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Primary Objective: & Outcome Measure: \\\\\n\\hline \\begin{tabular}{l} \nTo demonstrate that Symbicort Turbuhaler \\\\\n\\(160 / 4.5 \\mu g\\) 'as needed' is superior to \\\\\nterbutaline Turbuhaler 0.4 mg 'as needed'\n\\end{tabular} & Evaluation of asthma control as measured by well- \\\\\n& controlled asthma weeks as the primary variable \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Primary Objective: & Outcome Measure: \\\\\n\\hline \\begin{tabular}{l} \nTo demonstrate that Symbicort Turbuhaler \\\\\n\\(160 / 4.5 \\mu g\\) 'as needed' is superior to \\\\\nterbutaline Turbuhaler 0.4 mg 'as needed'\n\\end{tabular} & Evaluation of asthma control as measured by well- \\\\\n& controlled asthma weeks as the primary variable 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\\(200 \\mu g\\) twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed' & Evaluation of asthma control as measured by wellcontrolled asthma weeks as the primary variable \\\\\n\\hline \\begin{tabular}{l}\nTo evaluate the efficacy of Symbicort Turbuhaler \\(160 / 4.5 \\mu g\\) as compared to both: terbutaline Turbuhaler 0.4 mg 'as needed' And: \\\\\nPulmicort Turbuhaler \\(200 \\mu g\\) twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'\n\\end{tabular} & \\begin{tabular}{l}\nSecondary variables: \\\\\nTime to first severe asthma exacerbation \\\\\nTime to first moderate or severe asthma exacerbation \\\\\nAverage change from baseline in pre-dose Forced Expiratory Volume in one second \\\\\nAverage change from baseline in Morning Peak Expiratory Flow \\\\\nAverage change from baseline in Evening Peak Expiratory Flow \\\\\nAverage change from baseline in number of inhalations of 'as needed' medication \\\\\nAverage change from baseline in symptom score Percentage of Nighttime awakenings due to asthma Percentage of Symptom-free days \\\\\nPercentage of 'As needed' free days \\\\\nPercentage of Asthma control days \\\\\nPercentage of controller use days \\\\\nTime to asthma related discontinuation \\\\\nPoorly controlled asthma weeks \\\\\nTime to additional steroids for asthma \\\\\nAverage change from baseline in Asthma Control Questionnaire 5-item version \\\\\nAverage change from baseline in Asthma Quality of Life Questionnaire standard version\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Secondary Objectives: & Outcome Measure: \\\\\n\\hline To evaluate the relative efficacy of Symbicort Turbuhaler \\(160 / 4.5 \\mu g\\) 'as needed' and Pulmicort Turbuhaler \\(200 \\mu g\\) twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed' & Evaluation of asthma control as measured by wellcontrolled asthma weeks as the primary variable \\\\\n\\hline \\begin{tabular}{l}\nTo evaluate the efficacy of Symbicort 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The main aim of asthma management is to achieve and maintain","text_display":" airways that vary over time. The main aim of asthma management is to achieve and maintain","confidence":1,"confidence_rate":1},{"cnt":[[283,717],[1738,717],[1738,770],[283,770]],"region":{"top_left_x":283,"top_left_y":717,"width":1456,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed95b65a9cea4bceaeb8d0fa4a15697d","type":"text","conversion_output":true,"text":"asthma control. For this purpose a stepwise treatment approach increasing in intensity, is","text_display":" asthma control. 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Using a rapid acting \\(\\beta_{2}\\)-agonist, commonly salbutamol or","confidence":0.9917030334472656,"confidence_rate":0.9999132164954986},{"cnt":[[283,813],[1784,813],[1784,861],[283,861]],"region":{"top_left_x":283,"top_left_y":813,"width":1502,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b9fb568cfb045edb75accf5f1fec521","type":"text","conversion_output":true,"text":"terbutaline, on an as-needed basis in response to symptoms is the first treatment step (GINA","text_display":" terbutaline, on an as-needed basis in response to symptoms is the first treatment step (GINA","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[283,861],[1798,861],[1798,909],[283,909]],"region":{"top_left_x":283,"top_left_y":861,"width":1515,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb3f945fa2ac4305b7eb9dd15e058d2f","type":"text","conversion_output":true,"text":"step 1). 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In addition Symbicort 'as needed' will also be compared with Pulmicort \\({ }^{\\circledR}\\)","confidence":0.9771175384521484,"confidence_rate":0.9997730813509387},{"cnt":[[283,1645],[1802,1645],[1802,1702],[283,1702]],"region":{"top_left_x":283,"top_left_y":1644,"width":1520,"height":58},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0720e2151774a9ebe570502c949c1ae","type":"text","conversion_output":true,"text":"(budesonide) Turbuhaler \\({ }^{\\circledR} 200 \\mu g\\) twice daily plus terbutaline 'as needed' which is one of the","text_display":" (budesonide) Turbuhaler \\({ }^{\\circledR} 200 \\mu g\\) twice daily plus terbutaline 'as needed' which is one of the","confidence":0.9692816594615579,"confidence_rate":0.9997138020717198},{"cnt":[[283,1695],[1789,1695],[1789,1748],[283,1748]],"region":{"top_left_x":283,"top_left_y":1695,"width":1506,"height":53},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"182f9be9d2b247ab9c152f8b318ec932","type":"text","conversion_output":true,"text":"current standard treatments for patients at GINA step 2. Symbicort (budesonide/formoterol)","text_display":" current standard treatments for patients at GINA step 2. Symbicort (budesonide/formoterol)","confidence":1,"confidence_rate":1},{"cnt":[[283,1745],[1775,1745],[1775,1793],[283,1793]],"region":{"top_left_x":283,"top_left_y":1745,"width":1492,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9465551636654537a1a4b45b952f48bc","type":"text","conversion_output":true,"text":"Turbuhaler \\(160 / 4.5 \\mu g\\) 'as needed' is the strength mostly used on 'as needed' basis with the","text_display":" Turbuhaler \\(160 / 4.5 \\mu g\\) 'as needed' is the strength mostly used on 'as needed' basis with the","confidence":0.7199177742004395,"confidence_rate":0.9967516410741859},{"cnt":[[283,1791],[1761,1791],[1761,1839],[283,1839]],"region":{"top_left_x":283,"top_left_y":1790,"width":1479,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"292f30a7964c4aafbc1fe37f987389e4","type":"text","conversion_output":true,"text":"Symbicort SMART concept. It is considered to provide adequate anti-inflammatory effect","text_display":" Symbicort SMART concept. It is considered to provide adequate anti-inflammatory effect","confidence":1,"confidence_rate":1},{"cnt":[[283,1837],[1793,1837],[1793,1885],[283,1885]],"region":{"top_left_x":283,"top_left_y":1836,"width":1511,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3802eccee6394d478f469afa6d50d147","type":"text","conversion_output":true,"text":"due to the budesonide component, and yet is safe to use as evidenced by Symbicort SMART","text_display":" due to the budesonide component, and yet is safe to use as evidenced by Symbicort SMART","confidence":1,"confidence_rate":1},{"cnt":[[283,1878],[1743,1878],[1743,1935],[283,1935]],"region":{"top_left_x":283,"top_left_y":1877,"width":1460,"height":58},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2aac5c84f1d042b8b3ea1665d2e20b66","type":"text","conversion_output":true,"text":"data. The formoterol component of Symbicort \\({ }^{\\circledR}\\) Turbuhaler \\({ }^{\\circledR}\\) provides rapid and effective","text_display":" data. The formoterol component of Symbicort \\({ }^{\\circledR}\\) Turbuhaler \\({ }^{\\circledR}\\) provides rapid and effective","confidence":0.4675981738837436,"confidence_rate":0.9932359623329248},{"cnt":[[283,1933],[546,1933],[546,1981],[283,1981]],"region":{"top_left_x":283,"top_left_y":1932,"width":263,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b0911483e864b76945bc8a511d6c482","type":"text","conversion_output":true,"text":"symptom relief.","text_display":" symptom relief.","confidence":1,"confidence_rate":1},{"cnt":[[283,2022],[1741,2022],[1741,2067],[283,2067]],"region":{"top_left_x":283,"top_left_y":2021,"width":1458,"height":47},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef8ad5bf1afb42b693d9e6561dfc65bd","type":"text","conversion_output":true,"text":"During the treatment period of the study terbutaline will be provided in a Turbuhaler (dry","text_display":"\n\nDuring the treatment period of the study terbutaline will be provided in a Turbuhaler (dry","confidence":1,"confidence_rate":1},{"cnt":[[283,2061],[1784,2061],[1784,2118],[283,2118]],"region":{"top_left_x":283,"top_left_y":2060,"width":1502,"height":58},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08502fec39ed4eac863b89f74398510b","type":"text","conversion_output":true,"text":"powder inhaler - DPI) that is identical to the Symbicort \\({ }^{\\circledR}\\) Turbuhaler \\({ }^{(R)}\\) for blinding purposes.","text_display":" powder inhaler - DPI) that is identical to the Symbicort \\({ }^{\\circledR}\\) Turbuhaler \\({ }^{(R)}\\) for blinding purposes.","confidence":0.3316598395471715,"confidence_rate":0.9909204339854942},{"cnt":[[283,2115],[1798,2115],[1798,2163],[283,2163]],"region":{"top_left_x":283,"top_left_y":2115,"width":1515,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9a55c47c2d54aed98a21924339c4e02","type":"text","conversion_output":true,"text":"The dose of active substance in the terbutaline Turbuhaler ( 0.4 mg terbutaline per inhalation)","text_display":" The dose of active substance in the terbutaline Turbuhaler ( 0.4 mg terbutaline per inhalation)","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[283,2161],[1786,2161],[1786,2214],[283,2214]],"region":{"top_left_x":283,"top_left_y":2161,"width":1504,"height":53},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9681ebff1a05447ea090a9574d619b17","type":"text","conversion_output":true,"text":"is expressed as delivered dose that corresponds to 0.5 mg per inhalation in the commercially","text_display":" is expressed as delivered dose that corresponds to 0.5 mg per inhalation in the commercially","confidence":1,"confidence_rate":1},{"cnt":[[283,2202],[1620,2202],[1620,2259],[283,2259]],"region":{"top_left_x":283,"top_left_y":2202,"width":1337,"height":58},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"985f738ee69345329bc45fc03b613cfc","type":"text","conversion_output":true,"text":"available product, Bricanyl \\({ }^{\\text {® }}\\) Turbuhaler \\({ }^{\\text {® }}\\) (expressed as metered dose). Bricanyl \\({ }^{\\text {® }}\\)","text_display":" available product, Bricanyl \\({ }^{\\text {® }}\\) Turbuhaler \\({ }^{\\text {® }}\\) (expressed as metered dose). Bricanyl \\({ }^{\\text {® }}\\)","confidence":0.5911370231120223,"confidence_rate":0.995901333190825},{"cnt":[[283,2252],[1802,2252],[1802,2305],[283,2305]],"region":{"top_left_x":283,"top_left_y":2252,"width":1520,"height":53},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9e095c17c76c472d8092da360737282a","type":"text","conversion_output":true,"text":"Turbuhaler \\({ }^{\\circledR}\\) will be used during the run in period (see Section 7.1 'Identity of investigational","text_display":" Turbuhaler \\({ }^{\\circledR}\\) will be used during the run in period (see Section 7.1 'Identity of investigational","confidence":0.5048828125,"confidence_rate":0.994022943476532},{"cnt":[[283,2305],[466,2305],[466,2355],[283,2355]],"region":{"top_left_x":283,"top_left_y":2304,"width":184,"height":52},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ec2ebe2ff6c646fb9e70a1ba1b54f407","type":"text","conversion_output":true,"text":"products').","text_display":" products').","confidence":0.9951171875,"confidence_rate":0.9996941235162077},{"cnt":[[283,2389],[1750,2389],[1750,2442],[283,2442]],"region":{"top_left_x":283,"top_left_y":2389,"width":1467,"height":53},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb1ee651de1042b5b9b8f42f95fef7a2","type":"text","conversion_output":true,"text":"Evaluating asthma control is important in patients with asthma, especially in patients with","text_display":"\n\nEvaluating asthma control is important in patients with asthma, especially in patients with","confidence":1,"confidence_rate":1},{"cnt":[[283,2440],[1775,2440],[1775,2488],[283,2488]],"region":{"top_left_x":283,"top_left_y":2439,"width":1492,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51f5916d69e448cba94d4c4d37c815f3","type":"text","conversion_output":true,"text":"mild asthma. Well controlled asthma weeks (WCAW) are a well-known and well-accepted","text_display":" mild asthma. Well controlled asthma weeks (WCAW) are a well-known and well-accepted","confidence":1,"confidence_rate":1},{"cnt":[[283,2488],[1693,2488],[1693,2536],[283,2536]],"region":{"top_left_x":283,"top_left_y":2487,"width":1410,"height":49},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b97ac8d6add4939b306ca432a941102","type":"text","conversion_output":true,"text":"composite measure of asthma control (Bateman et al 2004). Therefore WCAW on the","text_display":" composite measure of asthma control (Bateman et al 2004). Therefore WCAW on the","confidence":1,"confidence_rate":1},{"cnt":[[1001,2632],[1112,2632],[1112,2680],[1001,2680]],"region":{"top_left_x":1000,"top_left_y":2631,"width":113,"height":49},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9fdc0dd651c47e4839adc9be2221f1b","type":"page_info","conversion_output":false,"text":"16(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-17","page":17,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6927b68262d548c0833ae68aa11009bd","type":"page_info","conversion_output":false,"text":"Revised Clinical Study Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,279],[715,279],[715,313],[283,313]],"region":{"top_left_x":283,"top_left_y":278,"width":433,"height":35},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cb9bf9b4370b496b90310b9011c0f357","type":"page_info","conversion_output":false,"text":"Drug Substance budesonide/formoterol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,311],[583,311],[583,343],[283,343]],"region":{"top_left_x":283,"top_left_y":310,"width":300,"height":33},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"ba65c5a546304013bba8f2a8d3afedf8","type":"page_info","conversion_output":false,"text":"Study Code D589SC00001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,370],[283,370]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":29},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2a25bdd7e435481595b0d8cf122a3946","type":"page_info","conversion_output":false,"text":"Edition Number 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"6d559ff857e6437cb61120f497d8336d","type":"page_info","conversion_output":false,"text":"Date 22 December 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,416],[1800,416],[1800,464],[283,464]],"region":{"top_left_x":283,"top_left_y":415,"width":1518,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9900c23d9c641379593ca40335b41f4","type":"text","conversion_output":true,"text":"randomised treatment has been chosen as the primary variable in the study. WCAW consists","text_display":"\nrandomised treatment has been chosen as the primary variable in the study. WCAW consists","confidence":1,"confidence_rate":1},{"cnt":[[283,461],[1702,461],[1702,509],[283,509]],"region":{"top_left_x":283,"top_left_y":461,"width":1419,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ebcdb1c54cd84eedbab4afbac9d3b7d3","type":"text","conversion_output":true,"text":"of several parameters including symptoms, nighttime awakenings, lung function and as","text_display":" of several parameters including symptoms, nighttime awakenings, lung function and as","confidence":1,"confidence_rate":1},{"cnt":[[283,507],[1812,507],[1812,555],[283,555]],"region":{"top_left_x":283,"top_left_y":507,"width":1529,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4557915961f4421680dadcb0be8d5c7a","type":"text","conversion_output":true,"text":"needed use measured on a daily basis. In addition WCAW on randomised treatment take into","text_display":" needed use measured on a daily basis. In addition WCAW on randomised treatment take into","confidence":1,"confidence_rate":1},{"cnt":[[283,557],[1768,557],[1768,605],[283,605]],"region":{"top_left_x":283,"top_left_y":557,"width":1486,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76b652979fdd448f932cae91ba6d0d49","type":"text","conversion_output":true,"text":"consideration any additional asthma therapy received by the patients. Moderate and severe","text_display":" consideration any additional asthma therapy received by the patients. Moderate and severe","confidence":1,"confidence_rate":1},{"cnt":[[283,603],[1684,603],[1684,651],[283,651]],"region":{"top_left_x":283,"top_left_y":603,"width":1401,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"563933be97264512880bcf8d6577019f","type":"text","conversion_output":true,"text":"asthma exacerbations, another important aspect of asthma control, will be collected as","text_display":" asthma exacerbations, another important aspect of asthma control, will be collected as","confidence":1,"confidence_rate":1},{"cnt":[[283,653],[642,653],[642,697],[283,697]],"region":{"top_left_x":283,"top_left_y":653,"width":359,"height":44},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64da224527f04ddb93412a3d46f0e686","type":"text","conversion_output":true,"text":"secondary end-points.","text_display":" secondary end-points.","confidence":1,"confidence_rate":1},{"cnt":[[283,740],[1766,740],[1766,788],[283,788]],"region":{"top_left_x":283,"top_left_y":740,"width":1483,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6dd34bd2e94d4bf583a01b57229b24bc","type":"text","conversion_output":true,"text":"Patients' recruitment will be balanced based on their pre-study treatment (i.e., patients who","text_display":"\n\nPatients' recruitment will be balanced based on their pre-study treatment (i.e., patients who","confidence":0.998046875,"confidence_rate":0.9999800508639274},{"cnt":[[283,786],[1679,786],[1679,834],[283,834]],"region":{"top_left_x":283,"top_left_y":785,"width":1397,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f8ced7253944025b744ad3743c06193","type":"text","conversion_output":true,"text":"are uncontrolled on an inhaled short acting bronchodilator (SABA and/or short acting","text_display":" are uncontrolled on an inhaled short acting bronchodilator (SABA and/or short acting","confidence":1,"confidence_rate":1},{"cnt":[[283,832],[1775,832],[1775,879],[283,879]],"region":{"top_left_x":283,"top_left_y":831,"width":1492,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac3e5559ad9a4ceb85d2a3895eb7aee5","type":"text","conversion_output":true,"text":"anticholinergic agent) 'as needed' or controlled on mono-maintenance therapy with either a","text_display":" anticholinergic agent) 'as needed' or controlled on mono-maintenance therapy with either a","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[283,882],[1757,882],[1757,930],[283,930]],"region":{"top_left_x":283,"top_left_y":881,"width":1474,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d823c4920874afdae71a194d4f09662","type":"text","conversion_output":true,"text":"low dose ICS or a leukotriene receptor antagonist (LTRA) in addition to 'as needed' use of","text_display":" low dose ICS or a leukotriene receptor antagonist (LTRA) in addition to 'as needed' use of","confidence":1,"confidence_rate":1},{"cnt":[[283,927],[1679,927],[1679,975],[283,975]],"region":{"top_left_x":283,"top_left_y":927,"width":1397,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5761c9ebf404f5c95df861faae1b707","type":"text","conversion_output":true,"text":"inhaled short-acting bronchodilator (SABA and/or short acting anticholinergic agent).","text_display":" inhaled short-acting bronchodilator (SABA and/or short acting anticholinergic agent).","confidence":1,"confidence_rate":1},{"cnt":[[283,975],[1510,975],[1510,1026],[283,1026]],"region":{"top_left_x":283,"top_left_y":975,"width":1227,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12b1f70e891049149b05ab8953a6b410","type":"text","conversion_output":true,"text":"Patients will be randomised to the three treatment arms in \\(1: 1: 1\\) proportion.","text_display":" Patients will be randomised to the three treatment arms in \\(1: 1: 1\\) proportion.","confidence":0.658203125,"confidence_rate":0.9950333072169617},{"cnt":[[283,1062],[1165,1062],[1165,1112],[283,1112]],"region":{"top_left_x":283,"top_left_y":1062,"width":883,"height":51},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7ddb5417e7f5489f9fabdde805488be8","type":"section_header","conversion_output":false,"children_ids":["1eecf4665b6b4a8e8afb164a2daeed85"],"text":"","text_display":""},{"cnt":[[286,1065],[1163,1065],[1163,1108],[286,1108]],"region":{"top_left_x":285,"top_left_y":1064,"width":878,"height":44},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1eecf4665b6b4a8e8afb164a2daeed85","type":"text","conversion_output":true,"parent_id":"7ddb5417e7f5489f9fabdde805488be8","text":"1.3 Benefit/risk and ethical assessment","text_display":"\n\n\\subsection*{1.3 Benefit/risk and ethical 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In this study patients","text_display":"\n\nSymbicort is effective as a reliever medication (Palmqvist et al 2001). 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In the Symbicort SMART program the patients have been","text_display":" Symbicort Turbuhaler per day. In the Symbicort SMART program the patients have been","confidence":1,"confidence_rate":1},{"cnt":[[283,1462],[1748,1462],[1748,1510],[283,1510]],"region":{"top_left_x":283,"top_left_y":1462,"width":1465,"height":48},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3784458ba12d4fab974c4349943c9b73","type":"text","conversion_output":true,"text":"allowed to use up to 12 inhalations per day ( 10 'as needed' inhalations in addition to their","text_display":" allowed to use up to 12 inhalations per day ( 10 'as needed' inhalations in addition to their","confidence":0.9858465194702148,"confidence_rate":0.9998629459671635},{"cnt":[[283,1508],[1752,1508],[1752,1556],[283,1556]],"region":{"top_left_x":283,"top_left_y":1507,"width":1470,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6dd55832e7d4b79931778eabffd7dc1","type":"text","conversion_output":true,"text":"maintenance treatment) and the safety profile of Symbicort was no different from that of a","text_display":" maintenance treatment) and the safety profile of Symbicort was no different from that of a","confidence":1,"confidence_rate":1},{"cnt":[[283,1556],[1802,1556],[1802,1604],[283,1604]],"region":{"top_left_x":283,"top_left_y":1555,"width":1520,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c50862fd7d744e3b8252659e006d421c","type":"text","conversion_output":true,"text":"fixed dose maintenance treatment. Furthermore a study in which patients took 10 inhalations","text_display":" fixed dose maintenance treatment. Furthermore a study in which patients took 10 inhalations","confidence":1,"confidence_rate":1},{"cnt":[[283,1604],[1688,1604],[1688,1652],[283,1652]],"region":{"top_left_x":283,"top_left_y":1603,"width":1406,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"833c6f3f56ff49c0a104cd18d9ed47ea","type":"text","conversion_output":true,"text":"of Symbicort Turbuhaler \\(160 / 4.5 \\mu g\\) per inhalation as an addition to a daily Symbicort","text_display":" of Symbicort Turbuhaler \\(160 / 4.5 \\mu g\\) per inhalation as an addition to a daily Symbicort","confidence":0.994631290435791,"confidence_rate":0.9999433366277997},{"cnt":[[283,1652],[1706,1652],[1706,1700],[283,1700]],"region":{"top_left_x":283,"top_left_y":1651,"width":1424,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c85ab2027aa14bef85aef53ce76da370","type":"text","conversion_output":true,"text":"maintenance dose of \\(640 / 18 \\mu g\\) revealed no new safety concerns compared to what was","text_display":" maintenance dose of \\(640 / 18 \\mu g\\) revealed no new safety concerns compared to what was","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[283,1700],[1761,1700],[1761,1748],[283,1748]],"region":{"top_left_x":283,"top_left_y":1699,"width":1479,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0911ed956c1944979a64df270061c91a","type":"text","conversion_output":true,"text":"already known for ICS and LABA (Ankerst et al 2003) demonstrating that occasional high","text_display":" already known for ICS and LABA (Ankerst et al 2003) demonstrating that occasional high","confidence":1,"confidence_rate":1},{"cnt":[[283,1745],[1236,1745],[1236,1793],[283,1793]],"region":{"top_left_x":283,"top_left_y":1745,"width":953,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e13f0480a42430088775c2a59c6be37","type":"text","conversion_output":true,"text":"doses of Symbicort Turbuhaler are safe and well tolerated.","text_display":" doses of Symbicort Turbuhaler are safe and well tolerated.","confidence":1,"confidence_rate":1},{"cnt":[[283,1832],[1821,1832],[1821,1880],[283,1880]],"region":{"top_left_x":283,"top_left_y":1832,"width":1538,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4371e16f35a4afc8c66c842dd5dd1c0","type":"text","conversion_output":true,"text":"Terbutaline Turbuhaler is a well-known and frequently used short acting \\(\\beta_{2}\\) agonists (SABAs).","text_display":"\n\nTerbutaline Turbuhaler is a well-known and frequently used short acting \\(\\beta_{2}\\) agonists (SABAs).","confidence":1,"confidence_rate":1},{"cnt":[[283,1878],[1706,1878],[1706,1926],[283,1926]],"region":{"top_left_x":283,"top_left_y":1877,"width":1424,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4095c569b60b4833a43627f2a6d33bcc","type":"text","conversion_output":true,"text":"It is widely acknowledged that terbutaline has a rapid onset of action within minutes of","text_display":" It is widely acknowledged that terbutaline has a rapid onset of action within minutes of","confidence":1,"confidence_rate":1},{"cnt":[[283,1928],[1812,1928],[1812,1976],[283,1976]],"region":{"top_left_x":283,"top_left_y":1928,"width":1529,"height":48},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"15ea8bf800a64b3abfe4b40f647a9a08","type":"text","conversion_output":true,"text":"inhalation and a favourable safety profile (Sears and Lötvall 2005). The maximum dose to be","text_display":" inhalation and a favourable safety profile (Sears and Lötvall 2005). The maximum dose to be","confidence":0.990234375,"confidence_rate":0.9998988337625115},{"cnt":[[283,1976],[1812,1976],[1812,2022],[283,2022]],"region":{"top_left_x":283,"top_left_y":1975,"width":1529,"height":47},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1e2ab4344d94672b713ac2876829463","type":"text","conversion_output":true,"text":"allowed in the study is within the approved dose range in most countries. The patients will be","text_display":" allowed in the study is within the approved dose range in most countries. The patients will be","confidence":1,"confidence_rate":1},{"cnt":[[283,2024],[1674,2024],[1674,2067],[283,2067]],"region":{"top_left_x":283,"top_left_y":2023,"width":1392,"height":45},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9662fcc8b39941fda5f387576b8c652c","type":"text","conversion_output":true,"text":"instructed to contact the investigator if using more than 12 as needed inhalations with","text_display":" instructed to contact the investigator if using more than 12 as needed inhalations with","confidence":1,"confidence_rate":1},{"cnt":[[283,2070],[793,2070],[793,2118],[283,2118]],"region":{"top_left_x":283,"top_left_y":2069,"width":510,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef4b84176bd84ab5a6a4cbaa1c4bd8bc","type":"text","conversion_output":true,"text":"terbutaline Turbuhaler per day.","text_display":" terbutaline Turbuhaler per day.","confidence":1,"confidence_rate":1},{"cnt":[[283,2156],[1725,2156],[1725,2204],[283,2204]],"region":{"top_left_x":283,"top_left_y":2156,"width":1442,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60e92f6a85a74334a202425f73da1081","type":"text","conversion_output":true,"text":"Pulmicort which will be used as a maintenance treatment in the other comparator arm, is","text_display":"\n\nPulmicort which will be used as a maintenance treatment in the other comparator arm, is","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[283,2204],[1336,2204],[1336,2250],[283,2250]],"region":{"top_left_x":283,"top_left_y":2204,"width":1054,"height":47},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb95130520ec4eaaa9972564a04de35b","type":"text","conversion_output":true,"text":"effective and safe controller medication in asthma (GINA 2012).","text_display":" effective and safe controller medication in asthma (GINA 2012).","confidence":1,"confidence_rate":1},{"cnt":[[283,2294],[1816,2294],[1816,2341],[283,2341]],"region":{"top_left_x":283,"top_left_y":2293,"width":1534,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d2407d1a85d41408cfb063b5f25be12","type":"text","conversion_output":true,"text":"All patients will be thoroughly monitored during the course of the study with clinic visits at 4 ,","text_display":"\n\nAll patients will be thoroughly monitored during the course of the study with clinic visits at 4 ,","confidence":0.97998046875,"confidence_rate":0.9998092385995055},{"cnt":[[286,2339],[1750,2339],[1750,2387],[286,2387]],"region":{"top_left_x":285,"top_left_y":2339,"width":1465,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bfaa09c4645345d78f061ddce84b3b46","type":"text","conversion_output":true,"text":"16, 28, 40 and 52 weeks of treatment and daily recording of Peak Expiratory Flow (PEF),","text_display":" 16, 28, 40 and 52 weeks of treatment and daily recording of Peak Expiratory Flow (PEF),","confidence":1,"confidence_rate":1},{"cnt":[[283,2387],[1702,2387],[1702,2433],[283,2433]],"region":{"top_left_x":283,"top_left_y":2387,"width":1419,"height":46},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94a2c0f860c845d0ab26cf1dbdb34301","type":"text","conversion_output":true,"text":"asthma symptoms, use of maintenance and 'as needed' investigational product (IP) and","text_display":" asthma symptoms, use of maintenance and 'as needed' investigational product (IP) and","confidence":1,"confidence_rate":1},{"cnt":[[283,2435],[1780,2435],[1780,2483],[283,2483]],"region":{"top_left_x":283,"top_left_y":2435,"width":1497,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"329610a8664e4b3bbf4276e53aa75285","type":"text","conversion_output":true,"text":"nighttime awakenings. Furthermore there will be triggers in the electronic diary (eDiary) to","text_display":" nighttime awakenings. Furthermore there will be triggers in the electronic diary (eDiary) to","confidence":1,"confidence_rate":1},{"cnt":[[283,2481],[1766,2481],[1766,2529],[283,2529]],"region":{"top_left_x":283,"top_left_y":2480,"width":1483,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56a411cd135d4a9e9868a7dd70442faa","type":"text","conversion_output":true,"text":"generate alerts warning the patients for worsening of their asthma. Upon receiving such an","text_display":" generate alerts warning the patients for worsening of their asthma. 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The investigators may prescribe additional","text_display":" assistance even without an alert. The investigators may prescribe additional","confidence":1,"confidence_rate":1},{"cnt":[[283,557],[1761,557],[1761,605],[283,605]],"region":{"top_left_x":283,"top_left_y":557,"width":1479,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"edbbfef5d851433496ed8df9ecc54a27","type":"text","conversion_output":true,"text":"glucocorticosteroid (GCS) treatment to patients having asthma exacerbations or poor long-","text_display":" glucocorticosteroid (GCS) treatment to patients having asthma exacerbations or poor long","confidence":0.99169921875,"confidence_rate":0.9999113292019236},{"cnt":[[283,603],[1750,603],[1750,651],[283,651]],"region":{"top_left_x":283,"top_left_y":603,"width":1467,"height":49},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5102608f23454025a1e34284df82d92a","type":"text","conversion_output":true,"text":"term asthma control. Strict discontinuation criteria are applied for an individual patient in","text_display":"term asthma control. Strict discontinuation criteria are applied for an individual patient in","confidence":1,"confidence_rate":1},{"cnt":[[283,651],[1149,651],[1149,697],[283,697]],"region":{"top_left_x":283,"top_left_y":651,"width":867,"height":46},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2a541bffcb4a49c5842edc2aeaebf197","type":"text","conversion_output":true,"text":"case of severe asthma exacerbations, see Section 3.9.","text_display":" case of severe asthma exacerbations, see Section 3.9.","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[283,740],[1377,740],[1377,788],[283,788]],"region":{"top_left_x":283,"top_left_y":740,"width":1095,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f69db6d465304e4fbbeacf64a0922f15","type":"text","conversion_output":true,"text":"To conclude, the overall benefit/risk ratio is considered acceptable.","text_display":"\n\nTo conclude, the overall benefit/risk 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See Appendix F for an overview of","text_display":" conducted in a sub-set of participating countries and sites. See Appendix F for an overview of","confidence":1,"confidence_rate":1},{"cnt":[[281,1775],[1802,1775],[1802,1823],[281,1823]],"region":{"top_left_x":280,"top_left_y":1774,"width":1523,"height":49},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a6350b710794f2f84b70b4b38ee0a71","type":"text","conversion_output":true,"text":"the qualitative sub-study. Countries and sites not participating in the sub-study will not enrol","text_display":" the qualitative sub-study. 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All patients will receive Bricanyl Turbuhaler for 'as needed'","confidence":0.9965834617614746,"confidence_rate":0.9999650782839314},{"cnt":[[283,1800],[752,1800],[752,1848],[283,1848]],"region":{"top_left_x":283,"top_left_y":1800,"width":469,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7140cd5b8d7d4f5bbc0f4c0210803933","type":"text","conversion_output":true,"text":"use during the run-in period.","text_display":" use during the run-in period.","confidence":1,"confidence_rate":1},{"cnt":[[283,1887],[1782,1887],[1782,1933],[283,1933]],"region":{"top_left_x":283,"top_left_y":1886,"width":1499,"height":47},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e87327b3164042839d1f13abfc2adc2b","type":"text","conversion_output":true,"text":"At Visit 2 instructions will be given to the patients on how to use the Turbuhaler (inhalation","text_display":"\n\nAt Visit 2 instructions will be given to the patients on how to use the Turbuhaler (inhalation","confidence":0.9883003234863281,"confidence_rate":0.9998846276727211},{"cnt":[[283,1933],[1748,1933],[1748,1981],[283,1981]],"region":{"top_left_x":283,"top_left_y":1932,"width":1465,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"75bfa0775fb94505be699d1e5cd8c0c5","type":"text","conversion_output":true,"text":"technique), theTUM, the eDiary and the PEF meter. Before taking the first dose of run-in","text_display":" technique), theTUM, the eDiary and the PEF meter. Before taking the first dose of run-in","confidence":1,"confidence_rate":1},{"cnt":[[283,1981],[1775,1981],[1775,2026],[283,2026]],"region":{"top_left_x":283,"top_left_y":1980,"width":1492,"height":47},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8314dbaba8f0467a8fbf9b7cfed2dbf7","type":"text","conversion_output":true,"text":"medication the patient will be instructed by the study personnel how to take the medication.","text_display":" medication the patient will be instructed by the study personnel how to take the medication.","confidence":1,"confidence_rate":1},{"cnt":[[283,2029],[1693,2029],[1693,2074],[283,2074]],"region":{"top_left_x":283,"top_left_y":2028,"width":1410,"height":47},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5a5bee37f7144071b27754a35af89bfd","type":"text","conversion_output":true,"text":"In order to inhale properly according to instructions the patient will practice inhalation","text_display":" In order to inhale properly according to instructions the patient will practice inhalation","confidence":1,"confidence_rate":1},{"cnt":[[283,2074],[1800,2074],[1800,2122],[283,2122]],"region":{"top_left_x":283,"top_left_y":2074,"width":1518,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7a6261c116c43deb8935362bfc65c02","type":"text","conversion_output":true,"text":"technique with a training device, as many times as judged necessary by the supervising study","text_display":" technique with a training device, as many times as judged necessary by the supervising study","confidence":1,"confidence_rate":1},{"cnt":[[283,2122],[1793,2122],[1793,2168],[283,2168]],"region":{"top_left_x":283,"top_left_y":2122,"width":1511,"height":46},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a534917a4b9b43c1b07d74a9f45d29e0","type":"text","conversion_output":true,"text":"personnel. Patients will complete ACQ and AQLQ questionnaires. Patients will be asked to","text_display":" personnel. Patients will complete ACQ and AQLQ questionnaires. Patients will be asked to","confidence":1,"confidence_rate":1},{"cnt":[[283,2170],[1615,2170],[1615,2216],[283,2216]],"region":{"top_left_x":283,"top_left_y":2170,"width":1333,"height":46},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8fd3052a77164c7d813af3f19be31e41","type":"text","conversion_output":true,"text":"fill in the eDiary twice daily during the run-in period. PEF (morning and evening","text_display":" fill in the eDiary twice daily during the run-in period. PEF (morning and evening","confidence":1,"confidence_rate":1},{"cnt":[[283,2216],[1802,2216],[1802,2264],[283,2264]],"region":{"top_left_x":283,"top_left_y":2215,"width":1520,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61dc7b1c50f14014afe9fe671e29bc02","type":"text","conversion_output":true,"text":"measurements), asthma symptoms and nighttime awakenings due to asthma will be recorded.","text_display":" measurements), asthma symptoms and nighttime awakenings due to asthma will be recorded.","confidence":1,"confidence_rate":1},{"cnt":[[283,2264],[1812,2264],[1812,2310],[283,2310]],"region":{"top_left_x":283,"top_left_y":2263,"width":1529,"height":47},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ea5046ae72f14c1f9b70d655c907727e","type":"text","conversion_output":true,"text":"To verify eligibility, lung function measurement including reversibility test will be performed","text_display":" To verify eligibility, lung function measurement including reversibility test will be performed","confidence":1,"confidence_rate":1},{"cnt":[[283,2312],[523,2312],[523,2360],[283,2360]],"region":{"top_left_x":283,"top_left_y":2311,"width":241,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69f1f7e98e5643ef843a261f50485086","type":"text","conversion_output":true,"text":"by spirometry.","text_display":" by spirometry.","confidence":1,"confidence_rate":1},{"cnt":[[283,2399],[1757,2399],[1757,2447],[283,2447]],"region":{"top_left_x":283,"top_left_y":2398,"width":1474,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fcb6af29d30545588a9f4d663607e5ec","type":"text","conversion_output":true,"text":"Height will be measured in cm (without shoes) and weight in kg (light clothes and without","text_display":"\n\nHeight will be measured in cm (without shoes) and weight in kg (light clothes and without","confidence":0.957560290931724,"confidence_rate":0.999590964876938},{"cnt":[[283,2444],[404,2444],[404,2492],[283,2492]],"region":{"top_left_x":283,"top_left_y":2444,"width":122,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1607f11824734faf95c44e1a9ba17a17","type":"text","conversion_output":true,"text":"shoes).","text_display":" shoes).","confidence":1,"confidence_rate":1},{"cnt":[[996,2632],[1112,2632],[1112,2680],[996,2680]],"region":{"top_left_x":995,"top_left_y":2631,"width":118,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d29901b69b9d40fdaf1d7de6746b3a91","type":"page_info","conversion_output":false,"text":"31(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-32","page":32,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f12662964101469082d8afe8098b0d05","type":"text","conversion_output":true,"text":"Revised Clinical Study Protocol","text_display":"\n\nRevised Clinical Study Protocol","confidence":1,"confidence_rate":1},{"cnt":[[283,279],[715,279],[715,313],[283,313]],"region":{"top_left_x":283,"top_left_y":278,"width":433,"height":35},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9246f483f953425687def7c77aaea8ae","type":"text","conversion_output":true,"text":"Drug Substance budesonide/formoterol","text_display":"\nDrug Substance budesonide/formoterol","confidence":1,"confidence_rate":1},{"cnt":[[283,311],[583,311],[583,343],[283,343]],"region":{"top_left_x":283,"top_left_y":310,"width":300,"height":33},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7a7692e69d5a45a7ac7c66fabdd39ebf","type":"text","conversion_output":true,"text":"Study Code D589SC00001","text_display":"\nStudy Code D589SC00001","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,368],[283,368]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":26},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3a6e0289104044c59850f263216220ef","type":"text","conversion_output":true,"text":"Edition Number 4","text_display":"\nEdition Number 4","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"969b3d01c91a4c7499a55dffb8dfb701","type":"text","conversion_output":true,"text":"Date 22 December 2016","text_display":"\nDate 22 December 2016","confidence":1,"confidence_rate":1},{"cnt":[[283,416],[1734,416],[1734,464],[283,464]],"region":{"top_left_x":283,"top_left_y":415,"width":1451,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6659ae055ffd42b6bee19cb712e03236","type":"text","conversion_output":true,"text":"Pregnancy test by urine dipstick should be performed for female patients aged \\(\\leq 60\\) years.","text_display":"\nPregnancy test by urine dipstick should be performed for female patients aged \\(\\leq 60\\) years.","confidence":1,"confidence_rate":1},{"cnt":[[283,503],[1574,503],[1574,551],[283,551]],"region":{"top_left_x":283,"top_left_y":502,"width":1291,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae378b73309143df83e0bb2cb6450078","type":"text","conversion_output":true,"text":"For the evaluation of smoking history, pack years will be calculated as follows:","text_display":"\nFor the evaluation of smoking history, pack years will be calculated as follows:","confidence":1,"confidence_rate":1},{"cnt":[[279,580],[1830,580],[1830,891],[279,891]],"region":{"top_left_x":278,"top_left_y":580,"width":1552,"height":311},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a8781facf7042d5b7ad0eda1e5bc490","type":"table","conversion_output":true,"children_ids":["195ad35ebcf04f3f82bf496f936ada6d","8d9b8d393dcd450a83370ca7eb73ec1d","8b23deae1dd24556aaee029d52758a59","7de59d07a9384dfcb5a4402994c2cc65","f6ceec85407f44a394b5b7d025c234ef"],"text":"\\begin{tabular}{|l|l|}\n\\hline \\begin{tabular}{l}\n10 pack years = \\\\\n1 pack (20 cigarettes) per day for 10 years or 2 pack ( 40 cigarettes) per day for 5 years or \\(\\frac{1}{2}\\) pack ( 10 cigarettes) per day for 20 years\n\\end{tabular} & \\begin{tabular}{l}\n1 cigar \\(=5\\) cigarettes \\\\\n1 cigarillo = 2 cigarettes \\\\\n50 g pipe tobacco \\(=65\\) cigarettes \\\\\nHand rolled cigarettes can be calculated as cigarettes or pipe tobacco\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline \\begin{tabular}{l}\n10 pack years = \\\\\n1 pack (20 cigarettes) per day for 10 years or 2 pack ( 40 cigarettes) per day for 5 years or \\(\\frac{1}{2}\\) pack ( 10 cigarettes) per day for 20 years\n\\end{tabular} & \\begin{tabular}{l}\n1 cigar \\(=5\\) cigarettes \\\\\n1 cigarillo = 2 cigarettes \\\\\n50 g pipe tobacco \\(=65\\) cigarettes \\\\\nHand rolled cigarettes can be calculated as cigarettes or pipe tobacco\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.955078125,"confidence_rate":0.9997166043789341},{"cnt":[[287,580],[983,580],[983,889],[287,889]],"region":{"top_left_x":287,"top_left_y":580,"width":696,"height":309},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"195ad35ebcf04f3f82bf496f936ada6d","type":"table_column","conversion_output":false,"parent_id":"7a8781facf7042d5b7ad0eda1e5bc490","text":"","text_display":""},{"cnt":[[1056,580],[1708,580],[1708,889],[1056,889]],"region":{"top_left_x":1056,"top_left_y":580,"width":652,"height":309},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d9b8d393dcd450a83370ca7eb73ec1d","type":"table_column","conversion_output":false,"parent_id":"7a8781facf7042d5b7ad0eda1e5bc490","text":"","text_display":""},{"cnt":[[278,582],[1830,582],[1830,886],[278,886]],"region":{"top_left_x":278,"top_left_y":582,"width":1552,"height":305},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8b23deae1dd24556aaee029d52758a59","type":"table_row","conversion_output":false,"parent_id":"7a8781facf7042d5b7ad0eda1e5bc490","text":"","text_display":""},{"cnt":[[290,598],[980,598],[980,836],[290,836]],"region":{"top_left_x":289,"top_left_y":598,"width":692,"height":238},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7de59d07a9384dfcb5a4402994c2cc65","type":"complex_cell","conversion_output":false,"parent_id":"7a8781facf7042d5b7ad0eda1e5bc490","children_ids":["6c8af7f3f4ae4aa4b571dd0646f60588","5e8377a7da9342c19a217585bdba6d56","395ababc3c6b45c5bbba5480074c90b1","0b53aa3214a042899d8635602dcb719d"],"text":"\\begin{tabular}{l}\n10 pack years = \\\\\n1 pack (20 cigarettes) per day for 10 years or 2 pack ( 40 cigarettes) per day for 5 years or \\(\\frac{1}{2}\\) pack ( 10 cigarettes) per day for 20 years\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n10 pack years = \\\\\n1 pack (20 cigarettes) per day for 10 years or 2 pack ( 40 cigarettes) per day for 5 years or \\(\\frac{1}{2}\\) pack ( 10 cigarettes) per day for 20 years\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9873046875,"confidence_rate":0.9997466815773396},{"cnt":[[292,601],[538,601],[538,644],[292,644]],"region":{"top_left_x":291,"top_left_y":600,"width":248,"height":45},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6c8af7f3f4ae4aa4b571dd0646f60588","type":"text","conversion_output":false,"parent_id":"7de59d07a9384dfcb5a4402994c2cc65","text":"10 pack years =","text_display":"10 pack years =","confidence":0.9873046875,"confidence_rate":0.9993277741199152},{"cnt":[[292,663],[930,663],[930,711],[292,711]],"region":{"top_left_x":291,"top_left_y":662,"width":639,"height":50},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e8377a7da9342c19a217585bdba6d56","type":"text","conversion_output":false,"parent_id":"7de59d07a9384dfcb5a4402994c2cc65","text":"1 pack (20 cigarettes) per day for 10 years","text_display":"\n1 pack (20 cigarettes) per day for 10 years","confidence":0.9951171875,"confidence_rate":0.9999021093440684},{"cnt":[[292,723],[950,723],[950,771],[292,771]],"region":{"top_left_x":291,"top_left_y":722,"width":660,"height":50},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"395ababc3c6b45c5bbba5480074c90b1","type":"text","conversion_output":false,"parent_id":"7de59d07a9384dfcb5a4402994c2cc65","text":"or 2 pack ( 40 cigarettes) per day for 5 years","text_display":" or 2 pack ( 40 cigarettes) per day for 5 years","confidence":0.99072265625,"confidence_rate":0.999844667959711},{"cnt":[[292,787],[980,787],[980,833],[292,833]],"region":{"top_left_x":291,"top_left_y":787,"width":690,"height":47},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b53aa3214a042899d8635602dcb719d","type":"text","conversion_output":false,"parent_id":"7de59d07a9384dfcb5a4402994c2cc65","text":"or \\(\\frac{1}{2}\\) pack ( 10 cigarettes) per day for 20 years","text_display":" or \\(\\frac{1}{2}\\) pack ( 10 cigarettes) per day for 20 years","confidence":0.994140625,"confidence_rate":0.9999122932719975},{"cnt":[[1056,594],[1708,594],[1708,882],[1056,882]],"region":{"top_left_x":1056,"top_left_y":593,"width":652,"height":289},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6ceec85407f44a394b5b7d025c234ef","type":"complex_cell","conversion_output":false,"parent_id":"7a8781facf7042d5b7ad0eda1e5bc490","children_ids":["625db49b1df44d2ca3d44cc0ff1685cb","cb41543440eb4ce294c115b426f88f16","dabd263f2c204faf9e5845b2ea6eddca","d3a46159053044c8b54661b4e8a15483","0c1b16fe948e4422a086e1160ab31cfb"],"text":"\\begin{tabular}{l}\n1 cigar \\(=5\\) cigarettes \\\\\n1 cigarillo = 2 cigarettes \\\\\n50 g pipe tobacco \\(=65\\) cigarettes \\\\\nHand rolled cigarettes can be calculated as cigarettes or pipe tobacco\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n1 cigar \\(=5\\) cigarettes \\\\\n1 cigarillo = 2 cigarettes \\\\\n50 g pipe tobacco \\(=65\\) cigarettes \\\\\nHand rolled cigarettes can be calculated as cigarettes or pipe tobacco\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.955078125,"confidence_rate":0.9996865280853956},{"cnt":[[1063,601],[1381,601],[1381,644],[1063,644]],"region":{"top_left_x":1063,"top_left_y":600,"width":318,"height":45},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"625db49b1df44d2ca3d44cc0ff1685cb","type":"text","conversion_output":false,"parent_id":"f6ceec85407f44a394b5b7d025c234ef","text":"1 cigar \\(=5\\) cigarettes","text_display":"1 cigar \\(=5\\) cigarettes","confidence":0.9951171875,"confidence_rate":0.9998252019797855},{"cnt":[[1065,663],[1432,663],[1432,707],[1065,707]],"region":{"top_left_x":1065,"top_left_y":662,"width":367,"height":45},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb41543440eb4ce294c115b426f88f16","type":"text","conversion_output":false,"parent_id":"f6ceec85407f44a394b5b7d025c234ef","text":"1 cigarillo = 2 cigarettes","text_display":"\n1 cigarillo = 2 cigarettes","confidence":0.955078125,"confidence_rate":0.9986081774978031},{"cnt":[[1061,727],[1560,727],[1560,771],[1061,771]],"region":{"top_left_x":1060,"top_left_y":727,"width":501,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dabd263f2c204faf9e5845b2ea6eddca","type":"text","conversion_output":false,"parent_id":"f6ceec85407f44a394b5b7d025c234ef","text":"50 g pipe tobacco \\(=65\\) cigarettes","text_display":"\n50 g pipe tobacco \\(=65\\) cigarettes","confidence":1,"confidence_rate":1},{"cnt":[[1061,787],[1703,787],[1703,831],[1061,831]],"region":{"top_left_x":1060,"top_left_y":787,"width":644,"height":44},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3a46159053044c8b54661b4e8a15483","type":"text","conversion_output":false,"parent_id":"f6ceec85407f44a394b5b7d025c234ef","text":"Hand rolled cigarettes can be calculated as","text_display":"\nHand rolled cigarettes can be calculated as","confidence":1,"confidence_rate":1},{"cnt":[[1061,833],[1450,833],[1450,877],[1061,877]],"region":{"top_left_x":1060,"top_left_y":833,"width":390,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c1b16fe948e4422a086e1160ab31cfb","type":"text","conversion_output":false,"parent_id":"f6ceec85407f44a394b5b7d025c234ef","text":"cigarettes or pipe tobacco","text_display":" cigarettes or pipe 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The patients will be instructed to contact their investigators. The","text_display":" exclusion criterion 16. The patients will be instructed to contact their investigators. 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at least 3 days of systemic glucocorticosteroids","confidence":1,"confidence_rate":1},{"cnt":[[283,1499],[1405,1499],[1405,1556],[283,1556]],"region":{"top_left_x":283,"top_left_y":1498,"width":1122,"height":58},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"73253bb7e2a94689aaef9b4377b51ba5","type":"text","conversion_output":true,"text":"\\({ }^{2}\\) Emergency room visit or other urgent unscheduled health care visit","text_display":"\n\\({ }^{2}\\) Emergency room visit or other urgent unscheduled health care visit","confidence":1,"confidence_rate":1},{"cnt":[[283,1645],[921,1645],[921,1688],[283,1688]],"region":{"top_left_x":283,"top_left_y":1644,"width":638,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cade070dfe224afdbd7de86f2236212c","type":"text","conversion_output":true,"text":"A moderate exacerbation is defined as:","text_display":"\n\nA moderate exacerbation is defined 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of","text_display":" treatment (inhaled budesonide \\(200 \\mu g\\) twice daily), to avoid progression of the worsening of","confidence":1,"confidence_rate":1},{"cnt":[[283,1786],[816,1786],[816,1830],[283,1830]],"region":{"top_left_x":283,"top_left_y":1786,"width":533,"height":44},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae699204566c4fd89738f25d8921a8ad","type":"text","conversion_output":true,"text":"asthma to a severe exacerbation.","text_display":" asthma to a severe exacerbation.","confidence":1,"confidence_rate":1},{"cnt":[[283,1873],[1764,1873],[1764,1917],[283,1917]],"region":{"top_left_x":283,"top_left_y":1873,"width":1481,"height":44},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8da650ffe60b480bab24aab775dc7572","type":"text","conversion_output":true,"text":"The start and end date of each asthma exacerbation will be recorded in the eCRF at the site","text_display":"\n\nThe start and end date of each asthma exacerbation will be recorded in the eCRF at the site","confidence":1,"confidence_rate":1},{"cnt":[[283,1921],[1759,1921],[1759,1967],[283,1967]],"region":{"top_left_x":283,"top_left_y":1921,"width":1476,"height":46},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7777629d8ada46859f05d818e219a8d8","type":"text","conversion_output":true,"text":"visits. For severe exacerbations the start date is defined as the first day of hospitalisation/-","text_display":" visits. For severe exacerbations the start date is defined as the first day of hospitalisation/","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[283,1969],[1793,1969],[1793,2015],[283,2015]],"region":{"top_left_x":283,"top_left_y":1969,"width":1511,"height":46},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35c2fb6c058a451294ba1915b0f707b7","type":"text","conversion_output":true,"text":"emergency room treatment or the first day of systemic (i.e. not inhaled) GCS treatment. The","text_display":"emergency room treatment or the first day of systemic (i.e. not inhaled) GCS treatment. 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If the same asthma exacerbation includes both","text_display":" of systemic GCS treatment. If the same asthma exacerbation includes both","confidence":1,"confidence_rate":1},{"cnt":[[283,2111],[1738,2111],[1738,2159],[283,2159]],"region":{"top_left_x":283,"top_left_y":2110,"width":1456,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7308f8b1c2844dc946cdcd37e7bc796","type":"text","conversion_output":true,"text":"hospitalisation/emergency room treatment and systemic GCS treatment, the start and end","text_display":" hospitalisation/emergency room treatment and systemic GCS treatment, the start and end","confidence":1,"confidence_rate":1},{"cnt":[[283,2156],[1636,2156],[1636,2204],[283,2204]],"region":{"top_left_x":283,"top_left_y":2156,"width":1353,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee73847eb868434eb1c98609769fd234","type":"text","conversion_output":true,"text":"dates are the first and last day that either of the criteria was fulfilled. For moderate","text_display":" dates are the first and last day that either of the criteria was fulfilled. For moderate","confidence":1,"confidence_rate":1},{"cnt":[[283,2202],[1780,2202],[1780,2250],[283,2250]],"region":{"top_left_x":283,"top_left_y":2202,"width":1497,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7882257771a74c2b886adde3f4f981eb","type":"text","conversion_output":true,"text":"exacerbations the start date is defined as the first day of additional prescribed ICS treatment","text_display":" exacerbations the start date is defined as the first day of additional prescribed ICS treatment","confidence":1,"confidence_rate":1},{"cnt":[[283,2252],[1738,2252],[1738,2300],[283,2300]],"region":{"top_left_x":283,"top_left_y":2252,"width":1456,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14b5d4772730444b8f33f2b3635cf7dd","type":"text","conversion_output":true,"text":"(inhaled budesonide \\(200 \\mu g\\) twice daily) and the end date is defined as the last day of this","text_display":" (inhaled budesonide \\(200 \\mu g\\) twice daily) and the end date is defined as the last day of this","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[283,2303],[452,2303],[452,2341],[283,2341]],"region":{"top_left_x":283,"top_left_y":2302,"width":170,"height":40},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"375f37e63dd84c90993c017fed9f6fd6","type":"text","conversion_output":true,"text":"treatment.","text_display":" treatment.","confidence":1,"confidence_rate":1},{"cnt":[[283,2387],[1679,2387],[1679,2433],[283,2433]],"region":{"top_left_x":283,"top_left_y":2387,"width":1397,"height":46},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"26eca109f00944abb4780dbfb88bd67b","type":"text","conversion_output":true,"text":"Additional hospitalisations/emergency room treatments and systemic GCS treatments","text_display":"\n\nAdditional hospitalisations/emergency room treatments and systemic GCS 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for at least 4 weeks, see Section 7.7.2","confidence":0.994140625,"confidence_rate":0.9999361258608116},{"cnt":[[283,1709],[1725,1709],[1725,1757],[283,1757]],"region":{"top_left_x":283,"top_left_y":1708,"width":1442,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b30d76590ab2473ca265762765ccdfd1","type":"text","conversion_output":true,"text":"After 2 and 4 weeks respectively of such an additional treatment, the investigator should","text_display":"\n\nAfter 2 and 4 weeks respectively of such an additional treatment, the investigator should","confidence":1,"confidence_rate":1},{"cnt":[[283,1759],[1825,1759],[1825,1807],[283,1807]],"region":{"top_left_x":283,"top_left_y":1758,"width":1543,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0da39f3ad16c40c2abee2e8b9ef1115d","type":"text","conversion_output":true,"text":"evaluate the patient and step down to the blinded maintenance treatment if 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After two","text_display":" evaluate the patient and step down to the blinded maintenance treatment if possible. After two","confidence":1,"confidence_rate":1},{"cnt":[[283,1805],[1784,1805],[1784,1853],[283,1853]],"region":{"top_left_x":283,"top_left_y":1804,"width":1502,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"47ff30b2a2694afcaa40ec5a1f2f78a2","type":"text","conversion_output":true,"text":"occasions of additional budesonide treatment either for a moderate exacerbation or for long-","text_display":" occasions of additional budesonide treatment either for a moderate exacerbation or for long","confidence":1,"confidence_rate":1},{"cnt":[[283,1853],[1814,1853],[1814,1898],[283,1898]],"region":{"top_left_x":283,"top_left_y":1852,"width":1531,"height":47},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a7e0d0a0caf4e42a2c278a24f4ab9d7","type":"text","conversion_output":true,"text":"term poorly controlled asthma, the investigator should consider continuing with the additional","text_display":"term poorly controlled asthma, the investigator should consider continuing with the additional","confidence":1,"confidence_rate":1},{"cnt":[[283,1901],[870,1901],[870,1946],[283,1946]],"region":{"top_left_x":283,"top_left_y":1900,"width":588,"height":47},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36438d371ab146dfb59b931e565a4814","type":"text","conversion_output":true,"text":"budesonide for the rest of the study.","text_display":" budesonide for the rest of the study.","confidence":1,"confidence_rate":1},{"cnt":[[279,1983],[1732,1983],[1732,2040],[279,2040]],"region":{"top_left_x":278,"top_left_y":1982,"width":1454,"height":58},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0df9b1e97924ed4a90f38fb4ebb089a","type":"section_header","conversion_output":false,"children_ids":["c51fa48d83314c048ba5699ab998ad6d"],"text":"","text_display":""},{"cnt":[[283,1987],[1727,1987],[1727,2035],[283,2035]],"region":{"top_left_x":283,"top_left_y":1987,"width":1444,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c51fa48d83314c048ba5699ab998ad6d","type":"text","conversion_output":true,"parent_id":"b0df9b1e97924ed4a90f38fb4ebb089a","text":"5.1.2 Lung function measurement by spirometry (FEV1, FVC) at the study site","text_display":"\n\n\\subsection*{5.1.2 Lung function measurement by spirometry (FEV1, FVC) at the study site}","confidence":1,"confidence_rate":1},{"cnt":[[283,2051],[715,2051],[715,2099],[283,2099]],"region":{"top_left_x":283,"top_left_y":2051,"width":433,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4417b59076d245059728b5ed4b05cfdb","type":"text","conversion_output":true,"text":"Equipment and conditions","text_display":"\n\nEquipment and conditions","confidence":1,"confidence_rate":1},{"cnt":[[283,2120],[1670,2120],[1670,2168],[283,2168]],"region":{"top_left_x":283,"top_left_y":2119,"width":1387,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66340255d29246f58c296703d0747f2b","type":"text","conversion_output":true,"text":"Spirometry will be performed by the Investigator or authorized delegate according to","text_display":"\nSpirometry will be performed by the Investigator or authorized delegate according to","confidence":1,"confidence_rate":1},{"cnt":[[283,2170],[1812,2170],[1812,2216],[283,2216]],"region":{"top_left_x":283,"top_left_y":2170,"width":1529,"height":46},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e69c614910e6413abbc1f0de0aba98ed","type":"text","conversion_output":true,"text":"American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines (Miller et al","text_display":" American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines (Miller et al","confidence":1,"confidence_rate":1},{"cnt":[[283,2216],[1686,2216],[1686,2264],[283,2264]],"region":{"top_left_x":283,"top_left_y":2215,"width":1403,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b946d773ec54485d982464f61ac48884","type":"text","conversion_output":true,"text":"2005). The study site personnel who will be performing the testing should be properly","text_display":" 2005). The study site personnel who will be performing the testing should be properly","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[283,2262],[578,2262],[578,2305],[283,2305]],"region":{"top_left_x":283,"top_left_y":2261,"width":295,"height":44},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a6450c6820a4ffb9e04f62edcaa3481","type":"text","conversion_output":true,"text":"certified / trained.","text_display":" certified / trained.","confidence":0.99365234375,"confidence_rate":0.9997453169059387},{"cnt":[[283,2351],[1588,2351],[1588,2396],[283,2396]],"region":{"top_left_x":283,"top_left_y":2350,"width":1305,"height":47},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c24c75f7eee843a4a5c88e899b7b9719","type":"text","conversion_output":true,"text":"The spirometer must meet ATS/ERS recommendations (Miller et al 2005). The","text_display":"\n\nThe spirometer must meet ATS/ERS recommendations (Miller et al 2005). The","confidence":1,"confidence_rate":1},{"cnt":[[283,2399],[1606,2399],[1606,2447],[283,2447]],"region":{"top_left_x":283,"top_left_y":2398,"width":1323,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22b690474b3b491fb7a2b5d9ff6ba62b","type":"text","conversion_output":true,"text":"monitor/vendor is responsible for checking that the spirometer in use meets these","text_display":" monitor/vendor is responsible for checking that the spirometer in use meets these","confidence":1,"confidence_rate":1},{"cnt":[[283,2444],[1711,2444],[1711,2492],[283,2492]],"region":{"top_left_x":283,"top_left_y":2444,"width":1428,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1fabde21020466aa63e14f272f22628","type":"text","conversion_output":true,"text":"recommendations. It should be serviced once a year or according to the manufacturer's","text_display":" recommendations. It should be serviced once a year or according to the manufacturer's","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[283,2492],[1766,2492],[1766,2538],[283,2538]],"region":{"top_left_x":283,"top_left_y":2492,"width":1483,"height":46},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"61331e8276fe4f5d90914e212df6dd19","type":"text","conversion_output":true,"text":"instruction at an authorised facility. All service measures and repairs must be documented.","text_display":" instruction at an authorised facility. All service measures and repairs must be documented.","confidence":1,"confidence_rate":1},{"cnt":[[996,2632],[1112,2632],[1112,2680],[996,2680]],"region":{"top_left_x":995,"top_left_y":2631,"width":118,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0672c256a4443e08896fc2e42466e6b","type":"page_info","conversion_output":false,"text":"34(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-35","page":35,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7e4d4e90cdd54f15acce28ce1e012b40","type":"page_info","conversion_output":false,"text":"Revised Clinical Study Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,279],[715,279],[715,313],[283,313]],"region":{"top_left_x":283,"top_left_y":278,"width":433,"height":35},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b8788974950e44cc8425e2ac6d550e91","type":"page_info","conversion_output":false,"text":"Drug Substance budesonide/formoterol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,311],[583,311],[583,343],[283,343]],"region":{"top_left_x":283,"top_left_y":310,"width":300,"height":33},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5f8a5608fb014082bb2dc5dbf1332471","type":"page_info","conversion_output":false,"text":"Study Code D589SC00001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,372],[283,372]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":31},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"028030e223fd4c91b3688a627382f287","type":"page_info","conversion_output":false,"text":"Edition Number 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f46a5f6e62694beeb5249d19e91d26bb","type":"page_info","conversion_output":false,"text":"Date 22 December 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,416],[1741,416],[1741,464],[283,464]],"region":{"top_left_x":283,"top_left_y":415,"width":1458,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"653ef43df89642678a31d28c5cd57be9","type":"text","conversion_output":true,"text":"Due to diurnal variation of lung function it is important that all spirometry assessments at","text_display":"\n\nDue to diurnal variation of lung function it is important that all spirometry assessments at","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[283,461],[1812,461],[1812,509],[283,509]],"region":{"top_left_x":283,"top_left_y":461,"width":1529,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08a2a5a564bf484fa511f178d7c0c650","type":"text","conversion_output":true,"text":"Visits \\(3,4,5,6,7\\) and 8 are performed \\(\\pm 1\\) hour in relation to the time of spirometry at Visit 2","text_display":" Visits \\(3,4,5,6,7\\) and 8 are performed \\(\\pm 1\\) hour in relation to the time of spirometry at Visit 2","confidence":0.4195019413430767,"confidence_rate":0.9918383272323071},{"cnt":[[283,507],[1101,507],[1101,555],[283,555]],"region":{"top_left_x":283,"top_left_y":507,"width":819,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b55f516eceb946cb974a316772e3f8b8","type":"text","conversion_output":true,"text":"and preferably after 7 am and no later than 11 am.","text_display":" and preferably after 7 am and no later than 11 am.","confidence":0.9985356330871582,"confidence_rate":0.9999759766796148},{"cnt":[[283,599],[1727,599],[1727,646],[283,646]],"region":{"top_left_x":283,"top_left_y":598,"width":1444,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"16c2de6a163e4f03a563ec8a6ceb3e73","type":"text","conversion_output":true,"text":"The spirometry should be conducted with the same spirometer within patients and for all","text_display":"\n\nThe spirometry should be conducted with the same spirometer within patients and for all","confidence":1,"confidence_rate":1},{"cnt":[[283,644],[1713,644],[1713,692],[283,692]],"region":{"top_left_x":283,"top_left_y":644,"width":1431,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e54cc673004e4888822de07bcf270257","type":"text","conversion_output":true,"text":"patients at each site. Preferably, the same study personnel should test the patient's lung","text_display":" patients at each site. Preferably, the same study personnel should test the patient's lung","confidence":1,"confidence_rate":1},{"cnt":[[283,690],[1770,690],[1770,738],[283,738]],"region":{"top_left_x":283,"top_left_y":689,"width":1488,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9cae2b4dd6e477e915d437b40eef2f8","type":"text","conversion_output":true,"text":"function throughout the study to reach optimal performance and to enhance reproducibility.","text_display":" function throughout the study to reach optimal performance and to enhance reproducibility.","confidence":1,"confidence_rate":1},{"cnt":[[283,740],[1830,740],[1830,788],[283,788]],"region":{"top_left_x":283,"top_left_y":740,"width":1547,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f1b7c664a313449685c1af2f874c0bc3","type":"text","conversion_output":true,"text":"The patient should rest at least 15 minutes prior to the test. For repeated measurements e.g., to","text_display":" The patient should rest at least 15 minutes prior to the test. For repeated measurements e.g., to","confidence":1,"confidence_rate":1},{"cnt":[[283,786],[1583,786],[1583,834],[283,834]],"region":{"top_left_x":283,"top_left_y":785,"width":1301,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89efcba913d241c88d77f9190a1c9d7d","type":"text","conversion_output":true,"text":"assess best of 3, a short pause ( 1 min.) between measurements is recommended.","text_display":" assess best of 3, a short pause ( 1 min.) between measurements is recommended.","confidence":0.6030796961858869,"confidence_rate":0.9941369536825616},{"cnt":[[283,873],[1786,873],[1786,923],[283,923]],"region":{"top_left_x":283,"top_left_y":872,"width":1504,"height":51},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0aca3cf3738470d9115998cf2f124a6","type":"text","conversion_output":true,"text":"The measurements are to be made with the patient seated in an upright position (preferably),","text_display":"\n\nThe measurements are to be made with the patient seated in an upright position (preferably),","confidence":1,"confidence_rate":1},{"cnt":[[283,923],[1789,923],[1789,971],[283,971]],"region":{"top_left_x":283,"top_left_y":922,"width":1506,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0478ab410e3f41ec897055ca9f191c9e","type":"text","conversion_output":true,"text":"or if not comfortable standing position is also acceptable. 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The accuracy of the calibration must","text_display":" Instead of using a 3 L syringe, a 1 L can be used 3 times. The accuracy of the calibration must","confidence":0.9990236759185791,"confidence_rate":0.9999913557807578},{"cnt":[[283,1521],[1823,1521],[1823,1569],[283,1569]],"region":{"top_left_x":283,"top_left_y":1521,"width":1540,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b9cc64143ac642d1906984ff2daf4705","type":"text","conversion_output":true,"text":"be within \\(\\pm 3 \\%\\) of the reading or \\(\\pm 0.05 L\\), whichever is greater. All calibration reports should","text_display":" be within \\(\\pm 3 \\%\\) of the reading or \\(\\pm 0.05 L\\), whichever is greater. All calibration reports should","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[283,1567],[1750,1567],[1750,1617],[283,1617]],"region":{"top_left_x":283,"top_left_y":1567,"width":1467,"height":51},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b812464906104e5b99b3b3078539c04b","type":"text","conversion_output":true,"text":"be signed, dated and filed in the ISF along with a signed and dated copy (if the calibration","text_display":" be signed, dated and filed in the ISF along with a signed and dated copy (if the calibration","confidence":1,"confidence_rate":1},{"cnt":[[283,1617],[1798,1617],[1798,1665],[283,1665]],"region":{"top_left_x":283,"top_left_y":1617,"width":1515,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0905b20d5854cf3be6bc231d765562b","type":"text","conversion_output":true,"text":"reports are not on archive-quality paper). If a calibration report cannot be printed, the results","text_display":" reports are not on archive-quality paper). If a calibration report cannot be printed, the results","confidence":1,"confidence_rate":1},{"cnt":[[283,1663],[1409,1663],[1409,1711],[283,1711]],"region":{"top_left_x":283,"top_left_y":1663,"width":1127,"height":48},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b7405c0f096433aadfbbfc6f83f4528","type":"text","conversion_output":true,"text":"should be documented in writing in the Investigator Study File (ISF).","text_display":" should be documented in writing in the Investigator Study File (ISF).","confidence":1,"confidence_rate":1},{"cnt":[[279,1750],[560,1750],[560,1805],[279,1805]],"region":{"top_left_x":278,"top_left_y":1749,"width":282,"height":56},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"311ba325890a4d368a489373b7f008b3","type":"section_header","conversion_output":false,"children_ids":["98bf6744250d47c783a1773be35a6180"],"text":"","text_display":""},{"cnt":[[283,1754],[555,1754],[555,1802],[283,1802]],"region":{"top_left_x":283,"top_left_y":1754,"width":273,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98bf6744250d47c783a1773be35a6180","type":"text","conversion_output":true,"parent_id":"311ba325890a4d368a489373b7f008b3","text":"FEV \\({ }_{1}\\) and FVC","text_display":"\n\n\\section*{FEV \\({ }_{1}\\) and FVC}","confidence":0.30870776337997086,"confidence_rate":0.9588916910258205},{"cnt":[[283,1818],[1674,1818],[1674,1866],[283,1866]],"region":{"top_left_x":283,"top_left_y":1818,"width":1392,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce85341502384eff937c22137f56d0e2","type":"text","conversion_output":true,"text":"The forced expiratory manoeuvre should start with a maximal inspiration and then be","text_display":"\n\nThe forced expiratory manoeuvre should start with a maximal inspiration and then be","confidence":1,"confidence_rate":1},{"cnt":[[283,1864],[1661,1864],[1661,1912],[283,1912]],"region":{"top_left_x":283,"top_left_y":1864,"width":1378,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"748c42709d684d1d9f2afdd32a849a83","type":"text","conversion_output":true,"text":"followed by a fast and forceful expiration that should last for at least 6 seconds. It is","text_display":" followed by a fast and forceful expiration that should last for at least 6 seconds. It is","confidence":1,"confidence_rate":1},{"cnt":[[283,1914],[1830,1914],[1830,1962],[283,1962]],"region":{"top_left_x":283,"top_left_y":1914,"width":1547,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d19e383f3cf4ad589a0971e0c96a81c","type":"text","conversion_output":true,"text":"important to encourage the patient to continue the expiration to be fast and forceful throughout","text_display":" important to encourage the patient to continue the expiration to be fast and forceful throughout","confidence":1,"confidence_rate":1},{"cnt":[[283,1960],[1738,1960],[1738,2008],[283,2008]],"region":{"top_left_x":283,"top_left_y":1959,"width":1456,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8691620dc464e53ad52b194dbe0b769","type":"text","conversion_output":true,"text":"the manoeuvre. Check that none of the following has occurred; coughing during the first","text_display":" the manoeuvre. Check that none of the following has occurred; coughing during the first","confidence":1,"confidence_rate":1},{"cnt":[[283,2006],[1485,2006],[1485,2054],[283,2054]],"region":{"top_left_x":283,"top_left_y":2005,"width":1202,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6183e7523087446b8a7cccea0bee69a0","type":"text","conversion_output":true,"text":"second, glottis closure, leak or obstruction of mouthpiece (by the tongue).","text_display":" second, glottis closure, leak or obstruction of mouthpiece (by the tongue).","confidence":1,"confidence_rate":1},{"cnt":[[283,2097],[1661,2097],[1661,2143],[283,2143]],"region":{"top_left_x":283,"top_left_y":2097,"width":1378,"height":46},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc734d72ec9646199999b38ecc4873ad","type":"text","conversion_output":true,"text":"At least 3 technically satisfactory forced vital capacity (FVC) manoeuvres should be","text_display":"\n\nAt least 3 technically satisfactory forced vital capacity (FVC) manoeuvres should be","confidence":1,"confidence_rate":1},{"cnt":[[283,2143],[1770,2143],[1770,2191],[283,2191]],"region":{"top_left_x":283,"top_left_y":2142,"width":1488,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b9a65cc51e64825a7681f65ae113242","type":"text","conversion_output":true,"text":"performed. The difference between highest and second highest FVC and \\(FEV _{1}\\), separately,","text_display":" performed. The difference between highest and second highest FVC and \\(FEV _{1}\\), separately,","confidence":0.8974354267120361,"confidence_rate":0.9989699203332281},{"cnt":[[283,2188],[1720,2188],[1720,2236],[283,2236]],"region":{"top_left_x":283,"top_left_y":2188,"width":1438,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0927a30d5794508b876fa6ba60a2d05","type":"text","conversion_output":true,"text":"should not be more than 150 mL . A maximum of 8 manoeuvres should be performed in","text_display":" should not be more than 150 mL . A maximum of 8 manoeuvres should be performed in","confidence":0.99365234375,"confidence_rate":0.9999322588021694},{"cnt":[[283,2239],[1816,2239],[1816,2287],[283,2287]],"region":{"top_left_x":283,"top_left_y":2238,"width":1534,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9500c5bb76e24509998af1d852a8e169","type":"text","conversion_output":true,"text":"attempting to meet reproducibility criteria. If the reproducibility criteria cannot be met within","text_display":" attempting to meet reproducibility criteria. If the reproducibility criteria cannot be met within","confidence":1,"confidence_rate":1},{"cnt":[[283,2284],[1793,2284],[1793,2332],[283,2332]],"region":{"top_left_x":283,"top_left_y":2284,"width":1511,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c7c18ee97ace403a9aee72a54ce9e7a6","type":"text","conversion_output":true,"text":"8 manoeuvres, the highest \\(FEV _{1}\\) value should be recorded, and a comment should be entered","text_display":" 8 manoeuvres, the highest \\(FEV _{1}\\) value should be recorded, and a comment should be entered","confidence":0.9892857074737549,"confidence_rate":0.9998974137969182},{"cnt":[[283,2330],[537,2330],[537,2378],[283,2378]],"region":{"top_left_x":283,"top_left_y":2330,"width":254,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7b23c2b06c74d4e99b6a9975d9ad946","type":"text","conversion_output":true,"text":"on the printout.","text_display":" on the printout.","confidence":1,"confidence_rate":1},{"cnt":[[996,2632],[1112,2632],[1112,2680],[996,2680]],"region":{"top_left_x":995,"top_left_y":2631,"width":118,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0187bdd0218a4f30a7ac3bfbfcf45e8c","type":"page_info","conversion_output":false,"text":"35(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-36","page":36,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b4e9bdcc2a8c482e9f8afa47c918c891","type":"page_info","conversion_output":false,"text":"Revised Clinical Study Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,279],[715,279],[715,313],[283,313]],"region":{"top_left_x":283,"top_left_y":278,"width":433,"height":35},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"be564ccceb74400a8a7966bd164f6e58","type":"page_info","conversion_output":false,"text":"Drug Substance budesonide/formoterol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,311],[583,311],[583,343],[283,343]],"region":{"top_left_x":283,"top_left_y":310,"width":300,"height":33},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"116b51518da441dcb4f3da61cb48102b","type":"page_info","conversion_output":false,"text":"Study Code D589SC00001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,370],[283,370]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":29},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7aa76aee004047c1b9f72ca81d173e6a","type":"page_info","conversion_output":false,"text":"Edition Number 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"24640fdb9d5d4a0782cbde96505be550","type":"page_info","conversion_output":false,"text":"Date 22 December 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,416],[1821,416],[1821,464],[283,464]],"region":{"top_left_x":283,"top_left_y":415,"width":1538,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f1b9e221aa34445a3f8507cba7ec9d3","type":"text","conversion_output":true,"text":"\\(FEV _{1}\\) values will be taken from the FVC curves. After examining the data from all acceptable","text_display":"\n\\(FEV _{1}\\) values will be taken from the FVC curves. After examining the data from all acceptable","confidence":0.9965834617614746,"confidence_rate":0.9999674063603947},{"cnt":[[283,461],[1775,461],[1775,509],[283,509]],"region":{"top_left_x":283,"top_left_y":461,"width":1492,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7288ed9667a34adca7199409a7d0e6b3","type":"text","conversion_output":true,"text":"curves, the highest FEV \\({ }_{1}\\) value and the highest FVC value should be recorded, even if the 2","text_display":" curves, the highest FEV \\({ }_{1}\\) value and the highest FVC value should be recorded, even if the 2","confidence":0.8140633067814633,"confidence_rate":0.9980427071099597},{"cnt":[[283,507],[953,507],[953,551],[283,551]],"region":{"top_left_x":283,"top_left_y":507,"width":670,"height":44},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0b5df64c263443caec124d7d0d48a4b","type":"text","conversion_output":true,"text":"values do not come from the same curve.","text_display":" values do not come from the same curve.","confidence":1,"confidence_rate":1},{"cnt":[[283,599],[1812,599],[1812,644],[283,644]],"region":{"top_left_x":283,"top_left_y":598,"width":1529,"height":47},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8fc9e7da6124d16821d10553b985fb2","type":"text","conversion_output":true,"text":"Signed and dated copies of the 3 best manoeuvres printouts must be kept in the ISF for source","text_display":"\n\nSigned and dated copies of the 3 best manoeuvres printouts must be kept in the ISF for source","confidence":1,"confidence_rate":1},{"cnt":[[283,644],[1766,644],[1766,692],[283,692]],"region":{"top_left_x":283,"top_left_y":644,"width":1483,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6de81ab89ff14b558b29e2e02634b79e","type":"text","conversion_output":true,"text":"data verification. The printouts must be marked with study code, enrolment code, date and","text_display":" data verification. The printouts must be marked with study code, enrolment code, date and","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[283,690],[1190,690],[1190,738],[283,738]],"region":{"top_left_x":283,"top_left_y":689,"width":908,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d558a136ba248f0a64b04e565474c23","type":"text","conversion_output":true,"text":"time of measurements, visit number and patient initials.","text_display":" time of measurements, visit number and patient initials.","confidence":1,"confidence_rate":1},{"cnt":[[279,774],[1677,774],[1677,879],[279,879]],"region":{"top_left_x":278,"top_left_y":774,"width":1399,"height":106},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07b74de92ce24abcb5744ca03ad4e0a7","type":"section_header","conversion_output":false,"children_ids":["02c9e893b8bb43aa9a78337f78619606","f93007c00017458e8dbbe1838a5819ee"],"text":"","text_display":""},{"cnt":[[283,781],[1672,781],[1672,827],[283,827]],"region":{"top_left_x":283,"top_left_y":781,"width":1390,"height":46},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02c9e893b8bb43aa9a78337f78619606","type":"text","conversion_output":true,"parent_id":"07b74de92ce24abcb5744ca03ad4e0a7","text":"5.1.2.1 Pre-bronchodilator and post-bronchodilator \\(FEV _{1}\\) and FVC including","text_display":"\n\n\\subsection*{5.1.2.1 Pre-bronchodilator and post-bronchodilator \\(FEV _{1}\\) and FVC including","confidence":0.5924855884176232,"confidence_rate":0.994618360715469},{"cnt":[[448,827],[1629,827],[1629,875],[448,875]],"region":{"top_left_x":447,"top_left_y":826,"width":1182,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f93007c00017458e8dbbe1838a5819ee","type":"text","conversion_output":true,"parent_id":"07b74de92ce24abcb5744ca03ad4e0a7","text":"reversibility testing and calculation of predicted normal values (PN)","text_display":" reversibility testing and calculation of predicted normal values (PN)}","confidence":0.99951171875,"confidence_rate":0.9999934000150488},{"cnt":[[283,891],[1738,891],[1738,939],[283,939]],"region":{"top_left_x":283,"top_left_y":890,"width":1456,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0305168b6c64c44a002bdd0c29763dc","type":"text","conversion_output":true,"text":"Pre-bronchodilator and post-bronchodilator \\(FEV _{1}\\) and FVC expressed in liters (L) will be","text_display":"\n\nPre-bronchodilator and post-bronchodilator \\(FEV _{1}\\) and FVC expressed in liters (L) will be","confidence":0.7761424770797021,"confidence_rate":0.9975893942719201},{"cnt":[[283,941],[715,941],[715,989],[283,989]],"region":{"top_left_x":283,"top_left_y":941,"width":433,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d1eb26cc9f9e4e649da86667d29cff72","type":"text","conversion_output":true,"text":"performed at Visits 2 to 8.","text_display":" performed at Visits 2 to 8.","confidence":0.9873046875,"confidence_rate":0.9996242886389913},{"cnt":[[283,1028],[1030,1028],[1030,1076],[283,1076]],"region":{"top_left_x":283,"top_left_y":1027,"width":748,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7458a417b0284287b513eea5e5ad6073","type":"text","conversion_output":true,"text":"The assessment will be performed as follows:","text_display":"\n\nThe assessment will be performed as follows:","confidence":1,"confidence_rate":1},{"cnt":[[286,1115],[1044,1115],[1044,1160],[286,1160]],"region":{"top_left_x":285,"top_left_y":1114,"width":759,"height":47},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aaf15b6773bf459db6919bd355727e3d","type":"text","conversion_output":true,"text":"1. Pre-bronchodilator \\(FEV _{1}\\) measurement","text_display":"\n1. Pre-bronchodilator \\(FEV _{1}\\) measurement","confidence":1,"confidence_rate":1},{"cnt":[[283,1202],[1144,1202],[1144,1250],[283,1250]],"region":{"top_left_x":283,"top_left_y":1201,"width":862,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77f25d92c39348df8f9cd4d5300d7d2b","type":"text","conversion_output":true,"text":"2. Inhalation of Bricanyl Turbuhaler \\(2 \\times 0.5 mg\\)","text_display":"\n2. Inhalation of Bricanyl Turbuhaler \\(2 \\times 0.5 mg\\)","confidence":0.99951171875,"confidence_rate":0.9999904235654993},{"cnt":[[283,1293],[772,1293],[772,1336],[283,1336]],"region":{"top_left_x":283,"top_left_y":1292,"width":490,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd5c06b1d0f448ffb1a029a8cbaa5a63","type":"text","conversion_output":true,"text":"3. Wait 15 to 30 minutes","text_display":"\n3. Wait 15 to 30 minutes","confidence":0.6842360496520996,"confidence_rate":0.9892170623678064},{"cnt":[[283,1380],[1067,1380],[1067,1423],[283,1423]],"region":{"top_left_x":283,"top_left_y":1379,"width":784,"height":45},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"32bb74e6ad68406aa0253015b1277ad4","type":"text","conversion_output":true,"text":"4. Post-bronchodilator \\(FEV _{1}\\) measurement.","text_display":"\n4. Post-bronchodilator \\(FEV _{1}\\) measurement.","confidence":1,"confidence_rate":1},{"cnt":[[283,1467],[1821,1467],[1821,1515],[283,1515]],"region":{"top_left_x":283,"top_left_y":1466,"width":1538,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af1295c261bc4c62977d5bfd4ed37fc7","type":"text","conversion_output":true,"text":"At Visit 2 these measurements are performed for inclusion verification and characterisation of","text_display":"\n\nAt Visit 2 these measurements are performed for inclusion verification and characterisation of","confidence":1,"confidence_rate":1},{"cnt":[[283,1512],[1816,1512],[1816,1560],[283,1560]],"region":{"top_left_x":283,"top_left_y":1512,"width":1534,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7f2e0a6217854f418636781d3f1dce96","type":"text","conversion_output":true,"text":"the patient population. Thus at this visit pre-bronchodilator and post-bronchodilator \\(FEV _{1}\\) PN","text_display":" the patient population. Thus at this visit pre-bronchodilator and post-bronchodilator \\(FEV _{1}\\) PN","confidence":0.6680154613349032,"confidence_rate":0.9963719670030053},{"cnt":[[283,1563],[1720,1563],[1720,1610],[283,1610]],"region":{"top_left_x":283,"top_left_y":1562,"width":1438,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fa043d2914b4e3aa1924b8cafa4c893","type":"text","conversion_output":true,"text":"will be calculated. \\(FEV _{1} PN\\) value will be based on the reference values from European","text_display":" will be calculated. \\(FEV _{1} PN\\) value will be based on the reference values from European","confidence":0.9970703125,"confidence_rate":0.9999720576529205},{"cnt":[[283,1608],[1780,1608],[1780,1656],[283,1656]],"region":{"top_left_x":283,"top_left_y":1608,"width":1497,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c6206b5149a421993f3edf45928120a","type":"text","conversion_output":true,"text":"Respiratory Society (ERS) guidelines for adult and adolescent patients (Quanjer et al 2012).","text_display":" Respiratory Society (ERS) guidelines for adult and adolescent patients (Quanjer et al 2012).","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[283,1695],[1642,1695],[1642,1743],[283,1743]],"region":{"top_left_x":283,"top_left_y":1695,"width":1360,"height":48},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aeea530746f94abe8d1a09a2d89640a5","type":"text","conversion_output":true,"text":"At Visits 3 to 8 the purpose of the assessment is to get pre-bronchodilator and post-","text_display":"\n\nAt Visits 3 to 8 the purpose of the assessment is to get pre-bronchodilator and post","confidence":1,"confidence_rate":1},{"cnt":[[283,1791],[283,1741],[1624,1743],[1624,1793]],"region":{"top_left_x":283,"top_left_y":1740,"width":1342,"height":54},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"56cdc1e37e8f4099a0d96e412acbbd74","type":"text","conversion_output":true,"text":"bronchodilator values of \\(FEV _{1}\\) and FVC as part of the evaluation of lung function.","text_display":"bronchodilator values of \\(FEV _{1}\\) and FVC as part of the evaluation of lung function.","confidence":0.7914199829101562,"confidence_rate":0.9976398954942536},{"cnt":[[279,1828],[756,1828],[756,1885],[279,1885]],"region":{"top_left_x":278,"top_left_y":1827,"width":479,"height":58},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bb2456ab1b54f74918bb1571257ed96","type":"section_header","conversion_output":false,"children_ids":["a143ebd6dff94e1b88a35e8a18d9675a"],"text":"","text_display":""},{"cnt":[[283,1832],[752,1832],[752,1880],[283,1880]],"region":{"top_left_x":283,"top_left_y":1832,"width":469,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a143ebd6dff94e1b88a35e8a18d9675a","type":"text","conversion_output":true,"parent_id":"5bb2456ab1b54f74918bb1571257ed96","text":"5.1.2.2 Reversibility test","text_display":"\n\n\\subsection*{5.1.2.2 Reversibility test}","confidence":0.99755859375,"confidence_rate":0.999921151775079},{"cnt":[[283,1896],[1816,1896],[1816,1944],[283,1944]],"region":{"top_left_x":283,"top_left_y":1896,"width":1534,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"100b68a9f2174ddd9abb296c44eb9200","type":"text","conversion_output":true,"text":"To fulfil the reversibility inclusion criterion at Visit 2 the increase in \\(FEV _{1}\\) relative to baseline","text_display":"\n\nTo fulfil the reversibility inclusion criterion at Visit 2 the increase in \\(FEV _{1}\\) relative to baseline","confidence":1,"confidence_rate":1},{"cnt":[[283,1946],[1793,1946],[1793,1994],[283,1994]],"region":{"top_left_x":283,"top_left_y":1946,"width":1511,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f25dcf8b764b445abcfc21a5674a0e84","type":"text","conversion_output":true,"text":"must be \\(\\geq 12 \\%\\) and \\(200 ml 15-30\\) minutes after inhalation of \\(2 \\times 0.5 mg\\) Bricanyl Turbuhaler.","text_display":" must be \\(\\geq 12 \\%\\) and \\(200 ml 15-30\\) minutes after inhalation of \\(2 \\times 0.5 mg\\) Bricanyl Turbuhaler.","confidence":0.9985356330871582,"confidence_rate":0.9999859093286404},{"cnt":[[283,2033],[957,2033],[957,2081],[283,2081]],"region":{"top_left_x":283,"top_left_y":2033,"width":675,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70d7d3acad3a4811823e8234598af216","type":"text","conversion_output":true,"text":"The reversibility is calculated as follows:","text_display":"\n\nThe reversibility is calculated as follows:","confidence":1,"confidence_rate":1},{"cnt":[[452,2115],[1195,2115],[1195,2227],[452,2227]],"region":{"top_left_x":452,"top_left_y":2115,"width":743,"height":113},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12062c2189524f5d9c5de50a01e639f2","type":"math","conversion_output":true,"text":"\\[\n\\text { Reversibility }=\\frac{F E V_{1(\\text { after })}-F E V_{1(\\text { before })}}{F E V_{1(\\text { before })}} X 100\n\\]","text_display":"\n\\[\n\\text { Reversibility }=\\frac{F E V_{1(\\text { after })}-F E V_{1(\\text { before })}}{F E V_{1(\\text { before })}} X 100\n\\]","confidence":0.7261546827641041,"confidence_rate":0.9968051920427077},{"cnt":[[283,2268],[1757,2268],[1757,2314],[283,2314]],"region":{"top_left_x":283,"top_left_y":2268,"width":1474,"height":47},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"982f1f715a1d429f977e78c177490d13","type":"text","conversion_output":true,"text":"The investigator should record the pre- and post-bronchodilator \\(FEV _{1}\\) in the eCRF and the","text_display":"\n\nThe investigator should record the pre- and post-bronchodilator \\(FEV _{1}\\) in the eCRF and the","confidence":0.9848833084106445,"confidence_rate":0.9998563111407742},{"cnt":[[283,2316],[991,2316],[991,2364],[283,2364]],"region":{"top_left_x":283,"top_left_y":2316,"width":709,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e4f6b3e133244fdc93034f1bff2bf91c","type":"text","conversion_output":true,"text":"calculation will be performed by the eCRF.","text_display":" calculation will be performed by the eCRF.","confidence":0.99658203125,"confidence_rate":0.9999271553479908},{"cnt":[[283,2403],[1688,2403],[1688,2451],[283,2451]],"region":{"top_left_x":283,"top_left_y":2403,"width":1406,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ccfe1d06d5d4597857e47212a330477","type":"text","conversion_output":true,"text":"If the reversibility inclusion criterion is not met at Visit 2, the reversibility test may be","text_display":"\n\nIf the reversibility inclusion criterion is not met at Visit 2, the reversibility test may be","confidence":0.85009765625,"confidence_rate":0.9983441882246038},{"cnt":[[283,2453],[1780,2453],[1780,2499],[283,2499]],"region":{"top_left_x":283,"top_left_y":2453,"width":1497,"height":47},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31857e9ec06846daae8e989e6e240958","type":"text","conversion_output":true,"text":"repeated at Visit 3. If patients on low dose ICS or LTRA in addition to inhaled short-acting","text_display":" repeated at Visit 3. If patients on low dose ICS or LTRA in addition to inhaled short-acting","confidence":0.9921875,"confidence_rate":0.9999191457692813},{"cnt":[[283,2499],[1780,2499],[1780,2547],[283,2547]],"region":{"top_left_x":283,"top_left_y":2499,"width":1497,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b127b10c5eb647e7a048fc7d8e565467","type":"text","conversion_output":true,"text":"bronchodilator(s)fail at both occasions, they can still be included if they have a documented","text_display":" bronchodilator(s)fail at both occasions, they can still be included if they have a documented","confidence":1,"confidence_rate":1},{"cnt":[[996,2632],[1112,2632],[1112,2680],[996,2680]],"region":{"top_left_x":995,"top_left_y":2631,"width":118,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07f5349fca554db0ada48a8d1eb9db78","type":"page_info","conversion_output":false,"text":"36(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-37","page":37,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"233e90057fc24500991d912c32daae15","type":"text","conversion_output":true,"text":"Revised Clinical Study Protocol","text_display":"\n\nRevised Clinical Study Protocol","confidence":1,"confidence_rate":1},{"cnt":[[283,279],[715,279],[715,313],[283,313]],"region":{"top_left_x":283,"top_left_y":278,"width":433,"height":35},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4b543e75f41040a7b200e5bfd69503ad","type":"text","conversion_output":true,"text":"Drug Substance budesonide/formoterol","text_display":"\nDrug Substance budesonide/formoterol","confidence":1,"confidence_rate":1},{"cnt":[[283,311],[583,311],[583,343],[283,343]],"region":{"top_left_x":283,"top_left_y":310,"width":300,"height":33},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"75ab8f5c9bf3426c9d93247b2894cb16","type":"text","conversion_output":true,"text":"Study Code D589SC00001","text_display":"\nStudy Code D589SC00001","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,370],[283,370]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":29},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d58adb37ec664d8084d61bcfafb8e1e5","type":"text","conversion_output":true,"text":"Edition Number 4","text_display":"\nEdition Number 4","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f1a815a291a84ebb89ea449184bdab2e","type":"text","conversion_output":true,"text":"Date 22 December 2016","text_display":"\nDate 22 December 2016","confidence":1,"confidence_rate":1},{"cnt":[[283,416],[1812,416],[1812,464],[283,464]],"region":{"top_left_x":283,"top_left_y":415,"width":1529,"height":49},"line":6,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9a8124bd1af24fca85f978ddee58e164","type":"text","conversion_output":true,"text":"historical reversibility within the last 12 months prior to Visit 3, see also inclusion criterion 6,","text_display":"\nhistorical reversibility within the last 12 months prior to Visit 3, see also inclusion criterion 6,","confidence":0.9990234375,"confidence_rate":0.9999909533775151},{"cnt":[[283,461],[482,461],[482,505],[283,505]],"region":{"top_left_x":283,"top_left_y":461,"width":200,"height":44},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1be90e1ca1de4c98b1fad0fdc89dcf5e","type":"text","conversion_output":true,"text":"Section 3.1.","text_display":" Section 3.1.","confidence":1,"confidence_rate":1},{"cnt":[[279,544],[1081,544],[1081,601],[279,601]],"region":{"top_left_x":278,"top_left_y":543,"width":803,"height":58},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c09d0362b4614e849aafe258a2c4dc56","type":"section_header","conversion_output":false,"children_ids":["4a3aa7fdf5074427912a7becafe479aa"],"text":"","text_display":""},{"cnt":[[283,548],[1074,548],[1074,596],[283,596]],"region":{"top_left_x":283,"top_left_y":548,"width":791,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4a3aa7fdf5074427912a7becafe479aa","type":"text","conversion_output":true,"parent_id":"c09d0362b4614e849aafe258a2c4dc56","text":"5.1.3 Recorded electronic diary variables","text_display":"\n\n\\subsection*{5.1.3 Recorded electronic diary variables}","confidence":1,"confidence_rate":1},{"cnt":[[283,617],[1752,617],[1752,665],[283,665]],"region":{"top_left_x":283,"top_left_y":616,"width":1470,"height":49},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a73271dff1e4413ab1586235d523b224","type":"text","conversion_output":true,"text":"Patients will complete an electronic diary (eDiary) and measure PEF with a handheld PEF","text_display":"\n\nPatients will complete an electronic diary (eDiary) and measure PEF with a handheld PEF","confidence":1,"confidence_rate":1},{"cnt":[[283,662],[1743,662],[1743,710],[283,710]],"region":{"top_left_x":283,"top_left_y":662,"width":1460,"height":49},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c6f86ce0dde34f4e86d532a1476239aa","type":"text","conversion_output":true,"text":"meter (Vitalograph ASMA-1) twice daily during the run-in and the treatment periods. At","text_display":" meter (Vitalograph ASMA-1) twice daily during the run-in and the treatment periods. At","confidence":1,"confidence_rate":1},{"cnt":[[283,708],[1805,708],[1805,761],[283,761]],"region":{"top_left_x":283,"top_left_y":708,"width":1522,"height":53},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0f31be4e2a704019ac7066546a841027","type":"text","conversion_output":true,"text":"Visit 2, all patients will be carefully instructed and trained in how to complete the eDiary and","text_display":" Visit 2, all patients will be carefully instructed and trained in how to complete the eDiary and","confidence":0.9970703125,"confidence_rate":0.9999709510413867},{"cnt":[[283,758],[1734,758],[1734,806],[283,806]],"region":{"top_left_x":283,"top_left_y":758,"width":1451,"height":49},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8796b3c74c5c45dfb870df0125c354e7","type":"text","conversion_output":true,"text":"how to handle the devices (eDiary, PEF meter and Turbuhaler Usage Monitor (TUM See","text_display":" how to handle the devices (eDiary, PEF meter and Turbuhaler Usage Monitor (TUM See","confidence":0.9882867336273193,"confidence_rate":0.9998645792033635},{"cnt":[[283,804],[1738,804],[1738,854],[283,854]],"region":{"top_left_x":283,"top_left_y":804,"width":1456,"height":51},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6908659cfe924d4f89eb31223044397d","type":"text","conversion_output":true,"text":"section 5.1.8). The patients must understand and be willing to complete the eDiary twice","text_display":" section 5.1.8). The patients must understand and be willing to complete the eDiary twice","confidence":0.99853515625,"confidence_rate":0.9999842375685026},{"cnt":[[283,852],[1720,852],[1720,902],[283,902]],"region":{"top_left_x":283,"top_left_y":852,"width":1438,"height":51},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"865b6255916e4bfb83d84cd6742e0534","type":"text","conversion_output":true,"text":"daily. Patients will also be instructed how and where to request help if problems should","text_display":" daily. Patients will also be instructed how and where to request help if problems should","confidence":1,"confidence_rate":1},{"cnt":[[283,905],[391,905],[391,943],[283,943]],"region":{"top_left_x":283,"top_left_y":904,"width":108,"height":40},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f8fe3df71b374f6db3d8fa0e50a5b7c6","type":"text","conversion_output":true,"text":"occur.","text_display":" occur.","confidence":1,"confidence_rate":1},{"cnt":[[283,987],[1798,987],[1798,1035],[283,1035]],"region":{"top_left_x":283,"top_left_y":986,"width":1515,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f63993ff9ae649ef8e25d104cbe5ec0e","type":"text","conversion_output":true,"text":"The patients will be informed that the recordings made electronically in the eDiary cannot be","text_display":"\n\nThe patients will be informed that the recordings made electronically in the eDiary cannot be","confidence":0.9716796875,"confidence_rate":0.9997068892057642},{"cnt":[[283,1035],[1798,1035],[1798,1085],[283,1085]],"region":{"top_left_x":283,"top_left_y":1034,"width":1515,"height":52},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1b36b378c7664806b94544d05c752bab","type":"text","conversion_output":true,"text":"retrospectively or prospectively entered. The recordings must be completed within a defined","text_display":" retrospectively or prospectively entered. The recordings must be completed within a defined","confidence":1,"confidence_rate":1},{"cnt":[[283,1083],[514,1083],[514,1126],[283,1126]],"region":{"top_left_x":283,"top_left_y":1082,"width":231,"height":45},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"548a3d210773488fab0237182b456db1","type":"text","conversion_output":true,"text":"time window.","text_display":" time window.","confidence":1,"confidence_rate":1},{"cnt":[[283,1170],[1816,1170],[1816,1218],[283,1218]],"region":{"top_left_x":283,"top_left_y":1169,"width":1534,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7dd1e0e3e800426e96b26c8bb2b143ef","type":"text","conversion_output":true,"text":"The eDiary will be completed twice each day from the evening of Visit 2 until the morning of","text_display":"\n\nThe eDiary will be completed twice each day from the evening of Visit 2 until the morning of","confidence":0.99658203125,"confidence_rate":0.9999657623526261},{"cnt":[[283,1215],[943,1215],[943,1263],[283,1263]],"region":{"top_left_x":283,"top_left_y":1215,"width":661,"height":49},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4493a377dab94b1ea0b1dd6ddd779fb8","type":"text","conversion_output":true,"text":"Visit 8. 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The following will be recorded:","confidence":0.99951171875,"confidence_rate":0.9999891467144949},{"cnt":[[283,1307],[1373,1307],[1373,1357],[283,1357]],"region":{"top_left_x":283,"top_left_y":1306,"width":1090,"height":51},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"eccfaa50f5854f21b35283dcf3483368","type":"text","conversion_output":true,"text":"- Morning and evening PEF (transferred from PEF meter)","text_display":"\n- Morning and evening PEF (transferred from PEF meter)","confidence":1,"confidence_rate":1},{"cnt":[[283,1398],[1090,1398],[1090,1446],[283,1446]],"region":{"top_left_x":283,"top_left_y":1398,"width":807,"height":49},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ddd1545d92d74347b000a79d0141a6e6","type":"text","conversion_output":true,"text":"- Asthma symptoms (entered by patient)","text_display":"\n- Asthma symptoms (entered by patient)","confidence":1,"confidence_rate":1},{"cnt":[[283,1485],[1592,1485],[1592,1537],[283,1537]],"region":{"top_left_x":283,"top_left_y":1484,"width":1310,"height":54},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"94a46d4bbfbc4e15b3ebea7ec3004b6b","type":"text","conversion_output":true,"text":"- Nights with awakenings due to asthma symptoms (entered by patient)","text_display":"\n- Nights with awakenings due to asthma symptoms (entered by patient)","confidence":0.9960978019516915,"confidence_rate":0.9999464420988274},{"cnt":[[283,1576],[1812,1576],[1812,1624],[283,1624]],"region":{"top_left_x":283,"top_left_y":1576,"width":1529,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0d8e2cc708654218a400c81319fb2e56","type":"text","conversion_output":true,"text":"- Use of 'as needed' and randomised maintenance treatment (transferred from TUM)","text_display":"\n- Use of 'as needed' and randomised maintenance treatment (transferred from TUM)","confidence":1,"confidence_rate":1},{"cnt":[[450,1622],[742,1622],[742,1668],[450,1668]],"region":{"top_left_x":450,"top_left_y":1621,"width":293,"height":47},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"85e79539e447410c9da53564657f9f6b","type":"text","conversion_output":true,"text":"See section 5.1.8.","text_display":" See section 5.1.8.","confidence":1,"confidence_rate":1},{"cnt":[[281,1709],[592,1709],[592,1757],[281,1757]],"region":{"top_left_x":280,"top_left_y":1708,"width":312,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1b9b322db2f04a429f30fd8adc062b5f","type":"text","conversion_output":true,"text":"PEF measurement","text_display":"\n\nPEF measurement","confidence":1,"confidence_rate":1},{"cnt":[[283,1777],[1764,1777],[1764,1830],[283,1830]],"region":{"top_left_x":283,"top_left_y":1777,"width":1481,"height":53},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f3c59add23f745f39d4741198afbbe0b","type":"text","conversion_output":true,"text":"Measurements of morning and evening PEF will be performed during the entire run-in and","text_display":"\nMeasurements of morning and evening PEF will be performed during the entire run-in and","confidence":1,"confidence_rate":1},{"cnt":[[283,1828],[875,1828],[875,1875],[283,1875]],"region":{"top_left_x":283,"top_left_y":1827,"width":592,"height":49},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ed922f2dd1974453a2f20e0fa9585285","type":"text","conversion_output":true,"text":"treatment period (Visit 2 to Visit 8).","text_display":" treatment period (Visit 2 to Visit 8).","confidence":1,"confidence_rate":1},{"cnt":[[283,1914],[1775,1914],[1775,1962],[283,1962]],"region":{"top_left_x":283,"top_left_y":1914,"width":1492,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ca41a6b0df014e1083bccab87e96fa67","type":"text","conversion_output":true,"text":"The patients will be requested to perform 3 manoeuvres twice daily (morning and evening),","text_display":"\n\nThe patients will be requested to perform 3 manoeuvres twice daily (morning and evening),","confidence":1,"confidence_rate":1},{"cnt":[[283,1960],[1684,1960],[1684,2008],[283,2008]],"region":{"top_left_x":283,"top_left_y":1959,"width":1401,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6c358a073e35467ebb4892831ddab693","type":"text","conversion_output":true,"text":"where the highest reading will be recorded. 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Decrease in morning PEF \\(>20 \\%\\) on at least two consecutive days, compared with","text_display":"\n1. Decrease in morning PEF \\(>20 \\%\\) on at least two consecutive days, compared with","confidence":0.9990234375,"confidence_rate":0.9999887697222805},{"cnt":[[402,1965],[925,1965],[925,2013],[402,2013]],"region":{"top_left_x":402,"top_left_y":1964,"width":524,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4fb16f4ee5ab48ae8a3e525bf8d1f3a1","type":"text","conversion_output":true,"text":"baseline (last 10 days of run-in)","text_display":" baseline (last 10 days of run-in)","confidence":1,"confidence_rate":1},{"cnt":[[343,2051],[1738,2051],[1738,2104],[343,2104]],"region":{"top_left_x":342,"top_left_y":2051,"width":1397,"height":53},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"99f89fb7d2dd42539bac88f32c6f2d6f","type":"text","conversion_output":true,"text":"2. Increase in total daily asthma symptom score of \\(\\geq 3\\) units (the sum of morning and","text_display":"\n2. Increase in total daily asthma symptom score of \\(\\geq 3\\) units (the sum of morning and","confidence":1,"confidence_rate":1},{"cnt":[[402,2097],[1672,2097],[1672,2150],[402,2150]],"region":{"top_left_x":402,"top_left_y":2097,"width":1271,"height":53},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42719d5a08da41c9ab770933fe772285","type":"text","conversion_output":true,"text":"evening score) compared with baseline (last 10 days of run-in) on at least two","text_display":" evening score) compared with baseline (last 10 days of run-in) on at least two","confidence":1,"confidence_rate":1},{"cnt":[[402,2147],[697,2147],[697,2195],[402,2195]],"region":{"top_left_x":402,"top_left_y":2147,"width":295,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04c607b40040443692682253427c80c4","type":"text","conversion_output":true,"text":"consecutive days.","text_display":" consecutive days.","confidence":1,"confidence_rate":1},{"cnt":[[283,2234],[1743,2234],[1743,2287],[283,2287]],"region":{"top_left_x":283,"top_left_y":2234,"width":1460,"height":53},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4438e69e48424cb786ca08ab87eeaf72","type":"text","conversion_output":true,"text":"The patient will be instructed to contact the investigator as soon as possible when an alert","text_display":"\n\nThe patient will be instructed to contact the investigator as soon as possible when an alert","confidence":1,"confidence_rate":1},{"cnt":[[283,2280],[1821,2280],[1821,2332],[283,2332]],"region":{"top_left_x":283,"top_left_y":2279,"width":1538,"height":54},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e705c5aa07e4336879ab97372a972c1","type":"text","conversion_output":true,"text":"appears in the eDiary. Investigator's judgement regarding the need for a patient visit has to be","text_display":" appears in the eDiary. Investigator's judgement regarding the need for a patient visit has to be","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[283,2330],[1766,2330],[1766,2378],[283,2378]],"region":{"top_left_x":283,"top_left_y":2330,"width":1483,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b468cf94b27746aa824fe9a13bea269d","type":"text","conversion_output":true,"text":"documented in the medical records. If judged necessary, the investigator will arrange for a","text_display":" documented in the medical records. If judged necessary, the investigator will arrange for a","confidence":1,"confidence_rate":1},{"cnt":[[283,2376],[1825,2376],[1825,2424],[283,2424]],"region":{"top_left_x":283,"top_left_y":2375,"width":1543,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e06b615188504dd69e88e86735c5bd96","type":"text","conversion_output":true,"text":"visit as soon as possible (if this coincides with the visit window for a scheduled study visit, the","text_display":" visit as soon as possible (if this coincides with the visit window for a scheduled study visit, the","confidence":1,"confidence_rate":1},{"cnt":[[283,2421],[1800,2421],[1800,2474],[283,2474]],"region":{"top_left_x":283,"top_left_y":2421,"width":1518,"height":53},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a637ffd9b7384fccaf8144df9f9f92be","type":"text","conversion_output":true,"text":"scheduled assessments may be performed). Additional asthma treatment could be prescribed","text_display":" scheduled assessments may be performed). Additional asthma treatment could be prescribed","confidence":1,"confidence_rate":1},{"cnt":[[283,2469],[1807,2469],[1807,2520],[283,2520]],"region":{"top_left_x":283,"top_left_y":2469,"width":1524,"height":51},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3bcbac908d1c4572956d8fa97d38539d","type":"text","conversion_output":true,"text":"by the investigator during such a visit after having the patient's status assessed (for additional","text_display":" by the investigator during such a visit after having the patient's status assessed (for additional","confidence":1,"confidence_rate":1},{"cnt":[[996,2632],[1112,2632],[1112,2680],[996,2680]],"region":{"top_left_x":995,"top_left_y":2631,"width":118,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d3f63203b26409a9e51d4629052cdee","type":"page_info","conversion_output":false,"text":"38(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-39","page":39,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a9ab2985dc1348d698071baa979e91e9","type":"page_info","conversion_output":false,"text":"Revised Clinical Study Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,279],[715,279],[715,313],[283,313]],"region":{"top_left_x":283,"top_left_y":278,"width":433,"height":35},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c62d94e989c643bcb19b3d12fe78089f","type":"page_info","conversion_output":false,"text":"Drug Substance budesonide/formoterol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,311],[583,311],[583,343],[283,343]],"region":{"top_left_x":283,"top_left_y":310,"width":300,"height":33},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2842b4ede41b4ecca3d88593ac14a67a","type":"page_info","conversion_output":false,"text":"Study Code D589SC00001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,370],[283,370]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":29},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"41f42c6552cb4869be83fc443d9a4c8e","type":"page_info","conversion_output":false,"text":"Edition Number 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4aff5269424a4ad79da57a30719199af","type":"page_info","conversion_output":false,"text":"Date 22 December 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,416],[1770,416],[1770,461],[283,461]],"region":{"top_left_x":283,"top_left_y":415,"width":1488,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c9f5bc840354271b854ff51c60df2a1","type":"text","conversion_output":true,"text":"treatments due to asthma exacerbations, see Section 5.1.1). Any action taken during such a","text_display":"\ntreatments due to asthma exacerbations, see Section 5.1.1). Any action taken during such a","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[283,461],[848,461],[848,505],[283,505]],"region":{"top_left_x":283,"top_left_y":461,"width":565,"height":44},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"973b82f4244c43629fa64db6def97276","type":"text","conversion_output":true,"text":"visit will be recorded in the eCRF.","text_display":" visit will be recorded in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[283,551],[1802,551],[1802,596],[283,596]],"region":{"top_left_x":283,"top_left_y":550,"width":1520,"height":47},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ecde71c81a347e79df256ce66fb23c7","type":"text","conversion_output":true,"text":"Even in the absence of eDiary triggers, patients experiencing worsening of asthma during the","text_display":"\n\nEven in the absence of eDiary triggers, patients experiencing worsening of asthma during the","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[283,599],[1734,599],[1734,644],[283,644]],"region":{"top_left_x":283,"top_left_y":598,"width":1451,"height":47},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6d5e7a8630eb44bc948b5c51bf273d95","type":"text","conversion_output":true,"text":"study should always be instructed to contact the investigator who should act according to","text_display":" study should always be instructed to contact the investigator who should act according to","confidence":1,"confidence_rate":1},{"cnt":[[283,644],[589,644],[589,692],[283,692]],"region":{"top_left_x":283,"top_left_y":644,"width":307,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c9b0f2ea10349dda09c08525c151be4","type":"text","conversion_output":true,"text":"medical judgment.","text_display":" medical judgment.","confidence":1,"confidence_rate":1},{"cnt":[[279,726],[1291,726],[1291,784],[279,784]],"region":{"top_left_x":278,"top_left_y":726,"width":1013,"height":58},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98bb474962064334bb9c8aac7e2958c0","type":"section_header","conversion_output":false,"children_ids":["d590fcfcd81048bc94ae29e11f767bda"],"text":"","text_display":""},{"cnt":[[283,731],[1286,731],[1286,779],[283,779]],"region":{"top_left_x":283,"top_left_y":730,"width":1004,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d590fcfcd81048bc94ae29e11f767bda","type":"text","conversion_output":true,"parent_id":"98bb474962064334bb9c8aac7e2958c0","text":"5.1.5 Asthma Control Questionnaire (5-item Version)","text_display":"\n\n\\subsection*{5.1.5 Asthma Control Questionnaire (5-item Version)}","confidence":1,"confidence_rate":1},{"cnt":[[283,800],[1821,800],[1821,848],[283,848]],"region":{"top_left_x":283,"top_left_y":799,"width":1538,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11129a8ceb454896a38683418a5e6c83","type":"text","conversion_output":true,"text":"The ACQ was developed by Juniper (Juniper et al 1999). The ACQ includes 7 items covering","text_display":"\n\nThe ACQ was developed by Juniper (Juniper et al 1999). The ACQ includes 7 items covering","confidence":1,"confidence_rate":1},{"cnt":[[283,845],[1814,845],[1814,893],[283,893]],"region":{"top_left_x":283,"top_left_y":845,"width":1531,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"479d6577896a43cdbdc24deaedef7369","type":"text","conversion_output":true,"text":"all the criteria (symptoms, \\(FEV _{1}\\), and SABA used as rescue medication) deemed necessary by","text_display":" all the criteria (symptoms, \\(FEV _{1}\\), and SABA used as rescue medication) deemed necessary by","confidence":0.9150390625,"confidence_rate":0.9992214565262123},{"cnt":[[283,891],[1743,891],[1743,939],[283,939]],"region":{"top_left_x":283,"top_left_y":890,"width":1460,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa190939a61b47968e455da42fc3d117","type":"text","conversion_output":true,"text":"international guidelines committees for determining the adequacy of asthma control. The","text_display":" international guidelines committees for determining the adequacy of asthma control. The","confidence":1,"confidence_rate":1},{"cnt":[[283,941],[1761,941],[1761,989],[283,989]],"region":{"top_left_x":283,"top_left_y":941,"width":1479,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"addc8a7e976a4ca699d6877864edbbad","type":"text","conversion_output":true,"text":"ACQ has undergone rigorous validation and has been shown to have strong evaluative and","text_display":" ACQ has undergone rigorous validation and has been shown to have strong evaluative and","confidence":0.9936552047729492,"confidence_rate":0.9999300572924009},{"cnt":[[283,987],[1716,987],[1716,1035],[283,1035]],"region":{"top_left_x":283,"top_left_y":986,"width":1433,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e41d4b418610464f92bf12e4adb64846","type":"text","conversion_output":true,"text":"discriminative measurement properties (Juniper et al 1999). In this study, the FEV \\({ }_{1}\\) and","text_display":" discriminative measurement properties (Juniper et al 1999). In this study, the FEV \\({ }_{1}\\) and","confidence":0.6904656020924449,"confidence_rate":0.9964104469980295},{"cnt":[[283,1035],[1766,1035],[1766,1083],[283,1083]],"region":{"top_left_x":283,"top_left_y":1034,"width":1483,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"048959f8f817459aa74a970a65832920","type":"text","conversion_output":true,"text":"SABA use questions will be excluded, and patients will be responding to the five symptom","text_display":" SABA use questions will be excluded, and patients will be responding to the five symptom","confidence":0.99755859375,"confidence_rate":0.9999737165675469},{"cnt":[[283,1083],[1780,1083],[1780,1131],[283,1131]],"region":{"top_left_x":283,"top_left_y":1082,"width":1497,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d60f2afdc42452f9e47d1832e1f144c","type":"text","conversion_output":true,"text":"questions (ACQ-5). It has been shown that exclusion of the questions for SABA use and/or","text_display":" questions (ACQ-5). It has been shown that exclusion of the questions for SABA use and/or","confidence":0.99658203125,"confidence_rate":0.9999631853728411},{"cnt":[[283,1128],[1716,1128],[1716,1176],[283,1176]],"region":{"top_left_x":283,"top_left_y":1128,"width":1433,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2576e6a5f594c23a93ea6d8bdb38943","type":"text","conversion_output":true,"text":"the \\(FEV _{1}\\) does not alter the validity and the measurement properties of the questionnaire","text_display":" the \\(FEV _{1}\\) does not alter the validity and the measurement properties of the questionnaire","confidence":0.99560546875,"confidence_rate":0.9999584516595247},{"cnt":[[283,1176],[1672,1176],[1672,1222],[283,1222]],"region":{"top_left_x":283,"top_left_y":1176,"width":1390,"height":47},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"adeb4328d19e4837b5d093f9bc981ee4","type":"text","conversion_output":true,"text":"(Juniper et al 2001). Linguistically validated translations of the ACQ-5 into the local","text_display":" (Juniper et al 2001). Linguistically validated translations of the ACQ-5 into the local","confidence":1,"confidence_rate":1},{"cnt":[[283,1224],[1654,1224],[1654,1272],[283,1272]],"region":{"top_left_x":283,"top_left_y":1224,"width":1371,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"034f89451f3748c082821c6955d65bda","type":"text","conversion_output":true,"text":"languages will be used. The original North American English version is included in","text_display":" languages will be used. The original North American English version is included in","confidence":1,"confidence_rate":1},{"cnt":[[283,1270],[496,1270],[496,1318],[283,1318]],"region":{"top_left_x":283,"top_left_y":1270,"width":213,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2f114bd0022e48daa1e6d0118680a1c1","type":"text","conversion_output":true,"text":"Appendix C.","text_display":" Appendix C.","confidence":1,"confidence_rate":1},{"cnt":[[283,1359],[1711,1359],[1711,1405],[283,1405]],"region":{"top_left_x":283,"top_left_y":1359,"width":1428,"height":46},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"86bc41ecf63e46ce8dd2f90ff02008c8","type":"text","conversion_output":true,"text":"The ACQ will be self-administered at clinical visits within the eDiary at the time points","text_display":"\n\nThe ACQ will be self-administered at clinical visits within the eDiary at the time points","confidence":0.99951171875,"confidence_rate":0.9999948042635181},{"cnt":[[283,1453],[283,1403],[1640,1405],[1640,1455]],"region":{"top_left_x":283,"top_left_y":1402,"width":1358,"height":54},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"df5351144a33429fa7609ec88b1d67d7","type":"text","conversion_output":true,"text":"indicated in Table 1. The questions take approximately 2 to 3 minutes to complete.","text_display":" indicated in Table 1. The questions take approximately 2 to 3 minutes to complete.","confidence":1,"confidence_rate":1},{"cnt":[[279,1489],[1528,1489],[1528,1547],[279,1547]],"region":{"top_left_x":278,"top_left_y":1489,"width":1251,"height":58},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f93746543ebd4b12b06f8448b2f14665","type":"section_header","conversion_output":false,"children_ids":["ad665617c6f24241aaee6f328602201f"],"text":"","text_display":""},{"cnt":[[283,1494],[1524,1494],[1524,1542],[283,1542]],"region":{"top_left_x":283,"top_left_y":1493,"width":1241,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad665617c6f24241aaee6f328602201f","type":"text","conversion_output":true,"parent_id":"f93746543ebd4b12b06f8448b2f14665","text":"5.1.6 Asthma Quality of Life Questionnaire (Standardised Version)","text_display":"\n\n\\subsection*{5.1.6 Asthma Quality of Life Questionnaire (Standardised Version)}","confidence":1,"confidence_rate":1},{"cnt":[[283,1560],[1780,1560],[1780,1610],[283,1610]],"region":{"top_left_x":283,"top_left_y":1560,"width":1497,"height":51},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7edff0040f2454ab01adbfaf65a1a35","type":"text","conversion_output":true,"text":"The AQLQ has been developed by Juniper (Juniper et al 1992) and includes 32 questions in","text_display":"\n\nThe AQLQ has been developed by Juniper (Juniper et al 1992) and includes 32 questions in","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[283,1608],[1793,1608],[1793,1656],[283,1656]],"region":{"top_left_x":283,"top_left_y":1608,"width":1511,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d0b022044654913a64699b6a37a2a97","type":"text","conversion_output":true,"text":"4 domains: activity limitation, symptoms, emotional function and exposure to environmental","text_display":" 4 domains: activity limitation, symptoms, emotional function and exposure to environmental","confidence":1,"confidence_rate":1},{"cnt":[[283,1656],[1665,1656],[1665,1702],[283,1702]],"region":{"top_left_x":283,"top_left_y":1656,"width":1383,"height":46},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c4f354dca7147e09a27b86d3b1e3239","type":"text","conversion_output":true,"text":"stimuli. A feature of the AQLQ is that patients themselves select 5 of the 11 activity","text_display":" stimuli. A feature of the AQLQ is that patients themselves select 5 of the 11 activity","confidence":0.984375,"confidence_rate":0.9998376589831813},{"cnt":[[283,1702],[1821,1702],[1821,1750],[283,1750]],"region":{"top_left_x":283,"top_left_y":1701,"width":1538,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e4912655630e4ed689ef6ac84084bd18","type":"text","conversion_output":true,"text":"questions. The standardised version of the AQLQ, the AQLQ(S), in which 5 generic activities","text_display":" questions. The standardised version of the AQLQ, the AQLQ(S), in which 5 generic activities","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[283,1750],[1782,1750],[1782,1798],[283,1798]],"region":{"top_left_x":283,"top_left_y":1749,"width":1499,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25573952cc8643318f8af48b91944539","type":"text","conversion_output":true,"text":"replace the 5 patient-specific activities of the AQLQ (Juniper et al 1999) will be used in this","text_display":" replace the 5 patient-specific activities of the AQLQ (Juniper et al 1999) will be used in this","confidence":0.9990236759185791,"confidence_rate":0.9999905165401506},{"cnt":[[283,1796],[1761,1796],[1761,1843],[283,1843]],"region":{"top_left_x":283,"top_left_y":1795,"width":1479,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de80f8cf21a54744b76ac5fd9e36defd","type":"text","conversion_output":true,"text":"study. The AQLQ(S) is more appropriate than AQLQ for long-term clinical studies, when","text_display":" study. The AQLQ(S) is more appropriate than AQLQ for long-term clinical studies, when","confidence":1,"confidence_rate":1},{"cnt":[[283,1846],[1789,1846],[1789,1894],[283,1894]],"region":{"top_left_x":283,"top_left_y":1845,"width":1506,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8077699c15f5410099e3e75adc5737e0","type":"text","conversion_output":true,"text":"patients' activities and priorities may change over time. The AQLQ(S) evaluates the impact","text_display":" patients' activities and priorities may change over time. The AQLQ(S) evaluates the impact","confidence":0.99072265625,"confidence_rate":0.9999018927461621},{"cnt":[[283,1891],[1816,1891],[1816,1939],[283,1939]],"region":{"top_left_x":283,"top_left_y":1891,"width":1534,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bc0898a899c4871b8b0e69637787d6f","type":"text","conversion_output":true,"text":"of asthma on patients every day functioning and wellbeing. The AQLQ(S) has been validated","text_display":" of asthma on patients every day functioning and wellbeing. The AQLQ(S) has been validated","confidence":1,"confidence_rate":1},{"cnt":[[283,1937],[1793,1937],[1793,1985],[283,1985]],"region":{"top_left_x":283,"top_left_y":1937,"width":1511,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10c85ca7bd6b4da9a7f87e45338c4203","type":"text","conversion_output":true,"text":"for use from the age of 12 years (Juniper et al 2005). Linguistically validated translations of","text_display":" for use from the age of 12 years (Juniper et al 2005). Linguistically validated translations of","confidence":1,"confidence_rate":1},{"cnt":[[283,1987],[1720,1987],[1720,2035],[283,2035]],"region":{"top_left_x":283,"top_left_y":1987,"width":1438,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c38df0059aa4473aba33cddc20ec213","type":"text","conversion_output":true,"text":"AQLQ(S) into the local languages will be used. The North American English version is","text_display":" AQLQ(S) into the local languages will be used. The North American English version is","confidence":0.9716796875,"confidence_rate":0.99967725357203},{"cnt":[[283,2033],[688,2033],[688,2081],[283,2081]],"region":{"top_left_x":283,"top_left_y":2033,"width":405,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ea0f0ac8c164b9e87d80e6ddb30f00c","type":"text","conversion_output":true,"text":"included in Appendix D.","text_display":" included in Appendix D.","confidence":1,"confidence_rate":1},{"cnt":[[283,2120],[1825,2120],[1825,2168],[283,2168]],"region":{"top_left_x":283,"top_left_y":2119,"width":1543,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd3d6b0133414e7bac5484dce4099fc9","type":"text","conversion_output":true,"text":"The AQLQ(S) will be self-administered within the eDiary at the time points indicated in Table","text_display":"\n\nThe AQLQ(S) will be self-administered within the eDiary at the time points indicated in Table","confidence":0.9683210492436274,"confidence_rate":0.9996715683918845},{"cnt":[[283,2168],[1766,2168],[1766,2218],[283,2218]],"region":{"top_left_x":283,"top_left_y":2167,"width":1483,"height":52},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ccc675774c9e44ff97b79409505bd98b","type":"text","conversion_output":true,"text":"1. The questionnaire takes approximately 15 minutes to complete. The patient needs to be","text_display":" 1. The questionnaire takes approximately 15 minutes to complete. The patient needs to be","confidence":1,"confidence_rate":1},{"cnt":[[283,2216],[1805,2216],[1805,2264],[283,2264]],"region":{"top_left_x":283,"top_left_y":2215,"width":1522,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ed7bd59ddb704df88c575d7bbf255c40","type":"text","conversion_output":true,"text":"able to read and to be fluent in the local language to be able to answer the questions. Patients","text_display":" able to read and to be fluent in the local language to be able to answer the questions. Patients","confidence":1,"confidence_rate":1},{"cnt":[[283,2262],[1800,2262],[1800,2310],[283,2310]],"region":{"top_left_x":283,"top_left_y":2261,"width":1518,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"353076a0b1b34ee083be1dcb28510db4","type":"text","conversion_output":true,"text":"who are not fluent in the local language will not perform the AQLQ(S) assessments, but they","text_display":" who are not fluent in the local language will not perform the AQLQ(S) assessments, but they","confidence":0.99609375,"confidence_rate":0.9999592310464812},{"cnt":[[283,2312],[1722,2312],[1722,2360],[283,2360]],"region":{"top_left_x":283,"top_left_y":2311,"width":1440,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90ee31bbfb47499da0c41c9bcfa2e7ce","type":"text","conversion_output":true,"text":"can still participate in the study. The assessment of AQLQ(S) will only be performed in","text_display":" can still participate in the study. The assessment of AQLQ(S) will only be performed in","confidence":1,"confidence_rate":1},{"cnt":[[283,2357],[1128,2357],[1128,2401],[283,2401]],"region":{"top_left_x":283,"top_left_y":2357,"width":846,"height":44},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"afbafff1fc824817b7dbadd10e4f602a","type":"text","conversion_output":true,"text":"countries where validated translations are available.","text_display":" countries where validated translations are available.","confidence":1,"confidence_rate":1},{"cnt":[[996,2632],[1112,2632],[1112,2680],[996,2680]],"region":{"top_left_x":995,"top_left_y":2631,"width":118,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"772e0870a3434a91b9a5bd19f3410811","type":"page_info","conversion_output":false,"text":"39(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-40","page":40,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"de95a80ada16402d956d5e93973e593b","type":"page_info","conversion_output":false,"text":"Revised Clinical Study Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,279],[715,279],[715,313],[283,313]],"region":{"top_left_x":283,"top_left_y":278,"width":433,"height":35},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b54587f74d974e07b42578895b07a8bb","type":"page_info","conversion_output":false,"text":"Drug Substance budesonide/formoterol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,311],[583,311],[583,343],[283,343]],"region":{"top_left_x":283,"top_left_y":310,"width":300,"height":33},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3a1c8158c9c042dc9363b6f679b44a07","type":"page_info","conversion_output":false,"text":"Study Code D589SC00001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,370],[283,370]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":29},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2f3dd447d5fb4a8496d6f6f842457b1d","type":"page_info","conversion_output":false,"text":"Edition Number 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"749d41918bfa48e2838a963a27bb63b1","type":"page_info","conversion_output":false,"text":"Date 22 December 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[279,411],[1483,411],[1483,468],[279,468]],"region":{"top_left_x":278,"top_left_y":411,"width":1205,"height":58},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e1d6ad1802440d4a2632f12b329bf18","type":"section_header","conversion_output":false,"children_ids":["87d078e208ce4770bec0e1b5e703fc8c"],"text":"","text_display":""},{"cnt":[[283,416],[1478,416],[1478,464],[283,464]],"region":{"top_left_x":283,"top_left_y":415,"width":1195,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87d078e208ce4770bec0e1b5e703fc8c","type":"text","conversion_output":true,"parent_id":"6e1d6ad1802440d4a2632f12b329bf18","text":"5.1.7 Administration of patient reported outcome questionnaires","text_display":"\n\n\\subsection*{5.1.7 Administration of patient reported outcome questionnaires}","confidence":0.9990234375,"confidence_rate":0.9999856318731074},{"cnt":[[283,482],[1800,482],[1800,532],[283,532]],"region":{"top_left_x":283,"top_left_y":482,"width":1518,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"512bf6237857439fbaf5d93aa1cb5175","type":"text","conversion_output":true,"text":"The questionnaires (ACQ and AQLQ[S]) should be completed in the eDiary at the scheduled","text_display":"\n\nThe questionnaires (ACQ and AQLQ[S]) should be completed in the eDiary at the scheduled","confidence":0.9970703125,"confidence_rate":0.9999681093407484},{"cnt":[[283,530],[1796,530],[1796,578],[283,578]],"region":{"top_left_x":283,"top_left_y":529,"width":1513,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42931091214a4e0c8b4b5a88c461b591","type":"text","conversion_output":true,"text":"visits before any other study-related procedures are performed to avoid biased responses. At","text_display":" visits before any other study-related procedures are performed to avoid biased responses. At","confidence":1,"confidence_rate":1},{"cnt":[[283,576],[1793,576],[1793,624],[283,624]],"region":{"top_left_x":283,"top_left_y":575,"width":1511,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08290850571e45029664febf1623e38f","type":"text","conversion_output":true,"text":"Visit 2 only, the questionnaires can be completed following the lung function measurements.","text_display":" Visit 2 only, the questionnaires can be completed following the lung function measurements.","confidence":1,"confidence_rate":1},{"cnt":[[283,624],[1793,624],[1793,669],[283,669]],"region":{"top_left_x":283,"top_left_y":623,"width":1511,"height":47},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0844516ec13c425991b0f1fa782461ae","type":"text","conversion_output":true,"text":"At Visit 2, all patients will be carefully instructed and trained in how to complete the eDiary.","text_display":" At Visit 2, all patients will be carefully instructed and trained in how to complete the eDiary.","confidence":1,"confidence_rate":1},{"cnt":[[283,669],[1492,669],[1492,720],[283,720]],"region":{"top_left_x":283,"top_left_y":669,"width":1209,"height":51},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fac15b9b48140a09b74720ebb77082c","type":"text","conversion_output":true,"text":"Written instructions will be provided to each patient in the local language.","text_display":" Written instructions will be provided to each patient in the local language.","confidence":0.9970703125,"confidence_rate":0.9999637785889149},{"cnt":[[283,758],[1656,758],[1656,806],[283,806]],"region":{"top_left_x":283,"top_left_y":758,"width":1374,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"920f3fdff34945f9ac5631e420acc2ff","type":"text","conversion_output":true,"text":"The patient should be informed about the purpose and importance of completing the","text_display":"\n\nThe patient should be informed about the purpose and importance of completing the","confidence":1,"confidence_rate":1},{"cnt":[[283,806],[1812,806],[1812,854],[283,854]],"region":{"top_left_x":283,"top_left_y":806,"width":1529,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0796c520d6fb494ab395b7a513f82501","type":"text","conversion_output":true,"text":"questionnaires and be given adequate time to complete all items. It is important to administer","text_display":" questionnaires and be given adequate time to complete all items. It is important to administer","confidence":1,"confidence_rate":1},{"cnt":[[283,854],[1805,854],[1805,902],[283,902]],"region":{"top_left_x":283,"top_left_y":854,"width":1522,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b15dad6610a48a498fc325cec3fd3c9","type":"text","conversion_output":true,"text":"the questionnaires according to the guidelines for standardised administration. The questions","text_display":" the questionnaires according to the guidelines for standardised administration. The questions","confidence":1,"confidence_rate":1},{"cnt":[[283,900],[1665,900],[1665,948],[283,948]],"region":{"top_left_x":283,"top_left_y":900,"width":1383,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f584e82130a845839b2178ddc4f741dc","type":"text","conversion_output":true,"text":"should be completed in a quiet place without influence from family, friends, or study","text_display":" should be completed in a quiet place without influence from family, friends, or study","confidence":1,"confidence_rate":1},{"cnt":[[283,946],[1738,946],[1738,996],[283,996]],"region":{"top_left_x":283,"top_left_y":945,"width":1456,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ec47133b2304a9b93847e9576b0d59c","type":"text","conversion_output":true,"text":"personnel. Family, friends, or study personnel should never help the patient to choose an","text_display":" personnel. Family, friends, or study personnel should never help the patient to choose an","confidence":1,"confidence_rate":1},{"cnt":[[283,996],[1236,996],[1236,1044],[283,1044]],"region":{"top_left_x":283,"top_left_y":995,"width":953,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c0cbbc44efe4bc591c9dbb4de277527","type":"text","conversion_output":true,"text":"answer, interpret, or rephrase the questions for the patient.","text_display":" answer, interpret, or rephrase the questions for the patient.","confidence":1,"confidence_rate":1},{"cnt":[[279,1078],[1067,1078],[1067,1135],[279,1135]],"region":{"top_left_x":278,"top_left_y":1078,"width":789,"height":58},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d719fde29be746748fa952c767eb483f","type":"section_header","conversion_output":false,"children_ids":["313efb028d7443f2b229118ab84d1686"],"text":"","text_display":""},{"cnt":[[283,1083],[1062,1083],[1062,1131],[283,1131]],"region":{"top_left_x":283,"top_left_y":1082,"width":780,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"313efb028d7443f2b229118ab84d1686","type":"text","conversion_output":true,"parent_id":"d719fde29be746748fa952c767eb483f","text":"5.1.8 Turbuhaler Usage Monitor (TUM)","text_display":"\n\n\\subsection*{5.1.8 Turbuhaler Usage Monitor (TUM)}","confidence":1,"confidence_rate":1},{"cnt":[[283,1147],[1818,1147],[1818,1197],[283,1197]],"region":{"top_left_x":283,"top_left_y":1146,"width":1536,"height":52},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5371246da7ef4b1ea8ef976e7678fdbd","type":"text","conversion_output":true,"text":"The Turbuhaler Usage Monitor (TUM, a SmartTurbo \\({ }^{ TM }\\) version manufactured by Nexus6 Ltd,","text_display":"\n\nThe Turbuhaler Usage Monitor (TUM, a SmartTurbo \\({ }^{ TM }\\) version manufactured by Nexus6 Ltd,","confidence":0.9307310418225825,"confidence_rate":0.9993099983996322},{"cnt":[[283,1197],[1684,1197],[1684,1245],[283,1245]],"region":{"top_left_x":283,"top_left_y":1197,"width":1401,"height":48},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"134f14d9bf2a4a329c4f8dac193177e2","type":"text","conversion_output":true,"text":"New Zealand) is a battery powered electronic data logger designed to be attached to a","text_display":" New Zealand) is a battery powered electronic data logger designed to be attached to a","confidence":1,"confidence_rate":1},{"cnt":[[283,1243],[1727,1243],[1727,1291],[283,1291]],"region":{"top_left_x":283,"top_left_y":1242,"width":1444,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c0bfc04c7fe4bd8b52a45d0bc401712","type":"text","conversion_output":true,"text":"Turbuhaler (DPI). The TUM contains an internal electronic clock and calendar that logs","text_display":" Turbuhaler (DPI). The TUM contains an internal electronic clock and calendar that logs","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[283,1291],[1816,1291],[1816,1341],[283,1341]],"region":{"top_left_x":283,"top_left_y":1290,"width":1534,"height":51},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"430832d6f8df4b2885adb510bc3f6578","type":"text","conversion_output":true,"text":"through a microprocessor the date and time when the Turbuhaler base grip is rotated back and","text_display":" through a microprocessor the date and time when the Turbuhaler base grip is rotated back and","confidence":0.99853515625,"confidence_rate":0.9999848875607663},{"cnt":[[283,1339],[377,1339],[377,1382],[283,1382]],"region":{"top_left_x":283,"top_left_y":1338,"width":94,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"07473ac669a141e5980b3984b672b80c","type":"text","conversion_output":true,"text":"forth.","text_display":" forth.","confidence":1,"confidence_rate":1},{"cnt":[[283,1425],[1638,1425],[1638,1473],[283,1473]],"region":{"top_left_x":283,"top_left_y":1425,"width":1355,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48bd280907d54286b3180b4fe1e92e01","type":"text","conversion_output":true,"text":"The TUM will be applicable for the 'as needed' and maintenance study medication","text_display":"\n\nThe TUM will be applicable for the 'as needed' and maintenance study medication","confidence":1,"confidence_rate":1},{"cnt":[[283,1471],[1816,1471],[1816,1524],[283,1524]],"region":{"top_left_x":283,"top_left_y":1471,"width":1534,"height":53},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0d12275bdb14280b85fa642b391ab03","type":"text","conversion_output":true,"text":"Turbuhalers, as well as the Bricanyl Turbuhaler used during the run-in phase (see Turbuhalers","text_display":" Turbuhalers, as well as the Bricanyl Turbuhaler used during the run-in phase (see Turbuhalers","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[283,1521],[674,1521],[674,1569],[283,1569]],"region":{"top_left_x":283,"top_left_y":1521,"width":391,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"931a0ee072b54cc58e2ee82aee8375b5","type":"text","conversion_output":true,"text":"described in Section 7).","text_display":" described in Section 7).","confidence":1,"confidence_rate":1},{"cnt":[[283,1608],[1802,1608],[1802,1656],[283,1656]],"region":{"top_left_x":283,"top_left_y":1608,"width":1520,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4117268ccc54d96becb10d5544b47dd","type":"text","conversion_output":true,"text":"The colour of the main body of all the TUMs will be white. The colour of the locking ring of","text_display":"\n\nThe colour of the main body of all the TUMs will be white. 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risks associated with overdosage of Symbicort are considered to be small, as the safety","text_display":"\n\nThe risks associated with overdosage of Symbicort are considered to be small, as the safety","confidence":1,"confidence_rate":1},{"cnt":[[283,1745],[1825,1745],[1825,1793],[283,1793]],"region":{"top_left_x":283,"top_left_y":1745,"width":1543,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96d690bdc44449828cd9cdf1b413135b","type":"text","conversion_output":true,"text":"margins for inhaled budesonide and formoterol are substantial. 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have a low toxicity, and are virtually without harmful effects after a","text_display":"\n\nGlucocorticosteroids have a low toxicity, and are virtually without harmful effects after a","confidence":0.99853515625,"confidence_rate":0.9999847301407262},{"cnt":[[283,2316],[1640,2316],[1640,2364],[283,2364]],"region":{"top_left_x":283,"top_left_y":2316,"width":1358,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3b29406cbd840b488e2194a732b6c40","type":"text","conversion_output":true,"text":"single or a few doses, even if the doses are very high. 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An","text_display":"\n\nThere is limited clinical experience regarding overdosage with inhaled formoterol. An","confidence":1,"confidence_rate":1},{"cnt":[[283,461],[1789,461],[1789,509],[283,509]],"region":{"top_left_x":283,"top_left_y":461,"width":1506,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a73e1a97c5641598348d683cafeaa8a","type":"text","conversion_output":true,"text":"overdose would likely lead to effects that are typical of \\(\\beta_{2}\\)-agonists such as tremor, headache","text_display":" overdose would likely lead to effects that are typical of \\(\\beta_{2}\\)-agonists such as tremor, headache","confidence":0.9975602623308077,"confidence_rate":0.9999777937131203},{"cnt":[[283,507],[1706,507],[1706,555],[283,555]],"region":{"top_left_x":283,"top_left_y":507,"width":1424,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"601e68da0c3546f3896fae1772f9731b","type":"text","conversion_output":true,"text":"and palpitations. Symptoms and signs reported with formoterol from isolated cases are","text_display":" and palpitations. 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The training Turbuhaler should be","text_display":"\n\nAn empty Turbuhaler will be used for training purpose. The training Turbuhaler should be","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[283,1197],[1789,1197],[1789,1245],[283,1245]],"region":{"top_left_x":283,"top_left_y":1197,"width":1506,"height":48},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"79b40076e4b64c96b1b1d16652679087","type":"text","conversion_output":true,"text":"kept at the study site and should not be taken home by the patients. The training Turbuhaler","text_display":" kept at the study site and should not be taken home by the patients. The training Turbuhaler","confidence":0.99658203125,"confidence_rate":0.9999647034750034},{"cnt":[[283,1243],[985,1243],[985,1291],[283,1291]],"region":{"top_left_x":283,"top_left_y":1242,"width":702,"height":49},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"53082f4453624bc29f43b4a90bcfee76","type":"text","conversion_output":true,"text":"will be labelled with an English label only.","text_display":" will be labelled with an English label only.","confidence":1,"confidence_rate":1},{"cnt":[[283,1330],[1825,1330],[1825,1377],[283,1377]],"region":{"top_left_x":283,"top_left_y":1329,"width":1543,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"630eebbf2815423ab41fcbda1a8da396","type":"text","conversion_output":true,"text":"Bricanyl Turbuhaler will be dispensed from Visit 2 and will be used as 'as needed' medication","text_display":"\n\nBricanyl Turbuhaler will be dispensed from Visit 2 and will be used as 'as needed' medication","confidence":1,"confidence_rate":1},{"cnt":[[283,1380],[1825,1380],[1825,1428],[283,1428]],"region":{"top_left_x":283,"top_left_y":1379,"width":1543,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d2e49df2e1324cf0a6a6d7570a22168e","type":"text","conversion_output":true,"text":"during the run-in period. Bricanyl Turbuhaler will have blue grip and blue label. Patients will","text_display":" during the run-in period. Bricanyl Turbuhaler will have blue grip and blue label. Patients will","confidence":1,"confidence_rate":1},{"cnt":[[283,1425],[1825,1425],[1825,1473],[283,1473]],"region":{"top_left_x":283,"top_left_y":1425,"width":1543,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5f9c0391cd0b46b2a4bad3c2b20dd8f1","type":"text","conversion_output":true,"text":"be instructed to use Bricanyl Turbuhaler whenever needed to relieve asthma symptoms but not","text_display":" be instructed to use Bricanyl Turbuhaler whenever needed to relieve asthma symptoms but not","confidence":0.9990236759185791,"confidence_rate":0.999989825041388},{"cnt":[[283,1473],[1750,1473],[1750,1519],[283,1519]],"region":{"top_left_x":283,"top_left_y":1473,"width":1467,"height":47},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f6ef73bb82154c6aa0519d75742e94ca","type":"text","conversion_output":true,"text":"for prophylactic reasons. In addition, those patients who are treated with low-dose ICS or","text_display":" for prophylactic reasons. In addition, those patients who are treated with low-dose ICS or","confidence":1,"confidence_rate":1},{"cnt":[[283,1521],[1549,1521],[1549,1569],[283,1569]],"region":{"top_left_x":283,"top_left_y":1521,"width":1266,"height":49},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fd8ef5de7ae04cd49f2eb5c7d08cc151","type":"text","conversion_output":true,"text":"LTRA at study entry will be asked to stop taking these medications at Visit 2.","text_display":" LTRA at study entry will be asked to stop taking these medications at Visit 2.","confidence":0.98876953125,"confidence_rate":0.9998622776965536},{"cnt":[[283,1608],[1679,1608],[1679,1656],[283,1656]],"region":{"top_left_x":283,"top_left_y":1608,"width":1397,"height":49},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a277a13a1c014c4d8c3106904c13fb03","type":"text","conversion_output":true,"text":"The Bricanyl Turbuhaler will also be used for the post-bronchodilator \\(FEV _{1}\\) and FVC","text_display":"\n\nThe Bricanyl Turbuhaler will also be used for the post-bronchodilator \\(FEV _{1}\\) and FVC","confidence":0.9642092557623982,"confidence_rate":0.9996355970345447},{"cnt":[[283,1656],[740,1656],[740,1697],[283,1697]],"region":{"top_left_x":283,"top_left_y":1656,"width":458,"height":42},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dfade6e973664375a5afc471a1a3fdc1","type":"text","conversion_output":true,"text":"measurements at Visits 2-8.","text_display":" measurements at Visits 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8)}","confidence":1,"confidence_rate":1},{"cnt":[[283,1809],[1574,1809],[1574,1857],[283,1857]],"region":{"top_left_x":283,"top_left_y":1809,"width":1291,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"173fe59e0f4f45de92c5140273bcba88","type":"text","conversion_output":true,"text":"At Visit 3 patients will be randomised to one of the 3 treatment groups with IP:","text_display":"\n\nAt Visit 3 patients will be randomised to one of the 3 treatment groups with IP:","confidence":0.9985356330871582,"confidence_rate":0.9999838963917971},{"cnt":[[283,1896],[1695,1896],[1695,1949],[283,1949]],"region":{"top_left_x":283,"top_left_y":1896,"width":1413,"height":53},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"88b48cff3fd440c2be36a508ccc71c8f","type":"text","conversion_output":true,"text":"- Maintenance Placebo BID (twice daily) + Symbicort \\(160 / 4.5 \\mu g\\) 'as needed'","text_display":"\n- Maintenance Placebo BID (twice daily) + Symbicort \\(160 / 4.5 \\mu g\\) 'as needed'","confidence":0.9897808637470007,"confidence_rate":0.9998777252130108},{"cnt":[[283,1987],[1576,1987],[1576,2040],[283,2040]],"region":{"top_left_x":283,"top_left_y":1987,"width":1294,"height":53},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"041927de672745ad8572bed798a5373c","type":"text","conversion_output":true,"text":"- Maintenance Pulmicort \\(200 \\mu g\\) BID + terbutaline 0.4 mg 'as needed'","text_display":"\n- Maintenance Pulmicort \\(200 \\mu g\\) BID + terbutaline 0.4 mg 'as needed'","confidence":0.9936635453486815,"confidence_rate":0.999922483307142},{"cnt":[[283,2079],[1432,2079],[1432,2129],[283,2129]],"region":{"top_left_x":283,"top_left_y":2078,"width":1150,"height":52},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"063e864fff104e01a092c510efd1b356","type":"text","conversion_output":true,"text":"- Maintenance Placebo BID + terbutaline 0.4 mg 'as needed'.","text_display":"\n- Maintenance Placebo BID + terbutaline 0.4 mg 'as needed'.","confidence":0.99853515625,"confidence_rate":0.9999787550418731},{"cnt":[[283,2168],[1720,2168],[1720,2218],[283,2218]],"region":{"top_left_x":283,"top_left_y":2167,"width":1438,"height":52},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cb2950cb69cb4981849beb7079f7c7b0","type":"text","conversion_output":true,"text":"At Visit 3 all randomised patients will receive maintenance study drug containing either","text_display":"\n\nAt Visit 3 all randomised patients will receive maintenance study drug containing either","confidence":1,"confidence_rate":1},{"cnt":[[283,2216],[1695,2216],[1695,2264],[283,2264]],"region":{"top_left_x":283,"top_left_y":2215,"width":1413,"height":49},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"78451d97c6cf4c148acc4bd53756ce4d","type":"text","conversion_output":true,"text":"Pulmicort or placebo as well as 'as needed' study drug, containing either Symbicort or","text_display":" Pulmicort or placebo as well as 'as needed' study drug, containing either Symbicort or","confidence":1,"confidence_rate":1},{"cnt":[[283,2262],[473,2262],[473,2305],[283,2305]],"region":{"top_left_x":283,"top_left_y":2261,"width":190,"height":44},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"50de18ea87964e30b7e33bf75bc17094","type":"text","conversion_output":true,"text":"terbutaline.","text_display":" terbutaline.","confidence":1,"confidence_rate":1},{"cnt":[[283,2348],[1684,2348],[1684,2396],[283,2396]],"region":{"top_left_x":283,"top_left_y":2348,"width":1401,"height":49},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"efd6baccb6754ad08fee40794e9755ec","type":"text","conversion_output":true,"text":"To avoid confusion, the maintenance Turbuhalers and the Turbuhalers for 'as needed'","text_display":"\n\nTo avoid confusion, the maintenance Turbuhalers and the Turbuhalers for 'as needed'","confidence":1,"confidence_rate":1},{"cnt":[[283,2399],[1775,2399],[1775,2444],[283,2444]],"region":{"top_left_x":283,"top_left_y":2398,"width":1492,"height":47},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4fb9c372a62d4ddeaf6e255e5efadfe5","type":"text","conversion_output":true,"text":"treatment will have labels with different colours and the Turbuhaler grip will have different","text_display":" treatment will have labels with different colours and the Turbuhaler grip will have different","confidence":1,"confidence_rate":1},{"cnt":[[283,2444],[1775,2444],[1775,2492],[283,2492]],"region":{"top_left_x":283,"top_left_y":2444,"width":1492,"height":49},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"61038809790f4dfd8d5b97727acb26c3","type":"text","conversion_output":true,"text":"colours for the two different treatments. The maintenance Turbuhaler will have brown grip","text_display":" colours for the two different treatments. The maintenance Turbuhaler will have brown grip","confidence":1,"confidence_rate":1},{"cnt":[[283,2492],[1770,2492],[1770,2540],[283,2540]],"region":{"top_left_x":283,"top_left_y":2492,"width":1488,"height":49},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"93a51a47c21d4b8d8373f004e00b6df7","type":"text","conversion_output":true,"text":"and yellow label. During the treatment period the Turbuhaler for 'as needed' treatment will","text_display":" and yellow label. During the treatment period the Turbuhaler for 'as needed' treatment will","confidence":1,"confidence_rate":1},{"cnt":[[996,2632],[1112,2632],[1112,2680],[996,2680]],"region":{"top_left_x":995,"top_left_y":2631,"width":118,"height":49},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3ea1306f8cde4c9ea4fd85c8a91e6b0a","type":"page_info","conversion_output":false,"text":"50(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-51","page":51,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"066018a557344f21869278a5a53364df","type":"page_info","conversion_output":false,"text":"Revised Clinical Study Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,279],[715,279],[715,313],[283,313]],"region":{"top_left_x":283,"top_left_y":278,"width":433,"height":35},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"332b6269969b42e9b155ba50e2a5f02f","type":"page_info","conversion_output":false,"text":"Drug Substance budesonide/formoterol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,311],[583,311],[583,343],[283,343]],"region":{"top_left_x":283,"top_left_y":310,"width":300,"height":33},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fbab40f7498848ba940c72942614fa78","type":"page_info","conversion_output":false,"text":"Study Code D589SC00001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,368],[283,368]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":26},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bf45fa92a2b04e90a1915ee7a48b8070","type":"page_info","conversion_output":false,"text":"Edition Number 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fd83ed1e6f9e4fb9a690946115c5e272","type":"page_info","conversion_output":false,"text":"Date 22 December 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,416],[1770,416],[1770,464],[283,464]],"region":{"top_left_x":283,"top_left_y":415,"width":1488,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb8ce3f3283f45bda731c90926f7b35a","type":"text","conversion_output":true,"text":"have white grip and white label. The patients will be instructed to take one inhalation from","text_display":"\nhave white grip and white label. The patients will be instructed to take one inhalation from","confidence":1,"confidence_rate":1},{"cnt":[[283,461],[1798,461],[1798,509],[283,509]],"region":{"top_left_x":283,"top_left_y":461,"width":1515,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5bddee8fdcd4f2c85ccba498c8a7d93","type":"text","conversion_output":true,"text":"the inhaler with the brown grip every morning upon rising and every evening before going to","text_display":" the inhaler with the brown grip every morning upon rising and every evening before going to","confidence":1,"confidence_rate":1},{"cnt":[[283,507],[1793,507],[1793,553],[283,553]],"region":{"top_left_x":283,"top_left_y":507,"width":1511,"height":46},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"97f14acb0823424b968be30798d30e24","type":"text","conversion_output":true,"text":"bed. Patients will further be instructed to take one inhalation from the inhaler with the white","text_display":" bed. Patients will further be instructed to take one inhalation from the inhaler with the white","confidence":1,"confidence_rate":1},{"cnt":[[283,557],[1579,557],[1579,605],[283,605]],"region":{"top_left_x":283,"top_left_y":557,"width":1296,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34b984c95dbe41f595be88deb6d0725b","type":"text","conversion_output":true,"text":"grip whenever needed to relieve asthma symptoms but not for prophylactic use.","text_display":" grip whenever needed to relieve asthma symptoms but not for prophylactic use.","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[283,644],[1725,644],[1725,692],[283,692]],"region":{"top_left_x":283,"top_left_y":644,"width":1442,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5bf1c5d704614f2bab8f38113dd143fc","type":"text","conversion_output":true,"text":"The patient should take the first dose of maintenance IP (morning dose) at the study site.","text_display":"\n\nThe patient should take the first dose of maintenance IP (morning dose) at the study site.","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[283,733],[1743,733],[1743,779],[283,779]],"region":{"top_left_x":283,"top_left_y":733,"width":1460,"height":46},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c165e07a7064231b98451b73b74d0d3","type":"text","conversion_output":true,"text":"During the treatment period, the patients are allowed to use up to 12 inhalations of the 'as","text_display":"\nDuring the treatment period, the patients are allowed to use up to 12 inhalations of the 'as","confidence":1,"confidence_rate":1},{"cnt":[[283,779],[1798,779],[1798,825],[283,825]],"region":{"top_left_x":283,"top_left_y":778,"width":1515,"height":47},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3561a8702b264f47bf7e60d0fdf661cf","type":"text","conversion_output":true,"text":"needed' medication during one single day. If a patient needs more 'as needed' medication in","text_display":" needed' medication during one single day. 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vs","text_display":" terbutaline and the secondary objective to estimate the relative efficacy of Symbicort vs","confidence":1,"confidence_rate":1},{"cnt":[[283,594],[1725,594],[1725,642],[283,642]],"region":{"top_left_x":283,"top_left_y":593,"width":1442,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"42e72f1947ad4d4ba67e5ceda427946a","type":"text","conversion_output":true,"text":"Pulmicort plus terbutaline in the overall population and pre-study treatment groups. The","text_display":" Pulmicort plus terbutaline in the overall population and pre-study treatment groups. The","confidence":1,"confidence_rate":1},{"cnt":[[283,642],[1711,642],[1711,688],[283,688]],"region":{"top_left_x":283,"top_left_y":641,"width":1428,"height":47},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3336145926448f3ba764760b836b087","type":"text","conversion_output":true,"text":"estimation of relative efficacy between the 2 treatments will be done as described in the","text_display":" estimation of relative efficacy between the 2 treatments will be done as described in the","confidence":0.9990236759185791,"confidence_rate":0.9999899299373404},{"cnt":[[283,685],[1757,685],[1757,733],[283,733]],"region":{"top_left_x":283,"top_left_y":685,"width":1474,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5e4139123c14d8682b5c38ce7a06f53","type":"text","conversion_output":true,"text":"\"EMA reflection paper on the need for active control in therapeutic areas where the use of","text_display":" \"EMA reflection paper on the need for active control in therapeutic areas where the use of","confidence":1,"confidence_rate":1},{"cnt":[[283,736],[1752,736],[1752,781],[283,781]],"region":{"top_left_x":283,"top_left_y":735,"width":1470,"height":47},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11f14b99e99f49e0a2c83c86f7318056","type":"text","conversion_output":true,"text":"placebo is deemed ethical.\" (EMA 2010). It is planned to estimate the relative efficacy of","text_display":" placebo is deemed ethical.\" (EMA 2010). 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at the date of their last visit or, for patients discontinuing the study, the day when it","text_display":" censored at the date of their last visit or, for patients discontinuing the study, the day when it","confidence":0.99853515625,"confidence_rate":0.9999857678907678},{"cnt":[[283,1197],[1551,1197],[1551,1245],[283,1245]],"region":{"top_left_x":283,"top_left_y":1197,"width":1269,"height":48},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"741250e3c11342c98fcfeb0ed24280a0","type":"text","conversion_output":true,"text":"was decided that the patient should discontinue the study for whatever reason.","text_display":" was decided that the patient should discontinue the study for whatever reason.","confidence":1,"confidence_rate":1},{"cnt":[[281,1284],[1099,1284],[1099,1336],[281,1336]],"region":{"top_left_x":280,"top_left_y":1283,"width":819,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"195e7c7df4654a34b1d16f6f03f0dd0d","type":"section_header","conversion_output":false,"children_ids":["24d4d4ea16df408fba4b7c49320b9806"],"text":"","text_display":""},{"cnt":[[283,1288],[1094,1288],[1094,1332],[283,1332]],"region":{"top_left_x":283,"top_left_y":1288,"width":812,"height":44},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24d4d4ea16df408fba4b7c49320b9806","type":"text","conversion_output":true,"parent_id":"195e7c7df4654a34b1d16f6f03f0dd0d","text":"8.4.1.8 Derivation of lung function variables","text_display":"\n\n\\subsection*{8.4.1.8 Derivation of lung function variables}","confidence":1,"confidence_rate":1},{"cnt":[[283,1352],[1807,1352],[1807,1400],[283,1400]],"region":{"top_left_x":283,"top_left_y":1352,"width":1524,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a63979a36e9941fe887cb17e32615b39","type":"text","conversion_output":true,"text":"Change from baseline (Visit 3) to Visits 4, 5, 6, 7 and 8 will be calculated for each patient for","text_display":"\n\nChange from baseline (Visit 3) to Visits 4, 5, 6, 7 and 8 will be calculated for each patient for","confidence":0.9990236759185791,"confidence_rate":0.9999909555872323},{"cnt":[[283,1403],[898,1403],[898,1446],[283,1446]],"region":{"top_left_x":283,"top_left_y":1402,"width":615,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a59b1e3e50194e18bde487f9fd16d2f0","type":"text","conversion_output":true,"text":"the following lung function variables:","text_display":" the following lung function variables:","confidence":1,"confidence_rate":1},{"cnt":[[283,1489],[1085,1489],[1085,1537],[283,1537]],"region":{"top_left_x":283,"top_left_y":1489,"width":803,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d553a20aa9814750b63075e43fa7c2a1","type":"text","conversion_output":true,"text":"- Pre- and post-bronchodilator \\(FEV _{1}\\) (L)","text_display":"\n- Pre- and post-bronchodilator \\(FEV _{1}\\) (L)","confidence":0.7926943129675124,"confidence_rate":0.9959325469826907},{"cnt":[[283,1581],[1396,1581],[1396,1629],[283,1629]],"region":{"top_left_x":283,"top_left_y":1580,"width":1113,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ae3bedce280f46519cb36bef34fce224","type":"text","conversion_output":true,"text":"- Pre- and post-bronchodilator \\(FEV _{1} \\%\\) of predicted normal","text_display":"\n- Pre- and post-bronchodilator \\(FEV _{1} \\%\\) of predicted normal","confidence":0.9917092323303223,"confidence_rate":0.9998875019063124},{"cnt":[[283,1672],[1071,1672],[1071,1716],[283,1716]],"region":{"top_left_x":283,"top_left_y":1672,"width":789,"height":44},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb22b54c30ae454f901af80ec2972ec2","type":"text","conversion_output":true,"text":"- Pre- and post-bronchodilator FVC (L)","text_display":"\n- Pre- and post-bronchodilator FVC (L)","confidence":0.99951171875,"confidence_rate":0.9999886419133848},{"cnt":[[283,1759],[1802,1759],[1802,1802],[283,1802]],"region":{"top_left_x":283,"top_left_y":1758,"width":1520,"height":45},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ab566afbf5244d6b4a3cda4b917c685","type":"text","conversion_output":true,"text":"If the baseline measurement is missing, the last non-missing value before Visit 3 will be used","text_display":"\n\nIf the baseline measurement is missing, the last non-missing value before Visit 3 will be used","confidence":1,"confidence_rate":1},{"cnt":[[283,1805],[596,1805],[596,1848],[283,1848]],"region":{"top_left_x":283,"top_left_y":1804,"width":314,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4876dfe9aef54d34a0466d4645de641c","type":"text","conversion_output":true,"text":"as baseline instead.","text_display":" as baseline instead.","confidence":1,"confidence_rate":1},{"cnt":[[283,1894],[1665,1894],[1665,1939],[283,1939]],"region":{"top_left_x":283,"top_left_y":1893,"width":1383,"height":47},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"508000445a7d43d4a3d6f2c5b497233e","type":"text","conversion_output":true,"text":"Percent predicted of normal for pre- and post-bronchodilator \\(FEV _{1}\\) will be calculated","text_display":"\n\nPercent predicted of normal for pre- and post-bronchodilator \\(FEV _{1}\\) will be calculated","confidence":1,"confidence_rate":1},{"cnt":[[283,1942],[811,1942],[811,1985],[283,1985]],"region":{"top_left_x":283,"top_left_y":1941,"width":528,"height":45},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d744e33f4e70493d870ce42627f42925","type":"text","conversion_output":true,"text":"according to Quanjer et al 2012.","text_display":" according to Quanjer et al 2012.","confidence":1,"confidence_rate":1},{"cnt":[[281,2029],[1135,2029],[1135,2076],[281,2076]],"region":{"top_left_x":280,"top_left_y":2028,"width":856,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c8bee9b676f416bacd5c8b1dc68797a","type":"section_header","conversion_output":false,"children_ids":["209286ca82f04f62bab3e846ebee0614"],"text":"","text_display":""},{"cnt":[[283,2031],[1135,2031],[1135,2074],[283,2074]],"region":{"top_left_x":283,"top_left_y":2030,"width":853,"height":45},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"209286ca82f04f62bab3e846ebee0614","type":"text","conversion_output":true,"parent_id":"4c8bee9b676f416bacd5c8b1dc68797a","text":"8.4.1.9 Derivation of electronic diary variables","text_display":"\n\n\\subsection*{8.4.1.9 Derivation of electronic diary variables}","confidence":1,"confidence_rate":1},{"cnt":[[283,2095],[1473,2095],[1473,2140],[283,2140]],"region":{"top_left_x":283,"top_left_y":2094,"width":1191,"height":47},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d528a19bc3a4fe3b82b19647de1774d","type":"text","conversion_output":true,"text":"The following variables will be derived for the electronic diary variables:","text_display":"\n\nThe following variables will be derived for the electronic diary variables:","confidence":1,"confidence_rate":1},{"cnt":[[286,2188],[889,2188],[889,2232],[286,2232]],"region":{"top_left_x":285,"top_left_y":2188,"width":604,"height":44},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad22849f3618433292980b6c7f49d928","type":"text","conversion_output":true,"text":"- Morning and evening PEF","text_display":"\n- Morning and evening 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D589SC00001","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,370],[283,370]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":29},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"54796907560044748b14a9720ee4818c","type":"text","conversion_output":true,"text":"Edition Number 4","text_display":"\nEdition Number 4","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"17a469f914f741af87adf80fadc103da","type":"text","conversion_output":true,"text":"Date 22 December 2016","text_display":"\nDate 22 December 2016","confidence":1,"confidence_rate":1},{"cnt":[[283,416],[1798,416],[1798,464],[283,464]],"region":{"top_left_x":283,"top_left_y":415,"width":1515,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7f1fa742f1f41c7a801746badc0e931","type":"text","conversion_output":true,"text":"Change from baseline will be calculated for each patient as defined by the change in all post-","text_display":"\nChange from baseline will be calculated for each patient as defined by the change in all post","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[283,461],[1658,461],[1658,507],[283,507]],"region":{"top_left_x":283,"top_left_y":461,"width":1376,"height":47},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b90ea5df36b64fc485268a8b94da942e","type":"text","conversion_output":true,"text":"randomisation observations to baseline, where baseline is defined as the mean of the","text_display":"randomisation observations to baseline, where baseline is defined as the mean of the","confidence":1,"confidence_rate":1},{"cnt":[[283,507],[1263,507],[1263,557],[283,557]],"region":{"top_left_x":283,"top_left_y":507,"width":981,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd19f463d61f4209a1c9c6d51d740b38","type":"text","conversion_output":true,"text":"measurements 10 days prior to randomisation during run-in.","text_display":" measurements 10 days prior to randomisation during run-in.","confidence":1,"confidence_rate":1},{"cnt":[[279,594],[614,594],[614,649],[279,649]],"region":{"top_left_x":278,"top_left_y":593,"width":337,"height":56},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb129b73fa2c4043b69a6f5945287031","type":"section_header","conversion_output":false,"children_ids":["f0670488054e41069e69cf3ce5869333"],"text":"","text_display":""},{"cnt":[[283,599],[610,599],[610,646],[283,646]],"region":{"top_left_x":283,"top_left_y":598,"width":327,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f0670488054e41069e69cf3ce5869333","type":"text","conversion_output":true,"parent_id":"eb129b73fa2c4043b69a6f5945287031","text":"Symptom-free days","text_display":"\n\n\\section*{Symptom-free 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variables}","confidence":0.9990236759185791,"confidence_rate":0.9999834441879605},{"cnt":[[279,480],[825,480],[825,532],[279,532]],"region":{"top_left_x":278,"top_left_y":479,"width":547,"height":54},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d3405e0d21c4c2f83b392844b65ed4e","type":"section_header","conversion_output":false,"children_ids":["d244956423c647e293a687d8ad844856"],"text":"","text_display":""},{"cnt":[[283,484],[820,484],[820,528],[283,528]],"region":{"top_left_x":283,"top_left_y":484,"width":538,"height":44},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d244956423c647e293a687d8ad844856","type":"text","conversion_output":true,"parent_id":"5d3405e0d21c4c2f83b392844b65ed4e","text":"8.4.2.1 Derivation of ACQ-5","text_display":"\n\n\\subsection*{8.4.2.1 Derivation of ACQ-5}","confidence":0.96484375,"confidence_rate":0.998882215566584},{"cnt":[[283,548],[1798,548],[1798,596],[283,596]],"region":{"top_left_x":283,"top_left_y":548,"width":1515,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"08af2a59c0bd4e1e8cd2f1d29268bc2a","type":"text","conversion_output":true,"text":"All 5 symptom questions are assessed on a 7 -point scale from 0 to 6 where 0 represents good","text_display":"\n\nAll 5 symptom questions are assessed on a 7 -point scale from 0 to 6 where 0 represents good","confidence":0.9742936305701733,"confidence_rate":0.9997675042454859},{"cnt":[[283,596],[1784,596],[1784,642],[283,642]],"region":{"top_left_x":283,"top_left_y":596,"width":1502,"height":46},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5f66fae4fbe4c51a894cb99cce72a8b","type":"text","conversion_output":true,"text":"control and 6 represents poor control. The overall score is the mean of the 5 items. At least","text_display":" control and 6 represents poor control. The overall score is the mean of the 5 items. At least","confidence":0.9936575889587402,"confidence_rate":0.9999388229331198},{"cnt":[[283,644],[1373,644],[1373,692],[283,692]],"region":{"top_left_x":283,"top_left_y":644,"width":1090,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc686db68e574c2c9fbf3aef0ad446ea","type":"text","conversion_output":true,"text":"4 out of the 5 symptom items are needed to provide an ACQ score.","text_display":" 4 out of the 5 symptom items are needed to provide an ACQ score.","confidence":1,"confidence_rate":1},{"cnt":[[283,731],[1768,731],[1768,779],[283,779]],"region":{"top_left_x":283,"top_left_y":731,"width":1486,"height":48},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81c069f9d3254d46952eb944466ffbec","type":"text","conversion_output":true,"text":"The minimal important difference (MID) has been defined as \"the minimal change in score","text_display":"\n\nThe minimal important difference (MID) has been defined as \"the minimal change in score","confidence":1,"confidence_rate":1},{"cnt":[[283,777],[1807,777],[1807,825],[283,825]],"region":{"top_left_x":283,"top_left_y":776,"width":1524,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c899045a2f074732ac625e08b4940ff6","type":"text","conversion_output":true,"text":"which clinicians consider to be clinically important and which would mandate, in the absence","text_display":" which clinicians consider to be clinically important and which would mandate, in the absence","confidence":1,"confidence_rate":1},{"cnt":[[283,827],[1777,827],[1777,870],[283,870]],"region":{"top_left_x":283,"top_left_y":826,"width":1495,"height":45},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fcc618945a04123afb57f7701bf7157","type":"text","conversion_output":true,"text":"of troublesome side effects and undue cost, a change in the patient's management\". For the","text_display":" of troublesome side effects and undue cost, a change in the patient's management\". For the","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[283,873],[1597,873],[1597,921],[283,921]],"region":{"top_left_x":283,"top_left_y":872,"width":1314,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"481eae675b644ec3b3b9df8d0e04d5d5","type":"text","conversion_output":true,"text":"ACQ, it has been estimated to be a change in score of 0.5 (Juniper et al \\(2005 / 2\\) ).","text_display":" ACQ, it has been estimated to be a change in score of 0.5 (Juniper et al \\(2005 / 2\\) ).","confidence":0.9655606163384989,"confidence_rate":0.9996232280205307},{"cnt":[[283,959],[1812,959],[1812,1007],[283,1007]],"region":{"top_left_x":283,"top_left_y":959,"width":1529,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8053cd5287e04a0daa3261ae3f925243","type":"text","conversion_output":true,"text":"Baseline is defined as the ACQ-5 assessment at Visit 3. In case of a missing value the Visit 2","text_display":"\n\nBaseline is defined as the ACQ-5 assessment at Visit 3. In case of a missing value the Visit 2","confidence":1,"confidence_rate":1},{"cnt":[[283,1007],[717,1007],[717,1049],[283,1049]],"region":{"top_left_x":283,"top_left_y":1007,"width":435,"height":42},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7ddbb1ba1a64429a993765c39983ccc","type":"text","conversion_output":true,"text":"value will be used instead.","text_display":" value will be used instead.","confidence":1,"confidence_rate":1},{"cnt":[[283,1096],[1176,1096],[1176,1142],[283,1142]],"region":{"top_left_x":283,"top_left_y":1096,"width":894,"height":47},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94f165f8aef24a6994f937ae08e8fbb0","type":"text","conversion_output":true,"text":"Based on MID the following variables will be derived:","text_display":"\n\nBased on MID the following variables will be derived:","confidence":0.99755859375,"confidence_rate":0.999957856209768},{"cnt":[[283,1183],[1323,1183],[1323,1231],[283,1231]],"region":{"top_left_x":283,"top_left_y":1183,"width":1040,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0fd6322eb1ed4a6f8604b11c107d0a98","type":"text","conversion_output":true,"text":"- Patients improved (end of treatment - baseline) \\(\\leq-0.5\\)","text_display":"\n- Patients improved (end of treatment - baseline) \\(\\leq-0.5\\)","confidence":0.99609375,"confidence_rate":0.999933664923639},{"cnt":[[283,1275],[1537,1275],[1537,1325],[283,1325]],"region":{"top_left_x":283,"top_left_y":1274,"width":1255,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f93174fb4cf9476cbddf0409f2ede58a","type":"text","conversion_output":true,"text":"- Patients unchanged (end of treatment - baseline) within (-0.5; 0.5)","text_display":"\n- Patients unchanged (end of treatment - baseline) within (-0.5; 0.5)","confidence":0.8992156786365513,"confidence_rate":0.9985654574576376},{"cnt":[[283,1366],[1323,1366],[1323,1414],[283,1414]],"region":{"top_left_x":283,"top_left_y":1366,"width":1040,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0070697cd6054d828b07de994c8b4f66","type":"text","conversion_output":true,"text":"- Patients worsened (end of treatment - baseline) \\(\\geq 0.5\\).","text_display":"\n- Patients worsened (end of treatment - baseline) \\(\\geq 0.5\\).","confidence":0.7369446754455566,"confidence_rate":0.9952419422034323},{"cnt":[[283,1453],[1505,1453],[1505,1501],[283,1501]],"region":{"top_left_x":283,"top_left_y":1452,"width":1223,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6f68ac6774146caa10df7d810318b4f","type":"text","conversion_output":true,"text":"In addition, an asthma control variable based on ACQ-5 will be derived as:","text_display":"\n\nIn addition, an asthma control variable based on ACQ-5 will be derived as:","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[283,1542],[1738,1542],[1738,1592],[283,1592]],"region":{"top_left_x":283,"top_left_y":1541,"width":1456,"height":52},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d435189f296042e785be4f6414f659d6","type":"text","conversion_output":true,"text":"- If the ACQ-5 value at the last visit (or last available value) is less than 0.75 the","text_display":"\n- If the ACQ-5 value at the last visit (or last available value) is less than 0.75 the","confidence":1,"confidence_rate":1},{"cnt":[[448,1590],[1661,1590],[1661,1638],[448,1638]],"region":{"top_left_x":447,"top_left_y":1589,"width":1214,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c4b417f9022548fbad5ea1bbe2b0dd2b","type":"text","conversion_output":true,"text":"patient would be considered to be 'in control'. 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Domain scores as well as the","text_display":" higher values indicating better health-related quality of life. Domain scores as well as the","confidence":1,"confidence_rate":1},{"cnt":[[283,1841],[1812,1841],[1812,1887],[283,1887]],"region":{"top_left_x":283,"top_left_y":1841,"width":1529,"height":46},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cb1a0a44bdce4abe991fa1e20622ffe4","type":"text","conversion_output":true,"text":"overall scores are calculated from the unweighted arithmetic means of the individual question","text_display":" overall scores are calculated from the unweighted arithmetic means of the individual question","confidence":1,"confidence_rate":1},{"cnt":[[283,1887],[1786,1887],[1786,1935],[283,1935]],"region":{"top_left_x":283,"top_left_y":1886,"width":1504,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"250ba61572b7482cba2998deed14b212","type":"text","conversion_output":true,"text":"scores. 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Symbicort vs Pulmicort plus terbutaline (non-inferiority)}","confidence":1,"confidence_rate":1},{"cnt":[[283,2129],[1350,2129],[1350,2172],[283,2172]],"region":{"top_left_x":283,"top_left_y":2129,"width":1068,"height":44},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31ad1ff85c564cd583385741c367bfcb","type":"text","conversion_output":true,"text":"Formally, the null and alternative hypothesis for comparison 1 is:","text_display":"\n\nFormally, the null and alternative hypothesis for comparison 1 is:","confidence":1,"confidence_rate":1},{"cnt":[[448,2211],[1190,2211],[1190,2353],[448,2353]],"region":{"top_left_x":447,"top_left_y":2211,"width":744,"height":142},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3bc54b31cea04358a92c1660c7dcdc26","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& H_{0}: \\text { odds-ratio }(\\text { Symbicort vs terbutaline })=1 \\\\\n& H_{A}: \\text { odds-ratio }(\\text { Symbicort vs terbutaline }) \\neq 1\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& H_{0}: \\text { odds-ratio }(\\text { Symbicort vs terbutaline })=1 \\\\\n& H_{A}: \\text { odds-ratio }(\\text { Symbicort vs terbutaline }) \\neq 1\n\\end{aligned}\n\\]","confidence":0.9970734105447718,"confidence_rate":0.9999784496418309},{"cnt":[[283,2389],[1816,2389],[1816,2437],[283,2437]],"region":{"top_left_x":283,"top_left_y":2389,"width":1534,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2c0b5312fd2465995d846809f45b3c8","type":"text","conversion_output":true,"text":"Hence, the odds of a well-controlled asthma week on Symbicort must be greater than the odds","text_display":"\n\nHence, the odds of a well-controlled asthma week on Symbicort must be greater than the odds","confidence":0.994140625,"confidence_rate":0.9999387872018195},{"cnt":[[283,2440],[1565,2440],[1565,2483],[283,2483]],"region":{"top_left_x":283,"top_left_y":2439,"width":1282,"height":45},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b3314ace82b4e6fb822275b88f97bd3","type":"text","conversion_output":true,"text":"of a well-controlled asthma week on terbutaline in order to declare superiority.","text_display":" of a well-controlled asthma week on terbutaline in order to declare superiority.","confidence":1,"confidence_rate":1},{"cnt":[[1001,2632],[1108,2632],[1108,2675],[1001,2675]],"region":{"top_left_x":1000,"top_left_y":2631,"width":108,"height":45},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b2185840ca304d8f867fb64168c26601","type":"page_info","conversion_output":false,"text":"62(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-63","page":63,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":19,"is_printed":true,"is_handwritten":false,"id":"429cd0159d844878b46aba5699ade214","type":"page_info","conversion_output":false,"text":"Revised Clinical Study 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2016","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999651063356614},{"cnt":[[283,503],[656,503],[656,551],[283,551]],"region":{"top_left_x":283,"top_left_y":502,"width":373,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fbbfc0a44a5b44a4814c228ac5238bc9","type":"text","conversion_output":true,"text":"And for comparison 2:","text_display":"\n\nAnd for comparison 2:","confidence":1,"confidence_rate":1},{"cnt":[[452,589],[1677,589],[1677,637],[452,637]],"region":{"top_left_x":452,"top_left_y":589,"width":1225,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6f2c2630d1a408eb7d636726ab43e96","type":"text","conversion_output":true,"text":"\\(H _{0}\\) : lower 95\\% confidence limit of odds-ratio (Symbicort vs Pulmicort plus","text_display":"\n\\(H _{0}\\) : lower 95\\% confidence limit of odds-ratio (Symbicort vs Pulmicort plus","confidence":0.9883134365081787,"confidence_rate":0.9998664249660758},{"cnt":[[448,635],[729,635],[729,683],[448,683]],"region":{"top_left_x":447,"top_left_y":635,"width":282,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5dd7ca0aafd479895ed4f1815184f8e","type":"text","conversion_output":true,"text":"terbutaline) \\(<0.8\\)","text_display":" terbutaline) \\(<0.8\\)","confidence":0.9990234375,"confidence_rate":0.999953475384788},{"cnt":[[450,724],[1684,724],[1684,772],[450,772]],"region":{"top_left_x":450,"top_left_y":724,"width":1234,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ecb624de4624890b1c863c94434b615","type":"text","conversion_output":true,"text":"\\(H _{ A }\\) : lower 95\\% confidence limit of odds-ratio (Symbicort vs Pulmicort plus","text_display":"\n\\(H _{ A }\\) : lower 95\\% confidence limit of odds-ratio (Symbicort vs Pulmicort 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a","confidence":1,"confidence_rate":1},{"cnt":[[283,907],[1802,907],[1802,955],[283,955]],"region":{"top_left_x":283,"top_left_y":906,"width":1520,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36c69875312342de9e6cfc2f26524e92","type":"text","conversion_output":true,"text":"well-controlled asthma week on Pulmicort plus terbutaline in order to declare non-inferiority.","text_display":" well-controlled asthma week on Pulmicort plus terbutaline in order to declare non-inferiority.","confidence":1,"confidence_rate":1},{"cnt":[[283,955],[1748,955],[1748,1003],[283,1003]],"region":{"top_left_x":283,"top_left_y":954,"width":1465,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3615e1ba8d1423a93e7d453009e4747","type":"text","conversion_output":true,"text":"The selection of 0.8 of the non-inferiority margin is detailed in section 8.2 of the protocol.","text_display":" The selection of 0.8 of the non-inferiority margin is detailed in section 8.2 of the protocol.","confidence":1,"confidence_rate":1},{"cnt":[[283,1042],[1816,1042],[1816,1090],[283,1090]],"region":{"top_left_x":283,"top_left_y":1041,"width":1534,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c44e8c6a2ff345b79ebc6bc14fbac9fb","type":"text","conversion_output":true,"text":"The two hypotheses will be tested sequentially. If the comparison 1 fails, no formal statistical","text_display":"\n\nThe two hypotheses will be tested sequentially. If the comparison 1 fails, no formal statistical","confidence":1,"confidence_rate":1},{"cnt":[[283,1092],[957,1092],[957,1135],[283,1135]],"region":{"top_left_x":283,"top_left_y":1091,"width":675,"height":45},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c38a30eba184c658a38f7aa04206d35","type":"text","conversion_output":true,"text":"inference will be made for comparison 2 .","text_display":" inference will be made for comparison 2 .","confidence":0.689453125,"confidence_rate":0.9924398135160635},{"cnt":[[283,1179],[1775,1179],[1775,1227],[283,1227]],"region":{"top_left_x":283,"top_left_y":1178,"width":1492,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19a1e6e4e0dd4b54873a6a0ba39cda91","type":"text","conversion_output":true,"text":"An important consideration when interpreting the results of the comparison of Symbicort to","text_display":"\n\nAn important consideration when interpreting the results of the comparison of Symbicort to","confidence":1,"confidence_rate":1},{"cnt":[[283,1224],[1812,1224],[1812,1272],[283,1272]],"region":{"top_left_x":283,"top_left_y":1224,"width":1529,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6d152b6ee8a43788273054f2e4130d8","type":"text","conversion_output":true,"text":"Pulmicort plus terbutaline is the extent to which the primary endpoint is driven by 'as needed'","text_display":" Pulmicort plus terbutaline is the extent to which the primary endpoint is driven by 'as needed'","confidence":1,"confidence_rate":1},{"cnt":[[283,1272],[1633,1272],[1633,1318],[283,1318]],"region":{"top_left_x":283,"top_left_y":1272,"width":1351,"height":47},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"df729faf4a674cc8aa989961d6bb9f86","type":"text","conversion_output":true,"text":"medication use. 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The aim is to look for","text_display":" endpoint and thoroughly describing the pattern of as needed use. The aim is to look for","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[283,1649],[1690,1649],[1690,1697],[283,1697]],"region":{"top_left_x":283,"top_left_y":1649,"width":1408,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"babc67bdf26f4b2889ccb1b399677d9f","type":"text","conversion_output":true,"text":"consistency of the treatment effect, across the analyses and secondary endpoints to aid","text_display":" consistency of the treatment effect, across the analyses and secondary endpoints to aid","confidence":1,"confidence_rate":1},{"cnt":[[283,1695],[1409,1695],[1409,1743],[283,1743]],"region":{"top_left_x":283,"top_left_y":1695,"width":1127,"height":48},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78a77e76c4cb4cb68b766c4260111b17","type":"text","conversion_output":true,"text":"interpretation. More details of the analyses will be given in the SAP.","text_display":" interpretation. 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Sensitivity","text_display":" possible, if the data are indeterminate then the week will be recorded as missing. 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Symbicort vs Pulmicort plus terbutaline","confidence":1,"confidence_rate":1},{"cnt":[[283,2344],[1748,2344],[1748,2392],[283,2392]],"region":{"top_left_x":283,"top_left_y":2343,"width":1465,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"570e72c765644abf8412e5bd1d01581e","type":"text","conversion_output":true,"text":"The two hypotheses will be tested sequentially for each secondary endpoint if the primary","text_display":"\n\nThe two hypotheses will be tested sequentially for each secondary endpoint if the primary","confidence":1,"confidence_rate":1},{"cnt":[[283,2389],[1798,2389],[1798,2437],[283,2437]],"region":{"top_left_x":283,"top_left_y":2389,"width":1515,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67d56eaf548f439c8631bef26008fc5b","type":"text","conversion_output":true,"text":"endpoint is significant. If the comparison 1 fails, no formal statistical inference will be made","text_display":" endpoint is significant. If the comparison 1 fails, no formal statistical inference will be made","confidence":1,"confidence_rate":1},{"cnt":[[283,2440],[573,2440],[573,2488],[283,2488]],"region":{"top_left_x":283,"top_left_y":2439,"width":291,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3033f03d0dcb4c439c05a4930a395c36","type":"text","conversion_output":true,"text":"for comparison 2.","text_display":" for comparison 2.","confidence":1,"confidence_rate":1},{"cnt":[[998,2632],[1112,2632],[1112,2680],[998,2680]],"region":{"top_left_x":998,"top_left_y":2631,"width":115,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"36ab358fd83a475cbfe4e05ca9b17a09","type":"page_info","conversion_output":false,"text":"63(73)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2067,"languages_detected":[]},{"image_id":"46e4dcef-a77a-457d-a53c-90d9754e1878-64","page":64,"lines":[{"cnt":[[283,249],[637,249],[637,281],[283,281]],"region":{"top_left_x":283,"top_left_y":248,"width":355,"height":33},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cea6cf2684484f57a9c4f27ac12951ce","type":"page_info","conversion_output":false,"text":"Revised Clinical Study Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,279],[715,279],[715,313],[283,313]],"region":{"top_left_x":283,"top_left_y":278,"width":433,"height":35},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"06ab15a438d7491887c7ca1bbb5d02f4","type":"page_info","conversion_output":false,"text":"Drug Substance budesonide/formoterol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,311],[583,311],[583,345],[283,345]],"region":{"top_left_x":283,"top_left_y":310,"width":300,"height":35},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"3aa24cdae5e14196b14b9eff0c723eaf","type":"page_info","conversion_output":false,"text":"Study Code D589SC00001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,343],[487,343],[487,372],[283,372]],"region":{"top_left_x":283,"top_left_y":342,"width":204,"height":31},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"01b210eb456f4ed59155db6df53570da","type":"page_info","conversion_output":false,"text":"Edition Number 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[555,375],[555,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":273,"height":31},"line":5,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"836e502cfbff484996622518c54e5102","type":"page_info","conversion_output":false,"text":"Date 22 December 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,416],[1798,416],[1798,459],[283,459]],"region":{"top_left_x":283,"top_left_y":415,"width":1515,"height":45},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8200cad6d0a24f1a9dcaa8f2925525b1","type":"text","conversion_output":true,"text":"Exacerbations: The number of moderate-to-severe and severe asthma exacerbations will be","text_display":"\n\nExacerbations: The number of moderate-to-severe and severe asthma exacerbations will be","confidence":1,"confidence_rate":1},{"cnt":[[283,461],[1821,461],[1821,509],[283,509]],"region":{"top_left_x":283,"top_left_y":461,"width":1538,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0ac7ab178f141e5b3262228a9e1076b","type":"text","conversion_output":true,"text":"analysed by a negative binomial regression model. The response variable in the model will be","text_display":" analysed by a negative binomial regression model. The response variable in the model will be","confidence":1,"confidence_rate":1},{"cnt":[[283,507],[1674,507],[1674,553],[283,553]],"region":{"top_left_x":283,"top_left_y":507,"width":1392,"height":46},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c77730f6df6143948f77151e753a4a68","type":"text","conversion_output":true,"text":"the number of moderate-to-severe and severe asthma exacerbations over the 52-week","text_display":" the number of moderate-to-severe and severe asthma exacerbations over the 52-week","confidence":0.73681640625,"confidence_rate":0.9964549436329937},{"cnt":[[283,557],[1738,557],[1738,605],[283,605]],"region":{"top_left_x":283,"top_left_y":557,"width":1456,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"79f17d0fdae24383be098303ecf74d39","type":"text","conversion_output":true,"text":"treatment period, respectively. The model will include covariates of treatment, pre-study","text_display":" treatment period, respectively. The model will include covariates of treatment, pre-study","confidence":1,"confidence_rate":1},{"cnt":[[283,603],[1812,603],[1812,651],[283,651]],"region":{"top_left_x":283,"top_left_y":603,"width":1529,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f392ce1464ac4ddd9df8521cf4833dc3","type":"text","conversion_output":true,"text":"treatment and region as factors. The logarithm of the follow-up time will be used as an offset","text_display":" treatment and region as factors. The logarithm of the follow-up time will be used as an offset","confidence":1,"confidence_rate":1},{"cnt":[[283,651],[1697,651],[1697,697],[283,697]],"region":{"top_left_x":283,"top_left_y":651,"width":1415,"height":46},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55c00e00e80f4a9981fb9e10165a57de","type":"text","conversion_output":true,"text":"variable. From the negative binomial model the annual moderate-to-severe and severe","text_display":" variable. From the negative binomial model the annual moderate-to-severe and severe","confidence":1,"confidence_rate":1},{"cnt":[[283,699],[1789,699],[1789,747],[283,747]],"region":{"top_left_x":283,"top_left_y":699,"width":1506,"height":48},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48e4d78a5bb6405a9208a621b34c7c22","type":"text","conversion_output":true,"text":"exacerbation rates will be estimated and treatments effects will be expressed as the rate ratio","text_display":" exacerbation rates will be estimated and treatments effects will be expressed as the rate ratio","confidence":1,"confidence_rate":1},{"cnt":[[283,745],[1183,745],[1183,793],[283,793]],"region":{"top_left_x":283,"top_left_y":744,"width":901,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a3e9a240078f4b7890e036d7589fd0b9","type":"text","conversion_output":true,"text":"along with its corresponding 95\\% confidence intervals.","text_display":" along with its corresponding 95\\% confidence intervals.","confidence":0.99853515625,"confidence_rate":0.9999751542462456},{"cnt":[[283,832],[1814,832],[1814,879],[283,879]],"region":{"top_left_x":283,"top_left_y":831,"width":1531,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"173d56120b48418d801ca027c9a9c98a","type":"text","conversion_output":true,"text":"Time to first moderate-to-severe and time to first severe asthma exacerbation will be analysed","text_display":"\n\nTime to first moderate-to-severe and time to first severe asthma exacerbation will be analysed","confidence":1,"confidence_rate":1},{"cnt":[[283,882],[1702,882],[1702,930],[283,930]],"region":{"top_left_x":283,"top_left_y":881,"width":1419,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d7689f911be34ad09a75ca44180ab1c8","type":"text","conversion_output":true,"text":"by a Cox proportional hazards model with treatment, pre-study treatment and region as","text_display":" by a Cox proportional hazards model with treatment, pre-study treatment and region as","confidence":1,"confidence_rate":1},{"cnt":[[283,927],[1750,927],[1750,975],[283,975]],"region":{"top_left_x":283,"top_left_y":927,"width":1467,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bd30f384d95844e6939a4c87157c7648","type":"text","conversion_output":true,"text":"factors. The hazard ratio and its corresponding 95\\% confidence interval will be estimated","text_display":" factors. 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The hazard ratio and its corresponding \\(95 \\%\\) confidence interval will be","text_display":" region as factors. 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by analysis of","confidence":1,"confidence_rate":1},{"cnt":[[283,1563],[1720,1563],[1720,1610],[283,1610]],"region":{"top_left_x":283,"top_left_y":1562,"width":1438,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac51e075be8f49fd9b9af30d90838f75","type":"text","conversion_output":true,"text":"covariance (ANCOVA) with treatment, pre-study treatment group and region as factors.","text_display":" covariance (ANCOVA) with treatment, pre-study treatment group and region as factors.","confidence":1,"confidence_rate":1},{"cnt":[[283,1608],[1638,1608],[1638,1658],[283,1658]],"region":{"top_left_x":283,"top_left_y":1608,"width":1355,"height":51},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f8cd8dbbf8e486886ea138ef2abd9dd","type":"text","conversion_output":true,"text":"Least squared means by treatment and differences in least squared means (between","text_display":" Least squared means by treatment and 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asthma","text_display":"\n\nDiscontinuation due to asthma related events: Time to study discontinuation due to asthma","confidence":0.998046875,"confidence_rate":0.9999792019733479},{"cnt":[[283,1791],[1793,1791],[1793,1839],[283,1839]],"region":{"top_left_x":283,"top_left_y":1790,"width":1511,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd7d1e7f920d4169a8c8ce641c6b7221","type":"text","conversion_output":true,"text":"related events will be analysed by Cox proportional hazards model with treatment, pre-study","text_display":" related events will be analysed by Cox proportional hazards model with treatment, 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The hazard ratio and its corresponding 95\\% confidence","text_display":" treatment and region as factors. 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Baseline \\(FEV _{1}\\) (Visit 3) will be included as covariate. Visit will be","text_display":" and treatment*visit. Baseline \\(FEV _{1}\\) (Visit 3) will be included as covariate. Visit will be","confidence":0.9084870163351297,"confidence_rate":0.999103442497886},{"cnt":[[283,2161],[1729,2161],[1729,2211],[283,2211]],"region":{"top_left_x":283,"top_left_y":2161,"width":1447,"height":51},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ddc9e141c684a15a41187b1f35865fd","type":"text","conversion_output":true,"text":"fitted as a categorical variable, and the variance-covariance matrix will be assumed to be","text_display":" fitted as a categorical variable, and the variance-covariance matrix will be assumed to be","confidence":1,"confidence_rate":1},{"cnt":[[283,2211],[1720,2211],[1720,2259],[283,2259]],"region":{"top_left_x":283,"top_left_y":2211,"width":1438,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8f508407c2f4bb49e638626b1d7570c","type":"text","conversion_output":true,"text":"unstructured. 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After this initial round of interviews,","confidence":1,"confidence_rate":1},{"cnt":[[283,1896],[1702,1896],[1702,1942],[283,1942]],"region":{"top_left_x":283,"top_left_y":1896,"width":1419,"height":46},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"076f0dac103d4f1fabec7b0b7c60a506","type":"text","conversion_output":true,"text":"an evaluation of saturation will be performed. If saturation is not achieved then further","text_display":" an evaluation of saturation will be performed. 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1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,375],[541,375],[541,404],[283,404]],"region":{"top_left_x":283,"top_left_y":374,"width":259,"height":31},"line":5,"column":0,"font_size":19,"is_printed":true,"is_handwritten":false,"id":"b6b4563fec5b4e048c1060e38e5e2d33","type":"page_info","conversion_output":false,"text":"Date 24 February 2016","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[283,503],[1615,503],[1615,551],[283,551]],"region":{"top_left_x":283,"top_left_y":502,"width":1333,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64a9d6cfb03d4e38b46dcdee0fa72d33","type":"text","conversion_output":true,"text":"Recruitment will be monitored across study sites to prevent clustering around key","text_display":"\n\nRecruitment will be monitored across study sites to prevent clustering around 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Therefore, other variables such as type of pre-study treatment status (previously","text_display":" included. Therefore, other variables such as type of pre-study treatment status (previously","confidence":1,"confidence_rate":1},{"cnt":[[283,644],[1807,644],[1807,690],[283,690]],"region":{"top_left_x":283,"top_left_y":644,"width":1524,"height":46},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6aeba9019e504ecfa387db7846718a08","type":"text","conversion_output":true,"text":"treated with inhaled short-acting bronchodilator(s) (SABA and/or short acting anticholinergic","text_display":" treated with inhaled short-acting bronchodilator(s) (SABA and/or short acting anticholinergic","confidence":1,"confidence_rate":1},{"cnt":[[283,690],[1825,690],[1825,738],[283,738]],"region":{"top_left_x":283,"top_left_y":689,"width":1543,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d175476b491c4c7da3c07980f6f916a2","type":"text","conversion_output":true,"text":"agent) only and previously treated with additional low dose ICS/LTRA) and amount of time in","text_display":" agent) only and previously treated with additional low dose ICS/LTRA) and amount of time in","confidence":1,"confidence_rate":1},{"cnt":[[283,740],[1821,740],[1821,788],[283,788]],"region":{"top_left_x":283,"top_left_y":740,"width":1538,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0c1251fd8989458ebbad197ffbc019e2","type":"text","conversion_output":true,"text":"study (e.g. 3-5 months; 6-8 months; 9-11 months) will be asked when the patient is enrolled in","text_display":" study (e.g. 3-5 months; 6-8 months; 9-11 months) will be asked when the patient is enrolled in","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[283,786],[1706,786],[1706,834],[283,834]],"region":{"top_left_x":283,"top_left_y":785,"width":1424,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65363f23e0484588aee0a08dd03ab5ab","type":"text","conversion_output":true,"text":"the interview study in order to ensure there is at least some of each group present in the","text_display":" the interview study in order to ensure there is at least some of each group present in the","confidence":1,"confidence_rate":1},{"cnt":[[283,834],[1775,834],[1775,879],[283,879]],"region":{"top_left_x":283,"top_left_y":833,"width":1492,"height":47},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2bac979dc7a548cab7925df2db8f9e35","type":"text","conversion_output":true,"text":"sample. 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A copy of the signed Informed Consent Form is","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[283,1928],[1720,1928],[1720,1976],[283,1976]],"region":{"top_left_x":283,"top_left_y":1928,"width":1438,"height":48},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d5b3cfe14934303a630289133e09eb1","type":"text","conversion_output":true,"text":"to be provided to the patient and/or their guardian/legal representative. The investigator","text_display":" to be provided to the patient and/or their guardian/legal representative. The investigator","confidence":1,"confidence_rate":1},{"cnt":[[283,1976],[1743,1976],[1743,2022],[283,2022]],"region":{"top_left_x":283,"top_left_y":1975,"width":1460,"height":47},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"49f8ec9e4510407292e2154c576faa4f","type":"text","conversion_output":true,"text":"should ensure the patient is notified they are free to discontinue from the sub-study at any","text_display":" should ensure the patient is notified they are free to discontinue from the sub-study at any","confidence":1,"confidence_rate":1},{"cnt":[[283,2024],[372,2024],[372,2063],[283,2063]],"region":{"top_left_x":283,"top_left_y":2023,"width":90,"height":40},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4dfa3896269c44ab87d39597261aca1f","type":"text","conversion_output":true,"text":"time.","text_display":" time.","confidence":1,"confidence_rate":1},{"cnt":[[283,2111],[1777,2111],[1777,2159],[283,2159]],"region":{"top_left_x":283,"top_left_y":2110,"width":1495,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ba0e2e86faf43e4ad1c2be85aff4eaa","type":"text","conversion_output":true,"text":"This appendix detailing the sub-study along with the Informed Consent Form and Interview","text_display":"\n\nThis appendix detailing the sub-study along with the Informed Consent Form and Interview","confidence":1,"confidence_rate":1},{"cnt":[[283,2156],[1752,2156],[1752,2204],[283,2204]],"region":{"top_left_x":283,"top_left_y":2156,"width":1470,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eae372f8c39c4fc5893be5ecebe2dbf0","type":"text","conversion_output":true,"text":"Guide should be approved by an Ethics Committee and the national Regulatory Authority,","text_display":" Guide should be approved by an Ethics Committee and the national Regulatory Authority,","confidence":1,"confidence_rate":1},{"cnt":[[283,2207],[1720,2207],[1720,2250],[283,2250]],"region":{"top_left_x":283,"top_left_y":2206,"width":1438,"height":45},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"409a74f8f2014ee69c7de51ba198fb4f","type":"text","conversion_output":true,"text":"including the final version of the separate Informed Consent Form and any other written","text_display":" including the final version of the separate Informed Consent Form and any other written","confidence":1,"confidence_rate":1},{"cnt":[[283,2252],[1798,2252],[1798,2300],[283,2300]],"region":{"top_left_x":283,"top_left_y":2252,"width":1515,"height":49},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dcd584240f1a48f483034facb480ff7c","type":"text","conversion_output":true,"text":"information and/or materials to be provided to the patients. AstraZeneca should approve any","text_display":" information and/or materials to be provided to the patients. 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