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composite of all-cause death,","text_display":" stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death,","confidence":1,"confidence_rate":1},{"cnt":[[249,378],[1422,378],[1422,423],[249,423]],"region":{"top_left_x":249,"top_left_y":378,"width":1174,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9167a314ce44479197eb6e14ff1cae0a","type":"text","conversion_output":true,"text":"protocol-defined Q-wave or non-Q-wave MI, and any clinically-driven TLR).","text_display":" protocol-defined Q-wave or non-Q-wave MI, and any clinically-driven TLR).","confidence":0.998046875,"confidence_rate":0.9999749357649362},{"cnt":[[120,490],[2013,490],[2013,535],[120,535]],"region":{"top_left_x":120,"top_left_y":489,"width":1894,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d08f28ec5d1429a96b4fc7fe419965b","type":"text","conversion_output":true,"text":"The percent residual stenosis, as assessed by the investigator visual estimate or on-line QCA during the procedure, will","text_display":"\n\nThe percent residual stenosis, as assessed by the investigator visual estimate or on-line QCA during the procedure, will","confidence":1,"confidence_rate":1},{"cnt":[[122,537],[2015,537],[2015,582],[122,582]],"region":{"top_left_x":122,"top_left_y":537,"width":1894,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"11f6b3971c9a4e9aa775d2508158798b","type":"text","conversion_output":true,"text":"be used as the primary analysis measure of the final \\% diameter stenosis for evaluating angiographic success criteria for","text_display":" be used as the primary analysis measure of the final \\% diameter stenosis for evaluating angiographic success criteria for","confidence":0.99169921875,"confidence_rate":0.9999338480248129},{"cnt":[[120,584],[2015,584],[2015,629],[120,629]],"region":{"top_left_x":120,"top_left_y":584,"width":1896,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92399f77f32b4c63a13a2b1a6fa2303b","type":"text","conversion_output":true,"text":"these endpoints. If investigator assessment of residual stenosis is not available, the final \\% diameter stenosis as assessed","text_display":" these endpoints. If investigator assessment of residual stenosis is not available, the final \\% diameter stenosis as assessed","confidence":0.96240234375,"confidence_rate":0.9997029690913581},{"cnt":[[122,632],[1775,632],[1775,677],[122,677]],"region":{"top_left_x":122,"top_left_y":631,"width":1653,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9e6ae2e229249be9d633ad6d911b31e","type":"text","conversion_output":true,"text":"by QCA will be used. In evaluating procedure success, MACE will be based on CEC adjudicated event data.","text_display":" by QCA will be used. In evaluating procedure success, MACE will be based on CEC adjudicated event data.","confidence":1,"confidence_rate":1},{"cnt":[[120,743],[2015,743],[2015,793],[120,793]],"region":{"top_left_x":120,"top_left_y":743,"width":1896,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"239333336a014675ac6cae2f70ff0437","type":"text","conversion_output":true,"text":"The following secondary clinical endpoints will be evaluated prior to discharge, at 1,6 and 12 months and annually","text_display":"\n\nThe following secondary clinical endpoints will be evaluated prior to discharge, at 1,6 and 12 months and 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or non-Q-wave MI, and any clinically-driven TVR)","confidence":0.8952698707580566,"confidence_rate":0.9979148171228258},{"cnt":[[185,1336],[1848,1336],[1848,1388],[185,1388]],"region":{"top_left_x":184,"top_left_y":1336,"width":1664,"height":52},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70fa96681b3f4d23a8b4a7c76d3d615b","type":"text","conversion_output":true,"text":"10) Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research","text_display":"\n10) Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[249,1386],[1721,1386],[1721,1433],[249,1433]],"region":{"top_left_x":249,"top_left_y":1385,"width":1472,"height":49},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9212fa6ca9f347da8c54b12b5c3c35d5","type":"text","conversion_output":true,"text":"Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis","text_display":" Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis","confidence":1,"confidence_rate":1},{"cnt":[[125,1500],[1334,1500],[1334,1549],[125,1549]],"region":{"top_left_x":124,"top_left_y":1499,"width":1211,"height":51},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e2a8b1dc069411db1bd0a31e8af15ef","type":"text","conversion_output":true,"text":"Analysis of secondary endpoints will be based on CEC adjudicated event 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Lunn et al. \\({ }^{1}\\); other analyses, including summaries, will be conducted using SAS (version 9.4), unless","text_display":" Gibbs Sampling), Lunn et al. \\({ }^{1}\\); other analyses, including summaries, will be conducted using SAS (version 9.4), unless","confidence":0.9985356330871582,"confidence_rate":0.9999890639393071},{"cnt":[[125,1869],[2007,1869],[2007,1919],[125,1919]],"region":{"top_left_x":124,"top_left_y":1869,"width":1883,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4394d6e88cb8484db8edbc4a39997cdb","type":"text","conversion_output":true,"text":"otherwise noted. Descriptive statistics for continuous variables will include mean, standard deviation, median, quartiles,","text_display":" otherwise noted. Descriptive statistics for continuous variables will include mean, standard deviation, median, quartiles,","confidence":1,"confidence_rate":1},{"cnt":[[127,1916],[1987,1916],[1987,1964],[127,1964]],"region":{"top_left_x":126,"top_left_y":1916,"width":1862,"height":48},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"015432fc578747e9a9c811234b7e994e","type":"text","conversion_output":true,"text":"minimum, maximum, and sample size for each treatment group. Categorical variables will be summarized using counts","text_display":" minimum, maximum, and sample size for each treatment group. Categorical variables will be summarized using counts","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[127,1962],[1880,1962],[1880,2009],[127,2009]],"region":{"top_left_x":126,"top_left_y":1961,"width":1754,"height":48},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b38ef4d303294f2ba00c5834188e4321","type":"text","conversion_output":true,"text":"and percentages. Proportions will be calculated using known non-missing values. Unless otherwise indicated, all","text_display":" and percentages. Proportions will be calculated using known non-missing values. 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& BIOFLOW -II & BIOFLOW-IV & BIOFLOW-V \\\\\n\\hline Eligibility Criteria & \\multicolumn{3}{|c|}{All subjects will match BIOFLOW-V clinical and angiographic inclusion/exclusion criteria} \\\\\n\\hline Primary or Secondary Endpoint Definition & \\multicolumn{3}{|c|}{TLF: cardiac death, target vessel Q-wave or non-Q wave MI, CABG, clinically driven TLR} \\\\\n\\hline Follow-up schedule & \\(1 mo , 6 mo , 9 mo\\) angio, 12 mo , 2yr, 3yr, 4yr, 5yr & \\(1 mo , 6 mo , 12 mo\\), 2yr, 3yr, 4yr, 5yr & \\(1 mo , 6 mo , 12 mo\\), 2yr, 3yr, 4yr, 5yr \\\\\n\\hline Enzyme measurements & \\begin{tabular}{l}\nCK, CKMB (optional) and Troponin: \\\\\n- Baseline \\\\\n- Within 6-24 hours after the index procedure or at discharge, whichever comes first\n\\end{tabular} & \\begin{tabular}{l}\nCK, CKMB (optional) or Troponin (if CK and CKMB are not used): \\\\\n- Baseline \\\\\n- Within 6-24 hours after the index procedure or at discharge, whichever comes first\n\\end{tabular} & \\begin{tabular}{l}\nCK, CKMB, Troponin (if CKMB is not available): \\\\\n- Baseline \\\\\n- Within 6-24 hours after the index procedure\n\\end{tabular} \\\\\n\\hline Clinical Monitoring & \\begin{tabular}{l}\n- \\(100 \\%\\) source verification \\\\\n- Independent core labs for angiography, IVUS \\& OCT \\\\\n- On-site monitoring \\\\\n- Independent CEC adjudication\n\\end{tabular} & \\begin{tabular}{l}\n- \\(100 \\%\\) source verification \\\\\n- Independent angiographic core lab \\\\\n- On-site Monitoring \\\\\n- Independent CEC adjudication\n\\end{tabular} & \\begin{tabular}{l}\n- \\(100 \\%\\) source verification \\\\\n- Independent angiographic core lab \\\\\n- On-site Monitoring \\\\\n- Independent CEC adjudication\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline & BIOFLOW -II & BIOFLOW-IV & BIOFLOW-V \\\\\n\\hline Eligibility Criteria & \\multicolumn{3}{|c|}{All subjects will match BIOFLOW-V clinical and angiographic inclusion/exclusion criteria} \\\\\n\\hline Primary or Secondary Endpoint Definition & \\multicolumn{3}{|c|}{TLF: cardiac death, target vessel Q-wave or non-Q wave MI, CABG, clinically driven TLR} \\\\\n\\hline Follow-up schedule & \\(1 mo , 6 mo , 9 mo\\) angio, 12 mo , 2yr, 3yr, 4yr, 5yr & \\(1 mo , 6 mo , 12 mo\\), 2yr, 3yr, 4yr, 5yr & \\(1 mo , 6 mo , 12 mo\\), 2yr, 3yr, 4yr, 5yr \\\\\n\\hline Enzyme measurements & \\begin{tabular}{l}\nCK, CKMB (optional) and Troponin: \\\\\n- Baseline \\\\\n- Within 6-24 hours after the index procedure or at discharge, whichever comes first\n\\end{tabular} & \\begin{tabular}{l}\nCK, CKMB (optional) or Troponin (if CK and CKMB are not used): \\\\\n- Baseline \\\\\n- Within 6-24 hours after the index procedure or at discharge, whichever comes first\n\\end{tabular} & \\begin{tabular}{l}\nCK, CKMB, Troponin (if CKMB is not available): \\\\\n- Baseline \\\\\n- Within 6-24 hours after the index procedure\n\\end{tabular} \\\\\n\\hline Clinical Monitoring & \\begin{tabular}{l}\n- 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with a standard PTCA only.","text_display":" have been treated with a standard PTCA only.","confidence":1,"confidence_rate":1},{"cnt":[[382,1942],[1583,1942],[1583,1992],[382,1992]],"region":{"top_left_x":382,"top_left_y":1942,"width":1202,"height":50},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1b85f5f40ae4825beb524c2afdc2016","type":"text","conversion_output":true,"text":"3) Target lesion must be in major coronary artery or branch (target vessel).","text_display":"\n3) Target lesion must be in major coronary artery or branch (target vessel).","confidence":1,"confidence_rate":1},{"cnt":[[380,1989],[1955,1989],[1955,2043],[380,2043]],"region":{"top_left_x":380,"top_left_y":1989,"width":1576,"height":55},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a48e7d4c4f7a4ed883530d75038ede90","type":"text","conversion_output":true,"text":"4) Target lesion must have angiographic evidence of \\(\\geq 50 \\%\\) and \\(<100 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\\# CIP FINAL v4.0 11Feb2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,279],[655,279],[655,324],[241,324]],"region":{"top_left_x":240,"top_left_y":279,"width":416,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d6fbca0a5284678bdf0a7d4384ae9a9","type":"section_header","conversion_output":false,"children_ids":["6ca0116d4bb84dbbaa90f9753bf1ea50"],"text":"","text_display":""},{"cnt":[[245,284],[651,284],[651,320],[245,320]],"region":{"top_left_x":244,"top_left_y":283,"width":407,"height":38},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ca0116d4bb84dbbaa90f9753bf1ea50","type":"text","conversion_output":true,"parent_id":"7d6fbca0a5284678bdf0a7d4384ae9a9","text":"Clinical Exclusion Criteria","text_display":"\n\n\\section*{Clinical Exclusion 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changes consistent with acute ST elevation MI (STEMI)","confidence":1,"confidence_rate":1},{"cnt":[[434,443],[1147,443],[1147,488],[434,488]],"region":{"top_left_x":433,"top_left_y":442,"width":715,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed3eeadf8f5a4cbbba975305a19c8786","type":"text","conversion_output":true,"text":"within 72 hours prior to the index procedure.","text_display":" within 72 hours prior to the index procedure.","confidence":0.99951171875,"confidence_rate":0.9999907849387211},{"cnt":[[438,494],[1964,494],[1964,539],[438,539]],"region":{"top_left_x":438,"top_left_y":494,"width":1526,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce62e8398abb44a7a46f04dcfc21d5f5","type":"text","conversion_output":true,"text":"- Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment","text_display":"\n- Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment","confidence":1,"confidence_rate":1},{"cnt":[[374,546],[1029,546],[1029,589],[374,589]],"region":{"top_left_x":373,"top_left_y":545,"width":657,"height":44},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58596da69aff47b4a9b2dfe32f817734","type":"text","conversion_output":true,"text":"2) Subject is hemodynamically unstable.","text_display":"\n2) Subject is hemodynamically unstable.","confidence":1,"confidence_rate":1},{"cnt":[[374,593],[1987,593],[1987,638],[374,638]],"region":{"top_left_x":373,"top_left_y":592,"width":1615,"height":47},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e379ff8e1fec491a9c87898ea68e9485","type":"text","conversion_output":true,"text":"3) Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the","text_display":"\n3) Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the","confidence":1,"confidence_rate":1},{"cnt":[[438,642],[537,642],[537,685],[438,685]],"region":{"top_left_x":438,"top_left_y":642,"width":100,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00c0922f3fb94389852b1355bdcadf5e","type":"text","conversion_output":true,"text":"study.","text_display":" study.","confidence":1,"confidence_rate":1},{"cnt":[[374,690],[1970,690],[1970,735],[374,735]],"region":{"top_left_x":373,"top_left_y":689,"width":1598,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7573a2a0e43649898fb154e3bf2f0e2c","type":"text","conversion_output":true,"text":"4) Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any","text_display":"\n4) Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or 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elements (cobalt, chromium, tungsten and nickel), acrylic,","confidence":0.9570722579956055,"confidence_rate":0.9995430587452818},{"cnt":[[438,829],[1412,829],[1412,874],[438,874]],"region":{"top_left_x":438,"top_left_y":829,"width":974,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eebce3bb8add4d6f9608ee6f7376572d","type":"text","conversion_output":true,"text":"fluoropolymers, silicon carbide, PLLA, sirolimus or everolimus.","text_display":" fluoropolymers, silicon carbide, PLLA, sirolimus or everolimus.","confidence":1,"confidence_rate":1},{"cnt":[[374,881],[1983,881],[1983,924],[374,924]],"region":{"top_left_x":373,"top_left_y":880,"width":1611,"height":44},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a67d522e3e064c7d916df54322a50037","type":"text","conversion_output":true,"text":"5) Revascularization of any target vessel within 9 months prior to the index procedure or previous 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ischemic attack (TIA) within 6 months prior to the index procedure.","text_display":"\n8) History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.","confidence":1,"confidence_rate":1},{"cnt":[[374,1220],[2000,1220],[2000,1265],[374,1265]],"region":{"top_left_x":373,"top_left_y":1220,"width":1628,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6a8032b6686452e99e95c240198740f","type":"text","conversion_output":true,"text":"9) Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible","text_display":"\n9) Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible","confidence":1,"confidence_rate":1},{"cnt":[[438,1268],[591,1268],[591,1308],[438,1308]],"region":{"top_left_x":438,"top_left_y":1267,"width":153,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1729e31e83fc4f7b90710006fd5f7cb1","type":"text","conversion_output":true,"text":"for DAPT.","text_display":" for DAPT.","confidence":1,"confidence_rate":1},{"cnt":[[374,1317],[1046,1317],[1046,1360],[374,1360]],"region":{"top_left_x":373,"top_left_y":1316,"width":674,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28362330f0d74cc18a414609527795a1","type":"text","conversion_output":true,"text":"10) Subject will refuse blood transfusions.","text_display":"\n10) Subject will refuse blood transfusions.","confidence":1,"confidence_rate":1},{"cnt":[[374,1366],[2000,1366],[2000,1412],[374,1412]],"region":{"top_left_x":373,"top_left_y":1366,"width":1628,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e69a959e42844508baada74ddee8eb14","type":"text","conversion_output":true,"text":"11) Subject has documented left ventricular ejection fraction (LVEF) < 30\\% as evaluated by angiography,","text_display":"\n11) Subject has documented left ventricular ejection fraction (LVEF) < 30\\% as evaluated by angiography,","confidence":0.8797795422788113,"confidence_rate":0.9988147407249958},{"cnt":[[438,1414],[1996,1414],[1996,1459],[438,1459]],"region":{"top_left_x":438,"top_left_y":1413,"width":1558,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a537d322e64c4e02953d6fc22f178b57","type":"text","conversion_output":true,"text":"echocardiogram, radionuclide ventriculography or any non-invasive imaging method within 90 days","text_display":" echocardiogram, radionuclide ventriculography or any non-invasive imaging method within 90 days","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[438,1461],[898,1461],[898,1506],[438,1506]],"region":{"top_left_x":438,"top_left_y":1460,"width":461,"height":47},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d982a1bd73c443dbaed9b26a6bea0ea4","type":"text","conversion_output":true,"text":"prior to the index procedure.","text_display":" prior to the index procedure.","confidence":1,"confidence_rate":1},{"cnt":[[374,1512],[904,1512],[904,1555],[374,1555]],"region":{"top_left_x":373,"top_left_y":1512,"width":532,"height":44},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cec71e89b15c4595a9bb607908ab5f5b","type":"text","conversion_output":true,"text":"12) Subject is dialysis-dependent.","text_display":"\n12) Subject is dialysis-dependent.","confidence":0.99609375,"confidence_rate":0.9998996486426847},{"cnt":[[376,1560],[1953,1560],[1953,1605],[376,1605]],"region":{"top_left_x":375,"top_left_y":1559,"width":1578,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e68cbc0a5f0c40b1931f84f5eb55ca3b","type":"text","conversion_output":true,"text":"13) Subject has impaired renal function (i.e., blood creatinine \\(>2.5 mg / dL\\) or \\(221 \\mu mol / L\\) determined","text_display":"\n13) Subject has impaired renal function (i.e., blood creatinine \\(>2.5 mg / dL\\) or \\(221 \\mu mol / L\\) determined","confidence":1,"confidence_rate":1},{"cnt":[[438,1607],[1124,1607],[1124,1652],[438,1652]],"region":{"top_left_x":438,"top_left_y":1607,"width":686,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"567d5930970049ca9f709a0a47da0f42","type":"text","conversion_output":true,"text":"within 7 days prior to the index procedure).","text_display":" within 7 days prior to the index procedure).","confidence":1,"confidence_rate":1},{"cnt":[[376,1656],[1914,1656],[1914,1704],[376,1704]],"region":{"top_left_x":375,"top_left_y":1656,"width":1540,"height":48},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bfbb0815d6834b0fba7a0c1824f50b90","type":"text","conversion_output":true,"text":"14) Subject has leukopenia (i.e. \\(<3,000\\) white blood cells/mm3), thrombocytopenia (i.e. \\(<100,000\\)","text_display":"\n14) Subject has leukopenia (i.e. \\(<3,000\\) white blood cells/mm3), thrombocytopenia (i.e. \\(<100,000\\)","confidence":0.3376017476241557,"confidence_rate":0.9894105035995634},{"cnt":[[438,1704],[1457,1704],[1457,1749],[438,1749]],"region":{"top_left_x":438,"top_left_y":1703,"width":1019,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"969f28109285403a8e4631626136709e","type":"text","conversion_output":true,"text":"platelets \\(/ mm 3\\) ) or thrombocytosis (i.e. \\(>700,000\\) platelet \\(/ mm 3\\) ).","text_display":" platelets \\(/ mm 3\\) ) or thrombocytosis (i.e. \\(>700,000\\) platelet \\(/ mm 3\\) ).","confidence":0.816983699798584,"confidence_rate":0.9976523398931568},{"cnt":[[374,1753],[1830,1753],[1830,1798],[374,1798]],"region":{"top_left_x":373,"top_left_y":1753,"width":1458,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04c071d4e34d418c9642e98e91363195","type":"text","conversion_output":true,"text":"15) Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are","text_display":"\n15) Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are","confidence":0.978515625,"confidence_rate":0.9997761227554405},{"cnt":[[438,1800],[1929,1800],[1929,1846],[438,1846]],"region":{"top_left_x":438,"top_left_y":1800,"width":1492,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"766bf8e75ae64a03a21b9937f541ba28","type":"text","conversion_output":true,"text":"permitted), or has known life-limiting immunosuppressive or autoimmune disease (e.g., human","text_display":" permitted), or has known life-limiting immunosuppressive or autoimmune disease (e.g., human","confidence":1,"confidence_rate":1},{"cnt":[[438,1848],[1811,1848],[1811,1893],[438,1893]],"region":{"top_left_x":438,"top_left_y":1847,"width":1374,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f710aa8b22424ef2b1c8682ca34703ba","type":"text","conversion_output":true,"text":"immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted).","text_display":" immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted).","confidence":1,"confidence_rate":1},{"cnt":[[378,1897],[2013,1897],[2013,1944],[378,1944]],"region":{"top_left_x":378,"top_left_y":1897,"width":1636,"height":48},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0b8207c2c944693aa90eb4a9f8f4d41","type":"text","conversion_output":true,"text":"16) Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any","text_display":"\n16) Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any","confidence":0.95263671875,"confidence_rate":0.9995589914043789},{"cnt":[[438,1946],[651,1946],[651,1987],[438,1987]],"region":{"top_left_x":438,"top_left_y":1946,"width":213,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"71cb8f8b8aa44a3dae54b3b97a8f13f3","type":"text","conversion_output":true,"text":"other agent).","text_display":" other agent).","confidence":1,"confidence_rate":1},{"cnt":[[378,1994],[1051,1994],[1051,2039],[378,2039]],"region":{"top_left_x":378,"top_left_y":1993,"width":673,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87e7c0ec43ff4f6d9ef7480c21ce611b","type":"text","conversion_output":true,"text":"17) Subject has life expectancy of \\(<1\\) year.","text_display":"\n17) Subject has life expectancy of \\(<1\\) year.","confidence":0.96484375,"confidence_rate":0.9992984989542134},{"cnt":[[378,2045],[1949,2045],[1949,2088],[378,2088]],"region":{"top_left_x":378,"top_left_y":2045,"width":1571,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e986a014896d4c379c877a8a7346438d","type":"text","conversion_output":true,"text":"18) Subject is participating in another investigational (medical device or drug) clinical study. Subjects","text_display":"\n18) Subject is participating in another investigational (medical device or drug) clinical study. Subjects","confidence":0.9917030334472656,"confidence_rate":0.9999242612505136},{"cnt":[[438,2090],[1987,2090],[1987,2136],[438,2136]],"region":{"top_left_x":438,"top_left_y":2090,"width":1550,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"063b7f0d3f0043d8beefcce3c4da1e51","type":"text","conversion_output":true,"text":"may be concurrently enrolled in a post-market study, as long as the post-market study device, drug","text_display":" may be concurrently enrolled in a post-market study, as long as the post-market study device, drug","confidence":1,"confidence_rate":1},{"cnt":[[438,2138],[1848,2138],[1848,2185],[438,2185]],"region":{"top_left_x":438,"top_left_y":2137,"width":1410,"height":48},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a4b0abc67794cf2a9d9181f8c6db0ef","type":"text","conversion_output":true,"text":"or protocol does not interfere with the investigational treatment or protocol of this study.","text_display":" or protocol does not interfere with the investigational treatment or protocol of this study.","confidence":1,"confidence_rate":1},{"cnt":[[378,2187],[1949,2187],[1949,2232],[378,2232]],"region":{"top_left_x":378,"top_left_y":2187,"width":1571,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02a6225ed0844e32b5679ca3b7955bf9","type":"text","conversion_output":true,"text":"19) In the investigator's opinion, subject will not be able to comply with the follow-up requirements.","text_display":"\n19) In the investigator's opinion, subject will not be able to comply with the follow-up requirements.","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[245,2282],[758,2282],[758,2331],[245,2331]],"region":{"top_left_x":244,"top_left_y":2281,"width":515,"height":51},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75a1f38092ed46b0be1d13a3e81ee307","type":"section_header","conversion_output":false,"children_ids":["3ccce0130815488a86df60a4802182dc"],"text":"","text_display":""},{"cnt":[[249,2286],[754,2286],[754,2327],[249,2327]],"region":{"top_left_x":249,"top_left_y":2285,"width":506,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ccce0130815488a86df60a4802182dc","type":"text","conversion_output":true,"parent_id":"75a1f38092ed46b0be1d13a3e81ee307","text":"Angiographic Exclusion Criteria","text_display":"\n\n\\section*{Angiographic Exclusion Criteria}","confidence":1,"confidence_rate":1},{"cnt":[[284,2333],[1861,2333],[1861,2374],[284,2374]],"region":{"top_left_x":283,"top_left_y":2333,"width":1578,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90f037a2cec4412d80472ae1190f8218","type":"text","conversion_output":true,"text":"Subjects will be excluded from the trial if any of the target lesions/vessels meets any of the following","text_display":"\n\nSubjects will be excluded from the trial if any of the target lesions/vessels meets any of the following","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[284,2380],[621,2380],[621,2421],[284,2421]],"region":{"top_left_x":283,"top_left_y":2380,"width":338,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f71ef77d573e41e99f57a5ccbc7128d9","type":"text","conversion_output":true,"text":"angiographic criteria:","text_display":" angiographic criteria:","confidence":1,"confidence_rate":1},{"cnt":[[378,2445],[1532,2445],[1532,2490],[378,2490]],"region":{"top_left_x":378,"top_left_y":2444,"width":1154,"height":47},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a2197905a6a457fba39969ce1447ae4","type":"text","conversion_output":true,"text":"1) Target lesion is located within a saphenous vein graft or arterial graft.","text_display":"\n1) Target lesion is located within a saphenous vein graft or arterial graft.","confidence":1,"confidence_rate":1},{"cnt":[[125,2501],[604,2501],[604,2537],[125,2537]],"region":{"top_left_x":124,"top_left_y":2500,"width":480,"height":38},"line":50,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"02a8d52ee5a640189bf4d29bebdee433","type":"page_info","conversion_output":false,"text":"BIOFLOW-V Statistical Analysis Plan (SAP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[881,2505],[1126,2505],[1126,2533],[881,2533]],"region":{"top_left_x":880,"top_left_y":2505,"width":246,"height":29},"line":51,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4efe0b04c3f0430391457daa258e339e","type":"page_info","conversion_output":false,"text":"Baim CONFIDENTIAL","text_display":"","confidence":0.9765625,"confidence_rate":0.9989225569219083},{"cnt":[[1792,2501],[1936,2501],[1936,2533],[1792,2533]],"region":{"top_left_x":1791,"top_left_y":2500,"width":145,"height":34},"line":52,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"92512a994c8a45fcaa71768cad3f0e3f","type":"page_info","conversion_output":false,"text":"Page 8 of 21","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[127,2537],[505,2537],[505,2572],[127,2572]],"region":{"top_left_x":126,"top_left_y":2537,"width":379,"height":35},"line":53,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"863967f412a249ee93749f4897736222","type":"page_info","conversion_output":false,"text":"14 September, 2017, Version 6.2","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"a2b4734a-0b6e-4d9e-a8b1-cd65b10f3aeb-12","page":12,"lines":[{"cnt":[[125,125],[260,125],[260,153],[125,153]],"region":{"top_left_x":124,"top_left_y":124,"width":136,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6d5692cce83f4ee8837c81674d537d1e","type":"page_info","conversion_output":false,"text":"BIOTRONIK","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1852,125],[1992,125],[1992,148],[1852,148]],"region":{"top_left_x":1851,"top_left_y":124,"width":141,"height":25},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fde52ea5d6124aa58f22e0665c9e24a5","type":"page_info","conversion_output":false,"text":"BIOFLOW-V","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1594,155],[2013,155],[2013,183],[1594,183]],"region":{"top_left_x":1594,"top_left_y":154,"width":420,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"3fa1d095cc3d484797ef40908ae4426d","type":"page_info","conversion_output":false,"text":"Protocol \\# CIP FINAL v4.0 11Feb2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[374,288],[1934,288],[1934,333],[374,333]],"region":{"top_left_x":373,"top_left_y":287,"width":1561,"height":47},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33ee5d0ffd4e4e86bab18ccd55606507","type":"text","conversion_output":true,"text":"2) Target lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting","text_display":"\n2) Target lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting","confidence":1,"confidence_rate":1},{"cnt":[[438,335],[853,335],[853,380],[438,380]],"region":{"top_left_x":438,"top_left_y":335,"width":415,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65325c3f408b4035a97b5e4ed3ba3262","type":"text","conversion_output":true,"text":"stent (in-stent restenosis).","text_display":" stent (in-stent restenosis).","confidence":1,"confidence_rate":1},{"cnt":[[374,387],[1274,387],[1274,432],[374,432]],"region":{"top_left_x":373,"top_left_y":386,"width":902,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81cd2f894e9442ecb29feb6265cf4b89","type":"text","conversion_output":true,"text":"3) Target lesion has any of the following characteristics:","text_display":"\n3) Target lesion has any of the following characteristics:","confidence":1,"confidence_rate":1},{"cnt":[[503,434],[1996,434],[1996,479],[503,479]],"region":{"top_left_x":502,"top_left_y":433,"width":1494,"height":47},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"108da183209644078bd61a98967ebccb","type":"text","conversion_output":true,"text":"a. Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left","text_display":"\na. Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left","confidence":0.9980475902557373,"confidence_rate":0.9999822336289093},{"cnt":[[529,481],[1317,481],[1317,526],[529,526]],"region":{"top_left_x":528,"top_left_y":481,"width":789,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e69a6e39130e4f09ac3bb608df801df0","type":"text","conversion_output":true,"text":"anterior descending (LAD) or left circumflex (LCX).","text_display":" anterior descending (LAD) or left circumflex (LCX).","confidence":1,"confidence_rate":1},{"cnt":[[503,533],[1278,533],[1278,574],[503,574]],"region":{"top_left_x":502,"top_left_y":532,"width":777,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"803503605aa34ddb97fd3d5f68de15f9","type":"text","conversion_output":true,"text":"b. Involves a side branch of \\(>2.0 mm\\) in diameter.","text_display":"\nb. Involves a side branch of \\(>2.0 mm\\) in diameter.","confidence":0.9729041685350239,"confidence_rate":0.9995345203631593},{"cnt":[[438,580],[1815,580],[1815,625],[438,625]],"region":{"top_left_x":438,"top_left_y":580,"width":1378,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f075412f355b411babfa029ae6dc56aa","type":"text","conversion_output":true,"text":"- Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.","text_display":"\n- Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.","confidence":0.99462890625,"confidence_rate":0.9999439018867602},{"cnt":[[374,632],[1955,632],[1955,677],[374,677]],"region":{"top_left_x":373,"top_left_y":631,"width":1583,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c09aca6d28f94d04a829bad1cae09037","type":"text","conversion_output":true,"text":"4) Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent","text_display":"\n4) Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent","confidence":1,"confidence_rate":1},{"cnt":[[438,679],[1996,679],[1996,724],[438,724]],"region":{"top_left_x":438,"top_left_y":678,"width":1558,"height":47},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"593e35d6fda3497c979891ca7cbf9677","type":"text","conversion_output":true,"text":"complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.","text_display":" complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.","confidence":1,"confidence_rate":1},{"cnt":[[374,728],[1283,728],[1283,776],[374,776]],"region":{"top_left_x":373,"top_left_y":728,"width":910,"height":48},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d8cfffa840c446128978f04b97682e49","type":"text","conversion_output":true,"text":"5) Target vessel has angiographic evidence of thrombus.","text_display":"\n5) Target vessel has angiographic evidence of thrombus.","confidence":1,"confidence_rate":1},{"cnt":[[374,778],[1205,778],[1205,823],[374,823]],"region":{"top_left_x":373,"top_left_y":777,"width":833,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89475e5ff17e407eb5c758505f429159","type":"text","conversion_output":true,"text":"6) Target lesion is totally occluded ( \\(100 \\%\\) stenosis).","text_display":"\n6) Target lesion is totally occluded ( \\(100 \\%\\) stenosis).","confidence":0.7486577033996582,"confidence_rate":0.9953419566085997},{"cnt":[[374,829],[1764,826],[1764,872],[374,875]],"region":{"top_left_x":373,"top_left_y":826,"width":1391,"height":49},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f075947484e5472db887181cbf65464c","type":"text","conversion_output":true,"text":"7) Target vessel was treated with brachytherapy any time prior to the index procedure.","text_display":"\n7) Target vessel was treated with brachytherapy any time prior to the index procedure.","confidence":1,"confidence_rate":1},{"cnt":[[120,967],[513,967],[513,1016],[120,1016]],"region":{"top_left_x":120,"top_left_y":966,"width":394,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7b36c7ce4814cc9af466c462d9aa397","type":"section_header","conversion_output":false,"children_ids":["88da3d4e753d4187a4b700677e259cbe"],"text":"","text_display":""},{"cnt":[[125,971],[509,971],[509,1012],[125,1012]],"region":{"top_left_x":124,"top_left_y":971,"width":386,"height":41},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88da3d4e753d4187a4b700677e259cbe","type":"text","conversion_output":true,"parent_id":"c7b36c7ce4814cc9af466c462d9aa397","text":"2.3 Bayesian Analysis","text_display":"\n\n\\subsection*{2.3 Bayesian Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[122,1025],[1910,1025],[1910,1068],[122,1068]],"region":{"top_left_x":122,"top_left_y":1024,"width":1788,"height":44},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61e06f0ca10b43fd8014c398292d0de0","type":"text","conversion_output":true,"text":"To assess the non-inferiority of the Orsiro stent compared to the Xience stent in the BIOFLOW-V study, a Bayesian","text_display":"\n\nTo assess the non-inferiority of the Orsiro stent compared to the Xience stent in the BIOFLOW-V study, a Bayesian","confidence":0.9917170886183158,"confidence_rate":0.9999295159985412},{"cnt":[[125,1070],[1936,1070],[1936,1115],[125,1115]],"region":{"top_left_x":124,"top_left_y":1069,"width":1812,"height":47},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1d5a382b3de4f5eb3604f9e742f8455","type":"text","conversion_output":true,"text":"approach using hierarchical models to formally incorporate data from the BIOFLOW-II and BIOFLOW-IV trials will be","text_display":" approach using hierarchical models to formally incorporate data from the BIOFLOW-II and BIOFLOW-IV trials will be","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[125,1117],[1955,1117],[1955,1162],[125,1162]],"region":{"top_left_x":124,"top_left_y":1117,"width":1832,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51074dcb95174d238d00190e4c3857cc","type":"text","conversion_output":true,"text":"employed. The approach proposes using Binomial analysis for the presence of a TLF event and a Bayesian model that","text_display":" employed. The approach proposes using Binomial analysis for the presence of a TLF event and a Bayesian model that","confidence":1,"confidence_rate":1},{"cnt":[[125,1164],[1962,1164],[1962,1205],[125,1205]],"region":{"top_left_x":124,"top_left_y":1164,"width":1838,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a54962a9113d4985a6597eee0407b354","type":"text","conversion_output":true,"text":"allows for a bias between the TLF event rates of the BIOFLOW-II and BIOFLOW-IV trials and the TLF event rates of the","text_display":" allows for a bias between the TLF event rates of the BIOFLOW-II and BIOFLOW-IV trials and the TLF event rates of the","confidence":1,"confidence_rate":1},{"cnt":[[125,1210],[1880,1210],[1880,1257],[125,1257]],"region":{"top_left_x":124,"top_left_y":1209,"width":1756,"height":48},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d49bab0af4694a2abc188328c8c6e0ed","type":"text","conversion_output":true,"text":"BIOFLOW-V trial in both the Orsiro and Xience groups. The parameters defining the bias are selected so that the","text_display":" BIOFLOW-V trial in both the Orsiro and Xience groups. The parameters defining the bias are selected so that the","confidence":0.99658203125,"confidence_rate":0.9999704847170539},{"cnt":[[125,1259],[1287,1259],[1287,1304],[125,1304]],"region":{"top_left_x":124,"top_left_y":1258,"width":1163,"height":47},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf417a18d0274b05918a66bc92bbe635","type":"text","conversion_output":true,"text":"proposed method is robust to misspecifications of the initial assumptions.","text_display":" proposed method is robust to misspecifications of the initial assumptions.","confidence":0.9951210021972656,"confidence_rate":0.9999380912965625},{"cnt":[[125,1349],[1996,1349],[1996,1396],[125,1396]],"region":{"top_left_x":124,"top_left_y":1349,"width":1872,"height":48},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2d11cc6b6d74268ab37737bf03e0e30","type":"text","conversion_output":true,"text":"Whenever not specified, priors in Bayesian analyses will be non-informative or weakly informative priors. The following","text_display":"\n\nWhenever not specified, priors in Bayesian analyses will be non-informative or weakly informative priors. The following","confidence":1,"confidence_rate":1},{"cnt":[[125,1396],[1992,1396],[1992,1442],[125,1442]],"region":{"top_left_x":124,"top_left_y":1396,"width":1868,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9eadc51f58de45bd8809fe2bb1b473b5","type":"text","conversion_output":true,"text":"priors will be employed unless otherwise specified: normal priors with mean 0 and large variance for slope parameters,","text_display":" priors will be employed unless otherwise specified: normal priors with mean 0 and large variance for slope parameters,","confidence":0.99267578125,"confidence_rate":0.9999416590627633},{"cnt":[[125,1444],[1644,1444],[1644,1489],[125,1489]],"region":{"top_left_x":124,"top_left_y":1443,"width":1520,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8936b104113f4a4198e63ec0a5b908de","type":"text","conversion_output":true,"text":"inverse gamma priors with parameter 0.001 and 0.001 and Beta \\((1,1)\\) for probability parameters.","text_display":" inverse gamma priors with parameter 0.001 and 0.001 and Beta \\((1,1)\\) for probability parameters.","confidence":0.73095703125,"confidence_rate":0.9971023488950409},{"cnt":[[120,1530],[535,1530],[535,1575],[120,1575]],"region":{"top_left_x":120,"top_left_y":1529,"width":415,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9c28aa10cdf4b10b794dee5b2edf89f","type":"section_header","conversion_output":false,"children_ids":["b70dfc308aa2475982dcabb43fe159c2"],"text":"","text_display":""},{"cnt":[[125,1534],[531,1534],[531,1573],[125,1573]],"region":{"top_left_x":124,"top_left_y":1533,"width":407,"height":40},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b70dfc308aa2475982dcabb43fe159c2","type":"text","conversion_output":true,"parent_id":"b9c28aa10cdf4b10b794dee5b2edf89f","text":"2.4 Criteria for Success","text_display":"\n\n\\subsection*{2.4 Criteria for Success}","confidence":0.9990236759185791,"confidence_rate":0.9999663177742859},{"cnt":[[125,1590],[2020,1590],[2020,1635],[125,1635]],"region":{"top_left_x":124,"top_left_y":1589,"width":1896,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97817f6957ea4b55a9ce5db5981071c2","type":"text","conversion_output":true,"text":"The criterion for success is based on the posterior probability of the alternative hypothesis (i.e., of non-inferiority being","text_display":"\n\nThe criterion for success is based on the posterior probability of the alternative hypothesis (i.e., of non-inferiority being","confidence":1,"confidence_rate":1},{"cnt":[[125,1637],[2020,1637],[2020,1682],[125,1682]],"region":{"top_left_x":124,"top_left_y":1637,"width":1896,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1bf4636fff049a1afa026fc448da053","type":"text","conversion_output":true,"text":"met). The Orsiro group will be declared non-inferior to the Xience group if the posterior probability of the alternative","text_display":" met). The Orsiro group will be declared non-inferior to the Xience group if the posterior probability of the alternative","confidence":1,"confidence_rate":1},{"cnt":[[125,1684],[593,1684],[593,1729],[125,1729]],"region":{"top_left_x":124,"top_left_y":1684,"width":469,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb99b5dc67da453eadb65dc8c38b38b7","type":"text","conversion_output":true,"text":"hypothesis \\(H_{A}\\) is large, that is","text_display":" hypothesis \\(H_{A}\\) is large, that is","confidence":1,"confidence_rate":1},{"cnt":[[700,1723],[1446,1723],[1446,1785],[700,1785]],"region":{"top_left_x":700,"top_left_y":1723,"width":746,"height":63},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15b586ce950f4e23ab8fc77707e3cac6","type":"math","conversion_output":true,"text":"\\[\nP\\left(H_{A} \\mid \\text { Data }\\right)=P\\left(\\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta \\mid \\text { Data }\\right)>\\pi^{*}\n\\]","text_display":"\n\\[\nP\\left(H_{A} \\mid \\text { Data }\\right)=P\\left(\\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta \\mid \\text { Data }\\right)>\\pi^{*}\n\\]","confidence":0.9990234375,"confidence_rate":0.9999860423881537},{"cnt":[[125,1826],[2020,1826],[2020,1876],[125,1876]],"region":{"top_left_x":124,"top_left_y":1826,"width":1896,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ead5f7e9c3e4a25af0e158dc20e8e30","type":"text","conversion_output":true,"text":"where \\(\\pi_{X}^{V}\\) and \\(\\pi_{O}^{V}\\) are the 1-year TLF for the Xience and Orsiro groups of the BIOFLOW-V study, respectively, \\(\\delta\\) is the","text_display":"\nwhere \\(\\pi_{X}^{V}\\) and \\(\\pi_{O}^{V}\\) are the 1-year TLF for the Xience and Orsiro groups of the BIOFLOW-V study, respectively, \\(\\delta\\) is the","confidence":0.8052706718444824,"confidence_rate":0.9984971247569588},{"cnt":[[127,1873],[2020,1873],[2020,1927],[127,1927]],"region":{"top_left_x":126,"top_left_y":1873,"width":1894,"height":55},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7637bb4f248843319f19a51d33187dad","type":"text","conversion_output":true,"text":"non-inferiority margin and \\(H_{A}: \\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\\) is the alternative hypothesis indicating that non-inferiority is met and","text_display":" non-inferiority margin and \\(H_{A}: \\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\\) is the alternative hypothesis indicating that non-inferiority is met and","confidence":0.99951171875,"confidence_rate":0.9999965605657873},{"cnt":[[125,1925],[1528,1925],[1528,1970],[125,1970]],"region":{"top_left_x":124,"top_left_y":1925,"width":1404,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ac1ed6d502c42c0bf68b4a3772b408d","type":"text","conversion_output":true,"text":"\\(\\pi^{*}=0.975\\) is the level of evidence we require to declare the alternative hypothesis true.","text_display":" \\(\\pi^{*}=0.975\\) is the level of evidence we require to declare the alternative hypothesis true.","confidence":1,"confidence_rate":1},{"cnt":[[122,2058],[666,2058],[666,2108],[122,2108]],"region":{"top_left_x":122,"top_left_y":2058,"width":545,"height":50},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3d319192fa34f0f987fa46e32e01981","type":"section_header","conversion_output":false,"children_ids":["bdd07c975db34687b2ceda2bbb0100f9"],"text":"","text_display":""},{"cnt":[[125,2062],[662,2062],[662,2103],[125,2103]],"region":{"top_left_x":124,"top_left_y":2062,"width":538,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdd07c975db34687b2ceda2bbb0100f9","type":"text","conversion_output":true,"parent_id":"e3d319192fa34f0f987fa46e32e01981","text":"2.5 Sample Size Determination","text_display":"\n\n\\subsection*{2.5 Sample Size Determination}","confidence":0.9990234375,"confidence_rate":0.9999712639526579},{"cnt":[[125,2116],[2022,2116],[2022,2161],[125,2161]],"region":{"top_left_x":124,"top_left_y":2116,"width":1898,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f29512153cc54dad8b38a810c6ac2e20","type":"text","conversion_output":true,"text":"The BIOFLOW-V trial will assess non-inferiority of the 12 -month TLF rate for the Orsiro stent vs. TLF rate in subjects","text_display":"\n\nThe BIOFLOW-V trial will assess non-inferiority of the 12 -month TLF rate for the Orsiro stent vs. TLF rate in subjects","confidence":0.998535871389322,"confidence_rate":0.9999884630469108},{"cnt":[[127,2161],[2022,2161],[2022,2209],[127,2209]],"region":{"top_left_x":126,"top_left_y":2161,"width":1896,"height":48},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e80f8ef65df45c1839e158eb5221ba9","type":"text","conversion_output":true,"text":"treated with the Xience stent. The null hypothesis \\(H_{0}\\) is that the Orsiro stent will have a primary endpoint (TLF) rate","text_display":" treated with the Xience stent. The null hypothesis \\(H_{0}\\) is that the Orsiro stent will have a primary endpoint (TLF) rate","confidence":0.9985356330871582,"confidence_rate":0.9999889817137398},{"cnt":[[127,2209],[2022,2209],[2022,2256],[127,2256]],"region":{"top_left_x":126,"top_left_y":2208,"width":1896,"height":48},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"898e0ed16f4447eb9e477cc3d6bbec02","type":"text","conversion_output":true,"text":"equal to or exceeding that of the Xience group by the non-inferiority margin or more. The alternative hypothesis \\(H_{A}\\) is","text_display":" equal to or exceeding that of the Xience group by the non-inferiority margin or more. The alternative hypothesis \\(H_{A}\\) is","confidence":1,"confidence_rate":1},{"cnt":[[127,2256],[1914,2256],[1914,2301],[127,2301]],"region":{"top_left_x":126,"top_left_y":2255,"width":1789,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad7dea37fb694d67a24683d2ae28628c","type":"text","conversion_output":true,"text":"that the Orsiro stent will have TLF rate less than the Xience group rate plus the non-inferiority margin. Specifically:","text_display":" that the Orsiro stent will have TLF rate less than the Xience group rate plus the non-inferiority margin. Specifically:","confidence":1,"confidence_rate":1},{"cnt":[[904,2342],[1248,2342],[1248,2460],[904,2460]],"region":{"top_left_x":904,"top_left_y":2341,"width":345,"height":119},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e7c0ebd00bf44e4bbb9be1bd2983b4f","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& H_{0}: \\pi_{X}^{V}-\\pi_{O}^{V} \\leq-\\delta \\\\\n& H_{A}: \\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& H_{0}: \\pi_{X}^{V}-\\pi_{O}^{V} \\leq-\\delta \\\\\n& H_{A}: \\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\n\\end{aligned}\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[129,2505],[608,2505],[608,2542],[129,2542]],"region":{"top_left_x":128,"top_left_y":2505,"width":481,"height":37},"line":46,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4fd406b04114483b80ad8000e91d91fe","type":"page_info","conversion_output":false,"text":"BIOFLOW-V Statistical Analysis Plan (SAP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[883,2505],[1132,2505],[1132,2537],[883,2537]],"region":{"top_left_x":883,"top_left_y":2505,"width":250,"height":33},"line":47,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"73549299467f436f96fec45a8f1f3837","type":"page_info","conversion_output":false,"text":"Baim CONFIDENTIAL","text_display":"","confidence":0.99560546875,"confidence_rate":0.9997998284195073},{"cnt":[[1796,2505],[1944,2505],[1944,2539],[1796,2539]],"region":{"top_left_x":1796,"top_left_y":2505,"width":149,"height":35},"line":48,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b62102e1e0a8448c87fafb7d661b2d86","type":"page_info","conversion_output":false,"text":"Page 9 of 21","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[129,2539],[509,2539],[509,2576],[129,2576]],"region":{"top_left_x":128,"top_left_y":2539,"width":382,"height":37},"line":49,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"3b370e825a47442f9514538f559f7f10","type":"page_info","conversion_output":false,"text":"14 September, 2017, Version 6.2","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"a2b4734a-0b6e-4d9e-a8b1-cd65b10f3aeb-13","page":13,"lines":[{"cnt":[[125,116],[260,116],[260,148],[125,148]],"region":{"top_left_x":124,"top_left_y":116,"width":136,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"98be5f8abbe549b6a0b3713d85ad2a64","type":"page_info","conversion_output":false,"text":"BIOTRONIK","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1852,116],[1996,116],[1996,148],[1852,148]],"region":{"top_left_x":1851,"top_left_y":116,"width":145,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b82bb3664dcf4fbea7411d720c0fbe1d","type":"page_info","conversion_output":false,"text":"BIOFLOW-V","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1592,148],[2017,148],[2017,183],[1592,183]],"region":{"top_left_x":1591,"top_left_y":148,"width":427,"height":35},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2b5f12621c4646ebbb863ce38bf2afe3","type":"page_info","conversion_output":false,"text":"Protocol \\# CIP FINAL v4.0 11Feb2016","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[120,277],[2020,277],[2020,333],[120,333]],"region":{"top_left_x":120,"top_left_y":277,"width":1900,"height":57},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c811db77865d44c1b0a994c0aa1319f1","type":"text","conversion_output":true,"text":"Where \\(\\pi_{O}^{V}\\) is the true 12 -month TLF rate for the Orsiro stent, \\(\\pi_{X}^{V}\\) is the true 12 -month TLF rate for the Xience arm, and \\(\\delta\\)","text_display":"\n\nWhere \\(\\pi_{O}^{V}\\) is the true 12 -month TLF rate for the Orsiro stent, \\(\\pi_{X}^{V}\\) is the true 12 -month TLF rate for the Xience arm, and \\(\\delta\\)","confidence":0.9990234375,"confidence_rate":0.9999936141403385},{"cnt":[[120,331],[580,331],[580,376],[120,376]],"region":{"top_left_x":120,"top_left_y":330,"width":461,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d851e8b253e64fe380a2895902bf613e","type":"text","conversion_output":true,"text":"is the non-inferiority margin.","text_display":" is the non-inferiority margin.","confidence":1,"confidence_rate":1},{"cnt":[[120,423],[718,423],[718,471],[120,471]],"region":{"top_left_x":120,"top_left_y":423,"width":598,"height":48},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78790718849448dbbb993a9ffe0f5489","type":"text","conversion_output":true,"text":"The assumptions for this analysis are:","text_display":"\n\nThe assumptions for this analysis 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and BIOFLOW-II data by \\(30 \\%\\).","text_display":"\n- Discount the results of the BIOFLOW-IV data by \\(20 \\%\\) and BIOFLOW-II data by \\(30 \\%\\).","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[185,726],[2022,726],[2022,776],[185,776]],"region":{"top_left_x":184,"top_left_y":726,"width":1838,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d9bad375bc64346baceeb2763341f74","type":"text","conversion_output":true,"text":"- Standard deviation of the bias terms between the odds of BIOFLOW-II TLF 12-month rates and odds of","text_display":"\n- Standard deviation of the bias terms between the odds of BIOFLOW-II TLF 12-month rates and odds 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posterior probability of the alternative hypothesis as","confidence":1,"confidence_rate":1},{"cnt":[[249,984],[814,984],[814,1033],[249,1033]],"region":{"top_left_x":249,"top_left_y":983,"width":566,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e0e48c499c14082ae34855365562c2e","type":"text","conversion_output":true,"text":"specified above, where \\(\\pi^{*}=0.975\\)","text_display":" specified above, where \\(\\pi^{*}=0.975\\)","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[125,1053],[2017,1053],[2017,1102],[125,1102]],"region":{"top_left_x":124,"top_left_y":1052,"width":1894,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5848eb723e8498bb37f80cdf64657e3","type":"text","conversion_output":true,"text":"Rejection of the null hypothesis signifies that the Orsiro stent is not inferior to the Xience stent with regards to 12 -","text_display":"\n\nRejection of the null hypothesis signifies that the Orsiro stent is not inferior to the Xience stent with regards to 12 ","confidence":0.6501767635345459,"confidence_rate":0.9966682679333889},{"cnt":[[125,1100],[2017,1100],[2017,1147],[125,1147]],"region":{"top_left_x":124,"top_left_y":1100,"width":1894,"height":48},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"108f5f0113fd44b6b9e5dc9a0ce6328c","type":"text","conversion_output":true,"text":"month TLF. A total of 1,200 subjects ( 800 in the Orsiro group and 400 in the Xience group) will have \\(89.6 \\%\\) power to","text_display":"month TLF. A total of 1,200 subjects ( 800 in the Orsiro group and 400 in the Xience group) will have \\(89.6 \\%\\) power to","confidence":0.9936652074143802,"confidence_rate":0.999952219618764},{"cnt":[[125,1145],[2017,1145],[2017,1192],[125,1192]],"region":{"top_left_x":124,"top_left_y":1145,"width":1894,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"baa08b096dcf4d3bbfe7cea80305f6fb","type":"text","conversion_output":true,"text":"reject the above null hypothesis in favor of the alternative under the stated assumptions. To account for loss to follow-","text_display":" reject the above null hypothesis in favor of the alternative under the stated assumptions. To account for loss to follow","confidence":1,"confidence_rate":1},{"cnt":[[125,1192],[2017,1192],[2017,1240],[125,1240]],"region":{"top_left_x":124,"top_left_y":1192,"width":1894,"height":48},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d3a220a21c4432ab5d797371df0fc2b","type":"text","conversion_output":true,"text":"up (expected to be approximately \\(10 \\%\\) ), a total of 1,334 subjects will need to be randomized. The one-sided type I error","text_display":"up (expected to be approximately \\(10 \\%\\) ), a total of 1,334 subjects will need to be randomized. The one-sided type I error","confidence":0.98828125,"confidence_rate":0.9999100196534205},{"cnt":[[125,1240],[2017,1240],[2017,1287],[125,1287]],"region":{"top_left_x":124,"top_left_y":1239,"width":1894,"height":48},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dcb0b45a330140f2a45cba0335e69427","type":"text","conversion_output":true,"text":"estimates are \\(4.0 \\%, 3.3 \\%\\), and \\(4.2 \\%\\) if the actual odds for the 12 -month TLF rate of event in the Xience group of the","text_display":" estimates are \\(4.0 \\%, 3.3 \\%\\), and \\(4.2 \\%\\) if the actual odds for the 12 -month TLF rate of event in the Xience group of 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Randomized clinical trials comparing treatment with DES and treatment with BMS with 9 months or","text_display":" DES and BMS. Randomized clinical trials comparing treatment with DES and treatment with BMS with 9 months or","confidence":1,"confidence_rate":1},{"cnt":[[125,1857],[2022,1855],[2022,1904],[125,1906]],"region":{"top_left_x":124,"top_left_y":1854,"width":1898,"height":52},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af5ffa92072b491bae67a10c30b8763f","type":"text","conversion_output":true,"text":"longer clinical follow-up data were included in the meta-analysis. Nine-month rates were used whenever 12-month rates","text_display":" longer clinical follow-up data were included in the meta-analysis. 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follow-up or experienced the primary endpoint) and no major","text_display":" have sufficient follow-up data (at least 330 days of follow-up or experienced the primary endpoint) and no major","confidence":0.99951171875,"confidence_rate":0.9999959300041316},{"cnt":[[116,808],[1871,808],[1871,855],[116,855]],"region":{"top_left_x":116,"top_left_y":807,"width":1756,"height":49},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d02531114854c16978cea93ca56bfb9","type":"text","conversion_output":true,"text":"protocol eligibility violations (i.e. inclusion/exclusion criteria violations that could impact the primary endpoint).","text_display":" protocol eligibility violations (i.e. inclusion/exclusion criteria violations that could impact the primary 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the","text_display":" inclusion/exclusion criteria and who have sufficient follow-up data (at least 330 days of follow-up or experience the","confidence":1,"confidence_rate":1},{"cnt":[[120,1332],[1244,1332],[1244,1379],[120,1379]],"region":{"top_left_x":120,"top_left_y":1332,"width":1124,"height":48},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e33f1966deb4c3ead109724c4191b35","type":"text","conversion_output":true,"text":"primary endpoint) will be included in the BIOFLOW V Bayesian analysis.","text_display":" primary endpoint) will be included in the BIOFLOW V Bayesian analysis.","confidence":0.9990236759185791,"confidence_rate":0.9999869760715292},{"cnt":[[120,1422],[2013,1422],[2013,1472],[120,1472]],"region":{"top_left_x":120,"top_left_y":1422,"width":1894,"height":50},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6561be040064c6ba6a202cf251a0a0f","type":"text","conversion_output":true,"text":"The subjects in BIOFLOW-II and BIOFLOW-IV who meet the inclusion/exclusion criteria of BIOFLOW-V will be determined","text_display":"\n\nThe subjects in BIOFLOW-II and BIOFLOW-IV who meet the inclusion/exclusion criteria of BIOFLOW-V will be determined","confidence":1,"confidence_rate":1},{"cnt":[[120,1470],[2004,1470],[2004,1519],[120,1519]],"region":{"top_left_x":120,"top_left_y":1469,"width":1885,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ace292895f03446da4ccdb426414e4d1","type":"text","conversion_output":true,"text":"before the BIOFLOW V database is locked and will be done by an independent statistician without the knowledge of any","text_display":" before the BIOFLOW V database is locked and will be done by an independent statistician without the knowledge of any","confidence":0.9868226051330566,"confidence_rate":0.9998903780165561},{"cnt":[[120,1519],[462,1519],[462,1566],[120,1566]],"region":{"top_left_x":120,"top_left_y":1518,"width":342,"height":49},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c566df38335f40d9812277479de916b3","type":"text","conversion_output":true,"text":"of the outcome data.","text_display":" of the outcome data.","confidence":1,"confidence_rate":1},{"cnt":[[122,1611],[2004,1611],[2004,1659],[122,1659]],"region":{"top_left_x":122,"top_left_y":1611,"width":1883,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"deee3d6c2fbe4dae8db9191f2caed6fa","type":"text","conversion_output":true,"text":"A sensitivity analysis of the ITT primary endpoint analysis will be performed by including all BIOFLOW-II and BIOFLOW-IV","text_display":"\n\nA sensitivity analysis of the ITT primary endpoint analysis will be performed by including all BIOFLOW-II and BIOFLOW-IV","confidence":1,"confidence_rate":1},{"cnt":[[122,1656],[1901,1656],[1901,1706],[122,1706]],"region":{"top_left_x":122,"top_left_y":1656,"width":1780,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1fe6a9b19dd487587b506accbbcbcca","type":"text","conversion_output":true,"text":"randomized subjects who have sufficient follow-up data (at least 330 days of follow-up or experience the primary","text_display":" randomized subjects who have sufficient follow-up data (at least 330 days of follow-up or experience the primary","confidence":1,"confidence_rate":1},{"cnt":[[122,1704],[1528,1704],[1528,1751],[122,1751]],"region":{"top_left_x":122,"top_left_y":1703,"width":1406,"height":48},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73820609cdae45dda7fc1323cba4213c","type":"text","conversion_output":true,"text":"endpoint) whether or not the subjects satisfy the BIOFLOW-V inclusion/exclusion criteria.","text_display":" endpoint) whether or not the subjects satisfy the BIOFLOW-V inclusion/exclusion criteria.","confidence":1,"confidence_rate":1},{"cnt":[[116,1839],[694,1839],[694,1893],[116,1893]],"region":{"top_left_x":116,"top_left_y":1839,"width":578,"height":54},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd6214bfdd524d30abc84691736e32dc","type":"section_header","conversion_output":false,"children_ids":["c0aede734bef4792bf466641d83652a7"],"text":"","text_display":""},{"cnt":[[122,1843],[690,1843],[690,1888],[122,1888]],"region":{"top_left_x":122,"top_left_y":1843,"width":568,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0aede734bef4792bf466641d83652a7","type":"text","conversion_output":true,"parent_id":"bd6214bfdd524d30abc84691736e32dc","text":"2.7 Analysis of Primary Endpoint","text_display":"\n\n\\subsection*{2.7 Analysis of Primary Endpoint}","confidence":1,"confidence_rate":1},{"cnt":[[120,1895],[1983,1895],[1983,1944],[120,1944]],"region":{"top_left_x":120,"top_left_y":1894,"width":1864,"height":51},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"12d13c52182a421c96fa2392e302487a","type":"text","conversion_output":true,"text":"This study will assess non-inferiority of the 12 -month TLF rate for the Orsiro stent vs. the Xience stent. The analysis will","text_display":"\n\nThis study will assess non-inferiority of the 12 -month TLF rate for the Orsiro stent vs. the Xience stent. The analysis will","confidence":0.99951171875,"confidence_rate":0.9999963278225461},{"cnt":[[122,1944],[1992,1944],[1992,1992],[122,1992]],"region":{"top_left_x":122,"top_left_y":1944,"width":1870,"height":48},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1d851da73244b4f80092cf20b399877","type":"text","conversion_output":true,"text":"be carried out on the ITT set (primary), modified ITT and PP analysis sets. The null hypothesis \\(H_{0}\\) is that the Orsiro stent","text_display":" be carried out on the ITT set (primary), modified ITT and PP analysis sets. The null hypothesis \\(H_{0}\\) is that the Orsiro stent","confidence":1,"confidence_rate":1},{"cnt":[[122,1989],[1979,1989],[1979,2039],[122,2039]],"region":{"top_left_x":122,"top_left_y":1989,"width":1857,"height":50},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e185a41eddf74c45a2b538287251dac6","type":"text","conversion_output":true,"text":"will have a primary endpoint ( 12 -month TLF) rate equal to or exceeding that of the Xience group by the non-inferiority","text_display":" will have a primary endpoint ( 12 -month TLF) rate equal to or exceeding that of the Xience group by the non-inferiority","confidence":0.9863855105359107,"confidence_rate":0.9998929118556134},{"cnt":[[125,2037],[2013,2037],[2013,2086],[125,2086]],"region":{"top_left_x":124,"top_left_y":2036,"width":1890,"height":51},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6f403f681904cff8eb3ad8196e7a9a9","type":"text","conversion_output":true,"text":"margin or more. The alternative hypothesis \\(H_{A}\\) is that the Orsiro stent will have a 12 -month TLF rate less than the Xience","text_display":" margin or more. The alternative hypothesis \\(H_{A}\\) is that the Orsiro stent will have a 12 -month TLF rate less than the Xience","confidence":0.9960975646972656,"confidence_rate":0.9999720713209299},{"cnt":[[125,2084],[1377,2084],[1377,2133],[125,2133]],"region":{"top_left_x":124,"top_left_y":2083,"width":1254,"height":51},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cddab80697bf4a858ec597e99680963c","type":"text","conversion_output":true,"text":"group rate plus the non-inferiority margin. The hypothesis is defined as follows:","text_display":" group rate plus the non-inferiority margin. The hypothesis is defined as follows:","confidence":1,"confidence_rate":1},{"cnt":[[900,2168],[1248,2168],[1248,2288],[900,2288]],"region":{"top_left_x":900,"top_left_y":2167,"width":349,"height":122},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec8fd6fd80334f3bb94ee5ee2354e01d","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& H_{0}: \\pi_{X}^{V}-\\pi_{O}^{V} \\leq-\\delta \\\\\n& H_{A}: \\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& H_{0}: \\pi_{X}^{V}-\\pi_{O}^{V} \\leq-\\delta \\\\\n& H_{A}: \\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\n\\end{aligned}\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[125,2325],[2017,2325],[2017,2378],[125,2378]],"region":{"top_left_x":124,"top_left_y":2324,"width":1894,"height":55},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf24ddae67dc477b931641b2c531163d","type":"text","conversion_output":true,"text":"where \\(\\pi_{O}^{V}\\) is the true 12 -month TLF rate for the Orsiro stent, \\(\\pi_{X}^{V}\\) is the true 12 -month TLF rate for the Xience arm, and \\(\\delta\\)","text_display":"\nwhere \\(\\pi_{O}^{V}\\) is the true 12 -month TLF rate for the Orsiro stent, \\(\\pi_{X}^{V}\\) is the true 12 -month TLF rate for the Xience arm, and 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6.2","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"a2b4734a-0b6e-4d9e-a8b1-cd65b10f3aeb-15","page":15,"lines":[{"cnt":[[125,120],[260,120],[260,146],[125,146]],"region":{"top_left_x":124,"top_left_y":120,"width":136,"height":27},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c9b7da0eb8e14c20937c423405ed2fd5","type":"page_info","conversion_output":false,"text":"BIOTRONIK","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1848,116],[1989,116],[1989,144],[1848,144]],"region":{"top_left_x":1847,"top_left_y":116,"width":143,"height":28},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"962d56a34e07470aac27db3cc0f99a02","type":"page_info","conversion_output":false,"text":"BIOFLOW-V","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1590,150],[2013,150],[2013,183],[1590,183]],"region":{"top_left_x":1589,"top_left_y":150,"width":425,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fb814822506540fe94b56300f19fbe1d","type":"page_info","conversion_output":false,"text":"Protocol \\# CIP FINAL v4.0 11Feb2016","text_display":"","confidence":0.9951193332672119,"confidence_rate":0.9998776920781475},{"cnt":[[120,331],[1998,331],[1998,376],[120,376]],"region":{"top_left_x":120,"top_left_y":330,"width":1879,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e5afa6e7eda4b5c81c03ccc5ef16f99","type":"text","conversion_output":true,"text":"The proposed model is a Bayesian hierarchical model that assumes a bias between the 12 -month TLF rates in BIOFLOW-","text_display":"\n\nThe proposed model is a Bayesian hierarchical model that assumes a bias between the 12 -month TLF rates in BIOFLOW","confidence":0.9692530632019043,"confidence_rate":0.9997461335136781},{"cnt":[[122,378],[1154,378],[1154,419],[122,419]],"region":{"top_left_x":122,"top_left_y":378,"width":1032,"height":41},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"efe0ff4a0a234799bc9c280f2a090f7b","type":"text","conversion_output":true,"text":"II and BIOFLOW-V as well as BIOFLOW-IV and BIOFLOW-V studies.","text_display":"II and BIOFLOW-V as well as BIOFLOW-IV and BIOFLOW-V studies.","confidence":0.998046875,"confidence_rate":0.999970378698783},{"cnt":[[125,468],[2007,468],[2007,513],[125,513]],"region":{"top_left_x":124,"top_left_y":468,"width":1883,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc567f1ec57c45caa563aff10ac26c73","type":"text","conversion_output":true,"text":"Estimation of the parameters and hypotheses testing of the primary hypotheses is based on the posterior distribution of","text_display":"\n\nEstimation of the parameters and hypotheses testing of the primary hypotheses is based on the posterior distribution of","confidence":1,"confidence_rate":1},{"cnt":[[122,516],[1955,516],[1955,561],[122,561]],"region":{"top_left_x":122,"top_left_y":515,"width":1834,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b7e8a32f971e4df7bcf40f1e1ab924a0","type":"text","conversion_output":true,"text":"the parameters. The posterior distribution for parameters which do not have closed form posterior inferences will be","text_display":" the parameters. The posterior distribution for parameters which do not have closed form posterior inferences will be","confidence":0.9990234375,"confidence_rate":0.9999919253247671},{"cnt":[[125,563],[1921,563],[1921,608],[125,608]],"region":{"top_left_x":124,"top_left_y":562,"width":1797,"height":47},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d63ca00192754d09863a8647c06725b0","type":"text","conversion_output":true,"text":"carried out by sampling from the posterior distribution of the parameters. The freely available program OpenBUGS","text_display":" carried out by sampling from the posterior distribution of the parameters. The freely available program OpenBUGS","confidence":1,"confidence_rate":1},{"cnt":[[125,610],[1858,610],[1858,655],[125,655]],"region":{"top_left_x":124,"top_left_y":610,"width":1735,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e922a6f3f0bb41828085f3d583a0dfb4","type":"text","conversion_output":true,"text":"(Bayesian inference using Gibbs Sampling) will be used to obtain samples from the posterior distribution of the","text_display":" (Bayesian inference using Gibbs Sampling) will be used to obtain samples from the posterior distribution of the","confidence":1,"confidence_rate":1},{"cnt":[[125,655],[1979,655],[1979,700],[125,700]],"region":{"top_left_x":124,"top_left_y":655,"width":1855,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6144e97bccc4127a065dcfd3abcede7","type":"text","conversion_output":true,"text":"parameters. Using OpenBUGS, 100,000 samples will be obtained from the posterior distribution of 12 -month TLF rates","text_display":" parameters. Using OpenBUGS, 100,000 samples will be obtained from the posterior distribution of 12 -month TLF rates","confidence":0.9463013598519865,"confidence_rate":0.9995620467355005},{"cnt":[[125,700],[1813,700],[1813,746],[125,746]],"region":{"top_left_x":124,"top_left_y":700,"width":1690,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7faf9ee2c0d24a578fc5276eb1739b7c","type":"text","conversion_output":true,"text":"after the initial 5,000 will be discarded. To decrease autocorrelation, only every tenth sample will be used in","text_display":" after the initial 5,000 will be discarded. To decrease autocorrelation, only every tenth sample will be used in","confidence":0.6546336782630533,"confidence_rate":0.9963542527124917},{"cnt":[[125,752],[324,752],[324,788],[125,788]],"region":{"top_left_x":124,"top_left_y":751,"width":201,"height":38},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8da4237316a24551ac5dc9c61ae67b6a","type":"text","conversion_output":true,"text":"calculations.","text_display":" calculations.","confidence":1,"confidence_rate":1},{"cnt":[[125,834],[2009,834],[2009,887],[125,887]],"region":{"top_left_x":124,"top_left_y":833,"width":1885,"height":55},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f8efc54ad0984954b6acfa28dbfa0647","type":"text","conversion_output":true,"text":"We will check convergence of the MCMC sampler using the Brooks-Gelman-Rubin method \\({ }^{2}\\). Convergence of the sampler","text_display":"\n\nWe will check convergence of the MCMC sampler using the Brooks-Gelman-Rubin method \\({ }^{2}\\). Convergence of the sampler","confidence":0.99951171875,"confidence_rate":0.999996184378388},{"cnt":[[125,887],[2013,887],[2013,932],[125,932]],"region":{"top_left_x":124,"top_left_y":887,"width":1890,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d85d41cc23244047a948c9025ccb1491","type":"text","conversion_output":true,"text":"will be established if the ratio of within-chain and between-chain variability for multiple chains starting at different initial","text_display":" will be established if the ratio of within-chain and between-chain variability for multiple chains starting at different initial","confidence":1,"confidence_rate":1},{"cnt":[[125,937],[507,937],[507,973],[125,973]],"region":{"top_left_x":124,"top_left_y":936,"width":384,"height":38},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a0cab73ddc24092bf4aaee4549214cc","type":"text","conversion_output":true,"text":"values will be close to 1 .","text_display":" values will be close to 1 .","confidence":0.99853515625,"confidence_rate":0.9999581175147387},{"cnt":[[122,1023],[1944,1023],[1944,1076],[122,1076]],"region":{"top_left_x":122,"top_left_y":1022,"width":1823,"height":55},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"613d2256b9e4400ca9fa2ff181fe13aa","type":"text","conversion_output":true,"text":"The percent of posterior samples that satisfy \\(\\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\\) will be used to estimate the posterior probability of the","text_display":"\n\nThe percent of posterior samples that satisfy \\(\\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\\) will be used to estimate the posterior probability of the","confidence":0.99853515625,"confidence_rate":0.9999892212516022},{"cnt":[[125,1076],[1274,1076],[1274,1119],[125,1119]],"region":{"top_left_x":124,"top_left_y":1076,"width":1151,"height":44},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"684654ccaa9b4894955c1b6632df586b","type":"text","conversion_output":true,"text":"alternative hypothesis will be calculated and reported in the table below.","text_display":" alternative hypothesis will be calculated and reported in the table below.","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[133,1216],[1248,1216],[1248,1261],[133,1261]],"region":{"top_left_x":133,"top_left_y":1216,"width":1116,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d91aeccd11d475dbcbda55f60c3b57f","type":"text","conversion_output":true,"text":"Table reporting the posterior probability of the Alternative Hypothesis:","text_display":"\n\nTable reporting the posterior probability of the Alternative Hypothesis:","confidence":1,"confidence_rate":1},{"cnt":[[597,1255],[1545,1255],[1545,1508],[597,1508]],"region":{"top_left_x":597,"top_left_y":1254,"width":948,"height":255},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9af7f772a14748a6be45a8b36a2d3721","type":"table","conversion_output":true,"text":"\\begin{tabular}{|c|c|}\n\\hline Alternative Hypothesis & \\begin{tabular}{c} \nPosterior \\\\\nProbability\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{c} \nOrsiro is non-inferior to Xience \\\\\n\\(\\left(\\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\\right)\\)\n\\end{tabular} & \\(XX . X \\%\\) \\\\\n\\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|c|c|}\n\\hline Alternative Hypothesis & \\begin{tabular}{c} \nPosterior \\\\\nProbability\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{c} \nOrsiro is non-inferior to Xience \\\\\n\\(\\left(\\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta\\right)\\)\n\\end{tabular} & \\(XX . X \\%\\) \\\\\n\\\\\n\\hline\n\\end{tabular}","confidence":0.681064686987444,"confidence_rate":0.9978683973812322},{"cnt":[[125,1555],[1384,1555],[1384,1601],[125,1601]],"region":{"top_left_x":124,"top_left_y":1555,"width":1260,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f42a16812fd64d42980d95bdeac1ae6a","type":"text","conversion_output":true,"text":"This probability will be contrasted against \\(\\pi^{*}=0.975\\) as outlined in Section 2.4.","text_display":"\n\nThis probability will be contrasted against \\(\\pi^{*}=0.975\\) as outlined in Section 2.4.","confidence":0.9970724578015506,"confidence_rate":0.9999691390463983},{"cnt":[[125,1646],[1944,1646],[1944,1691],[125,1691]],"region":{"top_left_x":124,"top_left_y":1645,"width":1821,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fc5dbe1aeb14ead9fe211d7eccc7962","type":"text","conversion_output":true,"text":"In addition the posterior means and standard deviations of the parameters will be reported along with \\(95 \\%\\) Credible","text_display":"\n\nIn addition the posterior means and standard deviations of the parameters will be reported along with \\(95 \\%\\) Credible","confidence":0.9965834617614746,"confidence_rate":0.9999719480333581},{"cnt":[[125,1693],[750,1693],[750,1734],[125,1734]],"region":{"top_left_x":124,"top_left_y":1692,"width":626,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6df028b62f7c4770adceaddd597494a6","type":"text","conversion_output":true,"text":"Intervals as outlined in the table below.","text_display":" Intervals as outlined in the table below.","confidence":1,"confidence_rate":1},{"cnt":[[125,1835],[1364,1835],[1364,1880],[125,1880]],"region":{"top_left_x":124,"top_left_y":1834,"width":1241,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1fa4e7e6c204908bb732cd5a8b8e50d","type":"text","conversion_output":true,"text":"Table reporting the posterior summaries of the \\(1\\)-year TLF rates in BIOFLOW-V:","text_display":"\n\nTable reporting the posterior summaries of the \\(1\\)-year TLF rates in BIOFLOW-V:","confidence":0.9209358696825802,"confidence_rate":0.9990749800463025},{"cnt":[[460,1869],[1682,1869],[1682,2133],[460,2133]],"region":{"top_left_x":459,"top_left_y":1869,"width":1224,"height":265},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e445f6097bf44f9a26af135b5922050","type":"table","conversion_output":true,"text":"\\begin{tabular}{|c|c|c|c|c|}\n\\hline & Mean & SD & \\begin{tabular}{c} \nLower Bound \\\\\n95\\% Credible \\\\\nInterval\n\\end{tabular} & \\begin{tabular}{c} \nUpper Bound \\\\\n95\\% Credible \\\\\nInterval\n\\end{tabular} \\\\\n\\hline\\(\\pi_{X}^{V}\\) & \\(X . XX\\) & \\(X . XX\\) & \\(X . XX\\) & \\(X . XX\\) \\\\\n\\hline\\(\\pi_{O}^{V}\\) & \\(X . XX\\) & \\(X . XX\\) & \\(X . XX\\) & \\(X . XX\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|c|c|c|c|c|}\n\\hline & Mean & SD & \\begin{tabular}{c} \nLower Bound \\\\\n95\\% Credible \\\\\nInterval\n\\end{tabular} & \\begin{tabular}{c} \nUpper Bound \\\\\n95\\% Credible \\\\\nInterval\n\\end{tabular} \\\\\n\\hline\\(\\pi_{X}^{V}\\) & \\(X . XX\\) & \\(X . XX\\) & \\(X . XX\\) & \\(X . XX\\) \\\\\n\\hline\\(\\pi_{O}^{V}\\) & \\(X . XX\\) & \\(X . XX\\) & \\(X . XX\\) & \\(X . XX\\) \\\\\n\\hline\n\\end{tabular}","confidence":0.8600173904385198,"confidence_rate":0.9994974507585302},{"cnt":[[120,2361],[2015,2361],[2015,2460],[120,2460]],"region":{"top_left_x":120,"top_left_y":2361,"width":1896,"height":99},"line":25,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5c3ba94beebc47649440c11f46a5e0a9","type":"footnote","conversion_output":false,"children_ids":["7418fd127ecf407d96a47e483a0419c9","e9654c23ed554bf3a72b8597c0b09658"],"text":"","text_display":""},{"cnt":[[127,2368],[2009,2368],[2009,2417],[127,2417]],"region":{"top_left_x":126,"top_left_y":2367,"width":1883,"height":50},"line":26,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7418fd127ecf407d96a47e483a0419c9","type":"text","conversion_output":true,"parent_id":"5c3ba94beebc47649440c11f46a5e0a9","text":"\\({ }^{2}\\) Brooks SP, Gelman A. Alternative methods for monitoring convergence of iterative simulations. Journal of Computational and Graphical Statistics.","text_display":"\n\n\\footnotetext{\n\\({ }^{2}\\) Brooks SP, Gelman A. Alternative methods for monitoring convergence of iterative simulations. Journal of Computational and Graphical Statistics.","confidence":1,"confidence_rate":1},{"cnt":[[129,2415],[337,2415],[337,2451],[129,2451]],"region":{"top_left_x":128,"top_left_y":2414,"width":210,"height":38},"line":27,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e9654c23ed554bf3a72b8597c0b09658","type":"text","conversion_output":true,"parent_id":"5c3ba94beebc47649440c11f46a5e0a9","text":"1998;7:434-455","text_display":" 1998;7:434-455\n}","confidence":1,"confidence_rate":1},{"cnt":[[129,2501],[604,2501],[604,2537],[129,2537]],"region":{"top_left_x":128,"top_left_y":2500,"width":476,"height":38},"line":28,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b936b334ca2e4f018a44d9be66107231","type":"page_info","conversion_output":false,"text":"BIOFLOW-V Statistical Analysis Plan (SAP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[881,2501],[1128,2501],[1128,2533],[881,2533]],"region":{"top_left_x":880,"top_left_y":2500,"width":248,"height":34},"line":29,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"854b1c2c5d394827b84fbd090a3a515b","type":"page_info","conversion_output":false,"text":"Baim CONFIDENTIAL","text_display":"","confidence":0.865234375,"confidence_rate":0.9934418331264326},{"cnt":[[1792,2501],[1953,2501],[1953,2537],[1792,2537]],"region":{"top_left_x":1791,"top_left_y":2500,"width":162,"height":38},"line":30,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f0601caf32094b949d71f4a166b8d516","type":"page_info","conversion_output":false,"text":"Page 12 of 21","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[129,2535],[507,2535],[507,2572],[129,2572]],"region":{"top_left_x":128,"top_left_y":2535,"width":380,"height":37},"line":31,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8140243be1f043b3a30ee2f402e301ae","type":"page_info","conversion_output":false,"text":"14 September, 2017, Version 6.2","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"a2b4734a-0b6e-4d9e-a8b1-cd65b10f3aeb-16","page":16,"lines":[{"cnt":[[125,120],[260,120],[260,148],[125,148]],"region":{"top_left_x":124,"top_left_y":120,"width":136,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ce3aaa49b7e544b48c16728a30bc5e23","type":"page_info","conversion_output":false,"text":"BIOTRONIK","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1852,120],[1989,120],[1989,148],[1852,148]],"region":{"top_left_x":1851,"top_left_y":120,"width":139,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a81cdee57e4e41f8813997bdf492feee","type":"page_info","conversion_output":false,"text":"BIOFLOW-V","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1590,155],[2013,155],[2013,185],[1590,185]],"region":{"top_left_x":1589,"top_left_y":154,"width":425,"height":31},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d49a927713d840bfa321674120b905d4","type":"page_info","conversion_output":false,"text":"Protocol \\# CIP FINAL v4.0 11Feb2016","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[122,286],[1893,286],[1893,333],[122,333]],"region":{"top_left_x":122,"top_left_y":285,"width":1771,"height":49},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"515953d476f64f91b07b8f106ae9fcc2","type":"text","conversion_output":true,"text":"In addition, an adjusted Bayesian analysis based on multivariable hierarchical logistic regression adjusted for age,","text_display":"\n\nIn addition, an adjusted Bayesian analysis based on multivariable hierarchical logistic regression adjusted for age,","confidence":1,"confidence_rate":1},{"cnt":[[120,331],[1867,331],[1867,380],[120,380]],"region":{"top_left_x":120,"top_left_y":330,"width":1747,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9fe5dc85d6f342baa189035207000503","type":"text","conversion_output":true,"text":"diabetes, history of PCI, ischemic status and LVEF will be performed. Treatment effect with logistic regression is","text_display":" diabetes, history of PCI, ischemic status and LVEF will be performed. Treatment effect with logistic regression is","confidence":0.9770617485046387,"confidence_rate":0.9998050154255573},{"cnt":[[120,378],[1955,378],[1955,425],[120,425]],"region":{"top_left_x":120,"top_left_y":378,"width":1836,"height":48},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cff1c325b84246c2ba23162d690f260c","type":"text","conversion_output":true,"text":"expressed on the log ODDS ratio scale. The value of non-inferiority margin used for the non-inferiority test on the log","text_display":" expressed on the log ODDS ratio scale. The value of non-inferiority margin used for the non-inferiority test on the log","confidence":0.6513671875,"confidence_rate":0.9965488579625243},{"cnt":[[120,425],[2013,422],[2013,471],[120,473]],"region":{"top_left_x":120,"top_left_y":422,"width":1894,"height":52},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b45c69ea1b848eba19045f8d6cc2bbf","type":"text","conversion_output":true,"text":"ODDS scale in the adjusted analyses is obtained by transforming the probability-scale non-inferiority margin of 0.0385 to","text_display":" ODDS scale in the adjusted analyses is obtained by transforming the probability-scale non-inferiority margin of 0.0385 to","confidence":1,"confidence_rate":1},{"cnt":[[120,473],[1179,473],[1179,518],[120,518]],"region":{"top_left_x":120,"top_left_y":472,"width":1060,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b79a1065442542ec898ccd637c3c3a10","type":"text","conversion_output":true,"text":"the log-odds scale. The transforming is achieved using the formula:","text_display":" the log-odds scale. The transforming is achieved using the formula:","confidence":1,"confidence_rate":1},{"cnt":[[526,559],[1613,559],[1613,617],[526,617]],"region":{"top_left_x":526,"top_left_y":558,"width":1088,"height":59},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9c72f76debe247f0a678a34bf332bf22","type":"math","conversion_output":true,"text":"\\[\n\\log \\{(0.07+0.0385) /(1-0.07-0.0385)\\}-\\log \\{0.07 /(1-0.07)\\}=0.481\n\\]","text_display":"\n\\[\n\\log \\{(0.07+0.0385) /(1-0.07-0.0385)\\}-\\log \\{0.07 /(1-0.07)\\}=0.481\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[120,657],[1141,657],[1141,707],[120,707]],"region":{"top_left_x":120,"top_left_y":657,"width":1021,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c13643ec5e1243f9b948fdc11240925a","type":"text","conversion_output":true,"text":"Thus, for the adjusted analyses, the non-inferiority will be met if","text_display":"\n\nThus, for the adjusted analyses, the non-inferiority will be met if","confidence":1,"confidence_rate":1},{"cnt":[[645,698],[1493,698],[1493,763],[645,763]],"region":{"top_left_x":644,"top_left_y":698,"width":850,"height":65},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20ebe59df79c4270892157db5a712a9a","type":"math","conversion_output":true,"text":"\\[\nP\\left(\\operatorname{logit}\\left(\\pi_{X}^{V}\\right)-\\operatorname{logit}\\left(\\pi_{O}^{V}\\right)>-0.481 \\mid \\text { Data }\\right)>0.975\n\\]","text_display":"\n\\[\nP\\left(\\operatorname{logit}\\left(\\pi_{X}^{V}\\right)-\\operatorname{logit}\\left(\\pi_{O}^{V}\\right)>-0.481 \\mid \\text { Data }\\right)>0.975\n\\]","confidence":0.9200052997330204,"confidence_rate":0.9987563583166671},{"cnt":[[116,838],[625,838],[625,896],[116,896]],"region":{"top_left_x":116,"top_left_y":837,"width":510,"height":59},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e2be3689f2394f1ebd531a39e028451a","type":"section_header","conversion_output":false,"children_ids":["656366b103404389b974260f39d25ab3"],"text":"","text_display":""},{"cnt":[[120,844],[621,844],[621,892],[120,892]],"region":{"top_left_x":120,"top_left_y":844,"width":501,"height":48},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"656366b103404389b974260f39d25ab3","type":"text","conversion_output":true,"parent_id":"e2be3689f2394f1ebd531a39e028451a","text":"2.7.1 Center Heterogeneity","text_display":"\n\n\\subsection*{2.7.1 Center Heterogeneity}","confidence":0.99365234375,"confidence_rate":0.999794605345316},{"cnt":[[120,898],[1996,898],[1996,947],[120,947]],"region":{"top_left_x":120,"top_left_y":898,"width":1876,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41d0aaa888ad46b8b96f323bab053ec1","type":"text","conversion_output":true,"text":"Consistency of treatment effect across centers will be tested within each of the three studies (BIOFLOW-II, BIOFLOW-IV","text_display":"\n\nConsistency of treatment effect across centers will be tested within each of the three studies (BIOFLOW-II, BIOFLOW-IV","confidence":1,"confidence_rate":1},{"cnt":[[120,945],[2002,945],[2002,995],[120,995]],"region":{"top_left_x":120,"top_left_y":945,"width":1883,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea6c34ecdd7843ddb0c98a19e89d145a","type":"text","conversion_output":true,"text":"and BIOFLOW-V). To assess consistency of treatment effect size across study centers, Bayesian models will be employed","text_display":" and BIOFLOW-V). To assess consistency of treatment effect size across study centers, Bayesian models will be employed","confidence":1,"confidence_rate":1},{"cnt":[[120,993],[2017,993],[2017,1042],[120,1042]],"region":{"top_left_x":120,"top_left_y":992,"width":1898,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00b3707e5d6f4b899ef2f86a73ca17aa","type":"text","conversion_output":true,"text":"for the subject level data. Any study center with less than 5 subjects per treatment group will be pooled with other study","text_display":" for the subject level data. Any study center with less than 5 subjects per treatment group will be pooled with other study","confidence":0.99951171875,"confidence_rate":0.9999962430801487},{"cnt":[[120,1040],[1175,1040],[1175,1089],[120,1089]],"region":{"top_left_x":120,"top_left_y":1039,"width":1056,"height":51},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bbdeb3259185468d8512d6235b3eaf76","type":"text","conversion_output":true,"text":"centers by geographic region prior to carrying out this assessment.","text_display":" centers by geographic region prior to carrying out this assessment.","confidence":1,"confidence_rate":1},{"cnt":[[122,1130],[2020,1130],[2020,1182],[122,1182]],"region":{"top_left_x":122,"top_left_y":1130,"width":1898,"height":52},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a138edcb770b4efea10831277c7e36bb","type":"text","conversion_output":true,"text":"Individual data for treatment \\(i\\) ( \\(i =1\\) for Xience and \\(i =2\\) for Orsiro), study \\(j(j=1\\) for BIOFLOW-V, \\(j=2\\) for BIOFLOW-II","text_display":"\n\nIndividual data for treatment \\(i\\) ( \\(i =1\\) for Xience and \\(i =2\\) for Orsiro), study \\(j(j=1\\) for BIOFLOW-V, \\(j=2\\) for BIOFLOW-II","confidence":0.7731803088100708,"confidence_rate":0.9981772448062792},{"cnt":[[120,1179],[1596,1179],[1596,1231],[120,1231]],"region":{"top_left_x":120,"top_left_y":1179,"width":1477,"height":53},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c229f5f98e74a99aa371c10fed042f9","type":"text","conversion_output":true,"text":"and \\(j=3\\) for BIOFLOW-IV) and individual \\(k\\) will be assumed to follow a Bernoulli distribution:","text_display":" and \\(j=3\\) for BIOFLOW-IV) and individual \\(k\\) will be assumed to follow a Bernoulli distribution:","confidence":1,"confidence_rate":1},{"cnt":[[782,1268],[1360,1268],[1360,1330],[782,1330]],"region":{"top_left_x":782,"top_left_y":1267,"width":578,"height":63},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59b376435bbd4cf58277437f380c2b08","type":"math","conversion_output":true,"text":"\\[\nY[i, j, k] \\sim \\operatorname{dbern}(p[i, j, \\operatorname{center}[k]])\n\\]","text_display":"\n\\[\nY[i, j, k] \\sim \\operatorname{dbern}(p[i, j, \\operatorname{center}[k]])\n\\]","confidence":0.69873046875,"confidence_rate":0.9906104073207157},{"cnt":[[122,1366],[1635,1366],[1635,1416],[122,1416]],"region":{"top_left_x":122,"top_left_y":1366,"width":1513,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d53fb6d6c0f4bbba3dc2da9577b5ec5","type":"text","conversion_output":true,"text":"where center is an index variable that indicates the center that the individual \\(k\\) was recruited in.","text_display":"\nwhere center is an index variable that indicates the center that the individual \\(k\\) was recruited in.","confidence":1,"confidence_rate":1},{"cnt":[[122,1452],[2017,1452],[2017,1508],[122,1508]],"region":{"top_left_x":122,"top_left_y":1452,"width":1896,"height":57},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c555c1a182c43a891b47d7299d73635","type":"text","conversion_output":true,"text":"The assumptions are based on a similar model to the model proposed in Legrand et al. \\({ }^{3}\\). The event rate is assumed to","text_display":"\nThe assumptions are based on a similar model to the model proposed in Legrand et al. \\({ }^{3}\\). The event rate is assumed to","confidence":0.99951171875,"confidence_rate":0.9999963000030714},{"cnt":[[122,1506],[1042,1506],[1042,1555],[122,1555]],"region":{"top_left_x":122,"top_left_y":1506,"width":920,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3478ed0c6274036859880465e0cc3e6","type":"text","conversion_output":true,"text":"have an additive effect for center that varies within study:","text_display":" have an additive effect for center that varies within study:","confidence":1,"confidence_rate":1},{"cnt":[[537,1590],[1665,1590],[1665,1661],[537,1661]],"region":{"top_left_x":537,"top_left_y":1589,"width":1129,"height":72},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb006e33df0e455b88c8bb143cb5361e","type":"math","conversion_output":true,"text":"\\[\n\\operatorname{logit}(p[i, j, \\text { center }[k]])=\\delta[j, \\text { center }[k]]+\\gamma[j, \\text { center }[k]] *(i=2)\n\\]","text_display":"\n\\[\n\\operatorname{logit}(p[i, j, \\text { center }[k]])=\\delta[j, \\text { center }[k]]+\\gamma[j, \\text { center }[k]] *(i=2)\n\\]","confidence":0.9814453125,"confidence_rate":0.9997567960060785},{"cnt":[[122,1697],[2017,1697],[2017,1747],[122,1747]],"region":{"top_left_x":122,"top_left_y":1697,"width":1896,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e0de1fd72a348bfb0faa0df02984239","type":"text","conversion_output":true,"text":"The two random effects can be interpreted as the influence of the center on the overall TLF rate in study \\(j\\) and on the","text_display":"\n\nThe two random effects can be interpreted as the influence of the center on the overall TLF rate in study \\(j\\) and on the","confidence":1,"confidence_rate":1},{"cnt":[[122,1745],[2017,1745],[2017,1798],[122,1798]],"region":{"top_left_x":122,"top_left_y":1744,"width":1896,"height":55},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93b2749208794c2c91c59c0671b92f79","type":"text","conversion_output":true,"text":"overall treatment effect, respectively. The center effects \\(\\delta[j, \\operatorname{center}[k]]\\) and \\(\\gamma[j, \\operatorname{center}[k]]\\) in study \\(j\\), are assumed to","text_display":" overall treatment effect, respectively. The center effects \\(\\delta[j, \\operatorname{center}[k]]\\) and \\(\\gamma[j, \\operatorname{center}[k]]\\) in study \\(j\\), are assumed to","confidence":0.99951171875,"confidence_rate":0.9999965114310986},{"cnt":[[125,1796],[2017,1796],[2017,1846],[125,1846]],"region":{"top_left_x":124,"top_left_y":1796,"width":1894,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"46f9cbf106da47c3a5360e76eb04ba2c","type":"text","conversion_output":true,"text":"be exchangeable and a priory to follow a normal distribution with mean \\(m u \\_d e l t a[j]\\) and \\(m u \\_g a m m a[j]\\) and standard","text_display":" be exchangeable and a priory to follow a normal distribution with mean \\(m u \\_d e l t a[j]\\) and \\(m u \\_g a m m a[j]\\) and standard","confidence":0.9634446190858565,"confidence_rate":0.9996947984549991},{"cnt":[[125,1843],[2017,1843],[2017,1893],[125,1893]],"region":{"top_left_x":124,"top_left_y":1843,"width":1894,"height":50},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb562284458f4fa09a45f62987078f42","type":"text","conversion_output":true,"text":"deviation sigma_delta[j] and sigma_gamma[j], respectively. A uniform prior on (0.1, 10) will be assumed on the random","text_display":" deviation sigma_delta[j] and sigma_gamma[j], respectively. A uniform prior on (0.1, 10) will be assumed on the random","confidence":0.48369053452977767,"confidence_rate":0.9940643257399461},{"cnt":[[125,1886],[2017,1886],[2017,1940],[125,1940]],"region":{"top_left_x":124,"top_left_y":1886,"width":1894,"height":55},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cf47b41a1394025b2759c339cb87d2f","type":"text","conversion_output":true,"text":"effect variances in study \\(j\\) (sigma_delta[j] and sigma_gamma2[j]) Geltman et al. \\({ }^{4}\\) Independent weakly informative \\(N (0\\),","text_display":" effect variances in study \\(j\\) (sigma_delta[j] and sigma_gamma2[j]) Geltman et al. \\({ }^{4}\\) Independent weakly informative \\(N (0\\),","confidence":0.9795295968694973,"confidence_rate":0.9998490418643019},{"cnt":[[125,1936],[2017,1936],[2017,1987],[125,1987]],"region":{"top_left_x":124,"top_left_y":1935,"width":1894,"height":53},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2bfb9eed03694dd08f1eb7bbda376902","type":"text","conversion_output":true,"text":"100) priors will be assumed for mu_delta's and mu_gamma's. The standard deviation of the random effects can be","text_display":" 100) priors will be assumed for mu_delta's and mu_gamma's. The standard deviation of the random effects can be","confidence":0.72802734375,"confidence_rate":0.9972436607292435},{"cnt":[[125,1983],[2022,1983],[2022,2032],[125,2032]],"region":{"top_left_x":124,"top_left_y":1983,"width":1898,"height":50},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15aa653a5834478fb37e0b9f73135cf1","type":"text","conversion_output":true,"text":"viewed as a measure of heterogeneity across centers and treatment effect. A value of 1 for standard deviation of","text_display":" viewed as a measure of heterogeneity across centers and treatment effect. A value of 1 for standard deviation of","confidence":1,"confidence_rate":1},{"cnt":[[125,2024],[2020,2024],[2020,2082],[125,2082]],"region":{"top_left_x":124,"top_left_y":2023,"width":1896,"height":59},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f4bc1af4c3f462cbad2d819cf6bb7db","type":"text","conversion_output":true,"text":"random effects '...corresponds to substantial heterogeneity.' Spiegelhalter et al. \\({ }^{5}\\); therefore, if in BIOFLOW-V the","text_display":" random effects '...corresponds to substantial heterogeneity.' Spiegelhalter et al. \\({ }^{5}\\); therefore, if in BIOFLOW-V the","confidence":0.9912221396807581,"confidence_rate":0.9999332097102905},{"cnt":[[120,2168],[2020,2168],[2020,2469],[120,2469]],"region":{"top_left_x":120,"top_left_y":2167,"width":1900,"height":302},"line":37,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bf75155cc9504b149ddd2d5c2f54a33f","type":"footnote","conversion_output":false,"children_ids":["a1505d21cebe446ab86b589c2c9b91f0","77cb32ec04e54a17b6c9126b67dfa2ba","fe1d9a4ec1084a7cb22baf4da585550d","c6bff509e9654e269caf2d4c66864a52","87d8c97a8e8c4cdb91ff5cf584d9aadd"],"text":"","text_display":""},{"cnt":[[125,2174],[2009,2174],[2009,2224],[125,2224]],"region":{"top_left_x":124,"top_left_y":2174,"width":1885,"height":50},"line":38,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a1505d21cebe446ab86b589c2c9b91f0","type":"text","conversion_output":true,"parent_id":"bf75155cc9504b149ddd2d5c2f54a33f","text":"\\({ }^{3}\\) Legrand C, Ducrocq V, Janssen P, Sylvester R, Duchateau L. A Bayesian approach to jointly estimate centre and treatment by centre heterogeneity","text_display":"\n\n\\footnotetext{\n\\({ }^{3}\\) Legrand C, Ducrocq V, Janssen P, Sylvester R, Duchateau L. A Bayesian approach to jointly estimate centre and treatment by centre heterogeneity","confidence":1,"confidence_rate":1},{"cnt":[[125,2219],[984,2219],[984,2262],[125,2262]],"region":{"top_left_x":124,"top_left_y":2219,"width":860,"height":44},"line":39,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"77cb32ec04e54a17b6c9126b67dfa2ba","type":"text","conversion_output":true,"parent_id":"bf75155cc9504b149ddd2d5c2f54a33f","text":"in a proportional hazards model. Stat Med 2005; 24(24):3789-804.","text_display":" in a proportional hazards model. Stat Med 2005; 24(24):3789-804.","confidence":1,"confidence_rate":1},{"cnt":[[125,2290],[1257,2290],[1257,2340],[125,2340]],"region":{"top_left_x":124,"top_left_y":2290,"width":1133,"height":50},"line":40,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fe1d9a4ec1084a7cb22baf4da585550d","type":"text","conversion_output":true,"parent_id":"bf75155cc9504b149ddd2d5c2f54a33f","text":"\\({ }^{4}\\) Gelman A, Carlin JB, Stern HS, Rubin DB. Bayesian Data Analysis, 1995 Chapman \\& Hall","text_display":"\n\\({ }^{4}\\) Gelman A, Carlin JB, Stern HS, Rubin DB. Bayesian Data Analysis, 1995 Chapman \\& Hall","confidence":0.99365234375,"confidence_rate":0.99993632314463},{"cnt":[[127,2372],[1957,2372],[1957,2426],[127,2426]],"region":{"top_left_x":126,"top_left_y":2371,"width":1832,"height":55},"line":41,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c6bff509e9654e269caf2d4c66864a52","type":"text","conversion_output":true,"parent_id":"bf75155cc9504b149ddd2d5c2f54a33f","text":"\\({ }^{5}\\) Spiegelhalter, D.J., Abrams, K.R. and Myles, J.P. Bayesian Approaches to Clinical Trials and Health-Care Evaluation, John Wiley and Sons, 2004,","text_display":"\n\\({ }^{5}\\) Spiegelhalter, D.J., Abrams, K.R. and Myles, J.P. 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A similar determination will be","text_display":" case the primary analysis may be re-run excluding study centers causing the interaction. 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For the","text_display":" and an interaction of region and treatment will be included in the Bayesian model for the BIOFLOW-V study. 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Data for these subjects will be included as","text_display":" experiencing the event and not reaching at least 330 days of follow-up. Data for these subjects will be included as","confidence":1,"confidence_rate":1},{"cnt":[[191,1994],[1811,1994],[1811,2039],[191,2039]],"region":{"top_left_x":191,"top_left_y":1993,"width":1621,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d6af132baf1c4782b5614467931afc38","type":"text","conversion_output":true,"text":"'NA'. Bayesian method will be used for the imputation. A model will be used for the event probabilities:","text_display":" 'NA'. Bayesian method will be used for the imputation. A model will be used for the event probabilities:","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[898,2082],[1315,2082],[1315,2140],[898,2140]],"region":{"top_left_x":898,"top_left_y":2081,"width":417,"height":59},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a6f12f5417d4691ab23c4ab494a2633","type":"math","conversion_output":true,"text":"\\[\nY[i, j, k] \\sim \\operatorname{dbern}(p[i, j, k]\n\\]","text_display":"\n\\[\nY[i, j, k] \\sim \\operatorname{dbern}(p[i, j, k]\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[189,2136],[269,2136],[269,2172],[189,2172]],"region":{"top_left_x":189,"top_left_y":2135,"width":80,"height":38},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed2a8f29f2b1404081e86d4d0cc7a929","type":"text","conversion_output":true,"text":"with","text_display":"\nwith","confidence":1,"confidence_rate":1},{"cnt":[[735,2174],[1480,2174],[1480,2230],[735,2230]],"region":{"top_left_x":734,"top_left_y":2174,"width":747,"height":57},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"220d076f6fa9466a8074ae30f2b448fe","type":"math","conversion_output":true,"text":"\\[\n\\operatorname{logit}(p[i, j, k])=\\operatorname{beta} * X[k]+\\operatorname{logit}(p[i, j])\n\\]","text_display":"\n\\[\n\\operatorname{logit}(p[i, j, k])=\\operatorname{beta} * X[k]+\\operatorname{logit}(p[i, j])\n\\]","confidence":0.931640625,"confidence_rate":0.9985259180661592},{"cnt":[[129,2505],[608,2505],[608,2537],[129,2537]],"region":{"top_left_x":128,"top_left_y":2505,"width":481,"height":33},"line":40,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"caae7216319f4152848ef70e77e75620","type":"page_info","conversion_output":false,"text":"BIOFLOW-V Statistical Analysis Plan (SAP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[885,2505],[1132,2505],[1132,2533],[885,2533]],"region":{"top_left_x":885,"top_left_y":2505,"width":248,"height":29},"line":41,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8e2b8229326b48869ee0974f158e2861","type":"page_info","conversion_output":false,"text":"Baim CONFIDENTIAL","text_display":"","confidence":0.72314453125,"confidence_rate":0.9853740961138588},{"cnt":[[1796,2505],[1955,2505],[1955,2537],[1796,2537]],"region":{"top_left_x":1796,"top_left_y":2505,"width":160,"height":33},"line":42,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bf73ee9fc0e84519abc30227ca73ed5f","type":"page_info","conversion_output":false,"text":"Page 14 of 21","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[129,2539],[509,2539],[509,2572],[129,2572]],"region":{"top_left_x":128,"top_left_y":2539,"width":382,"height":33},"line":43,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f8dc5a8aa21540e698c510c787fd17a5","type":"page_info","conversion_output":false,"text":"14 September, 2017, Version 6.2","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"a2b4734a-0b6e-4d9e-a8b1-cd65b10f3aeb-18","page":18,"lines":[{"cnt":[[120,116],[260,116],[260,148],[120,148]],"region":{"top_left_x":120,"top_left_y":116,"width":140,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"150f5fbabd5345bba8beea9a384b8645","type":"page_info","conversion_output":false,"text":"BIOTRONIK","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1848,116],[1992,116],[1992,148],[1848,148]],"region":{"top_left_x":1847,"top_left_y":116,"width":145,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"711c21da035d49a6988b8fccee25f65c","type":"page_info","conversion_output":false,"text":"BIOFLOW-V","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1586,150],[2017,150],[2017,187],[1586,187]],"region":{"top_left_x":1585,"top_left_y":150,"width":433,"height":37},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d5f38b15d34446869f87c49902d756cf","type":"page_info","conversion_output":false,"text":"Protocol \\# CIP FINAL v4.0 11Feb2016","text_display":"","confidence":0.92626953125,"confidence_rate":0.9980870815595098},{"cnt":[[180,279],[2017,279],[2017,331],[180,331]],"region":{"top_left_x":180,"top_left_y":279,"width":1838,"height":52},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"854c6ac3bb3d4029b70dc76dd4531a83","type":"text","conversion_output":true,"text":"where \\(X[k]\\) are predictors values for subject \\(k\\). A noninformative prior will be assumed on the slope parameters","text_display":"\nwhere \\(X[k]\\) are predictors values for subject \\(k\\). A noninformative prior will be assumed on the slope parameters","confidence":1,"confidence_rate":1},{"cnt":[[180,327],[2017,327],[2017,376],[180,376]],"region":{"top_left_x":180,"top_left_y":326,"width":1838,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0cb59e595bcd46449235fc93b238a96e","type":"text","conversion_output":true,"text":"beta and similarly to the analysis of the primary endpoint, bias will be assumed between TLF rates in different","text_display":" beta and similarly to the analysis of the primary endpoint, bias will be assumed between TLF rates in different","confidence":1,"confidence_rate":1},{"cnt":[[180,374],[312,374],[312,419],[180,419]],"region":{"top_left_x":180,"top_left_y":373,"width":132,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2e33a5a3ebbe470486ecc200ebc7df63","type":"text","conversion_output":true,"text":"studies.","text_display":" studies.","confidence":1,"confidence_rate":1},{"cnt":[[180,466],[1233,466],[1233,518],[180,518]],"region":{"top_left_x":180,"top_left_y":466,"width":1054,"height":52},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ab3245b8fd64331a68459bef8edb476","type":"text","conversion_output":true,"text":"The following variables will be included in the model as covariates:","text_display":"\n\nThe following variables will be included in the model as covariates:","confidence":0.9990236759185791,"confidence_rate":0.9999866192539584},{"cnt":[[243,529],[565,529],[565,574],[243,574]],"region":{"top_left_x":242,"top_left_y":528,"width":324,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"164560acf6074c12a88e2b75dc1b6609","type":"text","conversion_output":true,"text":"- Age (>75, <=75)","text_display":"\n- Age (>75, <=75)","confidence":0.96044921875,"confidence_rate":0.9981674009108829},{"cnt":[[245,580],[440,580],[440,625],[245,625]],"region":{"top_left_x":244,"top_left_y":580,"width":197,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d49ae30d4224052bf16d5bc8d8c4e67","type":"text","conversion_output":true,"text":"- Gender","text_display":"\n- Gender","confidence":1,"confidence_rate":1},{"cnt":[[245,632],[458,632],[458,677],[245,677]],"region":{"top_left_x":244,"top_left_y":631,"width":214,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f172d5fab03b42369c552b4c59b3a9b8","type":"text","conversion_output":true,"text":"- Diabetes","text_display":"\n- Diabetes","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[844,683],[844,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":601,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffef433a43a84e66948669a22fdca944","type":"text","conversion_output":true,"text":"- Lesion length ( \\(>26 mm,<=26 mm\\) )","text_display":"\n- Lesion length ( \\(>26 mm,<=26 mm\\) )","confidence":0.9980475902557373,"confidence_rate":0.9999575157246432},{"cnt":[[245,735],[752,735],[752,784],[245,784]],"region":{"top_left_x":244,"top_left_y":734,"width":508,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"840a261f5c7f46c28540c6f8847987b7","type":"text","conversion_output":true,"text":"- RVD ( \\(>2.75 mm,<=2.75 mm\\) )","text_display":"\n- RVD ( \\(>2.75 mm,<=2.75 mm\\) )","confidence":0.6717068367870525,"confidence_rate":0.9901009887569221},{"cnt":[[120,829],[1953,829],[1953,881],[120,881]],"region":{"top_left_x":120,"top_left_y":829,"width":1833,"height":52},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2befe2c4917d464595e113271cdc1afa","type":"text","conversion_output":true,"text":"3) Time to event analysis using a Bayesian time to event exponential regression analysis. The protocol specifies that","text_display":"\n3) Time to event analysis using a Bayesian time to event exponential regression analysis. The protocol specifies that","confidence":1,"confidence_rate":1},{"cnt":[[180,877],[1884,877],[1884,926],[180,926]],"region":{"top_left_x":180,"top_left_y":876,"width":1705,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"205e1b7bd5ec4445ae2c716c83b4de39","type":"text","conversion_output":true,"text":"time to event analysis using a Bayesian Cox regression analysis will be performed as a sensitivity analysis but","text_display":" time to event analysis using a Bayesian Cox regression analysis will be performed as a sensitivity analysis but","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[180,924],[2013,924],[2013,973],[180,973]],"region":{"top_left_x":180,"top_left_y":923,"width":1834,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bcbf07bcec4a4d3aa2e1ec03c89fbe1c","type":"text","conversion_output":true,"text":"subsequently we determined that an exponential regression is better for allowing incorporating a bias term between","text_display":" subsequently we determined that an exponential regression is better for allowing incorporating a bias term between","confidence":1,"confidence_rate":1},{"cnt":[[180,971],[1880,971],[1880,1021],[180,1021]],"region":{"top_left_x":180,"top_left_y":971,"width":1700,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5873f31a8b8b4059b3c763ccccb5bc84","type":"text","conversion_output":true,"text":"the log hazard rates in BIOFLOW-V and BIOFLOW II and BIOFLOW-IV. For each study, a separate hazard ratio","text_display":" the log hazard rates in BIOFLOW-V and BIOFLOW II and BIOFLOW-IV. For each study, a separate hazard ratio","confidence":0.9043433666229248,"confidence_rate":0.9990779834804087},{"cnt":[[180,1016],[1979,1016],[1979,1068],[180,1068]],"region":{"top_left_x":180,"top_left_y":1016,"width":1799,"height":52},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c2c007855de4e918207c66b74e4d3aa","type":"text","conversion_output":true,"text":"comparing Xience to Orsiro stent will be included. Similar to the method proposed as a primary method, a bias will","text_display":" comparing Xience to Orsiro stent will be included. Similar to the method proposed as a primary method, a bias will","confidence":1,"confidence_rate":1},{"cnt":[[183,1061],[1833,1061],[1833,1111],[183,1111]],"region":{"top_left_x":182,"top_left_y":1061,"width":1651,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a40a837648546b2abb2c04d7479bd09","type":"text","conversion_output":true,"text":"be assumed between the log hazard of BIOFLOW-II or BIOFLOW-IV and the log hazard of the BIOFLOW-V.","text_display":" be assumed between the log hazard of BIOFLOW-II or BIOFLOW-IV and the log hazard of the BIOFLOW-V.","confidence":0.9990236759185791,"confidence_rate":0.9999905165401506},{"cnt":[[178,1197],[299,1197],[299,1250],[178,1250]],"region":{"top_left_x":178,"top_left_y":1196,"width":121,"height":55},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"352929171e3c425abea841b78e3f3294","type":"section_header","conversion_output":false,"children_ids":["e068a30966194a9abaf0796e9b7d8c46"],"text":"","text_display":""},{"cnt":[[185,1199],[294,1199],[294,1244],[185,1244]],"region":{"top_left_x":184,"top_left_y":1198,"width":111,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e068a30966194a9abaf0796e9b7d8c46","type":"text","conversion_output":true,"parent_id":"352929171e3c425abea841b78e3f3294","text":"Model","text_display":"\n\n\\section*{Model}","confidence":1,"confidence_rate":1},{"cnt":[[183,1285],[1901,1285],[1901,1336],[183,1336]],"region":{"top_left_x":182,"top_left_y":1284,"width":1720,"height":53},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09f2293751b649a087c969820e4465d6","type":"text","conversion_output":true,"text":"For ease of presentation we assume that no censoring occurs. The below model will accommodate censoring.","text_display":"\n\nFor ease of presentation we assume that no censoring occurs. The below model will accommodate censoring.","confidence":1,"confidence_rate":1},{"cnt":[[185,1371],[1276,1371],[1276,1433],[185,1433]],"region":{"top_left_x":184,"top_left_y":1370,"width":1093,"height":64},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28c9103a43f5448893b2001fdcac04db","type":"text","conversion_output":true,"text":"For a subject \\(i\\) in the BIOFLOW-V study, if \\(Y_{X, i}^{V}\\) is the time to event, let","text_display":"\nFor a subject \\(i\\) in the BIOFLOW-V study, if \\(Y_{X, i}^{V}\\) is the time to event, let","confidence":0.8349227905273438,"confidence_rate":0.9980408778417083},{"cnt":[[683,1461],[1515,1461],[1515,1532],[683,1532]],"region":{"top_left_x":683,"top_left_y":1460,"width":832,"height":72},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7e45baf76ff4a74982678eebb3dc208","type":"math","conversion_output":true,"text":"\\[\nY_{X, i}^{V} \\sim \\operatorname{exponential}\\left(\\lambda_{X}^{V}\\right) \\text { and } Y_{o, i}^{V} \\sim \\operatorname{exponential}\\left(\\lambda_{O}^{V}\\right)\n\\]","text_display":"\n\\[\nY_{X, i}^{V} \\sim \\operatorname{exponential}\\left(\\lambda_{X}^{V}\\right) \\text { and } Y_{o, i}^{V} \\sim \\operatorname{exponential}\\left(\\lambda_{O}^{V}\\right)\n\\]","confidence":0.88720703125,"confidence_rate":0.9986093757482395},{"cnt":[[185,1560],[1987,1560],[1987,1618],[185,1618]],"region":{"top_left_x":184,"top_left_y":1559,"width":1804,"height":59},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fc6dfe75f1f4886be4de0be35a45bdd","type":"text","conversion_output":true,"text":"be the distributions of the time (years) to event in the Xience and Orsiro groups, respectively. The values \\(\\lambda_{X}^{V}\\) and \\(\\lambda_{O}^{V}\\)","text_display":"\nbe the distributions of the time (years) to event in the Xience and Orsiro groups, respectively. The values \\(\\lambda_{X}^{V}\\) and \\(\\lambda_{O}^{V}\\)","confidence":0.99951171875,"confidence_rate":0.9999965114310986},{"cnt":[[185,1611],[947,1611],[947,1661],[185,1661]],"region":{"top_left_x":184,"top_left_y":1611,"width":764,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8017da17bb0144049d1bf054446d1c93","type":"text","conversion_output":true,"text":"are the hazards in the Xience and Orsiro groups.","text_display":" are the hazards in the Xience and Orsiro groups.","confidence":0.99951171875,"confidence_rate":0.9999907849387211},{"cnt":[[185,1695],[1968,1695],[1968,1749],[185,1749]],"region":{"top_left_x":184,"top_left_y":1695,"width":1784,"height":54},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59acddb12cf44b0188fb32192dc8f3de","type":"text","conversion_output":true,"text":"Evidence from BIOFLOW-IV study: It is first discounted using the discount factor \\(a^{I V}\\). The discounted data are then","text_display":"\n\nEvidence from BIOFLOW-IV study: It is first discounted using the discount factor \\(a^{I V}\\). The discounted data are then","confidence":0.9990234375,"confidence_rate":0.9999924843386441},{"cnt":[[185,1745],[1854,1745],[1854,1800],[185,1800]],"region":{"top_left_x":184,"top_left_y":1744,"width":1671,"height":57},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e73e3c0fc46049ed8e2a029dca70d5ba","type":"text","conversion_output":true,"text":"assumed to follow exponential distributions with hazard rates \\(\\lambda_{X}^{I V}\\) and \\(\\lambda_{O}^{I V}\\) in the Xience and Orsiro groups,","text_display":" assumed to follow exponential distributions with hazard rates \\(\\lambda_{X}^{I V}\\) and \\(\\lambda_{O}^{I V}\\) in the Xience and Orsiro groups,","confidence":0.9990234375,"confidence_rate":0.9999926538642174},{"cnt":[[185,1794],[1497,1794],[1497,1852],[185,1852]],"region":{"top_left_x":184,"top_left_y":1793,"width":1314,"height":59},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"182b8c4e9cfb4341859019ffaa444cf4","type":"text","conversion_output":true,"text":"respectively. For a subject \\(i\\) in the BIOFLOW-IV study, if \\(Y_{X, i}^{I V}\\) is the time to event, let","text_display":" respectively. For a subject \\(i\\) in the BIOFLOW-IV study, if \\(Y_{X, i}^{I V}\\) is the time to event, let","confidence":1,"confidence_rate":1},{"cnt":[[679,1880],[1519,1880],[1519,1951],[679,1951]],"region":{"top_left_x":678,"top_left_y":1879,"width":841,"height":72},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4f0f160a10940afb23e855bd43c91c7","type":"math","conversion_output":true,"text":"\\[\nY_{X, i}^{I V} \\sim \\operatorname{exponential}\\left(\\lambda_{X}^{I V}\\right) \\text { and } Y_{O, i}^{I V} \\sim \\operatorname{exponential}\\left(\\lambda_{O}^{I V}\\right)\n\\]","text_display":"\n\\[\nY_{X, i}^{I V} \\sim \\operatorname{exponential}\\left(\\lambda_{X}^{I V}\\right) \\text { and } Y_{O, i}^{I V} \\sim \\operatorname{exponential}\\left(\\lambda_{O}^{I V}\\right)\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[185,1981],[1869,1981],[1869,2035],[185,2035]],"region":{"top_left_x":184,"top_left_y":1980,"width":1686,"height":55},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f2755d5bb5ed4511b4080a90ebded80e","type":"text","conversion_output":true,"text":"A bias term is assumed to link the TLF hazard rates in BIOFLOW-V and BIOFLOW-IV in each treatment group","text_display":"\n\nA bias term is assumed to link the TLF hazard rates in BIOFLOW-V and BIOFLOW-IV in each treatment group","confidence":1,"confidence_rate":1},{"cnt":[[580,2062],[1558,2062],[1558,2129],[580,2129]],"region":{"top_left_x":580,"top_left_y":2062,"width":978,"height":68},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"299c170ea0d645ec8941d373837a9875","type":"math","conversion_output":true,"text":"\\[\n\\bullet \\log \\left(\\lambda_{X}^{V}\\right)=\\log \\left(\\lambda_{X}^{I V}\\right)+\\delta_{X}^{I V} \\text { and } \\log \\left(\\lambda_{O}^{V}\\right)=\\log \\left(\\lambda_{O}^{I V}\\right)+\\delta_{O}^{I V}\n\\]","text_display":"\n\\[\n\\bullet \\log \\left(\\lambda_{X}^{V}\\right)=\\log \\left(\\lambda_{X}^{I V}\\right)+\\delta_{X}^{I V} \\text { and } \\log \\left(\\lambda_{O}^{V}\\right)=\\log \\left(\\lambda_{O}^{I V}\\right)+\\delta_{O}^{I V}\n\\]","confidence":0.6629040688276291,"confidence_rate":0.9962353153451834},{"cnt":[[185,2204],[1968,2204],[1968,2258],[185,2258]],"region":{"top_left_x":184,"top_left_y":2204,"width":1784,"height":55},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18bf9f67ce1245c28477050007c73c5e","type":"text","conversion_output":true,"text":"Evidence from BIOFLOW- 11 study: It is first discounted using the discount factor \\(a^{H}\\). The discounted data are then","text_display":"\n\nEvidence from BIOFLOW- 11 study: It is first discounted using the discount factor \\(a^{H}\\). The discounted data are then","confidence":0.19498639602181558,"confidence_rate":0.9877833161217572},{"cnt":[[185,2254],[1841,2254],[1841,2310],[185,2310]],"region":{"top_left_x":184,"top_left_y":2253,"width":1658,"height":57},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"324079f020b34fc49430d42134f8f2ba","type":"text","conversion_output":true,"text":"assumed to follow Exponential distributions with hazard rates \\(\\lambda_{X}^{I I}\\) and \\(\\lambda_{O}^{I I}\\) in the Xience and Orsiro groups,","text_display":" assumed to follow Exponential distributions with hazard rates \\(\\lambda_{X}^{I I}\\) and \\(\\lambda_{O}^{I I}\\) in the Xience and Orsiro groups,","confidence":0.9834063053131104,"confidence_rate":0.9998741965434169},{"cnt":[[185,2305],[393,2305],[393,2353],[185,2353]],"region":{"top_left_x":184,"top_left_y":2305,"width":210,"height":48},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab403603855b4e64a79907fae80dcb0c","type":"text","conversion_output":true,"text":"respectively,","text_display":" respectively,","confidence":1,"confidence_rate":1},{"cnt":[[690,2363],[1515,2363],[1515,2434],[690,2434]],"region":{"top_left_x":689,"top_left_y":2363,"width":826,"height":72},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"067b57f4dd9e4e6a8ffb822d62a6c3ca","type":"math","conversion_output":true,"text":"\\[\nY_{X, i}^{I I} \\sim \\operatorname{exponential}\\left(\\lambda_{X}^{I I}\\right) \\text { and } Y_{O, i}^{I I} \\sim \\operatorname{exponential}\\left(\\lambda_{O}^{I I}\\right)\n\\]","text_display":"\n\\[\nY_{X, i}^{I I} \\sim \\operatorname{exponential}\\left(\\lambda_{X}^{I I}\\right) \\text { and } Y_{O, i}^{I I} \\sim \\operatorname{exponential}\\left(\\lambda_{O}^{I I}\\right)\n\\]","confidence":0.9804871038068086,"confidence_rate":0.9997810707895813},{"cnt":[[125,2501],[604,2501],[604,2537],[125,2537]],"region":{"top_left_x":124,"top_left_y":2500,"width":480,"height":38},"line":40,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fe69d9631962446ea2b34952a8c60664","type":"page_info","conversion_output":false,"text":"BIOFLOW-V Statistical Analysis Plan (SAP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[877,2501],[1128,2501],[1128,2535],[877,2535]],"region":{"top_left_x":876,"top_left_y":2500,"width":252,"height":36},"line":41,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"91d672d3876049439d1728bc350e952a","type":"page_info","conversion_output":false,"text":"Baim CONFIDENTIAL","text_display":"","confidence":0.5126953125,"confidence_rate":0.9700894655349293},{"cnt":[[1788,2501],[1951,2501],[1951,2537],[1788,2537]],"region":{"top_left_x":1787,"top_left_y":2500,"width":164,"height":38},"line":42,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fd9abecd8bdc45b9b35454ad67cffc10","type":"page_info","conversion_output":false,"text":"Page 15 of 21","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[125,2535],[505,2535],[505,2572],[125,2572]],"region":{"top_left_x":124,"top_left_y":2535,"width":381,"height":37},"line":43,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"96f9dd796416499f99d41fea0a2a001b","type":"page_info","conversion_output":false,"text":"14 September, 2017, Version 6.2","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"a2b4734a-0b6e-4d9e-a8b1-cd65b10f3aeb-19","page":19,"lines":[{"cnt":[[120,120],[260,120],[260,148],[120,148]],"region":{"top_left_x":120,"top_left_y":120,"width":140,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"3f3bfa9352c14765a5f9d27af43743ba","type":"page_info","conversion_output":false,"text":"BIOTRONIK","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1848,116],[1992,116],[1992,148],[1848,148]],"region":{"top_left_x":1847,"top_left_y":116,"width":145,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e8c416eca2fb40739e5dc0505afa8dda","type":"page_info","conversion_output":false,"text":"BIOFLOW-V","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1590,150],[2015,150],[2015,183],[1590,183]],"region":{"top_left_x":1589,"top_left_y":150,"width":427,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a2d76b76e89f4a329c97e6e27185854c","type":"page_info","conversion_output":false,"text":"Protocol \\# CIP FINAL v4.0 11Feb2016","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999755743071164},{"cnt":[[180,284],[1751,284],[1751,329],[180,329]],"region":{"top_left_x":180,"top_left_y":283,"width":1571,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ad31289abdd4adcaefbed75a8f36a3a","type":"text","conversion_output":true,"text":"A bias term is assumed to link the TLF rates in BIOFLOW-II and BIOFLOW-V in each treatment group.","text_display":"\n\nA bias term is assumed to link the TLF rates in BIOFLOW-II and BIOFLOW-V in each treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[621,361],[1517,361],[1517,428],[621,428]],"region":{"top_left_x":620,"top_left_y":360,"width":897,"height":68},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dcc68b19737743e4bbd8cbc90e44b4ba","type":"math","conversion_output":true,"text":"\\[\n\\log \\left(\\lambda_{X}^{V}\\right)=\\log \\left(\\lambda_{X}^{I I}\\right)+\\delta_{X}^{I I} \\text { and } \\log \\left(\\lambda_{O}^{V}\\right)=\\log \\left(\\lambda_{O}^{I I}\\right)+\\delta_{O}^{I I}\n\\]","text_display":"\n\\[\n\\log \\left(\\lambda_{X}^{V}\\right)=\\log \\left(\\lambda_{X}^{I I}\\right)+\\delta_{X}^{I I} \\text { and } \\log \\left(\\lambda_{O}^{V}\\right)=\\log \\left(\\lambda_{O}^{I I}\\right)+\\delta_{O}^{I I}\n\\]","confidence":0.8112582520116121,"confidence_rate":0.9980651257775216},{"cnt":[[180,460],[462,460],[462,511],[180,511]],"region":{"top_left_x":180,"top_left_y":459,"width":282,"height":53},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b60fcfdb2f34be8acd44a3e3113817c","type":"section_header","conversion_output":false,"children_ids":["020cf8c1658447748e92084cdff4a453"],"text":"","text_display":""},{"cnt":[[185,464],[458,464],[458,505],[185,505]],"region":{"top_left_x":184,"top_left_y":464,"width":274,"height":41},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"020cf8c1658447748e92084cdff4a453","type":"text","conversion_output":true,"parent_id":"9b60fcfdb2f34be8acd44a3e3113817c","text":"Prior distribution","text_display":"\n\n\\section*{Prior distribution}","confidence":1,"confidence_rate":1},{"cnt":[[183,529],[1850,529],[1850,576],[183,576]],"region":{"top_left_x":182,"top_left_y":528,"width":1668,"height":48},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"400b09369b2d4a34a88df5a23d6407fa","type":"text","conversion_output":true,"text":"The bias terms are assumed to follow a normal distribution with mean 0 and standard deviation \\(\\tau_{1}\\) and \\(\\tau_{2}\\).","text_display":"\n\nThe bias terms are assumed to follow a normal distribution with mean 0 and standard deviation \\(\\tau_{1}\\) and \\(\\tau_{2}\\).","confidence":1,"confidence_rate":1},{"cnt":[[737,606],[1463,606],[1463,763],[737,763]],"region":{"top_left_x":736,"top_left_y":605,"width":728,"height":158},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0db78eba4fb04f728943136a75c94a90","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& \\delta_{X}^{I I} \\sim \\operatorname{Normal}\\left(0, \\tau_{1}\\right) \\text { and } \\delta_{O}^{I I} \\sim \\operatorname{Normal}\\left(0, \\tau_{1}\\right) \\\\\n& \\delta_{X}^{I V} \\sim \\operatorname{Normal}\\left(0, \\tau_{2}\\right) \\text { and } \\delta_{O}^{I V} \\sim \\operatorname{Normal}\\left(0, \\tau_{2}\\right)\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& \\delta_{X}^{I I} \\sim \\operatorname{Normal}\\left(0, \\tau_{1}\\right) \\text { and } \\delta_{O}^{I I} \\sim \\operatorname{Normal}\\left(0, \\tau_{1}\\right) \\\\\n& \\delta_{X}^{I V} \\sim \\operatorname{Normal}\\left(0, \\tau_{2}\\right) \\text { and } \\delta_{O}^{I V} \\sim \\operatorname{Normal}\\left(0, \\tau_{2}\\right)\n\\end{aligned}\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[185,795],[1861,795],[1861,844],[185,844]],"region":{"top_left_x":184,"top_left_y":794,"width":1677,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42394d37cba843dc8324075bc6f0da1a","type":"text","conversion_output":true,"text":"As with primary endpoint analysis, a value of 0.3 will be assumed for both \\(\\tau_{1}\\) and \\(\\tau_{2}\\). Non-informative prior","text_display":"\n\nAs with primary endpoint analysis, a value of 0.3 will be assumed for both \\(\\tau_{1}\\) and \\(\\tau_{2}\\). Non-informative prior","confidence":1,"confidence_rate":1},{"cnt":[[185,842],[1188,842],[1188,889],[185,889]],"region":{"top_left_x":184,"top_left_y":842,"width":1005,"height":48},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88fd10e707aa48268a96184937f37384","type":"text","conversion_output":true,"text":"distributions are assumed for TLF rates in the BIOFLOW-V study","text_display":" distributions are assumed for TLF rates in the BIOFLOW-V study","confidence":1,"confidence_rate":1},{"cnt":[[711,920],[1489,920],[1489,986],[711,986]],"region":{"top_left_x":711,"top_left_y":919,"width":778,"height":68},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4dda33f5e9164078b780f75ee63f9366","type":"math","conversion_output":true,"text":"\\[\n\\lambda_{X}^{V} \\sim \\operatorname{gamma}(0.1,0.1) \\text { and } \\lambda_{O}^{V} \\sim \\operatorname{gamma}(0.1,0.1)\n\\]","text_display":"\n\\[\n\\lambda_{X}^{V} \\sim \\operatorname{gamma}(0.1,0.1) \\text { and } \\lambda_{O}^{V} \\sim \\operatorname{gamma}(0.1,0.1)\n\\]","confidence":0.99365234375,"confidence_rate":0.9999005066953699},{"cnt":[[185,1018],[1921,1018],[1921,1068],[185,1068]],"region":{"top_left_x":184,"top_left_y":1018,"width":1737,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1b2c6bde3bc4b4eb6fe398e19f0179f","type":"text","conversion_output":true,"text":"The non-inferiority condition will be expressed in terms of 1 -year TLF rates in the BIOFLOW-V study as with the","text_display":"\n\nThe non-inferiority condition will be expressed in terms of 1 -year TLF rates in the BIOFLOW-V study as with the","confidence":0.6220703125,"confidence_rate":0.9960519628221645},{"cnt":[[185,1068],[496,1068],[496,1115],[185,1115]],"region":{"top_left_x":184,"top_left_y":1067,"width":313,"height":49},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a8d39c9ff03c4433a339a764b4285d7c","type":"text","conversion_output":true,"text":"primary hypothesis","text_display":" primary hypothesis","confidence":1,"confidence_rate":1},{"cnt":[[726,1147],[1480,1147],[1480,1216],[726,1216]],"region":{"top_left_x":726,"top_left_y":1147,"width":755,"height":70},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c6e82c7256c440ab6af8fc49fe50efc","type":"math","conversion_output":true,"text":"\\[\nP\\left(H_{A} \\mid \\text { Data }\\right)=P\\left(\\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta \\mid \\text { Data }\\right)>\\pi^{*}\n\\]","text_display":"\n\\[\nP\\left(H_{A} \\mid \\text { Data }\\right)=P\\left(\\pi_{X}^{V}-\\pi_{O}^{V}>-\\delta \\mid \\text { Data }\\right)>\\pi^{*}\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[185,1250],[990,1250],[990,1291],[185,1291]],"region":{"top_left_x":184,"top_left_y":1250,"width":807,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f62675ef36b4d6e9ad485988f2f9bb5","type":"text","conversion_output":true,"text":"where the 12 -month TLF rates will be calculated as","text_display":"\nwhere the 12 -month TLF rates will be calculated as","confidence":0.9766987636685371,"confidence_rate":0.9996004696241236},{"cnt":[[730,1332],[1472,1332],[1472,1399],[730,1399]],"region":{"top_left_x":730,"top_left_y":1332,"width":742,"height":67},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc09153b666b4882926daa3e1f8685e6","type":"math","conversion_output":true,"text":"\\[\n\\pi_{X}^{V}=1-\\exp \\left(-\\lambda_{X}^{V}\\right) \\text { and } \\pi_{O}^{V}=1-\\exp \\left(-\\lambda_{O}^{V}\\right)\n\\]","text_display":"\n\\[\n\\pi_{X}^{V}=1-\\exp \\left(-\\lambda_{X}^{V}\\right) \\text { and } \\pi_{O}^{V}=1-\\exp \\left(-\\lambda_{O}^{V}\\right)\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[125,1439],[1914,1439],[1914,1485],[125,1485]],"region":{"top_left_x":124,"top_left_y":1439,"width":1791,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02dee9bebd144f5eaa0a2324170e2ff8","type":"text","conversion_output":true,"text":"4) A tipping point analysis will be carried out. Here, it is assumed that for all Xience patients with missing primary","text_display":"\n4) A tipping point analysis will be carried out. Here, it is assumed that for all Xience patients with missing primary","confidence":1,"confidence_rate":1},{"cnt":[[185,1485],[2007,1485],[2007,1532],[185,1532]],"region":{"top_left_x":184,"top_left_y":1484,"width":1823,"height":48},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1681bd48e6be4e25ab62de873b625246","type":"text","conversion_output":true,"text":"endpoint ( 12 -month TLF) status, TLF did not occur. For Orsiro patients with missing data, it will be first assumed that","text_display":" endpoint ( 12 -month TLF) status, TLF did not occur. For Orsiro patients with missing data, it will be first assumed that","confidence":0.6810166981927068,"confidence_rate":0.9970263799688394},{"cnt":[[185,1532],[2009,1532],[2009,1577],[185,1577]],"region":{"top_left_x":184,"top_left_y":1531,"width":1825,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eda7948a4e394c438794c536ee794803","type":"text","conversion_output":true,"text":"the primary endpoint of TLF occurred for exactly one such patient; then the primary analyses will be re-run to assess","text_display":" the primary endpoint of TLF occurred for exactly one such patient; then the primary analyses will be re-run to assess","confidence":0.9907269477844238,"confidence_rate":0.9999236396809937},{"cnt":[[185,1577],[1962,1577],[1962,1624],[185,1624]],"region":{"top_left_x":184,"top_left_y":1576,"width":1778,"height":49},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec635d496dd44bd3b167289056b45c4d","type":"text","conversion_output":true,"text":"if non-inferiority is met under this assumption. Then it will be assumed the primary endpoint occurred for exactly","text_display":" if non-inferiority is met under this assumption. Then it will be assumed the primary endpoint occurred for exactly","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[185,1624],[1886,1624],[1886,1671],[185,1671]],"region":{"top_left_x":184,"top_left_y":1624,"width":1703,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a603a2750bf4b828495027ca869f44e","type":"text","conversion_output":true,"text":"two Orsiro patients with missing data, and the primary non-inferiority analysis will be rerun. The process will","text_display":" two Orsiro patients with missing data, and the primary non-inferiority analysis will be rerun. The process will","confidence":1,"confidence_rate":1},{"cnt":[[185,1671],[1910,1671],[1910,1717],[185,1717]],"region":{"top_left_x":184,"top_left_y":1671,"width":1726,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16ad6a3a67f54dffa4074ea38baf6827","type":"text","conversion_output":true,"text":"continue sequentially in this manner until all Orsiro patients with missing data are considered to have met the","text_display":" continue sequentially in this manner until all Orsiro patients with missing data are considered to have met the","confidence":0.998046875,"confidence_rate":0.9999831463934391},{"cnt":[[185,1719],[1953,1719],[1953,1764],[185,1764]],"region":{"top_left_x":184,"top_left_y":1718,"width":1769,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e1bf45d1012472aa9b23e3c9af9da3f","type":"text","conversion_output":true,"text":"primary endpoint of TLF. Of interest is the \"tipping point\", or i.e., the number of imputed Orsiro TLFs where non-","text_display":" primary endpoint of TLF. Of interest is the \"tipping point\", or i.e., the number of imputed Orsiro TLFs where non","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[185,1766],[761,1766],[761,1811],[185,1811]],"region":{"top_left_x":184,"top_left_y":1766,"width":577,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3f6c4584072436fbcd344bb730c9ef4","type":"text","conversion_output":true,"text":"inferiority is not met in this analysis.","text_display":"inferiority is not met in this analysis.","confidence":1,"confidence_rate":1},{"cnt":[[120,1895],[750,1895],[750,1949],[120,1949]],"region":{"top_left_x":120,"top_left_y":1894,"width":630,"height":55},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a070d55206b49fda62e0b162a1e9f9a","type":"section_header","conversion_output":false,"children_ids":["69bc9d73bcb041719dddd1c90787985b"],"text":"","text_display":""},{"cnt":[[125,1901],[746,1901],[746,1944],[125,1944]],"region":{"top_left_x":124,"top_left_y":1901,"width":622,"height":44},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"69bc9d73bcb041719dddd1c90787985b","type":"text","conversion_output":true,"parent_id":"2a070d55206b49fda62e0b162a1e9f9a","text":"2.9 Analysis of Secondary Endpoints","text_display":"\n\n\\subsection*{2.9 Analysis of Secondary Endpoints}","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[125,1955],[1968,1955],[1968,2002],[125,2002]],"region":{"top_left_x":124,"top_left_y":1955,"width":1844,"height":48},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3ddb7c9ac634f63a77e000322ff7de2","type":"text","conversion_output":true,"text":"The secondary endpoints in the BIOFLOW-V study will be analyzed using frequentist methods. For each endpoint, the","text_display":"\n\nThe secondary endpoints in the BIOFLOW-V study will be analyzed using frequentist methods. For each endpoint, the","confidence":1,"confidence_rate":1},{"cnt":[[125,2002],[1996,2002],[1996,2050],[125,2050]],"region":{"top_left_x":124,"top_left_y":2002,"width":1872,"height":48},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0209f1aafd034bd6a2e9837cd9848ccd","type":"text","conversion_output":true,"text":"proportion and sample size will be calculated and reported for the Xience group and for the Orsiro group. Fisher's exact","text_display":" proportion and sample size will be calculated and reported for the Xience group and for the Orsiro group. Fisher's exact","confidence":1,"confidence_rate":1},{"cnt":[[125,2050],[1987,2050],[1987,2095],[125,2095]],"region":{"top_left_x":124,"top_left_y":2049,"width":1864,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b36895e10d8c4b7788ddd2439fd455a6","type":"text","conversion_output":true,"text":"test will be used to test the difference between the groups. Analyses of secondary endpoints will be carried out on the","text_display":" test will be used to test the difference between the groups. Analyses of secondary endpoints will be carried out on the","confidence":1,"confidence_rate":1},{"cnt":[[125,2097],[1914,2097],[1914,2142],[125,2142]],"region":{"top_left_x":124,"top_left_y":2096,"width":1791,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d986a8be25c4fe4961d756c6b4c8bbd","type":"text","conversion_output":true,"text":"ITT, Modified ITT and PP analysis sets for BIOFLOW-V. However, there will be no direct imputation of missing data.","text_display":" ITT, Modified ITT and PP analysis sets for BIOFLOW-V. However, there will be no direct imputation of missing data.","confidence":1,"confidence_rate":1},{"cnt":[[125,2144],[971,2144],[971,2189],[125,2189]],"region":{"top_left_x":124,"top_left_y":2144,"width":848,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a74641d278f4234b0f3c955ea5307ad","type":"text","conversion_output":true,"text":"Secondary Endpoints include the following measures:","text_display":" Secondary Endpoints include the following measures:","confidence":1,"confidence_rate":1},{"cnt":[[189,2213],[492,2213],[492,2258],[189,2258]],"region":{"top_left_x":189,"top_left_y":2212,"width":303,"height":47},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3a35de8f90f414096375ea80cedf9dc","type":"text","conversion_output":true,"text":"1) Device success","text_display":"\n1) Device 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\\# CIP FINAL v4.0 11Feb2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[120,284],[2000,284],[2000,331],[120,331]],"region":{"top_left_x":120,"top_left_y":283,"width":1881,"height":48},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81138d64fe1840eba1e4c8981f227018","type":"text","conversion_output":true,"text":"BIOFLOW-V will utilize the percent residual stenosis, as assessed by the investigator for the primary analysis measure of","text_display":"\n\nBIOFLOW-V will utilize the percent residual stenosis, as assessed by the investigator for the primary analysis measure of","confidence":0.9990234375,"confidence_rate":0.9999922457471451},{"cnt":[[120,331],[2000,331],[2000,376],[120,376]],"region":{"top_left_x":120,"top_left_y":330,"width":1881,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4fb9d3659de84faf9a94bf2379d1c1c2","type":"text","conversion_output":true,"text":"the \\% residual 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If investigator","text_display":" the \\% residual stenosis for evaluating angiographic success for the aforementioned secondary endpoints. If investigator","confidence":0.9746215343475342,"confidence_rate":0.9997927146056053},{"cnt":[[120,378],[1968,378],[1968,423],[120,423]],"region":{"top_left_x":120,"top_left_y":378,"width":1848,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a375cbf8c0343f988fb683c2322ceae","type":"text","conversion_output":true,"text":"assessment of residual stenosis is not available, the in stent final \\% diameter stenosis as assessed by QCA will be used.","text_display":" assessment of residual stenosis is not available, the in stent final \\% diameter stenosis as assessed by QCA will be used.","confidence":0.9990236759185791,"confidence_rate":0.9999922476411908},{"cnt":[[120,425],[1394,425],[1394,471],[120,471]],"region":{"top_left_x":120,"top_left_y":425,"width":1275,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c90014fb427487db8df23a0e988f2c8","type":"text","conversion_output":true,"text":"MACE included in the procedure success will use the primary analysis definitions.","text_display":" MACE included in the procedure success will use the primary analysis definitions.","confidence":1,"confidence_rate":1},{"cnt":[[120,518],[2013,518],[2013,563],[120,563]],"region":{"top_left_x":120,"top_left_y":517,"width":1894,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3aa417817eb64cc79af42f7db86daf5d","type":"text","conversion_output":true,"text":"Treatment group difference (Orsiro minus Xience) in the success rates and the two-sided \\(95 \\%\\) confidence intervals of the","text_display":"\n\nTreatment group difference (Orsiro minus Xience) in the success rates and the two-sided \\(95 \\%\\) confidence intervals of 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- and 12 -months and annually:","confidence":0.40395592526028196,"confidence_rate":0.993051564306995},{"cnt":[[185,726],[350,726],[350,771],[185,771]],"region":{"top_left_x":184,"top_left_y":726,"width":167,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"455903fdd8584225972d27682be669fa","type":"text","conversion_output":true,"text":"4) Death","text_display":"\n4) Death","confidence":1,"confidence_rate":1},{"cnt":[[185,782],[569,782],[569,827],[185,827]],"region":{"top_left_x":184,"top_left_y":782,"width":386,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9de511a7f67a4c1fa61ecd536800ae10","type":"text","conversion_output":true,"text":"5) Protocol-defined MI","text_display":"\n5) Protocol-defined 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adequate follow-up (e.g., at least 23 days","confidence":1,"confidence_rate":1},{"cnt":[[122,1216],[1906,1216],[1906,1261],[122,1261]],"region":{"top_left_x":122,"top_left_y":1216,"width":1784,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3926aa6b05474574a41ec1c059fe3a81","type":"text","conversion_output":true,"text":"for 1 -month time point, at least 166 days for the 6 -month time point, and at least 330 days for the 12 -month time","text_display":" for 1 -month time point, at least 166 days for the 6 -month time point, and at least 330 days for the 12 -month 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modified ITT and PP) and the BIOFLOW- II and -","text_display":" the two treatment groups in each BIOFLOW-V analysis population ( ITT, modified ITT and PP) and the BIOFLOW- II and ","confidence":0.7737944254186004,"confidence_rate":0.9978828308098618},{"cnt":[[125,1641],[1897,1641],[1897,1687],[125,1687]],"region":{"top_left_x":124,"top_left_y":1641,"width":1774,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b89ae0ceff4748e1b13a9300f62f3a9d","type":"text","conversion_output":true,"text":"IV Bayesian analysis population by treatment. 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Treatment difference on dichotomous variables will be evaluated using Fisher's exact tests. Categorical","text_display":" variables). Treatment difference on dichotomous variables will be evaluated using Fisher's exact tests. Categorical","confidence":0.99072265625,"confidence_rate":0.9999223309636159},{"cnt":[[125,1824],[1970,1824],[1970,1876],[125,1876]],"region":{"top_left_x":124,"top_left_y":1824,"width":1847,"height":52},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1501d563d8eb4e5497bfbfa9ce2a60d9","type":"text","conversion_output":true,"text":"variables will be compared between treatments using the Cochran-Mantel-Haenszel (CMH) Modified Ridit Scores \\({ }^{6}\\), i.e.","text_display":" variables will be compared between treatments using the Cochran-Mantel-Haenszel (CMH) Modified Ridit Scores \\({ }^{6}\\), i.e.","confidence":1,"confidence_rate":1},{"cnt":[[125,1876],[1680,1876],[1680,1921],[125,1921]],"region":{"top_left_x":124,"top_left_y":1875,"width":1557,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"409fe8c4df9c40e0b075c21d5b74b317","type":"text","conversion_output":true,"text":"CMH of general association for nominal variables and CMH of row mean score for ordinal variables.","text_display":" CMH of general association for nominal variables and CMH of row mean score for ordinal variables.","confidence":1,"confidence_rate":1},{"cnt":[[125,1968],[1467,1968],[1467,2013],[125,2013]],"region":{"top_left_x":124,"top_left_y":1967,"width":1344,"height":47},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28c818182c2b4b1490dafc5fc4c08022","type":"text","conversion_output":true,"text":"Continuous variables will be compared between treatments using two-sample t-tests.","text_display":"\n\nContinuous variables will be compared between treatments using two-sample t-tests.","confidence":0.9936552047729492,"confidence_rate":0.9999268416533622},{"cnt":[[120,2054],[526,2054],[526,2108],[120,2108]],"region":{"top_left_x":120,"top_left_y":2053,"width":407,"height":55},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"428d26faf08c4b3291f037c0c9328d82","type":"section_header","conversion_output":false,"children_ids":["e35b41b653d1424aa3791f503bb0e446"],"text":"","text_display":""},{"cnt":[[125,2058],[522,2058],[522,2103],[125,2103]],"region":{"top_left_x":124,"top_left_y":2058,"width":399,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e35b41b653d1424aa3791f503bb0e446","type":"text","conversion_output":true,"parent_id":"428d26faf08c4b3291f037c0c9328d82","text":"2.11 Subgroup Analysis","text_display":"\n\n\\subsection*{2.11 Subgroup Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[125,2114],[1824,2114],[1824,2159],[125,2159]],"region":{"top_left_x":124,"top_left_y":2114,"width":1701,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ed401b581ec488799693a54c5b55703","type":"text","conversion_output":true,"text":"Subgroups for primary endpoint (TLF at 12-Month) using Bayesian analysis for the BIOFLOW-V study include:","text_display":"\n\nSubgroups for primary endpoint (TLF at 12-Month) using Bayesian analysis for the BIOFLOW-V study include:","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[120,2366],[1979,2363],[1979,2460],[120,2462]],"region":{"top_left_x":120,"top_left_y":2363,"width":1859,"height":100},"line":37,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8672a2803c5c48cd862c7c35c0c2d431","type":"footnote","conversion_output":false,"children_ids":["38e35ef6dc264f979609e1cfb41017f0","ac04832f1ea34b6394d4abb26288ac6e"],"text":"","text_display":""},{"cnt":[[125,2372],[1972,2372],[1972,2419],[125,2419]],"region":{"top_left_x":124,"top_left_y":2371,"width":1849,"height":49},"line":38,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"38e35ef6dc264f979609e1cfb41017f0","type":"text","conversion_output":true,"parent_id":"8672a2803c5c48cd862c7c35c0c2d431","text":"\\({ }^{6}\\) van Elteren, P.H. (1960), \"On the Combination of Independent Two-Sample Tests of Wilcoxon,\" Bulletin of the International Statistical Institute,","text_display":"\n\n\\footnotetext{\n\\({ }^{6}\\) van Elteren, P.H. (1960), \"On the Combination of Independent Two-Sample Tests of Wilcoxon,\" Bulletin of the International Statistical Institute,","confidence":1,"confidence_rate":1},{"cnt":[[125,2419],[294,2419],[294,2456],[125,2456]],"region":{"top_left_x":124,"top_left_y":2419,"width":171,"height":37},"line":39,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ac04832f1ea34b6394d4abb26288ac6e","type":"text","conversion_output":true,"parent_id":"8672a2803c5c48cd862c7c35c0c2d431","text":"37, 351-361.","text_display":" 37, 351-361.\n}","confidence":1,"confidence_rate":1},{"cnt":[[127,2505],[604,2505],[604,2539],[127,2539]],"region":{"top_left_x":126,"top_left_y":2505,"width":478,"height":35},"line":40,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b3ce5dcf855b4722b48a52a57885fefc","type":"page_info","conversion_output":false,"text":"BIOFLOW-V Statistical Analysis Plan (SAP)","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999681327320658},{"cnt":[[881,2505],[1128,2505],[1128,2537],[881,2537]],"region":{"top_left_x":880,"top_left_y":2505,"width":248,"height":33},"line":41,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1a600cbcee694869a0cfd900f6392256","type":"page_info","conversion_output":false,"text":"Baim CONFIDENTIAL","text_display":"","confidence":0.71240234375,"confidence_rate":0.9847039890451357},{"cnt":[[1792,2505],[1953,2505],[1953,2537],[1792,2537]],"region":{"top_left_x":1791,"top_left_y":2505,"width":162,"height":33},"line":42,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4fea431d152c48dcaf39c1c4987b57cc","type":"page_info","conversion_output":false,"text":"Page 17 of 21","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[129,2539],[509,2539],[509,2572],[129,2572]],"region":{"top_left_x":128,"top_left_y":2539,"width":382,"height":33},"line":43,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7c6c440875d5489998815ff177de2a8b","type":"page_info","conversion_output":false,"text":"14 September, 2017, Version 6.2","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"a2b4734a-0b6e-4d9e-a8b1-cd65b10f3aeb-21","page":21,"lines":[{"cnt":[[125,120],[260,120],[260,148],[125,148]],"region":{"top_left_x":124,"top_left_y":120,"width":136,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"517f9d04d6f84cbe94ac97c24822ec11","type":"page_info","conversion_output":false,"text":"BIOTRONIK","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1852,120],[1992,120],[1992,144],[1852,144]],"region":{"top_left_x":1851,"top_left_y":120,"width":141,"height":24},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ae5dcb8032f94456930bf5d075f3c6a4","type":"page_info","conversion_output":false,"text":"BIOFLOW-V","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1590,150],[2013,150],[2013,183],[1590,183]],"region":{"top_left_x":1589,"top_left_y":150,"width":425,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"33d19d45f76646e7a8a80f0da053813e","type":"page_info","conversion_output":false,"text":"Protocol \\# CIP FINAL v4.0 11Feb2016","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[185,284],[1940,284],[1940,329],[185,329]],"region":{"top_left_x":184,"top_left_y":283,"width":1757,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"783fd8091723452cb69fa83a6b2f7a39","type":"text","conversion_output":true,"text":"1) Reference vessel diameter \\(\\leq 2.75 mm />2.75 mm\\). Subjects with at least one target lesion \\(\\leq 2.75 mm\\) will be","text_display":"\n1) Reference vessel diameter \\(\\leq 2.75 mm />2.75 mm\\). Subjects with at least one target lesion \\(\\leq 2.75 mm\\) will be","confidence":1,"confidence_rate":1},{"cnt":[[249,331],[896,331],[896,376],[249,376]],"region":{"top_left_x":249,"top_left_y":330,"width":647,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0121950ef944417fa58e86d519ea1c04","type":"text","conversion_output":true,"text":"classified with the small vessel subgroup.","text_display":" classified with the small vessel subgroup.","confidence":1,"confidence_rate":1},{"cnt":[[185,389],[1085,389],[1085,432],[185,432]],"region":{"top_left_x":184,"top_left_y":388,"width":901,"height":44},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81dc05a592924f259d87c1453aa8615f","type":"text","conversion_output":true,"text":"2) Subjects \\(>75\\) years of age/subjects \\(\\leq 75\\) years of age.","text_display":"\n2) Subjects \\(>75\\) years of age/subjects \\(\\leq 75\\) years of age.","confidence":0.99755859375,"confidence_rate":0.9999629644533816},{"cnt":[[185,443],[475,443],[475,488],[185,488]],"region":{"top_left_x":184,"top_left_y":442,"width":291,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5421316865d45a68ca37b6a2456880b","type":"text","conversion_output":true,"text":"3) Women/men.","text_display":"\n3) Women/men.","confidence":1,"confidence_rate":1},{"cnt":[[185,503],[1033,503],[1033,548],[185,548]],"region":{"top_left_x":184,"top_left_y":502,"width":850,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77defaa9489745cf8a2745eeb6938fec","type":"text","conversion_output":true,"text":"4) Subjects with diabetes/subjects without diabetes.","text_display":"\n4) Subjects with diabetes/subjects without diabetes.","confidence":1,"confidence_rate":1},{"cnt":[[185,559],[969,559],[969,604],[185,604]],"region":{"top_left_x":184,"top_left_y":558,"width":785,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b05194be530410eb5121e27f41d0998","type":"text","conversion_output":true,"text":"5) Lesion length \\(>26 mm\\) and \\(\\leq 26 mm\\) in length","text_display":"\n5) Lesion length \\(>26 mm\\) and \\(\\leq 26 mm\\) in length","confidence":0.99560546875,"confidence_rate":0.9999253550642931},{"cnt":[[185,614],[1283,614],[1283,660],[185,660]],"region":{"top_left_x":184,"top_left_y":614,"width":1099,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13c942f2a44442aeb9ab7fc3b9813867","type":"text","conversion_output":true,"text":"6) Single stents versus overlapping stents for lesion lengths \\(>26 mm\\)","text_display":"\n6) Single stents versus overlapping stents for lesion lengths \\(>26 mm\\)","confidence":0.8840868748957291,"confidence_rate":0.9983365209769216},{"cnt":[[185,675],[993,675],[993,718],[185,718]],"region":{"top_left_x":184,"top_left_y":674,"width":809,"height":44},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c96b00e82f14904a2f4f4eaff8be007","type":"text","conversion_output":true,"text":"7) Subjects with baseline ACS versus without ACS.","text_display":"\n7) Subjects with baseline ACS versus without ACS.","confidence":0.9965834617614746,"confidence_rate":0.9999366244540019},{"cnt":[[922,730],[1283,730],[1283,769],[922,769]],"region":{"top_left_x":921,"top_left_y":730,"width":362,"height":40},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5008b32165a2435da3b3d316afeafb38","type":"text","conversion_output":true,"text":"ACS will be defined as:","text_display":"\n\nACS will be defined as:","confidence":1,"confidence_rate":1},{"cnt":[[335,778],[1867,775],[1867,819],[335,821]],"region":{"top_left_x":335,"top_left_y":774,"width":1533,"height":48},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"432f99071c724b67b26ec1bdca12626a","type":"text","conversion_output":true,"text":"Subjects with unstable angina or Braunwald Class IIB or any elevated cardiac enzymes at baseline.","text_display":"\nSubjects with unstable angina or Braunwald Class IIB or any elevated cardiac enzymes at baseline.","confidence":1,"confidence_rate":1},{"cnt":[[122,868],[1992,868],[1992,913],[122,913]],"region":{"top_left_x":122,"top_left_y":867,"width":1870,"height":47},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf8294d833244addb015b265a3d8d4db","type":"text","conversion_output":true,"text":"Treatment group difference (Orsiro minus Xience) in the primary endpoint rate and the two-sided \\(95 \\%\\) credible interval","text_display":"\n\nTreatment group difference (Orsiro minus Xience) in the primary endpoint rate and the two-sided \\(95 \\%\\) credible interval","confidence":0.99951171875,"confidence_rate":0.9999960928036482},{"cnt":[[122,915],[2013,915],[2013,960],[122,960]],"region":{"top_left_x":122,"top_left_y":915,"width":1892,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33bc785b461d480e97ee5f4b70a4b848","type":"text","conversion_output":true,"text":"of the difference will be presented within each subgroup. Only BIOFLOW-V data will be included in these analyses. A test","text_display":" of the difference will be presented within each subgroup. Only BIOFLOW-V data will be included in these analyses. A test","confidence":0.99951171875,"confidence_rate":0.9999960928036482},{"cnt":[[125,958],[1955,958],[1955,1008],[125,1008]],"region":{"top_left_x":124,"top_left_y":958,"width":1832,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35e40fc58c2a479c87bdcf7199842b82","type":"text","conversion_output":true,"text":"of interaction on the primary endpoint will be performed to formally assess heterogeneity of treatment effect on the","text_display":" of interaction on the primary endpoint will be performed to formally assess heterogeneity of treatment effect on the","confidence":1,"confidence_rate":1},{"cnt":[[125,1008],[1901,1008],[1901,1055],[125,1055]],"region":{"top_left_x":124,"top_left_y":1007,"width":1778,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7539217bc4774891bd463f5291ce82f2","type":"text","conversion_output":true,"text":"primary endpoint across subgroups in the same manner that will be used the assessment of region heterogeneity","text_display":" primary endpoint across subgroups in the same manner that will be used the assessment of region heterogeneity","confidence":1,"confidence_rate":1},{"cnt":[[125,1053],[1983,1053],[1983,1102],[125,1102]],"region":{"top_left_x":124,"top_left_y":1052,"width":1860,"height":51},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4dd4489eccd8468a89f2c207d643de88","type":"text","conversion_output":true,"text":"discussed above. The purpose of this analysis is not to formally assess non-inferiority within each subgroup, but simply","text_display":" discussed above. The purpose of this analysis is not to formally assess non-inferiority within each subgroup, but simply","confidence":1,"confidence_rate":1},{"cnt":[[122,1100],[1983,1100],[1983,1147],[122,1147]],"region":{"top_left_x":122,"top_left_y":1100,"width":1862,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3de29ed7b1645d5b93749511f1ae152","type":"text","conversion_output":true,"text":"to assess consistency of results across the various subgroups. Subjects with an event or with appropriate follow-up will","text_display":" to assess consistency of results across the various subgroups. Subjects with an event or with appropriate follow-up will","confidence":1,"confidence_rate":1},{"cnt":[[125,1147],[556,1147],[556,1192],[125,1192]],"region":{"top_left_x":124,"top_left_y":1147,"width":433,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2797a6f7cef482bbc970254852552ca","type":"text","conversion_output":true,"text":"be included in this analysis.","text_display":" be included in this analysis.","confidence":1,"confidence_rate":1},{"cnt":[[120,1280],[597,1280],[597,1330],[120,1330]],"region":{"top_left_x":120,"top_left_y":1280,"width":478,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a7e6d04429e48f092c43108e3cb95d8","type":"section_header","conversion_output":false,"children_ids":["3878832b450f48af9dc765ae5677eee8"],"text":"","text_display":""},{"cnt":[[125,1285],[595,1285],[595,1326],[125,1326]],"region":{"top_left_x":124,"top_left_y":1284,"width":472,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3878832b450f48af9dc765ae5677eee8","type":"text","conversion_output":true,"parent_id":"1a7e6d04429e48f092c43108e3cb95d8","text":"2.12 Adverse Event Analysis","text_display":"\n\n\\subsection*{2.12 Adverse Event Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[125,1388],[1618,1388],[1618,1433],[125,1433]],"region":{"top_left_x":124,"top_left_y":1387,"width":1494,"height":47},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e84abe3d0f6425aadf0a642f27fb6ea","type":"text","conversion_output":true,"text":"Adverse events collected in the BIOFLOW-V data will be summarized using descriptive statistics","text_display":"\n\nAdverse events collected in the BIOFLOW-V data will be summarized using descriptive statistics","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[185,1457],[1433,1457],[1433,1504],[185,1504]],"region":{"top_left_x":184,"top_left_y":1456,"width":1250,"height":48},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"895fe4d4478a4b45802e74079afd426a","type":"text","conversion_output":true,"text":"- Site-reported U(S)ADE presented by system organ class and preferred term","text_display":"\n- Site-reported U(S)ADE presented by system organ class and preferred term","confidence":1,"confidence_rate":1},{"cnt":[[185,1508],[1343,1508],[1343,1558],[185,1558]],"region":{"top_left_x":184,"top_left_y":1508,"width":1159,"height":50},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"318d20b063674249bd7a6b6456b522d7","type":"text","conversion_output":true,"text":"- Site-reported AE presented by system organ class and preferred term","text_display":"\n- Site-reported AE presented by system organ class and preferred term","confidence":1,"confidence_rate":1},{"cnt":[[185,1560],[1360,1560],[1360,1609],[185,1609]],"region":{"top_left_x":184,"top_left_y":1559,"width":1176,"height":51},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e2734175cf1471cbd9c1821e63f4ce6","type":"text","conversion_output":true,"text":"- Site-reported SAE presented by system organ class and preferred term","text_display":"\n- Site-reported SAE presented by system organ class and preferred term","confidence":1,"confidence_rate":1},{"cnt":[[185,1611],[1590,1611],[1590,1661],[185,1661]],"region":{"top_left_x":184,"top_left_y":1611,"width":1406,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"69169628eedc4c708de47579d91f5941","type":"text","conversion_output":true,"text":"- Site-reported device-related AEs presented by system organ class and preferred term","text_display":"\n- Site-reported device-related AEs presented by system organ class and preferred term","confidence":1,"confidence_rate":1},{"cnt":[[125,1714],[1901,1714],[1901,1760],[125,1760]],"region":{"top_left_x":124,"top_left_y":1714,"width":1778,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1886e4cb6394d2ea1a405de3f69580c","type":"text","conversion_output":true,"text":"Posterior probability calculations comparing the treatment groups will only be presented for AEs and SAEs whose","text_display":"\n\nPosterior probability calculations comparing the treatment groups will only be presented for AEs and SAEs whose","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[125,1757],[1962,1757],[1962,1807],[125,1807]],"region":{"top_left_x":124,"top_left_y":1757,"width":1838,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51469c6e7aae464c9fbe2f7376963e63","type":"text","conversion_output":true,"text":"frequency exceeds 10 . If \\(p_{O}\\) and \\(p_{X}\\) are the probability of the AE with the Orsiro and Xience stents, we will report the","text_display":" frequency exceeds 10 . If \\(p_{O}\\) and \\(p_{X}\\) are the probability of the AE with the Orsiro and Xience stents, we will report the","confidence":0.7348190899938345,"confidence_rate":0.9979060664587476},{"cnt":[[125,1805],[1940,1805],[1940,1854],[125,1854]],"region":{"top_left_x":124,"top_left_y":1804,"width":1817,"height":51},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1fcf21800bd34d86859efcd925346ea2","type":"text","conversion_output":true,"text":"posterior distribution that \\(p_{O}>p_{X}\\), that is, the posterior probability that the probability of the AE is larger with the","text_display":" posterior distribution that \\(p_{O}>p_{X}\\), that is, the posterior probability that the probability of the AE is larger with the","confidence":0.8492674827575684,"confidence_rate":0.9988500906246179},{"cnt":[[125,1852],[1972,1852],[1972,1901],[125,1901]],"region":{"top_left_x":124,"top_left_y":1851,"width":1849,"height":51},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e43dc810b7124b06bb7727dc73c038f7","type":"text","conversion_output":true,"text":"Orsiro stent than with Xience stent. Non-informative independent priors Beta (0.1, 0.1) will be assumed on \\(p_{O}\\) and \\(p_{X}\\),","text_display":" Orsiro stent than with Xience stent. Non-informative independent priors Beta (0.1, 0.1) will be assumed on \\(p_{O}\\) and \\(p_{X}\\),","confidence":0.5247198780095889,"confidence_rate":0.9955004281963473},{"cnt":[[124,1944],[125,1898],[334,1902],[333,1948]],"region":{"top_left_x":123,"top_left_y":1897,"width":211,"height":52},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f5bb3c57c70744ca88477043f0495566","type":"text","conversion_output":true,"text":"respectively.","text_display":" 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Zip files will be opened using WinZip software and their contents will be extracted to the","text_display":" stored, per guideline GIT.011. Zip files will be opened using WinZip software and their contents will be extracted to the","confidence":0.9965834617614746,"confidence_rate":0.9999728385598874},{"cnt":[[125,838],[1949,838],[1949,887],[125,887]],"region":{"top_left_x":124,"top_left_y":837,"width":1825,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2742d4f51914bc583418e59a099bd29","type":"text","conversion_output":true,"text":"same subfolders. Baim's Project Management representative will be notified once the download and extract of both","text_display":" same subfolders. 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The detailed schematic of the steps, qualify control (QC) associated with the data merge process are","text_display":"IV and BIOFLOW-V. 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