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\\multirow[b]{3}{*}{Study Assessments} & \\multicolumn{3}{|c|}{Screening} & \\multicolumn{12}{|c|}{Treatment Period} & \\multicolumn{2}{|c|}{End of Study} & Early Termi nation & Unsch eduled Visit \\\\\n\\hline & V1 & V2 & \\(V 3 ^{ 1 }\\) & V4 \\({ }^{ 1 }\\) & PC & V5 & PC & V6 & PC & V7 & PC & V8 & PC & V9 & V10 & V11 & V12 & ET & UV \\({ }^{ 2 }\\) \\\\\n\\hline & D-42 & & & D1 & D4 & D8 & D22 & M1 & M2 & M3 & M4.5 & M6 & M7.5 & M9 & M12 & & & & \\\\\n\\hline Informed consent & X & & & & & & & & & & & & & & & & & & \\\\\n\\hline Eligibility (inclusion/exclusion criteria) & \\(X ^{ 3 }\\) & & & X & & & & & & & & & & & & & & & \\\\\n\\hline Medical history \\({ }^{4}\\) & X & & & & & & & & & & & & & & & & & & \\\\\n\\hline Parental medical history of atopy & X & & & & & & & & & & & & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & & & & & & & & & & & & \\\\\n\\hline Physical examination \\({ }^{5}\\) & x & \\(X ^{6}\\) & \\(X ^{6}\\) & x & & x & & x & & x & & x & & X & \\(X ^{6}\\) & \\(X ^{6}\\) & x & x & X \\\\\n\\hline Vital signs7 & X & \\(X ^{6}\\) & \\(X ^{6}\\) & X & & X & & X & & X & & X & & X & \\(X ^{6}\\) & \\(X ^{6}\\) & X & X & X \\\\\n\\hline Spirometry (FEV \\({ }_{1}{ }^{8}\\) & X & & & & & & & & & X & & X & & X & X & & & X & X \\\\\n\\hline PEF & X & \\(X ^{6}\\) & \\(X ^{6}\\) & x & & X & & x & & X & & X & & X & \\(X ^{6}\\) & \\(X ^{6}\\) & & X & X \\\\\n\\hline SCORAD & X & & & & & & & & & X & & X & & & X & & & & \\\\\n\\hline Skin Prick Test & X & & & & & & & & & X & & X & & & X & & & X & \\\\\n\\hline Immunological markers \\({ }^{9}\\) & X & & & & & & & & & X & & X & & & X & & & X & \\\\\n\\hline Laboratory tests \\({ }^{10}\\) & X & & & & & & & & & X & & X & & & X & & & X & \\(X\\) \\\\\n\\hline FAQLQ/FAIM \\({ }^{11}\\) & X & & & & & & & & & & & & & & X & & & & \\\\\n\\hline Filaggrin gene: informed consent - blood sampling & & & & & & & & & & \\(X ^{ 1 2 }\\) & & \\(X ^{ 1 2 }\\) & & & \\(X ^{ 1 2 }\\) & & & & \\\\\n\\hline Pregnancy test & X & & & & & & & & & & & & & & X & & & \\(X\\) & \\\\\n\\hline Epigenetic analyses & X & & & & & & & & & \\(X\\) & & X & & & X & & & & \\\\\n\\hline DBPCFC & & X & X & & & & & & & & & & & & X & X & & & \\\\\n\\hline Randomization & & & & X & & & & & & & & & & & & & & & \\\\\n\\hline Adverse events & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Concomitant medications & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 1: Schedule of Procedures}\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline \\multirow[b]{3}{*}{Study Assessments} & \\multicolumn{3}{|c|}{Screening} & \\multicolumn{12}{|c|}{Treatment Period} & \\multicolumn{2}{|c|}{End of Study} & Early Termi nation & Unsch eduled Visit \\\\\n\\hline & V1 & V2 & \\(V 3 ^{ 1 }\\) & V4 \\({ }^{ 1 }\\) & PC & V5 & PC & V6 & PC & V7 & PC & V8 & PC & V9 & V10 & V11 & V12 & ET & UV \\({ }^{ 2 }\\) \\\\\n\\hline & D-42 & & & D1 & D4 & D8 & D22 & M1 & M2 & M3 & M4.5 & M6 & M7.5 & M9 & M12 & & & & \\\\\n\\hline Informed consent & X & & & & & & & & & & & & & & & & & & \\\\\n\\hline Eligibility (inclusion/exclusion criteria) & \\(X ^{ 3 }\\) & & & X & & & & & & & & & & & & & & & \\\\\n\\hline Medical history \\({ }^{4}\\) & X & & & & & & & & & & & & & & & & & & \\\\\n\\hline Parental medical history of atopy & X & & & & & & & & & & & & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & & & & & & & & & & & & \\\\\n\\hline Physical examination \\({ }^{5}\\) & x & \\(X ^{6}\\) & \\(X ^{6}\\) & x & & x & & x & & x & & x & & X & \\(X ^{6}\\) & \\(X ^{6}\\) & x & x & X \\\\\n\\hline Vital signs7 & X & \\(X ^{6}\\) & \\(X ^{6}\\) & X & & X & & X & & X & & X & & X & \\(X ^{6}\\) & \\(X ^{6}\\) & X & X & X \\\\\n\\hline Spirometry (FEV \\({ }_{1}{ }^{8}\\) & X & & & & & & & & & X & & X & & X & X & & & X & X 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D = Day; DBPCFC = Double-blind, placebo-controlled food challenge; ET = Early termination; FAQLQ/FAIM = Food Allergy Quality of Life","text_display":"\nAbbreviations: D = Day; DBPCFC = Double-blind, placebo-controlled food challenge; ET = Early termination; FAQLQ/FAIM = Food Allergy Quality of Life","confidence":0.6923387273679066,"confidence_rate":0.9975839762375583},{"cnt":[[899,411],[943,411],[943,2559],[899,2559]],"region":{"top_left_x":899,"top_left_y":410,"width":45,"height":2150},"line":94,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"296de1a7e982402daf3529a9560d63f3","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"Questionnaire/Food Allergy Independent Measure; FEV \\({ }_{1}=\\) Forced expiratory volume in one second; \\(M =\\) Month; \\(P C =\\) Phone contact; \\(PEF =\\) Peak expiratory","text_display":" Questionnaire/Food Allergy Independent Measure; FEV \\({ }_{1}=\\) Forced expiratory volume in one second; \\(M =\\) Month; \\(P C =\\) Phone contact; \\(PEF =\\) Peak expiratory","confidence":0.15974513292771733,"confidence_rate":0.989690932181309},{"cnt":[[938,1148],[980,1148],[980,2559],[938,2559]],"region":{"top_left_x":938,"top_left_y":1147,"width":42,"height":1413},"line":95,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96fa3f62498b40469fb7263bca7b32ff","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"flow; SCORAD = Scoring atopic dermatitis; SPT = Skin prick test; UV = Unscheduled Visit; V = Visit.","text_display":" flow; SCORAD = Scoring atopic dermatitis; SPT = Skin prick test; UV = Unscheduled Visit; V = Visit.","confidence":0.5055833235383034,"confidence_rate":0.9934633572126015},{"cnt":[[1783,2509],[1825,2509],[1825,2573],[1783,2573]],"region":{"top_left_x":1783,"top_left_y":2508,"width":42,"height":65},"line":96,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99014a2a512f49d8946c81b7f9ce014f","type":"page_info","conversion_output":false,"parent_id":"14cb00011d224f3594204a01159a6320","text":"CCI","text_display":"","confidence":0.998535871389322,"confidence_rate":0.9998168665841808},{"cnt":[[978,365],[1021,365],[1021,2490],[978,2490]],"region":{"top_left_x":977,"top_left_y":364,"width":45,"height":2127},"line":97,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b371985b3e464f33bc1f75f393ad1aec","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"1 Visit 3 within 2 weeks of V2 and through D-1. Visit 4 may take place on the same day as Visit 3, but this would result in a very long day for the subject","text_display":"\n1 Visit 3 within 2 weeks of V2 and through D-1. Visit 4 may take place on the same day as Visit 3, but this would result in a very long day for the subject","confidence":0.99951171875,"confidence_rate":0.9999970928584037},{"cnt":[[1017,1212],[1058,1212],[1058,2430],[1017,2430]],"region":{"top_left_x":1016,"top_left_y":1212,"width":43,"height":1219},"line":98,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"570a3e712fd1401e97d67a2d2da2e60c","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"(parents/guardians) as all Visit 4 procedures would then have to take place that same day.","text_display":" (parents/guardians) as all Visit 4 procedures would then have to take place that same day.","confidence":1,"confidence_rate":1},{"cnt":[[1056,535],[1097,535],[1097,2490],[1056,2490]],"region":{"top_left_x":1055,"top_left_y":535,"width":43,"height":1956},"line":99,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f480c07787174bf9847a7e1dd74fcde0","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"2 Unscheduled Visit in case of AEs, need for treatment re-supply, etc. Procedures will be performed as deemed necessary by the investigator.","text_display":"\n2 Unscheduled Visit in case of AEs, need for treatment re-supply, etc. Procedures will be performed as deemed necessary by the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[1093,457],[1136,457],[1136,2490],[1093,2490]],"region":{"top_left_x":1092,"top_left_y":456,"width":45,"height":2035},"line":100,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06906e78f4e34d25b4fb5a650af222df","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"3 Except for those that depend on the results of the immunological markers testing (peamut-specific IgE ) and on the outcome of the entry/screening","text_display":"\n3 Except for those that depend on the results of the immunological markers testing (peamut-specific IgE ) and on the outcome of the entry/screening","confidence":0.7362756740029681,"confidence_rate":0.9980518957345266},{"cnt":[[1134,2281],[1169,2281],[1169,2430],[1134,2430]],"region":{"top_left_x":1134,"top_left_y":2280,"width":35,"height":151},"line":101,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8deee61c6924611b24a0cd4d3358521","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"DBPCFC.","text_display":" DBPCFC.","confidence":0.998046875,"confidence_rate":0.9998370937010221},{"cnt":[[1171,1944],[1215,1944],[1215,2490],[1171,2490]],"region":{"top_left_x":1170,"top_left_y":1944,"width":45,"height":547},"line":102,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e6c887a81c954aab90e7f940b71201f4","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"4 Including history of peanut allergy.","text_display":"\n4 Including history of peanut allergy.","confidence":1,"confidence_rate":1},{"cnt":[[1212,1551],[1252,1551],[1252,2490],[1212,2490]],"region":{"top_left_x":1212,"top_left_y":1550,"width":40,"height":941},"line":103,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5fd7b782d4f9439aaebe6336143b6457","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"5 Including a complete skin examination, body weight and height.","text_display":"\n5 Including a complete skin examination, body weight and height.","confidence":1,"confidence_rate":1},{"cnt":[[1249,429],[1293,429],[1293,2490],[1249,2490]],"region":{"top_left_x":1249,"top_left_y":429,"width":45,"height":2062},"line":104,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d541a07c9254be2b2199fdfb1780fac","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"6 These examinations are to be done before the DBPCFC. Additionally, they can be repeated during the DBPCFC procedure on both days anytime if","text_display":"\n6 These examinations are to be done before the DBPCFC. Additionally, they can be repeated during the DBPCFC procedure on both days anytime if","confidence":1,"confidence_rate":1},{"cnt":[[1291,1917],[1330,1917],[1330,2435],[1291,2435]],"region":{"top_left_x":1290,"top_left_y":1916,"width":40,"height":519},"line":105,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74be6b611a9f4a61ae7e5e8bb54c2848","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"judged necessary by the Investigator.","text_display":" judged necessary by the Investigator.","confidence":1,"confidence_rate":1},{"cnt":[[1328,1795],[1367,1795],[1367,2490],[1328,2490]],"region":{"top_left_x":1327,"top_left_y":1794,"width":40,"height":697},"line":106,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a1ff37aa65b4933964b02e71267c775","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"7 Blood pressure, heart rate and respiratory rate.","text_display":"\n7 Blood pressure, heart rate and respiratory rate.","confidence":1,"confidence_rate":1},{"cnt":[[1364,1608],[1408,1608],[1408,2490],[1364,2490]],"region":{"top_left_x":1364,"top_left_y":1608,"width":45,"height":883},"line":107,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2af2e9aef00a456e834acdecd7d2886a","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"8 FEV1 will be measured in subjects 6 years of age and older.","text_display":"\n8 FEV1 will be measured in subjects 6 years of age and older.","confidence":1,"confidence_rate":1},{"cnt":[[1406,346],[1450,346],[1450,2492],[1406,2492]],"region":{"top_left_x":1405,"top_left_y":346,"width":45,"height":2147},"line":108,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4448c28a0e174bfa976992b1ed10912d","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"9 Peanut-specific IgE, peanut-specific IgG4, peanut specific IgE and peanut specific IgG4 to Ara h 1, Ara h 2, Ara h 3, Ara h 8 and Ara h 9. IgE specific to","text_display":"\n9 Peanut-specific IgE, peanut-specific IgG4, peanut specific IgE and peanut specific IgG4 to Ara h 1, Ara h 2, Ara h 3, Ara h 8 and Ara h 9. IgE specific to","confidence":0.994631290435791,"confidence_rate":0.99996697494488},{"cnt":[[1443,485],[1486,485],[1486,2430],[1443,2430]],"region":{"top_left_x":1442,"top_left_y":484,"width":45,"height":1947},"line":109,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b597489fc5c54879be5e9050591acf10","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"cow's milk, egg white, house dust mites, and grass pollen will be collected at Visit 1 and Visit 10 only and in case of an early termination visit.","text_display":" cow's milk, egg white, house dust mites, and grass pollen will be collected at Visit 1 and Visit 10 only and in case of an early termination visit.","confidence":0.996584415435791,"confidence_rate":0.9999783456079433},{"cnt":[[1484,434],[1526,434],[1526,2490],[1484,2490]],"region":{"top_left_x":1484,"top_left_y":433,"width":42,"height":2058},"line":110,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef9f06ae73374906b75075b662dba3e4","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"10 Laboratory tests performed centrally. Hematology: hemoglobin, hematocrit, platelets, red blood cells, white blood cells with differential cell count.","text_display":"\n10 Laboratory tests performed centrally. Hematology: hemoglobin, hematocrit, platelets, red blood cells, white blood cells with differential cell count.","confidence":1,"confidence_rate":1},{"cnt":[[1521,685],[1562,685],[1562,2430],[1521,2430]],"region":{"top_left_x":1520,"top_left_y":684,"width":43,"height":1747},"line":111,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"467e568ef9234707bc1bb15059c18339","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"Biochemistry: aspartate aminotransferase, alanine aminotransferase, total bilirubin, total protein, blood urea nitrogen, creatinine.","text_display":" Biochemistry: aspartate aminotransferase, alanine aminotransferase, total bilirubin, total protein, blood urea nitrogen, creatinine.","confidence":1,"confidence_rate":1},{"cnt":[[1558,342],[1602,342],[1602,2490],[1558,2490]],"region":{"top_left_x":1557,"top_left_y":341,"width":45,"height":2150},"line":112,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff9cd281af0848508c2a7498463bc352","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"11 For both FAQLQ and FAIM, subjects \\(\\geq 8\\) years of age will use the Child Form of the FAQLQ/FAIM. All parents/guardians will use the Parental Form for","text_display":"\n11 For both FAQLQ and FAIM, subjects \\(\\geq 8\\) years of age will use the Child Form of the FAQLQ/FAIM. All parents/guardians will use the Parental Form for","confidence":0.99951171875,"confidence_rate":0.9999968490340088},{"cnt":[[1597,667],[1638,667],[1638,2430],[1597,2430]],"region":{"top_left_x":1596,"top_left_y":666,"width":43,"height":1765},"line":113,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"33a192d3d4144e83927a443df853e8fb","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"children. The specific forms of FAQLQ and FAIM will be completed in the countries where they are available in local languages.","text_display":" children. 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However, collection of","confidence":1,"confidence_rate":1},{"cnt":[[1675,1346],[1717,1346],[1717,2430],[1675,2430]],"region":{"top_left_x":1675,"top_left_y":1345,"width":42,"height":1086},"line":115,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ab501c97e5e4eaea572f42e6cb37749","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"blood is recommended only once at any of the following visits: Visit 7,8 or 10 .","text_display":" blood is recommended only once at any of the following visits: Visit 7,8 or 10 .","confidence":0.6347676191944629,"confidence_rate":0.9950179867540764},{"cnt":[[1714,372],[1758,372],[1758,2490],[1714,2490]],"region":{"top_left_x":1714,"top_left_y":371,"width":45,"height":2120},"line":116,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7eae3a8bbe64e0ca38641dc636e99d4","type":"text","conversion_output":true,"parent_id":"14cb00011d224f3594204a01159a6320","text":"13 Check the reaction of the skin on the back of the subject and grade the severity of the local skin reactions. 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the last study visit date, the","confidence":1,"confidence_rate":1},{"cnt":[[361,745],[1830,745],[1830,790],[361,790]],"region":{"top_left_x":360,"top_left_y":744,"width":1470,"height":47},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"090bc1e234604f558a12359f4e11d6c5","type":"text","conversion_output":true,"text":"study duration (in days - calculated as last study visit exit date - first date of consent for","text_display":" study duration (in days - calculated as last study visit exit date - first date of consent for","confidence":0.98779296875,"confidence_rate":0.9998759455843587},{"cnt":[[361,790],[788,790],[788,838],[361,838]],"region":{"top_left_x":360,"top_left_y":790,"width":429,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"21840da20cc84783bb3df680b1248903","type":"text","conversion_output":true,"text":"first screened subject +1 ).","text_display":" first screened subject +1 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Listings will also","text_display":"\nStudy disposition and termination details will be listed for each subject. Listings will also","confidence":1,"confidence_rate":1},{"cnt":[[361,884],[1793,884],[1793,930],[361,930]],"region":{"top_left_x":360,"top_left_y":884,"width":1434,"height":46},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11c9937c162f4c53afa65cf7dcd83f39","type":"text","conversion_output":true,"text":"be created to show the study analysis set classifications and randomization assignments.","text_display":" be created to show the study analysis set classifications and randomization assignments.","confidence":1,"confidence_rate":1},{"cnt":[[356,1019],[834,1019],[834,1067],[356,1067]],"region":{"top_left_x":356,"top_left_y":1018,"width":478,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee45f6f8800542ec935dc8a0f74eb604","type":"section_header","conversion_output":false,"children_ids":["571b6d34c7af46cba5ac7c37dab1c0c2"],"text":"","text_display":""},{"cnt":[[361,1023],[829,1023],[829,1065],[361,1065]],"region":{"top_left_x":360,"top_left_y":1023,"width":470,"height":42},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"571b6d34c7af46cba5ac7c37dab1c0c2","type":"text","conversion_output":true,"parent_id":"ee45f6f8800542ec935dc8a0f74eb604","text":"4.3.2 Protocol Deviations","text_display":"\n\n\\subsection*{4.3.2 Protocol Deviations}","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[361,1110],[1825,1110],[1825,1158],[361,1158]],"region":{"top_left_x":360,"top_left_y":1110,"width":1466,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a07203779ea64da18f6bae6a20f150f6","type":"text","conversion_output":true,"text":"Deviations from the protocol including violations of inclusion/exclusion criteria will be","text_display":"\n\nDeviations from the protocol including violations of inclusion/exclusion criteria will be","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[361,1156],[1729,1156],[1729,1204],[361,1204]],"region":{"top_left_x":360,"top_left_y":1155,"width":1370,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"097afb2ec04841c28f229e09650afd14","type":"text","conversion_output":true,"text":"assessed as \"minor\" or \"major\" in cooperation with the Sponsor prior to unblinding.","text_display":" assessed as \"minor\" or \"major\" in cooperation with the Sponsor prior to unblinding.","confidence":1,"confidence_rate":1},{"cnt":[[359,1202],[1825,1202],[1825,1250],[359,1250]],"region":{"top_left_x":358,"top_left_y":1201,"width":1468,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9fedaa92c4240c5ac581ef70081be66","type":"text","conversion_output":true,"text":"Major protocol deviations (PDV) are defined as those deviations from the protocol likely","text_display":" Major protocol deviations (PDV) are defined as those deviations from the protocol likely","confidence":1,"confidence_rate":1},{"cnt":[[361,1250],[1825,1250],[1825,1300],[361,1300]],"region":{"top_left_x":360,"top_left_y":1249,"width":1466,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"830cf7a042924e5fa1346e80c7fef658","type":"text","conversion_output":true,"text":"to have an impact on the perceived efficacy and/or safety of the study treatment. The","text_display":" to have an impact on the perceived efficacy and/or safety of the study treatment. The","confidence":1,"confidence_rate":1},{"cnt":[[361,1298],[1825,1298],[1825,1345],[361,1345]],"region":{"top_left_x":360,"top_left_y":1297,"width":1466,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"607f174f8ea74b2da952bfa5cd6b1a31","type":"text","conversion_output":true,"text":"impact of major PDV on the efficacy and/or safety results will be investigated by","text_display":" impact of major PDV on the efficacy and/or safety results will be investigated by","confidence":1,"confidence_rate":1},{"cnt":[[361,1343],[1825,1343],[1825,1391],[361,1391]],"region":{"top_left_x":360,"top_left_y":1343,"width":1466,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"baae93da2a864782810779830a4510db","type":"text","conversion_output":true,"text":"assessing the robustness of the study results and conclusions to the choice of analysis","text_display":" assessing the robustness of the study results and conclusions to the choice of analysis","confidence":1,"confidence_rate":1},{"cnt":[[361,1389],[1830,1389],[1830,1437],[361,1437]],"region":{"top_left_x":360,"top_left_y":1388,"width":1470,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"50cd5ebffd794a1eaa4dc2b25baf8633","type":"text","conversion_output":true,"text":"population (see Section 4.4), both including and excluding data potentially affected by","text_display":" population (see Section 4.4), both including and excluding data potentially affected by","confidence":1,"confidence_rate":1},{"cnt":[[361,1435],[560,1435],[560,1483],[361,1483]],"region":{"top_left_x":360,"top_left_y":1434,"width":200,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3cde5f02fe854f69835bbabe4403475a","type":"text","conversion_output":true,"text":"major PDV.","text_display":" major PDV.","confidence":1,"confidence_rate":1},{"cnt":[[361,1483],[1738,1483],[1738,1531],[361,1531]],"region":{"top_left_x":360,"top_left_y":1482,"width":1379,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d32373c73deb4417adfc9df3606a8c9b","type":"text","conversion_output":true,"text":"Observable PDV data will be entered into PAREXEL'S Clinical Trials Management","text_display":"\nObservable PDV data will be entered into PAREXEL'S Clinical Trials Management","confidence":0.9990234375,"confidence_rate":0.9999880849533282},{"cnt":[[361,1531],[1798,1531],[1798,1579],[361,1579]],"region":{"top_left_x":360,"top_left_y":1530,"width":1438,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b348661015e743929762d892f66bc482","type":"text","conversion_output":true,"text":"System (CTMS). Some PDV will be identified via programmed edit checks and listings.","text_display":" System (CTMS). Some PDV will be identified via programmed edit checks and listings.","confidence":1,"confidence_rate":1},{"cnt":[[361,1576],[1812,1576],[1812,1624],[361,1624]],"region":{"top_left_x":360,"top_left_y":1576,"width":1452,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4de2114a17be458488bfc311ceb26346","type":"text","conversion_output":true,"text":"The study team and the Sponsor will conduct on-going reviews of the PDV data from the","text_display":" The study team and the Sponsor will conduct on-going reviews of the PDV data from the","confidence":1,"confidence_rate":1},{"cnt":[[361,1622],[1757,1622],[1757,1670],[361,1670]],"region":{"top_left_x":360,"top_left_y":1621,"width":1397,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5429d1935b84f739c1dfdce78e831e3","type":"text","conversion_output":true,"text":"CTMS and the PDV listings and the resulting set of evaluable subjects throughout the","text_display":" CTMS and the PDV listings and the resulting set of evaluable subjects throughout the","confidence":1,"confidence_rate":1},{"cnt":[[361,1668],[1478,1668],[1478,1716],[361,1716]],"region":{"top_left_x":360,"top_left_y":1667,"width":1118,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"244e1df8a6474d39a60b74580ef28c39","type":"text","conversion_output":true,"text":"study, adjusting the PDV criteria (major/minor PDV) as appropriate.","text_display":" study, adjusting the PDV criteria (major/minor PDV) as appropriate.","confidence":0.99951171875,"confidence_rate":0.9999932166827553},{"cnt":[[361,1713],[1448,1713],[1448,1764],[361,1764]],"region":{"top_left_x":360,"top_left_y":1713,"width":1089,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0f6d4aed1a64057a9dc558670650b6a","type":"text","conversion_output":true,"text":"The evaluable subject sets must be finalized prior to database lock.","text_display":" The evaluable subject sets must be finalized prior to database lock.","confidence":1,"confidence_rate":1},{"cnt":[[361,1764],[1597,1764],[1597,1812],[361,1812]],"region":{"top_left_x":360,"top_left_y":1763,"width":1237,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70680df37e854ad2b8575c6d667ca542","type":"text","conversion_output":true,"text":"PDV will help to define the subjects to be excluded from the PP population.","text_display":" PDV will help to define the subjects to be excluded from the PP population.","confidence":1,"confidence_rate":1},{"cnt":[[361,1809],[1702,1809],[1702,1857],[361,1857]],"region":{"top_left_x":360,"top_left_y":1809,"width":1342,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3e33ed15e744c488cb2287ac9ae5bd7","type":"text","conversion_output":true,"text":"The two following violation criteria (as Mentioned in Appendix 1: Major Protocol","text_display":" The two following violation criteria (as Mentioned in Appendix 1: Major Protocol","confidence":1,"confidence_rate":1},{"cnt":[[361,1855],[1658,1855],[1658,1903],[361,1903]],"region":{"top_left_x":360,"top_left_y":1854,"width":1299,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"184a8a75baac4db596d6829e87c02662","type":"text","conversion_output":true,"text":"deviations) have been pre-defined to be excluded subjects from the PP analysis:","text_display":" deviations) have been pre-defined to be excluded subjects from the PP analysis:","confidence":1,"confidence_rate":1},{"cnt":[[420,1905],[1716,1905],[1716,1953],[420,1953]],"region":{"top_left_x":420,"top_left_y":1905,"width":1296,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d5fce05c9984e15a0f69644674fd636","type":"text","conversion_output":true,"text":"- Subjects who do not perform the DBPCFC at 12 months of EPIT treatment,","text_display":"\n- Subjects who do not perform the DBPCFC at 12 months of EPIT treatment,","confidence":1,"confidence_rate":1},{"cnt":[[420,1955],[1382,1955],[1382,2003],[420,2003]],"region":{"top_left_x":420,"top_left_y":1955,"width":963,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bdec3567c2bd4f47865ce90f7371c6c7","type":"text","conversion_output":true,"text":"- Subjects with global treatment compliance below \\(80 \\%\\).","text_display":"\n- Subjects with global treatment compliance below \\(80 \\%\\).","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[361,2047],[1729,2047],[1729,2095],[361,2095]],"region":{"top_left_x":360,"top_left_y":2046,"width":1370,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa8c4e5be56a4b58ba9d7d3c2cabc257","type":"text","conversion_output":true,"text":"Listings will be created to aid the review of data and identification of possible PDV.","text_display":"\n\nListings will be created to aid the review of data and identification of possible PDV.","confidence":1,"confidence_rate":1},{"cnt":[[361,2143],[1793,2143],[1793,2188],[361,2188]],"region":{"top_left_x":360,"top_left_y":2142,"width":1434,"height":47},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5919459fa3df49b89b7e020ebbfd849e","type":"text","conversion_output":true,"text":"The number and percentage of subjects with major PDV will be summarized by type of","text_display":"\n\nThe number and percentage of subjects with major PDV will be summarized by type of","confidence":1,"confidence_rate":1},{"cnt":[[361,2188],[1802,2188],[1802,2236],[361,2236]],"region":{"top_left_x":360,"top_left_y":2188,"width":1443,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b932c58ade94f2b8defd9b3f6bb205e","type":"text","conversion_output":true,"text":"deviation, overall and by treatment group for all randomized subjects. All PDV data will","text_display":" deviation, overall and by treatment group for all randomized subjects. All PDV data will","confidence":1,"confidence_rate":1},{"cnt":[[361,2234],[514,2234],[514,2278],[361,2278]],"region":{"top_left_x":360,"top_left_y":2234,"width":154,"height":44},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e468781e8cef4e8ea4690b9d0c69562e","type":"text","conversion_output":true,"text":"be listed.","text_display":" be listed.","confidence":1,"confidence_rate":1},{"cnt":[[361,2325],[1830,2325],[1830,2373],[361,2373]],"region":{"top_left_x":360,"top_left_y":2325,"width":1470,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"acdd4c93a89e42e48ede52d226c0de8b","type":"text","conversion_output":true,"text":"Major PDV and any action to be taken regarding the exclusion of subjects or affected","text_display":"\n\nMajor PDV and any action to be taken regarding the exclusion of subjects or 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These outputs will first be blindly reviewed and","text_display":" DBV Technologies for review. 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Decisions made regarding the","text_display":" and/or subject data will be excluded from certain analyses. Decisions made regarding the","confidence":1,"confidence_rate":1},{"cnt":[[361,651],[1825,651],[1825,697],[361,697]],"region":{"top_left_x":360,"top_left_y":651,"width":1466,"height":46},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7daf77397deb4e939c4d3c6ff4f97432","type":"text","conversion_output":true,"text":"exclusion of subjects and/or subject data from analyses will be made prior to blind","text_display":" exclusion of subjects and/or subject data from analyses will be made prior to blind","confidence":1,"confidence_rate":1},{"cnt":[[361,699],[1825,699],[1825,742],[361,742]],"region":{"top_left_x":360,"top_left_y":699,"width":1466,"height":44},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fce9f49f96ff43269fa3306929231624","type":"text","conversion_output":true,"text":"breaking and will be documented and approved by DBV Technologies in the Blinded","text_display":" breaking and will be documented and approved by DBV Technologies in the Blinded","confidence":1,"confidence_rate":1},{"cnt":[[361,745],[724,745],[724,784],[361,784]],"region":{"top_left_x":360,"top_left_y":744,"width":365,"height":40},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8898a8e837f443ba509f034f78aac9e","type":"text","conversion_output":true,"text":"Data Review minutes.","text_display":" Data Review minutes.","confidence":1,"confidence_rate":1},{"cnt":[[361,836],[1825,836],[1825,884],[361,884]],"region":{"top_left_x":360,"top_left_y":836,"width":1466,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e27f4f0ec77a4ba18b162d2a6da2fdb9","type":"text","conversion_output":true,"text":"A summary of the number and percentage of subjects included in each analysis","text_display":"\n\nA summary of the number and percentage of subjects included in each 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[PP]) will be provided overall and by treatment group.","confidence":0.9274535386170851,"confidence_rate":0.9991991232253644},{"cnt":[[361,1026],[1825,1026],[1825,1071],[361,1071]],"region":{"top_left_x":360,"top_left_y":1025,"width":1466,"height":47},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"368292eefef24f74bcf29f5004853b45","type":"text","conversion_output":true,"text":"A by-subject listing of analysis populations (based on screened subjects) will be provided","text_display":"\n\nA by-subject listing of analysis populations (based on screened subjects) will be provided","confidence":0.99658203125,"confidence_rate":0.9999639604036571},{"cnt":[[361,1069],[1825,1069],[1825,1117],[361,1117]],"region":{"top_left_x":360,"top_left_y":1069,"width":1466,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2af38f4c91c84281b80620df9780ec0d","type":"text","conversion_output":true,"text":"ordered by treatment group and will include: treatment group, subject identifier, and","text_display":" ordered by treatment group and will include: treatment group, subject identifier, and","confidence":1,"confidence_rate":1},{"cnt":[[361,1119],[1825,1119],[1825,1163],[361,1163]],"region":{"top_left_x":360,"top_left_y":1119,"width":1466,"height":44},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef527158dacb42768fd34740b19b770c","type":"text","conversion_output":true,"text":"inclusion/exclusion flag for each population and reason for exclusion from each","text_display":" inclusion/exclusion flag for each population and reason for exclusion from 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This","text_display":"\n\nThe ITT population will be comprised of all subjects who are randomized. This","confidence":1,"confidence_rate":1},{"cnt":[[361,1768],[1727,1768],[1727,1816],[361,1816]],"region":{"top_left_x":360,"top_left_y":1768,"width":1367,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5760af87ee5d4a97a8acb622f585fc29","type":"text","conversion_output":true,"text":"population will be used to assess comparative efficacy information. Subjects will be","text_display":" population will be used to assess comparative efficacy information. Subjects will be","confidence":0.99853515625,"confidence_rate":0.9999835291504493},{"cnt":[[361,1818],[1446,1818],[1446,1862],[361,1862]],"region":{"top_left_x":360,"top_left_y":1818,"width":1087,"height":44},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"acfaaa984a354cbba28eb8688b0aea2d","type":"text","conversion_output":true,"text":"analyzed according to the treatment they have been randomized to.","text_display":" analyzed according to the treatment they have been randomized to.","confidence":1,"confidence_rate":1},{"cnt":[[356,1905],[770,1905],[770,1958],[356,1958]],"region":{"top_left_x":356,"top_left_y":1905,"width":414,"height":53},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"297f420569e24a4d83be7e3f74e773b7","type":"section_header","conversion_output":false,"children_ids":["c447b8fabbea413c821a1f1b972da8cc"],"text":"","text_display":""},{"cnt":[[361,1910],[765,1910],[765,1953],[361,1953]],"region":{"top_left_x":360,"top_left_y":1909,"width":406,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c447b8fabbea413c821a1f1b972da8cc","type":"text","conversion_output":true,"parent_id":"297f420569e24a4d83be7e3f74e773b7","text":"4.4.3 Full analysis set","text_display":"\n\n\\subsection*{4.4.3 Full analysis set}","confidence":1,"confidence_rate":1},{"cnt":[[361,2003],[1798,2003],[1798,2049],[361,2049]],"region":{"top_left_x":360,"top_left_y":2003,"width":1438,"height":47},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1ad12921c9c43f1825378b7aa3545c3","type":"text","conversion_output":true,"text":"The FAS will be comprised of all ITT subjects who are randomized and have performed","text_display":"\n\nThe FAS will be comprised of all ITT subjects who are randomized and have performed","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[361,2051],[1816,2051],[1816,2095],[361,2095]],"region":{"top_left_x":360,"top_left_y":2051,"width":1457,"height":44},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13f56beb456640239f4647c4d1283090","type":"text","conversion_output":true,"text":"at least the peanut challenge of the second DBPCFC at Month 12 (M12). Subjects will be","text_display":" at least the peanut challenge of the second DBPCFC at Month 12 (M12). Subjects will be","confidence":0.994631290435791,"confidence_rate":0.9999427338432282},{"cnt":[[361,2097],[1446,2097],[1446,2140],[361,2140]],"region":{"top_left_x":360,"top_left_y":2097,"width":1087,"height":44},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bfd1c37e27d147bebab3a7cf57dd820f","type":"text","conversion_output":true,"text":"analyzed according to the treatment they have been randomized to.","text_display":" analyzed according to the treatment they have been randomized to.","confidence":1,"confidence_rate":1},{"cnt":[[356,2188],[909,2188],[909,2239],[356,2239]],"region":{"top_left_x":356,"top_left_y":2188,"width":554,"height":51},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12e4d2b7b0b648d785084979c26623f8","type":"section_header","conversion_output":false,"children_ids":["790879fd9b8a47fb834cee57e98f2454"],"text":"","text_display":""},{"cnt":[[361,2188],[907,2188],[907,2234],[361,2234]],"region":{"top_left_x":360,"top_left_y":2188,"width":547,"height":47},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"790879fd9b8a47fb834cee57e98f2454","type":"text","conversion_output":true,"parent_id":"12e4d2b7b0b648d785084979c26623f8","text":"4.4.4 Per-protocol Population","text_display":"\n\n\\subsection*{4.4.4 Per-protocol Population}","confidence":1,"confidence_rate":1},{"cnt":[[361,2282],[1656,2282],[1656,2328],[361,2328]],"region":{"top_left_x":360,"top_left_y":2282,"width":1297,"height":46},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87f7f67e97c649a9ad57f7184d48fecd","type":"text","conversion_output":true,"text":"A PP population will be used to perform sensitivity analyses of the primary and","text_display":"\n\nA PP population will be used to perform sensitivity analyses of the primary and","confidence":1,"confidence_rate":1},{"cnt":[[361,2330],[1670,2330],[1670,2373],[361,2373]],"region":{"top_left_x":360,"top_left_y":2330,"width":1310,"height":44},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d6d5c5b3d034715b3eabb0a99d645f3","type":"text","conversion_output":true,"text":"secondary evaluations. This PP population will include all subjects from the ITT","text_display":" secondary evaluations. 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The deviations to consider will be listed","text_display":" primary (and secondary) efficacy endpoints. The deviations to consider will be listed","confidence":1,"confidence_rate":1},{"cnt":[[359,2467],[1830,2467],[1830,2515],[359,2515]],"region":{"top_left_x":358,"top_left_y":2467,"width":1472,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91420d85322644c3b074d950f772a1a1","type":"text","conversion_output":true,"text":"more in detail in Appendix 1: Major Protocol deviations of this SAP and will be reviewed","text_display":" more in detail in Appendix 1: Major Protocol deviations of this SAP and will be reviewed","confidence":1,"confidence_rate":1},{"cnt":[[359,2515],[425,2515],[425,2554],[359,2554]],"region":{"top_left_x":358,"top_left_y":2515,"width":67,"height":39},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"900c1792a71a4e1eb1dd50ab614bbbdf","type":"page_info","conversion_output":false,"text":"CCI","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[937,2527],[1830,2527],[1830,2565],[937,2565]],"region":{"top_left_x":936,"top_left_y":2526,"width":894,"height":40},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66fd01d7a22942d8a2def48685c30f4f","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL Project Document Version No. 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1156,2563],[1830,2563],[1830,2602],[1156,2602]],"region":{"top_left_x":1155,"top_left_y":2563,"width":675,"height":39},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"801387174dee497c9dc468b881282770","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: 04-Oct-2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1636,2604],[1825,2604],[1825,2638],[1636,2638]],"region":{"top_left_x":1635,"top_left_y":2604,"width":191,"height":35},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8341c1a79b341658d0f534510466ee7","type":"page_info","conversion_output":false,"text":"Page 24 of 79","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"4520d961-8076-4a3e-9288-40cbcbc6a794-25","page":25,"lines":[{"cnt":[[361,249],[770,249],[770,283],[361,283]],"region":{"top_left_x":360,"top_left_y":248,"width":410,"height":36},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b9a59b155f984ae1892028e3a145279f","type":"page_info","conversion_output":false,"text":"DBV TECHNOLOGIES S.A.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,288],[496,288],[496,322],[361,322]],"region":{"top_left_x":360,"top_left_y":287,"width":136,"height":36},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a945e99ee39d4bf68e554e7a57ea0228","type":"page_info","conversion_output":false,"text":"PEPITES","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1494,288],[1830,288],[1830,327],[1494,327]],"region":{"top_left_x":1493,"top_left_y":287,"width":337,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63ef34bcf47b4e6c8e1e435c7ff061ca","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,370],[1798,370],[1798,418],[361,418]],"region":{"top_left_x":360,"top_left_y":370,"width":1438,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b455a6e7717e457f9c15683324b01c02","type":"text","conversion_output":true,"text":"during the Blinded Data Review Meeting. 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recorded and coded using the latest available version of the World Health Organization","confidence":1,"confidence_rate":1},{"cnt":[[361,2341],[774,2341],[774,2389],[361,2389]],"region":{"top_left_x":360,"top_left_y":2341,"width":415,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"21e2c19a83744dc1b3000dbeb98fb191","type":"text","conversion_output":true,"text":"(WHO) Drug Dictionary.","text_display":" (WHO) Drug Dictionary.","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[359,2385],[1830,2385],[1830,2437],[359,2437]],"region":{"top_left_x":358,"top_left_y":2384,"width":1472,"height":54},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55edd233e01244b4958d0894e8914149","type":"text","conversion_output":true,"text":"Medications will be classified either as \"Prior only\" (P), \"Both Prior and Concomitant\"","text_display":"\nMedications will be classified either as \"Prior only\" (P), \"Both Prior and Concomitant\"","confidence":1,"confidence_rate":1},{"cnt":[[361,2435],[898,2435],[898,2483],[361,2483]],"region":{"top_left_x":360,"top_left_y":2435,"width":538,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"afe84acc820847d1891cc62337f287fe","type":"text","conversion_output":true,"text":"(PC) or \"Concomitant only\" (C).","text_display":" (PC) or \"Concomitant only\" 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3.0","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999800654844866},{"cnt":[[1156,2563],[1830,2563],[1830,2602],[1156,2602]],"region":{"top_left_x":1155,"top_left_y":2563,"width":675,"height":39},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e75faad67004bd9bdfe1617fe35e2a0","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: 04-Oct-2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1636,2604],[1825,2604],[1825,2641],[1636,2641]],"region":{"top_left_x":1635,"top_left_y":2604,"width":191,"height":37},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ad522367f0a46bb91c27ea093f0ae7e","type":"page_info","conversion_output":false,"text":"Page 28 of 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Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,370],[1784,370],[1784,418],[361,418]],"region":{"top_left_x":360,"top_left_y":370,"width":1425,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d5d412781724cf3a446a61d7c442249","type":"text","conversion_output":true,"text":"This classification will be made by comparing the study medication start and stop dates","text_display":"\n\nThis classification will be made by comparing the study medication start and stop dates","confidence":1,"confidence_rate":1},{"cnt":[[361,416],[1741,416],[1741,464],[361,464]],"region":{"top_left_x":360,"top_left_y":415,"width":1381,"height":49},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e545d20fccf244cdaa9c4b8797f93631","type":"text","conversion_output":true,"text":"with the date of first application of study medication (or V4 date if date of first patch","text_display":" with the date of first application of study medication (or V4 date if date of first patch","confidence":1,"confidence_rate":1},{"cnt":[[359,466],[848,466],[848,514],[359,514]],"region":{"top_left_x":358,"top_left_y":466,"width":490,"height":48},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91ff1b866f824b97adaac5a41ae0aa30","type":"text","conversion_output":true,"text":"application is not completed).","text_display":" application is not completed).","confidence":1,"confidence_rate":1},{"cnt":[[359,512],[1825,512],[1825,557],[359,557]],"region":{"top_left_x":358,"top_left_y":511,"width":1468,"height":47},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c06439905794a8e8ef857654508372b","type":"text","conversion_output":true,"text":"Medications starting after the completion/withdrawal date will be listed but will not be","text_display":"\nMedications starting after the completion/withdrawal date will be listed but will not 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before the first application of study","confidence":1,"confidence_rate":1},{"cnt":[[480,745],[678,745],[678,793],[480,793]],"region":{"top_left_x":479,"top_left_y":744,"width":200,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e91e8909179c4870bd1582d5d394ac73","type":"text","conversion_output":true,"text":"medication,","text_display":" medication,","confidence":1,"confidence_rate":1},{"cnt":[[420,795],[1775,795],[1775,843],[420,843]],"region":{"top_left_x":420,"top_left_y":794,"width":1355,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b15806ac68654e37a61be63225f81b94","type":"text","conversion_output":true,"text":"- Medications with partial start/stop date where there is clear evidence to suggest","text_display":"\n- Medications with partial start/stop date where there is clear evidence to 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medication and","confidence":1,"confidence_rate":1},{"cnt":[[480,1078],[1537,1078],[1537,1126],[480,1126]],"region":{"top_left_x":479,"top_left_y":1078,"width":1059,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0093a11154b942a2bff1e59baff426d6","type":"text","conversion_output":true,"text":"stops on or after the date of first application of study medication,","text_display":" stops on or after the date of first application of study medication,","confidence":0.9990234375,"confidence_rate":0.999986615984802},{"cnt":[[420,1128],[1775,1128],[1775,1176],[420,1176]],"region":{"top_left_x":420,"top_left_y":1128,"width":1355,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"988755e8671147eb912723157296e6e8","type":"text","conversion_output":true,"text":"- Medications with partial start/stop date where there is clear evidence to suggest","text_display":"\n- Medications with partial start/stop date 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the first dose of study medication,","confidence":1,"confidence_rate":1},{"cnt":[[420,1508],[1766,1508],[1766,1558],[420,1558]],"region":{"top_left_x":420,"top_left_y":1507,"width":1346,"height":51},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aeb0251c9a1f46cb9c70dd6d5b72f9be","type":"text","conversion_output":true,"text":"- Medications with partial or complete stop date where there is clear evidence to","text_display":"\n- Medications with partial or complete stop date where there is clear evidence to","confidence":1,"confidence_rate":1},{"cnt":[[480,1556],[1695,1556],[1695,1604],[480,1604]],"region":{"top_left_x":479,"top_left_y":1555,"width":1217,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a288583624ab4a9789b53bef3c92487a","type":"text","conversion_output":true,"text":"suggest that the medication stopped after the date of the first dose of study","text_display":" suggest that the medication stopped after the date of the first dose of study","confidence":1,"confidence_rate":1},{"cnt":[[480,1604],[1802,1604],[1802,1652],[480,1652]],"region":{"top_left_x":479,"top_left_y":1603,"width":1324,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eaafdc1bffee43d093d09953c8dc01de","type":"text","conversion_output":true,"text":"medication (no evidence for the start date or V4 date if date of first application is","text_display":" medication (no evidence for the start date or V4 date if date of first application is","confidence":1,"confidence_rate":1},{"cnt":[[480,1649],[742,1649],[742,1697],[480,1697]],"region":{"top_left_x":479,"top_left_y":1649,"width":264,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66dd41914a194659b7c05f0f05fd8797","type":"text","conversion_output":true,"text":"not completed),","text_display":" not 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stopped before or after the date of the","confidence":1,"confidence_rate":1},{"cnt":[[480,1791],[980,1791],[980,1839],[480,1839]],"region":{"top_left_x":479,"top_left_y":1790,"width":501,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1429d8a96074688b96ab144a2ba6b5b","type":"text","conversion_output":true,"text":"first dose of study medication.","text_display":" first dose of study medication.","confidence":1,"confidence_rate":1},{"cnt":[[361,1885],[1830,1885],[1830,1933],[361,1933]],"region":{"top_left_x":360,"top_left_y":1884,"width":1470,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1667b09ac4814043bb3d47a9f74648e1","type":"text","conversion_output":true,"text":"For prior and/or concomitant medications, number and percent of subjects overall and per","text_display":"\n\nFor prior and/or concomitant medications, number and percent of subjects overall and 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The following summaries","text_display":" ATC class (level 3) and preferred drug name will be calculated. 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3.0","text_display":"","confidence":0.998535871389322,"confidence_rate":0.9999700983757497},{"cnt":[[1156,2563],[1830,2563],[1830,2606],[1156,2606]],"region":{"top_left_x":1155,"top_left_y":2563,"width":675,"height":44},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b17b6bb191f745db820464909fa54cfd","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: 04-Oct-2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1631,2600],[1830,2600],[1830,2643],[1631,2643]],"region":{"top_left_x":1631,"top_left_y":2599,"width":199,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d6a6c8396d04ae8af943aea52f48470","type":"page_info","conversion_output":false,"text":"Page 32 of 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S.A.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999812155418875},{"cnt":[[359,288],[500,288],[500,322],[359,322]],"region":{"top_left_x":358,"top_left_y":287,"width":143,"height":36},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1ad03c96e931409891f0da4d95608ca6","type":"page_info","conversion_output":false,"text":"PEPITES","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1489,283],[1830,283],[1830,331],[1489,331]],"region":{"top_left_x":1489,"top_left_y":283,"width":341,"height":49},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"84c68edadf474294901c6686f472fb9b","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[420,370],[1757,370],[1757,418],[420,418]],"region":{"top_left_x":420,"top_left_y":370,"width":1337,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f3236531a904b869d27d61f7599189d","type":"text","conversion_output":true,"text":"- If the ED reported by the investigator in the eCRF is missing, then the CRD is","text_display":"\n- If the ED reported by the investigator in the eCRF is missing, then the CRD is","confidence":0.98486328125,"confidence_rate":0.9998205755313758},{"cnt":[[480,416],[619,416],[619,464],[480,464]],"region":{"top_left_x":479,"top_left_y":415,"width":141,"height":49},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63b3574cb8894ec2a6f000816fc9802f","type":"text","conversion_output":true,"text":"missing","text_display":" missing","confidence":1,"confidence_rate":1},{"cnt":[[420,461],[1812,461],[1812,514],[420,514]],"region":{"top_left_x":420,"top_left_y":461,"width":1392,"height":53},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0789c12f82944444b0d53f0d6fcc8983","type":"text","conversion_output":true,"text":"- If the ED reported by the investigator in the eCRF is not missing then the CRD is","text_display":"\n- If the ED reported by the investigator in the eCRF is not missing then the CRD is","confidence":0.9727179766632617,"confidence_rate":0.9996857188503352},{"cnt":[[480,507],[1768,507],[1768,560],[480,560]],"region":{"top_left_x":479,"top_left_y":507,"width":1290,"height":53},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a20cf6f0e93c413aa58973c1240f9c7a","type":"text","conversion_output":true,"text":"calculated as the sum of all doses given, including also the repeated and partial","text_display":" calculated as the sum of all doses given, including also the repeated and partial","confidence":1,"confidence_rate":1},{"cnt":[[480,555],[1764,555],[1764,605],[480,605]],"region":{"top_left_x":479,"top_left_y":555,"width":1285,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7332cad400a74e1b85a4f8490881362b","type":"text","conversion_output":true,"text":"doses; doses greater than the ED are not included in the calculation. Example:","text_display":" doses; doses greater than the ED are not included in the calculation. Example:","confidence":0.99951171875,"confidence_rate":0.999994115673962},{"cnt":[[480,603],[1345,603],[1345,651],[480,651]],"region":{"top_left_x":479,"top_left_y":603,"width":867,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e697057a74b34ea99c27a00068c57777","type":"text","conversion_output":true,"text":"For a particular patient if the set of recorded doses is","text_display":" For a particular patient if the set of recorded doses is","confidence":1,"confidence_rate":1},{"cnt":[[482,649],[1807,649],[1807,701],[482,701]],"region":{"top_left_x":482,"top_left_y":648,"width":1325,"height":54},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a432a698fa784e95b6ba46713f118ad8","type":"text","conversion_output":true,"text":"\\(\\{1,3,10,30,100,300,300,1000\\}\\), and recorded \\(ED =300 mg\\), then \\(C R D=1+\\)","text_display":" \\(\\{1,3,10,30,100,300,300,1000\\}\\), and recorded \\(ED =300 mg\\), then \\(C R D=1+","confidence":0.8870431061368436,"confidence_rate":0.9984644916373192},{"cnt":[[480,699],[1172,699],[1172,747],[480,747]],"region":{"top_left_x":479,"top_left_y":699,"width":693,"height":48},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bef9095073e94b779862350ea2734116","type":"text","conversion_output":true,"text":"\\(3+10+30+100+2 \\times 300=744 mg\\).","text_display":" 3+10+30+100+2 \\times 300=744 mg\\).","confidence":0.998046875,"confidence_rate":0.9999389070276328},{"cnt":[[356,790],[1825,790],[1825,843],[356,843]],"region":{"top_left_x":356,"top_left_y":790,"width":1470,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c4088390bbb145e8a12de86af9d68f9e","type":"text","conversion_output":true,"text":"No imputation will be performed for other efficacy, safety and exploratory parameters.","text_display":"\n\nNo imputation will be performed for other efficacy, safety and exploratory parameters.","confidence":1,"confidence_rate":1},{"cnt":[[359,836],[1830,836],[1830,889],[359,889]],"region":{"top_left_x":358,"top_left_y":836,"width":1472,"height":53},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e34d82a04e74b7497b63b93cea9e2a4","type":"text","conversion_output":true,"text":"In those instances observed data will be used, excepted for safety data where partial or","text_display":" In those instances observed data will be used, excepted for safety data where partial or","confidence":1,"confidence_rate":1},{"cnt":[[359,884],[1830,884],[1830,934],[359,934]],"region":{"top_left_x":358,"top_left_y":884,"width":1472,"height":51},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7893c37e7cc4509bd52b73e4cc44617","type":"text","conversion_output":true,"text":"missing data will be imputed according to the most conservative approach (See Section","text_display":" missing data will be imputed according to the most conservative approach (See Section","confidence":1,"confidence_rate":1},{"cnt":[[356,927],[752,927],[752,980],[356,980]],"region":{"top_left_x":356,"top_left_y":927,"width":396,"height":53},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97ab81726bae435db9041ab0afb7cd53","type":"text","conversion_output":true,"text":"4.9.1: Adverse Events).","text_display":" 4.9.1: Adverse Events).","confidence":1,"confidence_rate":1},{"cnt":[[359,1023],[1053,1023],[1053,1074],[359,1074]],"region":{"top_left_x":358,"top_left_y":1023,"width":696,"height":51},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9c8fe1f850a4fceac0cdfa51be0a5cd","type":"text","conversion_output":true,"text":"Actual values will be presented in listings.","text_display":"\n\nActual values will be presented in listings.","confidence":1,"confidence_rate":1},{"cnt":[[352,1110],[1090,1110],[1090,1172],[352,1172]],"region":{"top_left_x":351,"top_left_y":1110,"width":739,"height":62},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a6a4757ecbc459aa8357411e77fc747","type":"section_header","conversion_output":false,"children_ids":["330e38b08a464fb6995c9ffb306e6407"],"text":"","text_display":""},{"cnt":[[361,1117],[1085,1117],[1085,1167],[361,1167]],"region":{"top_left_x":360,"top_left_y":1117,"width":726,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"330e38b08a464fb6995c9ffb306e6407","type":"text","conversion_output":true,"parent_id":"9a6a4757ecbc459aa8357411e77fc747","text":"4.8.1.3 Multiple Comparisons/Multiplicity","text_display":"\n\n\\subsection*{4.8.1.3 Multiple Comparisons/Multiplicity}","confidence":1,"confidence_rate":1},{"cnt":[[359,1211],[1789,1211],[1789,1259],[359,1259]],"region":{"top_left_x":358,"top_left_y":1210,"width":1431,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"482eadd9719a4f3fb944c4bd5a293b8e","type":"text","conversion_output":true,"text":"In order to handle the multiple comparisons versus placebo, the overall type-I error will","text_display":"\n\nIn order to handle the multiple comparisons versus placebo, the overall type-I error will","confidence":1,"confidence_rate":1},{"cnt":[[359,1256],[1793,1256],[1793,1304],[359,1304]],"region":{"top_left_x":358,"top_left_y":1256,"width":1436,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0cbfe06a22db4318bc9b6954f21fb9b8","type":"text","conversion_output":true,"text":"be controlled at a level of 5\\% (2-sided) by the use of a hierarchical inferential approach.","text_display":" be controlled at a level of 5\\% (2-sided) by the use of a hierarchical inferential approach.","confidence":0.6247543997596949,"confidence_rate":0.9951120199663323},{"cnt":[[359,1302],[1796,1302],[1796,1355],[359,1355]],"region":{"top_left_x":358,"top_left_y":1302,"width":1438,"height":53},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0675a34174de4894ba6618e1549423e1","type":"text","conversion_output":true,"text":"The primary analysis in the overall population must be positive according to the clinical","text_display":" The primary analysis in the overall population must be positive according to the clinical","confidence":1,"confidence_rate":1},{"cnt":[[359,1348],[1757,1348],[1757,1400],[359,1400]],"region":{"top_left_x":358,"top_left_y":1347,"width":1399,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54408d2ae9d74e9ca254f4cf9255bebd","type":"text","conversion_output":true,"text":"relevance criterion (described in section 4.8.2) before drawing inferential conclusions","text_display":" relevance criterion (described in section 4.8.2) before drawing inferential conclusions","confidence":1,"confidence_rate":1},{"cnt":[[359,1398],[1823,1398],[1823,1446],[359,1446]],"region":{"top_left_x":358,"top_left_y":1398,"width":1465,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a8bedd0033a48ac9f31e681969eadf5","type":"text","conversion_output":true,"text":"about the secondary comparisons as defined by the hierarchical order. The first secondary","text_display":" about the secondary comparisons as defined by the hierarchical order. The first secondary","confidence":1,"confidence_rate":1},{"cnt":[[361,1444],[1757,1444],[1757,1492],[361,1492]],"region":{"top_left_x":360,"top_left_y":1443,"width":1397,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8760dbfe82f84a93a5da313227a29756","type":"text","conversion_output":true,"text":"efficacy analysis (difference in treatment response in Screening ED subgroup 2) must","text_display":" efficacy analysis (difference in treatment response in Screening ED subgroup 2) must","confidence":1,"confidence_rate":1},{"cnt":[[359,1489],[1686,1489],[1686,1537],[359,1537]],"region":{"top_left_x":358,"top_left_y":1489,"width":1328,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"82831b445d5f4e27bc94ba988b34fc5e","type":"text","conversion_output":true,"text":"meet its success criterion before drawing an inferential conclusion about the next","text_display":" meet its success criterion before drawing an inferential conclusion about the next","confidence":1,"confidence_rate":1},{"cnt":[[359,1535],[1768,1535],[1768,1588],[359,1588]],"region":{"top_left_x":358,"top_left_y":1535,"width":1411,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a33b98db8c94aa1bafd74d8dc1cca63","type":"text","conversion_output":true,"text":"secondary comparison (difference in treatment response in Screening ED subgroup 1).","text_display":" secondary comparison (difference in treatment response in Screening ED subgroup 1).","confidence":1,"confidence_rate":1},{"cnt":[[361,1585],[1816,1585],[1816,1633],[361,1633]],"region":{"top_left_x":360,"top_left_y":1585,"width":1457,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9595558600ba4d7886f8c76785242b19","type":"text","conversion_output":true,"text":"Inferential conclusions about the next successive secondary comparisons require meeting","text_display":" Inferential conclusions about the next successive secondary comparisons require meeting","confidence":1,"confidence_rate":1},{"cnt":[[361,1631],[1798,1631],[1798,1679],[361,1679]],"region":{"top_left_x":360,"top_left_y":1631,"width":1438,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06a75864d20f484ab6081b119eca0940","type":"text","conversion_output":true,"text":"the success criterion of the previous comparison. The pre-defined hierarchical order and","text_display":" the success criterion of the previous comparison. The pre-defined hierarchical order and","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[361,1677],[1067,1677],[1067,1722],[361,1722]],"region":{"top_left_x":360,"top_left_y":1676,"width":707,"height":47},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6f6ae9a99264e94b8853e2c1f82e893","type":"text","conversion_output":true,"text":"success criteria are summarized in Table 2.","text_display":" success criteria are summarized in Table 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Document Version No. 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1156,2563],[1830,2563],[1830,2604],[1156,2604]],"region":{"top_left_x":1155,"top_left_y":2563,"width":675,"height":42},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"852cd615b5334cb3bb094c21abcab996","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: 04-Oct-2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1631,2602],[1830,2602],[1830,2643],[1631,2643]],"region":{"top_left_x":1631,"top_left_y":2601,"width":199,"height":43},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f7b53c397f446a3b53c0702d0993b4e","type":"page_info","conversion_output":false,"text":"Page 33 of 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analysis, for each region and on the following subgroups:","confidence":1,"confidence_rate":1},{"cnt":[[420,608],[861,608],[861,656],[420,656]],"region":{"top_left_x":420,"top_left_y":607,"width":442,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cec0652348b04693be4fde9d29e951cf","type":"text","conversion_output":true,"text":"- Gender (Male/Female)","text_display":"\n- Gender (Male/Female)","confidence":1,"confidence_rate":1},{"cnt":[[420,658],[1368,658],[1368,706],[420,706]],"region":{"top_left_x":420,"top_left_y":657,"width":949,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7ffef52179e4124bf8607299abeaa07","type":"text","conversion_output":true,"text":"- Race (White/Black or African American/Asian/Other)","text_display":"\n- Race (White/Black or African 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In","text_display":" provided instead of 2 -sided Newcombe \\(95 \\%\\) CIs for the difference in response rates. 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Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[356,370],[599,370],[599,423],[356,423]],"region":{"top_left_x":356,"top_left_y":370,"width":243,"height":53},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c74ffb11fc84275b4d9edbab1f24766","type":"section_header","conversion_output":false,"children_ids":["3024351832ca4632bcded9f95bddd227"],"text":"","text_display":""},{"cnt":[[361,375],[594,375],[594,418],[361,418]],"region":{"top_left_x":360,"top_left_y":374,"width":234,"height":45},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3024351832ca4632bcded9f95bddd227","type":"text","conversion_output":true,"parent_id":"8c74ffb11fc84275b4d9edbab1f24766","text":"Main analysis","text_display":"\n\n\\section*{Main analysis}","confidence":1,"confidence_rate":1},{"cnt":[[361,466],[1825,466],[1825,509],[361,509]],"region":{"top_left_x":360,"top_left_y":466,"width":1466,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b944d18b77f742d0a282a20d995af3cb","type":"text","conversion_output":true,"text":"The primary efficacy endpoint is the difference between percentage of treatment","text_display":"\n\nThe primary efficacy endpoint is the difference between percentage of treatment","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[361,507],[1825,507],[1825,555],[361,555]],"region":{"top_left_x":360,"top_left_y":507,"width":1466,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0178ec052ede41869d53f7e1071164ee","type":"text","conversion_output":true,"text":"responders in the active Viaskin \\({ }^{\\circledR}\\) Peanut \\(250 \\mu g\\) group compared to the placebo group","text_display":" responders in the active Viaskin \\({ }^{\\circledR}\\) Peanut \\(250 \\mu g\\) group compared to the placebo group","confidence":0.87841796875,"confidence_rate":0.9987543077482904},{"cnt":[[361,557],[1713,557],[1713,605],[361,605]],"region":{"top_left_x":360,"top_left_y":557,"width":1354,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b5a95feb21645249e87bd6cd3a3fa37","type":"text","conversion_output":true,"text":"after 12 months of EPIT treatment. A subject is defined as a treatment responder if:","text_display":" after 12 months of EPIT treatment. A subject is defined as a treatment responder if:","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[423,608],[1825,608],[1825,656],[423,656]],"region":{"top_left_x":422,"top_left_y":607,"width":1404,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ed548254cfc4ee8ba6e3e7497076cb3","type":"text","conversion_output":true,"text":"- The initial ED was \\(\\leq 10 mg\\) peanut protein (Screening ED subgroup 1) and the ED","text_display":"\n- The initial ED was \\(\\leq 10 mg\\) peanut protein (Screening ED subgroup 1) and the ED","confidence":1,"confidence_rate":1},{"cnt":[[482,653],[1400,653],[1400,701],[482,701]],"region":{"top_left_x":482,"top_left_y":653,"width":919,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27294b0e74a242e49db2b0fcb6257758","type":"text","conversion_output":true,"text":"is \\(\\geq 300 mg\\) peanut protein at the Month 12 DBPCFC; or","text_display":" is \\(\\geq 300 mg\\) peanut protein at the Month 12 DBPCFC; or","confidence":1,"confidence_rate":1},{"cnt":[[423,704],[1825,704],[1825,752],[423,752]],"region":{"top_left_x":422,"top_left_y":703,"width":1404,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9e82728836447d899463b39a793cb0d","type":"text","conversion_output":true,"text":"- The initial ED was \\(>10 mg\\) peanut protein (Screening ED subgroup 2) and the ED","text_display":"\n- The initial ED was \\(>10 mg\\) peanut protein (Screening ED subgroup 2) and the ED","confidence":1,"confidence_rate":1},{"cnt":[[480,749],[1384,749],[1384,797],[480,797]],"region":{"top_left_x":479,"top_left_y":749,"width":906,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e12296075a1d4ec9b570f27c2577470c","type":"text","conversion_output":true,"text":"is \\(\\geq 1,000 mg\\) peanut protein at the Month 12 DBPCFC .","text_display":" is \\(\\geq 1,000 mg\\) peanut protein at the Month 12 DBPCFC .","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[361,843],[1825,843],[1825,889],[361,889]],"region":{"top_left_x":360,"top_left_y":842,"width":1466,"height":47},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60ae196e722146bc86f08e5e82889332","type":"text","conversion_output":true,"text":"The primary efficacy analysis will be performed on the ITT population, using","text_display":"\n\nThe primary efficacy analysis will be performed on the ITT population, using","confidence":1,"confidence_rate":1},{"cnt":[[361,889],[1825,889],[1825,934],[361,934]],"region":{"top_left_x":360,"top_left_y":888,"width":1466,"height":47},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1c09e7ab850440f881b3b328a15f335","type":"text","conversion_output":true,"text":"missing=failure imputation method (which means that subjects with missing DBPCFC","text_display":" missing=failure imputation method (which means that subjects with missing DBPCFC","confidence":0.99853515625,"confidence_rate":0.9999827540583306},{"cnt":[[361,937],[1556,937],[1556,982],[361,982]],"region":{"top_left_x":360,"top_left_y":936,"width":1196,"height":47},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0c5279e74f846b68146f77dc859b6ce","type":"text","conversion_output":true,"text":"peanut eliciting dose value at M12 will be considered as non-responders).","text_display":" peanut eliciting dose value at M12 will be considered as non-responders).","confidence":0.99853515625,"confidence_rate":0.9999812063601604},{"cnt":[[361,982],[1825,982],[1825,1030],[361,1030]],"region":{"top_left_x":360,"top_left_y":982,"width":1466,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e5b0c639b547478a988ab0b39b50d760","type":"text","conversion_output":true,"text":"The primary measure of treatment effect will be the difference in response rates between","text_display":"\nThe primary measure of treatment effect will be the difference in response rates between","confidence":1,"confidence_rate":1},{"cnt":[[361,1028],[1825,1028],[1825,1076],[361,1076]],"region":{"top_left_x":360,"top_left_y":1027,"width":1466,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a3ad033e1724c0496c9aa749c2d0497","type":"text","conversion_output":true,"text":"active and placebo treatment groups. The primary analysis will apply a Wald test at a 2 -","text_display":" active and placebo treatment groups. The primary analysis will apply a Wald test at a 2 ","confidence":0.6869696212197596,"confidence_rate":0.9961367064621731},{"cnt":[[361,1074],[1825,1074],[1825,1122],[361,1122]],"region":{"top_left_x":360,"top_left_y":1073,"width":1466,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d16d3bf0e41c471ab8222549ca6f6d1b","type":"text","conversion_output":true,"text":"sided \\(5 \\%\\) significance level to evaluate a null hypothesis of no difference, and the","text_display":"sided \\(5 \\%\\) significance level to evaluate a null hypothesis of no difference, and the","confidence":0.99169921875,"confidence_rate":0.9999084061226785},{"cnt":[[361,1119],[1825,1119],[1825,1167],[361,1167]],"region":{"top_left_x":360,"top_left_y":1119,"width":1466,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a993aaa6d0040129e0cc517dc0a2761","type":"text","conversion_output":true,"text":"corresponding 2 -sided Newcombe \\(95 \\%\\) confidence interval (CI) for the difference in","text_display":" corresponding 2 -sided Newcombe \\(95 \\%\\) confidence interval (CI) for the difference in","confidence":0.9464160413720037,"confidence_rate":0.9994079923317988},{"cnt":[[361,1215],[361,1163],[1825,1165],[1825,1218]],"region":{"top_left_x":360,"top_left_y":1162,"width":1466,"height":56},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1457f776837946a89fd092773974a3bb","type":"text","conversion_output":true,"text":"response rates will be calculated. The clinical relevance criterion for the primary analysis","text_display":" response rates will be calculated. The clinical relevance criterion for the primary analysis","confidence":1,"confidence_rate":1},{"cnt":[[361,1215],[1825,1215],[1825,1263],[361,1263]],"region":{"top_left_x":360,"top_left_y":1215,"width":1466,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c3531532f0ee43af8d9cc600e6a75f5d","type":"text","conversion_output":true,"text":"will be defined by a \\(\\geq 15 \\%\\) lower confidence bound, and this condition will determine","text_display":" will be defined by a \\(\\geq 15 \\%\\) lower confidence bound, and this condition will determine","confidence":1,"confidence_rate":1},{"cnt":[[361,1261],[1293,1261],[1293,1309],[361,1309]],"region":{"top_left_x":360,"top_left_y":1260,"width":933,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b06d98a8ca464e1d95786011c80d1a51","type":"text","conversion_output":true,"text":"whether the primary objective has been successfully met.","text_display":" whether the primary objective has been successfully met.","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[361,1307],[1825,1307],[1825,1355],[361,1355]],"region":{"top_left_x":360,"top_left_y":1306,"width":1466,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2babfd62604f47caa1b98077f3ecf9c8","type":"text","conversion_output":true,"text":"The Wald test p-value will be calculated using the SAS® GENMOD procedure, with","text_display":"\nThe Wald test p-value will be calculated using the SAS® GENMOD procedure, with","confidence":0.9926891326904297,"confidence_rate":0.9999115976104843},{"cnt":[[361,1355],[1492,1355],[1492,1400],[361,1400]],"region":{"top_left_x":360,"top_left_y":1354,"width":1132,"height":47},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16a801977c0b493b910ca7286314bb34","type":"text","conversion_output":true,"text":"DIST=binomial and LINK=identity option of the MODEL statement.","text_display":" DIST=binomial and LINK=identity option of the MODEL statement.","confidence":1,"confidence_rate":1},{"cnt":[[361,1448],[1825,1448],[1825,1496],[361,1496]],"region":{"top_left_x":360,"top_left_y":1448,"width":1466,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0b252847d734f0dbdea722537077878","type":"text","conversion_output":true,"text":"The 2 -sided Wilson \\(95 \\%\\) CIs of individual response rate will be presented overall and by","text_display":"\n\nThe 2 -sided Wilson \\(95 \\%\\) CIs of individual response rate will be presented overall and 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difference","text_display":"\n\nThe study will be considered positive if the lower bound of the \\(95 \\% CI\\) of the difference","confidence":0.9645180702209473,"confidence_rate":0.9996314280262127},{"cnt":[[361,1775],[1825,1775],[1825,1821],[361,1821]],"region":{"top_left_x":360,"top_left_y":1774,"width":1466,"height":47},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bcc6cf863a4b410789ec8c0df3ce1e1d","type":"text","conversion_output":true,"text":"between active treatment and placebo response rates is higher or equal to \\(15 \\%\\). This \\(15 \\%\\)","text_display":" between active treatment and placebo response rates is higher or equal to \\(15 \\%\\). This \\(15 \\%\\)","confidence":0.9545472892932594,"confidence_rate":0.999510455723605},{"cnt":[[361,1821],[1556,1821],[1556,1866],[361,1866]],"region":{"top_left_x":360,"top_left_y":1820,"width":1196,"height":47},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d1ffc5c016144c0b58f974762268c89","type":"text","conversion_output":true,"text":"difference is intended to exhibit a clear robustness of the treatment effect.","text_display":" difference is intended to exhibit a clear robustness of the treatment effect.","confidence":1,"confidence_rate":1},{"cnt":[[356,1914],[692,1914],[692,1965],[356,1965]],"region":{"top_left_x":356,"top_left_y":1914,"width":337,"height":51},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1223651158b4e4b85a41999cea59e36","type":"text","conversion_output":true,"text":"Sensitivity analyses","text_display":"\n\nSensitivity analyses","confidence":0.99072265625,"confidence_rate":0.9996272436375788},{"cnt":[[361,2006],[1821,2006],[1821,2054],[361,2054]],"region":{"top_left_x":360,"top_left_y":2005,"width":1461,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4cddea696aa74cddba236ea749a252ec","type":"text","conversion_output":true,"text":"Several sensitivity analyses of the primary efficacy variable will be performed by running","text_display":"\nSeveral sensitivity analyses of the primary efficacy variable will be performed by running","confidence":1,"confidence_rate":1},{"cnt":[[361,2056],[1821,2056],[1821,2104],[361,2104]],"region":{"top_left_x":360,"top_left_y":2055,"width":1461,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48a9b16b10864f67bb0740d48a76244a","type":"text","conversion_output":true,"text":"a primary efficacy analysis either on different analysis sets, or with alternative imputation","text_display":" a primary efficacy analysis either on different analysis sets, or with alternative imputation","confidence":1,"confidence_rate":1},{"cnt":[[361,2102],[1409,2102],[1409,2147],[361,2147]],"region":{"top_left_x":360,"top_left_y":2101,"width":1050,"height":47},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de150709dfad40cea733e984bb5fd299","type":"text","conversion_output":true,"text":"methods for missing data or using other or additional covariates.","text_display":" methods for missing data or using other or additional covariates.","confidence":1,"confidence_rate":1},{"cnt":[[361,2147],[1419,2147],[1419,2195],[361,2195]],"region":{"top_left_x":360,"top_left_y":2147,"width":1059,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1c0ccc4b96b4f40b32a7b32afca4791","type":"text","conversion_output":true,"text":"The sensitivity analyses that will be performed are the following:","text_display":"\nThe sensitivity analyses that will be performed are the following:","confidence":1,"confidence_rate":1},{"cnt":[[361,2241],[788,2241],[788,2287],[361,2287]],"region":{"top_left_x":360,"top_left_y":2240,"width":429,"height":47},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7ccba18048d45fd9cb1f0587ee4dca1","type":"text","conversion_output":true,"text":"Sensitivity to analysis set:","text_display":"\nSensitivity to analysis set:","confidence":1,"confidence_rate":1},{"cnt":[[397,2287],[1825,2287],[1825,2335],[397,2335]],"region":{"top_left_x":397,"top_left_y":2286,"width":1429,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97720ca57e224179bb55e06f12e68525","type":"text","conversion_output":true,"text":"i. 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In the case of sparse data (at least one of the percentages","confidence":0.9990236759185791,"confidence_rate":0.9999899299373404},{"cnt":[[361,697],[1825,697],[1825,745],[361,745]],"region":{"top_left_x":360,"top_left_y":696,"width":1466,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd0725e91113498bb5c0115badcdcbc6","type":"text","conversion_output":true,"text":"is zero), no individual response rate confidence intervals and no p -value will be","text_display":" is zero), no individual response rate confidence intervals and no p -value will be","confidence":0.96728515625,"confidence_rate":0.9996424086879994},{"cnt":[[361,745],[532,745],[532,790],[361,790]],"region":{"top_left_x":360,"top_left_y":744,"width":173,"height":47},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0ebc1b20b6348ff9aaf137f9674e361","type":"text","conversion_output":true,"text":"presented.","text_display":" presented.","confidence":1,"confidence_rate":1},{"cnt":[[361,836],[1825,836],[1825,884],[361,884]],"region":{"top_left_x":360,"top_left_y":836,"width":1466,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65a0ef987e584deca6b63e611a6075f2","type":"text","conversion_output":true,"text":"According to the sample size of each subgroup (if \\(N <50\\) ), a Fisher's exact test will be","text_display":"\n\nAccording to the sample size of each subgroup (if \\(N <50\\) ), a Fisher's exact test will be","confidence":1,"confidence_rate":1},{"cnt":[[361,882],[1825,882],[1825,930],[361,930]],"region":{"top_left_x":360,"top_left_y":881,"width":1466,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"301af7a86b1e40bb9fdfbd2d5f17c417","type":"text","conversion_output":true,"text":"performed instead of the Wald test, in which case exact 2 -sided \\(95 \\%\\) CIs will be provided","text_display":" performed instead of the Wald test, in which case exact 2 -sided \\(95 \\%\\) CIs will be provided","confidence":0.7157721635110192,"confidence_rate":0.9966616510191144},{"cnt":[[361,927],[921,927],[921,975],[361,975]],"region":{"top_left_x":360,"top_left_y":927,"width":561,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce0e2d59ec1f4edeb9bef7b5241f1a1e","type":"text","conversion_output":true,"text":"for the difference of response rate.","text_display":" for the difference of response rate.","confidence":1,"confidence_rate":1},{"cnt":[[361,1023],[1830,1023],[1830,1071],[361,1071]],"region":{"top_left_x":360,"top_left_y":1023,"width":1470,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"106eaef8895745de8077fc27ba46f1e7","type":"text","conversion_output":true,"text":"With respect to the hierarchical procedure described in Table 2, the success criterion for","text_display":"\n\nWith respect to the hierarchical procedure described in Table 2, the success criterion for","confidence":1,"confidence_rate":1},{"cnt":[[361,1069],[1825,1069],[1825,1117],[361,1117]],"region":{"top_left_x":360,"top_left_y":1069,"width":1466,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95d6b6c5a7034a279aac88600a7e9160","type":"text","conversion_output":true,"text":"the comparison of treatment responders between treatments in the 6-11 years of age","text_display":" the comparison of treatment responders between treatments in the 6-11 years of age","confidence":1,"confidence_rate":1},{"cnt":[[361,1117],[1825,1117],[1825,1163],[361,1163]],"region":{"top_left_x":360,"top_left_y":1117,"width":1466,"height":46},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"37a1f0eca47c4b6cb30ad1d6fa913a78","type":"text","conversion_output":true,"text":"group (ITT) [Number 6 in the pre-defined hierarchical order of the efficacy analyses] will","text_display":" group (ITT) [Number 6 in the pre-defined hierarchical order of the efficacy analyses] will","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[361,1163],[1825,1163],[1825,1208],[361,1208]],"region":{"top_left_x":360,"top_left_y":1162,"width":1466,"height":47},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7aad7c7ef8a74927b13c3efba7a50aae","type":"text","conversion_output":true,"text":"be claimed if the Newcombe \\(95 \\%\\) lower CI bound is \\(\\geq 0\\) and the results for the previous","text_display":" be claimed if the Newcombe \\(95 \\%\\) lower CI bound is \\(\\geq 0\\) and the results for the previous","confidence":0.9980478286743164,"confidence_rate":0.999979430955802},{"cnt":[[361,1208],[1825,1208],[1825,1256],[361,1256]],"region":{"top_left_x":360,"top_left_y":1208,"width":1466,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42008140a2014a75803920268a139907","type":"text","conversion_output":true,"text":"efficacy comparisons in the hierarchical order met their success criteria, and the same","text_display":" efficacy comparisons in the hierarchical order met their success criteria, and the same","confidence":1,"confidence_rate":1},{"cnt":[[361,1256],[1825,1256],[1825,1304],[361,1304]],"region":{"top_left_x":360,"top_left_y":1256,"width":1466,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"394797dde259469cac97681b48429ac0","type":"text","conversion_output":true,"text":"would apply for the next comparison in the order evaluating the \\(4-5\\) years of age group","text_display":" would apply for the next comparison in the order evaluating the \\(4-5\\) years of age group","confidence":0.5,"confidence_rate":0.9926532143675867},{"cnt":[[361,1302],[1652,1302],[1652,1350],[361,1350]],"region":{"top_left_x":360,"top_left_y":1302,"width":1292,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f9b0925ff0846a58d1dc0d40e2b49cc","type":"text","conversion_output":true,"text":"(ITT) [Number 7 in the pre-defined hierarchical order of the efficacy analyses].","text_display":" (ITT) [Number 7 in the pre-defined hierarchical order of the efficacy analyses].","confidence":0.9965834617614746,"confidence_rate":0.9999611099842716},{"cnt":[[359,1439],[1825,1439],[1825,1492],[359,1492]],"region":{"top_left_x":358,"top_left_y":1439,"width":1468,"height":53},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24e8bdea04a344c1ae1b09119469cbd6","type":"text","conversion_output":true,"text":"4.8.3.3 Cumulative reactive dose of peanut protein and change from Baseline at","text_display":"\n4.8.3.3 Cumulative reactive dose of peanut protein and change from Baseline at","confidence":1,"confidence_rate":1},{"cnt":[[507,1489],[672,1489],[672,1528],[507,1528]],"region":{"top_left_x":507,"top_left_y":1489,"width":165,"height":40},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e122ac6ae6f849d2beb57fd6ce074132","type":"text","conversion_output":true,"text":"Month 12","text_display":" Month 12","confidence":1,"confidence_rate":1},{"cnt":[[361,1581],[1796,1581],[1796,1629],[361,1629]],"region":{"top_left_x":360,"top_left_y":1580,"width":1436,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fa9dd1c811e434486680e9be15e57b8","type":"text","conversion_output":true,"text":"The following variables will be tabulated by treatment group using descriptive statistics:","text_display":"\n\nThe following variables will be tabulated by treatment group using descriptive statistics:","confidence":1,"confidence_rate":1},{"cnt":[[420,1631],[1638,1631],[1638,1679],[420,1679]],"region":{"top_left_x":420,"top_left_y":1631,"width":1218,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20d7d8a956984a25bb62801c39426c78","type":"text","conversion_output":true,"text":"- Peanut protein cumulative reactive dose (CRD) at Baseline and at M12","text_display":"\n- Peanut protein cumulative reactive dose (CRD) at Baseline and at M12","confidence":1,"confidence_rate":1},{"cnt":[[420,1681],[1684,1681],[1684,1729],[420,1729]],"region":{"top_left_x":420,"top_left_y":1681,"width":1264,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c38e2c949bb94f0997e3d716eebc3cae","type":"text","conversion_output":true,"text":"- Change in Peanut protein cumulative reactive dose at M12 since Baseline","text_display":"\n- Change in Peanut protein cumulative reactive dose at M12 since Baseline","confidence":1,"confidence_rate":1},{"cnt":[[361,1775],[1702,1775],[1702,1821],[361,1821]],"region":{"top_left_x":360,"top_left_y":1774,"width":1342,"height":47},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d672c6dc158e4f39805926c4336ef55e","type":"text","conversion_output":true,"text":"The above statistics will be tabulated overall and for each screening ED subgroup:","text_display":"\n\nThe above statistics will be tabulated overall and for each screening ED subgroup:","confidence":1,"confidence_rate":1},{"cnt":[[420,1823],[1759,1823],[1759,1871],[420,1871]],"region":{"top_left_x":420,"top_left_y":1822,"width":1339,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"306da8c2e6db4f6583a7049722b1a2f7","type":"text","conversion_output":true,"text":"- On the ITT population (using modified Baseline Observation Carried Forward","text_display":"\n- On the ITT population (using modified Baseline Observation Carried Forward","confidence":1,"confidence_rate":1},{"cnt":[[482,1869],[1396,1869],[1396,1921],[482,1921]],"region":{"top_left_x":482,"top_left_y":1868,"width":914,"height":54},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"359425c4dfa9485187d8ae7044640a01","type":"text","conversion_output":true,"text":"[mBOCF] method to impute missing data at Month 12),","text_display":" [mBOCF] method to impute missing data at Month 12),","confidence":0.9975595474243164,"confidence_rate":0.9999563681780758},{"cnt":[[361,1965],[994,1965],[994,2008],[361,2008]],"region":{"top_left_x":360,"top_left_y":1964,"width":634,"height":44},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0360701bff8497c92b028388bd83d6d","type":"text","conversion_output":true,"text":"mBOCF for CRD is defined as follow:","text_display":"\nmBOCF for CRD is defined as 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rules) or if the subject took the \\(2,000 mg\\) dose without any objective","confidence":1,"confidence_rate":1},{"cnt":[[361,2104],[1748,2104],[1748,2150],[361,2150]],"region":{"top_left_x":360,"top_left_y":2103,"width":1388,"height":47},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0fa90024c47f408c90fcdadff4552643","type":"text","conversion_output":true,"text":"symptom leading to ending the DBPCFC, the CRD value at M12 is considered as the","text_display":" symptom leading to ending the DBPCFC, the CRD value at M12 is considered as the","confidence":1,"confidence_rate":1},{"cnt":[[359,2152],[688,2152],[688,2195],[359,2195]],"region":{"top_left_x":358,"top_left_y":2151,"width":330,"height":45},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ebac77baa55e4b9da973837bb0d6c376","type":"text","conversion_output":true,"text":"maximum between:","text_display":" maximum 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Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[420,370],[1460,370],[1460,423],[420,423]],"region":{"top_left_x":420,"top_left_y":370,"width":1040,"height":53},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d72e1ebdf9c84b829d3889b4cbedf38d","type":"text","conversion_output":true,"text":"- On the FAS and on the PP population (using observed data)","text_display":"\n- On the FAS and on the PP population (using observed data)","confidence":1,"confidence_rate":1},{"cnt":[[359,466],[1793,466],[1793,514],[359,514]],"region":{"top_left_x":358,"top_left_y":466,"width":1436,"height":48},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"32049434115347fc9fd54d26aa218e61","type":"text","conversion_output":true,"text":"- If the M12 DBPCFC is stopped without any objective symptoms leading to ending the","text_display":"\n- If the M12 DBPCFC is stopped without any objective symptoms leading to ending the","confidence":1,"confidence_rate":1},{"cnt":[[361,512],[1793,512],[1793,562],[361,562]],"region":{"top_left_x":360,"top_left_y":511,"width":1434,"height":51},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a01dc62280c44f599ea0ad73b3a9ab64","type":"text","conversion_output":true,"text":"DBPCFC (stopping rules) or if the subject took the \\(2,000 mg\\) dose without any objective","text_display":" DBPCFC (stopping rules) or if the subject took the \\(2,000 mg\\) dose without any objective","confidence":1,"confidence_rate":1},{"cnt":[[359,557],[1812,557],[1812,610],[359,610]],"region":{"top_left_x":358,"top_left_y":557,"width":1454,"height":53},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c181338273a34534a0d67dd58dcf4fe8","type":"text","conversion_output":true,"text":"symptom leading to ending the DBPCFC, the CRD at Month 12 is considered as the sum","text_display":" symptom leading to ending the DBPCFC, the CRD at Month 12 is considered as the sum","confidence":1,"confidence_rate":1},{"cnt":[[359,605],[1606,605],[1606,656],[359,656]],"region":{"top_left_x":358,"top_left_y":605,"width":1248,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7030ecbb73184b6f87610a5fdea4202b","type":"text","conversion_output":true,"text":"of all doses given at Month 12, including also the repeated and partial doses.","text_display":" of all doses given at Month 12, including also the repeated and partial doses.","confidence":1,"confidence_rate":1},{"cnt":[[361,699],[1830,699],[1830,747],[361,747]],"region":{"top_left_x":360,"top_left_y":699,"width":1470,"height":48},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b1fca0c58259438eb1c8b65d135fadf8","type":"text","conversion_output":true,"text":"The peanut protein cumulative reactive dose in each treatment group at M12 will be","text_display":"\n\nThe peanut protein cumulative reactive dose in each treatment group at M12 will be","confidence":0.95458984375,"confidence_rate":0.9994659643289875},{"cnt":[[359,745],[1830,745],[1830,793],[359,793]],"region":{"top_left_x":358,"top_left_y":744,"width":1472,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a800323064594f029be4a4788c0b49c1","type":"text","conversion_output":true,"text":"compared using an analysis of covariance (ANCOVA) model. The ANCOVA model will","text_display":" compared using an analysis of covariance (ANCOVA) model. The ANCOVA model will","confidence":1,"confidence_rate":1},{"cnt":[[359,790],[1757,790],[1757,843],[359,843]],"region":{"top_left_x":358,"top_left_y":790,"width":1399,"height":53},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80774300ff7f4c13ba06d2538d1f14ec","type":"text","conversion_output":true,"text":"include the treatment group, adjusted for the Baseline cumulative reactive dose value.","text_display":" include the treatment group, adjusted for the Baseline cumulative reactive dose value.","confidence":1,"confidence_rate":1},{"cnt":[[359,836],[1830,836],[1830,889],[359,889]],"region":{"top_left_x":358,"top_left_y":836,"width":1472,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf8dad8a48e64e1bb6b33d813e774da9","type":"text","conversion_output":true,"text":"This comparison will be performed in the overall ITT population using mBOCF","text_display":" This comparison will be performed in the overall ITT population using mBOCF","confidence":1,"confidence_rate":1},{"cnt":[[359,886],[1830,886],[1830,934],[359,934]],"region":{"top_left_x":358,"top_left_y":886,"width":1472,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9fb4e37da75245048e3e0580ef2e738d","type":"text","conversion_output":true,"text":"imputation [Number 4 in the pre-defined hierarchical order of the efficacy analyses], as","text_display":" imputation [Number 4 in the pre-defined hierarchical order of the efficacy analyses], as","confidence":0.9970715045928955,"confidence_rate":0.9999694505516451},{"cnt":[[359,932],[1830,932],[1830,980],[359,980]],"region":{"top_left_x":358,"top_left_y":932,"width":1472,"height":48},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb376406323e43e18f22577bc963d0db","type":"text","conversion_output":true,"text":"well as for each screening ED subgroup [Number \\(10 \\& 12\\) in the pre-defined hierarchical","text_display":" well as for each screening ED subgroup [Number \\(10 \\& 12\\) in the pre-defined hierarchical","confidence":0.8030846426777316,"confidence_rate":0.9976191955503692},{"cnt":[[359,978],[866,978],[866,1028],[359,1028]],"region":{"top_left_x":358,"top_left_y":977,"width":508,"height":51},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c0093db8cd549218f3ed0d5244734ed","type":"text","conversion_output":true,"text":"order of the efficacy analyses].","text_display":" order of the efficacy analyses].","confidence":0.99951171875,"confidence_rate":0.9999868000736574},{"cnt":[[359,1069],[1830,1069],[1830,1122],[359,1122]],"region":{"top_left_x":358,"top_left_y":1069,"width":1472,"height":53},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da38ed3e115746289f68837d9b1f07b7","type":"text","conversion_output":true,"text":"Additionally, this analysis will be repeated on the FAS and the PP population, using","text_display":"\n\nAdditionally, this analysis will be repeated on the FAS and the PP population, using","confidence":1,"confidence_rate":1},{"cnt":[[359,1119],[1336,1119],[1336,1167],[359,1167]],"region":{"top_left_x":358,"top_left_y":1119,"width":979,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0afbe5bd547f4828b5a8cb657b9ab14d","type":"text","conversion_output":true,"text":"observed data, overall and for each screening ED subgroup.","text_display":" observed data, overall and for each screening ED subgroup.","confidence":1,"confidence_rate":1},{"cnt":[[359,1211],[1830,1211],[1830,1263],[359,1263]],"region":{"top_left_x":358,"top_left_y":1210,"width":1472,"height":54},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"281d8002dcf94db1ac202fa7f1331abe","type":"text","conversion_output":true,"text":"Finally, the M12 peanut protein cumulative reactive dose comparison will also be","text_display":"\n\nFinally, the M12 peanut protein cumulative reactive dose comparison will also be","confidence":1,"confidence_rate":1},{"cnt":[[356,1256],[1309,1256],[1309,1309],[356,1309]],"region":{"top_left_x":356,"top_left_y":1256,"width":953,"height":53},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cbe588c7fd054fc88d2938e92fb6b278","type":"text","conversion_output":true,"text":"performed for each age group (4-5 and 6-11 years of age):","text_display":" performed for each age group (4-5 and 6-11 years of age):","confidence":0.99951171875,"confidence_rate":0.999992122603638},{"cnt":[[420,1307],[1446,1307],[1446,1359],[420,1359]],"region":{"top_left_x":420,"top_left_y":1306,"width":1027,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11e7b4794b49489fadaad52692100968","type":"text","conversion_output":true,"text":"- On the overall ITT population (using mBOCF imputation),","text_display":"\n- On the overall ITT population (using mBOCF imputation),","confidence":1,"confidence_rate":1},{"cnt":[[420,1357],[1053,1357],[1053,1409],[420,1409]],"region":{"top_left_x":420,"top_left_y":1356,"width":634,"height":54},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63731db105c846ea9a4a7f9f373dbeeb","type":"text","conversion_output":true,"text":"- On the FAS (using observed data),","text_display":"\n- On the FAS (using observed data),","confidence":1,"confidence_rate":1},{"cnt":[[420,1407],[1208,1407],[1208,1457],[420,1457]],"region":{"top_left_x":420,"top_left_y":1407,"width":789,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"729a2f66a631417dbf9b45a9ce5b9c53","type":"text","conversion_output":true,"text":"- On the PP population (using observed data).","text_display":"\n- On the PP population (using observed data).","confidence":1,"confidence_rate":1},{"cnt":[[359,1494],[1748,1494],[1748,1549],[359,1549]],"region":{"top_left_x":358,"top_left_y":1493,"width":1390,"height":56},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69ade42610b4490286b0cff0fa55f897","type":"text","conversion_output":true,"text":"The ANCOVA will be performed through a mixed procedure. A sample of the SAS \\({ }^{\\circledR}\\)","text_display":"\n\nThe ANCOVA will be performed through a mixed procedure. A sample of the SAS \\({ }^{\\circledR}\\)","confidence":0.9912109375,"confidence_rate":0.9998996878256531},{"cnt":[[359,1544],[1652,1544],[1652,1597],[359,1597]],"region":{"top_left_x":358,"top_left_y":1544,"width":1294,"height":53},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8aa01d52cc11462dbb5654f0b8fa2402","type":"text","conversion_output":true,"text":"code to be used can be found in Appendix 2.3: Statistical analysis methods and","text_display":" code to be used can be found in Appendix 2.3: Statistical analysis methods and","confidence":1,"confidence_rate":1},{"cnt":[[356,1594],[1732,1594],[1732,1642],[356,1642]],"region":{"top_left_x":356,"top_left_y":1594,"width":1376,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8bf68b8c36af447eb2bba01ba4661c8c","type":"text","conversion_output":true,"text":"procedures used for the analysis of the cumulative reactive dose of peanut protein at","text_display":" procedures used for the analysis of the cumulative reactive dose of peanut protein at","confidence":1,"confidence_rate":1},{"cnt":[[359,1640],[532,1640],[532,1684],[359,1684]],"region":{"top_left_x":358,"top_left_y":1640,"width":175,"height":44},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c424dffed2d47cbafe5a16138626e94","type":"text","conversion_output":true,"text":"month 12.","text_display":" month 12.","confidence":1,"confidence_rate":1},{"cnt":[[359,1732],[1044,1732],[1044,1782],[359,1782]],"region":{"top_left_x":358,"top_left_y":1731,"width":686,"height":51},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c489b4f6ab8542e5b2283bd62a443c1c","type":"text","conversion_output":true,"text":"The following statistics will be presented:","text_display":"\n\nThe following statistics will be presented:","confidence":1,"confidence_rate":1},{"cnt":[[420,1782],[1768,1782],[1768,1832],[420,1832]],"region":{"top_left_x":420,"top_left_y":1781,"width":1349,"height":52},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66628eb1c48f4b1c89956e4cf4371286","type":"text","conversion_output":true,"text":"- The Least square means (LS Means) by treatment group: mean for the variable","text_display":"\n- The Least square means (LS Means) by treatment group: mean for the variable","confidence":1,"confidence_rate":1},{"cnt":[[480,1828],[1282,1828],[1282,1880],[480,1880]],"region":{"top_left_x":479,"top_left_y":1827,"width":803,"height":54},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aae9254c9ec14b5390c43bdf1921f778","type":"text","conversion_output":true,"text":"obtained by the model adjusted on the covariates","text_display":" obtained by the model adjusted on the covariates","confidence":1,"confidence_rate":1},{"cnt":[[420,1878],[1738,1878],[1738,1926],[420,1926]],"region":{"top_left_x":420,"top_left_y":1877,"width":1319,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c75e06991034f8398780a6bcf57b4bc","type":"text","conversion_output":true,"text":"- The difference between the LS Means and the associated confidence interval","text_display":"\n- The difference between the LS Means and the associated confidence interval","confidence":1,"confidence_rate":1},{"cnt":[[420,1928],[1816,1928],[1816,1976],[420,1976]],"region":{"top_left_x":420,"top_left_y":1928,"width":1397,"height":48},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19cd54ccc3a646759dbbc76f5fca979e","type":"text","conversion_output":true,"text":"- The effect size: calculated as the absolute difference in the LS means between the","text_display":"\n- The effect size: calculated as the absolute difference in the LS means between the","confidence":1,"confidence_rate":1},{"cnt":[[480,1974],[1375,1974],[1375,2024],[480,2024]],"region":{"top_left_x":479,"top_left_y":1973,"width":897,"height":51},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e487f2372ee4bcb8518a615147aa118","type":"text","conversion_output":true,"text":"treatment groups divided by pooled standard deviation","text_display":" treatment groups divided by pooled standard deviation","confidence":1,"confidence_rate":1},{"cnt":[[420,2024],[1720,2024],[1720,2074],[420,2074]],"region":{"top_left_x":420,"top_left_y":2023,"width":1301,"height":52},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1e4b3547c07f4315a307a94fc348d325","type":"text","conversion_output":true,"text":"- The p -value from the hypothesis test of no difference between the treatment","text_display":"\n- The p -value from the hypothesis test of no difference between the 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The treatment difference will be evaluated at the \\(5 \\%\\) level of","text_display":" means (adjusted means). The treatment difference will be evaluated at the \\(5 \\%\\) level of","confidence":0.9663562620989978,"confidence_rate":0.9996320815543452},{"cnt":[[361,2211],[573,2211],[573,2259],[361,2259]],"region":{"top_left_x":360,"top_left_y":2211,"width":214,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11ed5a61e53549d39bde3bb0179094bd","type":"text","conversion_output":true,"text":"significance.","text_display":" significance.","confidence":0.98046875,"confidence_rate":0.9989047943233336},{"cnt":[[359,2303],[1741,2303],[1741,2353],[359,2353]],"region":{"top_left_x":358,"top_left_y":2302,"width":1383,"height":51},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd122f141a464446af129d84d26b8005","type":"text","conversion_output":true,"text":"The assumption of normality underlying the statistical model will be tested using the","text_display":"\n\nThe assumption of normality underlying the statistical model will be tested using the","confidence":1,"confidence_rate":1},{"cnt":[[361,2348],[1684,2348],[1684,2401],[361,2401]],"region":{"top_left_x":360,"top_left_y":2348,"width":1324,"height":53},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8f065250654743ed986c295d46c84a03","type":"text","conversion_output":true,"text":"Shapiro-Wilk test. A p-value less than 0.05 will be taken to indicate evidence of","text_display":" Shapiro-Wilk test. A p-value less than 0.05 will be taken to indicate evidence of","confidence":0.9990234375,"confidence_rate":0.9999890220866866},{"cnt":[[361,2396],[1807,2396],[1807,2447],[361,2447]],"region":{"top_left_x":360,"top_left_y":2396,"width":1447,"height":51},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bfe4ba5004c04e9693af822e078768e0","type":"text","conversion_output":true,"text":"non-normality. In addition, a normal probability plot of the studentized residuals will be","text_display":" non-normality. 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A p-value less than 0.05 will be taken to indicate evidence of heterogeneity","text_display":" Levene's test. A p-value less than 0.05 will be taken to indicate evidence of heterogeneity","confidence":1,"confidence_rate":1},{"cnt":[[361,512],[560,512],[560,555],[361,555]],"region":{"top_left_x":360,"top_left_y":511,"width":200,"height":45},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d181e2ee88145d0a1e3e1c04453183d","type":"text","conversion_output":true,"text":"of variance.","text_display":" of variance.","confidence":0.99658203125,"confidence_rate":0.999798618906392},{"cnt":[[361,603],[1812,603],[1812,651],[361,651]],"region":{"top_left_x":360,"top_left_y":603,"width":1452,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a65f899d776447aabb9ba4b15d7811f","type":"text","conversion_output":true,"text":"If the assumptions of normality and/or homogeneity of variance underlying the statistical","text_display":"\n\nIf the assumptions of normality and/or homogeneity of variance underlying the statistical","confidence":1,"confidence_rate":1},{"cnt":[[359,649],[1770,649],[1770,697],[359,697]],"region":{"top_left_x":358,"top_left_y":648,"width":1413,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e46c95204ecf45d98967cf6e5eeb3e68","type":"text","conversion_output":true,"text":"model are violated, \\(\\log _{10}\\)-transformation of the data will be considered instead. In that","text_display":" model are violated, \\(\\log _{10}\\)-transformation of the data will be considered instead. In that","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[361,697],[1122,697],[1122,745],[361,745]],"region":{"top_left_x":360,"top_left_y":696,"width":762,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e8afa1b276542c0847ba78c4ca26e95","type":"text","conversion_output":true,"text":"case, the following statistics will be presented:","text_display":" case, the following statistics will be presented:","confidence":1,"confidence_rate":1},{"cnt":[[420,745],[1816,745],[1816,795],[420,795]],"region":{"top_left_x":420,"top_left_y":744,"width":1397,"height":51},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bbea6660682e4609ad292b24741428fc","type":"text","conversion_output":true,"text":"- The back transformed Least square means: the Geometric Least Square Means by","text_display":"\n- The back transformed Least square means: the Geometric Least Square Means 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performed using an","text_display":" of the \\(\\log _{10}\\)-transformed data, a sensitivity analysis will be performed using an","confidence":1,"confidence_rate":1},{"cnt":[[359,1220],[1784,1220],[1784,1270],[359,1270]],"region":{"top_left_x":358,"top_left_y":1219,"width":1427,"height":52},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"971a2096956a4f28bd86f9f7f2cc36e4","type":"text","conversion_output":true,"text":"appropriate non-parametric test procedure. 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This p-value will not be","text_display":" treatment groups (Wilcoxon rank-sum test) will be presented. This p-value will not be","confidence":0.99560546875,"confidence_rate":0.9999510654686117},{"cnt":[[359,1407],[1455,1407],[1455,1455],[359,1455]],"region":{"top_left_x":358,"top_left_y":1407,"width":1098,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c926582aa0b045edbb1e0f24c37a6cdd","type":"text","conversion_output":true,"text":"adjusted for multiplicity and provided for descriptive purpose only.","text_display":" adjusted for multiplicity and provided for descriptive purpose 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S.A.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,288],[496,288],[496,322],[361,322]],"region":{"top_left_x":360,"top_left_y":287,"width":136,"height":36},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e878574dbcfa497cb07c687373aa24b0","type":"page_info","conversion_output":false,"text":"PEPITES","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1494,288],[1830,288],[1830,327],[1494,327]],"region":{"top_left_x":1493,"top_left_y":287,"width":337,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2a895ab1efd4bdab67b98fdcda4a671","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,370],[1720,370],[1720,418],[361,418]],"region":{"top_left_x":360,"top_left_y":370,"width":1361,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a24c7ead9a9419dad116f4cd9890b6e","type":"text","conversion_output":true,"text":"- For the subjects who did not undergo the M12 DBPCFC, ED value at screening is","text_display":"\n- For the subjects who did not undergo the M12 DBPCFC, ED value at screening is","confidence":0.9936649702746081,"confidence_rate":0.999924345943127},{"cnt":[[361,416],[752,416],[752,459],[361,459]],"region":{"top_left_x":360,"top_left_y":415,"width":392,"height":45},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f59885d79e034664add1b483d6ce234b","type":"text","conversion_output":true,"text":"carried forward at M12.","text_display":" carried forward at 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to","confidence":1,"confidence_rate":1},{"cnt":[[361,653],[1825,653],[1825,701],[361,701]],"region":{"top_left_x":360,"top_left_y":653,"width":1466,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"616eab14066a44428aa8d38d42dc61eb","type":"text","conversion_output":true,"text":"ending the DBPCFC (stopping rules) or if the subject took the \\(2,000 mg\\) dose without any","text_display":" ending the DBPCFC (stopping rules) or if the subject took the \\(2,000 mg\\) dose without any","confidence":1,"confidence_rate":1},{"cnt":[[361,699],[1825,699],[1825,747],[361,747]],"region":{"top_left_x":360,"top_left_y":699,"width":1466,"height":48},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d77b190e78414ee780466e24c064a34d","type":"text","conversion_output":true,"text":"objective symptom leading to ending the DBPCFC, the last dose given at M12 DBPCFC","text_display":" objective symptom leading to ending the DBPCFC, the last dose given at M12 DBPCFC","confidence":1,"confidence_rate":1},{"cnt":[[361,745],[1825,745],[1825,793],[361,793]],"region":{"top_left_x":360,"top_left_y":744,"width":1466,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d5a89ea35da4dc287ca5849bf0d0b75","type":"text","conversion_output":true,"text":"will be considered for ED value. If the last dose given at M12 DBPCFC is only partially","text_display":" will be considered for ED value. 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calculated by dividing the sum of completed items by the number of completed","confidence":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[480,1142],[578,1142],[578,1186],[480,1186]],"region":{"top_left_x":479,"top_left_y":1142,"width":99,"height":44},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec42ac7b7b4f440fa2baf73e4ca1b7a9","type":"text","conversion_output":true,"text":"items","text_display":" items","confidence":1,"confidence_rate":1},{"cnt":[[480,1211],[1761,1211],[1761,1263],[480,1263]],"region":{"top_left_x":479,"top_left_y":1210,"width":1283,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71e8a72537f44ed1aa779ff8aa725e43","type":"text","conversion_output":true,"text":"3) If \\(>20 \\%\\) of items in any (sub-)domain are missing then the respective (sub-","text_display":"\n3) If \\(>20 \\%\\) of items in any (sub-)domain are missing then the respective 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AEs.","confidence":1,"confidence_rate":1},{"cnt":[[359,1215],[1830,1215],[1830,1266],[359,1266]],"region":{"top_left_x":358,"top_left_y":1215,"width":1472,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f531716941945858ff2465ed834dd75","type":"text","conversion_output":true,"text":"An overall overview table of AEs (to be distinguished from symptoms/reactions elicited","text_display":"\nAn overall overview table of AEs (to be distinguished from symptoms/reactions elicited","confidence":1,"confidence_rate":1},{"cnt":[[361,1263],[1830,1261],[1830,1311],[361,1314]],"region":{"top_left_x":360,"top_left_y":1260,"width":1470,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76fe9744ca7341688dd01b37ccdf5c30","type":"text","conversion_output":true,"text":"during the DBPCFCs) will be provided showing the number of subjects, the percentage","text_display":" during the DBPCFCs) will be provided showing the number of subjects, the percentage","confidence":0.99853515625,"confidence_rate":0.9999833419832634},{"cnt":[[361,1311],[1830,1311],[1830,1359],[361,1359]],"region":{"top_left_x":360,"top_left_y":1311,"width":1470,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48448cff58e54c01aff2b4d20f86af85","type":"text","conversion_output":true,"text":"of subjects and the number of events, overall and for each treatment group, for the","text_display":" of subjects and the number of events, overall and for each treatment group, for the","confidence":1,"confidence_rate":1},{"cnt":[[361,1357],[834,1357],[834,1405],[361,1405]],"region":{"top_left_x":360,"top_left_y":1356,"width":474,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bfd78ef5a33497d8a2a3aae0880a109","type":"text","conversion_output":true,"text":"following categories of AEs:","text_display":" following categories of AEs:","confidence":1,"confidence_rate":1},{"cnt":[[420,1407],[633,1407],[633,1455],[420,1455]],"region":{"top_left_x":420,"top_left_y":1407,"width":213,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c1117e97d6342f8aff415a8b2e80ade","type":"text","conversion_output":true,"text":"- Any AE,","text_display":"\n- Any AE,","confidence":1,"confidence_rate":1},{"cnt":[[420,1457],[774,1457],[774,1505],[420,1505]],"region":{"top_left_x":420,"top_left_y":1457,"width":355,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7cc829b3b7464b6f8e1b693687276ae6","type":"text","conversion_output":true,"text":"- Any serious AEs,","text_display":"\n- Any serious 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TEAEs:","confidence":1,"confidence_rate":1},{"cnt":[[420,1894],[683,1894],[683,1944],[420,1944]],"region":{"top_left_x":420,"top_left_y":1893,"width":264,"height":52},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bf3d9a7c056244cfbc1e5300904fe8ad","type":"text","conversion_output":true,"text":"- Any TEAE,","text_display":"\n- Any TEAE,","confidence":1,"confidence_rate":1},{"cnt":[[420,1944],[825,1944],[825,1994],[420,1994]],"region":{"top_left_x":420,"top_left_y":1944,"width":405,"height":51},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca4cc97da12448c0992e160fbcf23bd9","type":"text","conversion_output":true,"text":"- Any serious teates,","text_display":"\n- Any serious 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related,","confidence":0.99072265625,"confidence_rate":0.9997337312748514},{"cnt":[[544,2088],[1268,2088],[1268,2134],[544,2134]],"region":{"top_left_x":543,"top_left_y":2087,"width":725,"height":47},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8cca229926ef48318947c06910890ef9","type":"text","conversion_output":true,"text":"\\(r\\) Any TEAE reported as probably related,","text_display":"\n\\(r\\) Any TEAE reported as probably related,","confidence":0.62939453125,"confidence_rate":0.9895325107841234},{"cnt":[[544,2134],[1259,2134],[1259,2182],[544,2182]],"region":{"top_left_x":543,"top_left_y":2133,"width":716,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4da1b4939a234c13a9361cf920e52432","type":"text","conversion_output":true,"text":"\\(r\\) Any TEAE reported as possibly related,","text_display":"\n\\(r\\) Any TEAE reported as possibly 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(IP),","confidence":1,"confidence_rate":1},{"cnt":[[420,2371],[1574,2371],[1574,2424],[420,2424]],"region":{"top_left_x":420,"top_left_y":2371,"width":1154,"height":53},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"21fdaba9fa744a4ca80c5949e8b06c2b","type":"text","conversion_output":true,"text":"- Any TEAEs leading to permanent study treatment discontinuation,","text_display":"\n- Any TEAEs leading to permanent study treatment discontinuation,","confidence":1,"confidence_rate":1},{"cnt":[[420,2421],[1567,2421],[1567,2474],[420,2474]],"region":{"top_left_x":420,"top_left_y":2421,"width":1148,"height":53},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c409c98ace04fb68efb3f2e5c9daddd","type":"text","conversion_output":true,"text":"- Any TEAEs leading to temporary study treatment discontinuation,","text_display":"\n- Any TEAEs leading to temporary study treatment 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the above selections, especially regarding the route","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[359,2316],[1830,2316],[1830,2369],[359,2369]],"region":{"top_left_x":358,"top_left_y":2316,"width":1472,"height":53},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b7c30f7cd6d41a186df20c875df2bd0","type":"text","conversion_output":true,"text":"that can be reported as \"Other\" with a text field specification, will be checked during the","text_display":" that can be reported as \"Other\" with a text field specification, will be checked during the","confidence":1,"confidence_rate":1},{"cnt":[[361,2367],[813,2367],[813,2415],[361,2415]],"region":{"top_left_x":360,"top_left_y":2366,"width":454,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ddc8a616d16041b191aadb2333ffde58","type":"text","conversion_output":true,"text":"blind data review meeting).","text_display":" blind data 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below:","confidence":0.99853515625,"confidence_rate":0.9999804546219134},{"cnt":[[359,2517],[420,2517],[420,2554],[359,2554]],"region":{"top_left_x":358,"top_left_y":2517,"width":63,"height":37},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00acd564388e4b94b7a189c1cb5e8afc","type":"page_info","conversion_output":false,"text":"CCI","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[937,2524],[1830,2524],[1830,2565],[937,2565]],"region":{"top_left_x":936,"top_left_y":2524,"width":894,"height":42},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0affe8b316304908a6257e25f97aad9c","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL Project Document Version No. 3.0","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999800654844866},{"cnt":[[1156,2563],[1830,2563],[1830,2604],[1156,2604]],"region":{"top_left_x":1155,"top_left_y":2563,"width":675,"height":42},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"da6ae650cc134f5d8f76d5809fdf27f8","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: 04-Oct-2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1636,2604],[1830,2604],[1830,2643],[1636,2643]],"region":{"top_left_x":1635,"top_left_y":2604,"width":195,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89b6d3207ab94b55a291f7b24c0a9d1e","type":"page_info","conversion_output":false,"text":"Page 51 of 79","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"4520d961-8076-4a3e-9288-40cbcbc6a794-52","page":52,"lines":[{"cnt":[[361,247],[770,247],[770,286],[361,286]],"region":{"top_left_x":360,"top_left_y":246,"width":410,"height":40},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6398887a9ba34607b1891addbf3fa0d3","type":"page_info","conversion_output":false,"text":"DBV TECHNOLOGIES S.A.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,288],[496,288],[496,322],[361,322]],"region":{"top_left_x":360,"top_left_y":287,"width":136,"height":36},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b495334950944db0b625b505503aaefb","type":"page_info","conversion_output":false,"text":"PEPITES","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1494,288],[1830,288],[1830,327],[1494,327]],"region":{"top_left_x":1493,"top_left_y":287,"width":337,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ffdf5825f589496dad8ab673918df087","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[423,375],[1807,375],[1807,423],[423,423]],"region":{"top_left_x":422,"top_left_y":374,"width":1385,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a636ca8e9d4a485199d00bf9ab00be15","type":"text","conversion_output":true,"text":"- In the AE form: TEAEs for which a medication is administered (\"Were there any","text_display":"\n- In the AE form: TEAEs for which a medication is administered (\"Were there any","confidence":0.98681640625,"confidence_rate":0.9998420211852557},{"cnt":[[480,420],[1551,420],[1551,468],[480,468]],"region":{"top_left_x":479,"top_left_y":420,"width":1073,"height":49},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61ffb84e8e214d37bcfdafb1b2fd9ba2","type":"text","conversion_output":true,"text":"medication administered for this adverse event? answered \"Yes\")","text_display":" medication administered for this adverse event? answered \"Yes\")","confidence":1,"confidence_rate":1},{"cnt":[[420,471],[1581,471],[1581,514],[420,514]],"region":{"top_left_x":420,"top_left_y":470,"width":1161,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f922d86f9234348a8be9e158641f7a3","type":"text","conversion_output":true,"text":"- In the Concomitant medication form for the medication considered:","text_display":"\n- In the Concomitant medication form for the medication considered:","confidence":1,"confidence_rate":1},{"cnt":[[480,516],[1782,516],[1782,564],[480,564]],"region":{"top_left_x":479,"top_left_y":516,"width":1303,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30fe355754764d14b545e339a9b8433f","type":"text","conversion_output":true,"text":"corresponding AE numbers documented in the field \"Number of adverse events","text_display":" corresponding AE numbers documented in the field \"Number of adverse events","confidence":1,"confidence_rate":1},{"cnt":[[480,562],[1085,562],[1085,605],[480,605]],"region":{"top_left_x":479,"top_left_y":561,"width":607,"height":45},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69980708a4604823813954c5b26ee9df","type":"text","conversion_output":true,"text":"for which the medication was taken\"","text_display":" for which the medication was taken\"","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[359,649],[1830,649],[1830,697],[359,697]],"region":{"top_left_x":358,"top_left_y":648,"width":1472,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56c5c2aebf63418784d71b3fa409d3d7","type":"text","conversion_output":true,"text":"For TEAEs and TEAEs considered related to IP, additional tables will be provided","text_display":"\n\nFor TEAEs and TEAEs considered related to IP, additional tables will be provided","confidence":1,"confidence_rate":1},{"cnt":[[361,694],[1272,694],[1272,742],[361,742]],"region":{"top_left_x":360,"top_left_y":694,"width":913,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e31a2c28dc64d7f9d68119169ccf42b","type":"text","conversion_output":true,"text":"showing number of subjects and percentage of subjects:","text_display":" showing number of subjects and percentage of subjects:","confidence":1,"confidence_rate":1},{"cnt":[[420,745],[1825,745],[1825,793],[420,793]],"region":{"top_left_x":420,"top_left_y":744,"width":1406,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e3a67a2be904831befeadd4442758af","type":"text","conversion_output":true,"text":"- By maximum severity (severe, moderate and mild): Subjects will be counted once","text_display":"\n- By maximum severity (severe, moderate and mild): Subjects will be counted once","confidence":1,"confidence_rate":1},{"cnt":[[480,790],[1825,790],[1825,838],[480,838]],"region":{"top_left_x":479,"top_left_y":790,"width":1347,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a147043ee4554cd790b80247c0e01a52","type":"text","conversion_output":true,"text":"per SOC and once per PT at the worst severity. If the severity is missing, the","text_display":" per SOC and once per PT at the worst severity. If the severity is missing, the","confidence":1,"confidence_rate":1},{"cnt":[[480,836],[998,836],[998,884],[480,884]],"region":{"top_left_x":479,"top_left_y":836,"width":520,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e64f10a5a7524c169570b605f8cbfc2b","type":"text","conversion_output":true,"text":"worst severity will be assumed.","text_display":" worst severity will be assumed.","confidence":1,"confidence_rate":1},{"cnt":[[420,886],[1825,886],[1825,934],[420,934]],"region":{"top_left_x":420,"top_left_y":886,"width":1406,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30954f21d6144069b6469181b072a002","type":"text","conversion_output":true,"text":"- By maximum duration. For these tables TEAEs will be presented by SOC, PT","text_display":"\n- By maximum duration. For these tables TEAEs will be presented by SOC, PT","confidence":1,"confidence_rate":1},{"cnt":[[480,932],[1830,932],[1830,980],[480,980]],"region":{"top_left_x":479,"top_left_y":932,"width":1351,"height":48},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f84295b5cb3d4431b0c41d95296fbfc3","type":"text","conversion_output":true,"text":"within each SOC and maximum duration within each PT (using the classes for","text_display":" within each SOC and maximum duration within each PT (using the classes for","confidence":1,"confidence_rate":1},{"cnt":[[480,978],[1830,978],[1830,1028],[480,1028]],"region":{"top_left_x":479,"top_left_y":977,"width":1351,"height":51},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a1c0e0ac3b345218a527bc1a6af09b5","type":"text","conversion_output":true,"text":"duration in days: 1-7, 8-15, 16-30, 31-60, 61-90, above 91). For AEs ongoing at","text_display":" duration in days: 1-7, 8-15, 16-30, 31-60, 61-90, above 91). For AEs ongoing at","confidence":0.708984375,"confidence_rate":0.9959140632146576},{"cnt":[[480,1026],[1830,1026],[1830,1074],[480,1074]],"region":{"top_left_x":479,"top_left_y":1025,"width":1351,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb6890d6f1804aafa6d011431842b9dd","type":"text","conversion_output":true,"text":"the end of the study, duration will be imputed based on the date of subject end of","text_display":" the end of the study, duration will be imputed based on the date of subject end of","confidence":1,"confidence_rate":1},{"cnt":[[480,1074],[1830,1074],[1830,1122],[480,1122]],"region":{"top_left_x":479,"top_left_y":1073,"width":1351,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f49134af24a34e6d81fe4826fabb8f61","type":"text","conversion_output":true,"text":"study. For AEs not ongoing but with missing end date, duration will be imputed","text_display":" study. For AEs not ongoing but with missing end date, duration will be imputed","confidence":1,"confidence_rate":1},{"cnt":[[480,1119],[1090,1119],[1090,1167],[480,1167]],"region":{"top_left_x":479,"top_left_y":1119,"width":611,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19fdf71d5b5c4cc8aed94c8585835712","type":"text","conversion_output":true,"text":"based on date of last study treatment.","text_display":" based on date of last study treatment.","confidence":1,"confidence_rate":1},{"cnt":[[359,1165],[1830,1165],[1830,1213],[359,1213]],"region":{"top_left_x":358,"top_left_y":1165,"width":1472,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1ec32c3d4bd4bc6ade7f75fffe6bf87","type":"text","conversion_output":true,"text":"Additionally, for TEAEs and TEAEs considered related to IP, tables showing number of","text_display":"\nAdditionally, for TEAEs and TEAEs considered related to IP, tables showing number of","confidence":1,"confidence_rate":1},{"cnt":[[359,1213],[1825,1213],[1825,1263],[359,1263]],"region":{"top_left_x":358,"top_left_y":1213,"width":1468,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fd083ef738e4782924dd50eecf72a23","type":"text","conversion_output":true,"text":"subjects, percentage of subjects and number of events by severity will be provided.","text_display":" subjects, percentage of subjects and number of events by severity will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[359,1256],[1825,1256],[1825,1309],[359,1309]],"region":{"top_left_x":358,"top_left_y":1256,"width":1468,"height":53},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"75090859ecfd4d768aeeb2678d77109b","type":"text","conversion_output":true,"text":"Subjects will be counted once per SOC, per PT and per severity. For these specific tables,","text_display":" Subjects will be counted once per SOC, per PT and per severity. For these specific tables,","confidence":1,"confidence_rate":1},{"cnt":[[359,1307],[1793,1307],[1793,1355],[359,1355]],"region":{"top_left_x":358,"top_left_y":1306,"width":1436,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ca3ad47c5ce4e58868652ad51f110eb","type":"text","conversion_output":true,"text":"if the severity is missing, no hypothesis will be assumed to replace the missing severity.","text_display":" if the severity is missing, no hypothesis will be assumed to replace the missing severity.","confidence":1,"confidence_rate":1},{"cnt":[[359,1398],[1825,1398],[1825,1446],[359,1446]],"region":{"top_left_x":358,"top_left_y":1398,"width":1468,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e15615a54ce44686a45a01fe157d46c5","type":"text","conversion_output":true,"text":"Adverse event summaries will be ordered in terms of decreasing frequency for SOC, and","text_display":"\n\nAdverse event summaries will be ordered in terms of decreasing frequency for SOC, and","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[359,1439],[1825,1439],[1825,1494],[359,1494]],"region":{"top_left_x":358,"top_left_y":1439,"width":1468,"height":55},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f04fee940a34d8181a93670078a93fe","type":"text","conversion_output":true,"text":"PT within SOC, in the Viaskin \\({ }^{(R)}\\) treatment group, and then similarly by decreasing","text_display":" PT within SOC, in the Viaskin \\({ }^{(R)}\\) treatment group, and then similarly by decreasing","confidence":0.1873340606689453,"confidence_rate":0.9830547860288622},{"cnt":[[359,1489],[1761,1489],[1761,1542],[359,1542]],"region":{"top_left_x":358,"top_left_y":1489,"width":1404,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51e3540448a342bc90c4a6d929025e52","type":"text","conversion_output":true,"text":"frequency in the placebo group, and then alphabetically for SOC, and PT within SOC.","text_display":" frequency in the placebo group, and then alphabetically for SOC, and PT within SOC.","confidence":1,"confidence_rate":1},{"cnt":[[359,1585],[1825,1585],[1825,1633],[359,1633]],"region":{"top_left_x":358,"top_left_y":1585,"width":1468,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e8aaa723871d49be8ef54026ed2c2f3e","type":"text","conversion_output":true,"text":"The proportions of patches during the one-year exposure period that led to mild,","text_display":"\n\nThe proportions of patches during the one-year exposure period that led to mild,","confidence":0.994631290435791,"confidence_rate":0.9999366705598073},{"cnt":[[356,1631],[1825,1631],[1825,1679],[356,1679]],"region":{"top_left_x":356,"top_left_y":1631,"width":1470,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bade4647520041a2b0a98be06458ecbe","type":"text","conversion_output":true,"text":"moderate or severe TEAE considered related to IP will be summarized on the Safety","text_display":" moderate or severe TEAE considered related to IP will be summarized on the Safety","confidence":1,"confidence_rate":1},{"cnt":[[356,1677],[1825,1677],[1825,1727],[356,1727]],"region":{"top_left_x":356,"top_left_y":1676,"width":1470,"height":51},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3161efe360b4551bbb9300fac21f8eb","type":"text","conversion_output":true,"text":"population (overall, by screening ED subgroup and by class of age). For this analysis, the","text_display":" population (overall, by screening ED subgroup and by class of age). For this analysis, the","confidence":1,"confidence_rate":1},{"cnt":[[359,1725],[1830,1725],[1830,1775],[359,1775]],"region":{"top_left_x":358,"top_left_y":1724,"width":1472,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e305ec45728246b9af3ec17ef2636f3f","type":"text","conversion_output":true,"text":"worst ongoing severity will be considered for each day of exposure and the following","text_display":" worst ongoing severity will be considered for each day of exposure and the following","confidence":1,"confidence_rate":1},{"cnt":[[359,1773],[756,1773],[756,1816],[359,1816]],"region":{"top_left_x":358,"top_left_y":1772,"width":399,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af5b86e175ce49a2a4424004fd5aa9b7","type":"text","conversion_output":true,"text":"definitions will be used:","text_display":" definitions will be used:","confidence":1,"confidence_rate":1},{"cnt":[[384,1821],[1432,1821],[1432,1871],[384,1871]],"region":{"top_left_x":383,"top_left_y":1820,"width":1050,"height":51},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f248b4a899c74bb088983d541b470a51","type":"text","conversion_output":true,"text":"- \\% of patches leading to severe TEAE will be estimated as =","text_display":"\n- \\% of patches leading to severe TEAE will be estimated as =","confidence":0.99951171875,"confidence_rate":0.9999924861744118},{"cnt":[[681,1859],[1629,1859],[1629,1978],[681,1978]],"region":{"top_left_x":680,"top_left_y":1859,"width":949,"height":120},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e12c22c7da8e42bd84d126e6e20b6a2f","type":"math","conversion_output":true,"text":"\\[\n100\\left(\\frac{\\text { Number of days with ongoing severe TEAE }}{\\text { Exposure duration }}\\right)\n\\]","text_display":"\n\\[\n100\\left(\\frac{\\text { Number of days with ongoing severe TEAE }}{\\text { Exposure duration }}\\right)\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[384,2019],[1460,2019],[1460,2067],[384,2067]],"region":{"top_left_x":383,"top_left_y":2019,"width":1077,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"57e1e711cb05489dbb4cf356ebacf07b","type":"text","conversion_output":true,"text":"- \\% of patches leading to moderate TEAE will be estimated as =","text_display":"\n- \\% of patches leading to moderate TEAE will be estimated as =","confidence":0.9990236759185791,"confidence_rate":0.9999854209869283},{"cnt":[[621,2056],[1688,2056],[1688,2172],[621,2172]],"region":{"top_left_x":621,"top_left_y":2055,"width":1068,"height":118},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1eff4124beb449dba0d0d925eb68d7a7","type":"math","conversion_output":true,"text":"\\[\n100\\left(\\frac{\\text { Number of days with ongoing moderate (1) TEAE }}{\\text { Exposure duration }}\\right)\n\\]","text_display":"\n\\[\n100\\left(\\frac{\\text { Number of days with ongoing moderate (1) TEAE }}{\\text { Exposure duration }}\\right)\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[439,2161],[1227,2161],[1227,2214],[439,2214]],"region":{"top_left_x":438,"top_left_y":2161,"width":789,"height":53},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0c0e8de687d4c32a64f6b201b353c13","type":"text","conversion_output":true,"text":"\\({ }^{(1)}\\) without concomitant event of severe intensity","text_display":"\n\\({ }^{(1)}\\) without concomitant event of severe intensity","confidence":1,"confidence_rate":1},{"cnt":[[384,2262],[1382,2262],[1382,2310],[384,2310]],"region":{"top_left_x":383,"top_left_y":2261,"width":1000,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d069659e2b14ec09fcec6c85df27f33","type":"text","conversion_output":true,"text":"- \\% of patches leading to mild TEAE will be estimated as =","text_display":"\n- \\% of patches leading to mild TEAE will be estimated as =","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[642,2298],[1617,2298],[1617,2417],[642,2417]],"region":{"top_left_x":641,"top_left_y":2298,"width":977,"height":119},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6661166b91564250b9f01adaf571442a","type":"math","conversion_output":true,"text":"\\[\n100\\left(\\frac{\\text { Number of days with ongoing mild (2) TEAE }}{\\text { Exposure duration }}\\right)\n\\]","text_display":"\n\\[\n100\\left(\\frac{\\text { Number of days with ongoing mild (2) TEAE }}{\\text { Exposure duration }}\\right)\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[434,2403],[1428,2403],[1428,2456],[434,2456]],"region":{"top_left_x":434,"top_left_y":2403,"width":994,"height":53},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"916cf61cc43b44feaaf60e3dc60d3303","type":"text","conversion_output":true,"text":"\\({ }^{(2)}\\) without concomitant event of moderate or severe intensity","text_display":"\n\\({ }^{(2)}\\) without concomitant event of moderate or severe intensity","confidence":1,"confidence_rate":1},{"cnt":[[366,2517],[420,2517],[420,2554],[366,2554]],"region":{"top_left_x":365,"top_left_y":2517,"width":56,"height":37},"line":43,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b6c0393fa14b435196129d6a1dbefd5c","type":"page_info","conversion_output":false,"text":"CCI","text_display":"","confidence":0.90478515625,"confidence_rate":0.9875706702234517},{"cnt":[[937,2522],[1830,2522],[1830,2565],[937,2565]],"region":{"top_left_x":936,"top_left_y":2521,"width":894,"height":45},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"73a15fc64bfe4f3fb18558f5aee190c5","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL Project Document Version No. 3.0","text_display":"","confidence":0.99609375,"confidence_rate":0.9999201276936128},{"cnt":[[1156,2563],[1830,2563],[1830,2604],[1156,2604]],"region":{"top_left_x":1155,"top_left_y":2563,"width":675,"height":42},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ed775e870c474060a3843cecacd2ce3c","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: 04-Oct-2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999900326925697},{"cnt":[[1633,2604],[1830,2604],[1830,2641],[1633,2641]],"region":{"top_left_x":1633,"top_left_y":2604,"width":197,"height":37},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ceb7e5e97df74e0ca0a85eaf97047ce8","type":"page_info","conversion_output":false,"text":"Page 52 of 79","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"4520d961-8076-4a3e-9288-40cbcbc6a794-53","page":53,"lines":[{"cnt":[[361,249],[770,249],[770,283],[361,283]],"region":{"top_left_x":360,"top_left_y":248,"width":410,"height":36},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad7441456e41401cbc3164d8211a1eea","type":"page_info","conversion_output":false,"text":"DBV TECHNOLOGIES S.A.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,288],[496,288],[496,322],[361,322]],"region":{"top_left_x":360,"top_left_y":287,"width":136,"height":36},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9fbf448ab22e4792af1ce42b76bb4fa2","type":"page_info","conversion_output":false,"text":"PEPITES","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1494,288],[1830,288],[1830,327],[1494,327]],"region":{"top_left_x":1493,"top_left_y":287,"width":337,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a93bbb0957b64070a753455c83de5f96","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,366],[1830,366],[1830,418],[361,418]],"region":{"top_left_x":360,"top_left_y":365,"width":1470,"height":54},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34afa9a59dde45dbaffb43386dcda0ec","type":"text","conversion_output":true,"text":"The proportion of patches during the one-year exposure period that led to Viaskin \\({ }^{\\circledR}\\)","text_display":"\n\nThe proportion of patches during the one-year exposure period that led to Viaskin \\({ }^{\\circledR}\\)","confidence":0.99853515625,"confidence_rate":0.9999844052526365},{"cnt":[[361,416],[1620,416],[1620,464],[361,464]],"region":{"top_left_x":360,"top_left_y":415,"width":1260,"height":49},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad35130488fc4c0ea5817432542d54cd","type":"text","conversion_output":true,"text":"Peanut \\(250 \\mu g\\)-induced AEs will also be summarized the same way as above.","text_display":" Peanut \\(250 \\mu g\\)-induced AEs will also be summarized the same way as above.","confidence":1,"confidence_rate":1},{"cnt":[[359,507],[1825,507],[1825,557],[359,557]],"region":{"top_left_x":358,"top_left_y":507,"width":1468,"height":51},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d46a6f4e39cd4f7babcc1fa22299010f","type":"text","conversion_output":true,"text":"A by-subject listing of all adverse events will be provided. This listing will be presented","text_display":"\n\nA by-subject listing of all adverse events will be provided. This listing will be presented","confidence":1,"confidence_rate":1},{"cnt":[[359,557],[1825,557],[1825,605],[359,605]],"region":{"top_left_x":358,"top_left_y":557,"width":1468,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"93354925e72f49e7bfc936b1d0298a67","type":"text","conversion_output":true,"text":"by treatment group and will include: treatment group, subject identifier, age, sex, adverse","text_display":" by treatment group and will include: treatment group, subject identifier, age, sex, adverse","confidence":1,"confidence_rate":1},{"cnt":[[361,603],[1825,603],[1825,651],[361,651]],"region":{"top_left_x":360,"top_left_y":603,"width":1466,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48e52ee3f2074e0da456adca98603050","type":"text","conversion_output":true,"text":"event (SOC, PT, and verbatim term), date/time of onset (and corresponding study day),","text_display":" event (SOC, PT, and verbatim term), date/time of onset (and corresponding study day),","confidence":1,"confidence_rate":1},{"cnt":[[359,649],[1830,649],[1830,697],[359,697]],"region":{"top_left_x":358,"top_left_y":648,"width":1472,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04cf620dc8574519913c8c052c0e5f4d","type":"text","conversion_output":true,"text":"date/time of resolution (and corresponding study day), duration, severity, treatment","text_display":" date/time of resolution (and corresponding study day), duration, severity, treatment","confidence":1,"confidence_rate":1},{"cnt":[[359,697],[1828,697],[1828,745],[359,745]],"region":{"top_left_x":358,"top_left_y":696,"width":1470,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18d77f2917a34bb6ac48b8c8a94182e7","type":"text","conversion_output":true,"text":"required, relationship to study drug, relationship to an accidental peanut consumption and","text_display":" required, relationship to study drug, relationship to an accidental peanut consumption and","confidence":1,"confidence_rate":1},{"cnt":[[359,742],[1830,742],[1830,793],[359,793]],"region":{"top_left_x":358,"top_left_y":742,"width":1472,"height":51},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"200361c391774409af9ee377f7cf3146","type":"text","conversion_output":true,"text":"relationship to DBPCFC, action taken with the study drug, outcome, and whether the","text_display":" relationship to DBPCFC, action taken with the study drug, outcome, and whether the","confidence":1,"confidence_rate":1},{"cnt":[[359,790],[1448,790],[1448,838],[359,838]],"region":{"top_left_x":358,"top_left_y":790,"width":1091,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a7f8e5e7326430898b3a12ade550003","type":"text","conversion_output":true,"text":"event is classified as serious or not with the corresponding criteria.","text_display":" event is classified as serious or not with the corresponding criteria.","confidence":1,"confidence_rate":1},{"cnt":[[359,836],[1830,836],[1830,884],[359,884]],"region":{"top_left_x":358,"top_left_y":836,"width":1472,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8b7e6f723cc4549bf86a8002e3f01e3","type":"text","conversion_output":true,"text":"Pre-treatment emergent adverse events will be listed separately the same way as the","text_display":"\nPre-treatment emergent adverse events will be listed separately the same way as the","confidence":0.9990234375,"confidence_rate":0.9999888973383643},{"cnt":[[359,882],[939,882],[939,930],[359,930]],"region":{"top_left_x":358,"top_left_y":881,"width":581,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"33f9d469018e4e7f83e13b9fce4d2dee","type":"text","conversion_output":true,"text":"treatment emergent adverse events.","text_display":" treatment emergent adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[359,927],[1304,927],[1304,975],[359,975]],"region":{"top_left_x":358,"top_left_y":927,"width":947,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34d1122c671345bf99dd651e16049be3","type":"text","conversion_output":true,"text":"TEAE leading to an epinephrine intake will also be listed.","text_display":"\nTEAE leading to an epinephrine intake will also be listed.","confidence":1,"confidence_rate":1},{"cnt":[[359,973],[1830,973],[1830,1026],[359,1026]],"region":{"top_left_x":358,"top_left_y":973,"width":1472,"height":53},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e361e0621534f6d97f5126a1b826c63","type":"text","conversion_output":true,"text":"Finally, SAEs will also be listed the same way with an additional flag for treatment","text_display":"\nFinally, SAEs will also be listed the same way with an additional flag for treatment","confidence":1,"confidence_rate":1},{"cnt":[[359,1023],[630,1023],[630,1071],[359,1071]],"region":{"top_left_x":358,"top_left_y":1023,"width":273,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f4ba926401143dabf856bd7fbc942c6","type":"text","conversion_output":true,"text":"emergent SAEs.","text_display":" emergent SAEs.","confidence":0.99951171875,"confidence_rate":0.999974295041004},{"cnt":[[354,1156],[614,1156],[614,1208],[354,1208]],"region":{"top_left_x":354,"top_left_y":1155,"width":261,"height":54},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dacafc14caec4c8f9810332f1b5fd0d9","type":"section_header","conversion_output":false,"children_ids":["07c35d398244427aa0785e39a234d060"],"text":"","text_display":""},{"cnt":[[361,1160],[610,1160],[610,1204],[361,1204]],"region":{"top_left_x":360,"top_left_y":1160,"width":250,"height":44},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07c35d398244427aa0785e39a234d060","type":"text","conversion_output":true,"parent_id":"dacafc14caec4c8f9810332f1b5fd0d9","text":"4.9.2 Deaths","text_display":"\n\n\\subsection*{4.9.2 Deaths}","confidence":1,"confidence_rate":1},{"cnt":[[359,1254],[1830,1254],[1830,1304],[359,1304]],"region":{"top_left_x":358,"top_left_y":1254,"width":1472,"height":51},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ca9d4c0284c4786b82d2a8c560e20a5","type":"text","conversion_output":true,"text":"As detailed in the preceding section, a detailed table will be created showing the number","text_display":"\n\nAs detailed in the preceding section, a detailed table will be created showing the number","confidence":1,"confidence_rate":1},{"cnt":[[359,1302],[1832,1302],[1832,1350],[359,1350]],"region":{"top_left_x":358,"top_left_y":1302,"width":1475,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd91bd79521f498487100987071003ff","type":"text","conversion_output":true,"text":"of subjects who experienced one SAE leading to Death, the corresponding percentage of","text_display":" of subjects who experienced one SAE leading to Death, the corresponding percentage of","confidence":1,"confidence_rate":1},{"cnt":[[359,1348],[1336,1348],[1336,1396],[359,1396]],"region":{"top_left_x":358,"top_left_y":1347,"width":979,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98a8c15f7f5a47888315145b5ad4a8d1","type":"text","conversion_output":true,"text":"subjects and the number of events grouped by SOC and PT.","text_display":" subjects and the number of events grouped by SOC and PT.","confidence":1,"confidence_rate":1},{"cnt":[[359,1393],[1081,1393],[1081,1446],[359,1446]],"region":{"top_left_x":358,"top_left_y":1393,"width":723,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd4ac5612228460ea0a6cd180a5dbd34","type":"text","conversion_output":true,"text":"All deaths will be listed in a summary table.","text_display":"\nAll deaths will be listed in a summary table.","confidence":0.9931640625,"confidence_rate":0.9998628212188517},{"cnt":[[354,1485],[1259,1485],[1259,1542],[354,1542]],"region":{"top_left_x":354,"top_left_y":1484,"width":905,"height":58},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"189281c13b4345478c4472a9e86b79f8","type":"section_header","conversion_output":false,"children_ids":["0ccadb8819614a949e4f8c98eef03636"],"text":"","text_display":""},{"cnt":[[361,1489],[1254,1489],[1254,1537],[361,1537]],"region":{"top_left_x":360,"top_left_y":1489,"width":895,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ccadb8819614a949e4f8c98eef03636","type":"text","conversion_output":true,"parent_id":"189281c13b4345478c4472a9e86b79f8","text":"4.9.3 Local skin reactions as collected in the diary","text_display":"\n\n\\subsection*{4.9.3 Local skin reactions as collected in the diary}","confidence":1,"confidence_rate":1},{"cnt":[[359,1581],[1652,1581],[1652,1629],[359,1629]],"region":{"top_left_x":358,"top_left_y":1580,"width":1294,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"800146dfae5a49a2a38bffd7a7bf9733","type":"text","conversion_output":true,"text":"Number and percentage of subjects with evaluable diary data will be presented.","text_display":"\n\nNumber and percentage of subjects with evaluable diary data will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[359,1622],[1830,1622],[1830,1677],[359,1677]],"region":{"top_left_x":358,"top_left_y":1621,"width":1472,"height":56},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d135e967c18412ba7cd2fbe201f6ae5","type":"text","conversion_output":true,"text":"Local skin reactions at sites of Viaskin \\({ }^{\\circledR}\\) application as assessed by the patient and","text_display":" Local skin reactions at sites of Viaskin \\({ }^{\\circledR}\\) application as assessed by the patient and","confidence":0.9829182624816895,"confidence_rate":0.9998277217078196},{"cnt":[[361,1672],[1830,1672],[1830,1725],[361,1725]],"region":{"top_left_x":360,"top_left_y":1672,"width":1470,"height":53},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"838fde25f91746ddbd0229c0a8e22131","type":"text","conversion_output":true,"text":"documented in the diary during the first 6 months of the study treatment will be","text_display":" documented in the diary during the first 6 months of the study treatment will be","confidence":1,"confidence_rate":1},{"cnt":[[361,1720],[1830,1720],[1830,1770],[361,1770]],"region":{"top_left_x":360,"top_left_y":1720,"width":1470,"height":51},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef55c34553414c33914814cf31fb67ce","type":"text","conversion_output":true,"text":"summarized for itching, redness, swelling, and any local reaction (itching, redness and","text_display":" summarized for itching, redness, swelling, and any local reaction (itching, redness and","confidence":1,"confidence_rate":1},{"cnt":[[359,1768],[628,1768],[628,1816],[359,1816]],"region":{"top_left_x":358,"top_left_y":1768,"width":271,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"369eae1afaaf4fc9b44cdb51c8d3f9ed","type":"text","conversion_output":true,"text":"swelling) using:","text_display":" swelling) using:","confidence":1,"confidence_rate":1},{"cnt":[[420,1816],[1818,1816],[1818,1866],[420,1866]],"region":{"top_left_x":420,"top_left_y":1816,"width":1399,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0cdb9c14d34b4237a2e1bd73de637e7f","type":"text","conversion_output":true,"text":"- The number and percentage of subjects by maximum severity grade reported ( 1,2","text_display":"\n- The number and percentage of subjects by maximum severity grade reported ( 1,2","confidence":0.9551212682854384,"confidence_rate":0.999453518850661},{"cnt":[[480,1864],[1688,1864],[1688,1912],[480,1912]],"region":{"top_left_x":479,"top_left_y":1864,"width":1210,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81a3131dc14a4d7ea8d6909a5856cc6c","type":"text","conversion_output":true,"text":"or 3) among subjects with evaluable diary data and among subjects with a","text_display":" or 3) among subjects with evaluable diary data and among subjects with a","confidence":0.9839153154753149,"confidence_rate":0.9997894319499383},{"cnt":[[480,1910],[811,1910],[811,1960],[480,1960]],"region":{"top_left_x":479,"top_left_y":1909,"width":332,"height":51},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9c0d80938ad43fabce91742fdacb4db","type":"text","conversion_output":true,"text":"reaction (grade \\(\\geq 1\\) )","text_display":" reaction (grade \\(\\geq 1\\) 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between itching,","confidence":1,"confidence_rate":1},{"cnt":[[480,2054],[1789,2054],[1789,2104],[480,2104]],"region":{"top_left_x":479,"top_left_y":2053,"width":1310,"height":51},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16f777984aa8496998a2dd2e03ef7b8c","type":"text","conversion_output":true,"text":"redness and swelling when reported on any local reaction) among subjects diary","text_display":" redness and swelling when reported on any local reaction) among subjects diary","confidence":1,"confidence_rate":1},{"cnt":[[480,2102],[569,2102],[569,2147],[480,2147]],"region":{"top_left_x":479,"top_left_y":2101,"width":90,"height":47},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8e4074364da48bdb53e243422f28c02","type":"text","conversion_output":true,"text":"data,","text_display":" 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reported }}{\\text { Number of days with patches graded }}\\right)\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[359,2389],[1825,2389],[1825,2437],[359,2437]],"region":{"top_left_x":358,"top_left_y":2389,"width":1468,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"521fa446937c4b7c8fd9d0663fd041f8","type":"text","conversion_output":true,"text":"Proportion of days with no assessment of local skin reaction out the number of patches","text_display":"\n\nProportion of days with no assessment of local skin reaction out the number of patches","confidence":1,"confidence_rate":1},{"cnt":[[359,2435],[966,2435],[966,2488],[359,2488]],"region":{"top_left_x":358,"top_left_y":2435,"width":609,"height":53},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95924d0103b54b8aab1d6cb284db88da","type":"text","conversion_output":true,"text":"entered in the diary will be provided.","text_display":" entered in the diary will 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These graded reactions","confidence":1,"confidence_rate":1},{"cnt":[[361,1348],[1720,1348],[1720,1396],[361,1396]],"region":{"top_left_x":360,"top_left_y":1347,"width":1361,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"baa0c0376c6e448fb38b34fadcba5e21","type":"text","conversion_output":true,"text":"will be reported in summary tables showing the number and percentage of subjects:","text_display":" will be reported in summary tables showing the number and percentage of subjects:","confidence":1,"confidence_rate":1},{"cnt":[[420,1398],[1688,1398],[1688,1446],[420,1446]],"region":{"top_left_x":420,"top_left_y":1398,"width":1269,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"124d8daabe034b39854e89f24cd5b8f1","type":"text","conversion_output":true,"text":"- By grade (by localization and regardless of the localization) by study visit","text_display":"\n- By grade (by localization and regardless 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CTCAE grades for hematology and","text_display":" Visit 8 (M6) and Visit 10 (M12). CTCAE grades for hematology and","confidence":1,"confidence_rate":1},{"cnt":[[480,795],[1702,795],[1702,848],[480,848]],"region":{"top_left_x":479,"top_left_y":794,"width":1223,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30e85e429d2947f38fc9d1592620ab3c","type":"text","conversion_output":true,"text":"biochemistry measures will be derived according to Appendix 3: Common","text_display":" biochemistry measures will be derived according to Appendix 3: Common","confidence":0.99951171875,"confidence_rate":0.9999934000150488},{"cnt":[[480,845],[1453,845],[1453,893],[480,893]],"region":{"top_left_x":479,"top_left_y":845,"width":974,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dee987014bfb454a9c3008c0518b7952","type":"text","conversion_output":true,"text":"Terminology Criteria for Adverse Events (CTCAE) grades.","text_display":" Terminology Criteria for Adverse Events (CTCAE) 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D-42,","confidence":1,"confidence_rate":1},{"cnt":[[480,662],[1743,662],[1743,710],[480,710]],"region":{"top_left_x":479,"top_left_y":662,"width":1264,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30a30af330f044ffae09f602eda06d73","type":"text","conversion_output":true,"text":"Baseline (D1), D8, M1, 3, 6 and 12 for heart rate, systolic blood pressure and","text_display":" Baseline (D1), D8, M1, 3, 6 and 12 for heart rate, systolic blood pressure and","confidence":0.9990234375,"confidence_rate":0.9999890220866866},{"cnt":[[480,708],[1569,708],[1569,756],[480,756]],"region":{"top_left_x":479,"top_left_y":708,"width":1091,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ac199eb87e446ccaa52fd76a9b6da17","type":"text","conversion_output":true,"text":"diastolic blood pressure classified using the criteria defined below.","text_display":" diastolic blood pressure classified using the criteria 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Abnormalities (any of the following situation) \\\\\n\\hline Heart rate & \\begin{tabular}{l}\n- value \\(<60\\) beats \\(/ min\\), \\\\\n- value \\(>130\\) beats \\(/ min\\), \\\\\n- an increase from pre-dosing of \\(>20\\) beats \\(/ min\\), or \\\\\n- a decrease from pre-dosing of \\(>20\\) beats \\(/ min\\)\n\\end{tabular} \\\\\n\\hline Systolic blood pressure & \\begin{tabular}{l}\n- value \\(<70 mmHg\\) \\\\\n- value \\(>130 mmHg\\), \\\\\n- an increase from pre-dosing of \\(>40 mmHg\\), or \\\\\n- a decrease from pre-dosing of \\(>30 mmHg\\)\n\\end{tabular} \\\\\n\\hline Diastolic blood pressure & \\begin{tabular}{l}\n- value \\(<45 mmHg\\) \\\\\n- value \\(>85 mmHg\\), \\\\\n- an increase from pre-dosing of \\(>30 mmHg\\), or \\\\\n- a decrease from pre-dosing of \\(>20 mmHg\\)\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 3: Criteria to Determine Clinically Relevant Abnormalities in Vital 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from pre-dosing of \\(>20\\) beats \\(/ min\\), or \\\\\n- a decrease from pre-dosing of \\(>20\\) beats \\(/ min\\)\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.8278042861493304,"confidence_rate":0.998652955640662},{"cnt":[[812,979],[1218,979],[1218,1027],[812,1027]],"region":{"top_left_x":812,"top_left_y":978,"width":406,"height":49},"line":28,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"2d8650bb1ff6486c876eac35547f6fb5","type":"text","conversion_output":false,"parent_id":"e2d58a51f1e9482a95c8c8ad401376c0","text":"- value \\(<60\\) beats \\(/ min\\),","text_display":"- value \\(<60\\) beats \\(/ 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reaction (overall and by","text_display":"\n- Number and percentage of subjects with induced allergic reaction (overall and by","confidence":1,"confidence_rate":1},{"cnt":[[480,1741],[1816,1741],[1816,1793],[480,1793]],"region":{"top_left_x":479,"top_left_y":1740,"width":1338,"height":54},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11ca7fc818cf47dc803ef7377886da97","type":"text","conversion_output":true,"text":"type of symptom as classified by SOC and PT) (separately for confirmed and not","text_display":" type of symptom as classified by SOC and PT) (separately for confirmed and not","confidence":1,"confidence_rate":1},{"cnt":[[480,1786],[1065,1786],[1065,1839],[480,1839]],"region":{"top_left_x":479,"top_left_y":1786,"width":586,"height":53},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"943e7f51942a405ab754d8d7b481fdef","type":"text","conversion_output":true,"text":"confirmed accidental 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These data","text_display":"\nAll data related to accidental/voluntary peanut consumption will be listed. These data","confidence":1,"confidence_rate":1},{"cnt":[[359,2115],[1830,2115],[1830,2168],[359,2168]],"region":{"top_left_x":358,"top_left_y":2115,"width":1472,"height":53},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f119d1a76bce43979401bf54ebc6c45e","type":"text","conversion_output":true,"text":"include: confirmation (or not) of accidental consumption, food consumed, estimated","text_display":" include: confirmation (or not) of accidental consumption, food consumed, estimated","confidence":1,"confidence_rate":1},{"cnt":[[359,2166],[1830,2166],[1830,2214],[359,2214]],"region":{"top_left_x":358,"top_left_y":2165,"width":1472,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17b9f606585d46e285628ffc3b21241b","type":"text","conversion_output":true,"text":"quantity consumed at each occurrence, and associated reactions and severity of reactions.","text_display":" quantity consumed at each occurrence, and associated reactions and severity of reactions.","confidence":1,"confidence_rate":1},{"cnt":[[359,2211],[1830,2211],[1830,2259],[359,2259]],"region":{"top_left_x":358,"top_left_y":2211,"width":1472,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a40c34521e74629ba03b2c863b38d42","type":"text","conversion_output":true,"text":"The cumulative reactive dose the subject reached at screening DBPCFC will also be","text_display":" The cumulative reactive dose the subject reached at screening DBPCFC will also be","confidence":1,"confidence_rate":1},{"cnt":[[356,2257],[747,2257],[747,2310],[356,2310]],"region":{"top_left_x":356,"top_left_y":2256,"width":391,"height":54},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20f312a242ea4f68ae72ca22f265f236","type":"text","conversion_output":true,"text":"presented in the listing.","text_display":" presented in the 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change","text_display":" groups will be performed using actual values, change from baseline and relative change","confidence":1,"confidence_rate":1},{"cnt":[[361,557],[1825,557],[1825,605],[361,605]],"region":{"top_left_x":360,"top_left_y":557,"width":1466,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"055b3c0b27414099b2534b3f308dc6d7","type":"text","conversion_output":true,"text":"from baseline, for the overall ITT population, using observed data. Please Note that","text_display":" from baseline, for the overall ITT population, using observed data. Please Note that","confidence":1,"confidence_rate":1},{"cnt":[[361,603],[1359,603],[1359,651],[361,651]],"region":{"top_left_x":360,"top_left_y":603,"width":1000,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6419773c89fa492e997f3b5189a6e834","type":"text","conversion_output":true,"text":"Epigenetic data will not be available at time of database lock.","text_display":" Epigenetic data will not be available at time of database 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values).","confidence":1,"confidence_rate":1},{"cnt":[[359,749],[1812,749],[1812,797],[359,797]],"region":{"top_left_x":358,"top_left_y":749,"width":1454,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"806cf469b4cf48f3a2cd488f9474e6ee","type":"text","conversion_output":true,"text":"This will be reported for the ITT population and repeated for subjects with filaggrin gene","text_display":"\n\nThis will be reported for the ITT population and repeated for subjects with filaggrin gene","confidence":1,"confidence_rate":1},{"cnt":[[359,795],[953,795],[953,843],[359,843]],"region":{"top_left_x":358,"top_left_y":794,"width":595,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48d782cdccec4cdeac5c5676ad1b84e1","type":"text","conversion_output":true,"text":"mutations versus wild type subjects.","text_display":" mutations versus wild type subjects.","confidence":1,"confidence_rate":1},{"cnt":[[386,978],[761,978],[761,1026],[386,1026]],"region":{"top_left_x":386,"top_left_y":977,"width":375,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b552548428da4c439440b6c4fcd18fc9","type":"section_header","conversion_output":false,"children_ids":["397301f29fbe4db6a559e0364be8bf67"],"text":"","text_display":""},{"cnt":[[388,982],[756,982],[756,1021],[388,1021]],"region":{"top_left_x":388,"top_left_y":982,"width":369,"height":40},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"397301f29fbe4db6a559e0364be8bf67","type":"text","conversion_output":true,"parent_id":"b552548428da4c439440b6c4fcd18fc9","text":"4.11 Patch adhesion","text_display":"\n\n\\subsection*{4.11 Patch adhesion}","confidence":1,"confidence_rate":1},{"cnt":[[359,1069],[1830,1069],[1830,1122],[359,1122]],"region":{"top_left_x":358,"top_left_y":1069,"width":1472,"height":53},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6f13e0956074d28b05b819f8f2950e6","type":"text","conversion_output":true,"text":"The Viaskin \\({ }^{\\text {® }}\\) patch adhesion will be evaluated during 28 days between M3 and M6","text_display":"\n\nThe Viaskin \\({ }^{\\text {® }}\\) patch adhesion will be evaluated during 28 days between M3 and M6","confidence":0.9917030334472656,"confidence_rate":0.9999183211990407},{"cnt":[[361,1122],[1830,1122],[1830,1172],[361,1172]],"region":{"top_left_x":360,"top_left_y":1121,"width":1470,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cdeae2c4cd254cbf8a157c47785c04ed","type":"text","conversion_output":true,"text":"(whenever possible, these should be consecutive days - this assessment period can be","text_display":" (whenever possible, these should be consecutive days - this assessment period can be","confidence":1,"confidence_rate":1},{"cnt":[[359,1165],[1585,1165],[1585,1215],[359,1215]],"region":{"top_left_x":358,"top_left_y":1165,"width":1228,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a1189f1aaafb4b1ab13dff70dc3bb94b","type":"text","conversion_output":true,"text":"extended up to M9 in case it has not been completed between M3 and M6).","text_display":" extended up to M9 in case it has not been completed between M3 and M6).","confidence":1,"confidence_rate":1},{"cnt":[[359,1211],[1830,1211],[1830,1263],[359,1263]],"region":{"top_left_x":358,"top_left_y":1210,"width":1472,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c00693d52a14053a83fb02ebf44d514","type":"text","conversion_output":true,"text":"The scoring system for adhesion and occlusion of Viaskin \\({ }^{\\text {® }}\\) patches (assessed at patch","text_display":"\nThe scoring system for adhesion and occlusion of Viaskin \\({ }^{\\text {® }}\\) patches (assessed at patch","confidence":0.9346942901611328,"confidence_rate":0.999357009040182},{"cnt":[[359,1261],[1291,1261],[1291,1309],[359,1309]],"region":{"top_left_x":358,"top_left_y":1260,"width":933,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24285076b6e14095ad23d28d0b90f634","type":"text","conversion_output":true,"text":"application and at patch removal) is indicated as follows:","text_display":" application and at patch removal) is indicated as follows:","confidence":1,"confidence_rate":1},{"cnt":[[361,1309],[1825,1309],[1825,1359],[361,1359]],"region":{"top_left_x":360,"top_left_y":1308,"width":1466,"height":52},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4256fde5f4104664996a1bdfbda38fc5","type":"text","conversion_output":true,"text":"- \\(0=\\) no lift off or detachment of the dressing edges and the occlusion chamber of the","text_display":"\n- \\(0=\\) no lift off or detachment of the dressing edges and the occlusion chamber of the","confidence":1,"confidence_rate":1},{"cnt":[[416,1357],[662,1357],[662,1405],[416,1405]],"region":{"top_left_x":415,"top_left_y":1356,"width":248,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"052a85bb87474ee68fab40cd33716e38","type":"text","conversion_output":true,"text":"patch is intact.","text_display":" patch is intact.","confidence":1,"confidence_rate":1},{"cnt":[[361,1403],[1825,1403],[1825,1455],[361,1455]],"region":{"top_left_x":360,"top_left_y":1402,"width":1466,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22a9c4ca41da4b92ba8080c30af430b6","type":"text","conversion_output":true,"text":"- \\(1=\\) some edges of the dressing have lifted off the skin with no impact on the","text_display":"\n- \\(1=\\) some edges of the dressing have lifted off the skin with no impact on the","confidence":0.9873332977294922,"confidence_rate":0.99985178297496},{"cnt":[[420,1453],[1606,1453],[1606,1501],[420,1501]],"region":{"top_left_x":420,"top_left_y":1452,"width":1186,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"367b5b69f76444fca49b660d2061a78b","type":"text","conversion_output":true,"text":"occlusion chamber of the patch which remains fully adherent to the skin.","text_display":" occlusion chamber of the patch which remains fully adherent to the skin.","confidence":1,"confidence_rate":1},{"cnt":[[361,1503],[1560,1503],[1560,1551],[361,1551]],"region":{"top_left_x":360,"top_left_y":1503,"width":1201,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"17e46fb080d740d29fb727de613439c6","type":"text","conversion_output":true,"text":"- \\(2=\\) the occlusion chamber of the patch is partially or totally detached.","text_display":"\n- \\(2=\\) the occlusion chamber of the patch is partially or totally detached.","confidence":0.998046875,"confidence_rate":0.9999758640587357},{"cnt":[[361,1553],[1007,1553],[1007,1601],[361,1601]],"region":{"top_left_x":360,"top_left_y":1553,"width":648,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d01d92f4953484fb98f65bb9ea404d1","type":"text","conversion_output":true,"text":"- 3 = the patch has fallen off the skin.","text_display":"\n- 3 = the patch has fallen off the skin.","confidence":0.5231819152832031,"confidence_rate":0.9865942917900793},{"cnt":[[356,1599],[1825,1599],[1825,1647],[356,1647]],"region":{"top_left_x":356,"top_left_y":1599,"width":1470,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"612caf8bf7964e698aa80527fc17670d","type":"text","conversion_output":true,"text":"Even on those days when the patch has deliberately been removed prematurely by the","text_display":"\n\nEven on those days when the patch has deliberately been removed prematurely by the","confidence":1,"confidence_rate":1},{"cnt":[[359,1647],[1825,1647],[1825,1695],[359,1695]],"region":{"top_left_x":358,"top_left_y":1647,"width":1468,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bda085d1e68f474489fa421b6ee157d1","type":"text","conversion_output":true,"text":"subject or parents/guardians, the photos and assessment should be made as","text_display":" subject or parents/guardians, the photos and assessment should be made as","confidence":1,"confidence_rate":1},{"cnt":[[356,1690],[1825,1690],[1825,1738],[356,1738]],"region":{"top_left_x":356,"top_left_y":1690,"width":1470,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"071b0df6c71b40e7b02963f5792417fa","type":"text","conversion_output":true,"text":"recommended, even if the assessment will not be used in the analysis. That is why the","text_display":" recommended, even if the assessment will not be used in the analysis. That is why the","confidence":1,"confidence_rate":1},{"cnt":[[359,1738],[1830,1736],[1830,1786],[359,1789]],"region":{"top_left_x":358,"top_left_y":1736,"width":1472,"height":53},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40e071a7d7ac46a3870d1de3565f9684","type":"text","conversion_output":true,"text":"assessments may extend beyond 28 days to ensure that 28 days of usable evaluations of","text_display":" assessments may extend beyond 28 days to ensure that 28 days of usable evaluations of","confidence":0.9877986907958984,"confidence_rate":0.9998721294651948},{"cnt":[[359,1786],[962,1786],[962,1834],[359,1834]],"region":{"top_left_x":358,"top_left_y":1786,"width":604,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b228b4ba7ca438f87374deea5930ffb","type":"text","conversion_output":true,"text":"24 hours of application are recorded.","text_display":" 24 hours of application are recorded.","confidence":1,"confidence_rate":1},{"cnt":[[356,1832],[1825,1832],[1825,1880],[356,1880]],"region":{"top_left_x":356,"top_left_y":1832,"width":1470,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7caf68e4456469d86a567c711f3c849","type":"text","conversion_output":true,"text":"Assessment of the adhesion of each patch will be made at 2 time points by the","text_display":"\nAssessment of the adhesion of each patch will be made at 2 time points by the","confidence":0.998046875,"confidence_rate":0.9999769998546744},{"cnt":[[356,1878],[854,1878],[854,1928],[356,1928]],"region":{"top_left_x":356,"top_left_y":1877,"width":499,"height":52},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"497c2c4dc4c64d4ca671d7ccde50d6ff","type":"text","conversion_output":true,"text":"parents/guardians for 28 days:","text_display":" parents/guardians for 28 days:","confidence":1,"confidence_rate":1},{"cnt":[[420,1928],[1825,1928],[1825,1976],[420,1976]],"region":{"top_left_x":420,"top_left_y":1928,"width":1406,"height":48},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31eaddc1c8e541a1806440c431c1281e","type":"text","conversion_output":true,"text":"- Immediately after the application of a patch to assess that the patch was applied as","text_display":"\n- Immediately after the application of a patch to assess that the patch was applied as","confidence":1,"confidence_rate":1},{"cnt":[[480,1976],[1825,1976],[1825,2024],[480,2024]],"region":{"top_left_x":479,"top_left_y":1975,"width":1347,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1b1c325cbc24820a23adaa1814a84f9","type":"text","conversion_output":true,"text":"recommended and adhered well to the skin (including the edges of the dressing);","text_display":" recommended and adhered well to the skin (including the edges of the dressing);","confidence":1,"confidence_rate":1},{"cnt":[[480,2024],[553,2024],[553,2065],[480,2065]],"region":{"top_left_x":479,"top_left_y":2023,"width":74,"height":43},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"690d377cc51e4873b0fbf118ed992d65","type":"text","conversion_output":true,"text":"and","text_display":" and","confidence":1,"confidence_rate":1},{"cnt":[[420,2070],[1738,2070],[1738,2122],[420,2122]],"region":{"top_left_x":420,"top_left_y":2069,"width":1319,"height":54},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"edc982e48f884feab0910350c8886fc9","type":"text","conversion_output":true,"text":"- At the end of the 24-hours application period at time of removal of the patch.","text_display":"\n- At the end of the 24-hours application period at time of removal of the patch.","confidence":0.841796875,"confidence_rate":0.9979759742266997},{"cnt":[[356,2115],[1759,2115],[1759,2166],[356,2166]],"region":{"top_left_x":356,"top_left_y":2115,"width":1403,"height":51},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2af3de5a40443329d726f437e0c488e","type":"text","conversion_output":true,"text":"At the time of each patch removal, the subjects (parents/guardians) will also be asked:","text_display":"\n\nAt the time of each patch removal, the subjects (parents/guardians) will also be asked:","confidence":1,"confidence_rate":1},{"cnt":[[420,2166],[1825,2166],[1825,2218],[420,2218]],"region":{"top_left_x":420,"top_left_y":2165,"width":1406,"height":54},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"522fdefc3acc4f178dd4901f121e2c11","type":"text","conversion_output":true,"text":"- To specify the status at removal of the patch (removal at \\(24 \\pm 4\\) hours, deliberate","text_display":"\n- To specify the status at removal of the patch (removal at \\(24 \\pm 4\\) hours, deliberate","confidence":1,"confidence_rate":1},{"cnt":[[480,2216],[1277,2216],[1277,2262],[480,2262]],"region":{"top_left_x":479,"top_left_y":2215,"width":798,"height":47},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81634a95dd204504aa1da53145e0cfef","type":"text","conversion_output":true,"text":"removal before \\(24 \\pm 4\\) hours, accidental removal),","text_display":" removal before \\(24 \\pm 4\\) hours, accidental removal),","confidence":1,"confidence_rate":1},{"cnt":[[420,2262],[1825,2262],[1825,2314],[420,2314]],"region":{"top_left_x":420,"top_left_y":2261,"width":1406,"height":54},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1f0f47721a34f08baddd61e161d432e","type":"text","conversion_output":true,"text":"- To specify the suspected cause of adhesion issue (if any: scratching, swimming,","text_display":"\n- To specify the suspected cause of adhesion issue (if any: scratching, swimming,","confidence":1,"confidence_rate":1},{"cnt":[[480,2312],[697,2312],[697,2360],[480,2360]],"region":{"top_left_x":479,"top_left_y":2311,"width":218,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"91212df08e5c4555976ab465c9f3b230","type":"text","conversion_output":true,"text":"sweating...),","text_display":" sweating...),","confidence":1,"confidence_rate":1},{"cnt":[[420,2357],[1757,2357],[1757,2408],[420,2408]],"region":{"top_left_x":420,"top_left_y":2357,"width":1337,"height":51},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"39ae59698dfa478dbf85657455e65bc1","type":"text","conversion_output":true,"text":"- To grade the ease of patch removal (very easy/ easy / difficult / very difficult),","text_display":"\n- To grade the ease of patch removal (very easy/ easy / difficult / very difficult),","confidence":0.99755859375,"confidence_rate":0.9999725353059057},{"cnt":[[420,2408],[1830,2408],[1830,2460],[420,2460]],"region":{"top_left_x":420,"top_left_y":2407,"width":1410,"height":54},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1860cd3084fa4d40bc04582ef2ef36bf","type":"text","conversion_output":true,"text":"- To grade whether the removal of the patch was painful (very painful / painful /","text_display":"\n- To grade whether the removal of the patch was painful (very painful / painful /","confidence":1,"confidence_rate":1},{"cnt":[[480,2456],[966,2456],[966,2506],[480,2506]],"region":{"top_left_x":479,"top_left_y":2455,"width":488,"height":51},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"150affaaadb84dc7923fa98261a960bb","type":"text","conversion_output":true,"text":"slightly painful / not painful),","text_display":" slightly painful / not 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Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[420,375],[1579,375],[1579,423],[420,423]],"region":{"top_left_x":420,"top_left_y":374,"width":1159,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de65c65ff2544c2e9ab78167f51cbd63","type":"text","conversion_output":true,"text":"- To specify whether the patch removal caused skin injury (yes / no).","text_display":"\n- To specify whether the patch removal caused skin injury (yes / no).","confidence":0.82666015625,"confidence_rate":0.9974308518162196},{"cnt":[[361,466],[1830,466],[1830,514],[361,514]],"region":{"top_left_x":360,"top_left_y":466,"width":1470,"height":48},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e17ac7a032b44368b257151fe41b49a","type":"text","conversion_output":true,"text":"To guarantee the reliability of the adhesion scoring done by the subject's","text_display":"\n\nTo guarantee the reliability of the adhesion scoring done by the subject's","confidence":1,"confidence_rate":1},{"cnt":[[359,514],[1830,514],[1830,562],[359,562]],"region":{"top_left_x":358,"top_left_y":513,"width":1472,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1eea4c6f3f644789a5fd7116fc20802","type":"text","conversion_output":true,"text":"parents/guardians, the Investigator will review the parents/guardians' assessment of the","text_display":" parents/guardians, the Investigator will review the parents/guardians' assessment of the","confidence":1,"confidence_rate":1},{"cnt":[[359,560],[1825,560],[1825,610],[359,610]],"region":{"top_left_x":358,"top_left_y":559,"width":1468,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87c7d8a423a64397a169b96842290844","type":"text","conversion_output":true,"text":"patch adhesion based on the photographs made by the parents/guardians during these","text_display":" patch adhesion based on the photographs made by the parents/guardians during these","confidence":0.99755859375,"confidence_rate":0.9999719039424972},{"cnt":[[359,608],[500,608],[500,653],[359,653]],"region":{"top_left_x":358,"top_left_y":607,"width":143,"height":47},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03fd9183589849fe916f4ee4fab58d25","type":"text","conversion_output":true,"text":"28 days.","text_display":" 28 days.","confidence":1,"confidence_rate":1},{"cnt":[[359,653],[1825,653],[1825,701],[359,701]],"region":{"top_left_x":358,"top_left_y":653,"width":1468,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7346facb265649f38e12bf91e7b3404d","type":"text","conversion_output":true,"text":"If the parents/guardians did not or could not assess the patch adhesion with sufficient","text_display":"\nIf the parents/guardians did not or could not assess the patch adhesion with sufficient","confidence":1,"confidence_rate":1},{"cnt":[[359,699],[1830,699],[1830,747],[359,747]],"region":{"top_left_x":358,"top_left_y":699,"width":1472,"height":48},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6931b8487af24923ab88b658508bcf39","type":"text","conversion_output":true,"text":"reliability according to the Investigator's judgment and/or if the parents/guardians did not","text_display":" reliability according to the Investigator's judgment and/or if the parents/guardians did not","confidence":0.99755859375,"confidence_rate":0.9999748004067751},{"cnt":[[359,745],[1825,745],[1825,793],[359,793]],"region":{"top_left_x":358,"top_left_y":744,"width":1468,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ef94e64adc44a1b86b88d9a7a8532bc","type":"text","conversion_output":true,"text":"or could not take photos for a total of 28 days during M3 and M6, the Investigator can","text_display":" or could not take photos for a total of 28 days during M3 and M6, the Investigator can","confidence":1,"confidence_rate":1},{"cnt":[[359,790],[1825,790],[1825,843],[359,843]],"region":{"top_left_x":358,"top_left_y":790,"width":1468,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af5993d81ceb4bf5a8991bc75c7b3f00","type":"text","conversion_output":true,"text":"disqualify all or part of the data collected for the adhesion assessment and will re-train","text_display":" disqualify all or part of the data collected for the adhesion assessment and will re-train","confidence":1,"confidence_rate":1},{"cnt":[[359,836],[1825,836],[1825,889],[359,889]],"region":{"top_left_x":358,"top_left_y":836,"width":1468,"height":53},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97280d907ae34549b470ec3066ee3c65","type":"text","conversion_output":true,"text":"the parents/guardians so that the assessment of the patch adhesion can be repeated","text_display":" the parents/guardians so that the assessment of the patch adhesion can be repeated","confidence":1,"confidence_rate":1},{"cnt":[[359,886],[1825,886],[1825,934],[359,934]],"region":{"top_left_x":358,"top_left_y":886,"width":1468,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e698e0e775148da8feab133475e06b5","type":"text","conversion_output":true,"text":"between M6 and M9 either totally for 28 evaluable days or partially to compensate for","text_display":" between M6 and M9 either totally for 28 evaluable days or partially to compensate for","confidence":1,"confidence_rate":1},{"cnt":[[359,932],[1238,932],[1238,980],[359,980]],"region":{"top_left_x":358,"top_left_y":932,"width":881,"height":48},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6b54423d589a458ba90602c60208a04e","type":"text","conversion_output":true,"text":"the disqualified days of the first period of assessment.","text_display":" the disqualified days of the first period of assessment.","confidence":1,"confidence_rate":1},{"cnt":[[359,975],[1830,975],[1830,1028],[359,1028]],"region":{"top_left_x":358,"top_left_y":975,"width":1472,"height":53},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb06dc4218fa4f879cf7974b5aa0da7a","type":"text","conversion_output":true,"text":"The assessment of adhesion of the Viaskin \\({ }^{\\circledR}\\) patch will also be made at each site visit by","text_display":"\nThe assessment of adhesion of the Viaskin \\({ }^{\\circledR}\\) patch will also be made at each site visit 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The duration of application of the assessed","text_display":" site staff trained specifically for this purpose. The duration of application of the assessed","confidence":1,"confidence_rate":1},{"cnt":[[359,1069],[1825,1069],[1825,1122],[359,1122]],"region":{"top_left_x":358,"top_left_y":1069,"width":1468,"height":53},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3239b61baba47489e3d563b96138b5c","type":"text","conversion_output":true,"text":"Viaskin \\({ }^{\\text {® }}\\) patch must be noted, photographs must be taken and the assessment by the site","text_display":" Viaskin \\({ }^{\\text {® }}\\) patch must be noted, photographs must be taken and the assessment by the site","confidence":0.39921140670776367,"confidence_rate":0.9914548114097219},{"cnt":[[361,1119],[1140,1119],[1140,1167],[361,1167]],"region":{"top_left_x":360,"top_left_y":1119,"width":780,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8054f7551c0e4326b7f9e4c75864daf8","type":"text","conversion_output":true,"text":"staff will use the same scoring system as above.","text_display":" staff will use the same scoring system as above.","confidence":1,"confidence_rate":1},{"cnt":[[359,1165],[1825,1165],[1825,1213],[359,1213]],"region":{"top_left_x":358,"top_left_y":1165,"width":1468,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ceca0b09df4e47aa9a7147eceec7f43b","type":"text","conversion_output":true,"text":"A Per-Protocol Adhesion Set will include all evaluations except patches removed by the","text_display":"\nA Per-Protocol Adhesion Set will include all evaluations except patches removed by the","confidence":1,"confidence_rate":1},{"cnt":[[359,1211],[1825,1211],[1825,1263],[359,1263]],"region":{"top_left_x":358,"top_left_y":1210,"width":1468,"height":54},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"989c48d2045d4a38b7c4ea3de607fb2d","type":"text","conversion_output":true,"text":"investigator (intentionally removed early, for example due to intolerable irritation) (i.e. :","text_display":" investigator (intentionally removed early, for example due to intolerable irritation) (i.e. :","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[359,1256],[1830,1256],[1830,1309],[359,1309]],"region":{"top_left_x":358,"top_left_y":1256,"width":1472,"height":53},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"06f2c3c132cb4b6ab55714ddc07199d7","type":"text","conversion_output":true,"text":"the investigator answered \"No\" to the question \"do you confirm that the subject's","text_display":" the investigator answered \"No\" to the question \"do you confirm that the subject's","confidence":0.998046875,"confidence_rate":0.9999772672951848},{"cnt":[[361,1307],[1830,1307],[1830,1355],[361,1355]],"region":{"top_left_x":360,"top_left_y":1306,"width":1470,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e732fa4ee61a4bb2ae7b333a7f3d7d1f","type":"text","conversion_output":true,"text":"evaluation is valid for the adhesion analysis?\"). A listing of evaluations which will not","text_display":" evaluation is valid for the adhesion analysis?\"). A listing of evaluations which will not","confidence":0.7226192951202393,"confidence_rate":0.9965498722425796},{"cnt":[[361,1352],[1218,1352],[1218,1400],[361,1400]],"region":{"top_left_x":360,"top_left_y":1352,"width":858,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2ac17fc015847978a59d592317bfab4","type":"text","conversion_output":true,"text":"be included in the PP Adhesion set will be provided.","text_display":" be included in the PP Adhesion set will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[359,1398],[1071,1398],[1071,1446],[359,1446]],"region":{"top_left_x":358,"top_left_y":1398,"width":714,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf587d6913eb4f9f8e1e48de93c5c462","type":"text","conversion_output":true,"text":"The following tabulations will be provided:","text_display":"\nThe following tabulations will be 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","confidence":1,"confidence_rate":1},{"cnt":[[480,2216],[1341,2216],[1341,2264],[480,2264]],"region":{"top_left_x":479,"top_left_y":2215,"width":862,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56a8432030054dbead9dfbf6685c44e9","type":"text","conversion_output":true,"text":"very painful / painful / slightly painful / not painful).","text_display":"very painful / painful / slightly painful / not painful).","confidence":1,"confidence_rate":1},{"cnt":[[361,2262],[1768,2262],[1768,2310],[361,2310]],"region":{"top_left_x":360,"top_left_y":2261,"width":1409,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f0f05f757da450dbef1e080a1b50792","type":"text","conversion_output":true,"text":"Patch adhesion will be considered as acceptable if more than \\(90 \\%\\) of the patches at the","text_display":"\nPatch adhesion will be considered as acceptable if more than \\(90 \\%\\) of the patches at the","confidence":0.99853515625,"confidence_rate":0.9999844052526365},{"cnt":[[361,2310],[1702,2310],[1702,2360],[361,2360]],"region":{"top_left_x":360,"top_left_y":2309,"width":1342,"height":51},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7022fabf676f41c28902546824d36aca","type":"text","conversion_output":true,"text":"expected time of patch removal, i.e. at \\(24 \\pm 4\\) hours after patch application, have an","text_display":" expected time of patch removal, i.e. at \\(24 \\pm 4\\) hours after patch application, have an","confidence":0.98828125,"confidence_rate":0.999870470414384},{"cnt":[[361,2357],[1679,2357],[1679,2405],[361,2405]],"region":{"top_left_x":360,"top_left_y":2357,"width":1320,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d99c41265f4e4adfa59e0d45349fa77e","type":"text","conversion_output":true,"text":"adhesion score \\(\\leq 1\\) as assessed by the subjects' parents/guardians. In other words,","text_display":" adhesion score \\(\\leq 1\\) as assessed by the subjects' parents/guardians. In other words,","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[359,2403],[1812,2403],[1812,2451],[359,2451]],"region":{"top_left_x":358,"top_left_y":2403,"width":1454,"height":49},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b74b4355df4a4a608c2f2c34cf801c82","type":"text","conversion_output":true,"text":"adhesion of the patch will be considered as acceptable if less than \\(10 \\%\\) of the patches are","text_display":" adhesion of the patch will be considered as acceptable if less than \\(10 \\%\\) of the patches 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Document Version No. 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1156,2563],[1830,2563],[1830,2604],[1156,2604]],"region":{"top_left_x":1155,"top_left_y":2563,"width":675,"height":42},"line":50,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4cfeed7a1301426aaeed5008c4f2916d","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: 04-Oct-2017","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999800606141427},{"cnt":[[1636,2604],[1830,2604],[1830,2643],[1636,2643]],"region":{"top_left_x":1635,"top_left_y":2604,"width":195,"height":40},"line":51,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"aa9327c59a774892a92140bf656fe7b2","type":"page_info","conversion_output":false,"text":"Page 64 of 79","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"4520d961-8076-4a3e-9288-40cbcbc6a794-65","page":65,"lines":[{"cnt":[[361,247],[770,247],[770,286],[361,286]],"region":{"top_left_x":360,"top_left_y":246,"width":410,"height":40},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d0dd8ec8f2149019a3618d5781c6c35","type":"page_info","conversion_output":false,"text":"DBV TECHNOLOGIES S.A.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,288],[498,288],[498,322],[361,322]],"region":{"top_left_x":360,"top_left_y":287,"width":138,"height":36},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"32f913b43d7d4d938bffe7d4193a7b4e","type":"page_info","conversion_output":false,"text":"PEPITES","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1494,288],[1830,288],[1830,327],[1494,327]],"region":{"top_left_x":1493,"top_left_y":287,"width":337,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0570a787ca214e8cb6f929b3adf9b0d0","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,370],[1668,370],[1668,418],[361,418]],"region":{"top_left_x":360,"top_left_y":370,"width":1308,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9800cf64e00c4545a89f704e86fc5a0f","type":"text","conversion_output":true,"text":"evaluated with an adhesion grade 2 or 3 at time of removal, during the period of","text_display":"\nevaluated with an adhesion grade 2 or 3 at time of removal, during the period of","confidence":1,"confidence_rate":1},{"cnt":[[361,416],[953,416],[953,464],[361,464]],"region":{"top_left_x":360,"top_left_y":415,"width":593,"height":49},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"426dcc5b20d24707be4b9146eff62ee1","type":"text","conversion_output":true,"text":"adhesion, for the overall population.","text_display":" adhesion, for the overall population.","confidence":1,"confidence_rate":1},{"cnt":[[361,464],[1821,464],[1821,514],[361,514]],"region":{"top_left_x":360,"top_left_y":463,"width":1461,"height":51},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f3b5fe68e55c4896a7cf12328fca90a7","type":"text","conversion_output":true,"text":"In addition, the population of subjects with more than \\(10 \\%\\) of their patches evaluated as a","text_display":"\nIn addition, the population of subjects with more than \\(10 \\%\\) of their patches evaluated as a","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[359,507],[1818,507],[1818,560],[359,560]],"region":{"top_left_x":358,"top_left_y":507,"width":1461,"height":53},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d75c2be0c5a747cb95fb4ac09625e175","type":"text","conversion_output":true,"text":"grade 2 or 3 will be studied and suspected reason(s) for adhesion issues for the concerned","text_display":" grade 2 or 3 will be studied and suspected reason(s) for adhesion issues for the concerned","confidence":1,"confidence_rate":1},{"cnt":[[359,557],[1789,557],[1789,605],[359,605]],"region":{"top_left_x":358,"top_left_y":557,"width":1431,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01bb0eb068b7444cbd82438ccadfc1b1","type":"text","conversion_output":true,"text":"subjects will be tabulated. Response rate (primary efficacy variable) by treatment group","text_display":" subjects will be tabulated. Response rate (primary efficacy variable) by treatment group","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[359,603],[1435,603],[1435,651],[359,651]],"region":{"top_left_x":358,"top_left_y":603,"width":1077,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8722cd8699749b0bfba0549337ec955","type":"text","conversion_output":true,"text":"and overall will also be presented descriptively on this population","text_display":" and overall will also be presented descriptively on this population","confidence":1,"confidence_rate":1},{"cnt":[[361,697],[1802,697],[1802,745],[361,745]],"region":{"top_left_x":360,"top_left_y":696,"width":1443,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cdc5f0f3daf446159e5e3d4cac6fc4e1","type":"text","conversion_output":true,"text":"The use of hypoallergenic adhesive dressing (e.g. Tegaderm \\({ }^{\\circledR}\\) ) to prevent possible patch","text_display":"\n\nThe use of hypoallergenic adhesive dressing (e.g. Tegaderm \\({ }^{\\circledR}\\) ) to prevent possible patch","confidence":0.7413927037443587,"confidence_rate":0.9970991202743608},{"cnt":[[359,742],[1743,742],[1743,793],[359,793]],"region":{"top_left_x":358,"top_left_y":742,"width":1385,"height":51},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"662fae8bffcc4686b2984e201c056d1a","type":"text","conversion_output":true,"text":"adhesion issues was authorized on Dec 2, 2016 (at the time the last subject reached 4","text_display":" adhesion issues was authorized on Dec 2, 2016 (at the time the last subject reached 4","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[359,790],[1720,790],[1720,838],[359,838]],"region":{"top_left_x":358,"top_left_y":790,"width":1363,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7251de64c88c4948843a58156b21f007","type":"text","conversion_output":true,"text":"months of treatment) and is collected in the eCRF (investigator assessment at study","text_display":" months of treatment) and is collected in the eCRF (investigator assessment at study","confidence":1,"confidence_rate":1},{"cnt":[[359,836],[1805,836],[1805,884],[359,884]],"region":{"top_left_x":358,"top_left_y":836,"width":1447,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e35780c1b74a4fb580bbedbe9fa36d66","type":"text","conversion_output":true,"text":"visits). Following a comment from the FDA, this decision was cancelled on Feb 2, 2017.","text_display":" visits). Following a comment from the FDA, this decision was cancelled on Feb 2, 2017.","confidence":1,"confidence_rate":1},{"cnt":[[359,882],[1812,882],[1812,934],[359,934]],"region":{"top_left_x":358,"top_left_y":881,"width":1454,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d20ad447fcc845fc8b9c8156056bd657","type":"text","conversion_output":true,"text":"As some subjects may have already used a hypoallergenic adhesive dressing, the number","text_display":" As some subjects may have already used a hypoallergenic adhesive dressing, the number","confidence":1,"confidence_rate":1},{"cnt":[[359,927],[1757,927],[1757,978],[359,978]],"region":{"top_left_x":358,"top_left_y":927,"width":1399,"height":51},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2ad6fb2f6e84ae1a72cbb18dab4e0f2","type":"text","conversion_output":true,"text":"and percentage of subjects using at least one hypoallergenic adhesive dressing will be","text_display":" and percentage of subjects using at least one hypoallergenic adhesive dressing will be","confidence":1,"confidence_rate":1},{"cnt":[[359,975],[941,975],[941,1026],[359,1026]],"region":{"top_left_x":358,"top_left_y":975,"width":584,"height":51},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8296a90f68964365820641c31446eb95","type":"text","conversion_output":true,"text":"evaluated on the following periods:","text_display":" evaluated on the following periods:","confidence":1,"confidence_rate":1},{"cnt":[[420,1026],[1181,1023],[1181,1074],[420,1076]],"region":{"top_left_x":420,"top_left_y":1023,"width":762,"height":53},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0357e3e380554480afc01b683489113a","type":"text","conversion_output":true,"text":"- Between Month 3 (V7) and Month 6 (V8),","text_display":"\n- Between Month 3 (V7) and Month 6 (V8),","confidence":1,"confidence_rate":1},{"cnt":[[420,1074],[1181,1074],[1181,1124],[420,1124]],"region":{"top_left_x":420,"top_left_y":1073,"width":762,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6b4399219cf4b15a5147dc82510f583","type":"text","conversion_output":true,"text":"- Between Month 6 (V8) and Month 9 (V9),","text_display":"\n- Between Month 6 (V8) and Month 9 (V9),","confidence":1,"confidence_rate":1},{"cnt":[[420,1124],[1220,1124],[1220,1172],[420,1172]],"region":{"top_left_x":420,"top_left_y":1123,"width":800,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"df984d8693804b44bdc36200bdec4c55","type":"text","conversion_output":true,"text":"- Between Month 9 (V9) and Month 12 (V10),","text_display":"\n- Between Month 9 (V9) and Month 12 (V10),","confidence":1,"confidence_rate":1},{"cnt":[[420,1174],[820,1174],[820,1222],[420,1222]],"region":{"top_left_x":420,"top_left_y":1174,"width":401,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3362d225181e44d99bf2db5905c2c9a7","type":"text","conversion_output":true,"text":"- Whole study period.","text_display":"\n- Whole study period.","confidence":1,"confidence_rate":1},{"cnt":[[359,1220],[1775,1220],[1775,1268],[359,1268]],"region":{"top_left_x":358,"top_left_y":1219,"width":1417,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"191dd50c662a477cb43d098dc39e4d6e","type":"text","conversion_output":true,"text":"The quantity of dressing used (absolute and relative - compared to the total number of","text_display":"\n\nThe quantity of dressing used (absolute and relative - compared to the total number of","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[359,1266],[1798,1266],[1798,1318],[359,1318]],"region":{"top_left_x":358,"top_left_y":1265,"width":1440,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6cf1cb1bb0234fc5b71c277b70a90ac5","type":"text","conversion_output":true,"text":"patches applied collected in the diary) with a hypoallergenic adhesive dressing used will","text_display":" patches applied collected in the diary) with a hypoallergenic adhesive dressing used will","confidence":1,"confidence_rate":1},{"cnt":[[359,1311],[651,1311],[651,1357],[359,1357]],"region":{"top_left_x":358,"top_left_y":1311,"width":294,"height":46},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1df89d2d0d62485090d2a71a7faa735d","type":"text","conversion_output":true,"text":"also be tabulated.","text_display":" also be 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maximum drop-out rate of \\(15 \\%\\) ) in the overall population;","text_display":" method (based on a maximum drop-out rate of \\(15 \\%\\) ) in the overall population;","confidence":0.5427036285400391,"confidence_rate":0.9927503125000005},{"cnt":[[420,1976],[1830,1976],[1830,2022],[420,2022]],"region":{"top_left_x":420,"top_left_y":1975,"width":1410,"height":47},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f6b7b8ef45f46819384edd04f490586","type":"text","conversion_output":true,"text":"- A lower bound of the \\(95 \\%\\) CI of the difference between active treatment and","text_display":"\n- A lower bound of the \\(95 \\%\\) CI of the difference between active treatment 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method (based on a maximum drop-out rate of \\(15 \\%\\) );","confidence":0.9325647354125977,"confidence_rate":0.9991489390833183},{"cnt":[[420,2257],[1830,2257],[1830,2310],[420,2310]],"region":{"top_left_x":420,"top_left_y":2256,"width":1410,"height":54},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87bb2ca54a72434da72730fbde0f3c39","type":"text","conversion_output":true,"text":"- A \\(30 \\%\\) response rate for the active Viaskin \\({ }^{(R)}\\) Peanut \\(250 \\mu g\\) group and \\(10 \\%\\)","text_display":"\n- A \\(30 \\%\\) response rate for the active Viaskin \\({ }^{(R)}\\) Peanut \\(250 \\mu g\\) group and \\(10 \\%\\)","confidence":0.32634738832712173,"confidence_rate":0.9886385763089865},{"cnt":[[480,2307],[1830,2307],[1830,2355],[480,2355]],"region":{"top_left_x":479,"top_left_y":2307,"width":1351,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cc1839d01c048d485e263a2d7bf3c52","type":"text","conversion_output":true,"text":"response rate for the placebo group in screening ED Stratum 2, both estimated","text_display":" response rate for the placebo group in screening ED Stratum 2, both estimated","confidence":1,"confidence_rate":1},{"cnt":[[480,2353],[1761,2353],[1761,2401],[480,2401]],"region":{"top_left_x":479,"top_left_y":2352,"width":1283,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2cda79a0d57d445db98d0d7afe6453ee","type":"text","conversion_output":true,"text":"under \"Missing=failure\" method (based on a maximum drop-out rate of \\(15 \\%\\) );","text_display":" under \"Missing=failure\" method (based on a maximum drop-out rate of \\(15 \\%\\) );","confidence":0.7020354270935059,"confidence_rate":0.995695007669123},{"cnt":[[420,2403],[1515,2403],[1515,2451],[420,2451]],"region":{"top_left_x":420,"top_left_y":2403,"width":1095,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eac035ea9212429c957120a4a14f67d1","type":"text","conversion_output":true,"text":"- The following expected distribution of the screening ED strata:","text_display":"\n- The following expected distribution of the screening ED strata:","confidence":1,"confidence_rate":1},{"cnt":[[489,2449],[1512,2449],[1512,2499],[489,2499]],"region":{"top_left_x":488,"top_left_y":2448,"width":1025,"height":52},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e4e8102c57bb446995a8bcdb7761c56c","type":"text","conversion_output":true,"text":"\\(01 / 3\\) of children having a screening ED from 1 mg to 10 mg ;","text_display":" \\(01 / 3\\) of children having a screening ED from 1 mg to 10 mg ;","confidence":0.6136879920959473,"confidence_rate":0.9933337075182946},{"cnt":[[356,2513],[425,2513],[425,2554],[356,2554]],"region":{"top_left_x":356,"top_left_y":2512,"width":69,"height":42},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"43ba730eac28421c9d0b10b90c4cef38","type":"page_info","conversion_output":false,"text":"CCI","text_display":"","confidence":0.9651604618411511,"confidence_rate":0.9955771958121713},{"cnt":[[937,2522],[1195,2522],[1195,2561],[937,2561]],"region":{"top_left_x":936,"top_left_y":2521,"width":259,"height":40},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1f04a66a009e42c49fe1644b81249677","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1330,2522],[1832,2522],[1832,2565],[1330,2565]],"region":{"top_left_x":1329,"top_left_y":2521,"width":504,"height":45},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9368ae0a80dd49f1a2ef2e698c883240","type":"page_info","conversion_output":false,"text":"Project Document Version No. 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1156,2563],[1830,2563],[1830,2604],[1156,2604]],"region":{"top_left_x":1155,"top_left_y":2563,"width":675,"height":42},"line":48,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"07b8dc6042ab47ffbd01aafa0b94050d","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: 04-Oct-2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999900326925697},{"cnt":[[1633,2604],[1830,2604],[1830,2643],[1633,2643]],"region":{"top_left_x":1633,"top_left_y":2604,"width":197,"height":40},"line":49,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"dfa2b92e0bf6447d96caa0d332aac6e8","type":"page_info","conversion_output":false,"text":"Page 65 of 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S.A.","text_display":"","confidence":0.9951193332672119,"confidence_rate":0.9998118401626273},{"cnt":[[356,288],[496,288],[496,322],[356,322]],"region":{"top_left_x":356,"top_left_y":287,"width":140,"height":36},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e5e04afa6d8041579dc8d86ae7314660","type":"page_info","conversion_output":false,"text":"PEPITES","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1494,288],[1830,288],[1830,327],[1494,327]],"region":{"top_left_x":1493,"top_left_y":287,"width":337,"height":40},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0168571bf65c4aa9a0869595aad557f3","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[489,370],[1551,370],[1551,418],[489,418]],"region":{"top_left_x":488,"top_left_y":370,"width":1064,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27d63138ef9a41d5abeab5267b76f5c7","type":"text","conversion_output":true,"text":"\\(0 \\frac{2}{3}\\) of children having a screening ED from 30 mg to 300 mg .","text_display":"\n\\(0 \\frac{2}{3}\\) of children having a screening ED from 30 mg to 300 mg .","confidence":0.5343725848942995,"confidence_rate":0.9920989488389447},{"cnt":[[420,413],[1830,413],[1830,468],[420,468]],"region":{"top_left_x":420,"top_left_y":413,"width":1410,"height":56},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4874811e547d4765b434ea0192e2f296","type":"text","conversion_output":true,"text":"- A ratio 2:1 to maximize the number of subjects treated in the active Viaskin \\({ }^{®}\\)","text_display":"\n- A ratio 2:1 to maximize the number of subjects treated in the active Viaskin \\({ }^{®}\\)","confidence":0.901010274887085,"confidence_rate":0.998855176497059},{"cnt":[[480,466],[838,466],[838,514],[480,514]],"region":{"top_left_x":479,"top_left_y":466,"width":360,"height":48},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cac9afc3febe4f6fa5c09d252010643e","type":"text","conversion_output":true,"text":"Peanut \\(250 \\mu g\\) group.","text_display":" Peanut \\(250 \\mu g\\) group.","confidence":1,"confidence_rate":1},{"cnt":[[359,512],[1830,512],[1830,560],[359,560]],"region":{"top_left_x":358,"top_left_y":511,"width":1472,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5212750238d4459b8f13551f5c38f019","type":"text","conversion_output":true,"text":"Therefore, the overall sample size calculated is approximately 330 subjects evaluable for","text_display":"\nTherefore, the overall sample size calculated is approximately 330 subjects evaluable for","confidence":0.99853515625,"confidence_rate":0.9999848875607663},{"cnt":[[356,555],[1830,555],[1830,608],[356,608]],"region":{"top_left_x":356,"top_left_y":555,"width":1474,"height":53},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"408694ca9e5749d69b7354e413a49303","type":"text","conversion_output":true,"text":"the primary efficacy endpoint in the analysis ( 220 subjects in the active Viaskin \\({ }^{\\text {® }}\\) Peanut","text_display":" the primary efficacy endpoint in the analysis ( 220 subjects in the active Viaskin \\({ }^{\\text {® }}\\) Peanut","confidence":0.9776238387300396,"confidence_rate":0.999801508246752},{"cnt":[[359,605],[1830,605],[1830,653],[359,653]],"region":{"top_left_x":358,"top_left_y":605,"width":1472,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fcbc3c4a83694dec9b37c15a76285b60","type":"text","conversion_output":true,"text":"\\(250 \\mu g\\) group and 110 subjects in the placebo group). Hence, according to the expected","text_display":" \\(250 \\mu g\\) group and 110 subjects in the placebo group). Hence, according to the expected","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[359,653],[1830,653],[1830,701],[359,701]],"region":{"top_left_x":358,"top_left_y":653,"width":1472,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9332df5eae024b7991b7e09052639dfd","type":"text","conversion_output":true,"text":"distribution of the screening ED strata, approximately 110 children having a screening","text_display":" distribution of the screening ED strata, approximately 110 children having a screening","confidence":1,"confidence_rate":1},{"cnt":[[356,699],[1830,699],[1830,747],[356,747]],"region":{"top_left_x":356,"top_left_y":699,"width":1474,"height":48},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b74c6e280cf445e7909a6380682204ce","type":"text","conversion_output":true,"text":"ED from 1 mg to 10 mg and 220 children having a screening ED from 30 mg to 300 mg","text_display":" ED from 1 mg to 10 mg and 220 children having a screening ED from 30 mg to 300 mg","confidence":1,"confidence_rate":1},{"cnt":[[359,745],[733,745],[733,788],[359,788]],"region":{"top_left_x":358,"top_left_y":744,"width":376,"height":45},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"518e56c92fbd4b2b960c9a8b2dc7634e","type":"text","conversion_output":true,"text":"should be randomized.","text_display":" should be randomized.","confidence":1,"confidence_rate":1},{"cnt":[[359,790],[1830,790],[1830,838],[359,838]],"region":{"top_left_x":358,"top_left_y":790,"width":1472,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e45c4f19a96f4651a9fa85753fda2ff2","type":"text","conversion_output":true,"text":"This number of subjects leads to a power of \\(>90 \\%\\) in the overall population, \\(>99 \\%\\) in the","text_display":"\nThis number of subjects leads to a power of \\(>90 \\%\\) in the overall population, \\(>99 \\%\\) in the","confidence":1,"confidence_rate":1},{"cnt":[[359,836],[980,836],[980,882],[359,882]],"region":{"top_left_x":358,"top_left_y":836,"width":622,"height":46},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0761b81ddaf4eeea0f9564a0206fe56","type":"text","conversion_output":true,"text":"Stratum 1 and \\(>95 \\%\\) in the Stratum 2.","text_display":" Stratum 1 and \\(>95 \\%\\) in the Stratum 2.","confidence":1,"confidence_rate":1},{"cnt":[[359,882],[1067,882],[1067,934],[359,934]],"region":{"top_left_x":358,"top_left_y":881,"width":709,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27f51ab9e4f64f5bab14501dc24929d1","type":"text","conversion_output":true,"text":"This is summarized in the following Table.","text_display":"\nThis is summarized in the following 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Calculations}","confidence":1,"confidence_rate":1},{"cnt":[[338,1062],[1848,1062],[1848,1549],[338,1549]],"region":{"top_left_x":338,"top_left_y":1062,"width":1511,"height":487},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f595682076e462b83513e2cb25f3ac2","type":"table","conversion_output":true,"children_ids":["f8ba8af5fdbb41f1be1f5d711ccd1796","4a13c8f5f81342ada51f5cf8d09f5b80","39fae414bb2b4f9ba46912ae5aa16182","b70c4231486141c0a6fca45d0cabe249","15d412fe390e46158bbed2b91b12a0cb","d91739248a67435587a5bd8927475d4f","14852653c0884c4daf7b4242e87cddd7","70b1121e5a0740cfa4cf824bb8911cfd","d73c2b3b12fa47b0a44360e8ea292cd9","d38f9bd70ed240729db7339c293e6c77","78c769093e7c4b209a9ce6a140997acc","4ef444a618684a9c881f6967b5bc027d","9c3bd82a4c1641b794776be93026ba00","0b2f70610a434424a2a02d912afc52e0","30e4fae06a544f54bc886ff788cf26d9","9b19ff79072d44d28ddb77d55bc308b4","09fefba0411541b0911abbeadc8d5fe5","91ff2fa5ecbc4414b55d7dd6f513e1a0","35be42d305c44a139ec63dfecd14d635","08258f62bcf24e84bc4b862cc27d2048","203608d56cf24aabaa75dbf917292cd8","eca39d297a1c45dd81c3fdcce0423f87","36fb2678eb8d432383e36daf2a409c20","245977163ee645fcac75b013459eec9c","ebe0acbdddda4267a66f1c7f664d7ead","92e98d49d5b641ac94ba16dcf2d13cfa","f1aa07ba7fe04c58acba736efc0249f0","cfb227da82554056b3f5836376b885bd","113c8d1abf5644d4b92a0a17b39085cb","92a4bf7129bb4d3e9d9d01c32e797e3f","60f754ec408d468c92cd4ab1726b1b6c","74afba5c5dbc459dad8a8b8586343462","2dd3f6dcb5b243088663c880c525b6cc","b1a8d7bdd68f4098b42cce8db4c77d0f","aba2593269ee45b3bf8bc4458bb32a61","16efca54adef4f5d9729049a890e29e0"],"text":"\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline 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