_display":" net and focus on variation in genes within a \"pathway\", e.g. a cholesterol \\({ }^{12}\\) or thrombosis","confidence":1,"confidence_rate":1},{"cnt":[[434,2191],[2004,2191],[2004,2239],[434,2239]],"region":{"top_left_x":433,"top_left_y":2191,"width":1572,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f54ef9498ae4826abd5cb7c4d01a7e3","type":"text","conversion_output":true,"text":"\"pathway\". Indeed, this approach has been adopted to interrogate \\(>1500\\) SNPs in 18","text_display":" \"pathway\". Indeed, this approach has been adopted to interrogate \\(>1500\\) SNPs in 18","confidence":0.9990234375,"confidence_rate":0.9999888973383643},{"cnt":[[432,2234],[2004,2234],[2004,2282],[432,2282]],"region":{"top_left_x":431,"top_left_y":2234,"width":1574,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20074970f80849089208897eff308168","type":"text","conversion_output":true,"text":"candidate genes in an \"arrhythmia drug response pathway\" to study determinants of drug-","text_display":" candidate genes in an \"arrhythmia drug response pathway\" to study determinants of drug","confidence":1,"confidence_rate":1},{"cnt":[[434,2273],[1079,2273],[1079,2327],[434,2327]],"region":{"top_left_x":433,"top_left_y":2273,"width":646,"height":54},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"867d89f443e844d8b642da25b7f2c50b","type":"text","conversion_output":true,"text":"induced arrhythmias, among others. \\({ }^{13}\\)","text_display":"induced arrhythmias, among others. \\({ }^{13}\\)","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"12fc7f5360794548b89390f76c935945","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1841,2574],[1841,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05692e66530249adac7b70aae7eae48f","type":"page_info","conversion_output":false,"text":"Page 67 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-69","page":69,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae758eb909ee43f1bc0071790da0deec","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[303,245],[956,245],[956,303],[303,303]],"region":{"top_left_x":302,"top_left_y":244,"width":655,"height":59},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a06e6c70fe554f90a47e6646b35cb0c3","type":"section_header","conversion_output":false,"children_ids":["69806c78868b4c0c879ca8a1c2d6ea69"],"text":"","text_display":""},{"cnt":[[305,249],[952,249],[952,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":647,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69806c78868b4c0c879ca8a1c2d6ea69","type":"text","conversion_output":true,"parent_id":"a06e6c70fe554f90a47e6646b35cb0c3","text":"2.0 Rationale and Specific Aims","text_display":"\n\n\\subsection*{2.0 Rationale and Specific Aims}","confidence":0.9931671619415283,"confidence_rate":0.999809565668786},{"cnt":[[305,305],[1981,305],[1981,352],[305,352]],"region":{"top_left_x":305,"top_left_y":305,"width":1676,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"366d00e6712b4061ae03569b01279ad4","type":"text","conversion_output":true,"text":"The primary goal of the Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation","text_display":"\n\nThe primary goal of the Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation","confidence":0.99365234375,"confidence_rate":0.9999393552838918},{"cnt":[[305,348],[2002,348],[2002,397],[305,397]],"region":{"top_left_x":305,"top_left_y":348,"width":1698,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7b6c4642d5e47d7984c121ba5a83dff","type":"text","conversion_output":true,"text":"(CABANA) trial is to establish appropriate roles for medical and ablative intervention by randomizing","text_display":" (CABANA) trial is to establish appropriate roles for medical and ablative intervention by randomizing","confidence":0.998046875,"confidence_rate":0.9999815564452184},{"cnt":[[305,391],[1790,391],[1790,440],[305,440]],"region":{"top_left_x":305,"top_left_y":391,"width":1485,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfe61251403d4f91aa9089c3036333c1","type":"text","conversion_output":true,"text":"\\(2,000-2,200\\) patients. This protocol will create CABANAgene: a resource that will","text_display":" \\(2,000-2,200\\) patients. This protocol will create CABANAgene: a resource that will","confidence":0.986328125,"confidence_rate":0.9998361301452251},{"cnt":[[305,436],[1820,436],[1820,486],[305,486]],"region":{"top_left_x":305,"top_left_y":436,"width":1515,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e3cc519c75948bd85b2165d7f4fc427","type":"text","conversion_output":true,"text":"accumulate DNA samples from CABANA subjects to enable subsequent genotype-","text_display":" accumulate DNA samples from CABANA subjects to enable subsequent genotype","confidence":1,"confidence_rate":1},{"cnt":[[305,481],[1424,481],[1424,526],[305,526]],"region":{"top_left_x":305,"top_left_y":481,"width":1120,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7d44c0aa4fe49e8827665fd925943a7","type":"text","conversion_output":true,"text":"phenotype studies, based on the rationales described above.","text_display":"phenotype studies, based on the rationales described above.","confidence":1,"confidence_rate":1},{"cnt":[[305,524],[1364,524],[1364,574],[305,574]],"region":{"top_left_x":305,"top_left_y":524,"width":1060,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8da8481c2d2455298e325eb8ff5e5dd","type":"text","conversion_output":true,"text":"Examples of issues that CABANAgene could address include:","text_display":"\nExamples of issues that CABANAgene could address include:","confidence":1,"confidence_rate":1},{"cnt":[[432,571],[1678,571],[1678,621],[432,621]],"region":{"top_left_x":431,"top_left_y":571,"width":1247,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34f54d78ed254a3099ab5acba9f42f92","type":"text","conversion_output":true,"text":"- predictors of response to antiarrhythmic or rate control drug therapies","text_display":"\n- predictors of response to antiarrhythmic or rate control drug 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CABANA","confidence":1,"confidence_rate":1},{"cnt":[[305,1109],[2004,1109],[2004,1158],[305,1158]],"region":{"top_left_x":305,"top_left_y":1108,"width":1700,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aee9c13b1d984b7985e444516de58e60","type":"text","conversion_output":true,"text":"Executive Committee. The CABANAgene project is included in the Pharmacogenetics of Arrhythmia","text_display":" Executive Committee. The CABANAgene project is included in the Pharmacogenetics of Arrhythmia","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,1152],[1893,1152],[1893,1201],[305,1201]],"region":{"top_left_x":305,"top_left_y":1151,"width":1588,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea64662f5c374d439c74591ff519d52d","type":"text","conversion_output":true,"text":"Therapy (PAT) node of the Pharmacogenomics Research Network (PGRN). CABANAgene's","text_display":" Therapy (PAT) node of the Pharmacogenomics Research Network (PGRN). CABANAgene's","confidence":1,"confidence_rate":1},{"cnt":[[305,1195],[1876,1195],[1876,1244],[305,1244]],"region":{"top_left_x":305,"top_left_y":1194,"width":1571,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"350fd986ac0144b08f2881edeed583da","type":"text","conversion_output":true,"text":"participation under the PGRN umbrella will also provide access to advanced genotyping and","text_display":" participation under the PGRN umbrella will also provide access to advanced genotyping and","confidence":1,"confidence_rate":1},{"cnt":[[305,1242],[1068,1242],[1068,1291],[305,1291]],"region":{"top_left_x":305,"top_left_y":1241,"width":763,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6100197a05645d58d2458df68942cad","type":"text","conversion_output":true,"text":"genetic statistical methods via this resource.","text_display":" genetic statistical methods via this resource.","confidence":1,"confidence_rate":1},{"cnt":[[301,1319],[898,1319],[898,1373],[301,1373]],"region":{"top_left_x":300,"top_left_y":1319,"width":599,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0a3a1072cc34e519be08838ec4a2e6c","type":"section_header","conversion_output":false,"children_ids":["a120215f72c1465c8cacf4b73ae55876"],"text":"","text_display":""},{"cnt":[[305,1323],[892,1323],[892,1369],[305,1369]],"region":{"top_left_x":305,"top_left_y":1323,"width":587,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a120215f72c1465c8cacf4b73ae55876","type":"text","conversion_output":true,"parent_id":"b0a3a1072cc34e519be08838ec4a2e6c","text":"3.0 Previous Human Studies","text_display":"\n\n\\subsection*{3.0 Previous Human Studies}","confidence":1,"confidence_rate":1},{"cnt":[[305,1379],[1796,1379],[1796,1429],[305,1429]],"region":{"top_left_x":305,"top_left_y":1379,"width":1492,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8852ab0c9c7f413eabfa71320d9ed2b8","type":"text","conversion_output":true,"text":"PAT investigators, in collaboration with other arrhythmia groups around the country and","text_display":"\n\nPAT investigators, in collaboration with other arrhythmia groups around the country and","confidence":1,"confidence_rate":1},{"cnt":[[305,1422],[1912,1422],[1912,1472],[305,1472]],"region":{"top_left_x":305,"top_left_y":1422,"width":1608,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a95dc1aeab3c40829db159c5df98ab99","type":"text","conversion_output":true,"text":"internationally, have used family studies, candidate gene studies, and unbiased approaches to","text_display":" internationally, have used family studies, candidate gene studies, and unbiased approaches to","confidence":1,"confidence_rate":1},{"cnt":[[305,1470],[1949,1470],[1949,1515],[305,1515]],"region":{"top_left_x":305,"top_left_y":1469,"width":1644,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"950e79fa0eb64d3897f495541a746bed","type":"text","conversion_output":true,"text":"identify genetic predictors of variability in AF susceptibility and in response to drugs used to treat","text_display":" identify genetic predictors of variability in AF susceptibility and in response to drugs used to treat","confidence":1,"confidence_rate":1},{"cnt":[[305,1512],[2000,1512],[2000,1560],[305,1560]],"region":{"top_left_x":305,"top_left_y":1512,"width":1696,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3d4ffd2184241c987b8eb953973c436","type":"text","conversion_output":true,"text":"AF. Examples of these findings are presented here in brief to illustrate the value of a resource such","text_display":" AF. Examples of these findings are presented here in brief to illustrate the value of a resource such","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[305,1555],[1936,1555],[1936,1605],[305,1605]],"region":{"top_left_x":305,"top_left_y":1555,"width":1631,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"442a9d3ed72a4a60acd9e205a76444f9","type":"text","conversion_output":true,"text":"as CABANAgene with well-phenotyped patients and outcomes in advancing AF-related genome","text_display":" as CABANAgene with well-phenotyped patients and outcomes in advancing AF-related genome","confidence":1,"confidence_rate":1},{"cnt":[[305,1601],[1966,1601],[1966,1648],[305,1648]],"region":{"top_left_x":305,"top_left_y":1600,"width":1661,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d30713738c6841babfadacd257ed393e","type":"text","conversion_output":true,"text":"science. One important conclusion to draw from the studies presented is that large datasets, such","text_display":" science. One important conclusion to draw from the studies presented is that large datasets, such","confidence":1,"confidence_rate":1},{"cnt":[[305,1641],[1992,1641],[1992,1691],[305,1691]],"region":{"top_left_x":305,"top_left_y":1641,"width":1687,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d30239453b3441f0a5296c835bf2dcd6","type":"text","conversion_output":true,"text":"as Framingham, the Vanderbilt AF registry, the German AF network, or CABANAgene are enabling","text_display":" as Framingham, the Vanderbilt AF registry, the German AF network, or CABANAgene are enabling","confidence":1,"confidence_rate":1},{"cnt":[[305,1684],[1940,1684],[1940,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1684,"width":1636,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6c5bd0e5ef24957b8b68570598ddd6b","type":"text","conversion_output":true,"text":"for contemporary unbiased genomic studies. \\({ }^{14-17}\\) In addition, large datasets permit the accrual of","text_display":" for contemporary unbiased genomic studies. \\({ }^{14-17}\\) In addition, large datasets permit the accrual of","confidence":0.96142578125,"confidence_rate":0.9996519375124063},{"cnt":[[305,1732],[1876,1732],[1876,1781],[305,1781]],"region":{"top_left_x":305,"top_left_y":1731,"width":1571,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cd272d7db004d209706080573f50133","type":"text","conversion_output":true,"text":"subjects with specific intermediate phenotypes that may relate to AF risk. Examples of such","text_display":" subjects with specific intermediate phenotypes that may relate to AF risk. Examples of such","confidence":0.9833984375,"confidence_rate":0.9998256306949188},{"cnt":[[305,1770],[1897,1770],[1897,1824],[305,1824]],"region":{"top_left_x":305,"top_left_y":1770,"width":1593,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"789442a646fd4227b4d60accb05a2574","type":"text","conversion_output":true,"text":"phenotypes include prolonged P wave duration, \\({ }^{4}\\) atrial fibrillatory rate derived from frequency-","text_display":" phenotypes include prolonged P wave duration, \\({ }^{4}\\) atrial fibrillatory rate derived from frequency","confidence":1,"confidence_rate":1},{"cnt":[[305,1813],[1998,1813],[1998,1867],[305,1867]],"region":{"top_left_x":305,"top_left_y":1813,"width":1694,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b43016ab8de340dfacf42a4db5745129","type":"text","conversion_output":true,"text":"domain analysis of surface ECGs during AF, \\({ }^{18}\\) and right precordial J point elevation, that is reported","text_display":"domain analysis of surface ECGs during AF, \\({ }^{18}\\) and right precordial J point elevation, that is reported","confidence":0.98876953125,"confidence_rate":0.9999034746877672},{"cnt":[[305,1858],[1927,1858],[1927,1910],[305,1910]],"region":{"top_left_x":305,"top_left_y":1858,"width":1623,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57f0afcd184f43dab00bdfdcf31caaae","type":"text","conversion_output":true,"text":"to be common in lone \\(AF ^{19}\\) and that we have observed with AF-associated mutations in sodium","text_display":" to be common in lone \\(AF ^{19}\\) and that we have observed with AF-associated mutations in sodium","confidence":0.8357491547712925,"confidence_rate":0.9983400203574095},{"cnt":[[305,1901],[1949,1901],[1949,1957],[305,1957]],"region":{"top_left_x":305,"top_left_y":1901,"width":1644,"height":57},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32cc34cf52f5427ea80ff1af9a549cab","type":"text","conversion_output":true,"text":"channel genes. \\({ }^{20}\\) A resource such as CABANAgene will allow much more rigorous exploration of","text_display":" channel genes. \\({ }^{20}\\) A resource such as CABANAgene will allow much more rigorous exploration of","confidence":1,"confidence_rate":1},{"cnt":[[305,1951],[1938,1951],[1938,2000],[305,2000]],"region":{"top_left_x":305,"top_left_y":1950,"width":1633,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41ac4ca605d04656a0b98b34c8a4b143","type":"text","conversion_output":true,"text":"the relationships among these endophenotypes, genetic variants that underlie them, and clinical","text_display":" the relationships among these endophenotypes, genetic variants that underlie them, and clinical","confidence":1,"confidence_rate":1},{"cnt":[[305,1994],[544,1994],[544,2039],[305,2039]],"region":{"top_left_x":305,"top_left_y":1993,"width":239,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bef0be1f2bb04581a1fdcdfbc002ddc0","type":"text","conversion_output":true,"text":"course in AF.","text_display":" course in AF.","confidence":1,"confidence_rate":1},{"cnt":[[425,2075],[711,2075],[711,2133],[425,2133]],"region":{"top_left_x":425,"top_left_y":2075,"width":287,"height":59},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be825f0aa69140bfb8c595cfa050ca90","type":"section_header","conversion_output":false,"children_ids":["5f04c26805594e148b646c4f2bf550b1"],"text":"","text_display":""},{"cnt":[[432,2080],[707,2080],[707,2129],[432,2129]],"region":{"top_left_x":431,"top_left_y":2079,"width":276,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f04c26805594e148b646c4f2bf550b1","type":"text","conversion_output":true,"parent_id":"be825f0aa69140bfb8c595cfa050ca90","text":"Family studies","text_display":"\n\n\\section*{Family studies}","confidence":1,"confidence_rate":1},{"cnt":[[305,2133],[1790,2133],[1790,2185],[305,2185]],"region":{"top_left_x":305,"top_left_y":2133,"width":1485,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7be70f686adc4e9f9a606bc137be61b6","type":"text","conversion_output":true,"text":"With the support of the NHLBI's Resequencing and Genotyping (RS\\&G) resource, PAT","text_display":"\n\nWith the support of the NHLBI's Resequencing and Genotyping (RS\\&G) resource, PAT","confidence":0.71240234375,"confidence_rate":0.9960183896242316},{"cnt":[[305,2179],[1929,2179],[1929,2228],[305,2228]],"region":{"top_left_x":305,"top_left_y":2178,"width":1625,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1653cfa29e7b457e904830405329aac1","type":"text","conversion_output":true,"text":"investigators screened subjects in the Vanderbilt AF Registry for variants in genes encoding ion","text_display":" investigators screened subjects in the Vanderbilt AF Registry for variants in genes encoding ion","confidence":1,"confidence_rate":1},{"cnt":[[305,2224],[1876,2224],[1876,2271],[305,2271]],"region":{"top_left_x":305,"top_left_y":2223,"width":1571,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb9c8d0b234146c1accf4cc22cf9b43b","type":"text","conversion_output":true,"text":"candidate channel subunits (KCNQ1, KCNE1-5, KCNJ2, KCNA5, sodium channel [ \\(\\alpha\\) - and \\(\\beta\\) -","text_display":" candidate channel subunits (KCNQ1, KCNE1-5, KCNJ2, KCNA5, sodium channel [ \\(\\alpha\\) - and \\(\\beta\\) ","confidence":0.9907476719275792,"confidence_rate":0.9999041757592452},{"cnt":[[305,2262],[1953,2262],[1953,2316],[305,2316]],"region":{"top_left_x":305,"top_left_y":2262,"width":1648,"height":55},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1756bb44a7784189acb13ac2ced8c0ac","type":"text","conversion_output":true,"text":"subunits], L-type \\(Ca ^{2+}\\) ) and non-ion channel protein candidates (connexin40, PITX2, ANP). Non-","text_display":"subunits], L-type \\(Ca ^{2+}\\) ) and non-ion channel protein candidates (connexin40, PITX2, ANP). Non","confidence":1,"confidence_rate":1},{"cnt":[[305,2312],[2004,2312],[2004,2361],[305,2361]],"region":{"top_left_x":305,"top_left_y":2311,"width":1700,"height":51},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6231b0026d15480b96be45dc487a38ba","type":"text","conversion_output":true,"text":"synonymous variants in sodium channel \\(\\alpha\\)-subunits, \\(\\beta\\)-subunits, and potassium channels have been","text_display":"synonymous variants in sodium channel \\(\\alpha\\)-subunits, \\(\\beta\\)-subunits, and potassium channels have been","confidence":0.7548828125,"confidence_rate":0.9973754803977438},{"cnt":[[305,2355],[1998,2355],[1998,2404],[305,2404]],"region":{"top_left_x":305,"top_left_y":2354,"width":1694,"height":51},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"059e51ef0e1e42ddba0849b54e35efce","type":"text","conversion_output":true,"text":"identified in \\(\\sim 10 \\%\\) of subjects. These cosegregate in extended kindreds (where they are available),","text_display":" identified in \\(\\sim 10 \\%\\) of subjects. These cosegregate in extended kindreds (where they are available),","confidence":1,"confidence_rate":1},{"cnt":[[305,2393],[1962,2393],[1962,2447],[305,2447]],"region":{"top_left_x":305,"top_left_y":2393,"width":1657,"height":55},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75543055ee1249c8bc58f859ad68db52","type":"text","conversion_output":true,"text":"and those studied to date show abnormal electrophysiology in vitro. \\({ }^{5,20,21}\\) One common feature in","text_display":" and those studied to date show abnormal electrophysiology in vitro. \\({ }^{5,20,21}\\) One common feature in","confidence":1,"confidence_rate":1},{"cnt":[[305,2443],[1880,2443],[1880,2494],[305,2494]],"region":{"top_left_x":305,"top_left_y":2442,"width":1575,"height":53},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7287ada745e54cf38083211c7e6b3bd1","type":"text","conversion_output":true,"text":"these kindreds is that penetrance is variable; that is, each kindred includes multiple mutation","text_display":" these kindreds is that penetrance is variable; that is, each kindred includes multiple mutation","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[969,2574],[969,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":664,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21cc0624669d4e689dd2960a12fcd8f8","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,2574],[1841,2574],[1841,2619],[1611,2619]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":46},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bfaff60202c3481a818589c1c98cd814","type":"page_info","conversion_output":false,"text":"Page 68 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-70","page":70,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1bec0829ba243248b3e8ab3d4387f0f","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[309,251],[1972,251],[1972,299],[309,299]],"region":{"top_left_x":309,"top_left_y":251,"width":1664,"height":48},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e6decdb8fb047ada159b789d54b94ad","type":"text","conversion_output":true,"text":"carriers with early onset AF as well as other mutation carriers with no AF by age 50 . As described","text_display":"\ncarriers with early onset AF as well as other mutation carriers with no AF by age 50 . As described","confidence":0.9297513999044895,"confidence_rate":0.9993195022931947},{"cnt":[[309,296],[1854,296],[1854,342],[309,342]],"region":{"top_left_x":309,"top_left_y":296,"width":1546,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f176f2fc083f4d8aa4b407d7ae190a95","type":"text","conversion_output":true,"text":"below, GWAS has identified common variants at chromosome 4q25 as risk factors for atrial","text_display":" below, GWAS has identified common variants at chromosome 4q25 as risk factors for atrial","confidence":0.85595703125,"confidence_rate":0.9983289772723506},{"cnt":[[309,339],[1987,339],[1987,385],[309,385]],"region":{"top_left_x":309,"top_left_y":339,"width":1679,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cdcaa03e8f3432db8e1ffdcb97d2d94","type":"text","conversion_output":true,"text":"fibrillation. We studied 12 families in which AF was present in \\(\\geq 2\\) individuals who also shared a rare","text_display":" fibrillation. We studied 12 families in which AF was present in \\(\\geq 2\\) individuals who also shared a rare","confidence":0.998046875,"confidence_rate":0.9999825444841725},{"cnt":[[309,382],[1953,382],[1953,432],[309,432]],"region":{"top_left_x":309,"top_left_y":382,"width":1644,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79c71371dc964c0293ce49bc0d9e4d24","type":"text","conversion_output":true,"text":"genetic variant in ion channel or related genes thought to cause familial AF. There were a total of","text_display":" genetic variant in ion channel or related genes thought to cause familial AF. There were a total of","confidence":1,"confidence_rate":1},{"cnt":[[309,430],[1946,430],[1946,475],[309,475]],"region":{"top_left_x":309,"top_left_y":429,"width":1638,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35695b61a0bb4efb9694103b1f2908eb","type":"text","conversion_output":true,"text":"33 subjects with AF before age 40 and 17 mutation carriers who had reached age 50 without AF.","text_display":" 33 subjects with AF before age 40 and 17 mutation carriers who had reached age 50 without AF.","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[309,471],[1964,471],[1964,518],[309,518]],"region":{"top_left_x":309,"top_left_y":470,"width":1655,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bb68eb1f7224c9aa016cd44ddeef33a","type":"text","conversion_output":true,"text":"We found a very highly statistically significant association between the presence of common 4q25","text_display":" We found a very highly statistically significant association between the presence of common 4q25","confidence":1,"confidence_rate":1},{"cnt":[[309,511],[1923,511],[1923,561],[309,561]],"region":{"top_left_x":309,"top_left_y":511,"width":1614,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e90d945cd45540a9a67cbafd01f43d85","type":"text","conversion_output":true,"text":"variants and clinical AF in these families ( \\(P <10^{-9}\\) ): that is, those family members with AF carried","text_display":" variants and clinical AF in these families ( \\(P <10^{-9}\\) ): that is, those family members with AF carried","confidence":0.874507550150156,"confidence_rate":0.9988642526456813},{"cnt":[[309,559],[1970,559],[1970,604],[309,604]],"region":{"top_left_x":309,"top_left_y":558,"width":1662,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77dbd94a0cf3449c9bc2547e1b0433c1","type":"text","conversion_output":true,"text":"both rare mutation as well the common susceptibility allele, while those with only the rare mutation","text_display":" both rare mutation as well the common susceptibility allele, while those with only the rare mutation","confidence":1,"confidence_rate":1},{"cnt":[[309,602],[1983,602],[1983,649],[309,649]],"region":{"top_left_x":309,"top_left_y":601,"width":1675,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"892f5f1d69684ed7b8718777022be3f2","type":"text","conversion_output":true,"text":"(without the 4 q 25 susceptibility allele) did not display AF. \\({ }^{22}\\) These data support the overall concept","text_display":" (without the 4 q 25 susceptibility allele) did not display AF. \\({ }^{22}\\) These data support the overall concept","confidence":0.8205242156982422,"confidence_rate":0.9983930660353754},{"cnt":[[309,647],[1936,647],[1936,694],[309,694]],"region":{"top_left_x":309,"top_left_y":646,"width":1627,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9be89c564374c39a91a730c0a237cb0","type":"text","conversion_output":true,"text":"that AF risk includes multiple genomic components; identifying these components requires large","text_display":" that AF risk includes multiple genomic components; identifying these components requires large","confidence":1,"confidence_rate":1},{"cnt":[[309,692],[1966,692],[1966,735],[309,735]],"region":{"top_left_x":309,"top_left_y":691,"width":1657,"height":44},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b840bf8f648641349f053d326c21b278","type":"text","conversion_output":true,"text":"datasets. In addition, the rare ion channel and other variants that we and others have identified in","text_display":" datasets. In addition, the rare ion channel and other variants that we and others have identified in","confidence":1,"confidence_rate":1},{"cnt":[[309,735],[1919,735],[1919,780],[309,780]],"region":{"top_left_x":309,"top_left_y":734,"width":1610,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e57fa8e25de44fba9d12b05a628a6ea","type":"text","conversion_output":true,"text":"patients with AF have obvious (but as yet untested) therapeutic implications. A gain of function","text_display":" patients with AF have obvious (but as yet untested) therapeutic implications. A gain of function","confidence":0.998046875,"confidence_rate":0.9999806434067887},{"cnt":[[309,780],[1919,780],[1919,827],[309,827]],"region":{"top_left_x":309,"top_left_y":779,"width":1610,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9620791fddd0426dbf01e2044f8ad9d8","type":"text","conversion_output":true,"text":"potassium channel mutation would be predicted to respond to a potassium blocking drug, while","text_display":" potassium channel mutation would be predicted to respond to a potassium blocking drug, while","confidence":1,"confidence_rate":1},{"cnt":[[309,821],[1876,821],[1876,870],[309,870]],"region":{"top_left_x":309,"top_left_y":820,"width":1567,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dc5ae11466446d393a1809133b87fb0","type":"text","conversion_output":true,"text":"sodium channel blockers would be predicted to be ineffective (and possibly proarrhythmic) in","text_display":" sodium channel blockers would be predicted to be ineffective (and possibly proarrhythmic) in","confidence":1,"confidence_rate":1},{"cnt":[[309,868],[1592,868],[1592,913],[309,913]],"region":{"top_left_x":309,"top_left_y":867,"width":1283,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"383fafae81ac4f1cb8a390680d8b20a3","type":"text","conversion_output":true,"text":"subjects with AF arising from slow conduction or decreased sodium current.","text_display":" subjects with AF arising from slow conduction or decreased sodium current.","confidence":1,"confidence_rate":1},{"cnt":[[430,950],[872,950],[872,999],[430,999]],"region":{"top_left_x":429,"top_left_y":949,"width":444,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58dd378c26ea4164bec849288046dee7","type":"section_header","conversion_output":false,"children_ids":["f0d98f5d59cb4333b58424d89a3d2097"],"text":"","text_display":""},{"cnt":[[434,954],[870,954],[870,999],[434,999]],"region":{"top_left_x":433,"top_left_y":953,"width":438,"height":47},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0d98f5d59cb4333b58424d89a3d2097","type":"text","conversion_output":true,"parent_id":"58dd378c26ea4164bec849288046dee7","text":"Candidate gene studies","text_display":"\n\n\\section*{Candidate gene studies}","confidence":1,"confidence_rate":1},{"cnt":[[309,1008],[1895,1008],[1895,1053],[309,1053]],"region":{"top_left_x":309,"top_left_y":1007,"width":1586,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"046ea4f096d4459a85cf8924ed35ecee","type":"text","conversion_output":true,"text":"Candidate gene approaches have been especially useful in pharmacogenomics, where single","text_display":"\n\nCandidate gene approaches have been especially useful in pharmacogenomics, where single","confidence":1,"confidence_rate":1},{"cnt":[[309,1053],[1809,1053],[1809,1096],[309,1096]],"region":{"top_left_x":309,"top_left_y":1052,"width":1500,"height":44},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d30459851b2445abfcaa8d023d9ed98","type":"text","conversion_output":true,"text":"variants in genes responsible for drug disposition or for the interaction of drugs with their","text_display":" variants in genes responsible for drug disposition or for the interaction of drugs with their","confidence":1,"confidence_rate":1},{"cnt":[[309,1091],[1981,1091],[1981,1141],[309,1141]],"region":{"top_left_x":309,"top_left_y":1091,"width":1672,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b387dd01357d45d9ada315aa9f0adade","type":"text","conversion_output":true,"text":"pharmacologic targets may produce large and clinically important variability in drug action. \\({ }^{1}\\) This is","text_display":" pharmacologic targets may produce large and clinically important variability in drug action. \\({ }^{1}\\) This is","confidence":1,"confidence_rate":1},{"cnt":[[309,1139],[1815,1139],[1815,1184],[309,1184]],"region":{"top_left_x":309,"top_left_y":1138,"width":1507,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca0ce4343d4f4cccb811f1ddb9651cd4","type":"text","conversion_output":true,"text":"especially the case for drugs with narrow therapeutic indexes such as antiarrhythmic and","text_display":" especially the case for drugs with narrow therapeutic indexes such as antiarrhythmic and","confidence":1,"confidence_rate":1},{"cnt":[[309,1182],[1983,1182],[1983,1227],[309,1227]],"region":{"top_left_x":309,"top_left_y":1181,"width":1675,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e89159f791864ea69c439c1d4c3929bd","type":"text","conversion_output":true,"text":"anticoagulant agents. We and many others (including the International Warfarin Pharmacogenomic","text_display":" anticoagulant agents. We and many others (including the International Warfarin Pharmacogenomic","confidence":1,"confidence_rate":1},{"cnt":[[309,1220],[1996,1220],[1996,1274],[309,1274]],"region":{"top_left_x":309,"top_left_y":1220,"width":1687,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d56cee884594f0bbe8ed02eb1e747fa","type":"text","conversion_output":true,"text":"Consortium) \\({ }^{23-27}\\) have shown that \\(\\sim 50 \\%\\) of the variability in warfarin steady state dose is determined","text_display":" Consortium) \\({ }^{23-27}\\) have shown that \\(\\sim 50 \\%\\) of the variability in warfarin steady state dose is determined","confidence":0.9547732891514897,"confidence_rate":0.9996111566255549},{"cnt":[[309,1268],[2000,1268],[2000,1317],[309,1317]],"region":{"top_left_x":309,"top_left_y":1267,"width":1692,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7964c4f6e1c41458461ace2a30545b1","type":"text","conversion_output":true,"text":"by variants in CYP2C9 (responsible for the drug's metabolism) and VKORC1 (encoding the warfarin","text_display":" by variants in CYP2C9 (responsible for the drug's metabolism) and VKORC1 (encoding the warfarin","confidence":1,"confidence_rate":1},{"cnt":[[309,1315],[1837,1315],[1837,1360],[309,1360]],"region":{"top_left_x":309,"top_left_y":1314,"width":1528,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d4827b67801417dbe1ea41d590eb02c","type":"text","conversion_output":true,"text":"target). In addition, PAT investigators have shown that the time to initial anticoagulation is","text_display":" target). In addition, PAT investigators have shown that the time to initial anticoagulation is","confidence":1,"confidence_rate":1},{"cnt":[[309,1358],[1895,1358],[1895,1403],[309,1403]],"region":{"top_left_x":309,"top_left_y":1357,"width":1586,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf5c7c9962b049d793f43eefdfeb186f","type":"text","conversion_output":true,"text":"determined by VKOC1 variants. The extent to which warfarin use will be supplanted by newer","text_display":" determined by VKOC1 variants. The extent to which warfarin use will be supplanted by newer","confidence":1,"confidence_rate":1},{"cnt":[[309,1401],[1968,1401],[1968,1446],[309,1446]],"region":{"top_left_x":309,"top_left_y":1400,"width":1659,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a36539aa766e482586cb0bf4967fd96f","type":"text","conversion_output":true,"text":"agents in CABANA is uncertain, but the collection of a large set of patients with well-characterized","text_display":" agents in CABANA is uncertain, but the collection of a large set of patients with well-characterized","confidence":1,"confidence_rate":1},{"cnt":[[309,1446],[1880,1446],[1880,1491],[309,1491]],"region":{"top_left_x":309,"top_left_y":1445,"width":1571,"height":47},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57d23af7e4704b88bbdf825e158f95fe","type":"text","conversion_output":true,"text":"warfarin responses will be of considerable interest to the IWPC and other investigators in the","text_display":" warfarin responses will be of considerable interest to the IWPC and other investigators in the","confidence":0.99072265625,"confidence_rate":0.999905856489015},{"cnt":[[309,1491],[879,1491],[879,1536],[309,1536]],"region":{"top_left_x":309,"top_left_y":1491,"width":570,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a02e163252748b39bc7af3da202f332","type":"text","conversion_output":true,"text":"warfarin and anticoagulant areas.","text_display":" warfarin and anticoagulant areas.","confidence":1,"confidence_rate":1},{"cnt":[[309,1534],[1833,1534],[1833,1579],[309,1579]],"region":{"top_left_x":309,"top_left_y":1533,"width":1524,"height":47},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"621dfaf8984f48928c9e8671b402ead4","type":"text","conversion_output":true,"text":"Proarrhythmia is one well-recognized risk during drug therapy for AF. We have used both","text_display":"\nProarrhythmia is one well-recognized risk during drug therapy for AF. We have used both","confidence":1,"confidence_rate":1},{"cnt":[[309,1577],[2000,1577],[2000,1622],[309,1622]],"region":{"top_left_x":309,"top_left_y":1576,"width":1692,"height":47},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04774eaf4db04de98431f5158eecab39","type":"text","conversion_output":true,"text":"candidate and unbiased approaches to address risk for drug-induced torsades de pointes (diTdP) in","text_display":" candidate and unbiased approaches to address risk for drug-induced torsades de pointes (diTdP) in","confidence":1,"confidence_rate":1},{"cnt":[[309,1620],[1910,1620],[1910,1667],[309,1667]],"region":{"top_left_x":309,"top_left_y":1619,"width":1601,"height":49},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69dbb6891da14b00b818672db11cd626","type":"text","conversion_output":true,"text":"large cohorts generated by collaborations among multiple sites. Screening coding and flanking","text_display":" large cohorts generated by collaborations among multiple sites. Screening coding and flanking","confidence":1,"confidence_rate":1},{"cnt":[[309,1667],[1962,1667],[1962,1712],[309,1712]],"region":{"top_left_x":309,"top_left_y":1667,"width":1653,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29a3f6754a0048e692ed0042a282a45a","type":"text","conversion_output":true,"text":"regions of these has identified potential contributory rare DNA variants, i.e. sub-clinical congenital","text_display":" regions of these has identified potential contributory rare DNA variants, i.e. sub-clinical congenital","confidence":0.99658203125,"confidence_rate":0.9999680021628805},{"cnt":[[309,1710],[1979,1710],[1979,1755],[309,1755]],"region":{"top_left_x":309,"top_left_y":1710,"width":1670,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3e6613b52724d1b9cd48fc19d629c6a","type":"text","conversion_output":true,"text":"long QT syndrome, in \\(<10-20 \\%\\) of patients with diTdP. We used a candidate pathway approach to","text_display":" long QT syndrome, in \\(<10-20 \\%\\) of patients with diTdP. We used a candidate pathway approach to","confidence":1,"confidence_rate":1},{"cnt":[[309,1753],[1983,1753],[1983,1798],[309,1798]],"region":{"top_left_x":309,"top_left_y":1753,"width":1675,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ce929e397334138b4c83eaadfaa9126","type":"text","conversion_output":true,"text":"interrogate 1536 common SNPs in 18 candidate genes and identify rs1805128, resulting in KCNE1","text_display":" interrogate 1536 common SNPs in 18 candidate genes and identify rs1805128, resulting in KCNE1","confidence":1,"confidence_rate":1},{"cnt":[[309,1796],[1940,1796],[1940,1841],[309,1841]],"region":{"top_left_x":309,"top_left_y":1796,"width":1632,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7edcef526a014290aa85e190dbb8beab","type":"text","conversion_output":true,"text":"D85N, as a risk allele: the allelic odds ratio for 176 cases versus 530 drug-exposed controls was","text_display":" D85N, as a risk allele: the allelic odds ratio for 176 cases versus 530 drug-exposed controls was","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[309,1841],[1962,1841],[1962,1886],[309,1886]],"region":{"top_left_x":309,"top_left_y":1841,"width":1653,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"140b30c56d1146b8ae54051f926d7fad","type":"text","conversion_output":true,"text":"9.0 ( \\(95 \\%\\) confidence interval: \\(3.5-22.9\\) ), and the variant allele was present in \\(8.6 \\%\\) of cases, \\(2.9 \\%\\)","text_display":" 9.0 ( \\(95 \\%\\) confidence interval: \\(3.5-22.9\\) ), and the variant allele was present in \\(8.6 \\%\\) of cases, \\(2.9 \\%\\)","confidence":0.8494232810411972,"confidence_rate":0.9985439391878261},{"cnt":[[309,1884],[1983,1884],[1983,1931],[309,1931]],"region":{"top_left_x":309,"top_left_y":1884,"width":1675,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72016106ed004b51b7dc15b4faaea240","type":"text","conversion_output":true,"text":"of drug-exposed controls, and \\(1.8 \\%\\) of population controls. Other drug hypothesis: Do drugs create","text_display":" of drug-exposed controls, and \\(1.8 \\%\\) of population controls. Other drug hypothesis: Do drugs create","confidence":0.99658203125,"confidence_rate":0.9999673926902055},{"cnt":[[309,1929],[1446,1929],[1446,1974],[309,1974]],"region":{"top_left_x":309,"top_left_y":1929,"width":1137,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6bb1adb6c804c4f860a22059c86841d","type":"text","conversion_output":true,"text":"problems due to genetics? Is there a 'hopeless' patient population?","text_display":" problems due to genetics? Is there a 'hopeless' patient population?","confidence":1,"confidence_rate":1},{"cnt":[[432,2011],[840,2011],[840,2065],[432,2065]],"region":{"top_left_x":431,"top_left_y":2010,"width":410,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e27dd3ffe62b4b2290eead7bc45b3e67","type":"section_header","conversion_output":false,"children_ids":["ea19479914d84328a57ebe9bd841887b"],"text":"","text_display":""},{"cnt":[[438,2015],[836,2015],[836,2060],[438,2060]],"region":{"top_left_x":438,"top_left_y":2015,"width":398,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea19479914d84328a57ebe9bd841887b","type":"text","conversion_output":true,"parent_id":"e27dd3ffe62b4b2290eead7bc45b3e67","text":"Unbiased approaches","text_display":"\n\n\\section*{Unbiased approaches}","confidence":1,"confidence_rate":1},{"cnt":[[309,2069],[1927,2069],[1927,2116],[309,2116]],"region":{"top_left_x":309,"top_left_y":2068,"width":1619,"height":49},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd0e6f1f0b33449fbf46eae069133175","type":"text","conversion_output":true,"text":"The GWAS paradigm has been successfully applied to identify risk loci for AF at Chromosomes","text_display":"\n\nThe GWAS paradigm has been successfully applied to identify risk loci for AF at Chromosomes","confidence":1,"confidence_rate":1},{"cnt":[[309,2108],[1835,2108],[1835,2159],[309,2159]],"region":{"top_left_x":309,"top_left_y":2107,"width":1526,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0448e251f1f421f8e1f14a16b97ab37","type":"text","conversion_output":true,"text":"4q25, 1q21 and 16q22. \\({ }^{14,15,28}\\) Interestingly, these loci not only represent risk factors for the","text_display":" 4q25, 1q21 and 16q22. \\({ }^{14,15,28}\\) Interestingly, these loci not only represent risk factors for the","confidence":0.948448569397442,"confidence_rate":0.9995232874097969},{"cnt":[[309,2151],[1970,2151],[1970,2202],[309,2202]],"region":{"top_left_x":309,"top_left_y":2150,"width":1662,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a581125b3a84f7cbc89e8e33b0615af","type":"text","conversion_output":true,"text":"development of AF, but also appear to predict development of AF after cardiac surgery, \\({ }^{29}\\) stroke, \\({ }^{30}\\)","text_display":" development of AF, but also appear to predict development of AF after cardiac surgery, \\({ }^{29}\\) stroke, \\({ }^{30}\\)","confidence":0.9980475902557373,"confidence_rate":0.9999838487405106},{"cnt":[[309,2196],[1888,2196],[1888,2245],[309,2245]],"region":{"top_left_x":309,"top_left_y":2195,"width":1580,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aadd4b4491fb464ba70a542a86efc304","type":"text","conversion_output":true,"text":"and (in smaller studies) the success of ablation therapy \\({ }^{31}\\) and of antiarrhythmic or rate control","text_display":" and (in smaller studies) the success of ablation therapy \\({ }^{31}\\) and of antiarrhythmic or rate control","confidence":1,"confidence_rate":1},{"cnt":[[309,2239],[1897,2239],[1897,2290],[309,2290]],"region":{"top_left_x":309,"top_left_y":2238,"width":1589,"height":53},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86c2cddd21c6473e8cc37998039adbb9","type":"text","conversion_output":true,"text":"therapy in AF. \\({ }^{32,33}\\) The biologic underpinnings of this increased risk are now being explored in","text_display":" therapy in AF. \\({ }^{32,33}\\) The biologic underpinnings of this increased risk are now being explored in","confidence":0.7519140243530273,"confidence_rate":0.9974345280759292},{"cnt":[[309,2290],[1966,2290],[1966,2335],[309,2335]],"region":{"top_left_x":309,"top_left_y":2290,"width":1657,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c193325eaafe463aad5387092a43c499","type":"text","conversion_output":true,"text":"mouse models and for the \\(4 q 25\\) locus (the one with the largest signal), evidence points to variable","text_display":" mouse models and for the \\(4 q 25\\) locus (the one with the largest signal), evidence points to variable","confidence":0.41714899241924286,"confidence_rate":0.9917856985084585},{"cnt":[[309,2329],[1833,2329],[1833,2378],[309,2378]],"region":{"top_left_x":309,"top_left_y":2328,"width":1524,"height":51},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5561353d15a3498da7cf2e3a7e814c38","type":"text","conversion_output":true,"text":"expression of a cardiac isoform of the transcription factor PITX2c. \\({ }^{34,35}\\) Consistent with this","text_display":" expression of a cardiac isoform of the transcription factor PITX2c. \\({ }^{34,35}\\) Consistent with this","confidence":1,"confidence_rate":1},{"cnt":[[309,2376],[1944,2376],[1944,2421],[309,2421]],"region":{"top_left_x":309,"top_left_y":2376,"width":1636,"height":46},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1745f026ffba43f68868abca04077204","type":"text","conversion_output":true,"text":"observation is the finding that multiple SNPs at the 4q25 locus act independently to modulate AF","text_display":" observation is the finding that multiple SNPs at the 4q25 locus act independently to modulate AF","confidence":0.84375,"confidence_rate":0.9983192453715904},{"cnt":[[309,2415],[1923,2415],[1923,2464],[309,2464]],"region":{"top_left_x":309,"top_left_y":2414,"width":1614,"height":51},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4012319d08bc4f6f903b0fb50eb1b1dc","type":"text","conversion_output":true,"text":"risk; \\({ }^{36}\\) this finding allows the identification of small sets of subjects drawn from larger databases","text_display":" risk; \\({ }^{36}\\) this finding allows the identification of small sets of subjects drawn from larger databases","confidence":0.9175205230712891,"confidence_rate":0.9992582034496673},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5528b3037c1446b8196310005dabed2","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1837,2574],[1837,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":222,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7759ef6924904a9da7bd4eb2af1cd685","type":"page_info","conversion_output":false,"text":"Page 69 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-71","page":71,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20e6f7802ecb4c128184b658e78b1d51","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[309,251],[1899,251],[1899,299],[309,299]],"region":{"top_left_x":309,"top_left_y":251,"width":1591,"height":48},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54cf7d9751a34d3d8edc30d2f792f871","type":"text","conversion_output":true,"text":"(such as CABANA) in whom response to ablative or medical therapies may differ on a genetic","text_display":"\n(such as CABANA) in whom response to ablative or medical therapies may differ on a genetic","confidence":1,"confidence_rate":1},{"cnt":[[309,296],[2000,296],[2000,342],[309,342]],"region":{"top_left_x":309,"top_left_y":296,"width":1692,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d4350cad5a64d498562526df80f1f8b","type":"text","conversion_output":true,"text":"basis. GWAS has also been applied to study warfarin steady state dose, and has identified variants","text_display":" basis. GWAS has also been applied to study warfarin steady state dose, and has identified variants","confidence":1,"confidence_rate":1},{"cnt":[[309,339],[1992,339],[1992,385],[309,385]],"region":{"top_left_x":309,"top_left_y":339,"width":1683,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d2222111c29458396ebd97f2e24400e","type":"text","conversion_output":true,"text":"in CYP2C9, VKORC1, and CYP4F2 (which plays a role in vitamin K metabolism) with major effects,","text_display":" in CYP2C9, VKORC1, and CYP4F2 (which plays a role in vitamin K metabolism) with major effects,","confidence":1,"confidence_rate":1},{"cnt":[[309,378],[892,378],[892,423],[309,423]],"region":{"top_left_x":309,"top_left_y":378,"width":583,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d59ba66ad8e04606b93c9a7bb183e578","type":"text","conversion_output":true,"text":"but no other common variants. \\({ }^{25,26}\\)","text_display":" but no other common variants. \\({ }^{25,26}\\)","confidence":0.99951171875,"confidence_rate":0.9999893826542317},{"cnt":[[305,466],[947,466],[947,511],[305,511]],"region":{"top_left_x":305,"top_left_y":466,"width":643,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e6cca5dfb744307b12fb4b8e7c0ea81","type":"section_header","conversion_output":false,"children_ids":["5e5659e38a4f4f00a100e0b949989dae"],"text":"","text_display":""},{"cnt":[[309,468],[943,468],[943,507],[309,507]],"region":{"top_left_x":309,"top_left_y":468,"width":635,"height":40},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e5659e38a4f4f00a100e0b949989dae","type":"text","conversion_output":true,"parent_id":"4e6cca5dfb744307b12fb4b8e7c0ea81","text":"4.0 Inclusion/Exclusion Criteria","text_display":"\n\n\\subsection*{4.0 Inclusion/Exclusion Criteria}","confidence":0.9975600242614746,"confidence_rate":0.9999339763058676},{"cnt":[[309,524],[1970,524],[1970,569],[309,569]],"region":{"top_left_x":309,"top_left_y":524,"width":1662,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20a78deb0b394ac0803b6446b5699880","type":"text","conversion_output":true,"text":"Inclusion/exclusion in this study is dependent only on inclusion/exclusion in the primary study. The","text_display":"\n\nInclusion/exclusion in this study is dependent only on inclusion/exclusion in the primary study. The","confidence":1,"confidence_rate":1},{"cnt":[[309,567],[1222,567],[1222,612],[309,612]],"region":{"top_left_x":309,"top_left_y":567,"width":914,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c551abe7f80a4ebf881c5885e4a10250","type":"text","conversion_output":true,"text":"CABANA specific criteria can be found in Appendix A.","text_display":" CABANA specific criteria can be found in Appendix A.","confidence":1,"confidence_rate":1},{"cnt":[[305,649],[926,649],[926,694],[305,694]],"region":{"top_left_x":305,"top_left_y":648,"width":621,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78d566e02e9e4105ba0ffb249292d7ce","type":"section_header","conversion_output":false,"children_ids":["2addf7f9981641ae920dcf161c5bb759"],"text":"","text_display":""},{"cnt":[[309,653],[922,653],[922,692],[309,692]],"region":{"top_left_x":309,"top_left_y":653,"width":613,"height":39},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2addf7f9981641ae920dcf161c5bb759","type":"text","conversion_output":true,"parent_id":"78d566e02e9e4105ba0ffb249292d7ce","text":"5.0 Enrollment/Randomization","text_display":"\n\n\\subsection*{5.0 Enrollment/Randomization}","confidence":1,"confidence_rate":1},{"cnt":[[309,709],[1992,709],[1992,752],[309,752]],"region":{"top_left_x":309,"top_left_y":708,"width":1683,"height":44},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3cb01b58f7d46708a23ddd30516897a","type":"text","conversion_output":true,"text":"All enrollment will be performed at CABANA participating centers and subjects enrolled in CABANA","text_display":"\n\nAll enrollment will be performed at CABANA participating centers and subjects enrolled in CABANA","confidence":1,"confidence_rate":1},{"cnt":[[309,752],[1813,752],[1813,797],[309,797]],"region":{"top_left_x":309,"top_left_y":751,"width":1505,"height":47},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4b666bac7a449078fd4966c73a7427e","type":"text","conversion_output":true,"text":"are eligible to participate in this ancillary study. There will be no randomization specific to","text_display":" are eligible to participate in this ancillary study. There will be no randomization specific to","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[309,795],[1760,795],[1760,840],[309,840]],"region":{"top_left_x":309,"top_left_y":794,"width":1451,"height":47},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4587496ede3d4e09b9846e629230a0d7","type":"text","conversion_output":true,"text":"CABANAgene. No subjects will be enrolled at the CABANAgene Coordinating Center.","text_display":" CABANAgene. No subjects will be enrolled at the CABANAgene Coordinating Center.","confidence":0.9799900054931641,"confidence_rate":0.9997593991175372},{"cnt":[[305,877],[771,877],[771,930],[305,930]],"region":{"top_left_x":305,"top_left_y":876,"width":467,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8978244914e45e888b5dd7076686982","type":"section_header","conversion_output":false,"children_ids":["367061654e27418d8855b0b6ac6bf2ed"],"text":"","text_display":""},{"cnt":[[309,881],[767,881],[767,926],[309,926]],"region":{"top_left_x":309,"top_left_y":880,"width":458,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"367061654e27418d8855b0b6ac6bf2ed","type":"text","conversion_output":true,"parent_id":"b8978244914e45e888b5dd7076686982","text":"6.0 Study Procedures","text_display":"\n\n\\subsection*{6.0 Study Procedures}","confidence":0.998046875,"confidence_rate":0.9999218016642171},{"cnt":[[309,937],[1901,937],[1901,982],[309,982]],"region":{"top_left_x":309,"top_left_y":936,"width":1593,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14a9748dc689480c86b981b4179b4287","type":"text","conversion_output":true,"text":"Consent: PGRN has developed standard suggested language for consent to perform genomic","text_display":"\n\nConsent: PGRN has developed standard suggested language for consent to perform genomic","confidence":1,"confidence_rate":1},{"cnt":[[309,980],[1858,980],[1858,1025],[309,1025]],"region":{"top_left_x":309,"top_left_y":979,"width":1550,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"076f9e360e2547db8a69db4a45c092a6","type":"text","conversion_output":true,"text":"analyses of the type proposed here, subject to local IRB revision. We have created a model","text_display":" analyses of the type proposed here, subject to local IRB revision. We have created a model","confidence":1,"confidence_rate":1},{"cnt":[[309,1023],[2000,1023],[2000,1068],[309,1068]],"region":{"top_left_x":309,"top_left_y":1022,"width":1692,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc237b87003443fc85e78c7fe6b982fe","type":"text","conversion_output":true,"text":"consent form in which this language was incorporated and this form is provided to each site for local","text_display":" consent form in which this language was incorporated and this form is provided to each site for local","confidence":1,"confidence_rate":1},{"cnt":[[309,1068],[1998,1068],[1998,1111],[309,1111]],"region":{"top_left_x":309,"top_left_y":1067,"width":1690,"height":44},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5384fef3720349ef8bdbfc62674b4333","type":"text","conversion_output":true,"text":"modification if necessary and IRB submission. IRBs at PGRN affiliated centers have adopted this or","text_display":" modification if necessary and IRB submission. IRBs at PGRN affiliated centers have adopted this or","confidence":1,"confidence_rate":1},{"cnt":[[309,1113],[990,1113],[990,1156],[309,1156]],"region":{"top_left_x":309,"top_left_y":1112,"width":682,"height":44},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50f4e065c543456d95313dad9dc1052c","type":"text","conversion_output":true,"text":"very similar language in most instances.","text_display":" very similar language in most instances.","confidence":1,"confidence_rate":1},{"cnt":[[309,1199],[1944,1199],[1944,1244],[309,1244]],"region":{"top_left_x":309,"top_left_y":1198,"width":1636,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1df4888db3394ac19fe49436247ecfbf","type":"text","conversion_output":true,"text":"Current NIH guidelines require that the results of large genotyping efforts accomplished with NIH","text_display":"\n\nCurrent NIH guidelines require that the results of large genotyping efforts accomplished with NIH","confidence":0.99853515625,"confidence_rate":0.9999856283612877},{"cnt":[[309,1244],[1886,1244],[1886,1287],[309,1287]],"region":{"top_left_x":309,"top_left_y":1243,"width":1578,"height":44},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba497c34ec404c6cb04980397d72ea95","type":"text","conversion_output":true,"text":"funds be deposited in public databases such as the database for Genotypes and Phenotypes","text_display":" funds be deposited in public databases such as the database for Genotypes and Phenotypes","confidence":1,"confidence_rate":1},{"cnt":[[309,1285],[1934,1285],[1934,1330],[309,1330]],"region":{"top_left_x":309,"top_left_y":1284,"width":1625,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0218d5dc70744f9c96596365bc813647","type":"text","conversion_output":true,"text":"(dbGaP). dbGaP submissions include deidentified phenotypic data; thus, current consent forms","text_display":" (dbGaP). dbGaP submissions include deidentified phenotypic data; thus, current consent forms","confidence":0.995610237121582,"confidence_rate":0.9999546461194712},{"cnt":[[309,1332],[887,1332],[887,1377],[309,1377]],"region":{"top_left_x":309,"top_left_y":1332,"width":579,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28bb7d48716d4756a8f5c8036ca67a81","type":"text","conversion_output":true,"text":"include consent for such deposits.","text_display":" include consent for such deposits.","confidence":1,"confidence_rate":1},{"cnt":[[309,1418],[1992,1418],[1992,1463],[309,1463]],"region":{"top_left_x":309,"top_left_y":1417,"width":1683,"height":47},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4edb403b4314f5399755cab63d99b1b","type":"text","conversion_output":true,"text":"Once consent is obtained, a 30 mL blood sample for subsequent DNA extraction will be obtained at","text_display":"\n\nOnce consent is obtained, a 30 mL blood sample for subsequent DNA extraction will be obtained at","confidence":1,"confidence_rate":1},{"cnt":[[309,1463],[1970,1463],[1970,1506],[309,1506]],"region":{"top_left_x":309,"top_left_y":1463,"width":1662,"height":44},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60e503e92e3e455baecab9102054a239","type":"text","conversion_output":true,"text":"any time during the CABANA trial, preferably at the time of a scheduled venipuncture. Each study","text_display":" any time during the CABANA trial, preferably at the time of a scheduled venipuncture. Each study","confidence":1,"confidence_rate":1},{"cnt":[[309,1506],[1992,1506],[1992,1549],[309,1549]],"region":{"top_left_x":309,"top_left_y":1506,"width":1683,"height":44},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7dad93bebcd8403bba836ab319a4d922","type":"text","conversion_output":true,"text":"site will be provided with kits for mailing the samples to the Vanderbilt DNA Resources Core, where","text_display":" site will be provided with kits for mailing the samples to the Vanderbilt DNA Resources Core, where","confidence":1,"confidence_rate":1},{"cnt":[[309,1551],[1944,1551],[1944,1594],[309,1594]],"region":{"top_left_x":309,"top_left_y":1551,"width":1636,"height":44},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be65a71fd82940b6a6f205c9adcdb05e","type":"text","conversion_output":true,"text":"DNA extraction and archiving will be performed. Contents of each subject kit and instructions are","text_display":" DNA extraction and archiving will be performed. Contents of each subject kit and instructions are","confidence":1,"confidence_rate":1},{"cnt":[[309,1594],[1807,1594],[1807,1639],[309,1639]],"region":{"top_left_x":309,"top_left_y":1594,"width":1498,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45f66edb9b484991bfebaa8b658c8393","type":"text","conversion_output":true,"text":"listed in Appendix B. If it is determined that a sample is damaged/unusable upon arrival,","text_display":" listed in Appendix B. If it is determined that a sample is damaged/unusable upon arrival,","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[309,1637],[1830,1637],[1830,1682],[309,1682]],"region":{"top_left_x":309,"top_left_y":1637,"width":1522,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"069638a5e6f84bd2aae5d5ef79ca9371","type":"text","conversion_output":true,"text":"communication with the sender will be made and a replacement sample will be requested.","text_display":" communication with the sender will be made and a replacement sample will be requested.","confidence":1,"confidence_rate":1},{"cnt":[[309,1725],[1979,1725],[1979,1772],[309,1772]],"region":{"top_left_x":309,"top_left_y":1725,"width":1670,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b2d2a0d2f764150b3c06810a60f1619","type":"text","conversion_output":true,"text":"The Vanderbilt DNA Resources Core has extensive experience in storing and extracting DNA from","text_display":"\n\nThe Vanderbilt DNA Resources Core has extensive experience in storing and extracting DNA from","confidence":1,"confidence_rate":1},{"cnt":[[309,1770],[1957,1770],[1957,1815],[309,1815]],"region":{"top_left_x":309,"top_left_y":1770,"width":1649,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13fc428c09fc4c1d91545ab2660875ab","type":"text","conversion_output":true,"text":"over 100,000 individuals. 2D bar-coding of samples and aliquots eliminates repetitive paper work,","text_display":" over 100,000 individuals. 2D bar-coding of samples and aliquots eliminates repetitive paper work,","confidence":0.8535869121551514,"confidence_rate":0.998449165439262},{"cnt":[[309,1813],[1921,1813],[1921,1858],[309,1858]],"region":{"top_left_x":309,"top_left_y":1813,"width":1612,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07b44d50069744ad825dffd17a5e50e1","type":"text","conversion_output":true,"text":"thereby reducing recording errors. All DNA is currently extracted using the automated Autopure","text_display":" thereby reducing recording errors. All DNA is currently extracted using the automated Autopure","confidence":1,"confidence_rate":1},{"cnt":[[309,1856],[1970,1856],[1970,1901],[309,1901]],"region":{"top_left_x":309,"top_left_y":1856,"width":1662,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd4673b8636e452c8f34c2f5bc3da2e0","type":"text","conversion_output":true,"text":"system (Gentra systems, Minneapolis). Samples are logged into the system using a study specific","text_display":" system (Gentra systems, Minneapolis). Samples are logged into the system using a study specific","confidence":1,"confidence_rate":1},{"cnt":[[309,1901],[1884,1901],[1884,1944],[309,1944]],"region":{"top_left_x":309,"top_left_y":1901,"width":1576,"height":44},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f65a4a5d80494ded8972ccc243461825","type":"text","conversion_output":true,"text":"code number to match with the assigned DNA Resources Core sample number, and only the","text_display":" code number to match with the assigned DNA Resources Core sample number, and only the","confidence":1,"confidence_rate":1},{"cnt":[[309,1946],[2000,1946],[2000,1989],[309,1989]],"region":{"top_left_x":309,"top_left_y":1946,"width":1692,"height":44},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"353411e948e3427fb776e6839aba9c93","type":"text","conversion_output":true,"text":"sample number is used thereafter. Each sample must be associated with an IRB-approved consent","text_display":" sample number is used thereafter. Each sample must be associated with an IRB-approved consent","confidence":1,"confidence_rate":1},{"cnt":[[309,1989],[1906,1989],[1906,2035],[309,2035]],"region":{"top_left_x":309,"top_left_y":1989,"width":1597,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c6aaf3cc1994f209dab7393e054540f","type":"text","conversion_output":true,"text":"form. The Autopure system generates very high quality, high yield (routinely \\(20-30 \\mu g / ml\\) ), and","text_display":" form. The Autopure system generates very high quality, high yield (routinely \\(20-30 \\mu g / ml\\) ), and","confidence":1,"confidence_rate":1},{"cnt":[[309,2032],[1979,2032],[1979,2078],[309,2078]],"region":{"top_left_x":309,"top_left_y":2032,"width":1670,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef1031dc59b24b14b6eb5d8766b3b3a5","type":"text","conversion_output":true,"text":"substantial consistency across samples. All samples are quantitated and stored at \\(4^{\\circ} C\\) in a locked","text_display":" substantial consistency across samples. All samples are quantitated and stored at \\(4^{\\circ} C\\) in a locked","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[309,2075],[1992,2075],[1992,2121],[309,2121]],"region":{"top_left_x":309,"top_left_y":2075,"width":1683,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebd9bf593bc7476cb5607403f09ce0ec","type":"text","conversion_output":true,"text":"cold room. An aliquot is also frozen at \\(-20^{\\circ} C\\) to serve as a back-up in case a sample is accidentally","text_display":" cold room. An aliquot is also frozen at \\(-20^{\\circ} C\\) to serve as a back-up in case a sample is accidentally","confidence":1,"confidence_rate":1},{"cnt":[[309,2121],[1966,2121],[1966,2168],[309,2168]],"region":{"top_left_x":309,"top_left_y":2120,"width":1657,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee6ee8cf66c24648bdb3e93b867f0003","type":"text","conversion_output":true,"text":"contaminated, lost, or depleted. DNA samples for approved CABANA projects can be provided to","text_display":" contaminated, lost, or depleted. DNA samples for approved CABANA projects can be provided to","confidence":1,"confidence_rate":1},{"cnt":[[309,2166],[1433,2166],[1433,2211],[309,2211]],"region":{"top_left_x":309,"top_left_y":2165,"width":1125,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d950612de2664857974127582a63ed04","type":"text","conversion_output":true,"text":"investigators in a range of formats, most commonly 96-well plates.","text_display":" investigators in a range of formats, most commonly 96-well plates.","confidence":0.9501953125,"confidence_rate":0.9992807134105229},{"cnt":[[309,2254],[1923,2254],[1923,2297],[309,2297]],"region":{"top_left_x":309,"top_left_y":2253,"width":1614,"height":44},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e2a10c3594c429e947f4cb908b3cf6f","type":"text","conversion_output":true,"text":"Results of the tests run on specific samples will not be shared with or reported to subjects, care","text_display":"\n\nResults of the tests run on specific samples will not be shared with or reported to subjects, care","confidence":0.9970715045928955,"confidence_rate":0.9999715266981888},{"cnt":[[309,2299],[849,2299],[849,2344],[309,2344]],"region":{"top_left_x":309,"top_left_y":2298,"width":540,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b17bdcd73a3443cd99800c26f7c9998d","type":"text","conversion_output":true,"text":"providers, or the general public.","text_display":" providers, or the general public.","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f2dbcd96744479390c1e0615d8140d7","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1837,2574],[1837,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":222,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4b7414330a549519d40b27ccf36ff31","type":"page_info","conversion_output":false,"text":"Page 70 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-72","page":72,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3411a2d07919489d9a432b6c2527ada0","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,249],[531,249],[531,303],[305,303]],"region":{"top_left_x":305,"top_left_y":249,"width":226,"height":54},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4fb0ab3fd174c81a7b6bd71c6c87372","type":"section_header","conversion_output":false,"children_ids":["5a0458880447479bb168f44d20b85b82"],"text":"","text_display":""},{"cnt":[[309,254],[526,254],[526,299],[309,299]],"region":{"top_left_x":309,"top_left_y":253,"width":218,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a0458880447479bb168f44d20b85b82","type":"text","conversion_output":true,"parent_id":"e4fb0ab3fd174c81a7b6bd71c6c87372","text":"Genotyping","text_display":"\n\n\\section*{Genotyping}","confidence":1,"confidence_rate":1},{"cnt":[[309,305],[1929,305],[1929,350],[309,350]],"region":{"top_left_x":309,"top_left_y":305,"width":1621,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39a892a6fe3d4e45b6b191664a023e7f","type":"text","conversion_output":true,"text":"CABANA currently anticipates enrolling in 2009-2015, with an average of approximately 5 years","text_display":"\n\nCABANA currently anticipates enrolling in 2009-2015, with an average of approximately 5 years","confidence":1,"confidence_rate":1},{"cnt":[[307,350],[1979,350],[1979,397],[307,397]],"region":{"top_left_x":307,"top_left_y":350,"width":1672,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3e3efc2a1c74d05b42d1392259eaa13","type":"text","conversion_output":true,"text":"follow-up. Thus initial analyses of end-points will not be available until interim analysis early 2018.","text_display":" follow-up. Thus initial analyses of end-points will not be available until interim analysis early 2018.","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[307,395],[1968,395],[1968,440],[307,440]],"region":{"top_left_x":307,"top_left_y":395,"width":1661,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2248f67b3be844e797d9dcabe64fed12","type":"text","conversion_output":true,"text":"We anticipate that investigators will develop hypotheses that require accrual of specific genotypes","text_display":" We anticipate that investigators will develop hypotheses that require accrual of specific genotypes","confidence":1,"confidence_rate":1},{"cnt":[[309,438],[1854,438],[1854,483],[309,483]],"region":{"top_left_x":309,"top_left_y":438,"width":1546,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25743426a1d743f28fbae902added803","type":"text","conversion_output":true,"text":"(e.g. CYP2D6 and beta-blocker response; 4q25 variants and response to ablation therapy).","text_display":" (e.g. CYP2D6 and beta-blocker response; 4q25 variants and response to ablation therapy).","confidence":1,"confidence_rate":1},{"cnt":[[309,481],[1949,481],[1949,526],[309,526]],"region":{"top_left_x":309,"top_left_y":481,"width":1640,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00751919f670498d935f4cc60a83a279","type":"text","conversion_output":true,"text":"Further, we anticipate that the size and scope of the CABANA dataset will provide an opportunity","text_display":" Further, we anticipate that the size and scope of the CABANA dataset will provide an opportunity","confidence":1,"confidence_rate":1},{"cnt":[[309,524],[1760,524],[1760,569],[309,569]],"region":{"top_left_x":309,"top_left_y":524,"width":1451,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b32b6e9c8b64990b6d6cfd96a974b17","type":"text","conversion_output":true,"text":"for directed resequencing to test other hypotheses (e.g. do patients with a specific AF","text_display":" for directed resequencing to test other hypotheses (e.g. do patients with a specific AF","confidence":0.99169921875,"confidence_rate":0.999909401663201},{"cnt":[[309,571],[1944,571],[1944,617],[309,617]],"region":{"top_left_x":309,"top_left_y":571,"width":1636,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d50458cbc0b14d6994cac6121b28bb95","type":"text","conversion_output":true,"text":"endophenotype have coding region variants in specific candidate genes?). Finally, we anticipate","text_display":" endophenotype have coding region variants in specific candidate genes?). Finally, we anticipate","confidence":1,"confidence_rate":1},{"cnt":[[309,614],[1910,614],[1910,660],[309,660]],"region":{"top_left_x":309,"top_left_y":614,"width":1601,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c01ed24d59d44229f239f8a2910c03b","type":"text","conversion_output":true,"text":"that unbiased approaches will be proposed to address other questions (e.g. are there genomic","text_display":" that unbiased approaches will be proposed to address other questions (e.g. are there genomic","confidence":1,"confidence_rate":1},{"cnt":[[309,657],[1936,657],[1936,703],[309,703]],"region":{"top_left_x":309,"top_left_y":657,"width":1627,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9670779d00164f61965f09a4c7b8c41b","type":"text","conversion_output":true,"text":"regions that predict response to ablation therapy?); we anticipate that genome-wide analysis will","text_display":" regions that predict response to ablation therapy?); we anticipate that genome-wide analysis will","confidence":1,"confidence_rate":1},{"cnt":[[309,700],[1979,700],[1979,746],[309,746]],"region":{"top_left_x":309,"top_left_y":700,"width":1670,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a75f4e265dd4aa08c1c209209a23e58","type":"text","conversion_output":true,"text":"still be the standard for addressing these questions, although whole genome resequencing may be","text_display":" still be the standard for addressing these questions, although whole genome resequencing may be","confidence":0.998046875,"confidence_rate":0.9999804498427488},{"cnt":[[309,746],[816,746],[816,793],[309,793]],"region":{"top_left_x":309,"top_left_y":745,"width":508,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6f13e29026b460788b905f45b586c40","type":"text","conversion_output":true,"text":"a competing method by 2014.","text_display":" a competing method by 2014.","confidence":0.99853515625,"confidence_rate":0.9999527134508668},{"cnt":[[309,834],[1904,834],[1904,879],[309,879]],"region":{"top_left_x":309,"top_left_y":833,"width":1595,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a78630fb32ac4782968e7ea41978a12c","type":"text","conversion_output":true,"text":"Funds to support accrual of DNA at participating centers, mailing costs, and DNA extraction at","text_display":"\n\nFunds to support accrual of DNA at participating centers, mailing costs, and DNA extraction at","confidence":1,"confidence_rate":1},{"cnt":[[309,877],[1992,877],[1992,922],[309,922]],"region":{"top_left_x":309,"top_left_y":876,"width":1683,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"286515ef7e6e454ebd3babc51cde172f","type":"text","conversion_output":true,"text":"Vanderbilt have been incorporated into the CABANAgene proposal. We anticipate that the process","text_display":" Vanderbilt have been incorporated into the CABANAgene proposal. We anticipate that the process","confidence":1,"confidence_rate":1},{"cnt":[[309,920],[1966,920],[1966,965],[309,965]],"region":{"top_left_x":309,"top_left_y":919,"width":1657,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1baaf3917c954ce8aa35d367c04a0d37","type":"text","conversion_output":true,"text":"to access CABANAgene samples by CABANA (or other) Investigators will require submission of a","text_display":" to access CABANAgene samples by CABANA (or other) Investigators will require submission of a","confidence":1,"confidence_rate":1},{"cnt":[[309,965],[1949,965],[1949,1010],[309,1010]],"region":{"top_left_x":309,"top_left_y":964,"width":1640,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"943686e79bd84d67ba4d9622535cb3c8","type":"text","conversion_output":true,"text":"specific study plan, including appropriate quality control and statistical analysis, access to clinical","text_display":" specific study plan, including appropriate quality control and statistical analysis, access to clinical","confidence":1,"confidence_rate":1},{"cnt":[[309,1010],[1867,1010],[1867,1055],[309,1055]],"region":{"top_left_x":309,"top_left_y":1009,"width":1558,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fffe19889534ad6b5ec8792119cb673","type":"text","conversion_output":true,"text":"variables in the central CABANA dataset, and approval by the CABANA steering committee.","text_display":" variables in the central CABANA dataset, and approval by the CABANA steering committee.","confidence":1,"confidence_rate":1},{"cnt":[[307,1096],[1951,1096],[1951,1143],[307,1143]],"region":{"top_left_x":307,"top_left_y":1095,"width":1644,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a63710611542459ea13efd1c68ce1f15","type":"text","conversion_output":true,"text":"The current PAT budget includes support for genome-wide genotyping and analysis of genotype-","text_display":"\n\nThe current PAT budget includes support for genome-wide genotyping and analysis of genotype","confidence":1,"confidence_rate":1},{"cnt":[[307,1143],[1955,1143],[1955,1188],[307,1188]],"region":{"top_left_x":307,"top_left_y":1142,"width":1649,"height":47},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f3890f72db846e49ef252383f525832","type":"text","conversion_output":true,"text":"drug response phenotype relations and these will be used to develop a separate PAT proposal to","text_display":"drug response phenotype relations and these will be used to develop a separate PAT proposal to","confidence":1,"confidence_rate":1},{"cnt":[[307,1186],[1966,1186],[1966,1231],[307,1231]],"region":{"top_left_x":307,"top_left_y":1185,"width":1659,"height":47},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65e131345e554416aed4789aef1720aa","type":"text","conversion_output":true,"text":"access CABANA samples. The specific questions to be addressed and platform to be used will be","text_display":" access CABANA samples. The specific questions to be addressed and platform to be used will be","confidence":1,"confidence_rate":1},{"cnt":[[307,1229],[1897,1229],[1897,1274],[307,1274]],"region":{"top_left_x":307,"top_left_y":1228,"width":1591,"height":47},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"073be9f95b6c40c6b5e059219f458813","type":"text","conversion_output":true,"text":"selected at the time of projected analysis, at the termination of the trial \\((\\sim 3-5\\) years after study","text_display":" selected at the time of projected analysis, at the termination of the trial \\((\\sim 3-5\\) years after study","confidence":0.8239016532897949,"confidence_rate":0.9981913188629742},{"cnt":[[307,1272],[1927,1272],[1927,1317],[307,1317]],"region":{"top_left_x":307,"top_left_y":1271,"width":1621,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45be923e28514e1d94de19b4634be168","type":"text","conversion_output":true,"text":"initiation). Technologies available at the Vanderbilt, and at multiple other sites in PGRN, include","text_display":" initiation). Technologies available at the Vanderbilt, and at multiple other sites in PGRN, include","confidence":1,"confidence_rate":1},{"cnt":[[307,1315],[1940,1315],[1940,1360],[307,1360]],"region":{"top_left_x":307,"top_left_y":1314,"width":1634,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12846d576eaa4db8b5e7e1ca326cb8d5","type":"text","conversion_output":true,"text":"Affymetrix and Illumina high-throughput systems, as well as robust lower throughput systems for","text_display":" Affymetrix and Illumina high-throughput systems, as well as robust lower throughput systems for","confidence":1,"confidence_rate":1},{"cnt":[[307,1360],[1867,1360],[1867,1405],[307,1405]],"region":{"top_left_x":307,"top_left_y":1359,"width":1560,"height":47},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae99322188d34504909a13ad1c3a389f","type":"text","conversion_output":true,"text":"targeted genotyping, such as the Illumina Bead-station, Sequenom, or Taqman. Genotyping","text_display":" targeted genotyping, such as the Illumina Bead-station, Sequenom, or Taqman. Genotyping","confidence":1,"confidence_rate":1},{"cnt":[[307,1405],[1897,1405],[1897,1450],[307,1450]],"region":{"top_left_x":307,"top_left_y":1405,"width":1591,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"522e0b4bee59435fa892a8324d7dec7d","type":"text","conversion_output":true,"text":"laboratories in PGRN adhere to standard practice, including appropriate negative and positive","text_display":" laboratories in PGRN adhere to standard practice, including appropriate negative and positive","confidence":0.99365234375,"confidence_rate":0.9999350236591895},{"cnt":[[307,1448],[1944,1448],[1944,1493],[307,1493]],"region":{"top_left_x":307,"top_left_y":1448,"width":1638,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31c66a62e6bf4dd188111a0ff949f868","type":"text","conversion_output":true,"text":"controls, to ensure that the genotyping results are robust. Genotypic and phenotypic data will be","text_display":" controls, to ensure that the genotyping results are robust. Genotypic and phenotypic data will be","confidence":1,"confidence_rate":1},{"cnt":[[307,1491],[1996,1491],[1996,1536],[307,1536]],"region":{"top_left_x":307,"top_left_y":1491,"width":1689,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23f6350929eb493a9e02b6e93b8bd975","type":"text","conversion_output":true,"text":"combined in an Oracle database to allow biostatistical and genetic epidemiologic analysis. The PAT","text_display":" combined in an Oracle database to allow biostatistical and genetic epidemiologic analysis. The PAT","confidence":1,"confidence_rate":1},{"cnt":[[307,1536],[1893,1536],[1893,1583],[307,1583]],"region":{"top_left_x":307,"top_left_y":1536,"width":1586,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d42d63b551324008bb7df77c2ef4b10f","type":"text","conversion_output":true,"text":"center has developed expertise in robust quality control and statistical analyses of these large","text_display":" center has developed expertise in robust quality control and statistical analyses of these large","confidence":1,"confidence_rate":1},{"cnt":[[305,1581],[471,1581],[471,1620],[305,1620]],"region":{"top_left_x":305,"top_left_y":1581,"width":166,"height":39},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aebaf955f3344575a1582c880db8a821","type":"text","conversion_output":true,"text":"datasets.","text_display":" datasets.","confidence":1,"confidence_rate":1},{"cnt":[[305,1663],[544,1663],[544,1708],[305,1708]],"region":{"top_left_x":305,"top_left_y":1662,"width":239,"height":47},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78ee841c515749a2973f368d7f1ed4b4","type":"section_header","conversion_output":false,"children_ids":["9946d99416764695a5c9fbd5985d76e9"],"text":"","text_display":""},{"cnt":[[309,1667],[541,1667],[541,1704],[309,1704]],"region":{"top_left_x":309,"top_left_y":1667,"width":233,"height":37},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9946d99416764695a5c9fbd5985d76e9","type":"text","conversion_output":true,"parent_id":"78ee841c515749a2973f368d7f1ed4b4","text":"7.0 Risks","text_display":"\n\n\\subsection*{7.0 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bleeding or infection at the site of the needle stick are risks involved at the participating","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[309,1800],[449,1800],[449,1837],[309,1837]],"region":{"top_left_x":309,"top_left_y":1800,"width":141,"height":37},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aca327c61e2f4a2c9caf837bdbb0286e","type":"text","conversion_output":true,"text":"centers.","text_display":" centers.","confidence":1,"confidence_rate":1},{"cnt":[[309,1886],[1878,1886],[1878,1931],[309,1931]],"region":{"top_left_x":309,"top_left_y":1886,"width":1569,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"269f287c2cbb44c0973741f2a86442f5","type":"text","conversion_output":true,"text":"The risk of released PHI exists, but this is minimized by the use of code numbers in the DNA","text_display":"\n\nThe risk of released PHI exists, but this is minimized by the use of code numbers in the DNA","confidence":1,"confidence_rate":1},{"cnt":[[309,1931],[604,1931],[604,1970],[309,1970]],"region":{"top_left_x":309,"top_left_y":1931,"width":295,"height":40},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f01c46217c4429491e0f3565c694371","type":"text","conversion_output":true,"text":"Resources Core.","text_display":" Resources 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be reported to","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[309,2151],[1979,2151],[1979,2196],[309,2196]],"region":{"top_left_x":309,"top_left_y":2150,"width":1670,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f67e512c03de4a5fa494037992bbd237","type":"text","conversion_output":true,"text":"the IRB of record. Any release of information that occurs will be immediately reported to the PI and","text_display":" the IRB of record. Any release of information that occurs will be immediately reported to the PI and","confidence":0.7387828826904297,"confidence_rate":0.9971208080843167},{"cnt":[[309,2196],[634,2196],[634,2237],[309,2237]],"region":{"top_left_x":309,"top_left_y":2195,"width":325,"height":42},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"049834a2e3c347f99cc9da9ab46d4d2d","type":"text","conversion_output":true,"text":"the Vanderbilt IRB.","text_display":" the Vanderbilt IRB.","confidence":1,"confidence_rate":1},{"cnt":[[305,2320],[1063,2320],[1063,2374],[305,2374]],"region":{"top_left_x":305,"top_left_y":2320,"width":759,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a1be98674f44214b6d99360a813208b","type":"section_header","conversion_output":false,"children_ids":["da31fa081fdb439e9ec1a750b4ff3371"],"text":"","text_display":""},{"cnt":[[309,2325],[1059,2325],[1059,2370],[309,2370]],"region":{"top_left_x":309,"top_left_y":2324,"width":751,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da31fa081fdb439e9ec1a750b4ff3371","type":"text","conversion_output":true,"parent_id":"4a1be98674f44214b6d99360a813208b","text":"9.0 Study Withdrawal/Discontinuation","text_display":"\n\n\\subsection*{9.0 Study Withdrawal/Discontinuation}","confidence":1,"confidence_rate":1},{"cnt":[[309,2376],[1923,2376],[1923,2426],[309,2426]],"region":{"top_left_x":309,"top_left_y":2376,"width":1614,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b546ce3616d341df9778a821212252d3","type":"text","conversion_output":true,"text":"Participation in this study is voluntary. A patient who has agreed to participate in this study may","text_display":"\n\nParticipation in this study is voluntary. A patient who has agreed to participate in this study may","confidence":1,"confidence_rate":1},{"cnt":[[309,2421],[1906,2421],[1906,2469],[309,2469]],"region":{"top_left_x":309,"top_left_y":2421,"width":1597,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35aa1def36384338a2ce0c84efd6a224","type":"text","conversion_output":true,"text":"leave at any time. This will not affect their regular care or cause them to lose any benefits they","text_display":" leave at any time. This will not affect their regular care or cause them to lose any benefits they","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e58efd3e4c647498d55fb96cbf43b6c","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1837,2574],[1837,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":222,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78372ad6ed0f495a8f03578d772e123a","type":"page_info","conversion_output":false,"text":"Page 71 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-73","page":73,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"030c1180a75945e4ba7d853c8baf2939","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,251],[1981,251],[1981,299],[305,299]],"region":{"top_left_x":305,"top_left_y":251,"width":1676,"height":48},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73a1b565165040efa4c61bafaea81c28","type":"text","conversion_output":true,"text":"would normally have. If a patient wants to withdraw, they must contact the primary study physician.","text_display":"\nwould normally have. If a patient wants to withdraw, they must contact the primary study physician.","confidence":1,"confidence_rate":1},{"cnt":[[307,296],[1880,296],[1880,342],[307,342]],"region":{"top_left_x":307,"top_left_y":296,"width":1573,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4126b79cf4534892adf5f48d0eea957d","type":"text","conversion_output":true,"text":"Samples in storage at the Vanderbilt University DNA Resources Core will be destroyed upon","text_display":" Samples in storage at the Vanderbilt University DNA Resources Core will be destroyed upon","confidence":1,"confidence_rate":1},{"cnt":[[307,339],[1996,339],[1996,385],[307,385]],"region":{"top_left_x":307,"top_left_y":339,"width":1689,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ed381e551484d83b8ae5efea621bc52","type":"text","conversion_output":true,"text":"notification from the participating centers. Research data that have already been gathered using the","text_display":" notification from the participating centers. Research data that have already been gathered using the","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[1154,382],[1154,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":849,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9550e8168a8d40a5a176bb58aa006e38","type":"text","conversion_output":true,"text":"withdrawn subject's sample will not be withdrawn.","text_display":" withdrawn subject's sample will not be withdrawn.","confidence":1,"confidence_rate":1},{"cnt":[[305,468],[1893,468],[1893,518],[305,518]],"region":{"top_left_x":305,"top_left_y":468,"width":1588,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fcc3f5e8f064be791ded19210ebbf24","type":"text","conversion_output":true,"text":"The investigator or research sponsor (NHLBI) may decide to withdraw a subject if the study is","text_display":"\n\nThe investigator or research sponsor (NHLBI) may decide to withdraw a subject if the study is","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,516],[1222,516],[1222,561],[305,561]],"region":{"top_left_x":305,"top_left_y":515,"width":918,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"deeecb8beae94e268299a8e6a6ec87b0","type":"text","conversion_output":true,"text":"stopped. The sponsor may stop the study at any time.","text_display":" stopped. The sponsor may stop the study at any time.","confidence":1,"confidence_rate":1},{"cnt":[[305,597],[913,597],[913,647],[305,647]],"region":{"top_left_x":305,"top_left_y":597,"width":609,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bf84fe1919a4b8ebc5606bf0b835f39","type":"section_header","conversion_output":false,"children_ids":["dabf27e20c58462fbe7e39adffe1d266"],"text":"","text_display":""},{"cnt":[[309,602],[909,602],[909,642],[309,642]],"region":{"top_left_x":309,"top_left_y":601,"width":600,"height":42},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dabf27e20c58462fbe7e39adffe1d266","type":"text","conversion_output":true,"parent_id":"0bf84fe1919a4b8ebc5606bf0b835f39","text":"10.0 Statistical Considerations","text_display":"\n\n\\subsection*{10.0 Statistical Considerations}","confidence":0.99951171875,"confidence_rate":0.9999864334115239},{"cnt":[[309,645],[1906,645],[1906,694],[309,694]],"region":{"top_left_x":309,"top_left_y":644,"width":1597,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8721eb4c6c19491f85e9761617d1047e","type":"text","conversion_output":true,"text":"Study power will depend on the number of genotypes and other variables being assessed (the","text_display":"\n\nStudy power will depend on the number of genotypes and other variables being assessed (the","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[309,692],[1957,692],[1957,737],[309,737]],"region":{"top_left_x":309,"top_left_y":691,"width":1649,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb36b9176f3f4cf6a1a5fbf4a163e2a4","type":"text","conversion_output":true,"text":"problem of multiple comparisons), the effect size, the sample size, and variance of the phenotype","text_display":" problem of multiple comparisons), the effect size, the sample size, and variance of the phenotype","confidence":1,"confidence_rate":1},{"cnt":[[307,735],[2000,735],[2000,780],[307,780]],"region":{"top_left_x":307,"top_left_y":734,"width":1694,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2aa89720698b4cb89685e3d46505e0a3","type":"text","conversion_output":true,"text":"under study. For genome-wide experiments, even in a set of this magnitude, any analysis is likely to","text_display":" under study. For genome-wide experiments, even in a set of this magnitude, any analysis is likely to","confidence":1,"confidence_rate":1},{"cnt":[[307,778],[1992,778],[1992,827],[307,827]],"region":{"top_left_x":307,"top_left_y":777,"width":1685,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4c47915728c4102be777cdbf42e4132","type":"text","conversion_output":true,"text":"be underpowered and to require replication by analysis in other populations or by other approaches","text_display":" be underpowered and to require replication by analysis in other populations or by other approaches","confidence":1,"confidence_rate":1},{"cnt":[[307,821],[1910,821],[1910,870],[307,870]],"region":{"top_left_x":307,"top_left_y":820,"width":1603,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15782779a1854e90a951fc9f12a3817f","type":"text","conversion_output":true,"text":"(e.g. studies of biologic function). We anticipate that use of the CABANAgene resource will be","text_display":" (e.g. studies of biologic function). We anticipate that use of the CABANAgene resource will be","confidence":1,"confidence_rate":1},{"cnt":[[305,866],[1532,866],[1532,913],[305,913]],"region":{"top_left_x":305,"top_left_y":865,"width":1227,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"562fc244f4d94fd68a34639ee9867630","type":"text","conversion_output":true,"text":"conditioned on a statistical plan appropriate for the study size proposed.","text_display":" conditioned on a statistical plan appropriate for the study size proposed.","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[305,950],[941,950],[941,1003],[305,1003]],"region":{"top_left_x":305,"top_left_y":949,"width":637,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aac012626b0d4f88aa196c780a05a5d2","type":"section_header","conversion_output":false,"children_ids":["b1a405ea16214f9ea38c8fb0a1a4dc3c"],"text":"","text_display":""},{"cnt":[[309,954],[937,954],[937,999],[309,999]],"region":{"top_left_x":309,"top_left_y":953,"width":628,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1a405ea16214f9ea38c8fb0a1a4dc3c","type":"text","conversion_output":true,"parent_id":"aac012626b0d4f88aa196c780a05a5d2","text":"11.0 Privacy/Confidential Issues","text_display":"\n\n\\subsection*{11.0 Privacy/Confidential Issues}","confidence":1,"confidence_rate":1},{"cnt":[[309,997],[1968,997],[1968,1044],[309,1044]],"region":{"top_left_x":309,"top_left_y":996,"width":1659,"height":49},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"699dc16a003e4007b5626654db9c3d6a","type":"text","conversion_output":true,"text":"Samples will only be labeled with a study identification (ID) number. No other data will be included","text_display":"\n\nSamples will only be labeled with a study identification (ID) number. No other data will be included","confidence":1,"confidence_rate":1},{"cnt":[[305,1042],[1897,1042],[1897,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1041,"width":1593,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91c0c247b21d49fbad7e530fcac0bd08","type":"text","conversion_output":true,"text":"that would identify a person. Any health information which might identify the patient will not be","text_display":" that would identify a person. Any health information which might identify the patient will not be","confidence":1,"confidence_rate":1},{"cnt":[[305,1087],[1906,1087],[1906,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1087,"width":1601,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"416aee8807c94bc681938e3ad2ef4e11","type":"text","conversion_output":true,"text":"available to any person or group other than the investigators of this study. The files with the ID","text_display":" available to any person or group other than the investigators of this study. The files with the ID","confidence":1,"confidence_rate":1},{"cnt":[[307,1130],[1966,1130],[1966,1175],[307,1175]],"region":{"top_left_x":307,"top_left_y":1130,"width":1659,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e58fa09902a41da8021f60c38789db8","type":"text","conversion_output":true,"text":"numbers that link the sample to the patient will be kept in a locked, secure area accessible only to","text_display":" numbers that link the sample to the patient will be kept in a locked, secure area accessible only to","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1998,1173],[1998,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":1694,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb0fecd6ddf044b9a3e07b3e20f17fc4","type":"text","conversion_output":true,"text":"the study team. The results of any study using the resource may be published for all the subjects as","text_display":" the study team. The results of any study using the resource may be published for all the subjects as","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1162,1216],[1162,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1216,"width":858,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5b766bc1c014ae0919b45dda20b17a6","type":"text","conversion_output":true,"text":"a group but will not identify the patient individually.","text_display":" a group but will not identify the patient individually.","confidence":1,"confidence_rate":1},{"cnt":[[305,1298],[892,1296],[892,1354],[305,1356]],"region":{"top_left_x":304,"top_left_y":1295,"width":588,"height":61},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6b84d92f89c4e5b91673578fc960f49","type":"section_header","conversion_output":false,"children_ids":["9b978d7a84ce437aa6a247d82c97d200"],"text":"","text_display":""},{"cnt":[[309,1302],[887,1302],[887,1351],[309,1351]],"region":{"top_left_x":309,"top_left_y":1301,"width":579,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b978d7a84ce437aa6a247d82c97d200","type":"text","conversion_output":true,"parent_id":"c6b84d92f89c4e5b91673578fc960f49","text":"12.0 Follow-up and Retention","text_display":"\n\n\\subsection*{12.0 Follow-up and Retention}","confidence":1,"confidence_rate":1},{"cnt":[[309,1349],[1962,1349],[1962,1396],[309,1396]],"region":{"top_left_x":309,"top_left_y":1349,"width":1653,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8320e49ab1ec42a88bb82c342efa322e","type":"text","conversion_output":true,"text":"Samples for DNA extraction will be collected and genotyping will be performed the 4th year of the","text_display":"\n\nSamples for DNA extraction will be collected and genotyping will be performed the 4th year of the","confidence":1,"confidence_rate":1},{"cnt":[[307,1394],[1981,1394],[1981,1439],[307,1439]],"region":{"top_left_x":307,"top_left_y":1394,"width":1674,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"816bbc9824234513a869448299b9c9f7","type":"text","conversion_output":true,"text":"study. Following completion of the primary study, data analyses will be performed once genotyping","text_display":" study. Following completion of the primary study, data analyses will be performed once genotyping","confidence":1,"confidence_rate":1},{"cnt":[[305,1435],[2000,1435],[2000,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1435,"width":1696,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52db5b8072c34cc8a1fc43953fba3cf0","type":"text","conversion_output":true,"text":"is complete. Genotype data may be archived indefinitely for subsequent analyses. The DNA sample","text_display":" is complete. Genotype data may be archived indefinitely for subsequent analyses. 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Circulation","confidence":1,"confidence_rate":1},{"cnt":[[434,2093],[758,2093],[758,2138],[434,2138]],"region":{"top_left_x":433,"top_left_y":2092,"width":326,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"937df8d84240444194de32072fa703f4","type":"text","conversion_output":true,"text":"2010;122:976-984.","text_display":" 2010;122:976-984.","confidence":1,"confidence_rate":1},{"cnt":[[309,2574],[965,2574],[965,2615],[309,2615]],"region":{"top_left_x":309,"top_left_y":2573,"width":656,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fbe561524e764c3d847837f552951c5f","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1616,2574],[1841,2574],[1841,2615],[1616,2615]],"region":{"top_left_x":1615,"top_left_y":2573,"width":227,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2405ec2c478d46a397b95560c1c876fd","type":"page_info","conversion_output":false,"text":"Page 75 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-77","page":77,"lines":[{"cnt":[[370,155],[1794,155],[1794,200],[370,200]],"region":{"top_left_x":369,"top_left_y":154,"width":1425,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48f5b8f858e8443b9565ec76c69c95ff","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[301,245],[1268,245],[1268,303],[301,303]],"region":{"top_left_x":300,"top_left_y":244,"width":968,"height":59},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e45fc6487222401ea350528f17b7cd34","type":"section_header","conversion_output":false,"children_ids":["6a8f993ea3874255a827fb2ce82acd0c"],"text":"","text_display":""},{"cnt":[[305,249],[1265,249],[1265,299],[305,299]],"region":{"top_left_x":305,"top_left_y":249,"width":961,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a8f993ea3874255a827fb2ce82acd0c","type":"text","conversion_output":true,"parent_id":"e45fc6487222401ea350528f17b7cd34","text":"Appendix A: CABANA Inclusion / Exclusion Criteria","text_display":"\n\n\\section*{Appendix A: CABANA Inclusion / Exclusion Criteria}","confidence":1,"confidence_rate":1},{"cnt":[[303,335],[634,335],[634,385],[303,385]],"region":{"top_left_x":302,"top_left_y":335,"width":332,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be520ddf8889482a97b1a93b4441311a","type":"section_header","conversion_output":false,"children_ids":["3468beb9d9374949b2d43e7e96eb1619"],"text":"","text_display":""},{"cnt":[[305,339],[629,339],[629,380],[305,380]],"region":{"top_left_x":305,"top_left_y":339,"width":325,"height":42},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3468beb9d9374949b2d43e7e96eb1619","type":"text","conversion_output":true,"parent_id":"be520ddf8889482a97b1a93b4441311a","text":"Inclusion Criteria","text_display":"\n\n\\section*{Inclusion Criteria}","confidence":1,"confidence_rate":1},{"cnt":[[305,382],[1536,382],[1536,432],[305,432]],"region":{"top_left_x":305,"top_left_y":382,"width":1232,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d9ebaa2504b4310abed2c17746c676e","type":"text","conversion_output":true,"text":"To be eligible for the trial, subjects must meet all of the following criteria:","text_display":"\n\nTo be eligible for the trial, subjects must meet all of the following criteria:","confidence":1,"confidence_rate":1},{"cnt":[[370,466],[1038,466],[1038,518],[370,518]],"region":{"top_left_x":369,"top_left_y":466,"width":669,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31340f1c2cbb47f5825ee1833e85eea9","type":"text","conversion_output":true,"text":"1. Over the preceding 6 months have:","text_display":"\n1. Over the preceding 6 months have:","confidence":0.89892578125,"confidence_rate":0.9975812298381236},{"cnt":[[432,511],[2004,511],[2004,561],[432,561]],"region":{"top_left_x":431,"top_left_y":511,"width":1574,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5c9cf659fba4fdbacf1f56e775c01d9","type":"text","conversion_output":true,"text":"a) \\(\\geq 2\\) paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting","text_display":"\na) \\(\\geq 2\\) paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting","confidence":0.9791153246305839,"confidence_rate":0.99977785788782},{"cnt":[[430,554],[2004,554],[2004,604],[430,604]],"region":{"top_left_x":429,"top_left_y":554,"width":1576,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b17096fde1c45ef9299d4d8c923c2e9","type":"text","conversion_output":true,"text":"\\(\\geq 1\\) hour in duration: (that terminate spontaneously within 7 days or cardioversion is","text_display":" \\(\\geq 1\\) hour in duration: (that terminate spontaneously within 7 days or cardioversion is","confidence":1,"confidence_rate":1},{"cnt":[[430,597],[1076,597],[1076,647],[430,647]],"region":{"top_left_x":429,"top_left_y":597,"width":648,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca1473baa24a4a67b6cc912f4372c139","type":"text","conversion_output":true,"text":"performed within 48 h of AF onset): or","text_display":" performed within 48 h of AF onset): or","confidence":0.7772903442382812,"confidence_rate":0.9947649731601514},{"cnt":[[430,645],[2004,645],[2004,694],[430,694]],"region":{"top_left_x":429,"top_left_y":644,"width":1576,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae064d61d2ba4ed3a8ca023f0ea85bba","type":"text","conversion_output":true,"text":"b) electrocardiographic documentation of 1 persistent AF episode: (sustained for \\(\\geq 7\\) days","text_display":"\nb) electrocardiographic documentation of 1 persistent AF episode: (sustained for \\(\\geq 7\\) days","confidence":0.9970703125,"confidence_rate":0.9999703642024339},{"cnt":[[430,687],[1515,687],[1515,735],[430,735]],"region":{"top_left_x":429,"top_left_y":687,"width":1086,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5f0e341750f446b8240c0ef8c1d1a43","type":"text","conversion_output":true,"text":"or cardioversion is performed more than 48 h after AF onset): or","text_display":" or cardioversion is performed more than 48 h after AF onset): or","confidence":0.99755859375,"confidence_rate":0.9999669682301315},{"cnt":[[430,730],[2004,730],[2004,780],[430,780]],"region":{"top_left_x":429,"top_left_y":730,"width":1576,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4f4118c8c5c434ba557457c1b4f24be","type":"text","conversion_output":true,"text":"c) electrocardiographic documentation of 1 longstanding persistent AF episode:","text_display":"\nc) electrocardiographic documentation of 1 longstanding persistent AF episode:","confidence":0.9980475902557373,"confidence_rate":0.9999772756281954},{"cnt":[[432,776],[1051,776],[1051,823],[432,823]],"region":{"top_left_x":431,"top_left_y":775,"width":620,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38d22e948387435e9bdc13a140054273","type":"text","conversion_output":true,"text":"(continuous AF of duration \\(>1\\) year).","text_display":" (continuous AF of duration \\(>1\\) year).","confidence":0.93017578125,"confidence_rate":0.9983563137298426},{"cnt":[[367,819],[1884,819],[1884,868],[367,868]],"region":{"top_left_x":367,"top_left_y":818,"width":1518,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"913d9ea553bd4c5fa7f1c0219d369911","type":"text","conversion_output":true,"text":"2. Warrant active therapy (within the past 3 months) beyond simple ongoing observation","text_display":"\n2. Warrant active therapy (within the past 3 months) beyond simple ongoing observation","confidence":1,"confidence_rate":1},{"cnt":[[370,864],[2004,864],[2004,913],[370,913]],"region":{"top_left_x":369,"top_left_y":863,"width":1636,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff8cca09d6904c8e88b0bcc88941db3f","type":"text","conversion_output":true,"text":"3. Be eligible for catheter ablation and \\(\\geq 2\\) sequential rhythm control and/or \\(\\geq 2\\) rate control","text_display":"\n3. Be eligible for catheter ablation and \\(\\geq 2\\) sequential rhythm control and/or \\(\\geq 2\\) rate control","confidence":1,"confidence_rate":1},{"cnt":[[432,907],[548,907],[548,954],[432,954]],"region":{"top_left_x":431,"top_left_y":906,"width":117,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"725433f623f945ab8626adb39ea6801d","type":"text","conversion_output":true,"text":"drugs.","text_display":" drugs.","confidence":1,"confidence_rate":1},{"cnt":[[367,950],[2004,950],[2004,999],[367,999]],"region":{"top_left_x":367,"top_left_y":949,"width":1638,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8704c2aeb92441968ac309a8df7e9f3d","type":"text","conversion_output":true,"text":"4. Be \\(\\geq 65 yrs\\) of age, or <65 yrs with one or more of the following risk factors for stroke:","text_display":"\n4. Be \\(\\geq 65 yrs\\) of age, or <65 yrs with one or more of the following risk factors for stroke:","confidence":0.967803955078125,"confidence_rate":0.9996760352803576},{"cnt":[[432,993],[2007,993],[2007,1042],[432,1042]],"region":{"top_left_x":431,"top_left_y":992,"width":1576,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2222181232a4ef681bc7c09361c94ef","type":"text","conversion_output":true,"text":"Hypertension (treated and/or defined as a BP \\(>140 / 90 mmHg\\) ) [90], Diabetes (treated and/or","text_display":" Hypertension (treated and/or defined as a BP \\(>140 / 90 mmHg\\) ) [90], Diabetes (treated and/or","confidence":1,"confidence_rate":1},{"cnt":[[430,1040],[2007,1040],[2007,1087],[430,1087]],"region":{"top_left_x":429,"top_left_y":1039,"width":1578,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3be0443418bd4d6d810b6c7585d9ee5f","type":"text","conversion_output":true,"text":"defined as a fasting glucose \\(\\geq 126 mg / dl\\) ) [91], Congestive heart failure (including systolic or","text_display":" defined as a fasting glucose \\(\\geq 126 mg / dl\\) ) [91], Congestive heart failure (including systolic or","confidence":0.982959708198905,"confidence_rate":0.9998408724002652},{"cnt":[[430,1083],[2004,1083],[2004,1130],[430,1130]],"region":{"top_left_x":429,"top_left_y":1082,"width":1576,"height":49},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98cb9a44e90f4ddbb14a5a2d9f714550","type":"text","conversion_output":true,"text":"diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic vascular disease","text_display":" diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic vascular disease","confidence":1,"confidence_rate":1},{"cnt":[[432,1126],[2004,1126],[2004,1175],[432,1175]],"region":{"top_left_x":431,"top_left_y":1125,"width":1574,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f9576ab18124d16be2593ad4d03274c","type":"text","conversion_output":true,"text":"(previous MI, peripheral arterial disease or aortic plaque), LA size \\(>5.0 cm\\) (or volume index","text_display":" (previous MI, peripheral arterial disease or aortic plaque), LA size \\(>5.0 cm\\) (or volume index","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[430,1164],[2007,1164],[2007,1222],[430,1222]],"region":{"top_left_x":429,"top_left_y":1164,"width":1578,"height":59},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"014710a52e574f91b34fba968bc1ec9a","type":"text","conversion_output":true,"text":"\\(\\geq 40 cc / m ^{2}\\) ), or EF \\(\\leq 35\\). Subjects \\(<65 yrs\\) of age whose only risk factor is hypertension must","text_display":" \\(\\geq 40 cc / m ^{2}\\) ), or EF \\(\\leq 35\\). Subjects \\(<65 yrs\\) of age whose only risk factor is hypertension must","confidence":0.6867637271875693,"confidence_rate":0.9967658878921228},{"cnt":[[430,1216],[1356,1216],[1356,1263],[430,1263]],"region":{"top_left_x":429,"top_left_y":1216,"width":927,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85ab5981017143d9970521634b521810","type":"text","conversion_output":true,"text":"have a second risk factor or LV hypertrophy to qualify.","text_display":" have a second risk factor or LV hypertrophy to qualify.","confidence":1,"confidence_rate":1},{"cnt":[[370,1259],[1601,1259],[1601,1308],[370,1308]],"region":{"top_left_x":369,"top_left_y":1258,"width":1232,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f30fa25c4b4b48c59f70907d4afd94e5","type":"text","conversion_output":true,"text":"5. Have the capacity to understand and sign an informed consent form.","text_display":"\n5. Have the capacity to understand and sign an informed consent form.","confidence":1,"confidence_rate":1},{"cnt":[[370,1302],[793,1302],[793,1351],[370,1351]],"region":{"top_left_x":369,"top_left_y":1301,"width":424,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6833ed0b64c40b3a75a3dfa01da2ca0","type":"text","conversion_output":true,"text":"6 . Be \\(\\geq 18\\) years of age.","text_display":"\n\n6 . Be \\(\\geq 18\\) years of age.","confidence":0.8856638404540718,"confidence_rate":0.996090956635816},{"cnt":[[305,1388],[2004,1388],[2004,1437],[305,1437]],"region":{"top_left_x":305,"top_left_y":1387,"width":1700,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f6da8cca71448e68e7e9778456ed853","type":"text","conversion_output":true,"text":"NOTE: Subjects may have recent onset AF (in the past 4-6 months), AF present for a longer time","text_display":"\nNOTE: Subjects may have recent onset AF (in the past 4-6 months), AF present for a longer time","confidence":0.80810546875,"confidence_rate":0.9978501657428775},{"cnt":[[305,1435],[2004,1435],[2004,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1435,"width":1700,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"973a91b643774ea7a3f3271b823cfca5","type":"text","conversion_output":true,"text":"period, or may have been treated with a single anti-arrhythmic drug, providing they remain","text_display":" period, or may have been treated with a single anti-arrhythmic drug, providing they remain","confidence":1,"confidence_rate":1},{"cnt":[[305,1478],[2004,1478],[2004,1528],[305,1528]],"region":{"top_left_x":305,"top_left_y":1478,"width":1700,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfcf9a635d584851a8c9fdbfd625875a","type":"text","conversion_output":true,"text":"realistically eligible for \\(\\geq 2\\) membrane active drugs and/or \\(\\geq 2\\) rate control agents. Patients receiving","text_display":" realistically eligible for \\(\\geq 2\\) membrane active drugs and/or \\(\\geq 2\\) rate control agents. Patients receiving","confidence":1,"confidence_rate":1},{"cnt":[[305,1521],[2004,1521],[2004,1571],[305,1571]],"region":{"top_left_x":305,"top_left_y":1521,"width":1700,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd3d8a989b31491981b3efd694895233","type":"text","conversion_output":true,"text":"new drug therapy initiated within the previous 3 months may continue that therapy if randomized to","text_display":" new drug therapy initiated within the previous 3 months may continue that therapy if randomized to","confidence":1,"confidence_rate":1},{"cnt":[[305,1566],[2004,1566],[2004,1613],[305,1613]],"region":{"top_left_x":305,"top_left_y":1566,"width":1700,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca56114d5feb41d6bef210504988ebce","type":"text","conversion_output":true,"text":"the drug therapy arm. Reasonable expectation of a response to therapy must be present. Subjects","text_display":" the drug therapy arm. Reasonable expectation of a response to therapy must be present. Subjects","confidence":1,"confidence_rate":1},{"cnt":[[305,1609],[2004,1609],[2004,1659],[305,1659]],"region":{"top_left_x":305,"top_left_y":1609,"width":1700,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72c6e72348b745b9bf98146e48b53173","type":"text","conversion_output":true,"text":"will not be excluded because of advancing age or underlying heart disease. Subjects with a history","text_display":" will not be excluded because of advancing age or underlying heart disease. Subjects with a history","confidence":1,"confidence_rate":1},{"cnt":[[305,1654],[2004,1654],[2004,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1654,"width":1700,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c4bba4e6137474bb29557022d1b803e","type":"text","conversion_output":true,"text":"of a single episode of paroxysmal AF do not meet the \"crossing the threshold/warranting therapy\"","text_display":" of a single episode of paroxysmal AF do not meet the \"crossing the threshold/warranting therapy\"","confidence":1,"confidence_rate":1},{"cnt":[[305,1697],[2002,1697],[2002,1747],[305,1747]],"region":{"top_left_x":305,"top_left_y":1697,"width":1698,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94b0425ddaba4b2bbe70b7d1ccd80597","type":"text","conversion_output":true,"text":"litmus test. Subjects with persistent or long-standing persistent AF will require at least 1","text_display":" litmus test. Subjects with persistent or long-standing persistent AF will require at least 1","confidence":1,"confidence_rate":1},{"cnt":[[305,1742],[2004,1742],[2004,1790],[305,1790]],"region":{"top_left_x":305,"top_left_y":1742,"width":1700,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"452aef5c3ebd4d7f90a616a6ab29baf2","type":"text","conversion_output":true,"text":"documented episode, if it is of sufficient clinical importance that drug or ablative therapy is","text_display":" documented episode, if it is of sufficient clinical importance that drug or ablative therapy is","confidence":1,"confidence_rate":1},{"cnt":[[305,1783],[2004,1783],[2004,1835],[305,1835]],"region":{"top_left_x":305,"top_left_y":1783,"width":1700,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36c8559be4b14e0dac4c55177d297d7d","type":"text","conversion_output":true,"text":"warranted. Subjects can be randomized before cardioversion, even if restoration of sinus rhythm is","text_display":" warranted. Subjects can be randomized before cardioversion, even if restoration of sinus rhythm is","confidence":1,"confidence_rate":1},{"cnt":[[305,1830],[2004,1830],[2004,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1830,"width":1700,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88c250a03b7a4a24bdc534f90c5e5cb4","type":"text","conversion_output":true,"text":"a desired endpoint of therapy. Patients may have documented atrial flutter in addition to atrial","text_display":" a desired endpoint of therapy. Patients may have documented atrial flutter in addition to atrial","confidence":1,"confidence_rate":1},{"cnt":[[305,1873],[1063,1873],[1063,1923],[305,1923]],"region":{"top_left_x":305,"top_left_y":1873,"width":759,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ba95094761c4cf3a299465ad27d62bd","type":"text","conversion_output":true,"text":"fibrillation and remain eligible for enrollment.","text_display":" fibrillation and remain eligible for enrollment.","confidence":1,"confidence_rate":1},{"cnt":[[301,1955],[862,1955],[862,2017],[301,2017]],"region":{"top_left_x":300,"top_left_y":1955,"width":562,"height":63},"line":39,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"6917dfb4e6b544b08c46c5d78a244ad3","type":"section_header","conversion_output":false,"children_ids":["f990f00ea90c42e68854489cec5804cb"],"text":"","text_display":""},{"cnt":[[305,1964],[857,1964],[857,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1963,"width":553,"height":51},"line":40,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"f990f00ea90c42e68854489cec5804cb","type":"text","conversion_output":true,"parent_id":"6917dfb4e6b544b08c46c5d78a244ad3","text":"3.2 Exclusion Criteria","text_display":"\n\n\\subsection*{3.2 Exclusion Criteria}","confidence":1,"confidence_rate":1},{"cnt":[[305,2015],[1783,2015],[1783,2065],[305,2065]],"region":{"top_left_x":305,"top_left_y":2015,"width":1479,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e29a000178c24d5698fdd41ed86204c2","type":"text","conversion_output":true,"text":"If a subject has any of the following criteria, he or she may not be enrolled in the study:","text_display":"\n\nIf a subject has any of the following criteria, he or she may not be enrolled in the study:","confidence":1,"confidence_rate":1},{"cnt":[[370,2058],[1721,2058],[1721,2108],[370,2108]],"region":{"top_left_x":369,"top_left_y":2058,"width":1352,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eca25273217e4e9c97793c6d27de0176","type":"text","conversion_output":true,"text":"1. Lone AF in the absence of risk factors for stroke in patients \\(<65\\) years of age","text_display":"\n1. Lone AF in the absence of risk factors for stroke in patients \\(<65\\) years of age","confidence":0.5352056220872328,"confidence_rate":0.9934415561899645},{"cnt":[[367,2105],[2004,2105],[2004,2153],[367,2153]],"region":{"top_left_x":367,"top_left_y":2105,"width":1638,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3512f86b12fb4d43a2bdd6e47ffa6aeb","type":"text","conversion_output":true,"text":"2. Patients who in the opinion of the managing clinician should not yet receive any therapy for","text_display":"\n2. Patients who in the opinion of the managing clinician should not yet receive any therapy for","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[430,2148],[494,2148],[494,2196],[430,2196]],"region":{"top_left_x":429,"top_left_y":2148,"width":66,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83650a34118f4117aad9df39e7adcfb9","type":"text","conversion_output":true,"text":"AF","text_display":" AF","confidence":1,"confidence_rate":1},{"cnt":[[370,2191],[2004,2191],[2004,2241],[370,2241]],"region":{"top_left_x":369,"top_left_y":2191,"width":1636,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ebae1df63b34d519ea22197e9946909","type":"text","conversion_output":true,"text":"3. Patients who have failed \\(\\geq 2\\) membrane active anti-arrhythmic drugs at a therapeutic dose","text_display":"\n3. Patients who have failed \\(\\geq 2\\) membrane active anti-arrhythmic drugs at a therapeutic dose","confidence":1,"confidence_rate":1},{"cnt":[[430,2237],[1195,2237],[1195,2284],[430,2284]],"region":{"top_left_x":429,"top_left_y":2236,"width":766,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1236d493dfe4c959499d54a9ce936c3","type":"text","conversion_output":true,"text":"due to inefficacy or side effects (Table 5.2.2)","text_display":" due to inefficacy or side effects (Table 5.2.2)","confidence":0.9990236759185791,"confidence_rate":0.9999812155418875},{"cnt":[[370,2282],[1828,2282],[1828,2329],[370,2329]],"region":{"top_left_x":369,"top_left_y":2281,"width":1460,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8262db4e4c247a092bf41ce7003cd05","type":"text","conversion_output":true,"text":"4. An efficacy failure of full dose amiodarone treatment \\(\\geq 8\\) weeks duration at any time","text_display":"\n4. An efficacy failure of full dose amiodarone treatment \\(\\geq 8\\) weeks duration at any time","confidence":1,"confidence_rate":1},{"cnt":[[370,2325],[2004,2325],[2004,2374],[370,2374]],"region":{"top_left_x":369,"top_left_y":2324,"width":1636,"height":51},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c02d042095d4fd7ad09957b15b31ec4","type":"text","conversion_output":true,"text":"5. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major","text_display":"\n5. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major","confidence":1,"confidence_rate":1},{"cnt":[[432,2368],[960,2368],[960,2417],[432,2417]],"region":{"top_left_x":431,"top_left_y":2367,"width":530,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9293dc52971643f6b09b970665cacdfc","type":"text","conversion_output":true,"text":"surgical procedures, or trauma","text_display":" surgical procedures, or trauma","confidence":1,"confidence_rate":1},{"cnt":[[370,2413],[2004,2413],[2004,2460],[370,2460]],"region":{"top_left_x":369,"top_left_y":2412,"width":1636,"height":48},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b846ce54a884890a8709d2780f75737","type":"text","conversion_output":true,"text":"6. Recent cardiac events including \\(MI , PCl\\), or valve or bypass surgery in the preceding 3","text_display":"\n6. Recent cardiac events including \\(MI , PCl\\), or valve or bypass surgery in the preceding 3","confidence":0.5865383148193359,"confidence_rate":0.994783093949539},{"cnt":[[432,2458],[569,2458],[569,2499],[432,2499]],"region":{"top_left_x":431,"top_left_y":2457,"width":139,"height":42},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9241475425b4f54baf1b92bc602b103","type":"text","conversion_output":true,"text":"months","text_display":" months","confidence":1,"confidence_rate":1},{"cnt":[[305,2574],[967,2574],[967,2615],[305,2615]],"region":{"top_left_x":305,"top_left_y":2573,"width":662,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53dfe3a8288b44dda8bdd50d74d4af44","type":"page_info","conversion_output":false,"text":"CABANA Confidential 22 November, 2013","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999777947999976},{"cnt":[[1611,2574],[1841,2574],[1841,2615],[1611,2615]],"region":{"top_left_x":1611,"top_left_y":2573,"width":231,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3bc454ac0eec458898cfd4ce42d9c781","type":"page_info","conversion_output":false,"text":"Page 76 of 78","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"64d80bce-ca6a-44bc-b0be-c94a4a3841c8-78","page":78,"lines":[{"cnt":[[372,155],[1794,155],[1794,200],[372,200]],"region":{"top_left_x":371,"top_left_y":154,"width":1423,"height":46},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9e9d37302aa4a488493b62311ed818e","type":"page_info","conversion_output":false,"text":"Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[370,249],[1369,249],[1369,299],[370,299]],"region":{"top_left_x":369,"top_left_y":249,"width":1000,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af00ea75a59147fa99587fb04ffff0cd","type":"text","conversion_output":true,"text":"7. Hypertrophic obstructive cardiomyopathy (outflow track)","text_display":"\n7. Hypertrophic obstructive cardiomyopathy (outflow track)","confidence":1,"confidence_rate":1},{"cnt":[[370,296],[1800,296],[1800,342],[370,342]],"region":{"top_left_x":369,"top_left_y":296,"width":1432,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54ccd4d127514272a82ac2087da1da44","type":"text","conversion_output":true,"text":"8. Class IV angina or Class IV CHF (including past or planned heart transplantation)","text_display":"\n8. Class IV angina or Class IV CHF (including past or planned heart transplantation)","confidence":1,"confidence_rate":1},{"cnt":[[370,339],[1626,339],[1626,385],[370,385]],"region":{"top_left_x":369,"top_left_y":339,"width":1258,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca013b1259164853ab83f46983b6dd13","type":"text","conversion_output":true,"text":"9. 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Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs","confidence":1,"confidence_rate":1},{"cnt":[[372,425],[1412,425],[1412,475],[372,475]],"region":{"top_left_x":371,"top_left_y":425,"width":1041,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90b560bca9464ea3b4e16745772ed8b1","type":"text","conversion_output":true,"text":"11. Prior LA catheter ablation with the intention of treating AF","text_display":"\n11. Prior LA catheter ablation with the intention of treating AF","confidence":1,"confidence_rate":1},{"cnt":[[372,471],[1515,471],[1515,518],[372,518]],"region":{"top_left_x":371,"top_left_y":470,"width":1144,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07120f2ff90a4fa899492c99545e53cd","type":"text","conversion_output":true,"text":"12. Prior surgical interventions for AF such as the MAZE procedure","text_display":"\n12. Prior surgical interventions for AF such as the MAZE procedure","confidence":1,"confidence_rate":1},{"cnt":[[372,516],[831,516],[831,556],[372,556]],"region":{"top_left_x":371,"top_left_y":515,"width":461,"height":42},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccdb34eca21744238a1adb973cccf068","type":"text","conversion_output":true,"text":"13. Prior AV nodal ablation","text_display":"\n13. Prior AV nodal ablation","confidence":1,"confidence_rate":1},{"cnt":[[372,559],[1407,559],[1407,604],[372,604]],"region":{"top_left_x":371,"top_left_y":558,"width":1037,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ab8b96e42be405895fe6625149ec23d","type":"text","conversion_output":true,"text":"14. Patients with other arrhythmias requiring ablative therapy","text_display":"\n14. Patients with other arrhythmias requiring ablative therapy","confidence":1,"confidence_rate":1},{"cnt":[[372,602],[1384,602],[1384,649],[372,649]],"region":{"top_left_x":371,"top_left_y":601,"width":1013,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7409c631a1940c0b1925d47a4a430d7","type":"text","conversion_output":true,"text":"15. Contraindication to appropriate anti-coagulation therapy","text_display":"\n15. Contraindication to appropriate anti-coagulation therapy","confidence":0.99951171875,"confidence_rate":0.9999924861744118},{"cnt":[[370,645],[952,645],[952,694],[370,694]],"region":{"top_left_x":369,"top_left_y":644,"width":583,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c022f5b9421478c8a15a4937f57776d","type":"text","conversion_output":true,"text":"16. Renal failure requiring dialysis","text_display":"\n16. Renal failure requiring dialysis","confidence":1,"confidence_rate":1},{"cnt":[[372,692],[1377,692],[1377,737],[372,737]],"region":{"top_left_x":371,"top_left_y":691,"width":1007,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ed5befb08f24f9dbfae8d1459fe87f1","type":"text","conversion_output":true,"text":"17. Medical conditions limiting expected survival to \\(<1\\) year","text_display":"\n17. Medical conditions limiting expected survival to \\(<1\\) year","confidence":0.9912109375,"confidence_rate":0.9998701861600228},{"cnt":[[370,735],[1764,735],[1764,782],[370,782]],"region":{"top_left_x":369,"top_left_y":734,"width":1395,"height":49},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"808d9d42bf744f68a40e524f678b80f2","type":"text","conversion_output":true,"text":"18. Women of childbearing potential (unless post-menopausal or surgically sterile)","text_display":"\n18. Women of childbearing potential (unless post-menopausal or surgically sterile)","confidence":1,"confidence_rate":1},{"cnt":[[370,778],[2007,778],[2007,827],[370,827]],"region":{"top_left_x":369,"top_left_y":777,"width":1638,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32cc59622aa94503b4ee30c004c2b6f6","type":"text","conversion_output":true,"text":"19. Participation in any other clinical mortality trial (Participation in other non-mortality trials","text_display":"\n19. Participation in any other clinical mortality trial (Participation in other non-mortality trials","confidence":1,"confidence_rate":1},{"cnt":[[432,821],[1474,821],[1474,870],[432,870]],"region":{"top_left_x":431,"top_left_y":820,"width":1043,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9b1144c83ec448cb762fd64778e4ac5","type":"text","conversion_output":true,"text":"should be reviewed with the clinical trial management center)","text_display":" should be reviewed with the clinical trial management center)","confidence":1,"confidence_rate":1},{"cnt":[[370,866],[993,866],[993,913],[370,913]],"region":{"top_left_x":369,"top_left_y":865,"width":624,"height":49},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dca9e3227214ad0959fa89c8f935aa0","type":"text","conversion_output":true,"text":"20. Unable to give informed consent","text_display":"\n20. Unable to give informed consent","confidence":1,"confidence_rate":1},{"cnt":[[305,954],[1996,954],[1996,1001],[305,1001]],"region":{"top_left_x":305,"top_left_y":953,"width":1691,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2578fb3f88184233a957c16db1cc5b0f","type":"text","conversion_output":true,"text":"NOTE: Exclusion Criterion \\#3 includes failed membrane active antiarrhythmic drugs started within 3","text_display":"\n\nNOTE: Exclusion Criterion \\#3 includes failed membrane active antiarrhythmic drugs started within 3","confidence":1,"confidence_rate":1},{"cnt":[[432,999],[1886,999],[1886,1044],[432,1044]],"region":{"top_left_x":431,"top_left_y":999,"width":1456,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0895b3d6b9fc4c0fa027415f2cb53485","type":"text","conversion_output":true,"text":"months prior to enrollment. Prior ablation of the cavo-tricuspid isthmus alone is not an","text_display":" months prior to enrollment. Prior ablation of the cavo-tricuspid isthmus alone is not an","confidence":1,"confidence_rate":1},{"cnt":[[432,1040],[1962,1040],[1962,1089],[432,1089]],"region":{"top_left_x":431,"top_left_y":1039,"width":1531,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42537ce213de469aa94432bc9f321b1d","type":"text","conversion_output":true,"text":"exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in","text_display":" exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in","confidence":1,"confidence_rate":1},{"cnt":[[432,1087],[1424,1087],[1424,1128],[432,1128]],"region":{"top_left_x":431,"top_left_y":1087,"width":994,"height":41},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfa9f4d72fdb4fc3bc42c41eaeeec9f2","type":"text","conversion_output":true,"text":"combination with the left atrial ablation is not an exclusion.","text_display":" combination with the left atrial ablation is not an exclusion.","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1291,1173],[1291,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":987,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81ab321012834fd49c53c8a755011039","type":"text","conversion_output":true,"text":"Appendix B: CABANAgene Kit Contents and Instructions","text_display":"\n\nAppendix B: CABANAgene Kit Contents and Instructions","confidence":0.99853515625,"confidence_rate":0.9999742824766223},{"cnt":[[301,1257],[690,1257],[690,1308],[301,1308]],"region":{"top_left_x":300,"top_left_y":1256,"width":390,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"557dc93bef064f14a7fb2032455a3750","type":"section_header","conversion_output":false,"children_ids":["113a009f02a34ff2b2942cc2e74e52b9"],"text":"","text_display":""},{"cnt":[[305,1263],[683,1263],[683,1304],[305,1304]],"region":{"top_left_x":305,"top_left_y":1263,"width":379,"height":42},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"113a009f02a34ff2b2942cc2e74e52b9","type":"text","conversion_output":true,"parent_id":"557dc93bef064f14a7fb2032455a3750","text":"Patient Kit Contents","text_display":"\n\n\\section*{Patient Kit Contents}","confidence":1,"confidence_rate":1},{"cnt":[[370,1302],[821,1302],[821,1351],[370,1351]],"region":{"top_left_x":369,"top_left_y":1301,"width":452,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b08962179ac4ed296b3098dbc2d1ae6","type":"text","conversion_output":true,"text":"I. 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