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This includes sympathetic stimulation,","confidence":1,"confidence_rate":1},{"cnt":[[245,1298],[1854,1298],[1854,1341],[245,1341]],"region":{"top_left_x":244,"top_left_y":1297,"width":1611,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df4dd73705954ed9b6a4ba7675ee7b87","type":"text","conversion_output":true,"text":"enhanced automaticity, and increased after depolarization-induced triggered activity.[5] Conversely, caffeine also","text_display":" enhanced automaticity, and increased after depolarization-induced triggered activity.[5] Conversely, caffeine also","confidence":1,"confidence_rate":1},{"cnt":[[245,1341],[1766,1341],[1766,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1340,"width":1523,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8bcbc29aea134313ab55ce4db1c1511d","type":"text","conversion_output":true,"text":"has mechanisms that might reduce AF; for example, caffeine inhibits adenosine which can trigger AF, and it","text_display":" has mechanisms that might reduce AF; for example, caffeine inhibits adenosine which can trigger AF, and it","confidence":0.98095703125,"confidence_rate":0.9998268021955667},{"cnt":[[245,1384],[1714,1384],[1714,1424],[245,1424]],"region":{"top_left_x":244,"top_left_y":1383,"width":1471,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2ac2b25fea554a9ca4bacccedb1cac7d","type":"text","conversion_output":true,"text":"additionally has some antioxidant activity. Finally, it has been estimated that coffee contains over 1,000","text_display":" additionally has some antioxidant activity. Finally, it has been estimated that coffee contains over 1,000","confidence":0.9443359375,"confidence_rate":0.9994794690673832},{"cnt":[[245,1427],[1878,1427],[1878,1467],[245,1467]],"region":{"top_left_x":244,"top_left_y":1426,"width":1634,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58fa3b93a8fc4dfd8cf5011c18c718cf","type":"text","conversion_output":true,"text":"compounds, including some with described biological effects such as diterpene alcohols and chlorogenic acid.[4] As","text_display":" compounds, including some with described biological effects such as diterpene alcohols and chlorogenic acid.[4] As","confidence":1,"confidence_rate":1},{"cnt":[[245,1467],[1766,1467],[1766,1508],[245,1508]],"region":{"top_left_x":244,"top_left_y":1467,"width":1523,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d1fbcc2e00e4583b9990bbf2044e589","type":"text","conversion_output":true,"text":"a result, there are plausible mechanisms for coffee and its constituents to have both beneficial and harmful","text_display":" a result, there are plausible mechanisms for coffee and its constituents to have both beneficial and harmful","confidence":1,"confidence_rate":1},{"cnt":[[245,1508],[793,1508],[793,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1508,"width":549,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d26f3e2bd2c4298b596bd9f23df6f06","type":"text","conversion_output":true,"text":"cardiovascular and arrhythmic effects.","text_display":" cardiovascular and arrhythmic effects.","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1119,1594],[1119,1639],[245,1639]],"region":{"top_left_x":244,"top_left_y":1594,"width":876,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"209759bd6b504130af0039b515cdd17b","type":"section_header","conversion_output":false,"children_ids":["01d765c9bf7d47dd92daab697985ca28"],"text":"","text_display":""},{"cnt":[[247,1596],[1117,1596],[1117,1635],[247,1635]],"region":{"top_left_x":247,"top_left_y":1596,"width":871,"height":39},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01d765c9bf7d47dd92daab697985ca28","type":"text","conversion_output":true,"parent_id":"209759bd6b504130af0039b515cdd17b","text":"1.3. Prior Observational Studies on Coffee, Caffeine, and AF","text_display":"\n\n\\subsection*{1.3. Prior Observational Studies on Coffee, Caffeine, and AF}","confidence":0.99609375,"confidence_rate":0.9999397879771068},{"cnt":[[245,1680],[1824,1680],[1824,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1680,"width":1581,"height":41},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1be43cc1733847b4825efa3526845779","type":"text","conversion_output":true,"text":"A number of prior observational studies have evaluated the role of chronic coffee consumption and incident AF","text_display":"\n\nA number of prior observational studies have evaluated the role of chronic coffee consumption and incident AF","confidence":1,"confidence_rate":1},{"cnt":[[245,1723],[1871,1723],[1871,1764],[245,1764]],"region":{"top_left_x":244,"top_left_y":1723,"width":1628,"height":41},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e01513623f14cc5b7e1b163f01b5a23","type":"text","conversion_output":true,"text":"with varied results. In the Multifactor Primary Prevention Study, moderate coffee consumption of \\(1-4\\) cups per day","text_display":" with varied results. In the Multifactor Primary Prevention Study, moderate coffee consumption of \\(1-4\\) cups per day","confidence":0.5765849535819143,"confidence_rate":0.9954596561119641},{"cnt":[[245,1766],[1751,1766],[1751,1807],[245,1807]],"region":{"top_left_x":244,"top_left_y":1766,"width":1507,"height":41},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"efa78f2bc88f4318a27718798c226fe9","type":"text","conversion_output":true,"text":"was associated with increased risk.[7] Similarly, intermittent coffee consumption of less than 0.5 cups/day","text_display":" was associated with increased risk.[7] Similarly, intermittent coffee consumption of less than 0.5 cups/day","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[245,1807],[1852,1807],[1852,1850],[245,1850]],"region":{"top_left_x":244,"top_left_y":1806,"width":1608,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"170875a9d40e4b4d981cea4ff0de67e0","type":"text","conversion_output":true,"text":"appeared to be associated with greater AF risk in the Multi-Ethnic Study of Atherosclerosis.[8] In contrast, several","text_display":" appeared to be associated with greater AF risk in the Multi-Ethnic Study of Atherosclerosis.[8] In contrast, several","confidence":1,"confidence_rate":1},{"cnt":[[247,1848],[1854,1848],[1854,1893],[247,1893]],"region":{"top_left_x":247,"top_left_y":1847,"width":1608,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35cfbc84346f42e2876d42002e32fbac","type":"text","conversion_output":true,"text":"reports have found no clear relationship between coffee or caffeine intake and incident AF. These include reports","text_display":" reports have found no clear relationship between coffee or caffeine intake and incident AF. These include reports","confidence":0.962890625,"confidence_rate":0.9996795814212992},{"cnt":[[245,1891],[1772,1891],[1772,1934],[245,1934]],"region":{"top_left_x":244,"top_left_y":1890,"width":1529,"height":44},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92463d59a2b84768a54023b1cb74aff7","type":"text","conversion_output":true,"text":"from the Danish Diet, Cancer, and Health Study,[9] the Framingham heart Study,[10] two Cohort of Swedish","text_display":" from the Danish Diet, Cancer, and Health Study,[9] the Framingham heart Study,[10] two Cohort of Swedish","confidence":0.9990234375,"confidence_rate":0.9999910363736797},{"cnt":[[245,1934],[1867,1934],[1867,1979],[245,1979]],"region":{"top_left_x":244,"top_left_y":1933,"width":1623,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2723a2b7bb194bea8b118e0e3e96c79b","type":"text","conversion_output":true,"text":"Men,[11] and the Swedish Mammography Cohort.[11] Conversely, other studies have described results potentially","text_display":" Men,[11] and the Swedish Mammography Cohort.[11] Conversely, other studies have described results potentially","confidence":1,"confidence_rate":1},{"cnt":[[245,1977],[1843,1977],[1843,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1976,"width":1600,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d17ca304175d4ef989039d11cfd32eb7","type":"text","conversion_output":true,"text":"consistent with a linear benefit of increasing coffee consumption. These include reductions of risk in hospitalized","text_display":" consistent with a linear benefit of increasing coffee consumption. These include reductions of risk in hospitalized","confidence":1,"confidence_rate":1},{"cnt":[[245,2020],[1876,2020],[1876,2060],[245,2060]],"region":{"top_left_x":244,"top_left_y":2019,"width":1632,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc506fdaa64f47baa48d85a567297b3a","type":"text","conversion_output":true,"text":"Kaiser Permanente patients,[12] an updated analysis from the Danish Diet, Cancer, and Health Study,[13] an Italian","text_display":" Kaiser Permanente patients,[12] an updated analysis from the Danish Diet, Cancer, and Health Study,[13] an Italian","confidence":1,"confidence_rate":1},{"cnt":[[245,2058],[1826,2058],[1826,2103],[245,2103]],"region":{"top_left_x":244,"top_left_y":2058,"width":1583,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93110a5c86b14ff3b0b8da903cca4e46","type":"text","conversion_output":true,"text":"cohort,[14] and the UK Biobank.[15] Finally, a few investigators have demonstrated J- or U-shaped associations","text_display":" cohort,[14] and the UK Biobank.[15] Finally, a few investigators have demonstrated J- or U-shaped associations","confidence":0.9990236759185791,"confidence_rate":0.999991506114367},{"cnt":[[245,2101],[1755,2101],[1755,2144],[245,2144]],"region":{"top_left_x":244,"top_left_y":2101,"width":1512,"height":44},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0b8a8908d7244b1adc641a30d98c45f","type":"text","conversion_output":true,"text":"with benefit at modest intakes no effect or harm at higher levels, such as that seen in the Women's Health","text_display":" with benefit at modest intakes no effect or harm at higher levels, such as that seen in the Women's Health","confidence":1,"confidence_rate":1},{"cnt":[[245,2144],[1764,2144],[1764,2187],[245,2187]],"region":{"top_left_x":244,"top_left_y":2144,"width":1520,"height":44},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e8e962c2fcf44deadf601c89cff238b","type":"text","conversion_output":true,"text":"Study,[16] Physicians' Health Study,[17] the Seguimiento Universidad de Navarra (SUN) cohort,[18] and the","text_display":" Study,[16] Physicians' Health Study,[17] the Seguimiento Universidad de Navarra (SUN) cohort,[18] and the","confidence":0.9990234375,"confidence_rate":0.9999911178608298},{"cnt":[[245,2187],[1854,2187],[1854,2230],[245,2230]],"region":{"top_left_x":244,"top_left_y":2187,"width":1611,"height":44},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"728400e1073f4dcba3ce05d3ab532586","type":"text","conversion_output":true,"text":"Prevencion con Dieta Mediterranea (PREDIMED) cohort.[18] Meta-analyses including the aforementioned studies","text_display":" Prevencion con Dieta Mediterranea (PREDIMED) cohort.[18] Meta-analyses including the aforementioned studies","confidence":1,"confidence_rate":1},{"cnt":[[245,2230],[1725,2230],[1725,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2230,"width":1482,"height":41},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d37cf7d7e1349539d230bce091715b0","type":"text","conversion_output":true,"text":"have concluded either no effect or a reduced AF risk with coffee consumption.[11, 19, 20] Furthermore,","text_display":" have concluded either no effect or a reduced AF risk with coffee consumption.[11, 19, 20] Furthermore,","confidence":1,"confidence_rate":1},{"cnt":[[245,2273],[1738,2273],[1738,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2273,"width":1495,"height":41},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d558e5ccca7e421faf3571501441d220","type":"text","conversion_output":true,"text":"Mendelian randomization techniques using alleles associated with caffeine metabolism and hence coffee","text_display":" Mendelian randomization techniques using alleles associated with caffeine metabolism and hence coffee","confidence":1,"confidence_rate":1},{"cnt":[[245,2314],[1618,2314],[1618,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2313,"width":1374,"height":44},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a92b20232b74390a11984984e8df8f1","type":"text","conversion_output":true,"text":"consumption have also not provided supportive evidence for any significant effect on AF.[15, 21]","text_display":" consumption have also not provided supportive evidence for any significant effect on AF.[15, 21]","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[245,2402],[1863,2402],[1863,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2401,"width":1619,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d0390aa8e5346b88b0c0657670e82f8","type":"text","conversion_output":true,"text":"Comparatively fewer studies exist on the role of acute coffee or caffeine ingestion, or on AF and related outcomes","text_display":"\n\nComparatively fewer studies exist on the role of acute coffee or caffeine ingestion, or on AF and related outcomes","confidence":1,"confidence_rate":1},{"cnt":[[245,2443],[1738,2443],[1738,2486],[245,2486]],"region":{"top_left_x":244,"top_left_y":2442,"width":1495,"height":44},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b52f36010d784546a2c463fcae52235b","type":"text","conversion_output":true,"text":"in other settings. One study found that acute intravenous administration of caffeine did not alter invasive","text_display":" in other settings. One study found that acute intravenous administration of caffeine did not alter invasive","confidence":1,"confidence_rate":1},{"cnt":[[247,2484],[1843,2484],[1843,2529],[247,2529]],"region":{"top_left_x":247,"top_left_y":2483,"width":1597,"height":46},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8dc4e37d0b845ceacc3cbab5ace0d56","type":"text","conversion_output":true,"text":"measures of cardiac conduction or refractoriness.[22] Two reports suggest that modest coffee consumption may","text_display":" measures of cardiac conduction or refractoriness.[22] Two reports suggest that modest coffee consumption may","confidence":1,"confidence_rate":1},{"cnt":[[247,2595],[483,2595],[483,2623],[247,2623]],"region":{"top_left_x":247,"top_left_y":2595,"width":237,"height":29},"line":53,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b83cc2d92513467088150cd436822e86","type":"page_info","conversion_output":false,"text":"V1.4-12 June 2025","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1732,2595],[1876,2595],[1876,2628],[1732,2628]],"region":{"top_left_x":1731,"top_left_y":2595,"width":145,"height":33},"line":54,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b23bd01ab3a14a9fb4646fe25da3ee6e","type":"page_info","conversion_output":false,"text":"Page 6 of 21","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"c94cf12f-2223-41eb-a36c-a58bf0cb4540-07","page":7,"lines":[{"cnt":[[1680,172],[1880,172],[1880,204],[1680,204]],"region":{"top_left_x":1680,"top_left_y":171,"width":200,"height":34},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d6b745ddd4c34f42ba562bf97a4c8de7","type":"page_info","conversion_output":false,"text":"DECAF Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,206],[1878,206],[1878,234],[1706,234]],"region":{"top_left_x":1705,"top_left_y":206,"width":173,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"47f2ceb73b0446599987e5cb84c0341c","type":"page_info","conversion_output":false,"text":"NCT05121519","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,236],[1833,236],[1833,279],[245,279]],"region":{"top_left_x":244,"top_left_y":236,"width":1589,"height":44},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d8194bc8cdca4a6f95658d73058f62b2","type":"text","conversion_output":true,"text":"be associated with a greater likelihood for spontaneous cardioversion compared to higher consumption.[23, 24]","text_display":"\nbe associated with a greater likelihood for spontaneous cardioversion compared to higher consumption.[23, 24]","confidence":0.89892578125,"confidence_rate":0.9990657454165361},{"cnt":[[245,279],[1807,279],[1807,322],[245,322]],"region":{"top_left_x":244,"top_left_y":279,"width":1563,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"310d986a6f8545dd8fa31ad5d204a2fa","type":"text","conversion_output":true,"text":"Furthermore, no association between caffeine intake and atrial ectopy was found in another analysis from the","text_display":" Furthermore, no association between caffeine intake and atrial ectopy was found in another analysis from the","confidence":1,"confidence_rate":1},{"cnt":[[245,322],[715,322],[715,365],[245,365]],"region":{"top_left_x":244,"top_left_y":322,"width":472,"height":44},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c639ac3a12664a33bb45e509cf5835f3","type":"text","conversion_output":true,"text":"Cardiovascular Health Study.[25]","text_display":" Cardiovascular Health Study.[25]","confidence":1,"confidence_rate":1},{"cnt":[[243,404],[900,404],[900,453],[243,453]],"region":{"top_left_x":242,"top_left_y":403,"width":659,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c75c30c8b0cc49bd81a1410a1bae2a22","type":"section_header","conversion_output":false,"children_ids":["0767e9a044e54ac29820dc8c0c3dc9bf"],"text":"","text_display":""},{"cnt":[[245,408],[896,408],[896,449],[245,449]],"region":{"top_left_x":244,"top_left_y":408,"width":652,"height":42},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0767e9a044e54ac29820dc8c0c3dc9bf","type":"text","conversion_output":true,"parent_id":"c75c30c8b0cc49bd81a1410a1bae2a22","text":"1.4. Current Consumer and Physician Beliefs","text_display":"\n\n\\subsection*{1.4. Current Consumer and Physician Beliefs}","confidence":0.99853515625,"confidence_rate":0.9999694605146209},{"cnt":[[245,494],[1835,494],[1835,535],[245,535]],"region":{"top_left_x":244,"top_left_y":494,"width":1591,"height":41},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3064d6a9bc944e059f3b7dcc869aa4dd","type":"text","conversion_output":true,"text":"Despite the varied evidence described above, established notions exist that coffee and caffeine contribute to AF","text_display":"\n\nDespite the varied evidence described above, established notions exist that coffee and caffeine contribute to AF","confidence":1,"confidence_rate":1},{"cnt":[[245,535],[1861,535],[1861,578],[245,578]],"region":{"top_left_x":244,"top_left_y":534,"width":1617,"height":44},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"993484646ab14049a6defda5b52646e7","type":"text","conversion_output":true,"text":"and/or trigger AF episodes. In a large study of symptomatic patients with paroxysmal AF, caffeine was reported as","text_display":" and/or trigger AF episodes. In a large study of symptomatic patients with paroxysmal AF, caffeine was reported as","confidence":1,"confidence_rate":1},{"cnt":[[245,576],[1861,576],[1861,621],[245,621]],"region":{"top_left_x":244,"top_left_y":575,"width":1617,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7cf8405624c4ae492553928ce4bdc68","type":"text","conversion_output":true,"text":"the second most common triggering factor in almost one-third of individuals.[26] Prior surveys of physicians have","text_display":" the second most common triggering factor in almost one-third of individuals.[26] Prior surveys of physicians have","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[245,619],[1824,619],[1824,664],[245,664]],"region":{"top_left_x":244,"top_left_y":618,"width":1581,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2cc0a7ab88f4347aa8c64c724807889","type":"text","conversion_output":true,"text":"also suggested reductions in caffeine to assist with arrhythmias.[27] Conversely, professional society guidelines","text_display":" also suggested reductions in caffeine to assist with arrhythmias.[27] Conversely, professional society guidelines","confidence":1,"confidence_rate":1},{"cnt":[[245,662],[1863,662],[1863,707],[245,707]],"region":{"top_left_x":244,"top_left_y":661,"width":1619,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e691208eadf4a3296c03cb105cfb0d8","type":"text","conversion_output":true,"text":"either do not discuss coffee or caffeine [28] or suggest they are unlikely to contribute based on recent studies.[29]","text_display":" either do not discuss coffee or caffeine [28] or suggest they are unlikely to contribute based on recent studies.[29]","confidence":1,"confidence_rate":1},{"cnt":[[241,739],[728,739],[728,797],[241,797]],"region":{"top_left_x":240,"top_left_y":739,"width":489,"height":59},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc5a31bc2eee4129a60dcfae9fd86d72","type":"section_header","conversion_output":false,"children_ids":["b446645fbc53435091d9897d1cb39db1"],"text":"","text_display":""},{"cnt":[[245,748],[724,748],[724,788],[245,788]],"region":{"top_left_x":244,"top_left_y":747,"width":481,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b446645fbc53435091d9897d1cb39db1","type":"text","conversion_output":true,"parent_id":"dc5a31bc2eee4129a60dcfae9fd86d72","text":"1.4. Rationale for Current Study","text_display":"\n\n\\subsection*{1.4. Rationale for Current Study}","confidence":1,"confidence_rate":1},{"cnt":[[245,831],[1826,831],[1826,874],[245,874]],"region":{"top_left_x":244,"top_left_y":831,"width":1583,"height":44},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"111cf3dd8cfc41e78e6c0ff65b9058e8","type":"text","conversion_output":true,"text":"A key limitation of existing data on the effects of coffee and caffeine on AF has been their observational nature.","text_display":"\n\nA key limitation of existing data on the effects of coffee and caffeine on AF has been their observational nature.","confidence":1,"confidence_rate":1},{"cnt":[[245,872],[1646,872],[1646,917],[245,917]],"region":{"top_left_x":244,"top_left_y":872,"width":1402,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e45e4d13d834140a3ba37fad9a28200","type":"text","conversion_output":true,"text":"Even with careful study design methodology, including prospective data 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eliminate","confidence":0.99853515625,"confidence_rate":0.9999884574076989},{"cnt":[[245,958],[1833,958],[1833,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":958,"width":1589,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20aa00dbd6114b6c9d65d7223265d327","type":"text","conversion_output":true,"text":"the possibility of biases in observational studies such as residual confounding and reverse causality.[30] Instead,","text_display":" the possibility of biases in observational studies such as residual confounding and reverse causality.[30] Instead,","confidence":1,"confidence_rate":1},{"cnt":[[245,1001],[1783,1001],[1783,1044],[245,1044]],"region":{"top_left_x":244,"top_left_y":1001,"width":1540,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13a229a9303d41d481b463af7a2382fa","type":"text","conversion_output":true,"text":"appropriate randomization of subjects to an exposure of interest is more likely to produce reliable, unbiased","text_display":" appropriate randomization of subjects to an exposure of interest is more likely to produce reliable, unbiased","confidence":0.9892578125,"confidence_rate":0.9999052650021103},{"cnt":[[245,1042],[1858,1042],[1858,1087],[245,1087]],"region":{"top_left_x":244,"top_left_y":1041,"width":1615,"height":47},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b950edab23f4960975b52da7e7bd350","type":"text","conversion_output":true,"text":"results where observational evidence is conflicting or requires confirmation.[31] To the best of our knowledge, no","text_display":" results where observational evidence is conflicting or requires confirmation.[31] To the best of our knowledge, no","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[245,1085],[1472,1085],[1472,1128],[245,1128]],"region":{"top_left_x":244,"top_left_y":1084,"width":1228,"height":44},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6db36bbd62eb4f2f977b10934eaf65a2","type":"text","conversion_output":true,"text":"such assessment on the effect of coffee on AF outcomes has been undertaken to date.","text_display":" such assessment on the effect of coffee on AF outcomes has been undertaken to date.","confidence":1,"confidence_rate":1},{"cnt":[[245,1169],[1755,1169],[1755,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1168,"width":1512,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff4861e8821f44b3b4a6fc91c83b7646","type":"text","conversion_output":true,"text":"While the general effect of coffee or caffeine on incident AF would be of significant interest, undertaking a","text_display":"\n\nWhile the general effect of coffee or caffeine on incident AF would be of significant interest, undertaking a","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[245,1212],[1858,1212],[1858,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1211,"width":1615,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9e55ea66c414c3f86bb114ed85a4e54","type":"text","conversion_output":true,"text":"randomized trial in this setting would be challenging and likely to require an extremely large number of otherwise","text_display":" randomized trial in this setting would be challenging and likely to require an extremely large number of 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Many individuals may find this objectionable given the widely","text_display":" healthy individuals to agree to consume or abstain. Many individuals may find this objectionable given the widely","confidence":1,"confidence_rate":1},{"cnt":[[245,1298],[1149,1298],[1149,1343],[245,1343]],"region":{"top_left_x":244,"top_left_y":1297,"width":906,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"279b2ac4da2440ddbebf179464bbea88","type":"text","conversion_output":true,"text":"consumed nature of coffee and caffeine-containing substances.","text_display":" consumed nature of coffee and caffeine-containing substances.","confidence":1,"confidence_rate":1},{"cnt":[[245,1384],[1803,1384],[1803,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1383,"width":1559,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4dc1322221a40ec8a19285f9a253c80","type":"text","conversion_output":true,"text":"An alternative and potentially more practical setting would be in patients with existing AF who are not only at","text_display":"\n\nAn alternative and potentially more practical setting would be in patients with existing AF who are not only at","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[245,1422],[1820,1422],[1820,1467],[245,1467]],"region":{"top_left_x":244,"top_left_y":1422,"width":1576,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9e30aea63e744d6a1c1c169df94d1ef","type":"text","conversion_output":true,"text":"higher risk for (recurrent) AF episodes but may be more likely to be interested in such a randomized evaluation","text_display":" higher risk for (recurrent) AF episodes but may be more likely to be interested in such a randomized evaluation","confidence":1,"confidence_rate":1},{"cnt":[[245,1465],[677,1465],[677,1510],[245,1510]],"region":{"top_left_x":244,"top_left_y":1465,"width":433,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eaec7ddddadf4aac989ab488879b049e","type":"text","conversion_output":true,"text":"given their personal situation.","text_display":" given their personal situation.","confidence":1,"confidence_rate":1},{"cnt":[[245,1551],[1863,1551],[1863,1596],[245,1596]],"region":{"top_left_x":244,"top_left_y":1551,"width":1619,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"690b80f5cd2a49579a73bea47ee2abf6","type":"text","conversion_output":true,"text":"Thus, this study proposes to evaluate the effect of random allocation to coffee abstinence compared to continued","text_display":"\n\nThus, this study proposes to evaluate the effect of random allocation to coffee abstinence compared to continued","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1837,1594],[1837,1639],[245,1639]],"region":{"top_left_x":244,"top_left_y":1594,"width":1593,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e44c5f098f524a4d821bc5c19f69265b","type":"text","conversion_output":true,"text":"caffeinated coffee consumption in patients undergoing cardioversion for AF, with patients being followed up for","text_display":" caffeinated coffee consumption in patients undergoing cardioversion for AF, with patients being followed up for","confidence":0.91845703125,"confidence_rate":0.999266991567739},{"cnt":[[245,1637],[608,1637],[608,1680],[245,1680]],"region":{"top_left_x":244,"top_left_y":1637,"width":365,"height":44},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82dcc4d6b9e54645b0173203c7903979","type":"text","conversion_output":true,"text":"recurrent episodes of AF.","text_display":" recurrent episodes of AF.","confidence":1,"confidence_rate":1},{"cnt":[[245,1721],[1880,1721],[1880,1766],[245,1766]],"region":{"top_left_x":244,"top_left_y":1720,"width":1636,"height":47},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e59a36e956654b9185a97d4377effee1","type":"text","conversion_output":true,"text":"This study will provide the first, randomized evaluation of coffee on AF outcomes. Given the conflicting evidence to","text_display":"\n\nThis study will provide the first, randomized evaluation of coffee on AF outcomes. Given the conflicting evidence to","confidence":1,"confidence_rate":1},{"cnt":[[245,1764],[1850,1764],[1850,1809],[245,1809]],"region":{"top_left_x":244,"top_left_y":1763,"width":1606,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"327cc182529541fcb6592eaef5a4d961","type":"text","conversion_output":true,"text":"date and widespread consumption of coffee, this study will be of significant interest to consumers and physicians","text_display":" date and widespread consumption of coffee, this study will be of significant interest to consumers and physicians","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[245,1805],[329,1805],[329,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1804,"width":85,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"816ec09142cf4628bcbb4eedd6094561","type":"text","conversion_output":true,"text":"alike.","text_display":" 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As some decaffeinated coffee can also contain caffeine, patients","text_display":"containing products as much as feasibly possible. As some decaffeinated coffee can also contain caffeine, patients","confidence":1,"confidence_rate":1},{"cnt":[[245,2460],[1863,2460],[1863,2501],[245,2501]],"region":{"top_left_x":244,"top_left_y":2459,"width":1619,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab07f270516042c6b866d1942d7565c7","type":"text","conversion_output":true,"text":"will be encouraged to abstain from decaffeinated coffee as well. Other non-coffee caffeine-containing products to","text_display":" will be encouraged to abstain from decaffeinated coffee as well. Other non-coffee caffeine-containing products to","confidence":0.9990234375,"confidence_rate":0.9999917200372636},{"cnt":[[245,2595],[483,2595],[483,2625],[245,2625]],"region":{"top_left_x":244,"top_left_y":2595,"width":240,"height":31},"line":52,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4b7129afe34f48e3bcdb8ae5bc5808af","type":"page_info","conversion_output":false,"text":"V1.4-12 June 2025","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1714,2595],[1876,2595],[1876,2628],[1714,2628]],"region":{"top_left_x":1714,"top_left_y":2595,"width":162,"height":33},"line":53,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"852fd8d17b6e4199978e14112fd1d1c5","type":"page_info","conversion_output":false,"text":"Page 10 of 21","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"c94cf12f-2223-41eb-a36c-a58bf0cb4540-11","page":11,"lines":[{"cnt":[[1680,172],[1880,172],[1880,202],[1680,202]],"region":{"top_left_x":1680,"top_left_y":171,"width":200,"height":31},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"3fd610f71aec444f812cc73a9bc0309e","type":"page_info","conversion_output":false,"text":"DECAF Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1704,206],[1880,206],[1880,234],[1704,234]],"region":{"top_left_x":1703,"top_left_y":206,"width":177,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"3453560473e4474db34176b79444b92e","type":"page_info","conversion_output":false,"text":"NCT05121519","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,236],[1772,236],[1772,279],[245,279]],"region":{"top_left_x":244,"top_left_y":236,"width":1529,"height":44},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de037c92ad4d4df29b13e2b71648f97e","type":"text","conversion_output":true,"text":"avoid will include, but not be limited to, tea, cola, energy drinks, chocolate, chewing gum, and chocolate- or","text_display":"\navoid will include, but not be limited to, tea, cola, energy drinks, chocolate, chewing gum, and chocolate- or","confidence":1,"confidence_rate":1},{"cnt":[[245,279],[788,279],[788,320],[245,320]],"region":{"top_left_x":244,"top_left_y":279,"width":545,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44507da4e9654171a72631ce3bc0ad2a","type":"text","conversion_output":true,"text":"coffee-flavored foods (e.g. ice cream).","text_display":" coffee-flavored foods (e.g. ice cream).","confidence":0.99951171875,"confidence_rate":0.9999889000502842},{"cnt":[[241,404],[836,404],[836,453],[241,453]],"region":{"top_left_x":240,"top_left_y":403,"width":596,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"36bd122499ef4e88902398ae315addf8","type":"section_header","conversion_output":false,"children_ids":["2b1a3d09c367438e9dc80387dd438e57"],"text":"","text_display":""},{"cnt":[[245,408],[831,408],[831,449],[245,449]],"region":{"top_left_x":244,"top_left_y":408,"width":588,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b1a3d09c367438e9dc80387dd438e57","type":"text","conversion_output":true,"parent_id":"36bd122499ef4e88902398ae315addf8","text":"3.2 Continued Coffee Consumption","text_display":"\n\n\\subsection*{3.2 Continued Coffee Consumption}","confidence":0.9956097602844238,"confidence_rate":0.9998810907157483},{"cnt":[[245,494],[1850,494],[1850,535],[245,535]],"region":{"top_left_x":244,"top_left_y":494,"width":1606,"height":41},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f536e494ec74497cb66a84a8abe4f0f9","type":"text","conversion_output":true,"text":"If allocated to continued coffee consumption, patients will be encouraged to drink at least one cup of caffeinated","text_display":"\n\nIf allocated to continued coffee consumption, patients will be encouraged to drink at least one cup of caffeinated","confidence":1,"confidence_rate":1},{"cnt":[[245,535],[1807,535],[1807,578],[245,578]],"region":{"top_left_x":244,"top_left_y":534,"width":1563,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04f2cbc9db524db284d7324bd8adb530","type":"text","conversion_output":true,"text":"coffee (or one espresso shot) daily and other caffeine-containing products as per their usual lifestyle. It will be","text_display":" coffee (or one espresso shot) daily and other caffeine-containing products as per their usual lifestyle. It will be","confidence":1,"confidence_rate":1},{"cnt":[[245,576],[1691,576],[1691,621],[245,621]],"region":{"top_left_x":244,"top_left_y":575,"width":1447,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59f841135b6146fbacbaa0bd809562dc","type":"text","conversion_output":true,"text":"recommended that patients do not intentionally increase or decrease consumption of these products.","text_display":" recommended that patients do not intentionally increase or decrease consumption of these products.","confidence":0.97900390625,"confidence_rate":0.9997940052351879},{"cnt":[[241,657],[617,657],[617,703],[241,703]],"region":{"top_left_x":240,"top_left_y":657,"width":377,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0b867b2fbaf140aba4ec5c0f6db491b2","type":"section_header","conversion_output":false,"children_ids":["111d56c647c04b38a58cb9c57e8bf371"],"text":"","text_display":""},{"cnt":[[245,662],[612,662],[612,698],[245,698]],"region":{"top_left_x":244,"top_left_y":661,"width":369,"height":38},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"111d56c647c04b38a58cb9c57e8bf371","type":"text","conversion_output":true,"parent_id":"0b867b2fbaf140aba4ec5c0f6db491b2","text":"4.0 EARLY TERMINATION","text_display":"\n\n\\subsection*{4.0 EARLY TERMINATION}","confidence":1,"confidence_rate":1},{"cnt":[[245,748],[1828,748],[1828,788],[245,788]],"region":{"top_left_x":244,"top_left_y":747,"width":1585,"height":42},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2020e6b01466439bb9bdfe1959e5c0d9","type":"text","conversion_output":true,"text":"If a randomized participant terminates participation in the study early (i.e., prior to completion of all follow-up),","text_display":"\n\nIf a randomized participant terminates participation in the study early (i.e., prior to completion of all follow-up),","confidence":1,"confidence_rate":1},{"cnt":[[245,791],[1876,791],[1876,831],[245,831]],"region":{"top_left_x":244,"top_left_y":790,"width":1632,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9cbe40588984f4db22c93f17578ad50","type":"text","conversion_output":true,"text":"the Principal Investigator will determine the primary reason for early termination and report this. Participants who","text_display":" the Principal Investigator will determine the primary reason for early termination and report this. Participants who","confidence":1,"confidence_rate":1},{"cnt":[[245,834],[1446,834],[1446,874],[245,874]],"region":{"top_left_x":244,"top_left_y":833,"width":1202,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73af9128902e4dcb920f8f9e286e728e","type":"text","conversion_output":true,"text":"early terminate from the study will not be replaced with newly enrolled participants.","text_display":" early terminate from the study will not be replaced with newly enrolled participants.","confidence":1,"confidence_rate":1},{"cnt":[[241,911],[1420,911],[1420,960],[241,960]],"region":{"top_left_x":240,"top_left_y":910,"width":1181,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f17d8b1fe6d643f4b353e4e10558f012","type":"section_header","conversion_output":false,"children_ids":["39225e8ccaeb4cf893003eeadaca75f6"],"text":"","text_display":""},{"cnt":[[245,915],[1418,915],[1418,956],[245,956]],"region":{"top_left_x":244,"top_left_y":915,"width":1174,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39225e8ccaeb4cf893003eeadaca75f6","type":"text","conversion_output":true,"parent_id":"f17d8b1fe6d643f4b353e4e10558f012","text":"4.1 Randomized Participants - with exclusion found on day of cardioversion","text_display":"\n\n\\subsection*{4.1 Randomized Participants - with exclusion found on day of cardioversion}","confidence":0.9936633054167032,"confidence_rate":0.9999195366974533},{"cnt":[[245,1001],[1828,1001],[1828,1042],[245,1042]],"region":{"top_left_x":244,"top_left_y":1001,"width":1585,"height":41},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5fdce3f0b1d5460d860fcd52f5f21e3a","type":"text","conversion_output":true,"text":"A proportion of patients scheduled for electrical cardioversion do not convert to sinus rhythm, outlined in more","text_display":"\n\nA proportion of patients scheduled for electrical cardioversion do not convert to sinus rhythm, outlined in more","confidence":1,"confidence_rate":1},{"cnt":[[245,1044],[1815,1044],[1815,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1044,"width":1572,"height":41},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"12f2559f56a64cc8a9de7b7055e46436","type":"text","conversion_output":true,"text":"detail below. Thus, randomization will be undertaken after successful cardioversion from AF to sinus rhythm in","text_display":" detail below. Thus, randomization will be undertaken after successful cardioversion from AF to sinus rhythm in","confidence":1,"confidence_rate":1},{"cnt":[[245,1085],[1205,1085],[1205,1128],[245,1128]],"region":{"top_left_x":244,"top_left_y":1084,"width":962,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9fee52c6c1241cf9d40182773e1b691","type":"text","conversion_output":true,"text":"order to minimize exclusion of randomized patients for this reason.","text_display":" order to minimize exclusion of randomized patients for this reason.","confidence":1,"confidence_rate":1},{"cnt":[[245,1169],[1790,1169],[1790,1212],[245,1212]],"region":{"top_left_x":244,"top_left_y":1168,"width":1546,"height":44},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"227877bd4cb14319aef27aeab8a10f37","type":"text","conversion_output":true,"text":"In the event that another exclusion criterion is identified on the day of cardioversion after randomization has","text_display":"\n\nIn the event that another exclusion criterion is identified on the day of cardioversion after randomization has","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1772,1212],[1772,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1211,"width":1529,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91625610ff944e66ac64ea93f81c2af9","type":"text","conversion_output":true,"text":"occurred, the participant may or may not continue to be treated as allocated as deemed appropriate by the","text_display":" occurred, the participant may or may not continue to be treated as allocated as deemed appropriate by the","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[245,1255],[1407,1255],[1407,1298],[245,1298]],"region":{"top_left_x":244,"top_left_y":1254,"width":1164,"height":44},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dbe19ffd3ac94aa3b817b871a2c4a2fa","type":"text","conversion_output":true,"text":"Principal Investigator. All randomized patients will be included in the ITT analyses.","text_display":" Principal Investigator. All randomized patients will be included in the ITT analyses.","confidence":1,"confidence_rate":1},{"cnt":[[243,1336],[771,1336],[771,1381],[243,1381]],"region":{"top_left_x":242,"top_left_y":1336,"width":530,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"408db4a86cc74b9a92e346fbc99e21a9","type":"section_header","conversion_output":false,"children_ids":["717695a237234de9aa36982061c0d388"],"text":"","text_display":""},{"cnt":[[245,1341],[767,1341],[767,1377],[245,1377]],"region":{"top_left_x":244,"top_left_y":1340,"width":523,"height":38},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"717695a237234de9aa36982061c0d388","type":"text","conversion_output":true,"parent_id":"408db4a86cc74b9a92e346fbc99e21a9","text":"4.2 Unsuccessful cardioversion","text_display":"\n\n\\subsection*{4.2 Unsuccessful cardioversion}","confidence":0.9843823909759521,"confidence_rate":0.9995503625828355},{"cnt":[[245,1427],[1777,1427],[1777,1467],[245,1467]],"region":{"top_left_x":244,"top_left_y":1426,"width":1533,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f4a90c576444270b0d7d6726e547cf9","type":"text","conversion_output":true,"text":"Patients will be interviewed and consented prior to cardioversion occurring. However, a small proportion of","text_display":"\n\nPatients will be interviewed and consented prior to cardioversion occurring. However, a small proportion of","confidence":1,"confidence_rate":1},{"cnt":[[245,1467],[1848,1467],[1848,1510],[245,1510]],"region":{"top_left_x":244,"top_left_y":1467,"width":1604,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1cca7ab6457d4de88eb1d7c2a077d298","type":"text","conversion_output":true,"text":"patients do not have successful cardioversion. As a result, randomization will occur after successful cardioversion","text_display":" patients do not have successful cardioversion. As a result, randomization will occur after successful cardioversion","confidence":1,"confidence_rate":1},{"cnt":[[245,1508],[1629,1508],[1629,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1508,"width":1385,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cbc2c2538517439e91c893d7088b71b0","type":"text","conversion_output":true,"text":"from AF to sinus rhythm. Patients will be excluded in the event that cardioversion is unsuccessful.","text_display":" from AF to sinus rhythm. Patients will be excluded in the event that cardioversion is unsuccessful.","confidence":1,"confidence_rate":1},{"cnt":[[243,1594],[733,1594],[733,1639],[243,1639]],"region":{"top_left_x":242,"top_left_y":1594,"width":491,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ad083e94edd4ccab6da5b2337594564","type":"section_header","conversion_output":false,"children_ids":["34a30d75f77d49af95367b0f5593732d"],"text":"","text_display":""},{"cnt":[[245,1594],[728,1594],[728,1635],[245,1635]],"region":{"top_left_x":244,"top_left_y":1594,"width":485,"height":41},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34a30d75f77d49af95367b0f5593732d","type":"text","conversion_output":true,"parent_id":"4ad083e94edd4ccab6da5b2337594564","text":"4.3 Participant Withdrawals","text_display":"\n\n\\subsection*{4.3 Participant 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medical treatment or relationship with the treating physician.","text_display":" the study at any time without effect on subsequent medical treatment or relationship with the treating physician.","confidence":1,"confidence_rate":1},{"cnt":[[245,1766],[1766,1766],[1766,1807],[245,1807]],"region":{"top_left_x":244,"top_left_y":1766,"width":1523,"height":41},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"816d90553f1341bda1bd7caa04010742","type":"text","conversion_output":true,"text":"Participants who discontinue follow-up at any time after randomization will be included in the ITT analyses.","text_display":" Participants who discontinue follow-up at any time after randomization will be included in the ITT 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contacted via phone for follow-up (i.e. participants who become","text_display":"\nLost to Follow-Up: If a participant is unable to be contacted via phone for follow-up (i.e. participants who become","confidence":0.9902622492563751,"confidence_rate":0.9999184577189685},{"cnt":[[245,2062],[1749,2062],[1749,2103],[245,2103]],"region":{"top_left_x":244,"top_left_y":2062,"width":1505,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da66e73a63264fff813eb84dae500c6a","type":"text","conversion_output":true,"text":"lost to follow up and whose status is unclear because they fail to appear for study visits without stating an","text_display":" lost to follow up and whose status is unclear because they fail to appear for study visits without stating an","confidence":1,"confidence_rate":1},{"cnt":[[245,2103],[1783,2103],[1783,2144],[245,2144]],"region":{"top_left_x":244,"top_left_y":2103,"width":1540,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00ffb532c5214131b8db0131e62abdd9","type":"text","conversion_output":true,"text":"intention to withdraw) for any other reason and the study team is unable to confirm the status of their atrial","text_display":" intention to withdraw) for any other reason and the study team is unable to confirm the status of their atrial","confidence":1,"confidence_rate":1},{"cnt":[[245,2144],[1852,2144],[1852,2187],[245,2187]],"region":{"top_left_x":244,"top_left_y":2144,"width":1608,"height":44},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc75f7bf73c647be8f8784a045fd3013","type":"text","conversion_output":true,"text":"fibrillation post-cardioversion upon review of their medical record at study follow up visits, the participant will be","text_display":" fibrillation post-cardioversion upon review of their medical record at study follow up visits, the participant will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2187],[1704,2187],[1704,2230],[245,2230]],"region":{"top_left_x":244,"top_left_y":2187,"width":1460,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d8f944304ca42a7b53eb220c180f627","type":"text","conversion_output":true,"text":"designated an early termination. The clinical site Principal Investigator should show \"due diligence\" by","text_display":" designated an early termination. The clinical site Principal Investigator should show \"due diligence\" by","confidence":1,"confidence_rate":1},{"cnt":[[245,2230],[1811,2230],[1811,2273],[245,2273]],"region":{"top_left_x":244,"top_left_y":2230,"width":1568,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1dd1a143eaa74ab8925fdf5fa657eef3","type":"text","conversion_output":true,"text":"documenting in the source documents, all steps taken to contact the participant, e.g., dates of telephone calls,","text_display":" documenting in the source documents, all steps taken to contact the participant, e.g., dates of telephone calls,","confidence":1,"confidence_rate":1},{"cnt":[[245,2273],[565,2273],[565,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2273,"width":322,"height":41},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"421adcb558524c9eae1ceeebc9e2f56f","type":"text","conversion_output":true,"text":"registered letters, etc.","text_display":" registered letters, etc.","confidence":1,"confidence_rate":1},{"cnt":[[245,2359],[1813,2359],[1813,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2358,"width":1570,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff76daef3ab4448ebe183e6be1d0ea9a","type":"text","conversion_output":true,"text":"In the absence of a stated intention to withdraw, the physician or other healthcare professional of participants","text_display":"\n\nIn the absence of a stated intention to withdraw, the physician or other healthcare professional of participants","confidence":1,"confidence_rate":1},{"cnt":[[245,2402],[1485,2402],[1485,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2401,"width":1241,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ebf5a13a45dd414a9625f92f208810d7","type":"text","conversion_output":true,"text":"may be contacted in an attempt to ascertain the presence or absence of AF recurrence.","text_display":" may be contacted in an attempt to ascertain the presence or absence of AF recurrence.","confidence":1,"confidence_rate":1},{"cnt":[[245,2595],[483,2595],[483,2625],[245,2625]],"region":{"top_left_x":244,"top_left_y":2595,"width":240,"height":31},"line":45,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"52dbd8ccba2f4119872cde1ee6887c8c","type":"page_info","conversion_output":false,"text":"V1.4-12 June 2025","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1714,2595],[1876,2595],[1876,2628],[1714,2628]],"region":{"top_left_x":1714,"top_left_y":2595,"width":162,"height":33},"line":46,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ab1f6410662c4246ae852da1890585d9","type":"page_info","conversion_output":false,"text":"Page 11 of 21","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"c94cf12f-2223-41eb-a36c-a58bf0cb4540-12","page":12,"lines":[{"cnt":[[1680,174],[1880,174],[1880,202],[1680,202]],"region":{"top_left_x":1680,"top_left_y":174,"width":200,"height":28},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bd1579890274411d8eb7d38bba17f62b","type":"page_info","conversion_output":false,"text":"DECAF Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1706,206],[1878,206],[1878,234],[1706,234]],"region":{"top_left_x":1705,"top_left_y":206,"width":173,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7a95ad1ce0e94fa09c0de9fa9d1ff829","type":"page_info","conversion_output":false,"text":"NCT05121519","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,241],[1790,241],[1790,277],[247,277]],"region":{"top_left_x":247,"top_left_y":240,"width":1543,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b7800595669a451c886505f687749476","type":"text","conversion_output":true,"text":"Principal Investigator Determination: Participants should also be early terminated at any time if the Principal","text_display":"\n\nPrincipal Investigator Determination: Participants should also be early terminated at any time if the Principal","confidence":1,"confidence_rate":1},{"cnt":[[249,281],[1871,281],[1871,320],[249,320]],"region":{"top_left_x":249,"top_left_y":281,"width":1623,"height":40},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9719ac7b04b94f5095d567202378eb3f","type":"text","conversion_output":true,"text":"Investigator concludes that it would be in the participant's best interest for any reason. Protocol deviations should","text_display":" Investigator concludes that it would be in the participant's best interest for any reason. Protocol deviations should","confidence":0.99951171875,"confidence_rate":0.9999959967252418},{"cnt":[[249,322],[1558,322],[1558,363],[249,363]],"region":{"top_left_x":249,"top_left_y":322,"width":1309,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b96aa6a026214d3390bba41443b34817","type":"text","conversion_output":true,"text":"not lead to early termination unless they indicate a significant risk to the participant's safety.","text_display":" not lead to early termination unless they indicate a significant risk to the participant's safety.","confidence":1,"confidence_rate":1},{"cnt":[[247,408],[1846,408],[1846,449],[247,449]],"region":{"top_left_x":247,"top_left_y":408,"width":1599,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ad474c53a944272a64163c4857729a7","type":"text","conversion_output":true,"text":"Early Study Closure: The study may be terminated due to safety concerns. Should this be necessary, participants","text_display":"\n\nEarly Study Closure: The study may be terminated due to safety concerns. Should this be necessary, participants","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[247,451],[1772,451],[1772,492],[247,492]],"region":{"top_left_x":247,"top_left_y":451,"width":1526,"height":41},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37ba344968464175a4ffefc6affbe117","type":"text","conversion_output":true,"text":"currently in follow-up will be early terminated and scheduled for a Close-Out Visit, as soon as possible. The","text_display":" currently in follow-up will be early terminated and scheduled for a Close-Out Visit, as soon as possible. The","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[249,494],[1869,494],[1869,535],[249,535]],"region":{"top_left_x":249,"top_left_y":494,"width":1621,"height":41},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"847639acdc244198a6408b2549a73847","type":"text","conversion_output":true,"text":"Principal Investigator will be responsible for informing the appropriate local Institutional Review Board of the early","text_display":" Principal Investigator will be responsible for informing the appropriate local Institutional Review Board of the early","confidence":0.9956073760986328,"confidence_rate":0.9999642095850512},{"cnt":[[247,537],[513,537],[513,574],[247,574]],"region":{"top_left_x":247,"top_left_y":537,"width":267,"height":37},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70d11663c3224502ba8c610920814183","type":"text","conversion_output":true,"text":"study termination.","text_display":" study termination.","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[245,619],[621,619],[621,660],[245,660]],"region":{"top_left_x":244,"top_left_y":618,"width":377,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b81e2d12bdce44b4a4e5de0d3fbcded2","type":"section_header","conversion_output":false,"children_ids":["f8a21ef286014794b81289c0b09f1cb0"],"text":"","text_display":""},{"cnt":[[249,623],[621,623],[621,655],[249,655]],"region":{"top_left_x":249,"top_left_y":623,"width":372,"height":33},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f8a21ef286014794b81289c0b09f1cb0","type":"text","conversion_output":true,"parent_id":"b81e2d12bdce44b4a4e5de0d3fbcded2","text":"5.0 STUDY PROCEDURES","text_display":"\n\n\\subsection*{5.0 STUDY PROCEDURES}","confidence":1,"confidence_rate":1},{"cnt":[[245,707],[1846,707],[1846,746],[245,746]],"region":{"top_left_x":244,"top_left_y":706,"width":1602,"height":40},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d23d40a6898e4793a51f12c8a4eb65f7","type":"text","conversion_output":true,"text":"Table 2 provides an overview of the evaluations to be performed at each study visit/follow-up. See also Figure 1,","text_display":"\n\nTable 2 provides an overview of the evaluations to be performed at each study visit/follow-up. See also Figure 1,","confidence":1,"confidence_rate":1},{"cnt":[[245,748],[1179,748],[1179,788],[245,788]],"region":{"top_left_x":244,"top_left_y":747,"width":936,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7405e295e5514ed4b68bd663bf296921","type":"text","conversion_output":true,"text":"the study flow diagram, for details on timing of these evaluations.","text_display":" the study flow diagram, for details on timing of these evaluations.","confidence":1,"confidence_rate":1},{"cnt":[[245,834],[879,834],[879,870],[245,870]],"region":{"top_left_x":244,"top_left_y":833,"width":635,"height":38},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8dd8adbc83834b3e8e2b06b03fcb59dc","type":"figure_label","conversion_output":false,"text":"Table 2. Schedule of Evaluations and Visits","text_display":"","confidence":0.9921975089244484,"confidence_rate":0.9998368239443063},{"cnt":[[264,909],[1725,909],[1725,2479],[264,2479]],"region":{"top_left_x":264,"top_left_y":908,"width":1462,"height":1572},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"863e898f7d1a4850abbd8e363c2bb731","type":"table","conversion_output":true,"children_ids":["2bcece3c20f546f196f90479e4608d6f","3c3e542508834850b808fca7dc1aac67","4171184982374680aeb2e25e19e05fb1","26deb9427f8342e8977458e1a94f08a5","ddcf32da9cee4faf8d30957a6e665b5d","0ab26ddcd1bc4a6e9bbf9903bfb53590","c94b672c91a74641b4a2405efd6958a9","0c4985ea29514a7581da17be63a0c05a","a1ca3b63e2c54d9a99219022e7d55cdd","3bfc1fb794424462b1add9a28f67f818","3aa7b0f3c30d4341ba48fc9fdf1d78ef","ca4613df3ef142088d1b3b0f46dfd44b","87776676cae745f38007ffce582a0a7d","467055bf154d476d88cec8da3c295543","2450f9d456d34559b92705879b756bd2","e2fe9e7f8bf249cb83568638f63ac3e2","a0419a75ea9140fe863968b85c2bd7bf","ab72c8d933e84f2ea532dd80e34eafd3","04956ae239ec49d5a0ba56aedc0966c4","ea148ac52b6e4a3bbc460d66fd5d57a9","35266059cf8544de8642c89bf93ea9e6","d8ce2586e757418787ff7505e6fd1ef0","1706af729a89424095824db09efc143a","4d4f9371c18341a0bc55ebb3df6b2a58","20c0cfa0853148e3a9e0f768efa355ea","b30dcf20db864d83ba90fb90c5386b39","b056bac49e7b431d98c8f180c5d6a2fe","063fea339d594b00ba76385fcbe8c661","808734a7e4314044b5ee8159e7579db3","b4fb971af8aa47288687da5b3917140c","f04da8215b6841edbb1058e6a5479d63","9a50c4ccd1c04b20bd39f9fc4e4147cd","c7d6cf0c9bea4307833c36b5c8fe42d9","908678a068b84db2a237e9f3a766a136","6a14d7e158cf41d2b1c6622bcafa7940","eab37c4fb30c45ff92ba3eadb1016d0d","41ef1cf771284d539596d364423d442e","878ff21b8a8545d897822384336650d8","f2efc0b65acd43fe981c26f771436601","9523b8b0abdb4f6787dd458feb8139e0","29a1b2d8ce0e4fccbe56f13d314bdae9","41f1c36a614f4f73afbdafe09c3fddff","0ab4ba12378246fa834f5dd8881024c4","4a820a6c9921487db6d1c1f1787fdef7","f7713fcb1b9b4311af08ff840869765d","b8582b3d541546f8bbccfca5cae94d92","8860df9c3e6447c4a7f973316acb36c9","52a3a294395d406297f1131e441da9ac","d826008a1fb3430487c5ef32ead148b9","b073056a70284d6e858708988f76f966","7daf705ff636463ca026b6ad08a910f0","2bb66e4708d74e48be7c5124466825ac","849c0727ed0f40fabf5fdee057561591","5014978a662b41aeafb65dd5625dda70","882f7c1274f647199f10ac8aad50796c","a0439ac1a0b848d4a052e525ac91bc86","74dce539087744039a08a135c1b34f96","d097d9957be346e0933c1461979e9fe5","8622fb6c1ef94eb6a51ec863cb25165b","d0283f25bb06479db2ff471d4f84d0d9","aba0bb1925d04bc1b4005e693cdf3793","c8fd09655bcc4f239e3fbadf4843b289","6c175f85fcac4b8e8e24e14b394c66b5","6992ca69aa904412acd9910ff269f103","6d74c3c3deab48c3bc1dc6cf2c1faad5","453cc5ac76794c9392df3cadd5a5df81","fcd2d69832d649739109ee3a0ba41f72","b8061df756164814af74e86f0f154dd0","26d24f9ef7684511b6c7c9cbc2eb473d","fdb0fb7a20d74d96a27b19ed5a810778","89f1b2487e25432eb12e0d76e6171250","a5cb9036a8fe40bfad909724895db3a7","c7527884e4a046fcbaa83b1aaef1a188","feefb99dec6c4157b57e1f18c448a4cd","01bb8307ad5345b2af9e3d7a9e20b7a6","3e66d6b2c8564cd9b83309fc56531d41","01c3d361618240f496d0938a67c0ff78","9fa950564a844ed1a4440880be9e5cdc","421c9eb1f2bb48a8a7a3c733db71d33b","b575d1e2377a4e3db79b10a20fa89180","6829ba8ab56f40adbaeb963467ac4eac","4a14bdf7ced242ce9b9de700d2bcf3ce","c0e83e5298d54b8195b39379f04b9438","b381b8b5355e410490ea11cdb755e556","fa75910862b44e70a77c760b8025f4e2","6194df404fd74eaca4a4419822d68065","d844b1273fd34dc3bd78455eaf213632","4837bbdc1a6949879ccd6a4c32293c75","4b980e44af5e4096b816644eb5809900","e8589affc15b49b69a93d10c8a43c446","9bc9ffdd5fa84eef862f9c3ef0207fa4","47554bf624064fb884d700210019de9a","a336cb10d9714f15a8bb4e1c518ecceb"],"selected_labels":["8dd8adbc83834b3e8e2b06b03fcb59dc"],"text":"\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline & Screening & Baseline & \\multicolumn{3}{|c|}{Follow-Up Phone Calls} \\\\\n\\hline & Visits 1a-1b & Visit 1c & Visit 2 & Visit 3 & Visit 4 \\\\\n\\hline & & & Month 1 & Month 3 & Month 6 \\\\\n\\hline & & Cardioversion & & & \\\\\n\\hline Initial inclusion/exclusion evaluation & X & & & & \\\\\n\\hline Screen for coffee consumption habits & X & & & & \\\\\n\\hline Screen for significant other caffeinated product consumption & X & & & & \\\\\n\\hline Informed consent & X & & & & \\\\\n\\hline Demographics & & X & & & \\\\\n\\hline Height and weight & & X & & & \\\\\n\\hline Detailed history of coffee consumption habits & & X & X & X & X \\\\\n\\hline Detailed history of alcohol consumption habits & & X & X & X & X \\\\\n\\hline Detailed medical history & & X & X & X & X \\\\\n\\hline Targeted medication history & & X & X & X & X \\\\\n\\hline Assessment of clinically available pre-cardioversion ECG & & X & & & \\\\\n\\hline Assessment of clinically available post-cardioversion ECG & & X & & & \\\\\n\\hline Randomization & & X & & & \\\\\n\\hline Detailed history of other caffeinated product consumption & & & X & X & X \\\\\n\\hline AF symptoms & & & X & X & X \\\\\n\\hline Assessment of AliveCor KardiaMobile or Apple Watch ECG strip & & & X & X & X \\\\\n\\hline Assessment of clinically available ECG or ambulatory & & & X & X & X \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 2. 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Data entry will occur in a timely","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[249,2282],[372,2282],[372,2316],[249,2316]],"region":{"top_left_x":249,"top_left_y":2281,"width":123,"height":36},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"553b5d7e9338483f8f017f065d533272","type":"text","conversion_output":true,"text":"manner.","text_display":" manner.","confidence":1,"confidence_rate":1},{"cnt":[[247,2366],[1446,2363],[1446,2406],[247,2408]],"region":{"top_left_x":247,"top_left_y":2363,"width":1199,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7588963cd00451db8eb4ad724ac2d76","type":"text","conversion_output":true,"text":"For all procedures, clinical site personnel will only have access to their own site data.","text_display":"\n\nFor all procedures, clinical site personnel will only have access to their own site data.","confidence":1,"confidence_rate":1},{"cnt":[[247,2595],[483,2595],[483,2623],[247,2623]],"region":{"top_left_x":247,"top_left_y":2595,"width":237,"height":29},"line":45,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5f975c98d780482d93aceff5550aefdd","type":"page_info","conversion_output":false,"text":"V1.4-12 June 2025","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1719,2595],[1876,2595],[1876,2628],[1719,2628]],"region":{"top_left_x":1718,"top_left_y":2595,"width":158,"height":33},"line":46,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c1322d7129a641cfa87a0a171cafc64d","type":"page_info","conversion_output":false,"text":"Page 15 of 21","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"c94cf12f-2223-41eb-a36c-a58bf0cb4540-16","page":16,"lines":[{"cnt":[[1680,172],[1880,172],[1880,202],[1680,202]],"region":{"top_left_x":1680,"top_left_y":171,"width":200,"height":31},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"daf2adadd7564ad885c08c1546665693","type":"page_info","conversion_output":false,"text":"DECAF Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1704,206],[1878,206],[1878,234],[1704,234]],"region":{"top_left_x":1703,"top_left_y":206,"width":175,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"eeb7fc517a5444f494ebdde8fe76527d","type":"page_info","conversion_output":false,"text":"NCT05121519","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,236],[621,236],[621,284],[241,284]],"region":{"top_left_x":240,"top_left_y":236,"width":381,"height":48},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d96efd68668437ba787afa3a01f897a","type":"section_header","conversion_output":false,"children_ids":["61c38e2380cf4eba896bd7f708a2e74a"],"text":"","text_display":""},{"cnt":[[245,241],[617,241],[617,281],[245,281]],"region":{"top_left_x":244,"top_left_y":240,"width":373,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61c38e2380cf4eba896bd7f708a2e74a","type":"text","conversion_output":true,"parent_id":"2d96efd68668437ba787afa3a01f897a","text":"9.5 Data Monitoring","text_display":"\n\n\\subsection*{9.5 Data Monitoring}","confidence":1,"confidence_rate":1},{"cnt":[[249,322],[1652,322],[1652,363],[249,363]],"region":{"top_left_x":249,"top_left_y":322,"width":1404,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1d1ecc5fbe54e68a48c7c116b92f0ac","type":"text","conversion_output":true,"text":"[The investigators] will be responsible for monitoring procedures related to study conduct and data","text_display":"\n[The investigators] will be responsible for monitoring procedures related to study conduct and data","confidence":1,"confidence_rate":1},{"cnt":[[247,365],[1734,365],[1734,406],[247,406]],"region":{"top_left_x":247,"top_left_y":365,"width":1487,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0710cf4b90134c8da0fe386077918c02","type":"text","conversion_output":true,"text":"collection/reporting to ensure the quality and integrity of the study data. A representative will check the","text_display":" collection/reporting to ensure the quality and integrity of the study data. A representative will check the","confidence":1,"confidence_rate":1},{"cnt":[[247,408],[1861,408],[1861,449],[247,449]],"region":{"top_left_x":247,"top_left_y":408,"width":1614,"height":42},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e2ccdcb9488c4fa8aa6e06ec0411adbf","type":"text","conversion_output":true,"text":"completeness of participant study records, the accuracy of entries on the CRFs, the adherence to the protocol and","text_display":" completeness of participant study records, the accuracy of entries on the CRFs, the adherence to the protocol and","confidence":1,"confidence_rate":1},{"cnt":[[245,451],[1184,451],[1184,492],[245,492]],"region":{"top_left_x":244,"top_left_y":451,"width":940,"height":41},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a79ddf8ea7bb4c67bdd06b4b4144f4d6","type":"text","conversion_output":true,"text":"to Good Clinical Practice, as per the DECAF Monitoring Guidelines.","text_display":" to Good Clinical Practice, as per the DECAF Monitoring Guidelines.","confidence":0.99951171875,"confidence_rate":0.9999931211434043},{"cnt":[[245,537],[1873,537],[1873,578],[245,578]],"region":{"top_left_x":244,"top_left_y":537,"width":1630,"height":41},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"273c1312fa2f4df09471b38eb772b514","type":"text","conversion_output":true,"text":"To ensure data quality, we will perform the following Quality Assurance procedures: after the first two participants","text_display":"\n\nTo ensure data quality, we will perform the following Quality Assurance procedures: after the first two participants","confidence":1,"confidence_rate":1},{"cnt":[[247,576],[1807,576],[1807,617],[247,617]],"region":{"top_left_x":247,"top_left_y":575,"width":1560,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"068fb096d5854e669ffbe0b3afad1880","type":"text","conversion_output":true,"text":"are randomized and the study intervention is performed, \\(100 \\%\\) of inclusion/exclusion criteria and key baseline","text_display":" are randomized and the study intervention is performed, \\(100 \\%\\) of inclusion/exclusion criteria and key baseline","confidence":0.99951171875,"confidence_rate":0.999995825645481},{"cnt":[[245,621],[1826,621],[1826,660],[245,660]],"region":{"top_left_x":244,"top_left_y":620,"width":1583,"height":40},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"477086d4d6dc4a53bb7f084cb936b78e","type":"text","conversion_output":true,"text":"data points will be reviewed against source documentation collected from the site (such as the participant's de-","text_display":" data points will be reviewed against source documentation collected from the site (such as the participant's de","confidence":1,"confidence_rate":1},{"cnt":[[247,662],[1729,662],[1729,703],[247,703]],"region":{"top_left_x":247,"top_left_y":661,"width":1483,"height":42},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72bfce2fcf244da5b7211966b87fedaa","type":"text","conversion_output":true,"text":"identified initial EP H\\&P, procedure note and first follow-up EP note). In addition, specified de-identified","text_display":"identified initial EP H\\&P, procedure note and first follow-up EP note). In addition, specified de-identified","confidence":1,"confidence_rate":1},{"cnt":[[245,705],[1824,705],[1824,746],[245,746]],"region":{"top_left_x":244,"top_left_y":704,"width":1581,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b03b2bbb0f30416a979a825ce58b5b83","type":"text","conversion_output":true,"text":"documentation will be requested from each site to perform source verification on a random \\(10 \\%\\) sample of key","text_display":" documentation will be requested from each site to perform source verification on a random \\(10 \\%\\) sample of key","confidence":0.96630859375,"confidence_rate":0.9997020266589043},{"cnt":[[245,748],[1790,748],[1790,788],[245,788]],"region":{"top_left_x":244,"top_left_y":747,"width":1546,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1d149c19efe44d0957d42de714a53c3","type":"text","conversion_output":true,"text":"study data. If during the course of the study the error rate exceeds a 5\\% threshold, the percentage of source","text_display":" study data. If during the course of the study the error rate exceeds a 5\\% threshold, the percentage of source","confidence":0.55078125,"confidence_rate":0.9947819287488787},{"cnt":[[245,791],[1021,791],[1021,827],[245,827]],"region":{"top_left_x":244,"top_left_y":790,"width":777,"height":38},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d8085a22cc74a42b1bc732033e786d0","type":"text","conversion_output":true,"text":"verification will increase until control is demonstrated.","text_display":" verification will increase until control is demonstrated.","confidence":1,"confidence_rate":1},{"cnt":[[245,872],[660,872],[660,913],[245,913]],"region":{"top_left_x":244,"top_left_y":872,"width":416,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e7685b29e394b10a5cdc11d098b3ccd","type":"section_header","conversion_output":false,"children_ids":["51ae6853e3504b7c8dd0d40314116a67"],"text":"","text_display":""},{"cnt":[[249,877],[657,877],[657,909],[249,909]],"region":{"top_left_x":249,"top_left_y":876,"width":409,"height":33},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51ae6853e3504b7c8dd0d40314116a67","type":"text","conversion_output":true,"parent_id":"8e7685b29e394b10a5cdc11d098b3ccd","text":"10.0 STATISTICAL METHODS","text_display":"\n\n\\subsection*{10.0 STATISTICAL METHODS}","confidence":1,"confidence_rate":1},{"cnt":[[245,958],[840,958],[840,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":958,"width":597,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23f876375aaa4a2aab828ac8eff8c5f0","type":"section_header","conversion_output":false,"children_ids":["e4cec1eba3ee43488f4c1d0c5733d0a2"],"text":"","text_display":""},{"cnt":[[249,958],[836,958],[836,999],[249,999]],"region":{"top_left_x":249,"top_left_y":958,"width":587,"height":42},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4cec1eba3ee43488f4c1d0c5733d0a2","type":"text","conversion_output":true,"parent_id":"23f876375aaa4a2aab828ac8eff8c5f0","text":"10.1 Sample Size and Randomization","text_display":"\n\n\\subsection*{10.1 Sample Size and Randomization}","confidence":1,"confidence_rate":1},{"cnt":[[245,1044],[1502,1044],[1502,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1044,"width":1258,"height":41},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"12cf828c572444978a8013b6333a714c","type":"text","conversion_output":true,"text":"The goal of this trial is the enroll a total of 200 participants ( \\(n =100\\) per treatment group).","text_display":"\n\nThe goal of this trial is the enroll a total of 200 participants ( \\(n =100\\) per treatment group).","confidence":0.9029726525768638,"confidence_rate":0.9990554185176687},{"cnt":[[245,1171],[1846,1171],[1846,1210],[245,1210]],"region":{"top_left_x":244,"top_left_y":1170,"width":1602,"height":40},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4bb74d46e606454aa91660e0192e5c05","type":"text","conversion_output":true,"text":"Assuming a 0.05 two-tailed alpha level, \\(1: 1\\) randomization scheme, \\(50 \\%\\) recurrence rate in the absence of coffee,","text_display":"\n\nAssuming a 0.05 two-tailed alpha level, \\(1: 1\\) randomization scheme, \\(50 \\%\\) recurrence rate in the absence of coffee,","confidence":0.998046875,"confidence_rate":0.9999843598436221},{"cnt":[[245,1212],[1876,1212],[1876,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1211,"width":1632,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"347639322aa54987a1276c1b27c8ab87","type":"text","conversion_output":true,"text":"and potential \\(10 \\%\\) loss to follow-up, a sample size of \\(n =200\\) ( 100 per arm) will provide approximately \\(80 \\%\\) power to","text_display":" and potential \\(10 \\%\\) loss to follow-up, a sample size of \\(n =200\\) ( 100 per arm) will provide approximately \\(80 \\%\\) power to","confidence":0.7104994070001938,"confidence_rate":0.9974525996520046},{"cnt":[[245,1255],[1315,1255],[1315,1296],[245,1296]],"region":{"top_left_x":244,"top_left_y":1254,"width":1071,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a6918523f244d559b7d5886b5e1fe76","type":"text","conversion_output":true,"text":"detect a 1.63 times increased hazard of AF recurrence between the groups.","text_display":" detect a 1.63 times increased hazard of AF recurrence between the groups.","confidence":1,"confidence_rate":1},{"cnt":[[245,1341],[1807,1341],[1807,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1340,"width":1563,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a7f4029b009496ebb5f0e3bd07f5fcf","type":"text","conversion_output":true,"text":"The table below summarizes the minimum detectable relative hazards in Cox models with binary predictor, by","text_display":"\n\nThe table below summarizes the minimum detectable relative hazards in Cox models with binary predictor, by","confidence":1,"confidence_rate":1},{"cnt":[[245,1384],[1480,1384],[1480,1424],[245,1424]],"region":{"top_left_x":244,"top_left_y":1383,"width":1237,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e243725fe514746aaaafd9e6777dff2","type":"text","conversion_output":true,"text":"baseline AF recurrence rate (RR) (rows) and Percent Lost to Follow up (LTFU) (columns)","text_display":" baseline AF recurrence rate (RR) (rows) and Percent Lost to Follow up (LTFU) (columns)","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[245,1461],[1051,1461],[1051,1603],[245,1603]],"region":{"top_left_x":244,"top_left_y":1460,"width":807,"height":143},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0c3e05fef9e400e9cd661a1c0e373e7","type":"table","conversion_output":true,"text":"\\begin{tabular}{|l|l|l|}\n\\hline & \\(5 \\%\\) LTFU & \\(10 \\%\\) LTFU \\\\\n\\hline \\(50 \\%\\) RR & 1.68 & 1.69 \\\\\n\\hline \\(60 \\%\\) RR & 1.62 & 1.63 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline & \\(5 \\%\\) LTFU & \\(10 \\%\\) LTFU \\\\\n\\hline \\(50 \\%\\) RR & 1.68 & 1.69 \\\\\n\\hline \\(60 \\%\\) RR & 1.62 & 1.63 \\\\\n\\hline\n\\end{tabular}","confidence":0.9142265319824219,"confidence_rate":0.9991297294738938},{"cnt":[[245,1687],[1214,1687],[1214,1725],[245,1725]],"region":{"top_left_x":244,"top_left_y":1686,"width":970,"height":40},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c26bfe43c094bdca4a81f3763487f77","type":"text","conversion_output":true,"text":"Randomization will be performed \\(1: 1\\) with stratification across sites.","text_display":"\n\nRandomization will be performed \\(1: 1\\) with stratification across sites.","confidence":0.9819421768188477,"confidence_rate":0.9997633675416455},{"cnt":[[245,1766],[715,1766],[715,1815],[245,1815]],"region":{"top_left_x":244,"top_left_y":1766,"width":472,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6184fdf2893418d944eaba8f7b62296","type":"section_header","conversion_output":false,"children_ids":["412b254cb09e422582558bda088a8a56"],"text":"","text_display":""},{"cnt":[[249,1770],[713,1770],[713,1811],[249,1811]],"region":{"top_left_x":249,"top_left_y":1770,"width":465,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"412b254cb09e422582558bda088a8a56","type":"text","conversion_output":true,"parent_id":"f6184fdf2893418d944eaba8f7b62296","text":"10.2 Intention-to-Treat (ITT)","text_display":"\n\n\\subsection*{10.2 Intention-to-Treat (ITT)}","confidence":1,"confidence_rate":1},{"cnt":[[245,1856],[1798,1856],[1798,1897],[245,1897]],"region":{"top_left_x":244,"top_left_y":1856,"width":1555,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b4060ed791847cebdab0048a0f9fbf4","type":"text","conversion_output":true,"text":"The main intention-to-treat (ITT) analysis set will include all randomized participants, whether or not they are","text_display":"\n\nThe main intention-to-treat (ITT) analysis set will include all randomized participants, whether or not they are","confidence":1,"confidence_rate":1},{"cnt":[[245,1899],[1841,1899],[1841,1940],[245,1940]],"region":{"top_left_x":244,"top_left_y":1899,"width":1598,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1bee02b381464207b0878293280c9453","type":"text","conversion_output":true,"text":"compliant with the treatment allocation for this trial. Every attempt will be made to collect data until the end of","text_display":" compliant with the treatment allocation for this trial. Every attempt will be made to collect data until the end of","confidence":1,"confidence_rate":1},{"cnt":[[245,1938],[1760,1938],[1760,1981],[245,1981]],"region":{"top_left_x":244,"top_left_y":1937,"width":1516,"height":44},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b78e80a24494f1ca9ea527aeb74471f","type":"text","conversion_output":true,"text":"the follow-up period for all randomized participants and these data will be included as part of the main ITT","text_display":" the follow-up period for all randomized participants and these data will be included as part of the main ITT","confidence":1,"confidence_rate":1},{"cnt":[[245,1983],[1497,1983],[1497,2024],[245,2024]],"region":{"top_left_x":244,"top_left_y":1983,"width":1254,"height":41},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0a6caea01cb451da870eccec15217c5","type":"text","conversion_output":true,"text":"analysis. The analyses for the primary objective will be performed using the ITT dataset.","text_display":" analysis. The analyses for the primary objective will be performed using the ITT dataset.","confidence":1,"confidence_rate":1},{"cnt":[[245,2067],[1824,2067],[1824,2108],[245,2108]],"region":{"top_left_x":244,"top_left_y":2066,"width":1581,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a0d6cfdf94d4ce2a5341547d4a842f8","type":"text","conversion_output":true,"text":"Although substantial crossover is not anticipated, as treated and per protocol analyses will also be conducted if","text_display":"\n\nAlthough substantial crossover is not anticipated, as treated and per protocol analyses will also be conducted if","confidence":1,"confidence_rate":1},{"cnt":[[245,2110],[1717,2110],[1717,2151],[245,2151]],"region":{"top_left_x":244,"top_left_y":2109,"width":1473,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb46f7504b174d4ab986ee18453d24e5","type":"text","conversion_output":true,"text":"failure to comply with allocated treatment assignments occurs in more than \\(10 \\%\\) of cases or if there is a","text_display":" failure to comply with allocated treatment assignments occurs in more than \\(10 \\%\\) of cases or if there is a","confidence":0.9716932773590088,"confidence_rate":0.9997436481977281},{"cnt":[[245,2153],[1601,2153],[1601,2194],[245,2194]],"region":{"top_left_x":244,"top_left_y":2152,"width":1357,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b898d53540241bbbed0f1975712a136","type":"text","conversion_output":true,"text":"significantly different proportion of assignment adherence in one group compared to the other.","text_display":" significantly different proportion of assignment adherence in one group compared to the 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Sustained atrial fibrillation or atrial flutter (provided patient has history of atrial fibrillation)","confidence":1,"confidence_rate":1},{"cnt":[[245,1362],[1205,1362],[1205,1403],[245,1403]],"region":{"top_left_x":244,"top_left_y":1362,"width":962,"height":41},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9c8eaa3e00f4c17b75b7ee272676b00","type":"text","conversion_output":true,"text":"3. Planned/scheduled direct current electrical cardioversion","text_display":"\n3. Planned/scheduled direct current electrical cardioversion","confidence":1,"confidence_rate":1},{"cnt":[[245,1409],[1858,1409],[1858,1452],[245,1452]],"region":{"top_left_x":244,"top_left_y":1409,"width":1615,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50d1bb56377a4b30a1d06541769af553","type":"text","conversion_output":true,"text":"4. 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randomization.","confidence":1,"confidence_rate":1},{"cnt":[[241,1044],[539,1044],[539,1091],[241,1091]],"region":{"top_left_x":240,"top_left_y":1044,"width":300,"height":48},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de381defcccb4f07a095201fb1ddbfff","type":"section_header","conversion_output":false,"children_ids":["1f39024ad4674a419f00f4e12eca2258"],"text":"","text_display":""},{"cnt":[[245,1048],[535,1048],[535,1089],[245,1089]],"region":{"top_left_x":244,"top_left_y":1048,"width":291,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f39024ad4674a419f00f4e12eca2258","type":"text","conversion_output":true,"parent_id":"de381defcccb4f07a095201fb1ddbfff","text":"4.2 BLINDING","text_display":"\n\n\\subsection*{4.2 BLINDING}","confidence":1,"confidence_rate":1},{"cnt":[[247,1143],[1867,1143],[1867,1188],[247,1188]],"region":{"top_left_x":247,"top_left_y":1142,"width":1620,"height":47},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5c3063f7167409387951469440dcd1a","type":"text","conversion_output":true,"text":"Due to the nature of the intervention, it is not practical to have participants blinded to their randomized","text_display":"\n\nDue to the nature of the intervention, it is not practical to have participants blinded to their randomized","confidence":1,"confidence_rate":1},{"cnt":[[245,1190],[415,1190],[415,1227],[245,1227]],"region":{"top_left_x":244,"top_left_y":1190,"width":171,"height":37},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"850429bf372644ebb7e50e87a9fd419f","type":"text","conversion_output":true,"text":"allocation.","text_display":" allocation.","confidence":1,"confidence_rate":1},{"cnt":[[241,1276],[999,1276],[999,1321],[241,1321]],"region":{"top_left_x":240,"top_left_y":1276,"width":760,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3189c85e106404caab675ea4920f71b","type":"section_header","conversion_output":false,"children_ids":["9185f4b606f6463997a4f1f1c5f36da8"],"text":"","text_display":""},{"cnt":[[245,1280],[993,1280],[993,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1280,"width":749,"height":37},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9185f4b606f6463997a4f1f1c5f36da8","type":"text","conversion_output":true,"parent_id":"a3189c85e106404caab675ea4920f71b","text":"5.0 SAMPLE SIZE AND POWER CALCULATIONS","text_display":"\n\n\\subsection*{5.0 SAMPLE SIZE AND POWER 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assumptions: (1) a \\(50 \\%\\) incidence of AF recurrence; (2) \\(10 \\%\\)","text_display":"\n\nThe sample size is based on the following assumptions: (1) a \\(50 \\%\\) incidence of AF recurrence; (2) \\(10 \\%\\)","confidence":0.8812952041625977,"confidence_rate":0.9988197378927314},{"cnt":[[245,1512],[1738,1512],[1738,1555],[245,1555]],"region":{"top_left_x":244,"top_left_y":1512,"width":1495,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c323f4fe1e2415186efa69063400cf2","type":"text","conversion_output":true,"text":"loss to follow-up; and (3) 0.05 two-tailed alpha level. Under these assumptions, a sample of 200","text_display":" loss to follow-up; and (3) 0.05 two-tailed alpha level. Under these assumptions, a sample of 200","confidence":0.99755859375,"confidence_rate":0.9999762683268261},{"cnt":[[245,1558],[1867,1558],[1867,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1557,"width":1623,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f5bca1d227ff4a298f61969634b4b049","type":"text","conversion_output":true,"text":"individuals randomized \\(1: 1\\) to either coffee abstention or continued caffeinated coffee consumption will","text_display":" individuals randomized \\(1: 1\\) to either coffee abstention or continued caffeinated coffee consumption will","confidence":0.99072265625,"confidence_rate":0.9999160337385748},{"cnt":[[245,1607],[1592,1607],[1592,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1607,"width":1348,"height":41},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf8af9f5a57d4d7bb9f2551caf5b8346","type":"text","conversion_output":true,"text":"provide \\(80 \\%\\) power to detect a 1.63 times increased hazard of AF between the groups.","text_display":" provide \\(80 \\%\\) power to detect a 1.63 times increased hazard of AF between the groups.","confidence":0.9975602623308077,"confidence_rate":0.9999740139687203},{"cnt":[[241,1689],[683,1689],[683,1738],[241,1738]],"region":{"top_left_x":240,"top_left_y":1688,"width":444,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"363bcdf525fc4dad97def305fe54cf83","type":"section_header","conversion_output":false,"children_ids":["b332ad8d145d4aa3bb6b01c0344c0874"],"text":"","text_display":""},{"cnt":[[245,1693],[679,1693],[679,1734],[245,1734]],"region":{"top_left_x":244,"top_left_y":1692,"width":435,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b332ad8d145d4aa3bb6b01c0344c0874","type":"text","conversion_output":true,"parent_id":"363bcdf525fc4dad97def305fe54cf83","text":"6.0 STATISTICAL METHODS","text_display":"\n\n\\subsection*{6.0 STATISTICAL METHODS}","confidence":1,"confidence_rate":1},{"cnt":[[245,1788],[1742,1788],[1742,1830],[245,1830]],"region":{"top_left_x":244,"top_left_y":1787,"width":1499,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2fb48d0a67144fa9032970b3d5dbc9b","type":"text","conversion_output":true,"text":"All analyses will be conducted upon completion of data collection and database lock. No interim","text_display":"\n\nAll analyses will be conducted upon completion of data collection and database lock. No interim","confidence":1,"confidence_rate":1},{"cnt":[[245,1835],[587,1835],[587,1876],[245,1876]],"region":{"top_left_x":244,"top_left_y":1834,"width":343,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d16081e333844a85aa5eabad7e434a58","type":"text","conversion_output":true,"text":"analyses are planned.","text_display":" analyses are planned.","confidence":1,"confidence_rate":1},{"cnt":[[245,1927],[1798,1927],[1798,1970],[245,1970]],"region":{"top_left_x":244,"top_left_y":1927,"width":1555,"height":44},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0bf5e54192544c4ca40fbbd653e374d7","type":"text","conversion_output":true,"text":"The primary analysis will be by intention-to-treat (ITT), according to randomized allocation, without","text_display":"\n\nThe primary analysis will be by intention-to-treat (ITT), according to randomized allocation, without","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,1972],[1858,1972],[1858,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1972,"width":1615,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"52fd089ed54f43b092d30e4300e61975","type":"text","conversion_output":true,"text":"regard to participant compliance with this randomized allocation. Every attempt will be made to collect","text_display":" regard to participant compliance with this randomized allocation. Every attempt will be made to collect","confidence":1,"confidence_rate":1},{"cnt":[[245,2020],[1824,2020],[1824,2065],[245,2065]],"region":{"top_left_x":244,"top_left_y":2019,"width":1581,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56a524eeef6945b18627c553bca8e653","type":"text","conversion_output":true,"text":"data for both primary and secondary endpoints until the end of the six month follow-up period for all","text_display":" data for both primary and secondary endpoints until the end of the six month follow-up period for all","confidence":1,"confidence_rate":1},{"cnt":[[245,2067],[1622,2067],[1622,2112],[245,2112]],"region":{"top_left_x":244,"top_left_y":2066,"width":1379,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1eb19f33cc6149be9f4ed70be461b6d9","type":"text","conversion_output":true,"text":"randomized participants, and all data will be included as part of the primary ITT analysis.","text_display":" randomized participants, and all data will be included as part of the primary ITT analysis.","confidence":1,"confidence_rate":1},{"cnt":[[245,2161],[1876,2161],[1876,2202],[245,2202]],"region":{"top_left_x":244,"top_left_y":2161,"width":1632,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea80214c82c64b219d52969f00eb0c3a","type":"text","conversion_output":true,"text":"Although substantial crossover is not anticipated, as treated and per protocol analyses will be conducted","text_display":"\n\nAlthough substantial crossover is not anticipated, as treated and per protocol analyses will be conducted","confidence":1,"confidence_rate":1},{"cnt":[[245,2209],[1876,2209],[1876,2249],[245,2249]],"region":{"top_left_x":244,"top_left_y":2208,"width":1632,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31206751005c4fd99e85bfeb9b246be9","type":"text","conversion_output":true,"text":"if failure to comply with the randomized allocation occurs in more than \\(10 \\%\\) of all participants or if there","text_display":" if failure to comply with the randomized allocation occurs in more than \\(10 \\%\\) of all participants or if there","confidence":0.8804292678833008,"confidence_rate":0.9988932590983521},{"cnt":[[245,2254],[1863,2254],[1863,2297],[245,2297]],"region":{"top_left_x":244,"top_left_y":2253,"width":1619,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77ff9156e3c04dff83c5cb4d12ba075d","type":"text","conversion_output":true,"text":"is a significantly different proportion of assignment adherence in one group compared to the other. The","text_display":" is a significantly different proportion of assignment adherence in one group compared to the other. The","confidence":1,"confidence_rate":1},{"cnt":[[245,2299],[1835,2299],[1835,2344],[245,2344]],"region":{"top_left_x":244,"top_left_y":2298,"width":1591,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61a58a6e5b58422680ae05df71b0c314","type":"text","conversion_output":true,"text":"per protocol analyses will be restricted to a sub-sample excluding all the protocol violators, and adjust","text_display":" per protocol analyses will be restricted to a sub-sample excluding all the protocol violators, and adjust","confidence":1,"confidence_rate":1},{"cnt":[[245,2346],[1553,2346],[1553,2391],[245,2391]],"region":{"top_left_x":244,"top_left_y":2346,"width":1310,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1be7ed7ab3824fd5b9c590dbb741cae8","type":"text","conversion_output":true,"text":"for any baseline factors that are imbalanced ( \\(P <0.1\\) ) in the per-protocol sub-sample.","text_display":" for any baseline factors that are imbalanced ( \\(P <0.1\\) ) in the per-protocol sub-sample.","confidence":0.6853653636062518,"confidence_rate":0.9961126967948194},{"cnt":[[245,2436],[1699,2436],[1699,2479],[245,2479]],"region":{"top_left_x":244,"top_left_y":2436,"width":1456,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a57430f990eb46c78d2820a4e1d0adac","type":"text","conversion_output":true,"text":"Patient baseline characteristics will be summarized overall and by randomization assignment.","text_display":"\n\nPatient baseline characteristics will be summarized overall and by randomization assignment.","confidence":1,"confidence_rate":1},{"cnt":[[245,2484],[1747,2484],[1747,2529],[245,2529]],"region":{"top_left_x":244,"top_left_y":2483,"width":1503,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04c3430886d34389bf051ebafe0026aa","type":"text","conversion_output":true,"text":"Continuous variables will be summarized using means and standard deviations (SD) for normally","text_display":" Continuous variables will be summarized using means and standard deviations (SD) for normally","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[245,2595],[638,2595],[638,2625],[245,2625]],"region":{"top_left_x":244,"top_left_y":2595,"width":395,"height":31},"line":42,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"77dad7a64bc34cd98ede918cd0c63e25","type":"page_info","conversion_output":false,"text":"DECAF SAP V1.0 - June 122025","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1745,2595],[1880,2595],[1880,2632],[1745,2632]],"region":{"top_left_x":1744,"top_left_y":2595,"width":136,"height":37},"line":43,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ea87666709cb42d7978486c671080b98","type":"page_info","conversion_output":false,"text":"Page 5 of 7","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"c94cf12f-2223-41eb-a36c-a58bf0cb4540-27","page":27,"lines":[{"cnt":[[1504,125],[1880,125],[1880,161],[1504,161]],"region":{"top_left_x":1503,"top_left_y":124,"width":377,"height":38},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f4b1c413b181466fa3fcfa2d7b17dc1e","type":"page_info","conversion_output":false,"text":"DECAF Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1704,159],[1880,159],[1880,187],[1704,187]],"region":{"top_left_x":1703,"top_left_y":158,"width":177,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"94a1e8ef37344a58b84453806d63f4aa","type":"page_info","conversion_output":false,"text":"NCT05121519","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,258],[1777,258],[1777,299],[247,299]],"region":{"top_left_x":247,"top_left_y":257,"width":1530,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"54d95516c4f74a4c94417054707dfe8f","type":"text","conversion_output":true,"text":"distributed measures or medians and quartiles for non-normally distributed measures. Categorical","text_display":"\ndistributed measures or medians and quartiles for non-normally distributed measures. Categorical","confidence":1,"confidence_rate":1},{"cnt":[[245,305],[1669,305],[1669,346],[245,346]],"region":{"top_left_x":244,"top_left_y":305,"width":1426,"height":41},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91f2facd1b26499fa06b222b5a1e89c7","type":"text","conversion_output":true,"text":"variables will be summarized using contingency tables that display counts and percentages.","text_display":" variables will be summarized using contingency tables that display counts and percentages.","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[245,397],[1867,397],[1867,440],[245,440]],"region":{"top_left_x":244,"top_left_y":397,"width":1623,"height":44},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b566dd6aebc94c6ba37e0f16caf7318e","type":"text","conversion_output":true,"text":"All tests will be two-sided with a 0.05 -level of significance. Adjustment for multiple comparisons will not","text_display":"\n\nAll tests will be two-sided with a 0.05 -level of significance. Adjustment for multiple comparisons will not","confidence":0.9965846532722935,"confidence_rate":0.9999705073975188},{"cnt":[[245,443],[385,443],[385,483],[245,483]],"region":{"top_left_x":244,"top_left_y":442,"width":141,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0fb166fad914489682046c49d3b84b66","type":"text","conversion_output":true,"text":"be used.","text_display":" be used.","confidence":1,"confidence_rate":1},{"cnt":[[241,529],[872,529],[872,578],[241,578]],"region":{"top_left_x":240,"top_left_y":528,"width":633,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5fe04e3406e34b9f8b6a72444ad279ef","type":"section_header","conversion_output":false,"children_ids":["6a70bd2a38454048b9573e6eb78ad48c"],"text":"","text_display":""},{"cnt":[[245,533],[870,533],[870,574],[245,574]],"region":{"top_left_x":244,"top_left_y":532,"width":627,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a70bd2a38454048b9573e6eb78ad48c","type":"text","conversion_output":true,"parent_id":"5fe04e3406e34b9f8b6a72444ad279ef","text":"6.1 PRIMARY ENDPOINT ANALYSIS","text_display":"\n\n\\subsection*{6.1 PRIMARY ENDPOINT ANALYSIS}","confidence":0.9990234375,"confidence_rate":0.9999712639526579},{"cnt":[[245,627],[1858,627],[1858,672],[245,672]],"region":{"top_left_x":244,"top_left_y":627,"width":1615,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24dc7b53d7d64213a2cbd6211a0de8c2","type":"text","conversion_output":true,"text":"The primary endpoint, defined as the clinical recurrence of AF or device-detected AF lasting longer than","text_display":"\n\nThe primary endpoint, defined as the clinical recurrence of AF or device-detected AF lasting longer than","confidence":1,"confidence_rate":1},{"cnt":[[245,675],[1828,675],[1828,718],[245,718]],"region":{"top_left_x":244,"top_left_y":674,"width":1585,"height":44},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"032d58fb1d444678abfbce8e93b1968f","type":"text","conversion_output":true,"text":"30 seconds, will be analyzed as a time-to-event outcome. Follow-up time for participants who do not","text_display":" 30 seconds, will be analyzed as a time-to-event outcome. Follow-up time for participants who do not","confidence":1,"confidence_rate":1},{"cnt":[[245,718],[1772,718],[1772,763],[245,763]],"region":{"top_left_x":244,"top_left_y":717,"width":1529,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3932945a58ad4cd19243f002a4649012","type":"text","conversion_output":true,"text":"experience the primary endpoint will be censored at the time of study withdrawal or end of study","text_display":" experience the primary endpoint will be censored at the time of study withdrawal or end of study","confidence":0.99755859375,"confidence_rate":0.9999757983983905},{"cnt":[[245,765],[1800,765],[1800,810],[245,810]],"region":{"top_left_x":244,"top_left_y":764,"width":1557,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf34f3f778a7444a8abc184278c34863","type":"text","conversion_output":true,"text":"(month 6). Kaplan-Meier plots will be used descriptively to compare the survival distributions of the","text_display":" (month 6). Kaplan-Meier plots will be used descriptively to compare the survival distributions of the","confidence":0.9980475902557373,"confidence_rate":0.9999815632059917},{"cnt":[[245,812],[1785,812],[1785,857],[245,857]],"region":{"top_left_x":244,"top_left_y":812,"width":1542,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ed493d004c14e15ae1623586e292eba","type":"text","conversion_output":true,"text":"primary endpoint by randomization arm. Cox proportional hazards regression models including the","text_display":" primary endpoint by randomization arm. 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